Blood products, collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood products, possibly contaminated with air, were distributed.
Blood products, collected from a donor who traveled to a malaria endemic area, were distributed.
Blood products, collected using an expired blood collection set, were distributed.
Blood product, collected from a donor who traveled to a malaria endemic area, was distributed.
Blood product, collected from a donor who was at risk for leishmaniasis, was distributed.
Blood products, manufactured from Whole Blood units with extended collection times, were distributed.
Red Blood Cells Leukocytes Reduced Washed
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Hoxworth Blood Center University of Cincinnati Medical Center
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood products, for which there was no documentation for the time period out of controlled storage, were distributed.
Blood product, which were collected from a donor who traveled to a malarial endemic area, was distributed.
Blood products, which were not quarantined subsequent to receiving information regarding a post donation illness, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, recovered from an ineligible donor, was distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Blood Products, in which Antibody Screen Testing was performed incorrectly, were distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood product, labeled with incorrect expiration date and product code, was distributed.
Blood product, possibly contaminated with air, was distributed.
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood and Blood Products for Reprocessing
Blood products, collected from a donor who traveled to a malarial and leishmaniasis endemic area, were distributed.
Blood products, which reached unacceptable temperatures during storage, were distributed.
Blood products, collected from a donor with a history of high risk behavior, was distributed.
Blood products, not prepared in accordance with specifications, were distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood products, collected from a donor with a history of brain surgery, were distributed.
Vegetarian Burger Mix, Item #VB 100, Pack size: 25lbs.
Good Source Solutions is recalling Vegetarian Burger Mix because it may be contaminated with Salmonella.  The recalled product contains Soy Protein Isolate that is on recall by CHS Inc. for Salmonella.
Blood product, labeled as leukoreduced but failed to meet QC levels for White Blood Cell counts, was distributed.
ALYMAQ EXTRA FINE GRANULATED SUGAR AIB, www.alymaq.com, NET WT. 50 LBS. (22.68KG), KEEP IN A COOL AND DRY PLACE.  Multi-wall polyethylene lined bag. 55 bags per pallet.
Product has the potential to contain plastic fragments.
Blood products, collected from a donor who may be at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Contained within the tray are hand controller sheaths which are intended to enable increased flow control (when compared to hand injection) but with the feel of a hand syringe. It provides more control over the total volume delivered by allowing the physician to adjust contrast delivery during the injection and monitor total volume delivered to the patient.
Custom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the seal between the white polyethylene and the clear plastic may be missing on the package resulting in a potential breach of the sterility of this accessory.
Hoxworth Blood Center  UC Medical Center
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood product, which did not meet the acceptable product specifications, was distributed.
Acetylcysteine 10 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABCAFBA:73, Exp date: 9/30/2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Acetylcysteine 20 % solution, 100 ml bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABCAJBA:76, Exp date: 10/4/2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Acetylcysteine 2 % Solution,  Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABDBDAC:98, Exp date: 8/12/2013
Cataract drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABDAEAC:07, Exp date: 5/5/2013; Lot number  CABCCIBC:44, Exp date: 3/28/2013
Cyclosporine 1% ophthalmic drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABCBEBB:35, Exp date: 5/13/2013; Lot number CABACAB:76 Exp date: 7/1/2013; Lot number CABDAIAB:78, Exp date: 4/8/2013; Lot number CABDAEAC:80, Exp date: 5/5/2013 and Lot number CABDCCAC:31, Exp date: 5/23/2013.
Cyclosporine 2% ophthalmic, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABCCIBC:89, Exp date: 3/28/2013; Lot number CABDBEAB:07, Exp date: 4/14/2013; Lot number CABDCIAB:42, Exp date: 4/28/2013 and Lot number CABDCCAC:37, Exp date: 5/23/2013.
Diazepam 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABDBGAB:84, Exp date: 4/16/2013 and Lot number CABDAIAC:45, Exp date: 5/9/2013.
Estradiol Cypionate 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABCACBA:20, Exp date: 3/31/2013; Lot number CABCABBB:22, Exp date: 4/30/2013; Lot number CABCBJBB:25, Exp date: 5/18/2013 and Lot number CABDAFAC:79, Exp date: 8/4/2013.
Estradiol Valerate 20 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABCADBA:96, Exp date: 4/1/2013 and Lot number CABCAIBA:31, Exp date: 4/6/2013.
Estradiol Valerate 30 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABCBFBB:12, Exp date: 5/14/2013 and Lot number CABDAIAD:28, Exp date: 9/4/2013.
Gentamicin buffered 36.4 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABCAFBB:81, Exp date: 5/4/2013; Lot number CABCCEAJ:85 Exp date: 3/23/2013 and Lot number CABDCFAC:25 Exp date: 8/24/2013.
HCG 1000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABDAHAD:04 Exp date: 5/6/2013.
HCG 2000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABDAJAB:54, Exp date: 3/10/2013 and Lot number CABDABAC:38, Exp date: 5/31/2013.
HCG 500 units/ml, 10 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABDBDAC:06, Exp date: 4/14/2013.
Hydroxyprogesterone 250 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABDAIAB:64, Exp date: 4/8/2013; Lot number CABDAEAB:21, Exp date: 4/4/2013; Lot number CABDBIAB:75, Exp date: 4/18/2013; Lot number CABDAEAC:00, Exp date: 5/5/2013 and Lot number CABDJAC:67, Exp date: 5/20/2013.
Injection vehicle, 120 ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABCCHBB:59, Exp date: 5/26/2013.
Itraconazole 1% eye ointment, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABDCBAC:71, Exp date: 3/23/2013 and Lot number CABDCGAC:35, Exp date: 3/28/2013.
Laser ophthalmic drops, 12 mL bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABCCIBC:20, Exp date: 3/28/2013 and Lot number CABDAEAC:90, Exp date: 3/5/2013.
Latanoprost 0.025% eye drop, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABDAFAD:09, Exp date: 5/4/2013
Medroxyprogesterone 150 mg/ml,Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABDDBAB:21, Exp date: 7/30/2013; Lot number CABCBBBA:65, Exp date: 4/9/2013; Lot number CABCBBBA:77, Exp date: 4/9/2013; Lot number CABCBBBA:20 , Exp date: 4/9/2013; Lot number CABCCFBA:42, Exp date: 4/23/2013; Lot number CABCCFBA:59, Exp date: 4/23/2013; Lot number CABCCFBA:76, Exp date: 4/23/2013; Lot number CABCCFBA:85, Exp date: 4/23/2013; Lot number CABCCHBB:28, Exp date: 5/23/2013; Lot number CABCCHBB:46, Exp date: 5/23/2013; Lot number CABCCHBB:87, Exp date: 5/26/2013; Lot number CABCCHBB:30, Exp date: 5/26/2013; Lot number CABCBJBC:92, Exp date: 6/17/2013; Lot number CABCBJBC:93, Exp date: 6/17/2013; Lot number CABCBJBC:31, Exp date: 6/17/2013; Lot number CABDAIAC:21, Exp date: 8/7/2013; Lot number CABDDBAB:05, Exp date: 7/30/2013; Lot number CABDDBAB:03, Exp date: 7/30/2013; Lot numberCABDDBAB:43, Exp date: 7/30/2013; Lot number CABDAIAC:45, Exp date: 8/7/2013 and Lot number CABDAIAC:13, Exp date: 8/7/2013.
Medroxyprogesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABDABAC:01, Exp date: 5/2/2013.
Methionine/Choline/Inositol/ B-12, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABDAHAB:35, Exp date: 4/7/2013 and Lot number CABDBIAC:77, Exp date: 5/19/2013.
Methylcobalamin 1250 mcg/ml,  Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABDCGAC:49, Exp date: 3/28/2013.
Methylcobalamin 12.5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABCBJBA:55, Exp date: 4/17/2013; Exp date: Lot number CABDCCAB:52, Exp date: 7/21/2013 and Lot number CABDCGAC:50, Exp date: 8/25/2013.
Mitomycin 0.04% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABDAGAD:25, Exp date: 4/20/2013 and Lot number CABDAGAD:84, Exp date: 4/20/2013.
Mitomycin (modified) 0.02% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABDAGAD:68 , Exp date: 4/20/2013 and Lot number CABDAGAD:60, Exp date: 4/20/2013.
Ophthalmic dilation gel, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABDBDAC:11, Exp date: 8/12/2013; Lot number CABCCHAJ:28, Exp date: 3/26/2013; Lot number CABCBBBA:57, Exp date: 4/9/2013; Lot number CABCCGBA:11, Exp date: 4/24/2013; Lot number CABCACBB:26, Exp date: 5/1/2013; Lot number CABCBGBB:54, Exp date: 5/15/2013; Lot number CABCCJBB:38, Exp date: 5/28/2013; Lot number CABCBDBC:40, Exp date: 6/11/2013; Lot number CABCCIBC:73, Exp date: 6/26/2013; Lot number CABDBBAB:32, Exp date: 7/10/2013; Lot number CABDCEAB:92, Exp date: 7/23/2013; Lot number CABDAHAC:76, Exp date: 8/6/2013; Lot number  CABDCBAC:11, Exp date: 8/20/2013 and Lot number CABDAHAD:85, Exp date: 9/3/2013.
Ophthalmic dilation gel (MAR), Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABDBFAC:88, Exp date: 5/16/2013; and Lot number CABDCBAB:42, Exp date: 4/21/2013.
Pap 300 mg-phent 10 mg-prost 100 mcg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABDBFAC:52, Exp date: 5/16/2013; Lot number CABDBBAB:40, Exp date: 4/11/2013; Lot number CABDCAAC:15, Exp date: 5/21/2013; Lot number CABDCCAC:75, Exp date: 5/23/2013 and Lot number CABDAFAD:77, Exp date: 6/3/2013.
Phenylephrine-cyclopentolate, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABDBIAB:14, Exp date: 7/17/2013.
Progesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABDBFAC:48, Exp date: 5/17/2014; and Lot number CABDCEAB:14, Exp date: 4/25/2014.
Sodium Chloride (23.4%), Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABCCEAJ:09, Exp date: 3/23/2013; Lot number CABCBFBA:92, Exp date: 4/13/2013; Lot number CABDAGAC:58, Exp date: 8/5/2013 and Lot number CABDAEAD:01, Exp date: 8/31/2013.
Test Cyp 10 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABCAFBC:17, Exp date: 6/3/2013.
Test Cyp 100 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABCBFBA:15, Exp date: 4/13/2013; Lot number CABCACBA:58, Exp date: 3/31/2013; Lot number CABCAHBB:54, Exp date: 5/6/2013; Lot number CABCCHBB:63, Exp date: 5/26/2013; Lot number CABCAFBC:31, Exp date: 6/3/2013; Lot number CABCCHBS:23, Exp date: 6/25/2013; Lot number CABDBAAB:64, Exp date: 7/9/2013; Lot number CABDAIAB:59, Exp date: 7/7/2013; Lot number CABDAFAC:48, Exp date: 8/4/2013; Lot number CABDBJAC:27, Exp date: 8/18/2013 and Lot number CABDABAD:61, Exp date: 8/28/2013.
Test Cyp 200 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABCBJBA:26, Exp date: 4/17/2013; Lot number CABCBEBB:55, Exp date: 5/13/2013; Lot number CABCBEBB:75, Exp date: 5/13/2013; Lot number CABCCBBC:96, Exp date: 6/19/2013; Lot number CABCCHBC:80, Exp date: 6/25/2013; Lot number CABDAJAB:88, Exp date: 7/8/2013; Lot number CABDAEAB:41, Exp date: 7/3/2013; Lot number CABDBBAB:23, Exp date: 7/10/2013; Lot number CABDBHAB:14, Exp date: 7/16/2013; Lot number CABDCEAB:13, Exp date: 7/23/2013; Lot number CABDCFAB:33, Exp date: 7/24/2013 and Lot number CABDABAD:38, Exp date: 8/28/2013.
Test cyp 25 mg-Estadiol valerate 15 mg/mL, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABCBJBC:70, Exp date: 6/17/2013
Test cyp 25 mg-Estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABDBHAB:54, Exp date: 7/16/2013
Test Cyp 250 mg-lidocaine 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABCCABB:74, Exp date: 5/19/2013 and Lot number CABCCABB:31 Exp date: 7/29/2013.
Test cyp 25 mg-estradiol cyp 7 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABCAFBC:67, Exp date: 6/3/2013.
Test Cyp 25 mg-e(2) blend 12 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABCCHBB:03, Exp date: 5/26/2013.
Test cyp 35 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABDCAAC:13, Exp date: 8/19/2013.
Test cyp 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABCCHBB:81, Exp date: 5/26/2013.
Test Cyp 50 mg-estradiol cyp 2 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABCACBB:31, Exp date: 10/28/2013 and Lot number CABDBGAB:74, Exp date: 1/11/2014.
Lot number CABCACBA:23, Exp date: 3/31/2013 and Lot number CABDAIAD:13, Exp date: 9/4/2013.
Test Cyp 50 mg-estradiol cyp 7 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABCACBA:16, Exp date: 10/2/2013.
Test Cyp 50 mg-estradiol blend 22 mg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABCAIBA:36, Exp date: 4/6/2013; Lot number CABDDAAB:10, Exp date: 7/29/2013 and Lot number CABDAIAD:01 Exp date: 9/4/2013.
Test cyp 75 mg-estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABCAIBB:44, Exp date: 5/7/2013.
Tetracaine(buffered) 0.25% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABDCCAB:46, Exp date: 4/22/2013; Lot number CABDAGAC:58, Exp date: 5/7/2013 and Lot number CABDAGAD:07 Exp date: 6/4/2013.
Vancomycin 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot number CABDCCAC:54, Exp date: 3/24/2013.
Blood product, which did not meet the acceptable product specifications for release, was distributed.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed
Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed.
Clorox Healthcare Holdings, LLC (dba HealthLink)
Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AZ, CA, CO, FL, GA, IA, IL, IN, MI, MO, MS, MT, NC, NJ, NY, OH, SC,TX ,VA ,WA, WI, and HI, and the countries of Canada, Mexico, and New Zealand.
HealthLink***BIOPSY PUNCHES***   Disposable manual instrument for skin biopsy.
PSS Select medical products***Biopsy Punches***   Disposable manual instrument for skin biopsy.
ARGENT SURGICAL SYSTEMS***BIOPSY Punches***   Disposable manual instrument for skin biopsy.
Penrose-St Francis Health Services Blood Bank
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed
Blood product, with a low platelet count, was distributed.
Blood products, which were not quarantined subsequent to receiving post donation information, were distributed.
Blood product, manufactured without additive solution, was distributed.
Worldwide Distribution - USA Nationwide including the states of:  AZ, CA, FL, KY, ME, MI, MO, OH, PA, TN, TX , VA, and the countries of:  Australia, Egypt, Italy, Japan, Switzerland, Taiwan, and Turkey;
***REF SC2100***eMax 2 Plus Console***SN G 10307653002***   Product Usage:  The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no load on the cutting bur). This condition would not affect the power output of the Handpiece in the loaded working range (typically 50,000 to 70,000 RPM.
SC2100 System Console Emax 2 Plus;  SC2101 System Console, Single Port with irrigation;  SC2102 System Console, Single Port, without Irrigation.
The RPM of the Motor Handpiece may be less than 80,000 RPM.
***REF SC2101***eMax 2 Plus Console, Single Port, with Irrigation***SN G17307901802***   Product Usage:  The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no load on the cutting bur). This condition would not affect the power output of the Handpiece in the loaded working range (typically 50,000 to 70,000 RPM.
SC2100 System Console Emax 2 Plus;  SC2101 System Console, Single Port with irrigation;  SC2102 System Console, Single Port, without Irrigation;
***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402***   Product Usage:  The eMax console is intended to operate the eMax system which is used for cutting and shaping bone including spine and cranium. The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no load on the cutting bur). This condition would not affect the power output of the Handpiece in the loaded working range (typically 50,000 to 70,000 RPM).
Worldwide distribution - USA including AZ, CA, CO, FL, ID, IL, ME, NV,NY, NC, OK, TN, UT, and WI; and Internationally to Canada, Chile, France, Germany, Italy, Japan, Korea, Norway and Spain.
GE Healthcare, Innova 3100 and Innova 4100 systems.   The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures.
GE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration which affects  Innova 3100 and Innova 4100 Systems.
TX, LA, MD, IN, IL, NE, NC, MN, WI, FL, AL
Master Cases, Product Code #8534 (6-12 count retail boxes) Label of master case bears the name:  Donut House K -Cup Packs.  12-Count Retail Boxes, Product Code #8934, Donut House Decaffeinated K-Cup Packs
288,144 kcups/4,002 master cases (6 retail boxes per case)/ 24,012 retail boxes
Regular (caffeinated) Coffee individual K-cup packs were packaged inside multi unit retail boxes labeled Decaffeinated Coffee.
USA Nationwide Distribution - including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
Computed Tomography X-ray systems    Product Usage:  The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners are whole body 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. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
2348 total units: 2182 Brilliance CT 64 units; 95 Ingenuity Core units; and 71 Ingenuity Core128 units.
Philips Healthcare received reports from the field that certain Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 systems running software versions 2.6.1 or 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images, which may impair the diagnostic quality of affected images.
Maine, New Hampshire, Vermont, New York and Massachusetts.
Hannaford Gourmet Oatmeal Raisin Cookies (9 oz. package) UPC # 0004126872715
Cookies may contain undeclared tree nuts
Hanna ford Gourmet Cookie Platter (36 oz. package),  Includes oatmeal raisin cookies UPC # 04126874662
Worldwide Distribution - USA including Arizona, Georgia, North Dakota, South Carolina, Texas and Tennessee, Internationally to United Arab Emirates, Austria, Brazil, Canada, Switzerland, China, Germany, Spain, France, United Kingdom, Italy, Japan, Singapore, Thailand, Turkey, Serbia, and South Africa.
MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05.   The YUNO OTN is used to support and position patients for surgical procedures immediately before, during and after the surgical phase. The table top is radio translucent and enables intraoperative use of X-ray equipment.
YUNO OTN Mobile Operating Table: 1433.01F0 Extension Device:  1433.62A1
MAQUET has identified a potential issue with the extension device handle (part number 1433.62A1) and will make enhancements to the YUNO table (part number 1433.01F0).   Identification of the Extension device issue:  By fully actuating the lever of the extension device handle, the operator's skin can enter a gap between the handle lever and a recess in the handle bar.  When the lever is released, skin which might be within the gap could be pinched or cut.
US Distribution including the states of  FL, KY, LA, MI, NC, and NY.
GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502.    Reattachment of soft tissue to bone in orthopedic surgical procedures
1) Digoxin LS (0.05 mg/mL) Liver 50 mcg/mL Elixir, Oral for Veterinary Use Only  Various Sizes, Packaged in 60 mL amber plastic bottle  Store at room temperature    Item Codes DIGOXI-SOL502VC and DIGOXISOL0005VC    2) Digoxin LS (0.15 mg/mL) Liver 150 mcg/mL Elixir, Oral for Veterinary Use Only  Various Sizes, Packaged in 60 mL amber plastic bottle  Store at room temperature    Item Code: DIGOXI-SOL501VC
Digoxin LS (0.05 mg/mL) Liver 50 mcg/mL:   ITEM Code DIGOXI-SOL502VC and DIGOXISOL0005VC    Lot 20121002@228, Beyond Use Date 03/31/2013  Lot 20121009@233, Beyond Use Date 04/07/2013  Lot 20121207@062, Beyond Use Date 06/07/2013  Lot 20130107@298, Beyond Use Date 07/06/2013  Lot 20130110@052, Beyond Use Date 07/06/2013  Lot 20130306@086, Beyond Use Date 09/02/2013    ITEM Code DIGOXI-SOL501VC    Lot 20121101@195, Beyond Use Date 04/30/2013
Digoxin for veterinary patients is being recalled since potency of medication is less than labeled amount.
Digoxin LS (0.05 mg/mL) Chicken 50 mcg/mL Elixir, Oral for Veterinary Use Only  Packaged  in 60 mL amber plastic bottle  Store at room temperature    Item Code: DIGOXI-SOL003VC
Digoxin  (0.09 mg) Capsules, Oral for Veterinary Use Only  100 capsules Packaged in white plastic bottle  Store at room temperature    Item Code DIGOXI-CAP505VC
a) Digoxin  (Flavored) 0.015 mg/mL Suspension, Oral,  for Veterinary  Use Only  30 mL, Packaged in amber plastic bottle  Store at room temperature    Item Code DIGOXI-SUS509VC      b) Digoxin  (Flavored) 0.002 mg/mL Suspension, Oral,  for Veterinary  Use Only  30 mL, Packaged in amber plastic bottle   Store at room temperature    Item Code DIGOXI-SUS506VC      c) Digoxin  (Flavored) 0.075 mg/mL Suspension, Oral,  for Veterinary  Use Only, Various sizes,  Packaged in amber plastic bottle   Store at room temperature    Item Code DIGOXI-SUS502VC and DIGOXISUS0006VC     d) Digoxin  (Flavored) 0.1 mg/mL Suspension, Oral,  for Veterinary  Use Only, Various sizes,  Packaged in amber plastic bottle   Store at room temperature    Item Code DIGOXI-SUS503VC and DIGOXISUS0011VC    e) Digoxin  (Flavored) 0.125 mg/mL Suspension, Oral,  for Veterinary  Use Only, 60 mL ,  Packaged in amber plastic bottle   Store at room temperature    Item Code DIGOXI-SUS508VC and DIGOXISUS0030VC
Item Code DIGOXI-SUS509VC   Lot 201211022@246, Beyond Use date 05/01/2013      Item Code DIGOXI-SUS506VC    Lot 20121025@103 Beyond Use Date 04/23/2013      Item Code DIGOXI-SUS502VC and DIGOXISUS0006VC     Lot 20121022@296, Beyond Use Date 04/20/2013  Lot 20121120@307, Beyond Use Date 02/17/2013  Lot 20121207@229, Beyond Use Date 06/05/2013    Item Code DIGOXI-SUS503VC and DIGOXISUS0011VC    Lot 20121002@037, Beyond Use Date 03/31/2013  Lot 20121127@313, Beyond Use Date 05/26/2013  Lot 20130103@232, Beyond Use Date 07/02/2013  Lot 20130130@060, Beyond Use Date 07/29/2013  Lot 20130207@032, Beyond Use Date 08/06/2013  Lot 20130304@337, Beyond Use Date 08/31/2013  Lot 20130313@012, Beyond Use Date 09/09/2013      Item Code DIGOXI-SUS508VC and DIGOXISUS0030VC    Lot 20121003@015, Beyond Use Date 04/01/2013  Lot 20130219@021, Beyond Use Date 08/18/2013
National and Global distribution (Europe, European Economic Area, Argentina, China, and Brazil).
StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock device provides stabilization for compatible medical tubes and catheters.
BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly used during manufacture. The absence of the hydrocolloid strip on the bottom may pose an incremental risk including localized skin irritation. Missing directional arrow may lead to mis-orientation of the StatLock stabilization which may impact the securement of the catheter.
Surgical Instrument Service And Savings, Inc.
-Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279   -Instratek Carpal Tunnel Release Hook Blade.  REF 2055 Lot 122669     -Linvatec CTS Relief Kit.  REF 9971, lot 122504    -Biomet Indiana Tome Blade for Carpal Tunnel Release (White). REF 200060.  Lot 122504 and Lot 123190.    -KMI SafeGuard Knife, For SafeGuard Mini Carpal Tunnel Release System, (White).  REF 08-0003.  Lot # 122609    Surgical Knife
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
- ConMed Linvatec Spectrum II Suture Hook Crescent, Medium (Teal) 4.0 x 20.0mm.  REF C6386  Lot 122592.   - Arthrex SutureLasso SD, 25 Degree Tight Curve Left, Wire Loop, (Green) 1.8mm.  REF AR-4068-25TL  Lot 122518 and Lot 123190.    -- Arthrex SutureLasso SD, 25 Degree Tight Curve Right, w/Nitinol Wire Loop, (Lt. Green) 1.8mm.  REF AR-4068-25TR  Lot 122518 and Lot 123190.    - Arthrex SutureLasso  SD, 90 Degrees (Black) 1.8mm. REF AR-4068-90 Lot 122504.    - Arthrex SutureLasso, 45 Degree, Perforating Needle Cannula, w/Suture Loop, (Lt. Grey).  REF AR-4065S  Lot 122590.    -SutureLasso, w/Wire Loop, 90 Degree, (Blue) REF AR-4065-90W Lot 123263.    Manual surgical instrument for general use
-ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm. REF ATB35 Lot 122300.   -Ligaclip MCA Multiple Clip Applier, 20 Small Clips Small.  REF MCS20 Lot 122300.    - Ethicon Pistol Grip, Fixed Head Skin Stapler, Multi-Directional Release, (Grey) 35W.  REF PXW35  Lot 122309 and Lot 123263.    -Proximate Linear Cutter, w/o Staples 75mm.  REF TLC75 Lot 122490    -Ethicon Proximate Plus MD, Skin Stapler Regular.  REF PMR35 Lot 122753.    -Proximate Plus, Rotating Head, Skin Stapler (White) Wide.  REF PRW35 Lot 122406.    - Ethicon PROXIMATE PLUS, Skin Stapler, Pistol Grip, Fixed Head, Multi-Directional Release, (Grey) Regular.  REF PXR35  Lot 122675 and Lot 123263.    -TX Reloadable Linear Stapler 3.5mm Leg, w/o Staples 60mm. Ref. TX60B Lot 122490  Manual surgical instrument for general use
GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36'', double-Armed w/CP 2 Needles 2. Ref. 212034 Lot 123266   General and Plastic Surgery
-Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N  Lot 123263    -SureFire Scorpion Needle (purple). Ref. AR-13991N Lot 123263 and 122279      -Suture Passing Wire. Ref. AR-1255-18 Lot 123190     Manual surgical instrument for general use.
90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 7205441 Lot 122502 -Acromioplasty Electrode (Grey) 6.5'' x 165mm. Ref. C5012A Lot 122288 -CAPSure 30 ArthroWand, CW, 30 Degree Shaft Angle, (Grey) 3.0mm. Ref. AC 1830-01 Lot 122494 -Coblator II Evac 70 Xtra Plasma Wand, w/Integrated Saline Line & Integrated Cable. Ref. EIC 5872-01 Lot 122295, 122308, 122626, 122325, -Coblator II, ENT ReFlex Ultra 45 w/Integrated Cable, (Blue). Ref. EIC 4845-01 Lot 122651, 122419, 122671, 122633 Electrosurgical cutting and coagulation device and accessories. -CoVac 50, Suction ArthroWand, w/Integrated Cable, (White/Grey). Ref. ASC 2530-01 Lot 122483, 122745 -CoVac 70, ICW ArthroWand 70 angle 3.0mm. Ref. ASC 3730-01 Lot 122483, -Eliminator, Right Angle ArthroWand (Beige). Ref. A 1345-01 Lot 122446 -Eliminator, Right Angle ArthroWand, 90 Degree w/Integrated Cable, (Grey) 4.5mm. Ref. AC 1345-01 Lot 122494, 122446 -ENT Coblator II PROcise XP Wand, w/Integrated Cable, Suction & Saline, (Blue). Ref. EIC 8872-01 Lot 122651, 122762 -Ligament Chisel Probe,Curved w/Integrated Cable, (Grey/Green). Ref. 7209647 Lot 122512 -LightWave Suction Ablator, 90 Degree, Hand Control, Multi-Angle, (Blue/White) 4.5mm x 142mm. Ref. IA-2000-S Lot 122512 -Lo-Pro 90 Degree ArthroWand, w/Integrated Cable, (Grey) 3.6mm. Ref. AC1336-01 Lot 122654, 122325 -Meniscectomy Electrode, Standard Design (Grey) 165mm. Ref. C5010A Lot 122765 -MeniVac ArthroWand w/Suction, w/Integrated Cable, (Grey) 3.0mm. Ref. ASC 5500-01 Lot 122630, 122494 -Microblastor 30 Wand, 30 Degree, w/Integrated Cable, (Grey) 0.9mm Tip. Ref. AC 40500-01 Lot 122293 -Right Angle ArthroWand, 90 Degree, w/Integrated Cable, (Grey) 3.5mm. Ref. AC 1340-01 Lot 123044, 122673 -Saber 30 ArthroWand, 30 Degree, w/Integrated Cable, (Grey) 3.0mm. Ref. AC 4330-01 Lot 122630, 122494, 123044, 122283, 122765 -SAPHYRE II Bipolar Ablation Probe, w/suction, High Profile 50 Degree, (Pewter). Ref. 7210112 Lot 122734 -SERFAS ENERGY Hook Probe 3.5mm. Ref. 279-350-501 Lot 123
- Re-New II Endocut Scissor Tip, 16.51mm  5.0mm Ref. 3142 Lot 122295, 122308, 122455, 122875   Manual surgical instrument for general use.
- Average Medium Blade  9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 122447   - Cannulated Drill Bit, Quick Coupling, For 3.5 & 4mm Cannulated Screws, 1.35mm Cannulation 2.7mm x 160mm Ref. 310.67 Lot 122289    - Hall MicroChoice, Oscillating Blade, Fine, Flat, Stainless Steel 5.5mm x 12.0mm x 0.4mm Ref. 5023-160 Lot 123353    - Hall MicroChoice, Oscillating Saw Blade, Fine, Flat, Stainless Steel 5.5mm x 18.5mm x 0.4mm Ref. 5023-162 Lot 123353    - Hall MicroChoice, Sagittal Saw Blade, Fine  4.5mm x 25.5mm x 0.4mm Ref. 5023-139 Lot 122454    - Hall MicroChoice, Sagittal Saw Blade, Stainless Steel 9.5mm x 25.5mm x 0.4mm Ref. 5023-138 Lot 122454, 123353    - Large Sagittal Saw Blade  25mm x 89.5mm x 0.89mm Ref. 2108-102 Lot 122490    - Micro Choice Oscillating Saw Blade  5.5mm x 18.5mm x 0.40mm Ref. KM-3000 Lot 122440    - Micro Oscillating and Sagittal Saw Blade  9.0mm x 25mm x 0.51mm Ref. 2296-33-521 Lot 122609, 122429    - Oscillating and Sagittal Saw Blade  9.0mm x 31mm x 0.51mm Ref. 2296-33-225 Lot 122347     - Oscillating Sagittal  Blade  9mm x 31mm x .38mm Ref. 2296-3-525 Lot 123263    - Oscillating Saw Blade  9.0mm x 25.0mm x .38mm Ref. SP-511 Lot 122631    - Oscillating Saw Blade  9mm x 25mm x .38mm Ref. 2296-3-511 Lot 122447    - Reciprocating Saw Blade, Double Sided Fixed Point Travel: 3.56mm 70mm x 12.5mm x 0.64mm Ref. 227-96-275 Lot 122490    - Round Fast Cutting Stainless Steel Bur, 8 Flute 4.8mm Ref. 1608-6-139 Lot 122447    - Sagittal Saw Blade  4.5mm x 25.4mm Ref. KM-3102 Lot 122465    - Small Oscillating Blade  9.0mm x 31.0mm x .4mm Ref. 2296-3-125 Lot 122447    - Small Oscillating Saw Blade  5.5mm x 11.5mm x 0.38mm Ref. 2296-3-410 Lot 122429    - Small Oscillating Saw Blade  5.5mm x 18.0mm x  0.4mm Ref. 2296-3-212 Lot 122511    - Small Oscillating Saw Blade  5.5mm x 18mm x 0.38mm Ref. 2296-3-412 Lot 122447    - Small Oscillating Saw Blade  7mm x 18.5mm x 0.38mm Ref. 2296-3-114 Lot 122429, 122511    - Small Oscillating Saw Blade  9.0mm x 31mm x 0.4mm Ref. 2296-3-225 Lot 122590, 122447    - Sm
- Acorn Bur, Long, For Use With TPS Universal Drill, Long ''AM'' Attachment Head: 7.5mm Dia. x 9.5mm Length Ref. 5130-30-75 Lot 122665   - Cannulated Drill Bit, for 3.0mm Cannulated Screws, 1.2mm Cannulation, Quick Coupling 2.0mm x 150mm Ref. 310.221 Lot 122289    - Drill Bit, For Modular Hand System, Quick Coupling 2.8mm x 165mm Ref. 310.288 Lot 122322    - Drill Bit, Quick Coupling (Gold) 2.5mm Ref. DB-2.5 Lot 122289, 122322    - Egg Micro  Bur, 10 Flute, Stainless Steel  4.0mm Ref. 1608-2-35 Lot 122429, 122347    - Hall Micro Bur, Oval, Long, 8-Flute, Carbide 4.0mm x 8.0mm Ref. 5092-136 Lot 123353    - Micro Bur, Round, Stainless Steel  3.2mm Ref. 1608-2-11 Lot 122447, 122347    - Oval Bur, Fast Cutting, 8-Flutes, Carbide, 44.5mm Total Length, 18.6mm Exposure 4.0mm x 7.9mm Ref. 227-10-62 Lot 122411    - Oval Bur, Solid, 8-Flute, Medium, Head Length: 7.7mm, Carbide 4.0mm x 48mm Ref. 5300-10-901 Lot 122647    - Oval Cutting Carbide Bur, Medium, (8-Flute) 4.0mm Ref. 5091-136 Lot 123353, 122454    - Round Bur, Medium, Solid 8-Flute, Carbide 4.0mm x 48.3mm Ref. 5300-10-511 Lot 122665    - Round Bur, Micro, 8-Flute, Exposure: 28.2mm Stainless Steel 2.4mm x 54mm Ref. 1608-2-9 Lot 122447    - Twist Drill, Quick Coupling 110mm 2.5mm Ref. 310.25 Lot 122289, 122322    - Wire Pass Drill Bit  1.5mm Ref. 1608-2-59 Lot 122511    Surgical instrument motors and accessories/attachments
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336   Opthalmic
Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270 - AcromioBlaster Burr (Brick Red) 5.5mm Ref. 7205669 Lot 122590, 122454, 122465, 122434, 122665 - AcromioBlaster Burr (Sage Green) 4.0mm Ref. 7205668 Lot 122590, 123270 - Acromionizer Bur, Barrel, (Mauve) 4.0mm Ref. 7205326 Lot 122609 - BoneCutter Blade, Full Radius, Series 3000 (Orange/Black) 5.5mm Ref. 7206010 Lot 122609 - CoolCut Bone Cutter (Blue/Orange) 3.8mm Ref. AR-8380BC Lot 122631 arthoscope - CoolCut Bone Cutter (Blue/Orange) 4.0mm Ref. AR-8400BC Lot 122631 - CoolCut Bone Cutter (Blue/Orange) 5.5mm Ref. AR-8550BC Lot 122631 - CoolCut Dissector (Blue/Blue) 3.5mm Ref. AR-8350DS Lot 123190 - CoolCut Dissector (Blue/Blue) 4.0mm Ref. AR-8400DS Lot 123190, 122493, 122631 - CoolCut Dissector (Blue/Blue) 5.0mm Ref. AR-8500DS Lot 122493 - CoolCut Dissector Small Joint (Blue/Blue) 3.0mm Ref. AR-7300DS Lot 123190, 122493, 122631, - CoolCut Excalibur (Blue/Beige) 3.8mm Ref. AR-8380EX Lot 122631 - CoolCut Excalibur (Blue/Beige) 4.0mm Ref. AR-8400EX Lot 122631 - CoolCut Oval Burr (12 Flutes) (Blue/White) 5.5mm Ref. AR-8550OBT Lot 122631 - CoolCut Oval Burr (8 Flute) (Blue/White) 4.0mm Ref. AR-8400OBE Lot 122493, 122631, 122279 - CoolCut Oval Burr (8 Flute) (Blue/White) 5.0mm Ref. AR-8500OBE Lot 122493 - CoolCut Round Burr (8 Flute) (Blue/Red) 5.0mm Ref. AR-8500RBE Lot 123190 - CoolCut Sabre (Blue/Green) 3.8mm Ref. AR-8380SR Lot 122493 - DYONICS ELITE Achromobacter (Sage Green) 4.0mm Ref. 72200730 Lot 122665 - Elite* AcromioBlaster Burr (Brick Red/Yellow) 5.5mm Ref. 72200731 Lot 122665 - Formula Aggressive Plus Cutter (Beige/Blue) 5.5mm Ref. 375-564-000 Lot 122309 - Formula Aggressive Plus Cutter (Dk. Blue/Lt. Blue) 5.0mm Ref. 375-554-000 Lot 122490 - Formula Aggressive Plus Cutter (Yellow/Blue) 3.5mm Ref. 375-534-000 Lot 122518, 122309 - Formula Aggressive Plus Cutter Large Hub, (Red/Blue) 4.0mm Ref. 375-544-000 Lot 122594, 122588, 122518, 122278 - Formula Barrel Bur, 12-Flute (Beige/Beige) 5.5mm Ref. 375-951-012 Lot 122278 - Formula Barrel Bur, 12-Flute (Blu
Large Tear Cross Cut Rasp  14mm x 7mm Ref. 5100-37-114 Lot 122347      Manual surgical instrument for general use
- Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511   - Drill Bit, Straight Shank  2.7mm x 12.7cm Ref. 2318-027-00 Lot 122322    - Drill Bit, w/Depth Mark, Quick Coupling (Red) 2.0mm x 140mm Ref. 323.062 Lot 122347    - Fast Cutting Drill Bit  2.0mm Ref. FDB 2.0 Lot 122289, 122322    - Midas Rex Metal Cutting Drill Bit  3.0mm x 18.3mm Ref. MC30 Lot 122347      Orthopedic manual surgical instrument
- IDEAL 30 Suture Grasper (Green) 30 Degree Ref. 251721 Lot 122511   - IDEAL 60 Suture Grasper (Pink) 60 Degree Ref. 251723 Lot 122631      Passer
TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot 122518, 122447.     Orthopedic manual surgical instrument
- Calf Garment  Standard Ref. L501-M Lot 122549, 122985   - Calf Garment, DVT10  Standard Ref. DVT10 Lot 122570, 12546    - Calf Garment, DVT20  Large Ref. DVT20 Lot 122549, 122570    - SCD Express Compression Sleeve, Knee Length, (White) Large Ref. 9789 Lot 122574    - SCD Express Compression Sleeve, Knee Length, (White) Medium Ref. 9529 Lot 122547, 122574    - SCD Express Compression Sleeve, Thigh Length, (White) Medium Ref. 9530 Lot 122574  Compressible limb sleeve.     - Thigh Garment DVT30  Medium Ref. DVT30 Lot 122549, 122985    - Thigh Garment DVT40  Large Ref. DVT40 Lot 122549, 122985    - Vaso-Force Intermittent DVT Calf Garment, Large, Calf Sizes up to 24'' 24'' Ref. MDS601L Lot 122982, 122986    - Vaso-Force Intermittent DVT Calf Garment, Medium, Calf Sizes up to 18'' 18'' Ref. MDS601M Lot 122986, 122984    - VENAFLOW Calf Cuff, w/Foam (White) 19'' Max. Calf Circumference Ref. 3010-PL Lot 122692, 122715
- Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot 122429   - Relieva Luma Sentry 20 Tip Angle, 0.035 Diameter 100cm Ref. SIS100B Lot 122429    Manual surgical instrument for general use
- ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504   - Carpal Tunnel Release Blade Assembly, (White)  Ref. 81010 Lot 123263, 122406, 122482, 123043, 122518, 122511    - ENDO-SCRUB 2, (1) Sheath, 0 Degree, For K. Storz, Medtronic Sharpsite AC, (Green) 4.0mm Ref. 19-12000 Lot 122289    - Spectrum II Disposable Suture Hook 45 degree, Right (RED) Ref. C6380 Lot 122592  Orthopedic manual surgical instrument.
- CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 Lot 122631, 122609   - CLEAR-TRAC Flexible Cannula System Threaded, w/Obturator, (Lime Green) 8.0mm x 72mm Ref. 72200425 Lot 122631    - CLEAR-TRAC Flexible Cannula, Threaded, w/Obturator, (Orange) 6.5mm x 72mm Ref. 72200427 Lot 122465    - Crystal Cannula w/Obturator (Orange) 5.75mm I.D.  X  7cm Ref. AR-6460 Lot 122594, 122518    - Crystal Cannula, Partially Threaded, Distal End, w/Obturator, (Orange) 5.75mm I.D. x 7cm Ref. AR-6564 Lot 122493    - Dry-Doc Cannula System w/ Obturator (Translucent Green) 5.0mm x 85mm Ref. C7350 Lot 123263    - Dry-Doc Cannula w/ Obturator (Translucent Blue) 7.0mm x 85mm Ref. C7360 Lot 123263, 122594    - Instrument Cannula w/Obturator w/''No Squirt Cap'', (Purple) 7.0mm I.D.  X  7cm Ref. AR-6550 Lot 122590     - Partially Threaded Cannula and Obturator, w/o ''No Squirt Cap'', (Purple) 7.0mm I.D. x 7cm Ref. AR-6567* Lot 123043, 122278    - PassPort Button Cannula'' (Blue) 8mm ID x 4cm Ref. AR-6592-08-40 Lot 122594    - Smooth Clear Cannula w/Obturator (Orange) 5.5mm x 75mm Ref. 214106 Lot 122465    - Threaded Clear Cannula w/Obturator (Orange) 5.5mm x 75mm Ref. 214108 Lot 122665    - Threaded Clear Cannula w/Obturator (Yellow) 8.5mm x 75mm Ref. 214120 Lot 122440, 122588    - Threaded Clear Cannula w/Obturator, (Purple) 7.0mm x 75mm Ref. 214116 Lot 122465    - Tibial Tunnel Cannula, Accomodates 9-12 mm Tunnel Diameters, (Blue) Ref. AR-1802D Lot 122594, 122279    - Twist-In Cannula w/Obturator w/''No Squirt Cap'', (Gold) 8.25mm I.D.  X  7cm Ref. AR-6530 Lot 122590, 123190, 122665    - Twist-In Cannula w/Obturator, w/ ''No-Squirt'' Cap, (Green) 6.0mm I.D. x 7cm Ref. AR-6535 Lot 122590, 122665    - Twist-In Cannula w/Obturator, w/''No Squirt Cap'', (Purple) 7.0mm I.D. x 7cm Ref. AR-6570 Lot 123190    - Twist-In Cannula w/Obturator, w/o ''No Squirt Cap'', (Purple) 7.0mm I.D. x  7cm Ref. AR-6570* Lot 123043    - Twist-In Cannula w/Obturator, w/o No Squirt Cap, (Gold) 8.25mm I.D. x 7cm Ref. AR-653
- Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 Lot 123215   - TurboSonics Mini-Flared ABS Tip, 20 Degree Tip Angle, 45 Kelman, (Purplish Pink/Silver) 0.9mm Ref. 8065750853 Lot 122590, 123372    - TurboSonics Tapered ABS MicroTip'' 30 Kelman, (Purple/Silver) 0.9mm Ref. 8065750263 Lot 122309    Series 20000'' Legacy TurboSonics Flared ABS MicroTip, 30 Degree, Kelman, (Pink) 0.9mm Ref. 8065740839 Lot. 122309    Phacofragmentation system.
- ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm Ref. 511NA Lot 123215, 122647   - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Orange) 5.0mm Ref. 35LNA Lot 123215, 122647    - ENDOPATH Resposable Trocar w/Dilating Tip Obturator & Housing, 100mm, (Orange) 5mm Ref. 35LDA Lot 122647    - ENDOPATH Resposable Trocar, Dilating Tip w/Housing, 100mm, (Purple) 10/12mm Ref. 512DA Lot 123215    - ENDOPATH Sleeve Housing (Orange) 5mm Ref. 355HR Lot 123215, 122647    Endoscope and accessories     - ENDOPATH Trocar, Disposable Sleeve Housing, (Green) 10/11mm Ref. 511HR Lot 122647    - ENDOPATH Blunt Tip Obturator & Housing, w/Olive Plug, 100mm, (Purple) 10/12mm Ref. 512BA Lot 122647    - ENDOPATH Resposable Trocar w/ Dilating Tip Obturator & Housing, 100mm, (Green) 10/11mm Ref. 511DA Lot 122454, 122647    - ENDOPATH, Bladeless Trocar with Stability Sleeve, Non-handled 10/12mm Ref. 512NT Lot 123254    - ENDOPATH Xcel Bladeless Trocar, Handled, w/Stability Sleeve, (Teal) 11mm x 100mm Ref. 811LTH Lot 122300    - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve 12mm x 150mm Ref. B12XT Lot 122300    - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve 5.0mm x 150mm Ref. B5XT Lot 122429    - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, (Teal) 11mm x 100mm Ref. B11LT Lot 122454, 123254, 122429    - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, 100mm Length 5.0mm Ref. B5LT Lot 122347, 122454, 122592, 122490, 123254, 122429, 122300    - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, 75mm Length, (Teal) 5.0mm Ref. B5ST Lot 123254    - ENDOPATH Xcel Blunt Tip Trocar, w/Smooth Sleeve & Adjustable Plug,  (Purple) 12mm x 100mm Ref. H12LP Lot 122338, 122372, 123254, 123215    - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 11mm x 100mm Ref. D11LT Lot 122454    - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 12mm x 100mm Ref. D12LT Lot 122454    - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 5.0mm x 100mm Ref
Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref. ACE36E Lot 122295, 122308, 122762   Unclassified
Worldwide Distribution - USA Nationwide including the states of  AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI & WV, and countries of:  Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, PR, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain
1) VITROS 5,1 FS Chemistry System (product code 6801375) and  2) VITROS 5,1 FS Chemistry System Refurbished (product code 6801890)   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.
Total 101 units (84 units for # 6801375- 26 units domestic & 58 units foreign) and (17 units for # 6801890-15 units domestic, 2 units foreign)
There is evidence that an electrical short within the systems connector has caused an accumulation of  heat which has radiated back through the wiring harness causing the wires and connectors to melt.
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445)    Product Usage:  For use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)
Total 69 units (28 units domestically and 41 units internationally)
VITROS 5600 Integrated System (product code 6802413)    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.
Total 381 units ( 227 units domestically & 154 units internationally)
VITROS 3600 Immunodiagnostic System (product code 6802783)    Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Serial numbers: J36000111 and J36000520 through J36000617
Total 98 units (30 units domestically & 68 units internationally)
ORTHO Assay Software (OAS) Server, Catalog # 6842840   Usage:  The ORTHO Summit System (OSS) is a modular, integrated system for use with licensed blood screening tests. Consisting of networked processors and instruments linked together via a local area network, assay-specific pipetting protocols and ORTHO Assay Software (OAS), OSS automates many of the processing functions and data management requirements associated with ELISA (enzyme-linked immunosorbent assay) microplate testing.
Product was distributed to 1 distributor, Kirland Science Labs located in Seattle, WA.
''***DIETARY SUPPLEMENT 4HB STACK Mealtime***78 CAPLETS***MANUFACTURED EXCLUSIVELY FOR: Kirkland Science Labs 935 Jackson St #91810 Seattle, WA 98104-2818***''.
Customer reported that a product user complained that the caplets were not coated, making them difficult to swallow.
''***DIETARY SUPPLEMENT 4HB STACK Bedtime***52 CAPLETS***MANUFACTURED EXCLUSIVELY FOR: Kirkland Science Labs 935 Jackson St #91810 Seattle, WA 98104-2818***''.
Worldwide Distribution - USA including FL, KY, PA, ND, MN, IL, NJ, TX, TN, and VA.  Internationally to Belgium, China, Czech Republic, France, Germany, Switzerland, Australia, Finland, Holland, Lithunia, Malta, Poland, and Slovakia.
Delta Vaporizer   An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.
All; recalled products are traced by serial numbers D0312-XXXX to D1112-XXXX.
It has come to Penlon Ltd's attention of an instance where the installation and pre-use checks listed in the User Manual may not have been followed prior to the clinical use of the vaporizer.  Penlon Ltd has updated the Installation and daily Pre-Use Check sections of the User Manual to ensure that the instructions are explicit and clear.
0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (NDC 0338-0553-11), b) 100 mL (NDC 0338-0553-18), Rx Only, Baxter, Deerfield, IL 60015
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a) 50 mL (NDC 0338-0017-31), b) 100 mL (NDC 0338-0017-38), Baxter, Deerfield, IL 60015
Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000 USP Units, Viaflex Plus Container, 1000mL, (NDC 0338-0433-04), b) Product code 2B0953: 1000 USP Units, Viaflex Plus Container, 500 mL (NDC 0338-0431-03), Baxter, Deerfield, IL 60015
Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plastic Container, 500mL, Rx Only, Baxter, Deerfield, IL 60015
Lot #: Product code 2B0973: P279935, Exp 7/13
Lack of Assurance of Sterilty: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Container Quad Pack (NDC 0338-0049-11); b) 2B1302- 100mL in Viaflex Quad Pack (NDC 0338-0049-18); c) 2B1306- 50 mL in Viaflex Single Pack (NDC 0338-0049-41; d) 2B1307- 100mL in Viaflex Single Pack (NDC 0338-0049-48); e) 2B1308- 50 ML in Viaflex Multi Pack (NDC 0338-0049-31); f) 2B1309- 100mL in Viaflex Multi Pack (NDC 0338-0049-38), Rx Only, Baxter, Deerfield, IL 60015
Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48
Worldwide Distribution-USA (nationwide) including the states of NY, MI, MN, OH, IN, IL, VA, MD, PA, WA, KY, CT, RI, NH, TX, MT, and CA and the countries of Chile, China, South Korea, and Australia.
Bigliani/Flatow The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40.    Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
722 units (includes 2010 market withdrawal)
This is a recall expansion from the 2010 recall which now includes seven additional lots that were not previously included.  Zimmer, Inc. is initiating a recall of small and large Fukuda-type retractors due to fractures occurring at the grooves around the perimeter of the blades while being used during surgery.
Bigliani/Flatow The Complete Solution Fukuda Retractors  Small Nonsterile 00-4305-019-30.   Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
BIG COUNTRY BREAKFAST, CASE WEIGHT 26 LBS., MANUFACTURED BY:  FOOD CONCEPTS, LEBANON, TN 37087
Products contain texturized soy protein which was recalled by CHS, Inc. due to possible salmonella contamination.
SPANISH SENSATION, NET WEIGHT 32 LBS, MANUFACTURED BY:  FOOD CONCEPTS, LEBANON, TN 37087
RAGIN' CAJUN, WEIGHT 32 LBS, MANUFACTURED BY:  FOOD CONCEPTS, LEBANON, TN 37087
Soy Protein Isolate; 79 bulk raw material lots and 52 finished product lots.    Soy Protein Isolate was sold in bulk to two customers, both sausage manufacturers not under FDA jurisdiction. Also sold 48 bags of 34.875 bags to a third sausage manufacturer.  Finished product was made for Nurti-Cology - Allergy Research Group of Alameda, CA and Vinco Inc. of Evans City PA, both of whom will be conducting their own recalls.
52 lots of finished products, 70 bulk raw material lots.
ABCO products are being recalled as part of a larger recall from their supplier of certain soy based products produced in its Ashdod, Israel production facility.
The recall involved 2 customers with 6 shipping locations.  WV, SC, VA, GA, TN.
General Mills,  Cinnamon Toast Crunch, 25% Less Sugar, Self-Serve Bowl,  Net WT 1.0 oz ( 28g), Distributed by General Mills Sales, Minneapolis, MN 55440,  Package UPC 00016000294448.    Case: General Mills, BOWLPAK, Cinnamon Toast Crunch, Reduced Sugar, 96 - 1 oz (28g) containers, Distributed by General Mills Sales, Minneapolis, MN 55440, Case UPC 10016000294445.
Better if Used By: Case Date Code: 31AUG2013, 02SEP2013
168 cases ( 96 individual 1.0 oz bowlpacks)
General Mills is recalling a small quantity of single-serve reduced-sugar Cinnamon Toast Crunch bowlpak sold in foodservice establishments.  The company was notified by an ingredient supplier that it had recalled an ingredient due to the possible presence of salmonella.
The product has been distibuted to 13 military members in Europe and the Pacific regions, as well as customers in these states: AK, AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY.
Fudge Buttercream Frosted Peanut Butter cookies, some of which were mislabeled by being wrapped in Buttercream Frosted Cinnamon Pumpkin cookie wrappers, 1.6oz (45g) in size, 1 cookie per package, 100 cookies per case.
Undeclared allergen due to use of incorrect packaging on peanut butter cookies.
Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.5 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA
Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product  may not meet the dissolution specification for conjugated estrogens.
Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.0 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA 1910, NDC 0046-0875-11
Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product  may not meet the specification for conjugated estrogens dissolution.
Nationwide Distribution including FL, IL, LMD, MA, MN, NY, OH, PA, TN, and TX.
Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder.   Non-rechargeable disposable battery pack.
Braemar has recently became aware of a battery related incident that occurred with EWT battery packs that are used in a Braemer ER920W wireless event monitor and Fusion device.  The event did not result in any patient related injury or present any clinical impact.
Worldwide Distribution: USA Nationwide and countries of: Algeria, Angola, Argentina, Austria, Australia, Bahamas, Belgium, Bosnia Herzeg, Bulgaria, Brazil, Canada, Chile, Colombia, Croatia, Ecuador, Egypt, El Salvador, France, Germany, Greece, Hungary, India, Indonesia, Italy, Iran, Iraq, Ireland, Japan, Jordan, Kenya, DPR of Korea, Kosovo, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, Pakistan, Palestinian Ter, Peru, Philippines, P.R. China, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, Sri Lanka, South Africa, Sweden, Switzerlan, Taiwan, Thailand, Trinidad Tobago,Turkey, United Kingdom, Venezula, Vietnam, Rep of Yemen, and Zambia.
Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems with BEAMVIEW capability.   The intended use of the SIEMENS branded MEVATRON'', ARTISTE'', ONCOR'' and PRIMUS'' family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
All customers who use the BEAMVIEW  for position verification imaging on Siemens MEVATRON series, PRIMART (limited release) PRIMUS and/or ONCOR or ARTIST Linac Systems.
The information regarding the FILM Mode calibration may have been considered difficult to interpret when translated. SIEMENS HEALTHCARE CR / RADIATION ONCOLOGY had become aware that this issue  may have resulted in mistreatment of patients.
Nationwide Distribution including FL, IL, MD, MN, NY, OH, PA, SC, TN, and TX.
Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder.    Non-rechargeable disposable battery pack.
Braemar Inc.,  became aware of a battery related incident that occurred with an Able battery pack being used in a Braemar ER920W wireless event monitor.  The event did not result in any patient related injury or present any clinical impact.
Butterfly Bakery Harvest Berry Muffins (four muffins per package)  Net. Wt. 14.5 OZ (410 g) UPC 6 43482 60014 8  Manufactured by: Butterfly Bakery Inc.200 Clifton Boulevard, Clifton, NJ 07013 T: 973.815.1501    Packaged in a plastic clam shell.
Whole grain harvest berry muffins may contain undeclared walnuts.
Worldwide Distribution - USA Nationwide and in the countries of:  Japan, Singapore, Hong Kong, China, Australia, Europe, and Chile.
BD MAX Instrument, catalog #441916    Product Usage:  The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.
Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled.
ARNETT'S PLAIN CORN MEAL NET WT. 24 OZ. (1lb. 8 oz)(680g
ARNETT'S SELF RISING CORN MEAL NET WEIGHT 24 OZ. (1LB. 8 OZ) 680g
Dixie Lily Stone Ground Meal 24 oz & 5lbs
The cheese was sold/distributed to Laubscher Cheese 1468 Perry Highway Mercer, PA 16137, contact is Kevin at 800-798-4015; the liquid whey was sold/distributed to Miceli's Cheese 2721 E. 90th St Cleveland, Ohio 44104, contact is Cominick at 800-551-7196 Ext. 125.
40 lbs Cheddar Cheese block wrapped in flexible plastic vacuum packaging, one block per box.
Each 40 pound block of cheese had the date code of 05/20/13 and the vat letter. Each box of cheese had the manufacturing plant code 39-073 printed on the box.
The raw milk used to manufacture cheese was not tested for the concentration of Beta Lactam antibiotics, which are allergens.
Whey liquid packaged in unknown containers.
None; the liquid whey is stored in silos and pumped into tankers for shipping. The firm only tracks the volume that is being distributed.
The raw milk used to manufacture whey was not tested for the concentration of Beta Lactam antibiotics, which are allergens.
Worldwide Distribution - USA Nationwide and countries of: Australia, Belgium, China, Guatemala CentroAmeria, France, Hong Kong, India,Italy, Korea, Lebanon, Malaysia, Morocco, Pakistan, Paraguay, The Netherlands, Romania, Singapore, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom and Venezula,
VenaFlow Elite 30B-B and 30BI-B     Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.
DJO, LLC has recently identified a product safety issue with the battery assembly for the VenaFlow 30B-B and 30 BI-B products. There is a potential for battery leakage which could result in thermal meltdown (fire).
Distributed in the states of MN, FL, and UT.
20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S.   Designed to facilitate electrophysiological mapping of the atria of the heart.
Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly calibrated causing them to be recognized and displayed as a 10-Pole LASSO NAV Catheter Eco by the CARTO 3 System.