Blood product, collected from a donor who tested reactive for the antibody to hepatitis B core antigen on two separate occasions, was distributed.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia,  Puerto Rico and U.S. Virgin Islands; and countries of: Croatia, Dominican Republic, Turks and Caicos.
Plum A+ Hyperbaric Infusion Pump;    List Number 11005;     Labeled in part: PLUM A+ HYPERBARIC;     Product Usage:  The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not be detected. These errors invoke visual and audible warnings to the user. Hospira has identified the following design attributes of the pressure sensor that may cause the calibration to drift sooner than expected: strain gage protective layers' moisture resistance issues, pressure assembly chassis residual structural stress issues, and relaxation of clamping force from mounting screws for strain gage and pin stack.
Plum A+ Infusion Pump;    List Number: 11971;     Product Usage:  The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
Excessive data in the Code Information for this product has caused issues with the CSV download function.  The complete list of Code Information can be found at the <a href=''http://www.fda.gov/Safety/Recalls/EnforcementReports/UCM376115'' target=''_blank''>Addendum to Enforcement Report</a>.
Plum A+ Infusion Pump;    List Number: 11973;     Product Usage:  The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
Plum A+3 Infusion Pump System;    List Number: 12348;     Product Usage:  The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
Plum A+ Infusion Pump;    List Number: 12391;     Product Usage:  The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
Plum A+ Infusion Pump;    List Number: 12618;     Product Usage:  The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
*** 1) Plum A+ Infusion Pump;    List Number: 20678;     Labeled in part: PLUM A+3; for use with Hospira MedNet;   *** 2) Plum A+ Infusion Pump;     List Number: 20679;     Labeled in part: PLUM A+; for use with Hospira MedNet;   *** 3) Plum A+ Infusion Pump with Hospira MedNet Software;     List Number: 20792;     Labeled in part: PLUM A+; for use with Hospira MedNet;     Product Usage:  The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands;  and countries of: Costa Rica and Dominican Republic.
The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Hyperbaric Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Hyperbaric Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual.   The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken distal pressure pin could result in incorrect distal pressure readings, undetected distal occlusions and/or undetected cassette failures.
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual.   The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+3 Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
1) List Number 20679: 7,737 units; 2) List Number 20792:
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Platelets Pooled Leukocytes Reduced Irradiated
Blood and Blood Products for Reprocessing
Blood products, held in quarantine pending results of an investigation, were distributed.
Blood product, manufactured from an apheresis unit with insufficient platelet yield for the unit to be split, was distributed.
Donor Screening/Deferral screening not done or incorrectly performed, including incorrect ID used during search, prior deferral due to history.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, collected from a donor who had been temporarily deferred, were distributed.
Blood product, collected from a donor considered to be at increased risk for Creutzfeldt-Jakob Disease (CJD), was distributed.
PRIESTER'S PECANS brand brand ROASTED SALTED PISTACHIOS, item #18010, Net Wt. 1 lb (454g), UPC 720056180104; item #15502, Net Wt. 8 oz (226.8g),  UPC 001001155027; Stock No. 189, Net Wt. 2 lb (907g)
Pistachios, which were supplied by ARO and subsequently recalled, have the potential to be contaminated with Salmonella.
PRIESTER'S PECANS brand NUTTY FAVORITES ASST, Stock No. 79, Net Wt 1 lb 10 oz (737g)
PRIESTER'S PECANS brand FANCY ROASTED NUTS, Stock No. 7, Net Wt 12 oz (454g)
Blood products, exposed to unacceptable shipping temperatures, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Pennsylvania; North Carolina; Wisconsin; Ohio; California; New Jersey; Minnesota; New York
Blood products, collected from donors who were at risk for Leishmaniasis, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood Systems, Inc. dba United Blood Services Texas
Blood product, labeled with the incorrect platelet count and product volume, was distributed.
LifeSouth Community Blood Centers Inc - Birmingham Region
Blood product, with no documentation of monthly QC testing for pH, was distributed.
Blood products, which did not meet QC specifications for platelet pH, were distributed.
Lifesouth Community Blood Centers - Montgomery Region
Blood products, with platelet counts below the specified minimum requirement, were distributed.
Blood product, with platelet count below the specified minimum requirement, was distributed.
Blood products, with disparate weights between the two units collected during the apheresis procedure, were distributed.
So Ca Permamente Med Group Blood Donor Cntr
Blood product, not appropriately labeled as a low volume unit, was distributed.
Worldwide Distribution-USA (nationwide) and the country of Canada.
2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3.    Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may  disconnect and lead to blood loss
Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9.    Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
Combiset Blood Line  Hemodialysis use Catalog Number: 03-2622-3.    Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
American National Red Cross Southeastern Michigan Region
Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
Nationwide Distribution including FL, TX, OK, MO, IL, OH, VA, OR, CO, KS, CT
S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension shims are designed to slide down retractor blades, and are optional retractor components utilized during lumbar interbody fusion procedures. They are intended to manipulate tissue and prevent tissue from interfering inside the surgical field.
Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades. The firm's investigation revealed that extension shims may not fit down all retractor blades.
Nationwide Distribution including MO, MA, NY, WI, OH, NY, CA, FL, NC, MN, and WA.
Siemens syngo.plaza image processing system   image processing radiological system
The firm became aware of an unintended behavior when using the syngo.plaza. The ''Rename'' functionality can cause an unintended patient merge if the patient is sent to another system. This issue affects customers who transfer patient data between two or more syngo.plaza or syngo Imaging XS systems.
US Distribution including the states of AZ, KY, PA, IA WV, FL, MO, OK, CA, AR, MT, NY, KS, and CT.
Artis zee systems   x-ray, angiographic system
model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot
The firm became aware of a potential issue with Artis zee systems bearing model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot where a dislocation of the scatter radiation filter inside the card collimator may occur.
Worldwide Distribution: USA Nationwide and the countries of: Egypt, India, Germany, Turkey, Canada, Saudi Arabia, Greece, United Kingdom, Cayman Islands, Kazakhstan, Republic of Korea, Taiwan, Hong Kong, China, Lebanon, Argentina, Denmark, Belgium, Netherlands, Mexico, France, Australia, Panama, Italy, Guam, United Arab Emirates, Israel, Polan, Venezuela, Austria, Hungary, Lithuania, Norway, Malaysia, Colombia, Costa Rica, Ecuador, Jamaica, Peru, Thailand, Italy, Czech Republic, Cameroon, South Africa, Portugal, Finland, Sweden, Nigeria, Bahamas, Cambodia, Dominican Republic, Switzerland, Chile, Singapore, Spain, Syrian Arab Republic, Jordan, Japan.
Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, MicroMax Systems and XMax Motor Systems all models and serial numbers.     Product Usage:  Indication for use is cutting and shaping bone.
Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance requirements that determined the claim that the device is capable of dissection of biometals, bioplastics and cement has been verified, but is is not part of the currently cleared indications for use fo the device(s). The currently cleared indications for use for the pnuematic and electric motor systems is ''cutting and shaping bone''.
Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers.    Product Usage:  Indication for use is cutting and shaping bone
Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers.   Product Usage:  Indication for use is cutting and shaping bone.
US Pistachio Shelled, Halves, Raw, Net Weight: 30lbs.
Lot#TO010092, expiry date: September 2014
Primex International Trading Corp. is recalling Pistachios Shelled, Halves, because it has the potential to be contaminated with Salmonella.
Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Human cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.
Worldwide Distribution-USA including Puerto Rico and Canada.
SIGMA SPECTRUM Infusion Pump with Master Drug Library.   Intended to be used for the controlled administration of intravenous fluids.
Product Code: 35700BAX, 35700ABB Serial Numbers: All
Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions.
DePuy Mitek, Inc., a Johnson & Johnson Co.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Worldwide Distribution - USA (Nationwide) and in the countries of: Australia , Austria , Belgium , Canada , Czech Republic , Denmark , Finland , France, Germany , India, Ireland , Israel, Italy , Latvia , Netherlands , Norway , Nepal, Poland , Portugal , Spain , Sweden , Switzerland , United Kingdom.
DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142     Product Usage:  The Intermediary Tubing for FMS Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Intermediary Tubing is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy  .
Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not  perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination
DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649    Product Usage:  The Intermediary Tubing for FMS Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Outflow Tubing with One-Way valve is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy.
Worldwide distribution: US (Nationwide) including Puerto Rico and Virgin Islands; and countries of: Australia, Algeria, Belgium, Bolivia, Canada, Canary Islands, Chile, Croatia, Finland, France, Germany, Greece, Guatemala, Honduras, India, Israel, Italy, Japan, Jordan, Lima-Peru, Malaysia, Morocco, Nicaragua, Portugal, Saudi Arabia, Seoul Korea, Serbia, Singapore, South Africa, Spain, Switzerland, Turkey, Utd.Arab.Emir., United Kingdom, and Venezuela.
VerSys Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems.    Indicated for total hip arthroplasty.
Based on a review of historic packaging validations, it was determined that a subset of product packaged in one of the clean rooms at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity.  The number of samples required for packaging testing (seal integrity and seal strength) to provide a 90% confidence and 99% reliability were not available for testing.  As a result, Zimmer is recalling all lots of the product due to the potential that the sterile barrier integrity may be compromised.
GoPicnic Black Bean Dip & Plantain Chips; ready-to-eat meal kit with professor zim zam's extraordinary sweets dark chocolate with orange packaged in paperboard container; NET WT 4.2 OZ (116.2g); distributed by gopicnic brands, inc.; chicago, il 60613; www.gopicnic.com;
The chocolates included in the meal kits may contain undeclared milk allergens.
Gopicnic; Hummus & crackers; GoPicnic meal kit packaged in paperboard container. ready-to-eat meal; with professor zim zam's extraordinary sweets dark chocolate with sea salt.  NET WT 4.1 OZ (116g); distributed by gopicnic brands, inc.; chicago, il 60613; www.gopicnic.com
Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.
Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, WORKGROUP   The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1975903
Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Carestream Vue PACS; Virtual Access Plus SW, Workgroup   The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1013226
Carestream Vue PACS; Virtual PWR Reading Basic SW, Workgroup The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1308519
Carestream Vue PACS; Virtual PWR Reading Basic SW, 8 Pack   The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1530633
Carestream Vue PACS; Virtual PWR Reading Basic SW Workgroup   The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1467067
Carestream Vue PACS; Virtual PWR Reading Basic SW 8 Pack The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1405794
Carestream Vue PACS; Virtual Access Software, StandAlone   The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1301761
Carestream Vue PACS; Virtual Access Pluse SW, StandAlone   The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1337195
Carestream Vue PACS; Virtual Enterprise SW StandAlone   The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8171837
Carestream Vue PACS; Virtual PWR Reading Basic SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8230633
Carestream Vue PACS; Virtual Reading Basic SW StandAlone   The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1097229
Carestream Vue PACS; Unlimited Reading LIC<7.5K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8380354
Carestream Vue PACS; Unlimited Reading LIC<15K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8648503
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<7.5K EX/Y The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1673334
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8656456
Carestream Vue PACS; UNLIMITED READING LIC < 25K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1149418
Carestream Vue PACS; UNLIMITED READING LIC < 50K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1560713
Carestream Vue PACS; UNLIMITED READING LIC ADD 10K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8976268
Carestream Vue PACS; UNLIMITED READING LIC ADD 25K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1645324
Carestream Vue PACS; UNLIMITED READING LIC ADD 100K E/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8768178
Carestream Vue PACS; MX-O SA WORKSTATION SW LICENSE The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8978504
Carestream Vue PACS; MX CLINIC SOFTWARE DICOM VIEWING The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1384700
Carestream Vue PACS; MX RAD SW ADV CR/DR LAYOUT & VIEW The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8891640
Carestream Vue PACS; MX PRINT SW AUTO LAYOUT PAGE & PRINT The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8678468
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC< 7.5K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8101768
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 15K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1630185
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 25K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1961382
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 50K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1549377
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 75K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 848164
Carestream Vue PACS; UPG MX-O SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8215956
Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8485021
Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8711459
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8859811
Carestream Vue PACS; UPG MX-O SVR 75K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 886578
Carestream Vue PACS; MX WEB SW/ 1 MX-O CONCUR ACCESS LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1482116
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<75K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8274888
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<50K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8062374
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<25K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8446361
Carestream Vue PACS; MX WEB SW/1 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1849592
Carestream Vue PACS; MX WEB SW/5 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8203101
Carestream Vue PACS; MX WEB SW/10 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8795866
Carestream Vue PACS; MX WEB SW/15 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1387042
Carestream Vue PACS; MX WEB SW/25 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1618198
Carestream Vue PACS; UPG MX-RAD SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1738905
Carestream Vue PACS; UPG MX-RAD SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1981042
Carestream Vue PACS; UPG MX-RAD SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8296642
Carestream Vue PACS; UPG MX-RAD SVR 50K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8441602
Carestream Vue PACS; UPG MX-RAD SVR 75K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8553331
Worldwide Distribution - USA Nationwide in the states of:  AR, AZ, CA, CO, CT, FL, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NM, NY, OH, OK, OR, PA, TN, UT, VA, WA and WV and the country Canada.
SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B)   Product Usage:  Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.
Baxter Healthcare Corporation is recalling the LCD display screen on the SIGMA SPECTRUM Infusion Pump with Master Drug Library for not meeting standards for withstanding an electrostatic discharge.
Worldwide distribution: US (nationwide) in the state of: TX and countries of: Colombia, Hong Kong and Korea.
Access 2 Immunoassay System, Part Number: 81600N   The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Beckman Coulter is recalling the Access 2 Immunoassay System because they determined that the fuses in the system may be of the wrong amperage.
Product distributed to Arizona, California, Colorado, Idaho, Nevada, Oregon, Utah, and Washington.  Including Govt/military/VA.
Dannon LIGHT & FIT Nonfat Yogurt - 4 PACK of 6 oz cups.  Vanilla UPC 36632 02721
Dannon Company, Inc. is recalling Light n Fit Nonfat Yogurt because they may contain yeast.
Dannon LIGHT & FIT Nonfat Yogurt - 4 PACK of 6 oz cups.   Peach UPC 36632 02722.
Dannon LIGHT & FIT Nonfat Yogurt - 4 PACK of 6 oz cups.   Strawberry UPC 36632 02720.
Dannon LIGHT & FIT Nonfat Yogurt - 4 PACK of 6 oz cups.  Strawberry/Banana UPC 36632 02181.
Dannon LIGHT & FIT Nonfat Yogurt - 4 PACK of 6 oz cups.  Cherry UPC 36632 02180.
Dannon Company, Inc. is recallingLight n Fit Nonfat Yogurt because they may contain yeast.
Dannon LIGHT & FIT Nonfat Yogurt - 4 PACK of 6 oz cups.   Blueberry UPC 36632 02723.
Distribution was nationwide through retail and internet sales.  The distribution list is pending.
Apotheca Energique Gastrozyme, dietary supplement, 100 vegetarian capsules.
Lot number C3354   The product mathmatical analysis of potential Chloramphenicol level is 1.07 ppb.
The products may contain chloramphenicol.
Stryker Instruments Div. of Stryker Corporation
Worldwide distribution: US (nationwide) including states of: TX, FL, IL, IA, ND, WI, VA, and NJ.; and countries of: CANADA, POLAND and SWITZERLAND.
Acetabular Pressurizer; single use and six units per box.   The Acetabular Pressurizer 0206-522-000 is an accessory to the  Advanced Cement Mixer (ACM). The Acetabular Pressurizer  Tiplet P/N 0206-522-012 is sealed in a two pouches, sterilized, and labeled as part number 0206-522-000.    This Acetabular Pressurizer is an accessory used to pressurize the cement applied to the prosthesis to be implanted during the surgery. The Acetabular Pressurizer is an injection molded component made with resin material DOW HDPD 10462N which is a rigid plastic once it is molded.
On March 14, 2013 a Work Order was opened for 120 units (20 boxes) of the Acetabular Pressurizer (P/N 0206-522-000 Rev. H). On March 15, 2013, when the product was going to be placed in the pouch to be sealed, the manufacturing operator noticed that some assemblies were cracked. As a result of the injection pressure of the cement gun, a cracked tiplet may release from the Hub during cement application. There is also the potential for cement to leak out from the fissure in the tiplet during setting time, resulting in an inadequate supply of cement required to complete the surgery.
US Distribution including the states of AL, AR, CA, CT, FL, GA, IA, IL, MS, NY, OH, SC, TN, and TX.
Composite Series Skull Clamp, one clamp per tote.    The MAYFIELD Skull Clamp (A3059) is a cranial stabilization device, designed to provide rigid skeletal fixation. The Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary
An investigation of an adverse trend of complaints for the Skull Clamp index locking knob not easily unlocking or disengaging and malfunctions of the 80 lbs. torque knob was initiated.  None of the complaints resulted in a report of patient injury, adverse health consequence, or a delay / prolongation of the surgical procedure.
Worldwide Distribution - US including Michigan and the countries of  Ireland and Australia
3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM   The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety. The subject device is a Bone Screw designed for use with this system.
Part Number:. 00-0903-2634 and lot number 009U2
The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. Upon investigation, it has been determined that a lot number 009U2 was packaged and mislabeled internally by OrthoPediatrics.
Worldwide Distribution: USA (Nationwide) and countries of: Canada and Mexico.
Synthes 8.5 MM Medullary Reamer    Product Usage:  An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, bmT, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
Part No. 352.085 with lot numbers 20141 through 24510, and 4399543 through 5870257
Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.
Nationwide in US and worldwide to:   Australia, Canada, Malaysia, Taiwan, Italy
Cellulase:   ACTA 4-702  APEX 17-6262  APEX 6-9762  ARTH EB 10831  BETA GLUCANASE 1000  BROOK 8-352  CELLULASE 1000  CELLULASE 4000  CELLULASE CONC.  CENTURY 7-152  CLENZSEB  DIGESEB  DIGESEB PB  DIGESEB PLUS  DIGESEB PLUS 401  DIGESEB SUPER  DIGESEB SUPER 118  EB 10-14081  EB 10-15351  EB 12-706  EB 14-14201  EB 16-15612  EB 17-14161  EB 5-13302  EB 5-14121  EB 5-15361  EB 8-15731  EB 9-14181  EB 9-14191  EL 5-7212  GLOBAL 8-658  GREENZYME 427  HEMISEB  JARL 3-164  NAT 9-185  NF 525  NHK 14-9451  NPC 270  NPC 5005  NPC 6006  NW 7B 9142  PB 10401  SEB GLUTEN RELIEF  SEB GLUTEN RELIEF HNS  SUPER 108  TUMMYEASE  VEGPANZYME PLUS  VR 5-8451
Specialty Enzymes and Biotechnologies is recalling cellulase/mannanase and fungal protease because they may contain low levels of chloramphenicol.
Protease:   APEX 10-7082  CENTURY 7-152  EB 2-14511  EB 5-16901  EB 8-14861  EB 9-14191  EXCLZYME  EXCLZYME EN  GLOBAL 8-658  HFN 7-7113  META 10-185  MHNHEM 2-158  PEPZYME AG  PROTEASE - 1000  PROTEASE 250,000  SEB PRO FP 500  SEB PRO FP 600  SYS 7-7742  UT 11-216 N  VEGPANZYME 1213  VEGPANZYME PLUS
Cellulase & Protease:   APEX 10-639 A  DIGESEB  DIGESEB PLUS  DIGESEB SUPER  EB 10-14171  EB 10-16192  EB 12-11331  EB 12-9205  EB 14-14201  EB 15-13662  EB 18-13081  EB 7-12831  EB 7-12901  EB 7-14211  EB 8-15731  EL 5-7212  ENZIGEST N  FIZYME # 1209 N  GLOBAL 8-658  HERB 10-6973  HFI 4-7601  HFN 7-7113  META 10-185  NB 6-7812  NF 525  NHK 14-9451  NPC 7007  NPC 8008  NUTRO 8-7961  OHS - 9804  PROTHERA 18-9724  PROTHERA 19-9723  PROTHERA 8-12182  SD 7-581  SEB GLUTEN RELIEF  SEB GLUTEN RELIEF HNS  UT 11-216 N  VEGPANZYME 1213  VEGPANZYME 1X  VEGPANZYME PLUS  VT 11-693
Papain:   NF 4-608 B  NF 4-6152  NUTRA 6-452  PAPAIN  PROHYDROXY NF 4-714
Worldwide distribution: US (Nationwide) including Puerto Rico; and countries of: Algeria, Aruba, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malta, Martinique, Mexico, Morocco, Netherlands, Netherlands Antilles, New Caledonia, Norway, Oman, Pakistan, Panama, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Venezuela
Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.
Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions:  Switching between groups with Multiple programs or creating program groups.  Therapy can be restored with the Physician Recharge mode (RPM) of the Implantable Neurostimulator Recharger (INSR).
Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603.  Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation.
WELLTRIENTS DIGESTAIDS FORMULA #2, 90 capsules per bottle.    Item #61256-90
Creation's Garden Natural Products (CGNP) is recalling Welltrients Digestaids Formula #2 because it has been found to contain chloramphenicol.
Ultra Laboratories is recalling Digestive Health because a raw material used in its formulation may have been contaminated with chloramphenicol.
Nationwide in US and worldwide to Japan, Taiwan, Belgium, and Canada
Spectrazyme, 180 count, 60 count, 12 bottles/case, 20000 tablets/box, 14000 capsules/pail.
Metagenics is recalling Spectrazyme because their raw material supplier informed them that enzymes in the blend may contain the antibiotic chloramphenicol.
Worldwide distribution: US (Nationwide)and in the country of Canada. (note: the ceiling supply units are not classified as a medical device by Health Canada).
Draeger Movita 603x/DVE 803x Ceiling Supply Unit.  It is intended for use in operating theaters and intensive care
Cases were encountered with the Draeger Movita 603x/DVE 803x Ceiling Supply Units where the drive screw in the motor unit broke and the lift arm fell down approximately 60 cm (23.6 inches).
Worldwide Distribution-USA (nationwide) and the countries of  EMEA, APAC, Japan, Canada. AE, AU, BE, BH, CA, CH, CL, CN, CO, DE, EC, ES, GB, GR, HK, HU, IL, IN, IT, JP, KR, KW, MX, MY, NX, PA, PH, PK, PL, PR, QA, RU, SA, SG, SI, TH, VE, VN, ZA, and Tripoli.
Sterrad 100NX, Product Code: 10104.   Used to sterilize heat and moisture sensitive reusable medical devices.
Advanced Sterilization Products (ASP) is recalling the Sterrad 100NX Sterilizer some healthcare workers detected odors/smells emanating from the 100NX Sterilizers, and it may be related to normal breakdown of the oil used in the Sterrad 200 vacuum pumps.
Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CT,DE, FL,GA, HI, IL, IN, IA, KS, MD,MA, MI,MN, MS, O. NV, NH, NJ, NY, NC, OH, OK, OR, PA, SD, TN, TX , UT, VA, WA, WI. OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BYELO RUSSIAN, CANADA, CHINA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HON KONG, HUNGARY, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LATVIA, LIBYA, LITHUANIA, LUXEMBOURG, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, and UNITED KINGDOM. .
AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.): AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION): AW Server.   K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.
GE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products.   The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correct. The concern is that the patient right/left representation is from the Superior view, which could result in a misreading of the image and misdiagnosis.
US and Australia, Azerbaijan, Brazil, Canada, Germany, Great Britain, Hong Kong, Ireland (Eire, Japan, Malaysia, Malta, Mexico, New Zealand, Panama,  Philippines, Russia, South Korea, Spain, Switzerland, Thailand.
Serralase Enzyme Supplements; Packaged in 90 and 180 tablet bottled  UPC - 90 count: 8 28054 00542 6  UPC- 180 count 8 28054 00149 7;      Manufactured by:  ProThera, Inc.,   Reno, NV 89521
ProThera was notified by enzymes provided by Specialty Enzymes within the last 3-6 months may be contaminated with chloramphenicol.
Klaire Labs Vital-Zymes Chewable; Comprehensive Enzyme Supplement;  180 Chewable tablets.  UPC 7 09616 0218 5      Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera  Reno, NV 89521
Klaire Labs Vital-Zymes complete; Comprehensive Enzyme Supplement;  120 Vegetarian tablets.  UPC 790616310005      Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera  Reno, NV 89521
Klaire Labs Interfase;  Enzyme Supplement;  Packaged in 60 and 120  Vegetarian capsules bottles.  UPC  60 ct.- 7 0961 012270 7;  UPc 120 ct. - 7 09616-01229 1      Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera  Reno, NV 89521
Klaire Labs Interfase Plus;  Enzyme Supplement;  120  Vegetarian capsules bottles.  UPC 7 09616 01228 4      Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera  Reno, NV 89521  Notation:  Product #6 Clean Cut Enzyme wasn't entered into RES because the product never left the warehouse.
Nationwide in US and worldwide to Canada, United Kingdom
GlutenFlam (K-52) Enzyme & Bioflavonoid Dietary Supplement, 60 vegetarian capsules
Apex Energetics is recalling GlutenFlam, SuperDigestZyme, LGS-Zyme, and RepairVite because they may contain trace amounts of the antibiotic chloramphenicol.   The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol.
SuperDigestZyme (Z22), Plant Enzyme and Cofactor Dietary Supplement, 100 tablets
LGS-Zyme (Z12), Enzyme-Based Multivitamin & Amino Acid Dietary Supplement, 120 Capsules
RepairVite (K63), Enzyme-Based Herbal & Amino Acid Dietary Supplement Powder, Caramel Flavor, Net Wt. 0.34 lb (155g)
Distributed to ID, MN, and SC.  Foreign distribution to Sweden. No military/govt/VA consignees.
All-Natural Greens Dietary Supplement; Manufactured Exclusively for NatureRich, Maple Grove, MN 55369.
Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol.
Natural Balanced Nutrition Vanilla Energy Shake Dietary Supplement; Manufactured for NatureRich, Maple Grove, MN.
Vive Shake Up Your Health Chocolate; Made for and distributed by renewal wellness.
Empirical Labs Building Health SuperFuel Plus Mocha Flavor; Whey protein isolate (milk); Dietary Supplement
Empirical Labs Building Health SuperFuel Tropical Dietary Supplement
Dynamite Specialty Products Tri-Mins Daily Foundation, calcium, magnesium, potassium dietary supplement; 240 Capsules; Manufactured for Dynamite Marketing, Inc, Meridian, ID 83642.
Empirical Labs Building Health Superfuel; 240 Capsules Dietary Supplement
Empirical Labs Building Health Inte-Zyme; 180 Capsules Dietary Supplement
Empirical Labs Building Health Thyroid; 90 Capsules Dietary Supplement
Empirical Labs Building Health Vascuzyme; 90 Capsules Dietary Supplement
Empirical Labs Building Health P&L Enzymes; 180 Capsules Dietary Supplement
Non-GMO Ingredients Go Green Fuel for the Entire Body Dietary Supplement.  All-Natural Greens Dietary Supplement.  Manufactured Exclusiveley for: Hsin Ten Enterprise USA, Inc. Industry, CA 91748.
Empirical Labs Building Health Digesti-Zyme; 180 Capsules Dietary SupplementSupplement
Worldwide Distribution - USA (nationwide) and country: Canada.
Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA   IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.
Philips Healthcare became aware of a software problem with the IntelliSpace PACS system, in that a timing issue has been identified that may result in a condition where the device does not store additional images received before processing is complete. The missing images may contain pathology which may result in a different diagnosis if they had been available at time of interpretation.
Nationwide Distribution including the states of KY, OH, TX, MA, and NC.
Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO.   Intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter.
Catalog Number A700238, Batch Number 4113243, 4152911. Catalog Number A700240, Batch Number 4113242, 4124985.
St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batched of Safire Duo Ablation Catheter MediGuide Enabled. These units have a cable connector configuration that is different than intended.
Beachbody Optimize Enzymes Capusles, 126 CT, 8 oz.                                 Container size: JAR 8OZ WHITE 70MM NECK POLYPROPYLENE 126 capsules per bottle.                      Product labeling reads in part:'' BEACHBODY ULTIMATE OPTIMIZE Promotes healthy metabolism and effective body funtions***DIETARY SUPPLEMENT 126 Capsules***BEACHBODY, LLC Santa Monica, CA***''.
CGNP initiated this recall because the raw material Exclezyme received from Specialty Enzymes used by CGNP in the formulation of Beachbody Optimize Enzymes Capsules CG has been found to contain chloramphenicol.
Beach Body Ultimate Reset Kit 2.0( each Kit consist of 1 bottle of the above optimize enzymes capsules product and 5 bottles of additional product)                     Product labeling reads in part:'' BEACHBODY ULTIMATE RESET KIT 2.0*** BEACHBODY, LLC Santa Monica, CA***''.
US: Nationwide (AL, FL, GA, IL, IN, KS, KY, MI, MO, MS, NC, OH, SC, TN, WI)
*** 1) Corn meal mix packaged in a paper bag labeled in part: Aunt Jemima; Buttermilk; Self-Rising White; Corn Meal Mix; Flour, Salt & Baking Powder Already Blended In; NET WT 32 OZ (2 LB);    *** 2) Corn meal mix packaged in a paper bag labeled in part: Aunt Jemima; Buttermilk; Self-Rising White; Corn Meal Mix; Flour, Salt & Baking Powder Already Blended In; NET WT 5 LB
*** 1) Aunt Jemima; Buttermilk Self-Rising White Corn Meal Mix NET WT 32 OZ (2 LB);    UPC: 30000 05468, 300000 54604;     Best Before Date: March 4, 2014;     Cases of 12 bags labeled with UPC: 10030000054502;     *** 2) Aunt Jemima; Buttermilk Self-Rising White Corn Meal Mix NET WT 5 LB;     UPC: 30000 05450, 300000 54505;     Best Before Date: February 3, 2014;     Cases of 8 bags labeled with UPC: 00300000546004
Some Aunt Jemima brand Buttermilk Self-Rising Corn Meal Mix, Quick Grits Enriched with White Hominy, and Buttermilk Self-Rising Corn Meal Mix White have levels of aflatoxin above the legal limit..
White grits packaged in a paper bag labeled in part: Smooth & Creamy; Aunt Jemima; Quick GRITS; Cooks in about 5 minutes; ENRICHED WHITE HOMINY; NET WT 36.8 oz. (2 lb. 4.8 oz.) 1043g
Aunt Jemima Quick Grits Enriched White Hominy:    UPC:30000 04260, 300000 42601;     Best Before Date: February 26, 2014
Nationwide Distribution-including the states of AZ, CA, FL, GA, IL, KY, MA, MN, NC, NJ, NV, NY, OH, OR, TN, TX, and UT.
Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide.   The Prostiva RF Model 8929 Hand Piece Kit is the delivery system component of the Prostiva RF Therapy System. Prostiva RF Therapy delivers low-levels of radiofrequency (RF) energy directly into the hyperplastic tissue for the treatment of benign prostatic hyperplasia (BPH). The RF energy delivered by the system provides selective thermal ablation of prostate tissue to help reduce urethral  constriction and relieve BPH voiding symptoms.  The Prostiva RF Therapy System consists of the following major components:  '' Radio Frequency Generator  '' Hand Piece Kit  '' Telescope  The Model 8929 Prostiva RF Therapy Hand Piece Kit contains the following single-use, disposable components:  '' One sterile Hand Piece with radio  frequency cable (Model 8929)  '' One sterile Tubing System (Model 6101)  '' One non-sterile Return Electrode (Model 8934)    The hand piece has two insulated electrode needles that deliver the radio frequency energy interstitially to the prostate. These needles are covered by insulating shields that localize the lesions within the prostate, protect the urethra from thermal damage, and eliminate collateral thermal damage. The Hand Piece stainless steel (SS) tube is inserted into the urethral canal up to the prostate with the aid of a telescope for visualization during the therapy. The Hand Piece features two insulated Nitinol needles inside the SS tube. The needles can be deployed (extended), at approximately a 90-degree angle from the SS tube, to a preset depth of between 12 mm and 22 mm (at 2 mm intervals). The needles inside the SS tube are deployed into, or retracted from the prostate, using the handle lever. RF energy is delivered through the needles to the prostate tissue. The RF energy creates molecular friction eventually resulting in tissue heating and cell death (therapy intent).
Kit Lot Number:  215251, Hand Piece Lot Number: 13E005M.
Urologix is voluntarily recalling Prostiva RF Therapy Hand Piece Kits, Part Number 8929, Lot Number 215251 due to a Hand Piece not meeting an in-process force test specification.
US Distribution in the states of: California, Colorado, Delaware, Florida, Maryland, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Virginia
Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0.  The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.
DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer:  DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN  37849, MADE IN GUATEMALA   cleaning of fluids from surgical site in or near the eye
One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product.
Worldwide Distribution: US (nationwide) and countries of:  Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Mexico, New Zealand, Netherlands, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, Spain, South Africa, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
Applied Medical's Inzii 12/15mm Retrieval System.   Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.
Applied Medical is conducting a voluntary recall of the Inzii 12/15mm retrieval system. During shipment, the retrieval system packaging has the potential to become punctured with small holes, which could compromise the sterile barrier. The likelihood of this situation to occur and result in patient harm is highly unlikely; however, out of an abundance of caution for patient safety and a commitment to provide only the highest quality products, Applied has decided to recall all potentially affected units.
Worldwide Distribution-USA including DC and the states of MO,TX,OK, LA, MA, CA, WI, and MI and the country of Canada.
Sarns''  Soft-Flow Aortic Cannula without Suture Flange, angled tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8'' connector, 14'' (36 cm) long.   Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns''  Soft-Flow Aortic Cannulae and Sarns'' Venous Return Cannulae.
Sarns''  Soft-Flow Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 7.0 mm (21 Fr) OD with 3/8'' connector, 14'' (36 cm) long.   Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Sarns''  Soft-Flow Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8'' connector, 14'' (36 cm) long.   Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Sarns''  Venous Return Cannulae, 20 Fr with 1/4'' flare, 14.5'' (37 cm) long.   Indicated for venous drainage during cardiopulmonary bypass surgery for dial cannulation of the superior and inferior vena cava.
US only - CA, TX, FL, MS, WA, NC, MA, IN, NC, NY, PA.
Fruit Truffles - Cherry, Coconut, Key Lime, Lemon, Mango, Pear, Pineapple and Tangelo flavors.  (6 piece count/4.5 oz) Pear, Lemon, Key Lime, Coconut flavors contain FD&C Y5 and/or Y6;                                          (9 piece count/7 oz) Pear, Cherry, Tangelo, Coconut, Lemon, Key Lime flavors contain FD&C Y5 and/or Y6 ;   (12 piece count/9 oz) Mango, Pineapple, Tangelo, Cherry, Pear, Coconut, Key Lime, Lemon flavors contain FD&C Y5 and/or Y6;  Firm also sells 2 piece count/1.5 oz  products.  However, this product only contains 2 strawberry flavors and do not contain FD&C Y5 and/or Y6.       Sold to the hospitality industry.  Product of the USA.  Manufactured by Torn Ranch, Petaluma, CA 94954
(6 piece count/4.5 oz) =  ITEM CODE S307-H                                   (9 piece count/7 oz) = ITEM CODE S308-H         (12 piece count/9 oz) = ITEM CODE S309-H           Lot numbers:  1453-2963     Best By Date:  October 24, 2013-February 23, 2014  (Best by date is 4  months after manufacturing date of product)
FDA inspection at the firm found that Yellow # 5 and 6 used in decoration on top of fruit truffles was not declared in the ingredient statement.
Worldwide Distribution - USA (nationwide) United States and Internationally to Austria, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Turkey, and the United Kingdom.
Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001.   Device Name: Osseocare Pro console & Set Osseocare Pro.  Model: 1600870-001, 1700470-001, 1700471-001.  Marketing status: Class I, under K092214.  Device description: Software-based, electronically controlled tabletop device.    In dentistry for dental surgery, endodontics and implantology.
The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when used with the OseeoCare Pro iPad application software release 1.2.0.7.
Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108.   Biotene Mouth Spray is used for the treatment of dry mouth
Label indicates, ''Sweetened with xylitol and Sorbitol'', however product does not contain sorbitol.
USA Nationwide Distribution in the states of: CA, FL, GA, IA, NV, NY, LA, IN, PA, OR, TX, and WI.
Titan 3T MRI System, MRT-3010A/5.     Product Usage:  Usage:  MRI system.
Toshiba America Medical Systems, Inc. is recalling due to a potential problem with Specific Absorption Rate (SAR) values when using the Toshiba Titan 3T System.   When the system is used in combination with either the QD Head Coil (MJQH-142A) or the Large Knee  SPEEDER (MJAJ-182A), SAR values lower than the actual SAR values may be displayed on the operating  monitor.
Worldwide Distribution-Distributed in Puerto Rico and the countries of France, Indonesia, Korea, Nicaragua, Philippines, and Taiwan.
Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S.  It is a patient monitor with arrhythmia detection or alarms.
89 units total (1 in US and 88 International)
Spacelabs Healthcare elance Vital Signs Monitor with Option S, model 93330, is recalled because the monitor will not permit connection of any of the Spacelabs TruLink line of SpO2 sensors.
US and Australia, Guatemala, United Kingdom, Israel, Canada and Japan.
Bairn Biologics Candisol; Natural Enzymes to Support a Health Gastrointestinal Tract.  Dietary Supplement;  Ingredients: Vegetarian Cellulase, Vegetarian Hemicellulase, Vegetarian Xylanase, Vegetarian Beta-glucanase, microcrystalline Cellulose, L-Leucine, Vegetable Capsule.  Packaged in 40 and 120 count amber glass bottles.    Bairn Biologics,  P.O. Box 95966  Las Vegas, NV 89183
all lots manufactured from 2009 forward; Expiry dates: March 2011 through May 2015.
8232 bottles of 40 count;  27, 882 bottles of 120 count.
Firm was notified  by supplier of xylanase enzymes that they were contaminated with Chloramphenicol.
MD for further distribution by own label distributor
Walnut shaped soft Cookie packed on styrofoam tray with plastic over wrap   ASSI brand   Korean Cake   20644D  Net Wt.: 8 oz.  Distributed by Rhee Bros., Inc.  7461 Coca Cola Dr  Hanover, MD 21076    Expiration date 3/20/14    With Korean language labeling
product code: 20644D Expiration date: 3/20/14
''Wheat'' flour was not declared on the label
Doughnuts packed on styrofoam tray with plastic over wrap   ASSI brand   Korean Cake   20645D  Net Wt.: 8 oz.  Distributed by Rhee Bros., Inc.  7461 Coca Cola Dr  Hanover, MD 21076    Expiration date 1/29/14  With Korean language labeling
product code: 20645D Expiration date: 1/29/14
Sweet Bread known as Bam Bbang (Chestnut Bread)  packed on styrofoam tray with plastic over wrap   ASSI brand   Korean Cake   20646D  Net Wt.: 8 oz.  Distributed by Rhee Bros., Inc.  7461 Coca Cola Dr  Hanover, MD 21076    Expiration date 1/29/14  With Korean language labeling
product code: 20646D Expiration date: 1/21/14
US States: FL, OH, MN, WA, CA, UT, SC, TN, IA.
Digestive Enzymes, 60 Capsules/Bottle under the following brand names:    21st Century Digestive Enzymes, 60 Capsules/Bottle.  HyVee Digestive Eymes, 60 Capsules/Bottle.
This voluntary recall is initiated because raw material used may contain trace amounts of the antibiotic chloramphenicol.