Recalling Firm
Community Blood Centers of South Florida, Inc.
Hoxworth Blood Center University of Cincinnati Medical Center
Orthovita, Inc., dBA Stryker Orthobiologics.
Community Blood Bank of Lancaster County Medical Society
Blood Bank Of San Bernardino And Riverside Counties
Nora Apothecary and Alternative Therapies, Inc.

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
Switzerland, ID, Alaska, HI, CA, FL, TN, OR, NY
Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.
USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
CA, IA, MI, MO, NC, NV, NY, OH, PA, TX, UT, WI and Canada
Worldwide Distribution - USA Nationwide and the countries of Canada, Australia, Belgium, Czech Republic, France, French Polynesia, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Jordon, Kuwait, Lebanon, Malawi, Morocco, Namibia, Netherlands, oman, Panama, Paraguay, Qatar, Reunion, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom
USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.
Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
Worldwide Distribution-USA (nationwide) including DC and the states of OH, TX, IL, CA, GA, KY, FL, WI, NC, VA, WI, MN, MD, KS, OK, PA, OR ,HI, AZ, WA, TN, AR, IA, MI, CO, LA, NJ, IN, WV, MO, AL, NY, VT, and SC and the countries of France, Canada, Great Britain, Mexico, Australia, Sweden and Netherlands.
USA Nationwide including the states of CA, FL, IL, MD, MA, NJ, NY, NC, ND, OH, OR, PA, TN, TX, VA, WA, DC and Puerto Rico
Worldwide Distribution - USA Nationwide including Puerto Rico and countries of: UK, CHL, ENG, BEL, ITA, TKY, BEL, LIT, LTV, EGY, SPG, HOK, SWE, MEX, UAE, COR, ISR, MAL, AUS, POR, POL, SLN and STQ.
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AZ, CA, CO, CT, FL, IL, IN, IO, GA, KS, KY, LA, MD, MN, MS, MO, NK, NV, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN , TX, VT, VA, WA, and WV, and the countries of Guatemala, Poland, Panama, and United Kingdom.
Worldwide distribution - USA Nationwide and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom.
Meijer stores (201) located in Illinois, Indiana, Kentucky, Michigan, and Ohio may have received product from Meijer distribution centers.
Worldwide Distribution - USA Nationwide and countries of: Australia, Japan, Korea, Singapore and United Kingdom.
Worldwide Distribution- USA Nationwide and countries of: Argentina, Australia,Canada, Chile, China, Czech Republic, Egypt, India, Israel, Italy,Korea-Republic of, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Thailand, Turkey, and Venezuela.
Worldwide Distribution - USA including AL, GA, MI, MN, NC, ND, OH, PA, SD, VA, VT, OH, TX, MA, and Internationally to Korea.
Worldwide Distribution - USA Nationwide and tthe countries of Australia, Canada, Europe, Hong Kong, Mexico, New Zealand, Singapore, and Taiwan.
Worldwide Distribution-USA Nationwide and countries of: AU, CA, DE, ES, GB, IT, PT, and JP.
USA Nationwide Distribution including the states of: IL, GA, CA, NY OH, AZ, TX, NE, FL, PA, NC, WI, AL, IN, CO, MO, MT, NE, MA, VA, AK, IN, MI, NJ, MD, TN, CT, WA, MN
Worldwide distribution - USA (nationwide) and Chile.
Worldwide Distribution - USA including Connecticut, Florida, Massachusetts, Missouri, New York, Ohio, and foreign distribution to(Canada, Italy, Australia, Germany, Netherlands, and Switzerland.
Worldwide Distribution - US Nationwide and the countries of: Germany, France, Bulgaria, India, Colombia, Tunisia, Saudi Arabia, Finland, Denmark, Brasil, Italy, Estonia, South Korea, Russia, Greece, Thailand, Israel, Poland, Turkey, Slovakia, Portugal, Switzerland, Hungary, Great Britain, Netherlands, China, Indonesia, Australia, Sweden, Spain, Iran, Singapore, Norway, Austria and Czech Republic.
Worldwide Distribution-USA (nationwide) including the states of AL, CA, CO, FL, IL, KY, MI, MS, NJ, NY, PA, TX, UT, VA, WA, and WI, and the countries of Austria, Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Norway, Qatar, Romania, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Saudi Arabia, Singapore, and Venezuela.
Michigan, Oregon, Colorado, and New Jersey

Product Description
Blood and Blood Products for Reprocessing
Red Blood Cells Leukocytes Reduced Irradiated
Red Blood Cells (Apheresis) Leukocytes Reduced
Red Blood Cells Leukocytes Removed Washed
Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. ICON Novo: ICONNAN, ICONNAN-HT, ICONNAJ. ICON Premo: ICONPBN, ICONPBN-HT, ICONPBN-HTC. The ICON CPAP unit is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory. The device is not intended to be used as a life supporting device.
Platelets Pheresis Leukocytes Reduced Irradiated
Preserved Apricots -- NET WEIGHT 300gr (10.6oz) -- Ingredient: Salt, apricot, refined sugar. Firm on label: packed for Hong Lee Trading Inc., 225 Johnson Ave., Brooklyn, NY 11203. Product of Vietnam.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4'', Part Number 2090-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 6'', Part Number 2090-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4'', Part Number 2090-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6'', Part Number 2090-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4'', Part Number 2110-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8'', Part Number 2110-0526 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6'', Part Number 2110-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamond Needle, 4'', Part Number 2110-0506 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8'', Part Number 2110-0525 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6'', Part Number 2110-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 8'', Part Number 2110-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 6'', Part Number 2110-0524 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6'', Part Number 2110-0503 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Whole Foods Mini Peanut Butter Cookies 12 pack sold in small, plain brown bags featuring a cellophane window on the front with an oval Whole Foods Market sticker that reads ''mini peanut butter cookies - OLD-FASHIONED TREATS FROM WHOLE FOOD MARKET-'' PLU 22096100000
Whole Foods 3 oz Peanut Butter Cookies sold under PLU 47963 from the retail store self-serve pastry case.
Whole Foods 3 oz Peanut Butter Chocolate Chunk Cookies sold under PLU 47963 from the retail store self-serve pastry case.
Peanut Butter Ribbon, 40 lb Pail, Item Numbers 07-012-40, 07-212-40, and 49-00100-40, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212
Peanut Butter Crunch, 45 lb Case, Item Number 01-326-45, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212
Peanut Butter Fudge Ribbon, 50 lb Pail, Item Number 07-094-50, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212
Chunky Peanut Butter Ribbon, 40 lb Pail, Item Number 07-712-40, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212
Peanut Butter Base, 30 lb Pail, Item Numbers 08-010-30, 08-310-30, and 08-810-30, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212
Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF).
45 mm Screw, Item #BG7045 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Set Screw, Item #BG3010 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
50 mm Rod, Item #BG1650 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
60 mm Rod, Item #BG1660 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11mm 12mm x 27mm x 12mm 12mm x 27mm x 13mm 12mm x 27mm x 14mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9mm 7 deg 14 x 11 x 10mm 7 deg 14 x 11 x 11mm 7 deg 14 x 11 x 12mm 7 deg Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copperhead IBFD, Large Neutral, 8mm Copperhead IBFD, Large Neutral, 9mm Copperhead IBFD, Large Neutral, 10mm Copperhead IBFD, Large Neutral, 11mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, cemented, #2, left 2103-1320 Femoral component, CR, cemented, #3, left 2103-1330 Femoral component, CR, cemented, #4, left 2103-1340 Femoral component, CR, cemented, #5, left 2103-1350 Femoral component, CR, cemented, #6, left 2103-1360 Femoral component, CR, cemented, #1, right 2103-1410 Femoral component, CR, cemented, #2, right 2103-1420 Femoral component, CR, cemented, #3, right 2103-1430 Femoral component, CR, cemented, #4, right 2103-1440 Femoral component, CR, cemented, #5, right 2103-1450 Femoral component, CR, cemented, #6, right 2103-1460 Femoral component, PS, #1, left 2103-3110 Femoral component, PS, #2, left 2103-3120 Femoral component, PS, #3, left 2103-3130 Femoral component, PS, #4, left 2103-3140 Femoral component, PS, #5, left 2103-3150 Femoral component, PS, #6, left 2103-3160 Femoral component,PS, #1, right 2103-3210 Femoral component,PS, #2, right 2103-3220 Femoral component,PS, #3, right 2103-3230 Femoral component,PS, #4, right 2103-3240 Femoral component,PS, #5, right 2103-3250 Femoral component,PS, #6, right 2103-3260 Variety of hip and knee implants and instruments, multiple uses.
Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cemented,#3 2203-3030 Tibial baseplate,cemented,#4 2203-3040 Tibial baseplate, cemented, #5 2203-3050 Tibial baseplate, cemented, #6 2203-3060 Tibial insert,CR,plained,#1,9mm 2303-1211 Tibial insert,CR,plained,#1,11mm 2303-1212 Tibial insert,CR,plained,#1,13mm 2303-1213 Tibial insert,CR,plained,#1,15mm 2303-1214 Tibial insert,CR,plained,#1,18mm 2303-1215 Tibial insert,CR,plained,#2,9mm 2303-1221 Tibial insert,CR,plained,#2,11mm 2303-1222 Tibial insert,CR,plained,#2,13mm 2303-1223 Tibial insert,CR,plained,#2,15mm 2303-1224 Tibial insert,CR,plained,#2,18mm 2303-1225 Tibial insert,CR,plained,#3,9mm 2303-1231 Tibial insert,CR,plained,#3,11mm 2303-1232 Tibial insert,CR,plained,#3,13mm 2303-1233 Tibial insert,CR,plained,#3,15mm 2303-1234 Tibial insert,CR,plained,#3,18mm 2303-1235 Tibial insert,CR,plained,#4,9mm 2303-1241 Tibial insert,CR,plained,#4,11mm 2303-1242 Tibial insert,CR,plained,#4,13mm 2303-1243 Tibial insert,CR,plained,#4,15mm 2303-1244 Tibial insert,CR,plained,#4,18mm 2303-1245 Tibial insert,CR,plained,#5,9mm 2303-1251 Tibial insert,CR,plained,#5,11mm 2303-1252 Tibial insert,CR,plained,#5,13mm 2303-1253 Tibial insert,CR,plained,#5,15mm 2303-1254 Tibial insert,CR,plained,#5,18mm 2303-1255 Tibial insert,CR,plained,#6,9mm 2303-1261 Tibial insert,CR,plained,#6,11mm 2303-1262 Tibial insert,CR,plained,#6,13mm 2303-1263 Tibial insert,CR,plained,#6,15mm 2303-1264 Tibial insert,CR,plained,#6,18mm 2303-1265 Tibial insert, PS , #1, 9mm 2303-3011 Tibial insert, PS , #1, 11mm 2303-3012 Tibial insert, PS , #1, 13mm 2303-3013 Tibial insert, PS , #1, 15mm 2303-3014 Tibial insert, PS , #1, 18mm 2303-3015 Tibial insert, PS , #2, 9mm 2303-3021 Tibial insert, PS , #2, 11mm 2303-3022 Tibial insert, PS , #2, 13mm 2303-3023 Tibial insert, PS , #2, 15mm 2303-3024 Tibial insert, PS , #2, 18mm 2303-3025 Tibial insert, PS , #3, 9mm 2303-3031 Tibi
UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE Patella,X-large 2401-1040 UKNEE Onset Patella, 3 pegs, x-small 2403-1010 UKNEE Onset Patella, 3 pegs, small 2403-1020 UKNEE Onset Patella, 3 pegs, medium 2403-1030 UKNEE Onset Patella, 3 pegs, large 2403-1040 UKNEE Onset Patella, 3 pegs,X-large 2403-1050 Variety of hip and knee implants and instruments, multiple uses.
U2 Acetabular cup, Ti beads porous coated, 44mm U2 Acetabular cup, Ti beads porous coated, 46mm U2 Acetabular cup, Ti beads porous coated, 48mm U2 Acetabular cup, Ti beads porous coated, 50mm U2 Acetabular cup, Ti beads porous coated, 52mm U2 Acetabular cup, Ti beads porous coated, 54mm U2 Acetabular cup, Ti beads porous coated, 56mm U2 Acetabular cup, Ti beads porous coated, 58mm U2 Acetabular cup, Ti beads porous coated, 60mm U2 Acetabular cup, Ti beads porous coated, 62mm U2 Acetabular cup liner assembly, 10hooded,44mm U2 Acetabular cup liner assembly, 10hooded,46mm U2 Acetabular cup liner assembly, 10hooded,48mm U2 Acetabular cup liner assembly, 10hooded,50mm U2 Acetabular cup liner assembly, 10hooded,52mm U2 Acetabular cup liner assembly, 10hooded,54mm U2 Acetabular cup liner assembly, 10hooded,56mm U2 Acetabular cup liner assembly, 10hooded,58mm U2 Acetabular cup liner assembly, 10hooded,60mm U2 Acetabular cup liner assembly, 10hooded,62mm Variety of hip and knee implants and instruments, multiple uses.
Femoral head, standard, 26mm, +0mm Femoral head,medium, 26mm,+3mm Femoral head, long, 26mm, +6mm Femoral head, X-long, 26mm, +9mm Femoral head, 28mm, -3mm Femoral head, 28mm, +0mm Femoral head, 28mm, +5mm Femoral head, 28mm, +10mm Femoral head, 32mm, -3mm Femoral head, 32mm, +0mm Femoral head, 32mm, +5mm Femoral head, 32mm, +10mm Femoral head, 36mm, -3mm Femoral head, 36mm, +0mm Femoral head, 36mm, +5mm Femoral head, 36mm, +10mm Variety of hip and knee implants and instruments, multiple uses.
Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, OD46mm Bipolar Cap, ID28mm, OD48mm Bipolar Cap, ID28mm, OD50mm Bipolar Cap, ID28mm, OD52mm Bipolar Cap, ID28mm, OD54mm Bipolar Cap, ID28mm, OD56mm
Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone screw,25mm Co-Cr cancellous bone screw,30mm Co-Cr cancellous bone screw,35mm Co-Cr cancellous bone screw,40mm Variety of hip and knee implants and instruments, multiple uses.
Zweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard Sz 00 Zweimueller Type Stem SCS-Standard Sz 1 Zweimueller Type Stem SCS-Standard Sz 2 Zweimueller Type Stem SCS-Standard Sz 3 Zweimueller Type Stem SCS-Standard Sz 4 Zweimueller Type Stem SCS-Standard Sz 5 Zweimueller Type Stem SCS-Standard Sz 6 Zweimueller Type Stem SCS-Standard Sz 7 Zweimueller Type Stem SCS-Standard Sz 8 Zweimueller Type Stem SCS-Standard Sz 9 Zweimueller Type Stem SCS-Standard Sz 10 Zweimueller Type Stem SCL-Lateralized Sz 3 Zweimueller Type Stem SCL-Lateralized Sz 4 Zweimueller Type Stem SCL-Lateralized Sz 5 Zweimueller Type Stem SCL-Lateralized Sz 6 Zweimueller Type Stem SCL-Lateralized Sz 7 Zweimueller Type Stem SCL-Lateralized Sz 8 Zweimueller Type Stem SCL-Lateralized Sz 9 Zweimueller Type Stem SCR-Revision Sz 3 Zweimueller Type Stem SCR-Revision Sz 4 Zweimueller Type Stem SCR-Revision Sz 5 Zweimueller Type Stem SCR-Revision Sz 6 Zweimueller Type Stem SCR-Revision Sz 7 Zweimueller Type Stem SCR-Revision Sz 8 Zweimueller Type Stem SCR-Revision Sz 9 Zweimueller Type Stem SCR-Revision Sz 10 Zweimueller Type Stem SCR-Revision Sz 11 Variety of hip and knee implants and instruments, multiple uses.
Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 Short CERAMIC Ball Head, 32 Medium CERAMIC Ball Head, 32 Long CERAMIC Ball Head, 28 Short CoCr Ball Head, 28 Medium CoCr Ball Head, 28 Long CoCr Ball Head, 28 X-Long CoCr Ball Head, 28 XX-Long CoCr Ball Head, 32 Short Ball Head, 32 Medium Ball Head, 32 Long
Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets each, Rx only, TEVA Women Health, Inc., Subsidiary of TEVA Pharmaceuticals USA, Inc., Sellersville, PA NDC 51285-058-66
Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and Ethinyl Estradiol 0.01 Tablets, 2 Extended-Cycle Tablet Dispensers (NDC 0093-3134-82) and 1 Extended-Cycle Tablet Dispenser NDC 0093-3134-91), 91 Tablets Each, Rx only, TEVA Womens Health Inc., Subsidiary of TEVA Pharmaceuticals, Inc., Sellersville, PA
***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
Camila 0.35 mg Tablets, 6 cards of 28 pills, Dist. By: Physicians Total Care, Tulsa, OK --- NDC 54868-4814-0, MFG By TEVA Pharmaceuticals USA, Sellersville, PA
7th Heaven Bakeries Oatmeal Raisin Cookie, 7th Heaven Bakeries, Oklahoma City, OK
Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Made in India
Bimix Inj 30 :1 Syr, 12x1.5 ml syr, 10x1.2 ml syr, 2x2 ml syr, 2x1 ml syr, 12x.05 ml syr Penile Injection,30 and 90 day expiration,
Bimix Inj 30:0.5 MDV, 5 ml syr Penile Injection, 90 day expiration,
Bimix Inj 30:1 MDV: 5ml, 10 ml, 3x10ml, 2x10ml Penile Injection, 30 and 90 day expiration,
Papaverine Inj 30mg/ml Syr, 5mlsyr, 10mlsyr,10x0.95mlsyr Penile Injection, 90 day expiration,
PGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection, 90 day expiration,
PGE-1 Inj 20mcg/ml MDV: 5ml, 7ml, 10ml, 20ml Penile Injection, 90 day expiration,
PGE-1 Inj 30mcg/ml MDV, 7 ml Penile Injection, 90 day expiration,
PGE-1 Inj 40mcg/ml MDV, 5 ml Penile Injection, 90 day expiration,
Trimix Inj 30:1:10 MDV, 5 ml Penile Injection, 30 and 90 day expiration,
Trimix Inj 30:1:20 MDV: 5 ml, 10 ml, 2x5 ml Penile Injection, 30 and 90 day expiration,
Trimix Inj 30:1:40 MDV, 5 ml Penile Injection, 30 and 90 day expiration,
Trimix Inj 30:3:5 MDV, 10ml Penile Injection, 90 day expiration,
Trimix Inj 4.25ml Form MDV Penile Injection, 90 day expiration,
Super Trimix #1 Inj MDV, 12 ml Penile Injection, 90 day expiration,
Vancomycin Opth Soln 25mg/ml PF, 10ml Opthalmic Soln, 10 day expiration,
Vancomycin Opth Soln 30mg/ml PRES, 10ml Opthalmic Soln, 30 day expiration,
Vancomycin Opth Soln14mg/ml PF, 10ml Opthalmic Soln, 30 day expiration,
Tobramycin Opth Soln 14mg/ml, 7ml Opthalmic Soln, 10 day expiration,
Tobramycin Opth Soln 13mg/ml, 7ml Opthalmic Soln, 10 day expiration,
Chlorhexidine Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration,
Dexamethasone Opth Soln 0.1% PF, 10 ml Opthalmic Soln, 30 day expiration,
PHMB Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration,
Folic Acid Inj 5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration,
HCG Inj 1000un/ml MDV: 4ml, 8 ml Subcutaneous, 30 day expiration,
HCG Inj 1200un/ml MDV, 10 ml Subcutaneous, 30 day expiration,
HCG Inj 1250 un/ml MDV, 4 ml Subcutaneous, 30 day expiration,
HCG Inj 500un/ml MDV, 5 ml Subcutaneous, 30 day expiration,
Hydroxycobalamin Inj 1000mcg/ml MDV: 10 ml, 15 ml, 20 ml, 30 ml Subcutaneous, 90 day expiration,
Hydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration,
Hydroxycobalamin Inj 2500 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration,
Methylcobalamin Inj 1mg/ml MDV, 10 ml, 15 ml, 20 ml, 30 ml, 4x30 ml Subcutaneous, 90 day expiration,
Methylcobalamin Inj 5mg/ml MDV: 5 ml, 10 ml, 12 ml, 20 ml Subcutaneous, 90 day expiration,
Methylcobalamin 5mg/ml Inj Syr, 10x0.4syr Subcutaneous, 90 day expiration,
Methylcobalamin Inj 2.5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration,
Methylcobalamin Inj 25mg/ml Syr: 8x0.06mlsyr, 10x0.06 ml syr, 12x0.06 ml syr Subcutaneous, 30 and 90 day expiration,
Hydroxyprogesterone Inj 250mg/ml MDV, 5 ml Intramuscular, 30 day expiration,
Renacidin Irrigation: 1000 ml,1120ml Bladder Irrigation, 30 day expiration,
Gentamicin 24mg/60ml Irrigation, 15x60ml Syr Irrigation, 14 day expiration,
Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expiration
M.I.C.+B12 Inj MDV: 3x50ml, 4x50 ml 90 day expiration,
Lidocaine 2% Inj MDV, 20 ml 30 day expiration,
Meperidine 100mg/ml MDV, 5ml 90 day expiration,
Pyridoxine 100mg/ml Inj MDV, 1X30 ml 30 day expiration,
QuietCare-Networked. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia.
Alere'' hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine, as an aid in the early detection of pregnancy. It is for healthcare professionals only.
Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.
PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals with diabetes to measure glucose in whole blood
EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.
Asthmanefrin Starter Kit contains ten (10) Asthmanefrin vials and one (1) EZ Breathe Atomizer. For the delivery of liquid medications for respiratory usage.
EZ Breathe Medication Cup. For the delivery of liquid medications for respiratory usage.
Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad- 500 072 India
Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional (open) procedures that utilize a cervical incision because they leave no visible neck scar.
Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the Monopolar Curved Scissors instrument so that FR energy is only available at the scissors blades.
Meijer Diced Pears in Fruit Juice 8oz cup
Meijer Diced Peaches in Fruit Juice 8oz cup
Meijer Mandarin Oranges in Fruit Juice 8oz cup
Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body.
Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.
da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.
Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /ECG Monitoring electrodes Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies.
Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes. Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies.
BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria.
BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic aid for gram-negative bacteria.
User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral Otolaryngology Surgery.
Red Bone Alley Restaurant Wasabi All Natural Sauce for all Seafood & Chicken, Net Wt. 12 fl oz. Distributed by: Red Bone Alley Foods, LLC, 1903 W. Palmetto Street, Florence, SC 29501. Clear Plastic (Pet) Ring Neck Round bottle with neck band with white screw top cap. 6/12oz bottles= 1 case.
AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood.
AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597005, 2) AngioDynamics 5F Standard Micro-Introducer Kit, Sterile, Catalog number: 06597012; 3) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597013; 4) AngioDynamics 5F Standard Micro- Introducer Kit, Sterile, Catalog Number: 06597018; and 5) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597019. Product kits are individually wrapped in plastic, 10 units included per box. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling: 1) Gold-Tipped Fiber 45cm Kit, Catalog Number: 11403301; 2) Gold-Tipped Fiber 65cm Kit, Catalog Number: 11403302; 3) Gold-Tipped Fiber 90cm Kit, Catalog Number: 11403304. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usage: Used by trained professionals in hospitals, doctors offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring.
Talenti Roman Raspberry Sorbetto, 16fl oz, Crafted by Talenti, Marietta, GA 30062
RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
Leucadia Autolok'' Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.
8mm Precise Bipolar Forceps used in conjunction with the da Vinci S Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
8mm Maryland Bipolar Forceps used in conjunction with the da Vinci S Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci S Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
next by Nature brand DARK CHOCOLATE BANANAS, NET WT. 3 Oz. (85g), UPC 8 17582 25600 4, Produced by Tropical Valley Foods
GRATED 2/25 GRANA PADANO; Lot Code: 313701A01; Pack Size: 2/25#; Net Pounds: 50; PACK DATE: 05/18/13; ITEM#DGP03; arthur schuman inc, 40 new dutch lane fairfield nj 07004 U.S.A.; 937-227-0030 www.arthurschuman.com;

Code Info
Manufacturer Part Number 2090-0502, Lot Number Q1006003
Manufacturer Part Number 2090-0505, Lot Number A1006027
Manufacturer Part Number 2090-0501, Lot Numbers A1109035 and Q1006002
Manufacturer Part Number 2090-0504, Lot Numbers A1006026 and A1111020
Manufacturer Part Number 2110-0505, Lot Numbers E909002 and E909002R
Manufacturer Part Number 2110-0526, Lot Numbers E908004R and E908004
Manufacturer Part Number 2110-0501, Lot Numbers E909004R and E909004
Manufacturer Part Number 2110-0506, Lot Number E909005R
Manufacturer Part Number 2110-0525, Lot Numbers E909006R
Manufacturer Part Number 2110-0504, Lot Number E909007R
Manufacturer Part Number 2110-0502, Lot Number E909008R
Manufacturer Part Number 2110-0524, Lot Number E909009R and E909009R
Manufacturer Part Number 2110-0503, Lot Numbers E908003R and E908002
All cookies sold before September 29, 2012, manufactured from May 1, 2012 to September 24, 2012
All cookies sold before September 29, 2012, manufactured from May 1, 2012 to September 24, 2012,
All cookies sold before September 29, 2012, manufactured from May 1, 2012 to September 24, 2012.
Physicians Total Care Lots: 6Z4C Exp. 10/31/2013
All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Lot/Unit Codes: hCG1110133 & hCG1110135 Part Number: 92215 Expiration date, or Expected shelf life: 9/30/13 & 10/31/13
UPC: 71373337044 and All lots produced from November 29, 2012 through January 2, 2013.
UPC: 71373337017 and All lots produced from November 29, 2012 through January 2, 2013.
UPC: 88692601216 and All lots produced from November 29, 2012 through January 2, 2013.
Catalog Number 6937B002AA. All serial numbers from the first unit onward.
PYR kit - lot 2276481 with expiration date 09/30/13
Oxidase kit - lot 2222008 with expiration date 08/31/13
Corresponding Lot numbers: 1) 588918 (Expiration date 01/2016), 2) 588927 (Expiration date 12/2015), 3) 588915 (Expiration date 01/2016), 4) 588913 (Expiration date 12/2015) and 5) 588930 (Expiration date 01/2016).
Corresponding Lot numbers: 1) 588948, 2) 588495 and 3)588480. Expiration date for these lot numbers: 12/2013.
Software version and build numbers 2.0.0.15, 2.5.1.89, and 3.0.0.251 (to determine if the version used is affected, bring up the About box in the RayStation application and check the build number reported0.
Product Code: ARG07146JP; Lot No.: 311501A01

Product Quantity
Domestic(1,760 units): 1)260 units/26 boxes, 2)310 units/31 boxes,3)260 units/26 boxes,4)880 units/88 boxes,5)60 units/6 boxes,Foreign:10 units/1 box
Domestic Only: 1) 300 units, 2) 300 units, 3) 151 units.
US: 10,410 pieces; Outside US: 100 pieces

Reason for Recall
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Blood products, labeled leukoreduced which did not meet the requirements for leukoreduced products, were distributed.
Blood products, which did not meet the specified pH for platelets, were distributed.
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed.
Blood products, collected from a donor who was permanently deferred after testing reactive for Hepatitis B surface antigen (HbSAg), were distributed.
Blood product, manufactured from Whole Blood units that may have had an extended collection time, was distributed.
Blood product, which was not manufactured in accordance to acceptable product specifications, was distributed.
Blood products, collected from a donor whose temperature was not documented, were distributed.
Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Blood products, with unacceptable, undocumented, or incomplete product QC, were distributed.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Blood products, collected from a donor who emigrated from an area considered at risk for human immunodeficiency virus (HIV) Group O, were distributed.
Blood products, which were not screened for antibodies according to the reagent manufacturer's instructions, were distributed.
Blood products, collected from a donor whose close contact with partner who emigrated from an area at risk for HIV-Group O, were distributed.
Blood products, which may have been exposed to unacceptable temperature during storage, were distributed.
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
Fisher and Paykel Healthcare is recalling the ICON CPAP units because there is a potential power issue on certain ICON CPAP. These ICON CPAP units could potentially become inoperable, which would result in a lack of treatment to the patient's obstructive sleep apnea symptoms until a replacement unit is obtained.
Blood product, which may have been contaminated during collection, was distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood products, collected using a copper sulfate solution which had unacceptable specific gravity QC results were distributed.
Blood products, collected using a copper sulfate solution which had unacceptable specific gravity QC results, were distributed.
Blood products, labeled 'leukocytes reduced' which did not meet the QC requirements for leukoreduced products, were distributed.
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
Blood products, collected from a donor who was previously deferred for possibly exposure to vCJD, were distributed.
Blood products, collected using equipment that had not been validated, were distributed.
Blood products, collected from a donor who was previously deferred after receiving a tattoo within a year of donating, were distributed.
The product contained undeclared sulfites (108.8 ppm) and undeclared Yellow #5 based on sampling and analysis by New York State Department of Agriculture and Markets.
There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
The cookies were manufactured using peanut butter recalled by Sunland, Inc. for salmonella
The cookies were manufactured using peanut butter recalled by Sunland, Inc. for salmonella.
The Peanut Butter products were manufactured using peanut butter recalled by Sunland, Inc. for salmonella.
The Peanut Butter Ribbon and Chunky Peanut Butter Ribbon were manufactured using peanut butter recalled by Sunland, Inc. for salmonella.
The macadamia nuts have the potential to be contaminated with Salmonella.
Beckman Coulter initiated the recall for the Lactate Assay (LACT) Lot M206209 as they received a customer complaint of error message (RXN RATE HI), i.e. no numerical values reported for samples containing Lactate concentration greater than 6.5 mmol/L.
The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed.
Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed.
Blood products, collected from a donor with a history of Hepatitis A, were distributed.
Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.
Zimmer is initiating a lot specific recall of the Trabecular Metal'' Tibia Stop Drill due to the potential of the outside diameter being oversized. As a result, there is a potential for the drill to not pass through the applicable drill guide.
The firm initiated recall of Alere'' hCG Combo Cassette (20/10 mIU/mL) kit PN 92215, lots hCG1110133 and hCG1110135, because an investigation has indicated a portion of these Alere'' hCG Combo Cassette (20/10 mIU/mL) PN 92215 kit lots were incorrectly packaged with the Alere'' hCG Cassette (20 mIU/mL) PN 92210 Product Insert. The Alere'' hCG Cassette (20 mIU/mL) Product Insert contains information for hCG urine testing but lacks information for performing the hCG serum testing using the Alere'' hCG Combo Cassette product.
Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0.
Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk.
Possible dislodgement of the ''Plate A'', if this instance occurs, it presents a potential choking hazard.
Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label
Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).
Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System.
Meijer Diced Pears in Fruit Juice, Meijer Diced Peaches in Fruit Juice, and Meijer Mandarin Oranges in Fruit Juice 8 oz (226g) labels were developed, the Serving Size was updated to 1 cup (226g) but the nutrition facts still reflect the 4 oz (113g) information.
Canon Inc. had received 17 claims from our foreign sales companies between October to November 2012 that measurement value of RK-F2s refractive power (SPH value) sometimes indicated abnormal value which occurs approximately 5% in probability.
Clarification of existing labeling information and operating procedures.
On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installed in August 2012. The result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient.
In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.
Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it was determined that the tubing/joint connections associated with these MODs may leak concentrated detergent. Beckman Coulter has received complaints that the joint connecting the tubing appears to disintegrate over time, causing a leak.
AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit could be the incorrect French size.
AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit could be the wrong French size.
TZ Medical Inc is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible transparent defibrillation electrodes because it may contain a defective white wire on the connector assembly. If a failure were to occur, the end user would be able to identify the failure by inspecting the white wire 1/4 inch from the Gray Medtronic / Physio adapter. The consignees will notice discoloration in the protective plastic jacket.
Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avoid incorrect dose calculations during treatment planning.
Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape.
Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia'' Autolok set screw may interfere with the top of the screw head prior to fully locking the rod. If this condition occurs, the polyaxial screw head and rod may fail to provide a rigid construct under loading. To date there have been no reports of patient injury, adverse events or complaints received for this issue.
Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the presence of a software bug.
Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments.
The product contains the undeclared allergens walnuts and milk.
Grated Grana Padano Hard Italian Cheese was tested and found to be positive for Listeria monocytogenes.