Safety
Enforcement Report for June 6, 2012
As part of FDA's efforts to increase the transparency of its compliance and enforcement data, FDA will soon be introducing a very different Enforcement Report format aiming to deliver a simpler, clearer report that encourages data download and analyses while also providing savings and encouraging future innovation for Government. Instead of the narrative report you see now, you will find a data-driven report encouraging innovative stakeholders to extract more intelligence out of the data and providing FDA a baseline as it moves forward in its efforts to integrate the Agency's compliance and enforcement data.
We expect to publish the new report mid-June. This will not be the first and only iteration of the report. We want your feedback - the good, the bad, and the ugly. So please be on the lookout for the new report and e-mail us at webmail@oc.fda.gov with your comments.
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
PRODUCT
Natural pistachios packaged in 4 oz. bags, UPC 076056 09460. Recall # F-1267-2012
CODE
Date code 08361
RECALLING FIRM/MANUFACTURER
Fritz Company, Inc., Newport, MN, by e-mail on April 1, 2009. FDA initiated recall is complete.
REASON
The product was manufactured using pistachios recalled by Setton Pistachio Company of Terra Bella because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
MN, WI, IA, MO, ND, SD, MT
PRODUCT
1) Great Skott Foods Marathon Mix (14 oz.) UPC 7452670055 Great Skott Foods Marathon Mix Tubs (28 oz.) UPC 7452670553 Great Skott Foods Marathon Mix Deli (9 oz) UPC 7452670770 Great Skott Foods Marathon Mix Bulk (case) (no UPC), packaged in bags, tubs, deli containers or 20# bulk cases. Recall # F-1268-2012;
2) Great Skott Foods Super Energy Mix (14 oz.) UPC 7452670058; Great Skott Foods Super Energy Mix Deli (9 oz.) UPC 7452670771; Great Skott Foods Super Energy Mix Tubs (28 oz.) UPC 7452670540; Great Skott Foods Super Energy Mix Bulk (case) (no UPC), packaged in bags, tubs, deli containers or 20# Bulk case. Recall # F-1269-2012;
3) Great Skott Foods Diet Delight Mix (12 oz.) UPC 7452670062, packaged in either bags, tubs or deli containers. Recall # F-1270-2012;
4) Great Skott Foods All Natural Mix (12 oz.) UPC 7452670060, packaged in either bags, tubs or deli containers. Recall # F-1271-2012;
5) Great Skott Foods Oriental Mix 10 oz. UPC 7452670082; Great Skott Foods Oriental Mix Tubs 15 oz. UPC 7452670507, packaged in either bags, tubs or deli containers. Recall # F-1272-2012;
6) Great Skott Foods Beer Mix, 8 oz. UPC 7452670086, 17 oz. UPC 7452670504, packaged in bags, tubs or deli containers. Recall # F-1273-2012
7) Great Skott Foods Plantation Mix 14 oz. UPC 7452670051 packaged in bags, tubs or deli containers. Recall # F-1274-2012;
8) Great Skott Foods Cranberry Crunch (12 oz.) UPC 7452670331 packaged in bags, tubs or deli containers. Recall # F-1275-2012
CODE
Best By: All Dates prior to 1/31/20/10
RECALLING FIRM/MANUFACTURER
Great Skott Foods, Inc., West Allis, WI, by telephone on February 2, 2009. FDA initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
114,065 units
DISTRIBUTION
CT, IL, MA, MN, WI
PRODUCT
Sendik's Food Markets repackaged Pistachios Roasted & Salted, or Sendik's Food Markets repackaged roasted shelled pistachios, approximately 8 oz. or 16 oz., in clear, plastic, clamshell-type containers, UPCs beginning with 2-03030-, 2-03310-, 2-03311-, 2-00431-, 2-00190-. Recall # F-1276-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Sendik'S Food Market-Greenfiel, Milwaukee, WI, by telephone on April 7, 2010. FDA initiated recall is complete.
REASON
The product was manufactured using pistachios recalled by Setton Pistachio Company of Terra Bella because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
WI
PRODUCT
1) Crispy Pistachio Cookies, 400g, UPC 6 27265 00601 3. Recall # F-1311-2012;
2) Crispy Almond Cookies, UPC 6 27265 00120 9. Recall # F-1312-2012;
3) Crispy Coconut Cookies 400g, UPC 6 27265 00121 6. Recall # F-1313-2012;
4) Crispy Almond Cake Rusk 750 g, UPC 6 27265 00217 6. Recall # F-1314-2012
CODE
All lot codes.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fahman Enterprises, Inc., Garland, TX, by press release on April 5, 2012.
Manufacturer: Twi Foods Inc., Mississauga, Ontario, Canada. FDA initiated recall is ongoing.
REASON
The product was recalled due to undeclared milk or almonds.
VOLUME OF PRODUCT IN COMMERCE
73 cases
DISTRIBUTION
TX, AR, OK
PRODUCT
Galactooligosaccharides (GOS); a highly pure food grade galactooligosaccharide powder derived from milk lactose; This product is intended for food use only; Net Weight 20 kg (44.1 lbs) plastic bags; Product code 113001-156. Recall # F-1315-2012
CODE
Lot numbers: 0000117369, 0000117370 and 0000117371
RECALLING FIRM/MANUFACTURER
Recalling Firm: Corn Products International, Inc., Westchester, IL, by telephone on May 10, 2012 and on May 15-16, 2012.
Manufacturer: Corn Products Korea, Inc. Icheon-City, Korea, Republic Of (South). Firm initiated recall is ongoing.
REASON
The Purimune was found to be contaminated with Salmonella bacteria.
VOLUME OF PRODUCT IN COMMERCE
17,983.5 kg
DISTRIBUTION
AZ, CA, NB, NJ, PA, UT, VT, WA, Canada, Czech Republic, New Zealand and the United Kingdom
PRODUCT
Honeyville Honey Barbecue Dipping and Grill Sauce; Net Wt. 15 oz; UPC 0-3880171212-9. Recall # F-1316-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Culhane, Inc., Durango, CO, by press release May 22, 2012. Firm initiated recall is ongoing.
REASON
The firm's products including Honeyville Honey Barbecue Dipping and Grill Sauce and Handlebars BBQ Sauce do not include anchovies as a sub ingredient in the barbecue sauce ingredient statements. The anchovies are contained in the Worcestershire sauce used to manufacture the products.
VOLUME OF PRODUCT IN COMMERCE
1857 x 15 oz units
DISTRIBUTION
Nationwide
PRODUCT
1) Natural Tropic China (Orange) 5% Jugo Natural (Natural Juice) 1/2 gal and 1 gal Jonlly Fruits. Recall # F-1317-2012;
2) Natural Tropic China Zanahoria (Orange Carrot) 5% Jugo Natural (Natural Juice) 1/2 and 1 gal. Recall # F-1318-2012;
3) Natural Tropic Fruit Punch 5% Jugo Natural (Natural Juice) 1/2 gal Jonlly Fruits. Recall # F-1319-2012;
4) Natural Tropic Acerola (Wild Cherry) 5% Jugo Natural (Natural Juice) 1 gal and 1/2 gal. Recall # F-1320-2012;
5) Natural Tropic Guava Pina (Guava-Pineapple) 5% Jugo Natural (Natural Juice) 1/2 gal Jonlly Fruits. Recall #F-1321-2012;
6) Natural Tropic Mandarina (Mandarin) 5% Jugo Natural (Natural Juice) 1 gal Jonlly Fruits. Recall # F-1322-2012;
7) Jonlly Fruits China Zanahoria (Orange Carrot). Recall # F-1323-2012;
8) Jonlly Fruits Guava Pina (Guava Pineapple). Recall # F-1324-2012;
9) Jonlly Fruits Mandarina (Mandarin), 6% Jugo Natural (Natural Juice), 1 gal. Recall # F-1325-2012;
10) Jonlly Light China (Orange) 32% Jugo Natural (Natural Juice) 1gal, 1/2 gal (64 oz).
Recall # F-1326-2012;
11) Jonlly Gold Guanabana (Soursop), 1/2 gal (64 oz), 13% Jugo Natural (Natural Juice). Recall # F-1327-2012
CODE
All codes from APR 01 12 to AUG 03 12.
RECALLING FIRM/MANUFACTURER
Jonlly Fruits, Inc., Bayamon, PR, by letter dated April 4, 2012. FDA initiated recall is ongoing.
REASON
Undeclared allergens. The firm uses as an ingredient a cloud stabilizer containing the following undeclared sub-ingredients: sodium caseinate, coconut oil and soy lecithin.
VOLUME OF PRODUCT IN COMMERCE
116, 962 units
DISTRIBUTION
PR
PRODUCT
FunFresh Foods World Berry Organic Cacao Nibs 6 oz packaged in blue, brown, red, white, black and green packaging with red, black, yellow, white, and green print writing. The packaging is resealable. Recall # F-1328-2012
CODE
Lot number 161104 with use by date 4/2014.
RECALLING FIRM/MANUFACTURER
Recalling Firm: FunFresh Foods Inc., Ogden, UT, by telephone on May 4, 2012 and press release and electronically on May 5, 2012.
Manufacturer: Nutraceutical Corporation 3C, Ogden, UT. Firm initiated recall is ongoing.
REASON
FunFresh Foods World Berry Cacao Nibs 6 oz snack food possibly contaminated with pathogenic bacteria.
VOLUME OF PRODUCT IN COMMERCE
500 units
DISTRIBUTION
Nationwide
PRODUCT
1) Yellowfin Tuna AAA Strips, Individually Vacuum Packed Ingredients Frozen Tuna and Carbon Monoxide, Net Wt. 22 lbs (10 kgs). Recall # F-1331-2012;
2) Yellowfin Tuna AA Strips, Individually Vacuum Packed Ingredients Frozen Tuna and Carbon, Net Wt. 22 lbs (10 kgs).Recall # F-1330-2012
CODE
All lots
RECALLING FIRM/MANUFACTURER
Moon Fishery India Pvt Ltd, Cochin, India, by press release and letters on May 9, 2012. FDA initiated recall is ongoing.
REASON
Tuna Strips have the potential to be contaminated with Salmonella. FDA testing found Salmonella in an undistributed lot of tuna strips.
VOLUME OF PRODUCT IN COMMERCE
227 cases (22 lbs per case)
DISTRIBUTION
GA, MA, NJ and NY
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
PRODUCT
EX-EL Brand Hot Mixed Pickles packed in one (1) quart size glass jars and/or one (1) gallon size glass or plastic jars. The label reads: Contains: Cucumbers Cauliflower, Onions, Olives, Peppers, Vinegar, Spice Flavor, Alum, and Tumeric, Less than 1/10o1 1% Ben. of Soda. Recall # F-1266-2012
CODE
Manufactured from 4/25/2011 to 04/25/2012
RECALLING FIRM/MANUFACTURER
AJ Linz Sons, Inc., Cincinatti, OH, by letters on May 11, 2012. FDA initiated recall is ongoing.
REASON
The product contains undeclared sulfiting agents.
VOLUME OF PRODUCT IN COMMERCE
47 cases (564 x 1-quart jars) and 26 cases (104 x gal jars)
DISTRIBUTION
OH
PRODUCT
1) DO-CREST 60, dough strengthener, packaged in 50-lb poly-lined cartons, item # 124680. Recall # F-1277-2012;
2) ARCO YEAST FOOD, dough strengthener, packaged in 50-lb paper bags, item # 124667. Recall # F-1278-2012;
3) TALIANO, Acidulants for Speciality Breads, item # 124703, packaged in 50-lb paper bags. Recall # F-1279-2012;
4) SUTTER'S MILL SOUR DOUGH BASE, dry concentrated Sour Plus Salt and Malt, item # 125314, packaged in 50-lb poly-lined cartons. Recall # F-1280-2012;
5) EMPIRE NB, Bromate Free No-Time Dough Conditioner, item # 125423, packaged in 50-lb poly-lined cartons. Recall # F-1281-2012;
6) C M ENZYME, item # 126025, packaged in 50-lb poly-lined cartons. Recall # F-1282-2012;
7) BAKE-SOFT 989, item # 125477, packaged in 50-lb poly-lined cartons. Recall # F-1283-2012;
8) BAKE-SOFT 951, item # 125903, packaged in 50-lb poly-lined cartons. Recall # F-1284-2012;
9) ALL FREEZE 12, item # 126253, packaged in 50-lb paper bags. Recall # F-1285-2012;
10) PROTASE, item # 126290, packaged in 50-lb paper bags. Recall # F-1286-2012;
11) BAKE-SOFT 877, Softener and Shelf Life Extender, item # 126371, packaged in 50-lb poly-lines cartons. Recall # F-1287-2012;
12) SOY FREE NATURAL, Dough Conditioner, item # 126414, packaged in 50-lb paper bags. Recall # F-1288-2012;
13) BAKE-SOFT 197, Enzyme Crumb Softener and Shelf Life Extender, item # 126551, packaged in 50-lb poly-lined cartons. Recall # F-1289-2012;
14) SK BAGEL BASE, item # 129164, packaged in 37-lb poly-lined cartons, Recall # F-1290-2012;
15) IMPERIAL F.D., Dough Conditioner for Yeast Raised Frozen Products, item # 129348, packaged in 50-lb poly-lined cartons. Recall # F-1291-2012;
16) KKD #38016, Yeast Food and Brew Buffer, item # 129422, packaged in paper bags. Recall # F-1292-2012;
17) SYNERGY, Shelf-Life extender for donuts and sweet goods, item # 129468, packaged in paper bags. Recall # F-1293-2012;
18) CAKE DOUGHNUT STABILIZER, item # 129518, packaged in paper bags.Recall # F-1294-2012;
19) ROTELLA 1, Dough Improver, item # 133147, packaged in poly-lined cartons. Recall # F-1295-2012;
20) SUBWAY 1, item # 133150, packaged in poly-lined cartons. Recall # F-1296-2012;
21) BIG '49ER SOUR BREAD BASE, item # 133233, packaged in poly-lined cartons. Recall # F-1297-2012;
22) EINSTEIN BROS. BAGEL BASE, Concentrate for Bagels, item # 133679, packaged in poly-lined cartons. Recall # F-1298-2012;
23) Oakrun Farms EM 1.45, item # 134236 packaged in poly-lined cartons. Recall # F-1299-2012;
24) SFWY Bagel Base 8, item # 134366, packaged in poly-lined cartons. Recall # F-1300-2012;
25) JB's Bun Blend No Soy Flour, item # 134889, packaged in poly-lined cartons. Recall # F-1301-2012;
26) Flowers Tortilla Batch Pack, item # 135260, packaged in poly-lined cartons. Recall # F-1302-2012;
27) CB Bake-Soft 170 Trillium, item # 135542, packaged in poly-lined cartons. Recall # F-1303-2012;
28) CB Maturox Trillium, item # 135621, packaged in poly-lined cartons. Recall # F-1304-2012;
29) CB AA Trillium, item # 135623, packaged in poly-lined cartons. Recall # F-1305-2012;
30) Bake-Soft 197P, item # 135754, packaged in poly-lined carton. Recall # F-1306-2012
CODE
1) Lots: 1200400689, 1200602759, 1201600211;
2) Lot: 1200400747;
3) Lot: 1200500421;
4) Lot: 1200602915;
5) Lot: 1200500365;
6) Lot: 1201291557;
7) Lot: 1202400412;
8) Lots: 1200600461, 1201700371;
9) Lot: 1200300494;
10) Lot: 1200300488;
11) Lot: 1201200963;
12) Lot: 1200400713;
13) Lot: 1200602901, 1201300456, 12023003379;
14) Lot: 1201700298;
15) Lot 1200300499, 1202600691
16) Lot 1201300440;
17) Lot: 1200500461;
18) Lot: 1200500439;
19) Lot: 1201100581;
20) Lot: 1200400778, 1201600250;
21) Lots: 1136400079, 1200602919;
22) Lots: 1200300465, 1202300355;
23) Lot: 1200600370;
24) Lot: 1201000659;
25) Lot: 1202402133;
26) Lot: 1200500372;
27) Lot 120030053, 1202300362;
28) Lot 1200400772;
29) Lot: 1200400768;
30) Lot 1200602908
RECALLING FIRM/MANUFACTURER
Recalling Firm: Caravan Ingredients, Lenexa, KA, by letter via e-mail and by telephone on February 8, 2012.
Manufacturer: Caravan Ingredients, Kansas City, KA. Firm initiated recall is ongoing.
REASON
Pieces of stainless steel screen have been found in some of the product.
VOLUME OF PRODUCT IN COMMERCE
1,569/50-lb bags; 12,264/50-lb cartons; 36/37-lb cartons; 2,389/40-lb cartons; 696/55-lb cartons; 594/60-lb cartons
DISTRIBUTION
Nationwide and Canada
PRODUCT
Cooked Lobster Claw and Knuckle: Fresh Knuckle 2#, Claw Trays, Fancy Claw 6X2#. Recall # F-1307-2012
CODE
Lot 03412A (11 cases), Lot 03912B (29 cases)
RECALLING FIRM/MANUFACTURER
Portland Shellfish Co., Inc., Portland, ME, by email dated April 11, 2012. FDA initiated recall is complete.
REASON
Firm did not adhere to Consent Decree and manufactured 2 lots of cooked lobster claw and knuckle meat without adhering to environmental Listeria testing program for lobster.
VOLUME OF PRODUCT IN COMMERCE
40 cases
DISTRIBUTION
Unknown
PRODUCT
Yellowfin/Ahi tuna steaks, 6 oz, sold in 10 pound cardboard carton (from Vietnam), with a white label affixed to the carton labeled in part, "***S.F.C. TUNA YF STK 6 oz VP 1/10#***(SKU number) (01) 0 0000000 00000 0 (3202) 1000*** Net Wt: 10.00***PACK DATE 03/20/12***SUPC # 8824399***”. Recall # F-1329-2012
CODE
Lot Number (sticker on case): 970392
RECALLING FIRM/MANUFACTURER
Recalling Firm: Northstar Seafoods, Inc., Airway Heights, WA, by telephone and letter on April 18, 2012.
Manufacturer: Great Ocean Choice LTD, Co., Nha Trang, Vietnam. FDA initiated recall is complete.
REASON
Ahi Tuna Loin Steaks were found to have above 50 ppm of Histamine and organoleptic test found the product was decomposed.
VOLUME OF PRODUCT IN COMMERCE
40 cases
DISTRIBUTION
ID, WA, OR
PRODUCT
Suave Professionals Keratin Infusion 30 Day Smoothing Kit Unilever Trumbull. CT 06611. Actual Kit UPC 7940019562 Modular Display Unit Description and Case UPC : Suave SA Keratin Smoothing Kit 8PC PDQ 10079400228786 Suave Mixed Keratin 17 PC PDQ 10079400233025 Suave Keratin Kit 12PC Wing 10079400240221 SV SH CD Kit Keratin 12PC 15 Inch PDQ 10079400241372 Suave SH/CD/SA Keratin 258PC Bin 10079400244359 SV MB Naturals/Keratin 670 PC Pallet 10079400245790 Standard Case: SV Smoothing Kit (ATG) 12 1ct 10079700195620. Recall # F-1332-2012
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Unilever United States, Inc., Englewood Cliffs, NJ, by letters dated May 8, 2012.
Manufacturer: Les Emballages Knowlton Inc., Knowlton, Canada. Firm initiated recall is ongoing.
REASON
Unilever has received numerous consumer complaints related to undesired hair treatment outcomes and potential consumer misunderstanding for Suave Professionals Keratin Infusion 30 Day Smoothing Kit.
VOLUME OF PRODUCT IN COMMERCE
381,288 Kits
DISTRIBUTION
Nationwide
PRODUCT
1) lPenne Rigate Farro Pasta, Net Wt. 1.10 lb. (500 g) paper bags; UPC 8 52885 00308 5. Recall # F-1333-2012;
2) Casarecce Farro Pasta, Net Wt. 1.10 lb. (500 g) paper bags; Product of Italy; UPC 8 52885 00309 2. Recall # F-1334-2012
CODE
1) Lot 36, best before date 02/22/13;
2) Lot 35, best before date 02/22/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Faithful to Foods Inc., Chicago, IL, by e-mails on May 18, 2012 and May 21, 2012, and by letters dated May 22, 2010.
Manufacturer: Pastificio oleificio Iannini SRL unipersonale, Monteprandone,
Italy. FDA initiated recall is ongoing.
REASON
The pastas contain wheat flour which is only declared as farro medio in the ingredients statement, with no allergen statement
VOLUME OF PRODUCT IN COMMERCE
1) 368 bags; 2) 354 bags
DISTRIBUTION
CA, IL, MD, NY and WI
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
PRODUCT
1) Chocolate spread. Belge brand milk chocolate and cappuccino spread. The labeing reads in part: "Belge***milk chocolate and cappuccino spread*** Prodcuct of Belgium***Net Wt 7 oz (200g)***Nutrition Facts Serving Size 1 cup (20g)***"; UPC 8 91114 33307 4. Recall # F-1308-2012;
2) Chocolate spread. Belge brand dark chocolate with cocoa nibs spread. The labeing reads in part:"Belge***dark chocolate with cocoa nibs spread***Prodcuct of Belgium***Net Wt 7 oz (200g) ***Nutrition Facts Serving Size 1 cup (20g) ***": UPC 8 -1114 33407 1. Recall # F-1309-2012;
3) Chocolate spread. Belge brand milk chocolate and strawberry spread. The labeing reads in part:"Belge***milk chocolate and strawberry spread***Prodcuct of Belgium***Net Wt 7 oz (200g) ***Nutrition Facts Serving Size 1 cup (20g) ***"; UPC 8 -1114 33207 7. Recall # F-1310-2012
CODE
Code information pending.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aim Trading Corp., Los Angeles, CA, by telephone, fax, and email on April 26, 2012.
Manufacturer: Natra All Crump NV, Oost Malle, Belgium. Firm initiated recall is ongoing.
REASON
Products are recalled because the serving size of the nutrition facts incorrectly lists "1 cup", instead of the correct "2 tbsp".
VOLUME OF PRODUCT IN COMMERCE
2,457 cases
DISTRIBUTION
Unknown
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
RECALLS PENDING CLASSIFICATION: DRUGS
PRODUCT
HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged 10-count Carpujects per carton, NDC 0409-1283-31
CODE
Lot #07547LL, Exp 07/01/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL
Manufacturer: Hospira Inc., McPherson, KS
REASON FOR RECALL
Superpotent (Single Ingredient) Drug: The prefilled cartridge units have the potential to be overfilled and may contain more than the 1 mL labeled fill volume.
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
PRODUCT
Alprazolam Extended-release Tablets, USP, 2mg, 60 count bottle, Rx Only, NDC 0378-5023-91. Recall # D-1361-2012
CODE
Lot No. 3029082
RECALLING FIRM/MANUFACTURER
Mylan Pharmaceuticals Inc., Morgantown, WV, by letter on April 3, 2012. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Test Requirements: Routine stability testing for Alprazolam XR tablets yielded out of specification dissolution results.
VOLUME OF PRODUCT IN COMMERCE
20,921 bottles
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
PRODUCT
Duragesic 25 mcg/h (Fentanyl Transdermal System), One (25 mcg/h) System (patch), CII, Rx only, NDC 50458-091-05. Recall # D-1357-2012
CODE
Lot 1103836P1; Exp, 03/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho-McNeil-Janssen Pharmaceuticals, Inc., Titusville, NJ, by letter beginning April 19, 2012,
Manufacturer: Alza Corp., Vacaville, CA. Firm initiated recall is ongoing.
REASON
Crystallization: One lot of Duragesic 25 mcg/h (fentanyl transdermal system) exhibited white spots, which were determined to be small fentanyl crystals.
VOLUME OF PRODUCT IN COMMERCE
53, 640 patches
DISTRIBUTION
Nationwide
PRODUCT
1) Methylin Chewable Tablets (methylphenidate HCl) 2.5 mg, 100 count bottle, Rx only, NDC 59630-760-10. Recall # D-1358-2012;
2) Methylin Chewable Tablets (methylphenidate HCl) 5 mg, 100 count bottle, Rx only NDC 59630-761-10. Recall # D-1359-2012;
3) Methylin Chewable Tablets (methylphenidate HCl) 10 mg, 100 count bottle, Rx only, NDC 59630-762-10. Recall # D-1360-2012
CODE
1) Lot # AMT21102A;
2) Lot # AMT51101A; AMT51102A;
3) Lot # AMTIOI lOlA; AMTIOII02A
RECALLING FIRM/MANUFACTURER
Mallinckrodt Inc., Hobart, NY, by letters on March 15, 2012. Firm initiated recall is ongoing.
REASON
Stability Data does not Support Expiration Date: Covidien Mallinckrodt Inc. is conducting a voluntary recall of Methylin Chewable Tablets because of failed stability testing.
VOLUME OF PRODUCT IN COMMERCE
7,380 100-ct bottles
DISTRIBUTION
Nationwide
PRODUCT
1) Ropinirole Hydrochloride Tablets, 3 mg, 500 tablets per Bottle, Rx only, NDC 60429-797-05. Recall D-1363-2012;
2) Ropinirole Hydrochloride Tablets, 4 mg, 500 tablets per Bottle, Rx only, NDC 60429-798-05. Recall # D-1364-2012;
3) Ropinirole Hydrochloride Tablets, 5 mg, 500 tablets per Bottle, Rx only, NDC 60429-799-05. Recall # D-1365-2012
CODE
1) Lot # 102797A, Exp. 11/11; 103538A, 103538B, 103538C, Exp 01/12;
2) Lot # 103255A, 103255B, Exp.12/11;
3) Lot # 102799A, 102799B, 102799C, 102799D, Exp 11/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Golden State Medical Supply Inc., Camarillo, CA, by letter on April 28, 2011.
Manufacturer: Corepharma LLC, Middlesex, NJ. Firm initiated recall is ongoing.
REASON
Labeling: Incorrect or Missing Package Insert. Recall due to discrepancy with package outsert.
VOLUME OF PRODUCT IN COMMERCE
148 bottles
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
PRODUCT
1) Plasma Frozen within 24 hours (FP24). Recall # B-1402-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1403-12
CODE
1) and 2) Unit: W125611201975
RECALLING FIRM/MANUFACTURER
Blood Bank Of San Bernardino And Riverside Counties, San Bernardino, CA, by letter on February 17, 2012. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1404-12
CODE
Unit: W036511087625
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by letter on March 13, 2012. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1405-12
CODE
Unit: W045011088505
RECALLING FIRM/MANUFACTURER
Community Blood Cntr Of Greater Kansas City, Kansas City, MO, by facsimile on March 6, 2012. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KS
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1439-12
CODE
Recall # W117011502849R
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific - Irwin Center, San Francisco, CA, by facsimile and telephone on March 15, 2012.
Blood Centers of the Pacific - Santa Rosa Center, Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1446-12;
2) Platelets Leukocytes Reduced. Recall # B-1447-12
CODE
1) and 2) Unit: 2969537
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by letter dated January 29, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to malarial endemic areas, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY, OH
PRODUCT
Source Plasma. Recall # B-1448-12
CODE
Units: 0300109400, 0300108943, 0300108438, 0300108286, 0300107788, 0300107313, 0300106853, 0300105774, 0300105604, 0300105154, 0300104619, 0300104408, 0300103859, 0300103096, 0300103000, 0300102389, 0300102178, 0300101740, 0300101535, 0300101013, 0300100796, 0300099343, 0300099234, 0300098671, 0300098503, 0300098133, 0300097736, 0300094532, 0300094133, 0300093509, 0300093056, 0300092774, 0300092395, 0300092193, 0300091763, 0300091183, 0300091024, 0300090501
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Reno, NV, by fax on December 29, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
38 units
DISTRIBUTION
Spain
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1449-12
CODE
Unit: 2803749
RECALLING FIRM/MANUFACTURER
Northern California Community Blood Bank, Eureka, CA, by facsimile on January 16, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1450-12
CODE
Unit: 6060356
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone on January 9, 2006 and letter on January 30, 2006.
Manufacturer: Blood Centers of the Pacific, Fairfield, CA. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
Red Blood Cells. Recall # B-1451-12
CODE
Unit: T32752
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone on February 12, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1452-12
CODE
Unit: R23149
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone on February 5, 2007 and a follow-up letter on March 16, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1453-12
CODE
Unit: W036911251819
RECALLING FIRM/MANUFACTURER
Blood Bank Of Delmarva, Inc., Newark, DE, by letter dated April 3, 2012. Firm initiated recall is complete.
REASON
Blood product, with a high platelet yield, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
DE
PRODUCT
1) Recovered Plasma. Recall # B-1454-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1455-12
CODE
1) and 2) Unit: 21N39862
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by electronic notification or facsimile on February 22, 2012. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OR, CA
PRODUCT
Fresh Frozen Plasma. Recall # B-1456-12
CODE
Unit: W227710404910
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by facsimile on March 22, 2012. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall #B-1457-12
CODE
Unit: 13KE12895
RECALLING FIRM/MANUFACTURER
American National Red Cross Southeastern Michigan Region, Detroit, MI, by telephone and facsimile on February 14, 2012. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1458-12
CODE
Unit: 013LK33113 (2 units)
RECALLING FIRM/MANUFACTURER
American National Red Cross Southeastern Michigan Region, Detroit, MI, by facsimile on March 14, 2012. Firm initiated recall is complete.
REASON
Blood products, which were not quarantined after receiving post donation information concerning an illness following donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
PRODUCT
Source Plasma. Recall # B-1459-12
CODE
Units: 3750137556, 3750137116
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Killeen, TX, by letter dated April 3, 2012. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who may not have had a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
PRODUCT
1) Red Blood Cells. Recall # B-1460-12;
2) Fresh Frozen Plasma. Recall # B-1461-12;
3) Red Blood Cells Leukocytes Reduced. Recall # B-1462-12;
4) Cryoprecipitated AHF. Recall # B-1463-12
CODE
1) Unit: K17318
2) Units: S94728, K09330;
3) Units: K03856, K00109, K09330;
4) Unit: K03856
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone on August 17, 2007 and follow-up letter dated September 7, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
CA
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall #B-1465-12
CODE
Unit: 84LP51120
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by letter on August 27, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
Recovered Plasma. Recall # B-1477-12
CODE
Unit: W088411552400
RECALLING FIRM/MANUFACTURER
Blood Bank Of Hawaii, Honolulu, HI, by e-mail on March 13, 2012. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1478-12;
2) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1479-12;
3) Platelets Pheresis Leukocytes Reduced. Recall # B-1480-12
CODE
1) Units: W0470116539820; W0470116539820; W0470116448270; W0470116448510; W0470116539730; W0470116539080;
2) Units: W0470116538020; W0470116539730; W0470116538840; W0470116538840; W0470116539820; W0470116448320; W0470116448320; W0470116537980; W0470116448630; W0470116448400; W0470116448630; W0470116448710; W0470116539080; W0470120202710; W0470116537890; W0470116448580; W0470120202710; W0470116538190; W0470116538190; W0470116448330; W0470116448330; W0470116448530; W0470116448530; W0470116538070; W0470116538500; W0470116448180; W0470120202990; W0470116539900; W0470116538410; W0470116539900;
3) Units: W0470116448710; W0470116538020; W0470116539080; W0470116539440; W0470116539730; W0470116538410; W0470116538070; W0470116448180; W0470116448270; W0470116448400; W0470116538500; W0470116448510; W0470116448270; W0470116538020; W0470116448180; W0470116448710; W0470120202990; W0470116448580; W0470116537980; W0470116537890; W0470116537980
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., Long Island City, NY, by fax on February 28, 2012. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
57 units
DISTRIBUTION
NY
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1481-12
CODE
Units: 27KP35714; 27LK45995; 27T19586; 27FX74136
RECALLING FIRM/MANUFACTURER
American Red Cross Greater Alleghenies Region, Johnstown, PA, by teleohone on February 2, 2012 and letter dated February 14, 2012. Firm initiated recall is complete.
REASON
Blood products, collected from donors who reported travel to an area potentially endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
PA, WV
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1482-12;
2) Fresh Frozen Plasma. Recall # B-1483-12
CODE
1) and 2) Unit: W036811274620
RECALLING FIRM/MANUFACTURER
Community Blood Centers of Florida, Inc., Lauderhill, FL, by telephone and follow up letter on April 2, 2012. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, NY
PRODUCT
1) Red Blood Cells. Recall # B-1484-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1486-12
CODE
1) Unit: W036811260073;
2) Unit: W036809120752
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Hialeah, FL, by telephone and letter on April 9, 2012. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland, FL
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1489-12
CODE
Unit: 3121727
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by letter dated November 30, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH, Switzerland
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1490-12;
2) Platelets Leukocytes Reduced Irradiated. Recall # B-1491-12
CODE
1) and 2) Unit: 2803529
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center University of Cincinnati Medical Center, Cincinnati, OH, by letter dated August 9, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH, KY
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1495-12
CODE
Unit: 1623291
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center University of Cincinnati Medical Center, Cincinnati, OH, by letter dated September 12, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
PRODUCT
1) Red Blood Cells. Recall # B-1496-12;
2) Fresh Frozen Plasma (Apheresis). Recall # B-1497-12;
3) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1498-12
CODE
1) Unit: 1282399;
2) Units: 1295105 (Part A); 1295105 (Part B);
3) Units: 1293565; 1292514
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by letter dated November 17, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
OH
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1501-12
CODE
Unit: W1151121185278
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by fax on April 2, 2012.
Manufacturer: LifeSouth Community Blood Center, Inc., Gainesville, GA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1502-12
CODE
Unit: W066512700679
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK,
by telephone on March 22, 2012. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but exceeded the White Blood Cell count limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AK
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1503-12
CODE
Unit: W0352113635462
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter on April 4, 2012. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled as negative for the Kell red cell antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
PRODUCT
Platelets Pooled Leukocytes Reduced Irradiated. Recall # B-1504-12
CODE
Unit: W037912889935
RECALLING FIRM/MANUFACTURER
LifeServe Blood Center, Des Moines, IA, by telephone on March 19, 2012. Firm initiated recall is complete.
REASON
Blood product, collected from donors, whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IA
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1505-12
CODE
Unit: W042011040019W
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Lafayette, LA, by telephone on March 22, 2012. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1506-12;
2) Recovered Plasma: Recall # B-1507-12
CODE
1) and 2) Unit: W0898211413027
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Inova Blood Donor Services, Sterling, VA, by facsimile and letter dated on March 13, 2012. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA, IN
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1508-12;
2) Red Blood Cells. Recall # B-1509-12;
3) Platelets Pooled Leukocytes Reduced. Recall # B-1510-12;
4) Platelets Pheresis Leukocytes Reduced. Recall # B-1511-12
CODE
1) Units: W036812361652; W036812361666; W036812361656;
2) Unit: W036812358847;
3) Units: W036812831625; W036812831586; W036812831570; W036812831569; W036812831555; W036812831680; W036812831666; W036812831595; W036812831549; W036812831618; W036812831625; W036812831643; W036812831651; W036812358953;
4) Units: W036812361660; W036812361662; W036812361663; W036812361654; W036812361671; W036812361670; W036812361661; W036812361647; W036812361664; W036812361655; W036812361666; W036812361650
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Hialeah, FL, by telephone on February 22, 2012. Firm initiated recall is complete.
REASON
Blood products, collected from donors, during a French speaking blood drive that had incorrect donor health questions were distributed.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
MI, FL, NY
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall #B-1464-12
CODE
Units: 6054313; 6054313; 6054317; 6054317; 6054332; 6054332; 6054341; 6054341
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco. CA, by telephone on January 13, 2006.
Manufacturer: Blood Centers of the Pacific, Fairfield, CA. Firm initiated recall is complete.
REASON
Blood products, collected without documentation and review of the Quality Control results for the instrument used in blood collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
CA
PRODUCT
Recovered Plasma, Recall # B-1466-12
CODE
Unit: 84LP51120
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by letter on August 27, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
PRODUCT
Recovered Plasma. Recall # B-1485-12
CODE
Units: W036811260073; W036809120752
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Hialeah, FL, by telephone and letter on April 9, 2012. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland, FL
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1499-12;
2) Platelets Leukocytes Reduced. Recall # B-1500-12
CODE
1) and 2) Unit: 1692522
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center University of Cincinnati Medical Center, Cincinnati, OH, by letter dated July 26, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a high body temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH, KY
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1512-12;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-1513-12
CODE
1) Units: W038111345385; W038111345385;
2) Units: W038111345389; W038111345378; W038111345377; W038111345377; W038111345378; W038111345380; W038111345381; W038111345390; W038111345390
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida's Blood Centers, Inc., Orlando, FL, by letter dated March 6, 2012.
Manufacturer: Florida's Blood Centers, Inc., Ocala, FL. Firm initiated recall is complete.
REASON
Blood products, which were stored at an unacceptable temperature range, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
FL
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS I
PRODUCT
Abacus TPN Calculating Software Product Usage: LIMS Windows-based program for order entry and TPN calculation. Catalogue Numbers: 8300-0045: Abacus Calculator Only (Abacus CE) 8300-0046: Abacus Single Work Station (Abacus SE) 8300-0047: Abacus Multi-Work Station (Abacus ME). Recall # Z-1436-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Baxa Corp., Englewood, CO, by letter dated January 19, 2009. Firm initiated recall is ongoing.
REASON
Ordering salt-based ingredients on an ion-based template resulted in medication errors when calculating amounts of ingredients required.
VOLUME OF PRODUCT IN COMMERCE
670 units
DISTRIBUTION
Nationwide, Canada, China, Australia, Panama and Columbia
PRODUCT
1) Other-Sonic Generic Ultrasound Transmission Gel 250 mL Hypoallergenic Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body. Recall # Z-1652-2012;
2) Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body. Recall # Z-1653-2012
CODE
1) and 2) Units: 060111, 080111, 090111, 100811
RECALLING FIRM/MANUFACTURER
Pharmaceutical Innovations, Inc., Newark, NJ, by letter dated March 02, 2012 with a followup letter dated March 9, 2012 and an Inventory Withdrawal letter dated March 23, 2012 via email and fax. Firm initiated recall is ongoing.
REASON
Recall due to possible microbial contamination.
VOLUME OF PRODUCT IN COMMERCE
40,164 units
DISTRIBUTION
Nationwide, Canada and Australia
PRODUCT
1) Non-DEHP Microbore Administration Set with Non-Vented Spike Packaged Assembly, product code: 340-4114, Method of Sterilization using Ethylene Oxide. The Curlin� Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1659-2012;
2) Non-DEHP Microbore Administrative Set with Female Luer Adapter Packaged Assembly, product code: 340-4115, Method of Sterilization using Ethylene Oxide. The Curlin� Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1660-2012;
3) Epidural Admin Set with Non-Vented Bag Spike and 0.2 Micron Filter Package Assembly, product code: 340-4126, Method of Sterilization using Ethylene Oxide. The Curlin� Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1661-2012;
4) Non-DEHP Admin Set with Non-Vented Spike and 1.2 Micron Filter Packaged Assembly, product code: 340-4128, Method of Sterilization using Ethylene Oxide. The Curlin� Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1662-2012;
5) Non-DEHP Admin Set with Non-Vented Spike and 1.2 Micron Filter Packaged Assembly, product code: 340-4128-V, Method of Sterilization using Ethylene Oxide. The Curlin� Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1663-2012;
6) Non-DEHP Admin Set with Non-Vented Spike and 0.2 Micron Filter Packaged Assembly, product code: 340-4130, Method of Sterilization using Ethylene Oxide. The Curlin� Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1664-2012;
7) Non-DEHP Admin Set with Non-Vented Spike and 0.2 Micron Filter Packaged Assembly, product code: 340-4130-V, Method of Sterilization using Ethylene Oxide. The Curlin� Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1665-2012;
8) Non-DEHP Microbore Admin Set with Female Male Luer Locks and Y-Site with Check Valve Packaged Assembly, product code: 340-4137, Method of Sterilization using Ethylene Oxide. The Curlin� Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1666-2012;
9) Non-DEHP Epidural Yellow Striped Tubing Admin Set with Vented Vial Spike and 0.2 Micron Filter Packaged Assembly, product code: 340-4144, Method of Sterilization using Ethylene Oxide. The Curlin� Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1667-2012;
10) Non-DEHP Epidural Admin Set with 0.2 Micron Filter Non-Vented Bag Spike ASV Packaged, product code: 340-4165, Method of Sterilization using Ethylene Oxide. Recall # Z-1668-2012;
11) Non-DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged, product code: 340-4166, Method of Sterilization using Ethylene Oxide. The Curlin� Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1669-2012;
12) Non-DEHP Admin Set Non-Vented Spike and 1.2 Micron Filter ASV Packaged Assembly, product code: 340-4173, Method of Sterilization using Ethylene Oxide. The Curlin� Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1670-2012;
13) Non-DEHP Microbore Admin Set with Non-Vented Spike and Needleless Injection Port Positive Pressure Package Assembly, product code: 340-4133, Method of Sterilization using Ethylene Oxide. The Curlin� Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1671-2012;
14) Non-DEHP Microbore Administrative Set with Female Luer Adapter Packaged Assembly, product code: 340-4176, Method of Sterilization using Ethylene Oxide. The Curlin� Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1672-2012
CODE
1) Lot #: CF1127990, CF1131190, CF1131191, CF1200290, CF1200291, CF1200292, CF1200490, CF1200491, CF1201890, CF1202592, CF1204092, CF1204093, CF1205492, CF1205493, CF1205990, CF1206890, CF1206891;
2) Lot #: CF1203390;
3) Lot #: CF1130190, CF1200492, CF1200493, CF1202590, CF1202591, CF1206090, CF1206091;
4) Lot #: CF1127991, CF1130690, CF1130691, CF1132290, CF1132291, CF1133490, CF1134390, CF1134391, CF1134392, CF1134393, CF1134990, CF1135490, CF1135491, CF1135492, CF1201891, CF1201892, CF1209091;
5) Lot #: CF1203391, CF1203392, CF1204091, CF1206092, CF1207590, CF1207591;
6) Lot #: CF1130693, CF1133491, CF1200293, CF1200294, CF1200494, CF1201190, CF1205490;
7) Lot #: CF1127992, CF1201191, CF1201192, CF1204690, CF1204691, CF1205491, CF1206893, CF1208091, CF1208092;
8) Lot #: CF1208090;
9) Lot #: CF1130692, CF1207593;
10) Lot #: CF1201893;
11) Lot #: CF1207592;
12) Lot #: CF1204692;
13) Lot #: CF1129990;
14) Lot #: CF1204090
RECALLING FIRM/MANUFACTURER
Recalling Firm: MOOG Medical Devices Group, Salt Lake City, UT, by letter and a press release dated May 21, 2012.
Manufacturer: Moog Medical Devices Group, Srl, Alajuela, Costa Rica. Firm initiated recall is ongoing.
REASON
Moog Medical Device Group became aware via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
VOLUME OF PRODUCT IN COMMERCE
409,300 sets
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
PRODUCT
50 Portal Vein Cannula REF 61.110.10.030 Size: Fr 10 Length: 12 Inches LL Connector NON STERILE. For use in humans. No indication of use is on the label. However, the device can be used for infusion. Recall # Z-1625-2012
CODE
Lot 120493
RECALLING FIRM/MANUFACTURER
Meddev USA, Inc., Dallas, TX, by telephone on May 10, 2012. Firm initiated recall is ongoing.
REASON
The device was marketed without a 510(k) and is not sterile.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
Nationwide
PRODUCT
The ECHELON 60 Endoscopic Linear Cutter - Straight, compact ECHELON 60 Endoscopic Linear Cutter - Straight, and the Long ECHELON 60 Endoscopic Linear Cutter - Straight are sterile, single patient use instruments that deliver staples while simultaneously dividing tissue between rows. a) Model # EC60; b) Model # LONG60; c) Model # SC60. ECHELON 60 instruments with white, blue, gold, and green reloads deliver two triple-staggered rows of staples. The instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. Sterile products are individually packed in a transparent tray sealed with Tyvek�. Each tray is placed in an individual carton. 3 individual cartons are placed in a corrugated shipper. The ECHELON 60 Endoscopic Linear Cutter Straight, Compact ECHELON 60 Endoscopic Linear Cutter Straight, and the Long ECHELON 60 Endoscopic Linear Cutter Straight are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. Recall # Z-1627-2012
CODE
a) H44T06, J4A56P, J4A67X, H44T6E, J4A650, J4A762, J4A49A, J4A65N, J4A766, J4A49G, J4A677, J4A76F, J4A567, J4A67D, J4A76L, J4A56F, J4A67H, J4A771; b) lots: H44R8A , H44U3R , H44X17 , J4A55E , J4A64A; c) lots:H44R6C, J4A777, J4A58D, J4A77F, J4A58N, J4A78Y, J4A58P
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethicon Endo-Surgery Inc., Cincinnati, OH, by letter dated March 19, 2012.
Manufacturer: Ethicon Endo-surgery, Inc. S.a. De C.v., Cd. Juarez, Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON
There is a possibility of a component breakage, which may cause the device to stay locked on tissue after firing. If the component exhibits this issue, the device does not open either with the anvil release button or with the manual firing release lever.
VOLUME OF PRODUCT IN COMMERCE
3,120 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up. Recall # Z-1644-2012
CODE
Versions 4.30.00, 4.31.00, 4.32.00, 4.33.00, 4.33.01, 4.33.02, 4.34.00, 4.34.01, 4.34.02, 4.40.00, 4.40.04, 4.40.05, 4.41.00, 4.41.01, 4.41.02, 4.42.00, 4.43.00, 4.44.01, 4.44.02, 4.44.03, 4.44.04, 4.45.00, 4.46.00, 4.46.01, 4.47.00, 4.50.00, 4.50.01, 4.50.02, 4.50.03, 4.50.04, 4.51.00, 4.51.01, 4.51.02, 4.60.00, 4.60.01, 4.61.00, 4.62.00, 4.62.01, 4.62.02, 4.62.03, 4.62.04, 4.62.05, 4.62.06, 4.63.00, and 4.64.00
RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letter the week of April 30, 2012. Firm initiated recall is on going.
REASON
XiO will underestimate the dose delivered when the closed leaf gap is set to 0mm on XiO and a value other than 0mm is set on the accelerator.
VOLUME OF PRODUCT IN COMMERCE
1,652 sites
DISTRIBUTION
Nationwide and Canada
PRODUCT
1) Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: "***Part Number CP40012***12mm Drill Bit***" "***Part Number CP40014***14mm Drill Bit***”. The Captiva Spine SmartLOX Cervical Plate System is intended for the anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Recall #Z-1648-2012;
2) Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: a) "***Part Number CP50150*** Single Barrel Variable Drill Guide"; b) “***Part Number CP50160*** Single Barrel Fixed Drill Guide; c) “*** Part Number CP50170***Double Barrel Fixed Drill Guide***". Products are packaged individually and shipped as replacement parts to be placed in the SmartLOX Cervical Plate System tray. The Captiva Spine SmartLOX Cervical Plate System is intended for the anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Recall # Z-1649-2012
CODE
1) Lot Numbers: 89427-2 R & 89427-3-R;
2) a) Lot Numbers: 1500705A, 06110041; b) 1500707A, 06110043; c) 1500708A, and 06110044
RECALLING FIRM/MANUFACTURER
Captiva Spine, Inc., Jupiter, FL, by letter on November 23, 2011. Firm initiated recall is ongoing.
REASON
There is a potential risk for the drills to not properly fit through the drill guides due to an overlap in the dimensional tolerance of these parts and the drills were not properly hardened.
VOLUME OF PRODUCT IN COMMERCE
101 units
DISTRIBUTION
Nationwide
PRODUCT
ECMO Heaters Model 333W, 115V - Part #86135, and 230V & 240V - Part #86136, Cardiopulmonary by-pass temperature controllers. The ECMO Heaters are used in conjunction with a heat exchanger to warm the fluid temperature. The device is composed of a heater, a circulating pump, fan, safety high limit, and a microprocessor board. Water is heated and pumped from the unit to the heat exchanger. The device can be set so that the operator can monitor the actual water temperature or, with the use of a 400 series probe, the fluid (external) temperature. This device is intended to provide temperature-controlled warm water flow to a blood heat exchanger in order to maintain a patient's blood temperature. It can be used during extracorporeal circulation procedures. It is intended to use with commercially available heat exchangers. Recall # Z-1656-2012
CODE
Serial Numbers: 032-E5201 Through 091-E6690. The Serial Numbers for the 115V units are as follows: 032-E5201 032-E5202 032-E5203 032-E5204 032-E5205 032-E5226 032-E5227 032-E5228 032-E5229 032-E5230 033-E5286 033-E5287 033-E5288 033-E5289 033-E5290 033-E5306 033-E5307 033-E5308 033-E5309 033-E5310 033-E5311 033-E5312 033-E5313 033-E5314 033-E5315 034-E5327 034-E5328 034-E5329 034-E5330 034-E5331 034-E5332 034-E5333 034-E5334 034-E5335 034-E5336 034-E5352 034-E5353 034-E5354 034-E5355 034-E5356 034-E5367 034-E5388 034-E5369 034-E5370 034-E5371 041-E5422 041-E5423 041-E5424 041-E5425 041-E5426 041-E5442 041-E5443 041-E5444 041-E5445 041-E5446 042-E5502 042-E5503 042-E5504 042-E5505 042-E5506 042-E5507 042-E5508 042-E5509 042-E5510 042-E5511 Q44-E5572 044-E5573 044-E5574 Q44-E5575 Q44-E5591 Q44-E5S92 Q44-E5593 Q44-E5594 051-E5605 052-E5646 052-ES647 052-E5648 052-E5664 052-E5665 052-E5692 052-E5693 052-E5694 052-E5710 052-E5711 052-E5712 052-E5718 053-E5724 053-E5725 053-E5731 053-E5732 053-E5733 053-E5734 053-E5740 053-E5741 053-E5757 053-E5758 053-E5759 053-E5775 053-E5776 053-E5777 053-E5778 053-E5779 054-E5785 054-E5811 054-E5812 054-E5828 054-E5829 054-E5830 054-E5831 054-E5832 054-E5833 054-E5834 054-E5835 054-E5836 054-E5837 054-E5838 054-E5839 054-E5840 061-E5881 061-E5882 061-E5883 061-E5884 061-E5885 061E5901 061-E5902 061-E5903 061-E5904 061-E5905 061-E5927 061-E5928 061-E5904 061-E5930 061-E5931 062-E5952 062-E5953 062-E5954 062-E5955 062-E5956 062-E5957 062-E5958 062-E5959 062-E5960 062-E5961 063-E6003 063-E6004 063-E6005 063-E6006 063-E6007 063-E6013 063-E6014 063-E6015 063-E6016 063-E6017 063-E6018 063-E6019 063-E6020 063-E6021 063-E6022 063-E6028 063-E6029 063-E6030 063-E6031 063-E6032 063-E6033 063-E6034 063-E6035 063-E6036 063-E6037 063-E6038 063-E6039 064-E6040 064-E6041 064-E6042 064-E6043 064-E6044 064-E6089 064-E6090 064-E6091 064-E6092 064-E6093 064-E6119 064-E6120 064-E6121 064-E6122 064-E6123 071-E6129 071-E6130 071-E6131 071-E6132 071-E6133 071-E6134 071-E6150 071-E6151 071-E6152 071-E6153 071-E6154 071-E6160 071-E6161 071-E6162 071-E6163 071-E6164 072-E6180 072-E6181 072-E6182 072-E6183 072-E6184 072-E6196 072-E6197 072-E6198 072-E6199 072-E6200 072-E6206 072-E6207 072-E6208 072-E6209 073-E6277 073-E6278 073-E6279 073-E6280 073-E6281 073-E6292 073-E6293 073-E6294 073-E6295 073-E6296 074-E6297 074-E6298 074"E6299 074-E6300 074-E6301 074-E6318 074-E6319 074-E6320 074-E6327 074-E6328 074-E6329 074-E6330 074-E6331 081-E6363 081-E6364 081-E6365 081-E6366 081-E6367 081-E6378 081-E6379 081-E6360 081-E6381 081-E6382 081-E6393 081-E6394 081-E6395 081-E6396 081-E6397 081-E6429 081-E6430 081-E6431 081-E6432 081-E6433 082-E6454 082-E6455 082-E6456 082-E6457 082-E6458 082-E6494 082-E6495 082-E6496 082-E6497 082-E6498 082-E6519 082-E6520 082-E6521 082-E6522 082-E6523 083-E6614 083-E6615 083-E6616 083-E6617 083-E6618 083-E6619 083-E6620 084-E6621 084-E6622 084-E6623 084-E6624 084-E6625 091-E6651 091-E6652 091-E6653 091-E6654 091-E6655 091-E6686 091-E6687 091-E6668 091-E6689, and 091-E6690. The Serial Numbers for the 230V units are as follows: 052-E5666 230V, 061-E5911 230V, and 081-E6408 230V
RECALLING FIRM/MANUFACTURER
Cincinnati Sub-Zero Products Inc., Cincinnati, OH, by letter dated January 31, 2012. Firm initiated recall is ongoing.
REASON
Design error. The probe jack contacts (terminals on certain of the firm's ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with one another. If this situation occurs, a Service Technician, Operator/User, and/or Patient could be exposed to electric shock during device servicing or use.
VOLUME OF PRODUCT IN COMMERCE
295 units Nationwide and 3 units Internationally
DISTRIBUTION
Nationwide
PRODUCT
1) Becton Dickinson Phoenix" System Software, catalog # 448035/448046, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID panels. Product Usage: Automated Microbiology System for the quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of Gram Positive bacteria from pure culture. Recall # Z-1657-2012;
2) Becton Dickinson Phoenix" Update Disks (PUD), catalog # 441107/ 448047, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID panels. Product Usage: This update disk was an interim corrective action recommended by FDA to be installed in Phoenix instruments so that test results associated with E.faecium susceptibility can not be printed by the labs until a final algorithm correction (change) is implemented by the firm. BD Phoenix" Update Disks (PUD). Recall # Z-1658-2012
CODE
1) Software versions: 5.55R, 5.66A, 5.70A, 5.75A, 5.83A, and 6.01A;
2) Software versions: 4.51R, 4,56G, 4.61A, 4.65A, 4.71A, 4.75A, 4.81A, 4.85A, 4.91A, 5.11A, 5.15A, 5.21A
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Co., Sparks, MD, by letter dated April 18, 2012. Firm initiated recall is ongoing.
REASON
In vitro diagnostics manufacturer identified an increase in vancomycin-resistant strains that may exhibit erroneous results on all PMIC or PMIC/ID panels and could lead to ineffective treatment regimen in affected patients.
VOLUME OF PRODUCT IN COMMERCE
3,454,993 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
HPBLUE: HARMONIC� Blue Hand Piece; HP054: HARMONIC� Hand Piece; Non-Sterile products are individually packed in a poly bag and then placed into an individual carton. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels. Recall # Z-1673-2012
CODE
HARMONIC� HP054 Lot Numbers produced to-date: H92Y3M, J9039C, J90817, J90E7C, J9000C, J90432, J9084W, J90E7Z, J90029, J90470, J9088L, J90F3G, J9006C, J9054E, J9093L, J90F7Z, J9011D, J9056K, J9095C, J90G32, J90151, J9057V, J90974, J90G9Y, J9018H, J9058L, J90A45, J90H37, J9020F, J90624, J90A72, J90H4U, 9023D, J90681, J90C7X, J90H7D, J9027C, J9069F, J90C84, J90H9Y, J90314, J90726, J90D4N, J90J2N, J9034N, J90762, J90E0R, J90J8E, J9038W, J9076A, and J90E29;
HARMONIC HPBLUE Hand Pieces Lot Numbers produced to-date: J9001P, J9053N, J9091G, J90D84, J9005J, J9057E, J90A2C, J90E55, J9010E, J9065U, J90A64, J90F76, J9042G, J90696, J90C36, J90G4C, J9050E, J9086W, J90C7U, and J90H46
RECALLING FIRM/MANUFACTURER
Ethicon Endo-Surgery Inc., Cincinnati, OH, by letter dated March 2012. Firm initiated recall is ongoing.
REASON
Ethicon Endo-Surgery initiated a voluntary recall due to some lot numbers of the HARMONIC Hand Piece (HP054) and the HARMONIC Blue Hand Piece (HPBLUE), which impacts their compatibility with the HARMONIC Generator 300 (GEN04). The problem occurs after successful set up and initial use of HARMONIC Hand Pieces (HP054 and HPBLUE) with the Generator 300 (GEN04). The procedure is interrupted when the Generator 300 (GEN04) goes into stand-by mode after one minute of cumulative activation time (approximately 10 activations). Once the Generator 300 (GEN04) goes into stand-by mode, the device cannot be activated to complete the procedure without fully re-setting the system. The problem will continue to occur each time the system is re-set and one minute of cumulative activation time is reached
VOLUME OF PRODUCT IN COMMERCE
1,896 in US; 5,962 world wide
DISTRIBUTION
Nationwide and Internationally
PRODUCT
Water Pik Sinusense battery operated device including a blue semi-transparent water reservoir, a white hand held button initiated injector device, and a soft seal nozzle affixed to the white injector. The product is sold individually in white, blue red and orange cartons with a photo of the device as well as a stream of water flowing through it. The contents of the container include the device as well as a package insert with utilization instructions. Product Usage: Sinus washing device to keep sinus passages clear of congestion. Recall # Z-1674-2012
CODE
All lots and codes manufactured between May 2010 and July 2011.
RECALLING FIRM/MANUFACTURER
Water Pik, Inc., Fort Collins, CO, by letter dated May 2012. Firm initiated recall is ongoing.
REASON
Customer complaints related to cross contamination of sinus rinse solution between the battery compartment and solution reservoir used for rinsing nasal passages.
VOLUME OF PRODUCT IN COMMERCE
105,257 individual units
DISTRIBUTION
Nationwide
PRODUCT
Tibial Alignment Handle Triathlon Instruments CAT #: 6541-2-807 Nav Tibial Alignment Handle Triathlon Instruments CAT #; 6541-2-808. The tibial alignment handles Cat# 6451-2-807 and 6541-2-808 are part of the Triathlon Knee Instruments set. The alignment handle is used after the tibial resection portion of a total knee arthroplasty procedure. The alignment handle helps holding and orienting the tibial template and trial, which are used to estimate the size and assess the orientation of the final implant. The implant will provide the new bearing surface of the knee, replacing the damaged joint. Catalog No.: 6541-2-807, customer Parts associated with cat. no. 6540-2-807 I-K2072AH00 - Triathlon Tibial Align. Handle with Secondary Lock I-K2336AH00 - Tibial Alignment Handle with Lock I-K2021TA00 - Triathlon Alignment Handle with Navigation Post I-K2059KT00 - Triathlon Tibia Alignment Handle I-K3254TA00 - Triathlon Tibial Alignment Handle with Lock I-K3251AH00 - Triathlon Tibial Alignment Handle for Sizes 1-3 I-K3113TH00 - Triathlon Tibial Alignment Handles (Augment) I-K2980 - Triathlon Tibia Alignment Handle I-K2954AH00 - Triathlon Tibia Alignment Handle I-K2916TA00 - Triathlon Tibial Alignment Handle I-K2797AH00 - Tibial Alignment Handle with no swivel b) Catalog No. 6541-2-8089. Recall # Z-1619-2012
CODE
a) N1A0l, N1K07 N1K14 N1N64 N1W04 N2A11 N2H10 N2L16 N2N04 N2V25 N2V26 N3E08 N3H12 N3H29 N3K02 N3K56 N3L13 N3S33 N3S39 N3T78 N3V21 N3W18 N3W29 N3W47 NYC02 NYC10 NYL09 NZC10 NZH09 NZL08 NZM01 NZS08 NZV09;
b) N1K14 N1N63 N1W08 N3K50 N3M43 N3T61 N3V56 N4E36
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter dated October 10, 2011. Firm initiated recall is ongoing.
REASON
Stryker received a Product Experience Report (PER) that a swivel block was improperly oriented on a Triathlon Tibial Alignment Handle, catalog no. 6541-2-807.
VOLUME OF PRODUCT IN COMMERCE
6,126 units
DISTRIBUTION
Nationwide, Asia Pacific, Canada, Europe, Middle East and Africa (EMEA), and Japan
PRODUCT
SOLUS Anterior Lumbar Interbody Fusion Spinal Spacer System, Solus Proximal/Distal Deployment Wrenches, 510(k) K102402. The Alphatec Solus Anterior Lumbar Interbody Fusion (AUF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondyiolisthesis or retrolisthesis at the involved level(s). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Alphatec Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades. The Alphatec Solus implant is intended for use with supplemental spinal fixation. Specifically, the Alphatec Solus implant is to be used with the Alphatec's Zodiac� Spinal Fixation System, Aspida" Anterior Lumbar Plating System, or the ILLlCO MIS Posterior Fixation System. Intervertebral body fusion device. Part Numbers: 25975 & 25976. Product Code(s): MAX. Market Clearance: 510(k). Recall # Z-1676-2012
CODE
K102402
RECALLING FIRM/MANUFACTURER
Alphatec Spine, Inc., Carlsbad, CA, by letter dated March 30, 2012. Firm initiated recall is ongoing.
REASON
Alphatec Spine has received several complaints (n+4) on the Alphatec Solus Distal Deployment Wrench for twisting or bending, which has been discovered either during or after instrumentation use. A fifth complaint received in which it was reported that the spline tip of the Alphatec Solus Proximal Deployment Wrench had sheared from the instrument upon use.
VOLUME OF PRODUCT IN COMMERCE
18 devices
DISTRIBUTION
Nationwide and Germany
PRODUCT
Restoration HA Reduced Neck 25 mm Long Stem. The Restoration HA cementless Hip System is designed to address the problems of revision surgery where extensive fixation both distally and proximally is required for support of the prosthesis. A comprehensive size range mates a variety of proximal cross sections and lengths with 10 distal cylindrical diameters to provide for patient matched sizing in revision circumstances. The stem design incorporates a physiologic 127 degree neck stem angle, neck length ranges and a C-Taper head to provide the surgeon with the ability to restore near anatomic head position for proper leg length and biomechanical function. Restoration HA femoral component accepts C-Taper heads, 22mm, 26mm, 28mm, and 32mm with a negative 5mm to positive 10mm offsets. 510(K) #K951671 Catalog #: S-2653-0812-L. Recall # Z-1677-2012
CODE
Lot Codes 45041401 49051101 50024801 21578001 26464501A 49051101A 26464501C 97161201 54123101A 45041401C 18826701 49051101C 49760101A 49051101D 21473201 49051101E 54123101C 54008001C 50024801C 50024801D 97161201A 49760101C 50024801E 21473201A RK8MKE RK9MKE T7DMKE MHLL7Y MHM0DA MHJRE8-R
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter dated October 27, 2011. Firm initiated recall is ongoing.
REASON
An incorrect laser mark was noted on specific lots of product, incorrectly implying a stem size of 9, when the product is actually size 8.
VOLUME OF PRODUCT IN COMMERCE
31 units
DISTRIBUTION
Nationwide and Canada
PRODUCT
Altrus Energy Source REF 60-9500-120 Tissue Fusion Energy Source. The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. Recall # Z-1678-2012
CODE
Lot #: 11AGZ003, 10KGZ001, 10MGZ001, 10MGZ003, 10MGZ004, 11AGZ001, 11AGZ002, 11AGZ003, 11AGZ004, 11AGZ006, 11AGZ007, 11BGZ001, 11BGZ002, 11BGZ003, 11DGZ001, 11DGZ002, 11DGZ003, 11DGZ004, 11DGZ005, 11DGZ006, 11DGZ007, 11DGZ008, 11DGZ009, 11DGZ010, 11DGZ011, 11DGZ012, 11DGZ013, 11DGZ014, 11DGZ015, 11DGZ016, 11DGZ017, 11DGZ018, 11FGZ001, 11FGZ002, 11FGZ003, 11FGZ005, 11FGZ006, 11FGZ007, 11FGZ008, 11GGZ001, 11GGZ002, 11GGZ003, 11GGZ004, 11GGZ006, 11GGZ007, 11GGZ008, 11GGZ009, 11HGZ001, 11HGZ002, 11HGZ003, 11HGZ005, 11HGZ007, 11HGZ008, 11HGZ009, 11HGZ010, 11HGZ011, 11HGZ012, 11HGZ013, 11HGZ014, 11HGZ015, 11HGZ016, 11HGZ017, 11HGZ018, 11HGZ019, 11HGZ020, 11HGZ021, 11HGZ022, 11HGZ023, 11HGZ024, 11HGZ025, 11HGZ026, 11HGZ027, 11JGZ001, 11JGZ002, 11JGZ003, 11JGZ004, 11KGZ001, 11KGZ002, 11KGZ003, 11KGZ004, 11KGZ005, 11KGZ006, 11KGZ007, 11KGZ008, 11KGZ009, 11KGZ010, 11KGZ011, 11KGZ012, 11KGZ013, 11KGZ014, 11KGZ015, 11LGZ002, 11LGZ003, 11LGZ004, 11LGZ005, 11LGZ006, 11LGZ007, 11LGZ008, 11LGZ009, 11LGZ010, 11LGZ011, 11LGZ012, 11LGZ013, 11LGZ014, 11LGZ015, 11LGZ016, 11LGZ017, 11LGZ018, 11MGZ001, 11MGZ002, 11MGZ003, 12AGZ001, 12AGZ003, 12AGZ004, 12AGZ005, 12AGZ006, 12AGZ007, 12AGZ008, 12AGZ009, 12AGZ010, 12AGZ011, 12AGZ012, 12AGZ013, 12AGZ014, 12AGZ015, 12AGZ016, 12BGZ001, 12BGZ002, 12BGZ003, 12BGZ004, 12BGZ005, 12BGZ006, 12BGZ008, 12BGZ009, 12CGZ001, 12CGZ002, 12CGZ003, 12CGZ004, 12CGZ005, 12CGZ006, 12CGZ008, 12CGZ009, 12CGZ010, 12CGZ011
RECALLING FIRM/MANUFACTURER
ConMed Electrosurgery, Centennial, CO, by letter dated May 2, 2012. Firm initiated recall is ongoing.
REASON
An investigation of the ConMed Electrosurgery Altrus Energy Source revealed that the device could have been calibrated incorrectly resulting in error messages or delays in surgery.
VOLUME OF PRODUCT IN COMMERCE
145 units
DISTRIBUTION
Nationwide and Canada
PRODUCT
1) Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 36 cm Shaft, Catalog Number 60-9522-001, Sterile/EO. The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. Recall # Z-1679-2012;
2) Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 23 cm Shaft, Catalog Number 60-9521-001, Sterile/ EO. The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. Recall # Z-1680-2012;
3) Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 16 cm Shaft, Catalog Number 60-9520-001, Sterile/EO. The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. Recall # Z-1681-2012;
4) Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 10 mm O.D., 23 cm Shaft, Catalog Number 60-9511-001, Sterile/EO. The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. Recall # Z-1682-2012
CODE
1) Lot codes: 11DHB001, 10MHB002, 11DHB006, 10MHB002, 10MHB006;
2) Lot codes: 11DHB004, 11AHB001, 11AHB006;
3) Lot codes: 11AHB005, 11DHB005;
4) Lot codes: 11GHB009, 11HHB002
RECALLING FIRM/MANUFACTURER
ConMed Electrosurgery, Centennial, CO, by letter dated May 2, 2012. Firm initiated recall is ongoing.
REASON
The devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding.
VOLUME OF PRODUCT IN COMMERCE
237 units
DISTRIBUTION
Nationwide
PRODUCT
Spectra Optia Apheresis System, Country of Origin: US. Catalog No 61000. Product Usage: For use in humans. Within the US marketplace, this device is approved for use in Therapeutic Plasma Exchange. Internationally, this device is approved for use in Mono Nucleo Cell engraftment. Recall # Z-1683-2012
CODE
Lot numbers 1P00881 1P00545 1P00310 1P00888 1P00595 1P00652 1P00594 1P00230 1P00592 1P00804 1P00596 1P00878 1P00327 1P00166 1P00566 1P00135 1P00882 1P00681 1P00482 1P00604 1P00379 1P00422 1P00781 1P00235 1P00184 1P00441 1P00523 1P00520 1P00854 1P00795 1P00299 1P00671 1P00941 1P00461 1P00817 1P00787 1P00822 1P00672 1P00840 1P00866 1P00622 1P00389 1P00392 1P00391 1P00400 1P00394 1P00384 1P00430 1P00168 1P00933 1P00167 1P00462 1P00211 1P00162 1P00541 1P00703 1P00874 1P00591 1P00884 1P00782 1P00440 1P00646 1P00457 1P00542 1P00600 1P00147 1P00701 1P00298 1P00358 1P00393 1P00732 1P00228 1P00560 1P00177 1P00176 1P00242 1P00616 1P00387 1P00780 1P00142 1P00557 1P00172 1P00774 1P00791 1P00655 1P00511 1P00451 1P00472 1P00207 1P00669 1P00768 1P00290 1P00641 1P00534 1P00429 1P00598 1P00538 1P00515 1P00608 1P00916 1P00551 1P00353 1P00240 1P00790 1P00815 1P00268 1P00642 1P00621 1P00537 1P00361 1P00687 1P00522 1P00160 1P00512 1P00586 1P00402 1P00785 1P00731 1P00447 1P00239 1P00640 1P00453 1P00191 1P00851 1P00169 1P00606 1P00662 1P00277 1P00684 1P00311 1P00436 1P00885 1P00226 1P00302 1P00385 1P00345 1P00229 1P00803 1P00778 1P00222 1P00509 1P00666 1P00459 1P00267 1P00434 1P00141 1P00251 1P00143 1P00565 1P00382 1P00232 1P00491 1P00627 1P00553 1P00636 1P01183 1P00349 1P00981 1P00513 1P00617 1P00238 1P00639 1P00688 1P00285 1P00995 1P00810 1P01182 1P00212 1P00559 1P00982 1P00590 1P00848 1P01115 1P00900 1P01185 1P00811 1P00203 1P00605 1P00321 1P00868 1P00459 1P00267 1P00669 1P00560 1P00884 1P00141 1P00143
RECALLING FIRM/MANUFACTURER
CaridianBCT, Inc., Lakewood, CO, by letter dated May 18, 2012. Firm initiated recall is ongoing.
REASON
Defective product may result in decreased efficacy.
VOLUME OF PRODUCT IN COMMERCE
372 units
DISTRIBUTION
Nationwide and Canada
PRODUCT
1) Siemens brand ACUSON S2000 Ultrasound Systems, and the Advanced SieClearTM spatial compounding feature Software Versions 3.0, 3.0A and 3.1. (VB20, VB20A, and VB21A); Model #: 10041461 - ACUSON S2000 Mainframe; The ACUSON S2000 Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display. The ACUSON S2000 ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Recall # Z-1684-2012;
2) Siemens brand ACUSON S2000 Ultrasound Systems, and the Advanced SieClearTM spatial compounding feature Software Versions 3.0, 3.0A and 3.1. (VB20, VB20A, and VB21A); Model #: 10440017 - ACUSON S2000 Refurb. Mainframe; The ACUSON S2000 Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display. The ACUSON S2000 ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Recall # Z-1685-2012
CODE
1) All units, including: 200109, 200113, 200162, 200164, 200146, 200175, 200177, 210001, 200145, 200198, 200214, 200219, 200225, 200284, 200315, 200354, 200404, 200407, 200435, 200467, 200364, 200539, 200373, 200574, 200719, 200853, 200858, 200875, 200909, 201006, 201040, 201043, 201113, 201096, 201070, 201071, 201112, 201121, 201168, 201212, 201215, 201298, 201226, 201397, 201306, 201452, 201442, 201510, 201527, 201631, 201678, 201673, 201674, 201675, 201699, 201731, 201727, 201728, 201755, 201816, 201821, 201891, 201928, 201943, 202019, 202030, 202102, 202098, 202111, 202137, 202119, 202131, 202139, 202148, 202167, 202158, 202240, 202267, 202250, 202266, 202312, 202314, 202401, 202412, 202500, 202364, 202420, 202385, 202383, 202374, 202391, 202465, 202384, 202445, 202514, 202448, 202523, 202524, 202460, 202456, 202534, 202379, 202566, 202554, 202570, 202574, 202608, 202610, 202581, 202731, 202744, 202649, 202787, 202679, 202797, 202799, 202803, 202806, 202812, 202834, 202841, 202844, 202857, 202869, 202888, 202902, 202929, 202963, 202583, 202976, 202986, 203012, 203017, 203037, 202955, 202935, 203069, 203086, 203092, 203095, 203113, 203143, 203150, 203199, 203211, 203222, 203224, 203245, 203248, 203249, 203259, 203275, 203289, 203329, 203330, 203351, 203355, 203380, 203381, 203391, 203396, 203401, 203403, 203422, 203424, 203426, 203430, 203437, 203446, 203458, 203462, 203474, 205007, 205015, 205020, 203527, 203539, 203593, 203595, 203582, 203605, 203608, 203626, 203623, 203625, 205034, 205031, 205027, 201013, 205032, 202100, 205126, 203643, 205049, 205039, 205172, 205082, 205083, 205142, 205067, 205043, 205072, 205200, 205075, 205134, 205085, 205106, 205133, 205057, 205102, 205078, 205056, 205147, 205110, 205283, 205279, 205137, 205112, 205270, 205281, 205269, 205100, 205178, 203632, 205104, 205152, 205153, 205293, 205294, 205296, 205164, 205084, 205161, 205300, 205166, 205046, 205155, 205165, 205188, 205222, 205223, 205113, 205169, 205170, 205229, 205402, 205316, 205237, 205232, 205256, 205258, 205291, 205347, 205295, 205179, 205249, 205305, 205326, 205303, 205245, 205250, 205337, 205343, 205180, 205204, 205181, 205255, 205192, 205208, 205261, 205148, 205058, 205132, 205215, 205328, 205265, 205335, 205139, 205230, 205271, 205186, 205240, 205187, 205189, 205263, 205238, 205210, 205216, 205217, 205234, 201677, 205266, 205393, 205177, 205251, 205322, 205330, 205174, 205312, 205429, 205182, 205205, 205206, 205213, 205371, 205430, 201170, 205292, 205306, 205317, 205362, 205396, 205241, 205309, 205356, 205390, 205236, 205235, 205389, 205353, 205298, 205397, 205308, 205324, 205359, 205310, 205253, 205191, 205360, 205368, 205198, 205214, 205321, 205323, 205345, 201233, 202370, 200432, 205370, 205351, 202776, 205302, 205364, 205354, 205338, 205329, 205372, 205355, 205401, 205443, 205352, 205332, 205442, 205375, 201363, 205331, 205434, 202458, 202489, 205394, 205315, 205311, 205340, 205218, 205319, 205307, 205334, 205325, 205185, 202072, 205348, 205383, 205399, 205380, 202450, 201773, 205482, 205350, 205475, 205484, 205486, 205485, 205508, 205488, 205131, 205365, 205385, 205384, 205367, 205379, 205400, 205398, 205373, 205366, 205357, 205286, 205378, 201540, 205436, 205435, 205427, 205423, 205422, 205420, 205418, 205403, 205327, 205369, 205457, 205454, 205503, 205382, 205341, 205510, 205444, 205438, 205437, 205455, 205424, 205496, 205358, 205493, 205392, 202490, 200319, 205417, 205377, 205349, 205492, 205419, 200669, 205473, 205491, 205411, 205453, 202954, 202382, 202738, 205495, 205490, 205504, 201364, 205044, 205481, 205458, 205465, 205415, 205487, 205426, 205439, 205474, 205440, 205408, 205471, 205498, 205446, 205467, 205499, 205460, 202277, 201191, 205410, 205428, 205409, 205404, 205407, 205413, 205500, 205483, 205466, 205469, 205470, 205472, 205478, 205480, 202142, 205520, 205524, 205527, 205431, 205529, 202629, 202953, 205462, 205406, 205412, 205414, 205421, 205468, 205511, 205433, 205432, 205512, 205513, 205516, 205448, 201225, 200252, 205452, 205532, 205526, 205459, 205533, 205531, 202010, 200183, 205464, 205416, 205447, 205534, 202754, 205450, 205314, 205502, 205515, 205517, 205518, 205528, 205519, 205522, 205525, 205463, 205538, 202546, 205543, 205547, 205544, 205548, 205553, 205559, 205562, 205566, 205567, 205497, 205536, 205539, 205541, 205549, 205550, 205554, 205425, 202943, 205445, 205545, 205667, 205676, 200979, 201086, 203238, 201159, 205476, 202940, 205514, 205561, 205617, 205620, 205660, 201230, 202360, 205555, 205697, 205663, 205542, 205693, 205695, 205670, 205672, 205683, 205684, 205692, 205573, 205574, 205576, 205664, 205584, 205665, 205668, 205590, 205587, 205591, 201293, 205608, 205592, 205609, 205611, 205615, 205621, 205622, 205618, 205619, 205589, 205626, 205627, 205629, 205632, 205633, 205711, 205714, 205718, 205593, 205585, 205610, 205586, 202757, 205723, 205655, 205579, 205606, 205623, 205624, 205653, 202832, 205595, 205599, 205658, 203193, 201294, 201427, 205582, 202427, 205696, 205564, 205575, 205578, 200227, 205647, 205570, 205594, 205588, 205565, 205648, 205613, 205640, 205642, 205643, 205634, 205635, 205639, 205644, 205654, 205645, 205749, 200725, 205646, 205659, 205577, 202299, 205656, 205571, 205706, 205748, 205731, 205702, 205728, 205602, 205607, 205612, 205637, 205744, 205638, 203084, 205712, 205600, 205736, 205735, 202308, 205160, 205203, 205207, 205219, 200468, 205267, 202756, 205246, 203267, 200286, 205339, 205733, 205603, 205739, 202918, 205740, 205745, 205719, 205690, 205757, 205681, 205752, 205729, 205703, 205738, 205671, 205687, 205688, 205734, 205669, 205710, 205725, 205767, 205769, 205699, 205768, 205727, 205686, 205746, 205754, 205765, 205641, 205713, 205724, 205743, 205760, 205772, 205774, 205762, 205764, 205705, 205202, 205755, 205780, 205781, 205784, 205792, 205787, 205833, 205798, 205822, 205823, 205825, 205827, 205830, 202625, 205838, 205842, 205813, 205846, 205850, 205790, 205852, 205853, 205857, 202965, 205860, 205680, 205770, 205144, 205777, 203229, 205815, 205753, 205794, 205766, 205763, 205716, 205596, 205799, 205802, 205834, 205809, 205837, 205872, 205847, 205839, 205806, 205868, 205776, 205076, 205817, 205832, 205836, 205855, 205694, 205810, 205874, 205717, 205720, 205816, 205854, 205831, 205829, 205844, 205922, 205906, 205904, 205895, 205883, 206009, 205913, 205917, 206017, 205845, 205879, 205819, 205912, 206005, 205867, 205835, 205849, 205841, 205863, 205843, 205824, 205891, 205878, 205915, 205882, 201330, 205888, 205862, 205884, 205861, 205869, 206018, 205818, 205925, 206008, 206000, 205924, 205870, 205865, 205803, 205661, 205919, 205900, 206027, 206003, 206023, 206016, 205892, 205875, 206036, 206034, 206026, 205698, 206035, 206010, 206045, 205957, 206042, 205907, 205885, 206052, 205905, 205911, 205947, 206074, 205928, 206069, 206059, 205800, 206043, 205826, 205805, 205828, 206014, 205877, 205318, 205903, 205916, 205936, 205859, 205989, 205986, 206071, 206102, 205650, 205996, 205930, 205995, 206011, 206076, 205894, 202138, 206110, 206093, 203214, 200128, 201211, 202928;
2) All units including: 200109, 200113, 200162, 200164, 200146, 200175, 200177, 210001, 200145, 200198, 200214, 200219, 200225, 200284, 200315, 200354, 200404, 200407, 200435, 200467, 200364, 200539, 200373, 200574, 200719, 200853, 200858, 200875, 200909, 201006, 201040, 201043, 201113, 201096, 201070, 201071, 201112, 201121, 201168, 201212, 201215, 201298, 201226, 201397, 201306, 201452, 201442, 201510, 201527, 201631, 201678, 201673, 201674, 201675, 201699, 201731, 201727, 201728, 201755, 201816, 201821, 201891, 201928, 201943, 202019, 202030, 202102, 202098, 202111, 202137, 202119, 202131, 202139, 202148, 202167, 202158, 202240, 202267, 202250, 202266, 202312, 202314, 202401, 202412, 202500, 202364, 202420, 202385, 202383, 202374, 202391, 202465, 202384, 202445, 202514, 202448, 202523, 202524, 202460, 202456, 202534, 202379, 202566, 202554, 202570, 202574, 202608, 202610, 202581, 202731, 202744, 202649, 202787, 202679, 202797, 202799, 202803, 202806, 202812, 202834, 202841, 202844, 202857, 202869, 202888, 202902, 202929, 202963, 202583, 202976, 202986, 203012, 203017, 203037, 202955, 202935, 203069, 203086, 203092, 203095, 203113, 203143, 203150, 203199, 203211, 203222, 203224, 203245, 203248, 203249, 203259, 203275, 203289, 203329, 203330, 203351, 203355, 203380, 203381, 203391, 203396, 203401, 203403, 203422, 203424, 203426, 203430, 203437, 203446, 203458, 203462, 203474, 205007, 205015, 205020, 203527, 203539, 203593, 203595, 203582, 203605, 203608, 203626, 203623, 203625, 205034, 205031, 205027, 201013, 205032, 202100, 205126, 203643, 205049, 205039, 205172, 205082, 205083, 205142, 205067, 205043, 205072, 205200, 205075, 205134, 205085, 205106, 205133, 205057, 205102, 205078, 205056, 205147, 205110, 205283, 205279, 205137, 205112, 205270, 205281, 205269, 205100, 205178, 203632, 205104, 205152, 205153, 205293, 205294, 205296, 205164, 205084, 205161, 205300, 205166, 205046, 205155, 205165, 205188, 205222, 205223, 205113, 205169, 205170, 205229, 205402, 205316, 205237, 205232, 205256, 205258, 205291, 205347, 205295, 205179, 205249, 205305, 205326, 205303, 205245, 205250, 205337, 205343, 205180, 205204, 205181, 205255, 205192, 205208, 205261, 205148, 205058, 205132, 205215, 205328, 205265, 205335, 205139, 205230, 205271, 205186, 205240, 205187, 205189, 205263, 205238, 205210, 205216, 205217, 205234, 201677, 205266, 205393, 205177, 205251, 205322, 205330, 205174, 205312, 205429, 205182, 205205, 205206, 205213, 205371, 205430, 201170, 205292, 205306, 205317, 205362, 205396, 205241, 205309, 205356, 205390, 205236, 205235, 205389, 205353, 205298, 205397, 205308, 205324, 205359, 205310, 205253, 205191, 205360, 205368, 205198, 205214, 205321, 205323, 205345, 201233, 202370, 200432, 205370, 205351, 202776, 205302, 205364, 205354, 205338, 205329, 205372, 205355, 205401, 205443, 205352, 205332, 205442, 205375, 201363, 205331, 205434, 202458, 202489, 205394, 205315, 205311, 205340, 205218, 205319, 205307, 205334, 205325, 205185, 202072, 205348, 205383, 205399, 205380, 202450, 201773, 205482, 205350, 205475, 205484, 205486, 205485, 205508, 205488, 205131, 205365, 205385, 205384, 205367, 205379, 205400, 205398, 205373, 205366, 205357, 205286, 205378, 201540, 205436, 205435, 205427, 205423, 205422, 205420, 205418, 205403, 205327, 205369, 205457, 205454, 205503, 205382, 205341, 205510, 205444, 205438, 205437, 205455, 205424, 205496, 205358, 205493, 205392, 202490, 200319, 205417, 205377, 205349, 205492, 205419, 200669, 205473, 205491, 205411, 205453, 202954, 202382, 202738, 205495, 205490, 205504, 201364, 205044, 205481, 205458, 205465, 205415, 205487, 205426, 205439, 205474, 205440, 205408, 205471, 205498, 205446, 205467, 205499, 205460, 202277, 201191, 205410, 205428, 205409, 205404, 205407, 205413, 205500, 205483, 205466, 205469, 205470, 205472, 205478, 205480, 202142, 205520, 205524, 205527, 205431, 205529, 202629, 202953, 205462, 205406, 205412, 205414, 205421, 205468, 205511, 205433, 205432, 205512, 205513, 205516, 205448, 201225, 200252, 205452, 205532, 205526, 205459, 205533, 205531, 202010, 200183, 205464, 205416, 205447, 205534, 202754, 205450, 205314, 205502, 205515, 205517, 205518, 205528, 205519, 205522, 205525, 205463, 205538, 202546, 205543, 205547, 205544, 205548, 205553, 205559, 205562, 205566, 205567, 205497, 205536, 205539, 205541, 205549, 205550, 205554, 205425, 202943, 205445, 205545, 205667, 205676, 200979, 201086, 203238, 201159, 205476, 202940, 205514, 205561, 205617, 205620, 205660, 201230, 202360, 205555, 205697, 205663, 205542, 205693, 205695, 205670, 205672, 205683, 205684, 205692, 205573, 205574, 205576, 205664, 205584, 205665, 205668, 205590, 205587, 205591, 201293, 205608, 205592, 205609, 205611, 205615, 205621, 205622, 205618, 205619, 205589, 205626, 205627, 205629, 205632, 205633, 205711, 205714, 205718, 205593, 205585, 205610, 205586, 202757, 205723, 205655, 205579, 205606, 205623, 205624, 205653, 202832, 205595, 205599, 205658, 203193, 201294, 201427, 205582, 202427, 205696, 205564, 205575, 205578, 200227, 205647, 205570, 205594, 205588, 205565, 205648, 205613, 205640, 205642, 205643, 205634, 205635, 205639, 205644, 205654, 205645, 205749, 200725, 205646, 205659, 205577, 202299, 205656, 205571, 205706, 205748, 205731, 205702, 205728, 205602, 205607, 205612, 205637, 205744, 205638, 203084, 205712, 205600, 205736, 205735, 202308, 205160, 205203, 205207, 205219, 200468, 205267, 202756, 205246, 203267, 200286, 205339, 205733, 205603, 205739, 202918, 205740, 205745, 205719, 205690, 205757, 205681, 205752, 205729, 205703, 205738, 205671, 205687, 205688, 205734, 205669, 205710, 205725, 205767, 205769, 205699, 205768, 205727, 205686, 205746, 205754, 205765, 205641, 205713, 205724, 205743, 205760, 205772, 205774, 205762, 205764, 205705, 205202, 205755, 205780, 205781, 205784, 205792, 205787, 205833, 205798, 205822, 205823, 205825, 205827, 205830, 202625, 205838, 205842, 205813, 205846, 205850, 205790, 205852, 205853, 205857, 202965, 205860, 205680, 205770, 205144, 205777, 203229, 205815, 205753, 205794, 205766, 205763, 205716, 205596, 205799, 205802, 205834, 205809, 205837, 205872, 205847, 205839, 205806, 205868, 205776, 205076, 205817, 205832, 205836, 205855, 205694, 205810, 205874, 205717, 205720, 205816, 205854, 205831, 205829, 205844, 205922, 205906, 205904, 205895, 205883, 206009, 205913, 205917, 206017, 205845, 205879, 205819, 205912, 206005, 205867, 205835, 205849, 205841, 205863, 205843, 205824, 205891, 205878, 205915, 205882, 201330, 205888, 205862, 205884, 205861, 205869, 206018, 205818, 205925, 206008, 206000, 205924, 205870, 205865, 205803, 205661, 205919, 205900, 206027, 206003, 206023, 206016, 205892, 205875, 206036, 206034, 206026, 205698, 206035, 206010, 206045, 205957, 206042, 205907, 205885, 206052, 205905, 205911, 205947, 206074, 205928, 206069, 206059, 205800, 206043, 205826, 205805, 205828, 206014, 205877, 205318, 205903, 205916, 205936, 205859, 205989, 205986, 206071, 206102, 205650, 205996, 205930, 205995, 206011, 206076, 205894, 202138, 206110, 206093, 203214, 200128, 201211, 202928
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on April 23, 2012. Firm initiated recall is ongoing.
REASON
When using the Advanced SieClear spatial compounding feature a synchronization error may occur this can cause a mismatch between the image and the depth scale.
VOLUME OF PRODUCT IN COMMERCE
879 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
1) Symbia E Series SPECT System; Single-Photon Emission Computed Tomography. The Siemens Symbia E system is a high performance dual detector variable angle system with flexible patient positioning for planar imaging, whole-body scans, and SPECT studies. Material number 10275879. Recall # Z-1686-2012;
2) e.cam Emission Computed Tomography Systems. Siemens e.cam Emission Imaging Computed Tomography Systems is used for all common nuclear medicine procedures. a) Material number 4380213; b) material number 4380221; c) material number 5227397; d) material number 5242826; e) material number 5977066; f) material number 5977074; g) material number 5984005; h) material number 5989079; i) Material number 5989087; j) material number 5991109; k) material number 5991117; l) material number 5992099; m) material number 7324143; n) material number 7760809; o) material number 7760932; p) material number 7823920; q) material number 7823946; r) material number 7823953; s) material number 7823979; t) material number 1015153122; and u) material number 10151532. Recall # Z-1687-2012
CODE
1) Serial numbers 1028, 1034, 1062, 1098, 1106, 1134, 1138, 1205 and 1283;
2) a) Serial numbers 1018 and 3020; b) serial numbers 0009, 1039, 1047, 1056, 1075, 1094, 1099, 1109, 1137, 1166, 1181 and 1190; c) serial number 1136; d) serial numbers 1005, 1024, 1060, 1065, 1070, 1071, 2046, 2050, 2053, 2059, 2070, 2071, 2111, 2114, 3005, 3007, 3019, 3060, 3092, 3098, 3122, 3124, 4024, 4027, 4035, 4039, 4042, 4044, 4060, 4067 and 4075; e) serial numbers 4092, 4165, 5030, 5048 and 5103; f) serial number 5031; g) serial number 7006; h) serial numbers 7538, 8003, 8009, 8031, 8046, 8097, 8527, 8546, 8652, 8665, 8694, 8730, 8744, 8764 and 08501/7823920; i) serial numbers 7503, 8018, 8514 and 8542; j) serial numbers 5564, 5649,7009, 7017 and 7038; k) serial number 4005; l) serial numbers 5154, 5157 and 5502; m) serial number 0573; n) serial number 8502; o) serial numbers 8528, 8575 and 9024; p) serial number 8508; q) serial numbers 9088, 9092, 9112, 9128, 9161, 9171, 9203, 9210, 9237, 10036, 10038, 10095, 10097, 10137, 10161, 10239, 10306, 11017, 11040, 11071, 11145, 11186, 11195, 11226, 11291, 11298, 11411, 11419, 11477, 11496, 11505, 11653, 11660, 11762 and 11789; r) serial numbers 9024, 11057 and 11139; s) serial number 9013; t) serial numbers 1021, 1022; and u) serial numbers 1027, 1049, 1134, 1137, 1138, 1317, 1321, 1343 and 1345
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, by letter dated April 11, 2012. Firm initiated recall is ongoing.
REASON
Siemens has identified a potential patient safety issue for e.cam and Symbia E camera systems that have had the radial drive motor assembly replaced during a Service action. There is a remote chance that during the motor replacement the radial drive gear may have been replaced incorrectly. If the gear is installed incorrectly the mechanical brake may not engage creating a patient hazard if the system is in the 180 degree head configuration.
VOLUME OF PRODUCT IN COMMERCE
146 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
The Brilliance iCT: Model# 728306 and iCT SP: Model# 728311, are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Recall # Z-1688-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated May 8, 2012. Firm initiated recall is ongoing.
REASON
Philips Healthcare was notified of one incident involving a Brilliance iCT scanner that resulted in damage to the gantry and slight injury to the user when the heat exchanger detached from the cooling unit due to some missing welds.
VOLUME OF PRODUCT IN COMMERCE
372 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
Philips Practix Convenio Mobile X-ray System Model: 70455 The Practix Convenio is a mains independent motor driven mobile x-ray system, to x-ray body parts of patients to create images for medical diagnostic purposes. The Practix Convenio is intended to x-ray in rooms for medical use. Recall # Z-1689-2012
CODE
Serial numbers: PC1-0504 through PC1 -0588
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Healthcare Inc., Andover, MA, by letter dated April 26, 2012.
Manufacturer: Philips Medical Systems Gmbh, DMC, Hamburg, Germany. Firm initiated recall is ongoing.
REASON
Unexpected Low-level X-ray pulse.
VOLUME OF PRODUCT IN COMMERCE
78 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
1) Brilliance 16 - Model #728246, CT Scanning System is subject to recall/correction Product Usage: The Brilliance 6, 16, 40 64, Big Bore, iCT, iCT SP and Ingenuity CT are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment , patient, and equipment supports, components and accessories. Recall # Z-1690-2012;
2) Brilliance 40 - Model #72835, and Brilliance 64 - Model #728231, and Ingenuity - Model #728326, CT Scanning Systems are subject to recall/correction Product Usage: The Brilliance 6, 16, 40 64, Big Bore, iCT, iCT SP and Ingenuity CT are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Recall Z-1691-2012;
3) Brilliance Big Bore - Model #728243, and - Model #728244, CT Scanning System is subject to recall/correction Product Usage: The Brilliance 6, 16, 40 64, Brilliance Big Bore, iCT, iCT SP and Ingenuity CT are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Recall # Z-1692-2012;
4) Brilliance iCT - Model #728306, and Brilliance iCT SP - Model #728311, CT Scanning System is subject to recall/correction Product Usage: The Brilliance 6, 16, 40 64, Brilliance Big Bore, iCT, iCT SP and Ingenuity CT are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Recall # Z-1693-2012
CODE
1) Serial Numbers: 6205, 6220, 6129, 6180, 6132, 6158, 6154, 6229, 6321, 6152;
2) Serial Numbers: 10299, 10256, 30004, 10373, 10370, 10394, 10332, 10337, 10263, 10291;
3) Serial numbers: 7511, 7543, 7508, 7536, 7510, 7532, 7533, 7523, 7530, 7514, 7502, 7551;
4) Serial Numbers: 100165, 100193, 200041
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated March 27, 2012. Firm intiated recall is ongoing.
REASON
Component defect. The metal blocks which support the scissor slide rails underneath the scanning table (couch) of several of the firm's CT scanning systems were not manufactured to specification and may crack.
VOLUME OF PRODUCT IN COMMERCE
286 units
DISTRIBUTION
Nationwide and PR
PRODUCT
VITROS 5600 Integrated System Software Version 1.6 & Below Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. Product code: 6802413. Recall # Z-1699-2012
CODE
Serial numbers: 56000118 - 56001498
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY, by letter dated April 26, 2012. Firm initiated recall is ongoing.
REASON
Recall because of an anomaly that may inadvertently add a surfactant to a CurveTip position.
VOLUME OF PRODUCT IN COMMERCE
1,357 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
1) IMMULITE --- Insulin --- Catalog Number: LKIN1 (100 test), LKIN5 (500 tests) --- Test Code: INS, Color: Orange Product Usage: For in vitro diagnostic use with IMMULITE and IMMULITE 1000 Systems Analyzers --- for the quantitative measurement of insulin in serum or heparinized plasma, for the management of diabetes. Recall # Z-1700-2012;
2) IMMULITE 2000 --- Insulin --- Catalog Number: L2KIN2 (200 test), L2KIN6 (600 tests) --- Test Code: INS, Color: Orange --- Product Usage: For in vitro diagnostic use with IMMULITE and IMMULITE 1000 Systems Analyzers --- for the quantitative measurement of insulin in serum or heparinized plasma, for the management of diabetes. Recall # Z-1701-2012
CODE
1) Kit lot 0335;
2) Kit lots 312, 313, 314, 315, 316
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Healthcare Diagnostics, Tarrytown, NY, by letter dated April 2012.
Manufacturer: Siemens Healthcare Diagnostics Products Ltd., Caernarfon, United Kingdom. Firm initiated recall is ongoing.
REASON
Siemens Healthcare Diagnostics has observed a negative bias in the Immulite Insulin assay.
VOLUME OF PRODUCT IN COMMERCE
6,433 kits
DISTRIBUTION
Nationwide and Internationally
PRODUCT
1) Monoject Insulin Safety Syringe 3/l0mL 29 X 1/2" Product ID: 8881511144 Indications for Use: Injection of U-1 00 insulin. Recall # Z-1694-2012;
2) Monoject Insulin Safety Syringe 3/10mL 30 X 5/16" Product ID: 8881511344 Indications for Use: Injection of U-1 00 insulin. Recall # Z-1695-2012;
3) Monoject Insulin Safety Syringe 1/2mL 29 X 1/2" Product ID: 8881511136 Indications for Use: Injection of U-1 00 insulin. Recall # Z-1696-2012;
4) Monoject Insulin Safety Syringe 1/2mL 30 X 5/16" Product ID: 8881511336 Indications for Use: Injection of U-1 00 insulin. Recall # Z-1697-2012
CODE
1) Lot Codes: 013816, 017007, 019113, 020608, 029905;
2) Lot Code: 019115;
3) Lot Code: Any lot in the series 015806-033106;
4) Lot Codes: 015605, 034606, 019114
RECALLING FIRM/MANUFACTURER
Recalling Firm: Covidien LLC, Mansfield MA, by letter dated May 21, 2012.
Manufacturer: Covidien, LP, Norfolk, NB. Firm initiated recall is ongoing.
REASON
Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick.
VOLUME OF PRODUCT IN COMMERCE
26,655,000 syringes
DISTRIBUTION
Nationwide, Canada, Australia, Belgium, and Panama
PRODUCT
Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter used in the Genesys Spine Apache" Interbody Fusion System. The TLIF PEEK inserter is used to introduce the TLIF PEEK implant into the patient’s spine by threading the implant onto the tip of the inserter shaft. Once the implant is seated within the vertebrae the inserter is removed by unthreading the inserter from the implant. Model GP200. Recall # Z-1698-2012
CODE
Lot # 1086
RECALLING FIRM/MANUFACTURER
Genesys Orthopedic Systems, LLC, Austin, TX, by telephone on August 24, 2011. Firm initiated recall is complete.
REASON
The inserters have the potential to break.
VOLUME OF PRODUCT IN COMMERCE
4 inserters
DISTRIBUTION
Nationwide
PRODUCT
Knee walker, one unit per box. The intended use is to provide additional mobility to individuals who have difficulty walking. Model number 65960. Recall # Z-1704-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Fimr: Invacare Corp., Elyria, OH, by letter dated May 16, 2012.
Manufacturer: Kenstone Metal Co., Kuhstan City, China. Firm initiated recall is ongoing.
REASON
Adverse event data prompted testing of device, which revealed that the rod supporting the knee pad was not made to specifications. Upon placing a load on the knee pad, the rod may break or bend causing the walker to collapse. As a result, the user may fall.
VOLUME OF PRODUCT IN COMMERCE
1,640 units
DISTRIBUTION
Nationwide and China
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
PRODUCT
Microsoft Amalga UIS 2009 (previously known as Microsoft Amalga Unified Intelligence System), Calculator/data processing module, for clinical use. Microsoft Amalga UIS 2009 enables healthcare providers to create a comprehensive continually updated data ecosystem to aggregate, store, display, and share disparate data either coming from many source systems or directly entered by end users for rapid self-service data exploration and analysis by front line managers, clinicians and ancillary staff. Furthermore, Amalga UIS allows healthcare providers to rapidly create new applications to respond to evolving business and clinical needs. Recall # Z-1702-2012
CODE
R2 release, Service Packs (SP)1, SP2, SP3
RECALLING FIRM/MANUFACTURER
Microsoft Corporation Health Solutions Group, Redmond, WA, by letter dated April 12, 2012. Firm initiated recall is ongoing.
REASON
Microsoft Amalga UIS 2009 has an issue with the display of lab results in the Lab Details window of the lab result viewer. The Lab Details view does not freeze/pin the row header when the user scrolls horizontally.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
Nationwide and China
PRODUCT
Brand Name: QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04 -- Classification Name: System, Environmental Control. The system is a passive behavior-monitoring device. QuietCare uses strategically placed unobtrusive, passive wireless infrared pyroelectric sensors in the senior's residence to detect their movement. Data from these sensors are sent to a base station that periodically transmits the information to a centralized secure file server through standard phone lines over a toll-free number. Sophisticated algorithms analyze the data, learning each individual's normal patterns of behavior. When the system detects significant deviations from these baselines it automatically alerts designated caregivers. QuietCare also generates alerts of late wake-ups, potential bathroom falls and if household temperatures become dangerously low or high. The behavioral changes that the system tracks can often serve as subtle indicators of the potential emerging health problems. These changes include: nighttime bathroom usage, entering or exiting the bedroom at a different time than usual, change in the number of times the refrigerator door is opened/closed change in the number of times the medicine cabinet door is opened/closed. The intended users of the QuietCare device are the caregivers at the Assisted Living Facilities and Independent Living Facilities. The monitored individuals (seniors) do not actively operate the device and the device function is not dependent upon the senior resident's ability to use the device. --- Class 2 device, 510(k) exempt, Device Listing Number D117156. Recall # Z-1703-2012
CODE
Serial Numbers: 020685, 020267, 021542, 018880, 021585, 024179, 022003, 020232, 020272, 024148, 024252, 017044, 017648, 023385, 018651, 024376, 023988, 018567, 017151, 018460, 026701, 021130, 021366, 017735, 019229, 026371, 026317, 018010, 026334, 017471, 019952, 026293, 019476, 026292, 017089, 019953, 026335, 018630, 026439, 026378, 026260, 026239, 022050, 019477, 018379, 024346, 018224, 023936, 020421, 022129, 022216, 018543, 026760, 024270, 021649, 021918, 023465, 023531, 020716, 018962, 020718
RECALLING FIRM/MANUFACTURER
Recalling Firm: Intel-GE Care Innovations LLC, Roseville, CA, by e-mail dated August 12, 2011.
Manufacturer: RDI, Inc., Mount Kisco, NY. Firm initiated recall is complete.
REASON
The QuietCare production system experienced a partial outage from about 15:00 hours until 22:30. During the engineering investigation into the cause of the service disruption, it was discovered that some residents did not have the wander and night motion features properly activated, and alerts were not being transmitted. Failure to generate alerts in a timely manner could result in a missed fall or injury, which could then cause a delayed response time to a resident.
VOLUME OF PRODUCT IN COMMERCE
61 units
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS I
PRODUCT
Tri County Lamb Feed, A Mix For Lambs, the non-medicated feed is packaged in 50 lb. (22.7 kg) uncoded poly bags; Placed on pallets containing 40 x 50 lb bags per pallet. The product is labeled to contain Copper, minimum - 3 PPM and Copper, maximum - 8 PPM. The Feeding Directions read: Work lambs up to full feed gradually. Once lambs are on full feed, feed as much as the .....? Recall # V-074-2012
CODE
Uncoded product.
RECALLING FIRM/MANUFACTURER
Tri-County Feeds, Liberty, KY, by visit and telephone on March 24, 2012. Kentucky initiated recall is ongoing.
REASON
Lamb feed was suspected to have excessive copper content after a producers lamb became ill and died and was examined and found to have high copper levels. The feed was tested by a Kentucky State Inspector and was found to be high in copper.
VOLUME OF PRODUCT IN COMMERCE
40 bags
DISTRIBUTION
KY
END OF ENFORCEMENT REPORT FOR JUNE 6, 2012