United States nationwide distribution including PR, and USVI.  Costa Rica, Turks and Caicos, and Dominican Republic.
Plum A+3 Infusion Pump.  List Number 12391. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of  therapy.
Plum A+ Infusion Pump.  List Number 11971. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
Plum A+3 Infusion Pump.  List Number 12618. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
Plum A+ Infusion Pump with Hospira MedNet Software.  List Number 20679. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
Plum A+ Infusion Pump with Hospira MedNet Software.  List Number 20792. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
Plum A+ Infusion Pump.  List Number 11973. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
Plum A+ Hyperbaric Infusion Pump.  List Number 11005.  The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
Plum A+3 Infusion Pump System.  List Number 12348. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
Plum A+3 Infusion Pump with Hospira MedNet Software.  List Number 20678. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. DICOM devices (e.g. modalities, workstations) communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction other systems have with the Centricity Enterprise Archive. Centricity Enterprise Archive is not intended for use in patient vicinity. The intended users for Centricity Enterprise Users service personnel and System administrators, and non clinical users. As of V4.0 XDS enabled systems can communicate with the archive using the XDS and XDS-I profiles (published by IHE).
There is a potential for data loss associated with empty path names resulting from HL-7 updates when the cache disk is almost full. In an unlikely event that the cache disk is almost full (<100MB) and HL-7 update events are received, the update action fails and an empty path name is written to the EA database. As a result the instance is not deleted from the storage device but no longer referenced. When trying to retrieve the instance an error is returned.
Nationwide Distribution to the states of :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, TX, TN, UT, VA, WA, WI, WV, Alaska, Hawaii, & Washington, DC.     Worldwide Distribution to the countries of : Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Canada, Cayman Islands, Chile, Columbia, Croatia, Democratic Republic of Congo, Denmark, Ecuador, Egypt, Estonia, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jordan, Kazakhstan, Republic of Korea, Lebanon, Libya, Malaysia, Mauritius, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, State of Palestine, Panama, Papua New Guinea, Philippines, Poland, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Taiwan Province, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, United Republic of Tanzania, Uzbekistan, & Vietnam.
The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Internet, or may function as a stand-alone device.
Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze
Product was distributed to MO, IL, and IA.  There was no military/foreign/government distribution.
Maytag Blue cheese cut and wrapped in clear plastic wrap at store level, sold in various sizes (approximately 3-4 oz pieces), labeled with company issued Maytag Blue cheese label and Schnuck Markets scale label, UPC 0021806200000.
Product may be contaminated with Listeria monocytogenes.
Product was sold from 2/4/2016 throught 2/29/2016
Distributed nationwide to the following states: AK, AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, MA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY.
Lysander's All Natural Bourbon Flavor Rub; for beef, chicken, pork, and fish; 3.8 oz (107.7 g), foil bag, 6 units per case.  Manufactured by Geneva Foods, LLC.
Product contains undeclared allergens soy and wheat. Also does not declare sulfites.
Lysander's Premium Teriyaki Marinade, 1 oz (28 g), polypropylene and clamshell style card, 12 units per case.  Manufactured by Geneva Foods, LLC.
Cases coded 2014-2015, if not visible all lots; UPC: 0-34795-00036-5.
Lysander's All Natural Spicy Bourbon Flavor Rub; for beef, chicken, pork, and fish; 3.8 oz (107.7 g) foil bag, 6 units per case. Manufactured by Geneva Foods, LLC.
Lot codes ending in 14 or 15; UPC: 0-34795-00051-8
1,370,995 eaches have been distributed to the field
Terumo Medical is initiating this recall due to complaints of valve leakage that have been related to a manufacturing issue.  If affected introducer sheaths are used, there is possible risk of incremental blood loss through the valve.
Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-110-06
Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.
The product was shipped to Aldi Inc. , 1200 Kirk Road, Batavia, IL 60510 from there it is further shipped to distribution centers andd then to Aldi stores. no product was distributed to foreign firms.
Aldi's Millville protein chew bars, peanut, dark chocolate & almond packaged 5 bars per box in a yellow and brown box with brown and white lettering.
64,955 cases (or) 779,460 cartons,  12 Cartons per case
A supplier of one of the ingredients in the protein chewy bars informed firm of Listeria Monocytogenes positive.
Aldi's Millville protein chew bars, dark chocolate peanut butter packaged 5 bars to a box in a yellow and brown box with brown and white lettering.
Worldwide Distribution: US (Nationwide) including states of: District of Columbia and Puerto Rico and countries of: Algeria, Argentina, Austria, Australia, Bangladesh, Bahrain, Belarus, Belgium, Brazil, Cameroon, Canada, Chile, China, Colombia, Congo-The Democratic Republic of the, Costa Rica,  Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Great Britain, India, Iran, Ireland, Israel, Italy,  Japan, Kazakhstan, Korea, Kuwait, Lebanon, Mauritius, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, Nigeria, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Spain, Serbia (Republic of Serbia), South Africa, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Uganda, United Arab Emirates, Uzbekistan, Viet nam, and Yemen.
e.cam and Symbia E gamma camera systems with patient beds    To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.
Nature Made(R) Super B-Complex, KEY B VITAMINS + VITAMIN C, 140 count, UPC 0-31604-02727-8
Specific lots of Nature Made(R) product may have possible Staphylococcus aureus contamination.
Specific lots of Nature Made(R) Vitamin D tablets may exceed specifications for yeast/mold.
Nature Made(R) adult gummies Multi for Her plus Omega-3, 100 count, UPC 0-31604-04236-3
Specific lots of Nature Made(R) product may have possible Salmonella contamination.
Nature Made(R) Multi + Omega-3, 150 count, UPC 0-31604-04173-1
Nature Made(R) adult gummies Hair.Skin.Nails, 90 count, UPC 0-31604-04016-1
Specific lots of Nature Made(R) adult gummies Hair.Skin.Nails may exceed specifications total viable plate count.
Nature Made(R) adult gummies Multi, 150 count, UPC 0-31604-04172-4
Super B-Complex, KEY B VITAMINS + VITAMIN C, 360 count, UPC 0-31604-02729-2
Lot No. 1173146, exp. JUL 2017 of Nature Made(R) product may have possible Staphylococcus aureus contamination. Salmonella.  Lot No 1204001, exp. MAR 2018 of Nature Made(R) product may have possible contamination.
Nature Made(R) Super B-Complex, KEY B VITAMINS + VITAMIN C, 460 count, UPC 0-31604-02728-5
Lot No. 1170987, exp. JUL 2017 of Nature Made(R) product may have possible Staphylococcus aureus contamination. Lot No1204735, exp. MAR 2018 of Nature Made(R) product may have possible Salmonella contamination.
Nature Made(R) adult gummies Multi for Her plus Omega-3, 150 count, UPC 0-31604-04275-2
Nature Made(R) adult gummies Multi, 90 count, UPC 0-31604-02841-1
Nature Made(R) adult gummies Hair.Skin.Nails, 150 count, UPC 0-31604-04132-8-1
Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC#  0703-9060-31- (Single Use Container), NDC# 0703-9060-33 (Box of 10 Singe Use Containers)
Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-1179-01.
Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454  NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton)
ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-0020-31 (Single Use Bag), NDC # 0703-0020-32 (5 Single Use Bags in One Carton).
Intended for tissue separation and other procedures that require a sharp surgical blade to puncture or cut.
After receiving a complaint the firm disclosed that Conventional Stainless Steel Surgical Blade catalog number 371712 lot 0088464 was incorrectly identified in the single unit foil pack as 12 instead of 12B.
Nationwide and Puerto Rico. No Canadian, other foreign, govt/VA/military consignees.
Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment  The Achillon Suture System is a single use, sterile device used to treat acute Achilles tendon ruptures. The Achillon Suture System is a mini-invasive procedure indicated to teat acute Achilles tendon ruptures: Acute rupture of the Achill tendon(<10 days); Rupture located between 2 and 8 cm above calcaneum; Open or closed ruptures
Data from internal studies suggests there may be a potential that the secondary package seal integrity does not provide the level of sterility intended for Minimally Invasive Achilles Tendon Suture System Achillon.
Worldwide Distribution -- US, to Massachusetts and Washington, DC; and, the countries of Canada, Germany, and United Kingdom.
Innocor Cardiopulmonary Exercise and Lung Function Testing System      Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.
The purpose of the recall is to replace data transmission cable (USB-cable) connecting the lnnocor device with an external computer.    The replacement USB cable will provide galvanic isolation of the lnnocor from the external computer via opto-couplers, as opposed to the grounding protection currently in use.    The replacement is intended to prevent risk of electric shock.
Fresh products are delivered daily through a daily distribution network. Shelf life and date of expiration indicated above.
7-Eleven, Fresh To Go, 	Walnut Fudge Brownie   Net weight: 	3.8 Ounces, Number of units per package: One  Shelf life: Three Days   Expiration date: 0708   (July 8, 2016)
1461 Packets of Walnut Fudge Brownies were ordered and shipped to the customer through a distribution network that supplies 7-Eleven convenience store
Bakery Express Mid Atlantic, Inc.  is recalling the 7-Eleven, Fresh To Go, Walnut Fudge Brownie products because of an undeclared walnut allergen.   An incorrect chocolate cookie label was placed on the retail packets of walnut fudge brownies.
Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203.  Sterile EO.  Microtek Medical, Inc., Columbus, MS  39702.
Ecolab is recalling 2 models of Angiography Drapes with Radiation Shields because the sterile packaging may contain small holes in the film of the pouch.
Product was distributed to distributors in the following US state: AL, AZ, FL, GA, LA, MA, MD, ME, MS, NC, NM, NY, OR, PA, SC, TX, VA, and WA.  No foreign or military/government distribution.
PF Chang's Home Menu Brand Shrimp Lo Mein, UPC 3100067005, 22 oz bag, 4 bags per case, ConAgra Foods, Omaha, NE 68102
Metal fragments were discovered in an raw ingredient used in the manufacture of frozen meal products
Nationwide. There are no foreign consignees.
Fire roasted Poblano & Jalapeno popper bites packaged in a white box with black lettering. The product is labeled in part: Canchor Poppers Fire Roasted  & Jalapeno popper bites, 2-4 lbs.
Firm used Flour from General Mills that has been contaminated with E. Coli O121.
Breaded stuffed Jalapenos poppers labeled in part: Anchor breaded Fiesta Bold Poppers, breaded stuffed jalapenos, keep frozen. The product is packaged in a green 4 lb. box with white, green and orange lettering.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
US Distribution to sates of: NC, NY, and OR.
Axiom REG implants Sterile    The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters and different lengths for each diameter.
Following a FDA inspection showing that the firm failed to validate the design and process of its implants.
Axiom 2.8 implants  Sterile    The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters and different lengths for each diameter.
US Distribution to the states of : CA, FL, IN, KS, LA, MI, MO, NC, NY, OK, OR, PA, TN, TX, WA, WY    Foreign:BULGARIA, INDIA, UNITED ARAB EMIRATES
Affinity Four Birthing Bed  Model  P3700    The primary packaging is pictured below, and utilizes a metal packing brace, standard corrugated cardboard and plastic banding. When possible these beds are shipped as a quantity of two (2) together as shown with the nylon strapping. These are shipped in standard freight containers. There is no secondary packaging.
Worldwide distribution.  US nationwide, and the countries of:  AU, AT, BE, CA, CH, CR, DB, DE, ES, FI, FR, GB, GR, IC, IL, IN, IT, MY, NL, NO, PL, PR, PT,SE, SG, TH, and ZA.
Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture.   PN: 7211015 Used during ligament reconstruction.
Sterility compromised due to breach in sterile packaging
Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base,  REF KTTIHA40, SIZE 4 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FEMUR & SIZE 4 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base,  REF KTTIHA10, SIZE 1 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base,  REF KTTIHA21, SIZE 2+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base,  REF KTTIHA30, SIZE 3 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 3 FEMUR & SIZE 3 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base,  REF KTTIHA60, SIZE 6 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 6 FEMUR & SIZE 6 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base,  REF KTTIHA20, SIZE 2 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base,  REF KTTIHA11, SIZE 1+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base,  REF KTTIHA41, SIZE 4+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FEMUR & SIZE 4 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base,  REF KTTIHA50, SIZE 5 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 5 FEMUR & SIZE 5 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base,  REF KTTIHA51, SIZE 5+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 5 FEMUR & SIZE 5 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base,  REF KTTIHA31, SIZE 3+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 3 FEMUR & SIZE 3 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY,MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
Worldwide Distribution - US including AZ, CA, FL, MO, NH, PA, TX, & VA, and Internationally to Austria, Canada, England, Germany, Greece, Italy, Netherlands, & South Africa.
Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made.  HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.
Custom made, one per customer. Affected units were sealed between April 28, 2016 and June 7, 2016
Distributed to the states of TX, NH, MA, PA, and MN.
Pacemakers:  Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111.      These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias.
Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuration were shipped to US customers and implanted.  This alternate configuration did not receive FDA approval yet.
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI.  ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)
Tip Breakage at the glue joint between the obturator body and tip
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI.  ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12MR Handpiece    Product Usage:  The Sure Sight Obturator Introducer Localization System (ILS-OB) is a Hologic accessory kit. It is sold as an independent product for use with the ATEC MRI hand pieces. This sterile accessory kit is available in two lengths, is sold only in the US and has a 6 month shelf life. It contains a single use introducer stylet, introducer sheath, needle guide and localizing obturator
Cooked King crab legs & claws were recalled due to a contamination with Listeria monocytogenes.
Distribution was made to medical facilities in AL, MI, MO, PA, TN, and TX.
Merge RadSuite software. Radiological image processing system.
10 sites have the affected software that is configured with the specific conditions listed in Code Information
it is possible in some circumstances that the demographics of one patient will be applied to a study or studies for another patient.
RadSuite Versions:  5.30.8, 5.35.3, 5.35.4, 5.35.5, 8.30.7.3, 8.30.7.4, 8.30.7.5, 8.30.7.7 are affected, BUT ONLY  if they are configured with all of the following conditions:  (1) Must have IPID enabled;    (2) Must use IPID morphers    (3) Must Define a Defaultvalue in the IPID Morpher;    (4) Must use the Aggregating Morpher;    (5) Must not set OverwritelfPresent=false; and    (6) Must be on an internal store (this is data that is already present on EA being stored to Radsuite, this excludes direct DICOM stores to the EA).
Distributed to one (1) account in the state of PA.  Distributed to one (1) account in Canada
Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1 inner carton consists of a set of two liquids (1 acid & 1 buffer)  banded together.
3,023 cases USA; 666 cases shipped to Canada (OTC drug there)
Certain lots of the acid solution in Acecide-C are degrading faster than normal.
Apple Cider: Ricker Hill Orchards Apple Cider 1/2 GAL (64 FL OZ) 1.89 LITERS; NORTHLAND APPLES Pure SWEET MAINE CIDER 1 QUART 947.2ML, UPC: 074613 70009 1 and   NORTHLAND APPLES Pure SWEET MAINE CIDER 12 FL. OZ. 355.2 ML, UPC: 0 74613 60009
Product contains patulin at levels higher than the FDA established limit of 50 ppb.
Ricker Hill Orchards Cran-Breeze, 1/2 GAL (64 FL OZ) 1.89 LITERS Produced by Ricker Hill Orchards, Turner, ME 04282
1,391 gallons  (total for all recalled products)
Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01); and b) 25 x 2 mL Vials (NDC 69053-008-02), Rx only, Manufactured for: Andersen Pharmaceutical, White Plains, NY  10605.
Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.
CO, MN, GA, NC, IN, OH, KY, IL, NY, AL, MO, LA, PA, and SD Denmark
2 over 2 Elevating Monitor Suspension  - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems.
Elevating Monitor Suspension separated from the lifting column bracket
Model:  Elevating Monitor Suuspension P/Ns:  1000-0085, 1000-0095 and (1000-0129 one unit produced does not use bracket 1040-0071 or 1040-0031).
US Nationwide distribution in the states of ID, MA, OR, NY and in the country of Australia.
Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon.  Product is sterile. Part numbers:  663BK  663BL  664BL  928BK    Product Usage:  For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.
2110 boxes distributed in the US and 72 boxes distributed outside US
Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.
Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part number: GP8665    Product Usage:  For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.
Polypropylene Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.
Worldwide Distribution - US Nationwide and Canada,
Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747.    Product Usage:  The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP)
Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal Amplifier and the Patient Cable are incorrectly labeled as Type CF Applied Parts.
Part Number 4208: Serial Numbers 0014 and 0016 Only  Part Number 5703: All Serial Numbers   Part Number 5748: All Serial Numbers   Part Number 5747: All Serial Numbers
Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons.     Product Usage:  The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP)
Part Number 4460: All Serial Numbers  Part Number 6735: All Serial Numbers
Worldwide distribution.  US nationwide, Algeria, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Finland France, Gabon, Germany, Greece, India, Indonesia, Ireland, Japan, Korea, Republic of Korea, Republic of Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Viet Nam.
The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient.  The issue was caused by a software defect in the workflow setup script.
BrightView X, model #882478; gamma camera designed for single or dual detector nuclear imaging
BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)
Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand.
Tall Height TE With Sutures 450cc PN: 354-9313    The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.
Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
Tall Height TE With Sutures 350cc PN: 354-9312    The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.
Prime CAP Sugar, S 95-135, Encapsulated Sugar.  Ingredients:  Sugar and Hydrogenated Palm Oil, #10040870, Net WT. 125 lbs. Poly lined cardboard drum.   DIFP, Inc., 2125 Airport Dr., Ferial, MN  55021
Specific lots of Prime Cap Sugar 95-135 is being recalled because of possible contamination caused by metal shavings.
Affected geographies: Andorra, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brunei Darussalam, Canada, China, Columbia, Croatia, Czech Republic, Egypt, Ecuador, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Lebanon, Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, Uruguay and Vietnam.
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System.    Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis System).  Catalog No. B23858 (Unicel DxH600 Coulter Cellular Analysis System).
There is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 where the Primary Identifier is configured to Tube Position ID.
Nationwide Distribution to CA, FL, IA, IN, MO, UT and WI
The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operating room table immediately before, during and after surgical interventions as well as for examination and treatment.   The fixture is used to adapt a range of different head and horseshoe head rests with a central square mount
Post Market Surveillance cases reported to Maquet showing instances in which the welded joint between the square mount and the first fixable swivel joint of Maquet's Connecting Bracket (Fixture) Device is broken.
Nationwide   Albania  Algeria  Angola  Armenia  Austria  Bahrain  Belgium  Bulgaria  Burkina Faso  Croatia  Cyprus  Czech Republic  Denmark  Egypt  Estonia  Finland  France  Georgia  Germany  Great Britain  Greece  Hungary  Iceland  Iraq  Italy  Jordan  Kazakhstan  Latvia  Lithuania  Luxembourg  Macedonia  Malta  Netherlands  Norway  Pakistan  Poland  Portugal  Qatar  Romania  Russian Fed.  Senegal  Serbia  Slovakia  Slovenia  Spain  Sweden  Switzerland  Tunisia  Turkey  Unit.Arab Emir.  Uzbekistan  Vatican
Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy.
Worldwide Distribution - US including AL, AZ, CA, CT, GA, MN, NC, OH, OR  and Internationally to Australia, Germany, Japan, Korea, and Taiwan.
Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts are placed into an inner cavity and are sealed using a nitrogen process. The inner cavity is then placed into an outer cavity and heat sealed with outer Tyvek lid on the outer cavity. The patient record label is placed on the Tyvek outerlid. The sealed cavities and package insert is placed into a folding carton, sealed and shrink wrapped.  Total elbow prosthesis designed for use with bone cement
Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small because the lot was packaged with a missing humeral bushing.  The missing bushing could result in a surgical delay or additional surgery if a replacement is not available.
Worldwide Distribution - US including IL, MO, TX. Internationally to Canada and Italy.
Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The cuff is pre-molded to its inflated configuration and is purposely positioned directly over a hole generated in the extruded tube for purposes of receiving the infused cardioplegia solution. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.
The tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement.
Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery.  The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.  The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip
Sorin Group USA, Inc. announces a voluntary field for the Aortic Arch Cannula and Coronary Artery Perfusion Cannula With Ballon because the tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement.
Alabama, Arkansas, Arizona, California, Florida, Georgia, Illinois, Indiana, Kentucky,  Louisiana, Massachusetts, Maine, Minnesota, Missouri, Mississippi, North Carolina, Nebraska,  New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico,  South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, Wyoming
Activia FIBER Lowfat Yogurt Strawberry/Pineapple Flavors 12 Packs of 4 OZ Cups UPC 3663202884 packaged in form fill seal plastic cups
mark while the product contains and the overwrap label correctly lists WHEAT as an ingredient.
US      No recalled product was distributed to any foreign consignees by Lupin.
Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-752-03
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-750-09
Archer Farms Quinoa 10 oz packaged in flexible plastic bag
Archer Farms Corn & Black Bean Quinoa Blend with pineapple & red pepper packaged in a flexible plastic bag
Worldwide Distribution - US (nationwide) and Internationally to United Arab Emirates, Australia, Canada, Germany, Spain, and United Kingdom.
Certegra Workstation used in conjunction with Medrad Stellant CT Injection System   Catalog Number # CWKS DISPLAY  Serial Numbers   The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications
CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal events, such as: smoke and sparks of fire.
AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA. HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY , Puerto Rico, Afghanistan, Argentina, Australia, Bahamas, Bahrain, Belgium, Bermuda, Chile, China, Columbia, Denmark, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Kuwait, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Saudi Arabia, Papua New Guinea, Philippines, Poland, Qatar, Saudi Arabia, Slovenia, South Africa, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, UAE, United Kingdom, Venezuela, Vietnam
NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X-Ray System Black, Part Number 08500022; NOMAD Pro2 Vet Packaged X-Ray System, Part Number 08500023; NOMAD Pro2 Vet Packaged X-Ray System Black, Part Number 08500024; NOMAD Pro2 Packaged X-Ray System, GBL, Part Number 08500025 and Part Number 08500026; NOMAD Pro2 Packaged X-Ray System, GLB, Vet, Part Number 08500027 and Part Number 08500028; NOMAD Pro2 Package X-Ray System, GLB, Black, Part Number 08500029
Investigation found that the internal lithium ion batteries had entered into a thermal runaway condition as a result of a short circuit on the battery pack PCB.
NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray System, Part Number 08500011; NOMAD Pro Packaged X-Ray System - Europe, Part Number 08500013; NOMAD Pro X-Ray System, Remote Config., Part Number 08500017; NOMAD Pro Packaged X-Ray System JP, Part Number 08500019
Part Number 08500009 - Serial Number Range BX-011008-01 - XB-141219049; Part Number 08500011- Serial Number Range XC -090305-03 - XC-140312-02; Part Number 08500013 - Serial Number Range XB-110411-01 - XB-140616-13; Part Number 08500017 - Serial Number Range XB-120911-04 - XB-141210-50; Part Number 08500019 - Serial Number Range XB-120517-09 - XB-121212-24
Nationwide Distribution to OH, IN, TN, NC, and KY.
Radial Artery Catheterization Kit with Sharps Safety Features  Permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.
Arterial Line Catheterization Kit with Sharps Safety Features  Permits access to the peripheral arterial circulation or to other small vessels.
CT, FL, GA, MA, MD, NC, NJ, NY, PA, SC, and VA.
Reduced Fat Seafood Cheese Spread, Net Wt. 7 oz. (198 g.), for Publix
Possible contamination with foreign matter; wood pieces.
Spinach Krab & Artichoke Dip, 12 x 8 oz., for Whole Foods Market.
Smoked Whitefish Salad, 12 x 8 oz., for Whole Foods Market.
Alaskan Salmon Salad, 12 x 8 oz. and 5 lb., for Whole Foods Market
Original Seafood Cheese Spread, Net Wt. 7 oz. (198 g.), for Publix
Inland Market, Traditional Crab Cake, Net Wt. 5 lbs, Inland Market, 1667 Lewis Way,  Stone Mountain, GA 30083, for Whole Foods Market
Inland Market, Maryland Crab Cake, Net Wt. 5 lbs, Inland Market, 1667 Lewis Way,  Stone Mountain, GA 30083, for Whole Foods Market
Inland Market, Premium, Maine Lobster Spread, Net Wt. 7 oz. (198 g.) and 16 oz. (454g), Inland Market, 1667 Lewis Way,  Stone Mountain, GA 30083.
Spicy Crab Dip, 12 x 8 oz., for Whole Foods Market.
Inland Market, Premium Blue Crab Spread, Net Wt. 7 oz. (198 g.) and 16 oz. (454g), Inland Market, 1667 Lewis Way,  Stone Mountain, GA 30083.
Inland Market, Dungeness Crab Cake, Net Wt. 5 lbs, Inland Market, 1667 Lewis Way,  Stone Mountain, GA 30083, for Whole Foods Market
US Distribution in states of: FL, MI, and VA.
Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001))    The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures.  For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (BABG) surgery.
Novadaq is informing SK6000 PAQ users that a pinhole through the drape pouch film material was identified in some SK6000 PAQs during shipping validation testing.
Worldwide Distribution US Nationwide in the states of FL, IL, KY, MI, NY and OK and countries of Mexico and Canada.
Misbranded: Incorrect etching on the device.
Product Code: 337111, Lot Number: 06F1515745.
Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: Stason Pharmaceuticals, Inc. Irvine, CA 92618 Distributed by: Libertas Pharma, Inc. Montgomery, AL 36117. NDC 51862-146-06
Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples.
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Nationwide and VA/govt/military.  No foreign consignees.
Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering the misplaced IFUs during its review of packaging in its warehouse
Department of Army William Beaumont Army Medical Center
Apheresis product, collected from a donor who previously tested repeat reactive for anti-HTLV on two separate occasions, was distributed.
AL, AZ, CA, FL, GA, KY, MI, MN, MO, NE, NJ, NY, NC, OH, OK, PA, SC, TX, WA, WV, Argentina, Austria, Australia, Bosnia and Herzegovinia, Bangladesh, Belgium, Bulgaria, Brazil,  China, Columbia, Cuba, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Iran, Italy, Japan, Jordan, Lebanon, Libya, Morocco, Mexico, Nigeria, Netherlands, Norway, Pakistan, Panama, Peru, Philippines, Portugal, Serbia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Syria, Taiwan, Thailand, Turkey, United Kingdom, Venezuela, Vietnam, Yemen
There have been instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.
Product was distributed in the following states: Nationwide
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 30 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---   Carton NDC 60687-154-25; Blister NDC 60687-154-95
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 25 mg 20 UD Capsules (5 x 4), Rx,  Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-909-32; Blister NDC 68084-909-33
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 15 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-898-32; Blister NDC 68084-898-33
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules, CII 20 mg, 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-832-25; Blister NDC 68084-832-95
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 15 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ----   Carton NDC 60687-133-25; Blister NDC 60687-133-95
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 10 mg 30 UD Capsules (5 x 6), Rx,  Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-815-25; Blister NDC 68084-815-95
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 10 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ----   Carton NDC 68084-936-25; Blister NDC 68084-936-95
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 5 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---   Carton NDC 68084-874-25; Blister NDC 68084-874-95
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 30 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-887-32; Blister NDC 68084-887-33
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 20 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---   Carton NDC 68084-943-25; Blister NDC 68084-943-95
US: AZ, CA, CT, FL, IL, MA, MS, MO, NC, PR, TX, WI.    OUS: Algeria, Australia, Bangladesh, Belgium, Brazil, Canada, Colombia, Dominican republic, Egypt, France, Germany, Ghana, Guatemala, HONG KONG, Hungary, India, Indonesia, Iran, Italy, Jamaica, Japan, Korea, Kuwait, LEBANON, Lithuania, Maldives, Martinique, Mexico, MOROCCO, Netherlands, New Zealand, OMAN, Pakistan, Philippines, Poland, Portugal, Romania, SAUDI ARABIA, Singapore, South Africa, Spain,Sweden, Tanzania, Thailand,   Turkey, United Arab Emirates, United Kingdom, Vietnam.
GE Healthcare SIGNA Creator, SIGNA Explorer.  Diagnostic Imaging Device.
GE Healthcare is conducting a recall dealing with  an incorrect RF Power Monitor Function  involving  SIGNA CREATOR and SIGNA EXPLORER which  could result in higher than expected thermal dose to the patient and higher than expected localized heating. There have been no failures of this type reported, and no injuries reported as a result of this issue.