The American National Red Cross - Southern Region
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood and Blood Products for Reprocessing
Red Blood Cells Leukocytes Reduced Washed
Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed.
The ARC Blood Center in Cleveland, OH distributed products to three hospitals in Ohio.
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood products, which may have reached an unacceptable temperature during shipment, were distributed.
Blood products, in which phenotype testing was performed incorrectly, were distributed.
Red Blood Cells Degylcerolized Leukocytes Reduced
Red Blood Cells Leukocytes Reduced Irradiated
Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated
Red Blood Cells Rejuvenated Deglycerolized
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Blood products were released for distribution in a foreign country.
Blood products collected from a donor who was permanently deferred for unsuitable test results, were distributed.
Blood product, collected from a donor whose hematocrit was not recorded  during donor screening, was distributed.
Blood products, for which the nucleic acid testing (NAT) for HIV/HCV was invalid, were distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood product, documented as being out of controlled storage for more than 30 minutes, was distributed.
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Blood products, collected from a donor who was previously deferred for IV drug use, were distributed.
Blood products, for which antigen testing was performed without documentation that a positive control was run, were distributed.
Blood products, collected from a donor with a history of high risk behaviors, were distributed.
Blood products, lacking assurance of having been maintained at an acceptable temperature during shipping, were distributed.
Blood product, collected from a donor with a history of high risk behaviors, was distributed.
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
New York Blood Center,inc-cellular Therapy Laboratory
Blood products, which was labeled with an incorrect expiration date, were distributed.
Blood products, collected from a donor with a history of Hepatitis A, were distributed.
Community Blood Center of Greater Kansas City
Blood products, possibly contaminated with Propionibacterium species, were distributed.
Blood products, collected from a donor who was previously deferred, were distributed.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood products, collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood products, collected from an ineligible donor due to a history of hepatitis A, were distributed.
Blood products, collected from an ineligible donor due to a history of Hepatitis A, were distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Hoxworth Blood Center University of Cincinnati Medical Center
Blood product which did not meet the acceptable product specifications was distributed.
Blood products, collected from a donor at risk for human immunodeficiency virus (HIV) Group O, were distributed.
Blood product, collected from a donor whose scheduled physical examination was incomplete, was distributed.
Blood products, which were collected from a donor with a history of high risk behaviors, were distributed
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufactured in India by: Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai - 400 030, Distributed by: PACK Pharmaceuticals, LLC, Buffalo Grove, IL 60089, NDC 16571-412-10.
Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.
Distributed to retail natiowide to US states.
Probitotic Dietary Supplement. :   iFlora Kids Multi-Probiotic
On the evening of Friday, July 6, 2012, Ingredion, Inc. (f/k/a Corn Products U.S., Inc.) the supplier of Galactooligosaccharide (GOS), an ingredient included, in iFlora Kids Multi Probiotic, notified our contract manufacturer that two lots of  their GOS material supplied for inclusion in our products were being recalled for a suspected salmonella contamination. Although our contract manufacturer tested each lot of iFlora Kids Multi Probiotic and confirmed that our products tested free of salmonella, in compliance with the suppliers recall and in an abundance of caution, we immediately contacted the FDA and initiated a full recall of our iFlora Kids Multi Probiotic products.
Platelet Pheresis Leukocytes Reduced Part 1 of 2 and 2 of 2
9684969 (part 1 of 2 and part 2 of 2); 9764768 (part 1 of 2 and part 2 of 2); 9765357 (part 1 of 2 and part 2 of 2); 9771884 (part 1 of 2 and part 2 of 2); 9763523 (part 1 of 2 and part 2 of 2); 9745447 (part 1 of 2 and part 2 of 2); 9761407 (part 1 of 2 and part 2 of 2); 9755010 (part 1 of 2 and part 2 of 2); 8721317 (part 1 of 2 and part 2 of 2); 7396779 (part 1 of 2 and part 2 of 2); 7385402 (part 1 of 2 and part 2 of 2); 7392161( part 1 of 2 and part 2 of 2); 8728456 (part 1 of 2 and part 2 of 2); 8729268 (part 1 of 2 and part 2 of 2); 8723646 (part 1 of 2 and part 2 of 2); 8676244 (part 1 of 2 and part 2 of 2) ; 8714796 (part 1 of 2 and part 2 of 2) ,8636458 (part 1 of 2 and part 2 of 2)
Blood products, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Platelet Pheresis Leukocytes Reduced, Part 1 of 3, Part 2 of 3 and Part 3 of 3
9767339 (part 1 of 3, part 2 of 3 and part 3 of 3); 8699301 (part 1 of 3, part 2 of 3 and part 3 of 3)
Blood product, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Platelet Pheresis Leukocytes Reduced Irradiated, Part 1 of 2 and 2 of 2
Blood products, collected from a donor who had a tattoo within 12 months of donation, were distributed.
CA.       Name and address of consignee involved: Talecris Biotherapeutics, Inc. (TBI), 8368 US 70 Business Highway West, Clayton, NC 27520
Blood products, collected from a donor whose routine physical examination was inadequately performed, were distributed.
Blood product, manufactured with lactated ringer's solution instead os normal saline, was distributed.
Affected products were distributed to Israel, South Korea, United Kingdom , Turkey and domestically to TX, FL, MI, IN, NJ, IL, MO AZ, OK, OK and WI.
Cancellous Chips.  Product is labeled in part:  ''***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method:  supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***''   .25-.5mm 15cc Cancellous Chips, Product Code 0306Al
Tissue ID/Donor ID# Al1000082005 and Al1000082006
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Cancellous Chips.  Product is labeled in part:  ''***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method:  Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***''   .5-1mm 15cc, 30cc, and 1cc Cancellous Chips:  Product Code 0308Al, .5-1mm 15cc Cancellous Chips  Product Code 0309AI, .5-1mm 30cc Cancellous Chips  Product Code 0326AI, .5-1mm 1cc Cancellous Chips
Cancellous Chips.  Product is labeled in part:  ''***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method:  Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***''   1-4mm 15cc, 30cc, and 60cc Cancellous Chips  Product Code 0310Al, 1-4mm 15cc Cancellous Chips  Product Code 0311AI, 1-4mm 30cc Cancellous Chips  Product Code 0313AI, 1-4mm 60cc Cancellous Chips
Cancellous Chips.  Product is labeled in part:  ''***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method:  Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***''   4-10mm 15cc, 30cc, and 60cc Cancellous Chips:       Product Code 0317AI, 4-10mm 15cc Cancellous Chips    Product Code 0318Al, 4-10mm 30cc Cancellous Chips  Product Code 0320Al. 4-10mm 60cc Cancellous Chips
Achilles with Bone Block.   ''***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method:  supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***''   Product Code 0201Al
Patella Hemi.   ''***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method:  Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***''   Product Code 1901Al
Patella Hemi Pre-Sized.   ''***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method:  Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***''   Product Code 1903Al
Tibialis Anterior  ''***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method:  Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***''   Product Code 2701Al
Tibialis Posterior  ''***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method:  Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***''   Product Code 2702Al Donor#/Tissue ID# A100011-0012 and A100011-0013.
Peroneous Longus ''***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method:  Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***''   Product Code 2101Al
Nature Wise CHICK STARTER GROWER 18% CRUMBLES (LL), 91577-25LL 1110, NET WEIGHT 25 LB (11.33 kg), UPC:  722304275631 and 91577LL, NET WEIGHT 50 LB (22.67 kg), UPC:  none, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN  55440
Animal feeds may have Aflatoxin levels above the legal limit.
Nature Wise MEAT BIRD 22% CRUMBLES (LL), 91585-40LL, NET WEIGHT 40 LB (18.14 kg), UPC:  722304275754 and 91585 LL 1101, NET WEIGHT 50 LB (22.67 kg), UPC:  none, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN  55440
DUMOR(R) CHICK STARTER/GROWER 20% CR (LL), 93971 LL, NET WEIGHT 20 LB (9.07 kg), UPC: 749394067411 and 93978 LL 1006, NET WEIGHT 50 LB (22.67 kg), ON BAG OR BULK, UPC: 749394067404, DISTRIBUTED BY:  TRACTOR SUPPLY COMPANY, 200 POWELL PLACE, BRENTWOOD, TN  37027
date codes:  4K1249 through 4K1335; actual date codes distributed:  1193, 1234
DUMOR(R) POULTRY GRO/FINISH 15% (LL), 93975 LL,  NET WEIGHT ON BAG OR BULK, DISTRIBUTED BY:  TRACTOR SUPPLY COMPANY, 200 POWELL PLACE, BRENTWOOD, TN  37027, UPC:  749394067374
date codes:  4K1249 through 4K1335; actual date code distributed:  1192
Nutrena(R) NATUREWISE(R) CRACKED CORN (25#) (LL) 91868-25 LL1006, NET WEIGHT 25 LB (11.33 kg), UPC:  722304029036 and 91868 LL, NET WEIGHT 50 LB (22.67 kg), UPC:  72230429036, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN  55440
Producer's PRIDE CRACKED CORN (LL), 93951 LL, NET WEIGHT ON BAG OR BULK, DISTRIBUTED BY:  TRACTOR SUPPLY COMPANY, 200 POWELL PLACE, BRENTWOOD, TN  37027, UPC:  750889222030
date codes:  4K1249 through 4K1335; actual date code distributed:  1202
Producers's PRIDE WHOLE CORN (LL), 93952 LL, NET WEIGHT ON BAG OR BULK, DISTRIBUTED BY:  TRACTOR SUPPLY COMPANY, 200 POWELL PLACE, BRENTWOOD, TN  37027, UPC:  749394016333
date codes:  4K1249 through 4K1335; actual date code distributed:  1182
ACCO FEEDS(R) SHOWMASTER(R) CALF GROWER (B13.6) (LL) MEDICATED, 10568-B LL , NET WEIGHT ON BAG OR BULK, ACCO FEEDS, GENERAL OFFICE, MINNEAPOLIS, MN  55440, UPC:  722304042103
date codes:  4K1249 through 4K1335; Actual date codes distributed: 1208, 1229, 1257, 1278, 1305, 1333
US nationwide Distribution in the state of CA.
epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System     Product Usage:  Usage:  epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system
Customer reported problem while performing incoming QC of newly received lot of test cards.  Liquid quality control results were found to be out of range.  Further investigation by Epocal determined that a portion of the test card lot (approximately 3000 cards) could potentially report low glucose results.
Worldwide Distribution-USA (nationwide) and the countries of  United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, China, Colombia, Germany, Denmark, Estonia, Spain, Finland, France, Great Brittain, Greenland, Greece, Hungaria, Ireland, Israel, Iceland, Italy, Japan, South Korea, Kuwait, Lithuania, Luxembourg, Latvia, Malaysia, Netherlands, Norway, Poland, Portugal, Rumania, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, and Thailand.
Etac Ono Walker,  Etac Avant Walker, and Etac Salsa Walker.   These products are four-wheeled walkers intended as a walking aid for indoor and outdoor use for persons weighing up to 125 KG.
204,323 units of the Etac Ono Walker, 15,601 units of the Etac Avant Walker, and 6,771 units of the ETAC Salsa Walker
The recall has been initiated because there is the potential that users may fall and become injured, with the potential for serious injury, including bone fracture. One death occurred in a user fall incident, but it is unclear whether the fall was caused by the loss of a wheel. Among the walkers distributed worldwide, Etac has received a total of 49 reports from Europe and Japan of wheels falling off the walkers.  No incidents have been reported in the United States.   Etac is recalling the Etac Ono and Etac Avant model walkers that were distributed in the United States between January 2002 and December 2011 and the Etac Salsa model walkers that were distributed in the United States between January 2006 and December 2011. A total of 637 Ono, 2,858 Avant, and 175 Salsa walkers have been distributed in the U.S. market. The recall includes all Ono walkers with serial numbers preceding 223,000, and all serial numbers of Avant and Salsa walkers.
Worldwide Distribution-USA (nationwide) and the countries of  ARGENTINA, BANGLADESH, BELGIUM, Bolivia, BRAZIL, BRISBANE, CANADA, CHILE, China, COLOMBIA, COLOMBIA, Costa Rica, DENMARK, Dominican Republic, Ecuador, Egypt, FRANCE, GERMANY, Guatemala, HOLLAND, Honduras, Hong Kong, India, INDIA, Indonesia, Israel, ITALY, Jordan, KOREA, Kuwait, Lebanon, LEICESTERSHIRE, Malaysia, Mexico, NETHERLANDS, New Zealand, Nicaragua, NORWAY, Pakistan, Panama, PERU, Philippines, Russia, Saudi Arabia, SINGAPORE , SOUTH AFRICA, South Korea, SPAIN, Sri Lanka, SWEDEN, SWITZERLAND, Taiwan, THAILAND, Turkey, UNITED ARAB EMIRATES (UAE), Uruguay, Venezuela, Vietnam, WEST GERMANY and Yemen.
Terumo Advanced Perfusion System 1.  System 1 base 100/120V.   The Terumo Advanced Perfusion System I is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only When used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
Catalog Number 801763 and serial number 0011-1450
Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (oversensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in systems that were distributed after the corrective actions had been implemented.
Terumo Advanced Perfusion System 1.  System 1 base 220/240V.   The Terumo Advanced Perfusion System I is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only When used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
Catalog Number 801764 and serial number 0006-1441
Sarns Modular Perfusion System 8000 base, 4 pump 115V.   The Sarns Modular Perfusion system 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Catalog Number 16400 and serial number 1001-1333
Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in systems that were distributed after the corrective actions had been implemented.
Sarns Modular Perfusion System 8000 base, 5 pump 115V.   The Sarns Modular Perfusion Systern 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Catalog Number 16401 and serial number PT003, 1001-3001
Sarns Modular Perfusion System 8000 base, 4 pump 220/240V.   The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Catalog Number 16405 and serial number 1001-1461
Sarns Modular Perfusion System 8000 base, 5 pump 220/240V.   The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Catalog Number 16406 and serial number 1001-1823
Sarns Modular Perfusion System 8000 base, 4 pump 100V.   The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Catalog Number 16409 and serial number 1001-1026
Sarns Modular Perfusion System 8000 base, 5 pump 100V.   he Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Catalog Number 16410 and serial number 1001-1622
Sarns Modular Perfusion System 9000, 115V with color screen.   The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
Catalog Number 164300 and serial number 1006-5462
Sarns Modular Perfusion System 9000, 220/240V with color screen.   The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
Catalog Number 164290 and serial number 1005-5463
Sarns Modular Perfusion System 9000, 100V with color screen.   The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
Catalog Number 164280 and serial number 1019-5379
Morphine Sulfate Injection, USP,  4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartridge Unit with Luer Lock, packaged 10 Carpujects/carton, CII, Rx only, Hospira, Inc., Lake Forest, IL  ---- NDC 0409-1258-30
Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL
Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC industries, Inc. Irving ton, NJ 07111, For: Alaven Pharmaceutical LLC Marietta, GA 30062, NDC 68220-086-30
478,569 Softgel Capsules (172,740 trade plus 305,829 samples).
Labeling: Presence of Undeclared Color Additive; The product is being recalled because several inactive ingredients were not included in the labeling for this product: Undeclared D&C Red #33, FD&C Blue #1, Titanium Dioxide Suspension, Purified Water USP.
Worldwide Distribution -  US (nationwide) including Puerto Rico, and Canada.
SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software.     Product Usage:  A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.
Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum Infusion Pump System because it may result in a facility drug library that does not represent common clinical practices.
Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and IM Use, For IV and IC Use after Dilution,  Rx Only, American Regent, Inc., Shirely, NY 11967 --NDC 0517-1071-25
Stryker AVS Navigator Trials 6mm-15mm Manufactured by:  Stryker Spine SAS  Z.1 Marticot-33610-Cestas -France  +33 (0) 5.57.97.06.30  http;//www.stryker.com    Distributed in the USA by   Stryker Spine  2 Pearl Court. Allendale  NJ 07401-1677 USA  +1-201-780-8000  Cestas France 33610.    Intended Use: The trials are designed and intended to measure the height of the disc space intra-operatively.
Beginning in February 2011, Stryker Spine began receiving reports related to the shaft of the AVS Navigator trial failing at the junction of the trial head.
Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV. and the countries of ARGENTINA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.
System 1 Base, 100/120V.   The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Terumo Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons indicating a loss or fluctuation of internal power on one side of the system's base. Terumo Cardiovascular Systems' initial investigation has determined that there may be more than one cause for the malfunction and is investigating further to determine the root cause. Potential risks with the loss or fluctuation of internal power on one side of the system base include:  '' Loss of function of any module, including pumps  '' Loss of safety systems  '' Loss of ability to control the gas blender through the CCM; NOTE: in this case, the user can control the gas blender locally
System 1 Base, 220/240V.   The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Worldwide Distribution-USA (nationwide) including the states of , AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of ARGENTINA, AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.
Terumo Advanced Perfusion System 1   System 1 Base, 100/120V.    The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system network for Terumo Advanced Perfusion System 1. Issues that affect a single pump or module are: '' The appearance of a red X on a single pump or module icon on the CCM   '' The appearance or a single '?' symbol on a pump or module icon on the CCM  '' The failure of a pump or module to power on, or to lose power after powering on    The loss or fluctuation of power or communication in the system network can result in a variety of potential hazards, depending on the system's user-determined configuration.  Potential hazards include:  '' Loss of function of one or multiple modules, including pumps  '' Loss of one or multiple safety systems  '' Loss of ability to control the gas blender through the CCM.    Terumo CVS is notifying users because the Operators Manual for the Terumo System 1 does not contain sufficient instruction for responding to these issues. As an interim precaution, Terumo CVS is informing users of Terumo System 1 of the risks associated with these failures and providing additional instruction.
Terumo Advanced Perfusion System 1   System 1 Base, 220/240V.    The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet,  and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin.   Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocci.
Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles.    Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
Old Fashioned Foods, Jalapeno Bean Dip, Ingredients: water, pinto beans, partially hydrogenated soybean oil, red bell pepper,  jalapeno peppers, salt, dehydrated onions, green bell peppers, sorbic acid (as a preservative), vinegar, citric acid, paprika, ,pepper flavor, gallic powder,Net WT, 3 oz (86g), MFG by Old Fashioned Foods, Mayville, WI, 53050
Sell by 11 SEPT2013 -Jalapeno Bean Dip Item #43335
Old Fashioned Foods Inc is recalling Zesty Bean Dip and Jalapeno Bean Dip because of inadequate processing according to 21CFR114, acidified food regulations.
Abbott Acres, Meal Pals, Zesty Bean Dip, Ingredients: water, pinto beans, soybean oil, tomato paste, less than 2% sugar, , salt jalapeno peppers, dehydrated onions, vinegar, sorbic acid (as a preservative), citric acid, caramel color, FD&C yellow #5, paprika, red bell pepper, sodium benzoate (as a preservative), pepper concentrate, gallic powder, Net WT 3 0z ( 85 g),  Dist by JA Foodservice, Buchanan, MI 49107
Best By 14 MAR2013 - Zesty Bean Dip Item# 42193 Best By 09 APR 2013 (not distributed)
Nationwide:  PA, NC, AL, FL, OH, WI, MN, IL, MI, NJ, GA, TX, MA, CA   Worldwide:  Taiwan, Israel, and Canada.
5 LB Natural Balance Sweet Potato & Venison Dog UPC# 7-23633-88650-5
UPC# 7-23633-88650-5,    Lot Code NBH1202 Best By Date: December 12, 2012; December 13, 2012.    Lot Code NBH0103 Best By Date: March 13, 2013.
The recall was initiated because Natural Balance Pet Foods has confirmed that certain dry pet food formulas manufactured by Diamond Pet Foods may be contaminated with Salmonella.
15 LB Natural Balance Sweet Potato & Venison Dog
UPC# 7-23633-88615-4,    Lot Code NBH0101 Best By Date: March 5, 2013; March 6, 2013.  Lot Code NBH1202 Best By Date: December 12, 2012; December 13, 2012.  Lot Code NBH1203 Best By Date: December 13, 2012; December 14, 2012.
28 LB Natural Balance Sweet Potato & Venison Dog
UPC# 7-23633-88628-4,    Lot Code NBH0101 Best By Date: March 5, 2013; March 6, 2013.  Lot Code NBH0102 Best By Date: March 7, 2013; March 8, 2013.  Lot Code NBH0103 Best By Date: March 12, 2013.  Lot Code NBH1202 Best By Date: December 12, 2012; December 13, 2012. Lot Code NBH1203 Best By Date: December 13, 2012; December 14, 2012.
5 LB Natural Balance Lamb Meal & Brown Rice Dog
UPC# 7-23633-78755-0,    Lot Code NBR1202 Best By Date: December 10, 2012.  Lot Code NBR1203 Best By Date: December 21, 2012; December 22, 2012.
15 LB Natural Balance Lamb Meal & Brown Rice Dog
UPC# 7-23633-78715-4,    Lot Code NBR1202 Best By Date: December 10, 2012;   Lot Code NBR1203 Best By Date: December 21, 2012; December 22, 2012.
28 LB Natural Balance Lamb Meal & Brown Rice Dog
UPC# 7-23633-78728-4,    Lot Code NBR1202 Best By Date: December 10, 2012;  Lot Code NBR1203 Best By Date: December 21, 2012; December 22, 2012.
5 LB Natural Balance Sweet Potato & Bison Dog
UPC# 7-23633-65553-8,    Lot Code NBT1202 Best By Date: December 17, 2012; December 18, 2012;  Lot Code NBT1203 Best By Date: December 28, 2012; December 29, 2012.
15 LB Natural Balance Sweet Potato & Bison Dog
UPC# 7-23633-61718-5,    Lot Code NBT1201 Best By Date: December 9, 2012;  Lot Code NBT1202 Best By Date: December 17, 2012; December 18, 2012; Lot Code NBT1203 Best By Date: December 28, 2012; December 29, 2012.
28 LB Natural Balance Sweet Potato & Bison Dog
UPC# 7-23633-63031-3,    Lot Code NBT1201 Best By Date: December 9, 2012   Lot Code NBT1202 Best By Date: December 17, 2012; December 18, 2012; Lot Code NBT1203 Best By Date: December 28, 2012; December 29, 2012.
UPC# 7-23633-80855-2,    Lot Code NBV1201 Best By Date: December 9, 2012.
28 LB Natural Balance Lamb Meal & Brown Rice Dog Large Breed Bites
UPC# 7-23633-44443-9,    Lot Code NLB1202 Best By Date: December 12, 2012;  Lot Code NLB1203 Best By Date: December 20, 2012; December 21, 2012.
5 LB Natural Balance Lamb Meal & Brown Rice Dog Small Breed Bites
UPC# 7-23633-42300-7,    Lot Code NSL1201 Best By Date: December 21, 2012.
12.5 LB Natural Balance Lamb Meal & Brown Rice Dog Small Breed Bites
UPC# 7-23633-42301-4,    Lot Code NSL1201 Best By Date: December 21, 2012.
Product was distributed to FL, OR, OH, PA, CA, TX, MO, NY, MN, IA, NE, NJ.
PROIN 75MG COUNT BOTTLES HAVE THE CORRECT BASE LABEL OF:  ''***PROIN 75 mg (phenylpropanolamine hydrochloride) CHEWABLE TABLETS 75 mg per tablet***For oral use in dogs only***60 tablets***CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.***Sympathomimetic amine drug***NADA #141-324, Approved by FDA***PRN PHARMACAL Pegasus Laboratories, Inc.***Each scored tablet contains 75 mg phenylpropanolamine, as hydrochloride.***Indications:  PROIN is indicated for the control of urinary incontinence due to urethral sphincter hypotonus in dogs.***Dosage:  The total recommended dosage for oral administration is 2mg/kg (0.91 mg/lb) of body weight twice daily.  Tablets are scored and dosage should be calculated in half-tablet increments.***Warnings:  Keep out of reach of children.  Not for human use.  Consult a physician in case of accidental ingestion by humans.  For use in dogs only.***Precautions:  PROIN Chewable Tablets should be stored out of reach of dogs in a secured area.***Manufactured by:  Pegasus Laboratories, Inc. An Employee-Owned Company Pensacola, FL 32514, USA***Made in USA***''                  INCORRECT BOOKLET TOP LABEL IS A PROIN 25MG LABEL.  INSERT/BOOKLET LABELING THAT MAY BE ON PROIN 75 mg 60 COUNT BOTTLES:  ''***PROIN 25 mg (phenylpropanolamine hydrochloride) CHEWABLE TABLETS 25 mg per tablet***For oral use in dogs only***60 tablets***CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.***Sympathomimetic amine drug***NADA #141-324, Approved by FDA***PRN PHARMACAL Pegasus Laboratories, Inc.***Warnings:  Keep out of reach of children.  Not for human use.  Consult a physician in case of accidental ingestion by humans.  For use in dogs only.***Precautions:  PROIN Chewable Tablets should be stored out of reach of dogs in a secured area.***Manufactured by:  Pegasus Laboratories, Inc. An Employee-Owned Company Pensacola, FL 32514, USA***Made in USA***''    CORRECT BOOKLET TOP LABEL IS A PROIN 75 MG LABEL.  INSERT/BOOKLET LA
Pegasus Laboratories, Inc. is recalling 75 mg, 60 count bottles of Proin Lots 120416 and 120213 for misbranding.  The affected product has the potential to have a 75mg base label with a 25mg Insert attached to the label.  Proin is a veterinary drug used to treat incontinence in dogs.
Product was distributed to 93 retail accounts/customers.
Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC,  Distributed by Bayer Health Care, Morristown, NJ 07962   NDC 0280-8015-24
Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.
Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a) 16 ct. blister (NDC 0280-8005-16), b)24 ct. blister, Distributed by Bayer Health Care, Morristown, NJ 07962 (NDC 0280-8005-25)
Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, Manufactured and Distributed by: JHP Pharmaceuticals, LLC Rochester, MI 48307 NDC 42023-116-02
Labeling: Label Mix-up: Pitocin storage conditions should be labeled, ''Store between 20 to 25C (68 to 77F)''. Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, ''Store between 20 to 25C (28 to 77F)''.
Worldwide Distribution - USA including OH, KY, and TN and the countries of Switzerland, Germany, Austria, Czech Republic, Slovakia Republic, Poland, Netherlands, Belgium, Luxembourg, United Kingdom, Republic of Ireland, Slovenia, Costa Rica, Argentina, Brazil, Dominican Republic, Taiwan, Korea, Greece, Mexico, Italy, Uruguay, Paraquay, Yugoslavia, New Zealand, India, Venezuela, South America, Norway, Sweden, Denmark, Turkey, Great Britain, Israel, Spain, Portugal, Greece, Korea, China, and Japan.
EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-56130; 500-56140; 500-56150)  is a catheter, continuous infusion.  it consists of the Intelligent Drug Delivery Catheter (IDDC) and the MicroSonic Device (MSD).     It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature.     All therapeutic agents utilized with the EkoSonic Endovascular System should be fully prepared and used according to the instruction for use of the specific therapeutic agent.    The Kit MACH4 is labeled in parts: ''***EkoSonic MACH4 Endovascular Device***MicroSonic Device and Intelligent Drug Delivery Catheter***''.    The Pouch MSD is labeled in parts: ''***EKOS***MicroSonic Device***Sterile***''.    EkoSonic Endovascular System is a catheter, continuous infusion. It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. The system is also intended for the infusion of solutions into pulmonary arteries.
EKOS Corporation have recently received several complaints from users where the radio-opaque marker bands on the Intelligent Drug Delivery Catheter (IDDC) were dislodged during a procedure and report of  MicroSonic Device (MSD) breaking during insertion or operation.
Worldwide Distribution - USA (nationwide)
Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. ''Instructions For Use'' (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handling of Bipolar Forceps.    Bipolar Forceps designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures powered by a high frequency generator.
Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. ''Instructions For Use'' (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handling of Bipolar Forceps.
On 05/23/2012, Stingray Surgical Products, LLC., Boca Raton, FL initiated a recall initiated due to  ''Instructions For Use'' of Bipolar Forceps not being cleared by FDA and incorrect ''Instructions For Use'' . The sterilization instructions have been altered without the clearance of the FDA.
Stryker T2 Arthrodesis Nailing System.  Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany.  Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430.   The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
Code information is listed as Catalogue Number, Description and Lot Number (K Number) and is as follows: Catalog No. Description Lot No. 18291104S Arthrodesis Nail, LEFT 11.5 x 540mm K948548 18291104S Arthrodesis Nail, LEFT 11.5 x 540mm K102535 18291104S Arthrodesis Nail, LEFT 11.5 x 540mm K141824 18291104S Arthrodesis Nail, LEFT 11.5 x 540mm K155506 18291104S Arthrodesis Nail, LEFT 11.5 x 540mm K114992 18291104S Arthrodesis Nail, LEFT 11.5 x 540mm K395488 18291104S Arthrodesis Nail, LEFT 11.5 x 540mm K105496 18291104S Arthrodesis Nail, LEFT 11.5 x 540mm K923725 18291104S Arthrodesis Nail, LEFT 11.5 x 540mm K252636 18291108S Arthrodesis Nail, LEFT 11.5 x 580mm K137348 18291108S Arthrodesis Nail, LEFT 11.5 x 580mm K965902 18291108S Arthrodesis Nail, LEFT 11.5 x 580mm K695563 18291108S Arthrodesis Nail, LEFT 11.5 x 580mm K857453 18291108S Arthrodesis Nail, LEFT 11.5 x 580mm K862864 18291108S Arthrodesis Nail, LEFT 11.5 x 580mm K739588 18291108S Arthrodesis Nail, LEFT 11.5 x 580mm K245215 18291108S Arthrodesis Nail, LEFT 11.5 x 580mm K228300 18291112S Arthrodesis Nail, LEFT 11.5 x 620mm K219678 18291112S Arthrodesis Nail, LEFT 11.5 x 620mm K237017 18291112S Arthrodesis Nail, LEFT 11.5 x 620mm K133228 18291112S Arthrodesis Nail, LEFT 11.5 x 620mm K128489 18291112S Arthrodesis Nail, LEFT 11.5 x 620mm K960393 18291112S Arthrodesis Nail, LEFT 11.5 x 620mm K178967 18291112S Arthrodesis Nail, LEFT 11.5 x 620mm K923723 18291112S Arthrodesis Nail, LEFT 11.5 x 620mm K243246 18291112S Arthrodesis Nail, LEFT 11.5 x 620mm K252638 18291112S Arthrodesis Nail, LEFT 11.5 x 620mm K224305 18291112S Arthrodesis Nail, LEFT 11.5 x 620mm K172103 18291112S Arthrodesis Nail, LEFT 11.5 x 620mm K117496 18291112S Arthrodesis Nail, LEFT 11.5 x 620mm K261302 18291116S Arthrodesis Nail, LEFT 11.5 x 660mm K210496 18291116S Arthrodesis Nail, LEFT 11.5 x 660mm K189318 18291116S Arthrodesis Nail, LEFT 11.5 x 660mm K161024 18291116S Arthrodesis Nail, LEFT 11.5 x 660mm K255675 18291116S Arthrodesis Nail, LEFT 11.5 x 660mm K249773 18291116S Arthrode
Stryker has become aware that there exists a potential for breach of the sterile barrier of packaging associated with certain lots of T2 Knee Arthrodesis Nails.
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Distributed to Veterinary Clinics and Veterinarians by perscription Nationwide and Internationally to Hong Kong, Trinidad, Grand Cayman Islands, and Columbia.
INJECTABLES: (No product labeling available) ACEPROMAZINE MALEATE 2MG/ML INJECTABLE 50 ML. ACEPROMAZINE MALEATE** 10 MG/ML INJECTABLE 50 ML. ACETYLCYSTEINE 10% INJECTABLE 100 ML. ACETYLCYSTEINE 20% INJECTABLE 30 ML, 50 ML, 90 ML, 100 ML, 120 ML, 120 ML, 180 ML, 200 ML, 300 ML, 400 ML, 600 ML. ACETYL-D-GLUCOSAMINE 10% INJECTABLE 10 ML, 20 ML, 25 ML, 60 ML, 90 ML, 100 ML, 300 ML, 400 ML, 500 ML, 600 ML, 1000 ML, 1200 ML, 1800 ML, 2000 ML, 2400 ML. ACETYL-D-GLUCOSAMINE 20% INJECTABLE 50 ML 100 ML 200 ML 300 ML 400 ML 600 ML 2000 ML. ACETYL-D-GLUCOSAMINE 25% INJECTABLE 50 ML 100 ML 400 ML 500 ML 1500 ML. ACTH GEL 10UNITS/ML INJECTABLE 2 ML. ACTH GEL 12.2UNITS/ML INJECTABLE 5 ML. ACTH GEL 20UNITS/ML INJECTABLE 3 ML, 5 ML, 10 ML. ACTH GEL 25UNITS/ML INJECTABLE 1 ML 3 ML 6 ML ACTH GEL 40UNITS/ML INJECTABLE 1 ML 2.5 ML 3 ML 4 ML 5 ML 10 ML 15 ML 40 ML. ACTH GEL 50UNITS/ML INJECTABLE 1.28 ML. ACTH GEL 80UNITS/ML INJECTABLE 1.2 ML 2 ML 5 ML 6 ML 10 ML 20 ML 30 ML 40 ML 100 ML. ADENOSINE MONOPHOSPHATE 200MG/ML INJECTABLE 30 ML 50 ML 100 ML 150 ML 180 MLS 250 ML 400 ML. ALTRENOGEST (DUO-RELEASE VEHICLE) 150 MG/ML INJECTABLE 10 ML 11 ML 25 ML 30 ML. AMIKACIN (VET) IM/IV 100MG/ML INJECTABLE 20 ML. AMIKACIN (VET) IM/IV 50MG/ML INJECTABLE 20 ML 50 ML. AMIKACIN P. F. 250MG/ML INJECTABLE 10 ML 12 ML. AMIKACIN SULFATE (VET) 250MG/ML INJECTABLE 2 ML 4 ML 6 ML 8 ML 10 ML 12 ML 16 ML 20 ML 24 ML 30 ML 32 ML 34 ML 36 ML 40 ML 42 ML 48 ML 50 ML 60 ML 80 ML 100 ML 120 ML 150 ML 160 ML. 200 ML 250 ML 300 ML 400 ML 2400 ML. AMIKACIN SULFATE**** 4ML SDV 250MG/ML INJECTABLE 40 ML 400 MLS. AMINO ACID WITH VIT. B12 INJECTABLE 100 ML. AMINOPENTAMIDE, P.F. 0.5MG/ML INJECTABLE 10 ML 20 ML 30 ML. AMINOSYN II** (12X500ML) 8.5% INJECTABLE 18000 ML. AMMONIUM CHLORIDE 2% INJECTABLE 200 ML. AMMONIUM SULFATE 0.75% INJECTABLE 100 ML 200 ML. AMMONIUM SULFATE 10% INJECTABLE 30 MLS 60 MLS 100 MLS 200 MLS 800 MLS. AMMONIUM SULFATE 5% INJECTABLE 100 ML. ANTICOAGULANT CITRATE DEXTROSE (NO CLOT) INJECTABLE 50 ML. APOMORPHINE 1MG/ML INJECTABLE 10 ML 30 ML 250
Franck's Lab Inc. d.b.a. Franck's initiated a recall of all Sterile  Veterinary Drugs distributed between 11/21/2011 and 05/21/2012.  FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Nationwide Distribution-including Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI.
Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102.   Intended for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration.
Firm became aware of the potential for breakage of the anti free flow clip catch, located on the inside of the pump door, when the IV set anti free flow clip is incorrectly inserted into the pump and the pump door forced closed.  If the clip catch is broken and the door opened, free flow protection is still ensured.  However, after the set is manually removed from the pump without the closure of the IV set roller clamp, the anti free flow clip may not re-engage the tubing thereby leaving an open fluid path and creating a potential for free flow.  When the pump and IV set are operated in accordance with the Instructions for Use (IFU), any potential for free flow is fully mitigated.  From the time the set is properly inserted into the pump to the time the set is removed from the pump, the pump's free flow protection remains activated regardless of the integrity of the clip catch.  Additionally, as described in the IFU, the roller clamp should always remain closed after priming the line until the set is properly inserted into the pump.  A warning light is present inside the pump which only turns off once the IV set anti free flow clip is properly positioned in the clip channel in the pump.  Further, per the IFU, the roller clamp is to be closed at the end of infusions before disconnecting the patient.  Adherence to the IFU by the user mitigates the risk of potential free flow should the clip catch be broken.  The original report of correction informed the Agency of a retrospective upgrade conducted at 14 customer accounts that consisted of a new hardware component intended to act as a door jam and a new software version G03.  B. Braun is expanding this field correction to include the following additional actions:  -- Customers with Infusomat Space Pumps with software versions G02 and prior are being informed of the importance of following the Instructions for Use in order to avoid potential IV set misloading and are being provided with information regarding the potential risks should the IFU not be followed.  Inc
Worldwide Distribution -- USA (nationwide)  including the states  of AK, CA, IL, MS, NJ, PR, SD, TN, TX, and  VA. and the countries of  ARGENTIAN, AUSTRALIA, BELGIUM, CHINA, GERMANY, ALGERIA, ECUADOR, EGYPT, FINLAND, UNITED KINGDOM, JORDAN, JAPAN, MOROCCO, MAURITUS, NETHERLANDS, OMAN, PERU, SEBIA, SUDI ARABIA, SINGAPORE, EL SALVADOR, TURKEY, URUGUAY and  SOUTH AFRICA.
GE Healthcare, Invasive Blood Pressure Care Cables.   Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004.
GE Healthcare has become aware through complaints of a potential safety issue with its Invasive Blood Pressure Cable made for use with a Spectramed / BD invasive blood pressure transducer. Due to use of an incorrect O-ring, the mating of the cable with the transducer is faulty. This situation inhibits blood pressure measurement from being monitored correctly.
USA including the state of California  and the countries of  Austria, Spain, United Kingdom, and Italy.
Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E.   The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbant assay (ELISA) in a microtiter plate format. The Presage ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.
The recall was initiated because Critical Diagnostics has confirmed that it is possible to obtain inaccurate test results for specimens when using the Presage ST2 Assay kits.
Worldwide Distribution - U.S. (nationwide) and the countries of  Argentina, Australia, Brazil, Canada, Chile, China, Europe, India, Japan, Mexico, South Korea, Taiwan and UK.
Hudson RCI Concha Therm Neptune Humidifier, Rx Only,    Product Usage:  Usage:  Device that is intended to add moisture to, and sometime to warm, the breathing gases for administration to a patient.
Speaker Failure. If the speaker fails and an event occurs which would generate an audio alarm, the alarm will not sound and could cause a potential delay in patient treatment.
Alere Triage Tox+MTD Drug Screen, PN 94400   Product Usage:  The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses. This test provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography/ Mass Spectrometry/ Mass Spectrometry (LC/MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods. A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results.
A recall was initiated because Alere San Diego has confirmed that the Triage TOX Drug Screen may have significantly decreased precision and accuracy than claimed.  An increased frequency of false positive and/or false negative results has been observed for Triage TOX Drug Screen.
SunOpta Ingredients Group (Corporate HQ)
Arizona, Michigan, Virginia, and Holland   Recall expanded on 6/19/12 to include California.
SunOpta, Canadian Harvest Oat Fiber, Oat Fiber 300-33, Manufactured by SunOpta Ingredients, Chelmsford, MA 01824
SunOpta Ingredients Group, Cambridge, MN is voluntarily withdrawing from the market a number of lots of Canadian Harvest Oat Fiber 300-33 because of the possible contamination caused by Cronobactor sakazakii.
California, Florida, Maryland, Oregon and Virginia, and internationally to Belgium, Brazil, China, France, Germany, Hong Kong, Japan, Malaysia, Mexico, Qatar, Switzerland and United Kingdom
Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code Scanner LN 6L89-01, a component of the Abbott m2000 Instrument System; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list number 06L88-02.   Language configuration bar codes - Intended Use: The bar code scanner is a hand-held device that provides a convenient means of scanning sample bar codes to allow positive sample identification and is supplementary to the computer keyboard. Both the scanner and the keyboard transmit data to a System Control Center (SCC) through a single wedge (cable with branched connectors). The bar code scanner must be configured to match the keyboard language being used. In its default configuration set by the manufacturer (Jadak), the scanner is in English format. If a keyboard other than the English keyboard is being used, the user is required to use the scanner to scan an appropriate language configuration bar code provided in the User's Guide to match the language of the keyboard. Users in the U.S have the ability to convert to another language.
In the Abbott Molecular Bar Code Scanner User's Guide, List Number 6L88-02/09, the section Modifying the Keyboard Format for Bar Code Scanner LN 6L89-01 contains incorrect bar codes that can prevent the correct configuration of the bar code scanner language format.   The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories.  It is comprised of the Abbott m2000sp and the Abbott m2000rt instruments.
Product was directly distributed to California, Oregon, and Washington.
Truitt Brothers, Pacific Northwest Premium Navy Beans, net weight 15 oz. per metal can.  The UPC is 0 82225 24145 1.   The product is labeled in parts: ''***TRUITT BROTHERS***Pacific Northwest PREMIUM NAVY BEANS***NET WT 15 OZ***INGREDIENTS: NAVY BEANS, WATER, SEA SALT, NATURAL CALCIUM CHLORIDE***TRUITT BROS., INC.***SALEM, OREGON 97308***www.truittbros.com***www.foodalliance.org***''.
Can code: MDSB S1GTD best by 7/18/14.   Code interpretation:  MDSB is the internal code for this product.  S = Salem, 1 = Year (2011), G = month, T = Day, D = Shift (of manufacture).  Best by date is 7/18/14 (3 year shelf life)
Navy Beans with the can code MDSB S1GTD best by 7/18/14 are recalled  due to undeclared soy.  Truitt Bros,. Inc discovered that some canned chili beans were labeled as Navy Beans and soy was not declared on the Navy Beans label.
Worldwide Distribution--USA (nationwide) and the countries of Canada, United Kingdom, ZA, and Australia.
LMA Esophageal Intubation Detector (EID), Catalog Number EID100   The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to eliminate clinical judgment
The recall was initiated because LMANA has received a complaint that the Esophageal Intubation Detector (EID100) has a potential to create a false positive if used on a patient during confirmation of intubation.
Itoen Green Tea 11.5 fl oz  (340 mL) can. Natural Source of Antioxidants;  0 calories, no sugar:    ITO-EN USA Inc.  125 Puuhale Road  Honolulu, HI 96819
IHAPR1013;  Costo item number 17800;  Brown carboard tray side 1: GREEN TEA 041012  Brown cardboard side 2: GT 041013
ITO EN discovered that unretorted product was inadvertently released for distribution.
Nationwide Distribution including AZ, CA, CO, FL, IL, KY, ME, MI, MO, MN, MT, ND, NJ, NM, NV, NY, OK, PA, SC, SD, TX , UT, WI, and WV.
CareFusion EnVe Ventilator   Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively. It is not intended for homecare use.
CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously or it may alarm for a Patient Circuit Fault.  The unit will activate either a Low PEEP or Patient Circuit Fault Alarm both audibly and Visually to alert the healthcare professional.  Ventilation delivery to the patient may be compromised.
US Nationwide Distribution to the following states of: MD, MI, MX, ND, NY, OH and TX.
Hitachi Scenaria CT System Software   Product Usage:  The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the Scenaria can be post processed by the Scenaria to provide additional information. Post processing capabilities included in the Scenaria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
Hitachi discovered a software error in the Reconstruction Status function that creates a potential risk that a patient study will not be fully reconstructed. When multiple reconstructions are queued for processing, if a queue is suspended and the task order changed, the second queue may not reconstruct the full range of slices. This may result in missing diagnostic data.
OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures.   The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgery technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray.
GE OEC recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of an FDA inspection identifying that the vertical lift column power supply in the mainframe C-arm is defective and subject to early life failure.
OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures.   The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures.   The OEC 8800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
Part numbers: OEC 8800 All serial numbers.
Worldwide distribution: USA (nationwide) including states of: AL, CA, CO, FL, MI, NC, NJ, NY, OH, PA, TN, TX and WI and country of: South Africa.
GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink.    GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink is used to transmit light.
The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm's 510k due to light transmitting fiber material difference.
Varian Medical Systems, Inc. Oncology Systems
Worldwide distribution: USA (nationwide) and countries including of: Austria, Australia, Bahrain, Belgium, Brazil, Canada, China, Chile, Colombia, Denmark, Egypt, Finland, France,Germany, Greece, Hungary, Hong Kong, India, Indonesia, Israel, Ireland, Italy, Japan, Latvia, Malaysia, Mexico, Morocco, Nepal, Netherlands, Norway, Panama, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, United Kingdom, Taiwan, Turkey, Ukraine, United Arab Emirates and Venezuela.
Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48;  Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA    The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where changing the prescription in a calculated VMAT or RapidArc plan may lead to Monitor Units which do not reflect the new prescription. If the dose prescription of a VMAT or RapidArc plan is changed after the initial Dose Volume Optimization, the Monitor Units and dose distribution may not reflect the intended prescription.
Worldwide Distribution - USA including Florida, Iowa, Oklahoma, South Caroline and the countries of India, Germany and Panama.
Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or alarms.   The Spacelabs Healthcare Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other devices via Flexport interfaces. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Spacelabs Healthcare Xprezzon Bedside Monitor may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitor allows network based applications to open windows and display information the Xprezzon and other networked monitors. The Spacelabs Healthcare Xprezzon Bedside Monitor is designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. The Xprezzon Bedside Monitors is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.
There were reports that a certain combination of key presses will cause the module to disconnect from the Xprezzon bedside monitor, model 91393, and the patient parameters will drop from the display. The parameters return after power cycling the monitor.
Nationwide Distribution including AL, FL, GA, KY, LA, MS, NC, OH, SC, TN, and VA
MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras.   The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.
Product Code: 92340 (Large), Lot #AH9103, AH9110, AH9139, AH9140, AG9154, AH9155 and AH9160; Product Code: 92342 (X-Large), Lot #AH9116, AH9142, AH9143, AH9145, AH9150, AH9151, AH9155, AH9157, AH9159, AH9160, AH9166, AH9168 and AH9076. Customers were notified to include Lot range AH9076xxx to AH9175xxx. On November 17, 2009 the recall was expanded to include the following: Product number 92340 (Large), Lot numbers: AH9072, AH9073, AH9074, AH9103, AH9140 and AH9146; Product number: 92342 (X-Large), Lot numbers: AH9073, AH9074, AH9112, AH9158, AH9160, AH9163, AH9165, AH9167 and AH9168; Product number: 92344 (XX-Large), Lot numbers: AH9074, AH9139, AH9152, AH9153, and AH9155; Product number: 92353 (X-Large Specialty), Lot numbers: AH9143, AH9146 and AH9160 and Product number: 92357 (XX-Large Specialty), Lot number range AH9072xxx to AH9175xxx.
Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.
MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), Made in Honduras.   The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.
Product Code: 92354 (Secure-Fit Large), Lot #AH9141 and Product Code: 92355 (Secure Fit  X-Large), Lot #AH9143. Customers were notified to include Lot range AH9076xxx to AH9175xxx. On November 17, 2009 the recall was expanded to include the following: Product number: 92354 (Large), Lot number range AH9072xxx to AH9175xxx; Product number: 92355 (X-Large), Lot number: AH9141 and Product number: 92358 (XX-Large), Lot number: AH9173.
Nationwide Distribution including SD and NE.
Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04  GEO-MED TOTAL HIP PACK, REF 89-6664.03    surgical kits
Surgical kits and trays contain Stryker Hytrel Togas which were recalled because the clear tape, that is intended to aid in the prevention of patient's fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process.
USA (nationwide) including the states of  AZ, CA, IL, MA, MN, NJ, OK, TN, TX, VA, WA and WI.
Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments.   Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecological surgery and other operative procedures under endoscopic observations. For use when a rigid endoscopic instrument for grasping, dissecting and/or other manipulation of soft tissue is determined to be appropriate by the surgeon.
The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification.
AL, AZ, AR, CA,CO, CT, DE, DC, FL,GA, IL, IN, IA, KS, KY, LA, ME,  MD, MA, MI, MN, MS, MO, NE, NV, NY, NH,NM, NY,  NC, OH, OK, PA, RI,SC, TN,TX,VT, VA, WA, WV, WI.
SP Standard Process, Cataplex ACP (Product #0700 and 0750) , Dietary supplement,  90 & 360 Tablets, Proprietary Blend: Dried buckwheat ( leaf) juice, buckwheat  (seed), carrot (root), calcium lactate, nutritional yeast, bovine adrenal, bovine kidney, alfalfa flour, dried alfalfa, (whole plant) juice, magnesium citrate, mushroom, bovine bone, Echinacea (root, deflated wheat, (germ), oat flour, soybean lecithin, yeast bone, calcium acid, phosphate, mixed tocopherols, (soy), rice (bran), and carrot oil., Other ingredients: Honey ascorbic acid, calcium stearate, arabic, gum, starch, sucrose, vitamin A palmate., UPC 8 12122 01003 0 18.
Lot 114,  Lot 114,   Best Used By dates of 05/13.
Standard Process, Inc. is voluntarily recalling 3 dietary supplements due to potential Salmonella contamination.
SP Standard Process, Cataplex C, Dietary Supplement,  (Product # 1650 and 1655) , 90 & 360 Tablets, Proprietary Blend: Veal bone PMG extract, bovine adrenal, dried buckwheat (leaf) juice, buckwheat (seed), nutritional yeast, dried alfalfa( whole plant) juice, alfalfa flour, mushroom , magnesium citrate, bovine bone, deflated wheat (germ), calcium acid phosphate, Echinacea(root), carrot (root), veal bone, soybean lecithin, mixed tocopherols (soy , and rice (bran)., Other Ingredients calcium lactate, honey, aerola (berry), camu camu (berry), manloc (root), calcium stearate, and arabic gum, UPC 8 12122 01029 0 16.
Lot 114, Lot 114,   Best Used By dates of 05/13.
Standard Process, Pancreatrophin PMG (Product # 6650), 90 Tablets, Proprietary Blend: Bovine pancreas PMG extract, dried alfalfa (whole plant) juice, nutritional yeast, porcine duodenum, deflated wheat (gem) , dried buckwheat (leaf) juice and buckwheat (seed). Other Ingredients: Arabic gum and calcium stearate. Standard Process Inc., PO Box 904, Palmyra, WI  59158, UPC 8 12122 01153 2 12.
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for:  QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-1310-58, UPC 3 0603-1310-58 4.
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
GE Healthcare Optima Mobile X-ray System.  The GE Automatic Mobile X-Ray  (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )
Model Numbers Optima XR200 15kw  Optima XR 200 30kw  Optima XR 220 15kw  Optima XR 220 30kw
254 units have been shipped to/installed in the U.S.
GE Healthcare hos become aware of o software issue on the interfoce of the mobile radiogrophic product, Optima XR200amx, ond Optima XR22Oamx reloted to Visual indicotion as mandoted by the US Code of Federol Regulations (21CFR) and IEC 60601-1-3.