Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, for which the quality control testing was incomplete, were distributed.
Blood product, identified as unsuitable due to a donor screening deviation, was distributed.
Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed.
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood product, collected from a donor who did not have a  required  physical examination, was distributed.
Worldwide Distribution -- US (nationwide) including the states of  AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, MA, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OK, OR, PA, TN, TX, UT, WA, WV, and WY., and the country Canada,   We have not yet defined our European or International facilities at this time.
Liko Standard Slingbar 450.   The Standard Slingbar 450 is a versatile sling bar which can be used for most lifting situations. It can be used with different Liko ceiling and mobile lifts.
Liko/Hill-Rom has received reports from facilities which indicate that serious injuries have been received related to the Standard Sling bar 450. There have been 6 complaints of injury related to the product over the past 32 years (6 out of 838,687,856 estimated patient uses). One of the injuries was associated with a patient during use, four injuries occurred when the slingbar was not in use where someone tripped and fell onto the unit, and one where a child was playing on a lift and was injured when they tried to jump from the lift.
Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
Methylprednisolone Acetate  40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Methylprednisolone Acetate  80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Center, Framingham, MA
Betamethasone Sodium Phosphate  6 mg/mL P Injection, Betamethasone Sodium Phosphate  6 mg/mL PF Injection, Betamethasone Sodium Phosphate  8 mg/mL PF Injection, Betamethasone Sodium Phosphate  12 mg/mL PF Injection, manufactured by New England Compounding Center, Framingham, MA
Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England Compounding Center, Framingham, MA
Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA
Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Framingham, MA
Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA
Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, Framingham, MA
Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA
Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Triamcinolone 10 mg/mL P,  40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Blood Systems Inc/dba United Blood Services
Blood and Blood Products for Reprocessing
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Blood product, labeled with an incorrect expiration date, was distributed.
Blood Centers of the Pacific - Irwin Center
Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell counts, were distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Community Blood Centers of Florida, Inc.
Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Southern California Permanente Medical Group Blood Donor Ctr
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, which were collected from a donor who lived in a malarial endemic area, were distributed.
Blood product, collected from a donor who emigrated from an area considered endemic for malaria, was distributed.
Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Epinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM, Hospira, Inc., Lake Forest, IL --- NDC 0409-7241-01
Presence of Particulates; may contain glass particles
Stryker Medical Division of Stryker Corporation
Worldwide Distribution - Nationwide and Canada
Medical Surgical Bed, Model 3002SEX   Medical Surgical Bed The S3'' MedSurg Bed, is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital facilities. The intended user for this product is both Health Care Providers (HCPs: nurses, nurses aides, and medical doctors) and human patients. Lockout features may limit patient accessible controls
Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2012. The affected beds may have been built with brake rings that do not meet specifications,  negatively impacting the holding force of the brakes.
Medical Surgical Bed, Model 3005S3EX   Medical Surgical Bed The S3'' MedSurg Bed, Model 3005 is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital facilities. The intended user for this product is both Health Care Providers (HCPs: nurses, nurses aides, and medical doctors) and human patients. Lockout features may limit patient accessible controls.
Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2012. may have been built with brake rings that do not meet specifications,  negatively impacting the holding force of the brakes.
Mindray DS USA, Inc. d.b.a. Mindray North America
Nationwide Distribution including OH and GA
DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430    The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.
There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient.
AZ, CA, CO, HI, ID, KS, MO, MT, NE, NV, NM, OK, OR, SD, TX, UT, WA and WY.
Fresh Express brand, Fresh Spinach, 9 oz.
Cocoa~Latte Hot Drink Maker; an electric hot drink mixer and dispenser with a 32 fl.oz. heating and mixing jar, twist and lock lid, ''perfect temperature'' feature, mixing paddle, and dripless faucet;  Focus Electrics, LLC, West Bend, WI 53095
West Bend brand - model number 65032; Back to Basics brand - model numbers CM300BK, CM300BKL, CM300BLSS, CM300BR, CM300BR-BRL, CM300BRL and CM300W
The Cocoa~Latte Hot Drink Maker was manufactured with a small brass metal bushing in the liquid containing vessel that may leach lead.
US Nationwide, including Puerto Rico, and Canada.
AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
The lenses exceeded the acceptance limit for silicone oil residual.
Worldwide Distribution - USA (nationwide) and internationally to Algeria, Argentina, Australia, Austria, Azerbaijan, Belgium, Bolivia, Brazil, Burkina Faso, Burundi, Cameroon, Canada, Chad, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ethiopia, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Guinea, Haiti, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Mali, Mexico, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam and Zambia
Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14   The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories.
list 09K14, all serial numbers and all software versions 1.0 - 5.0
An issue with the m2000sp Instrument software has been identified whereby, after a series of steps, if changes are made to the control or calibrator information on the Sample Extraction Assay Details screen, the changes are not saved.
Medtronic Inc. Cardiac Rhythm Disease Management
Worldwide Distribution--USA (nationwide) including the states of  AZ, CA, CT, FL, GA, IL IA, MD, MA, MI, MS, NJ, NY, OH, OK, SC, TN, TX and WI. and the countries of  CANADA and MALAYSIA.
Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the following Model numbers:   0E27R16, 1A30R6, 2493R24, 2493R25, 5D56R5, 5Z93R4, 5Z93R5, 7E64R2, 7J53R2, 7M13R1, 7M14R1, 7N16R, 7P25R1, 7P93R1, 7Q11R1, BB7L63R2, BB7N26R, CB5174R11, CB175R13, CB5Q03R6, CB5Q03R7, CB6C53R6, CB7C15R2, CB7C59R2, CB7C60R2, CB7C74R2, CB7D91R5, CB7E35R2, CB7E38R1, CB7G21R4, CB7L48R1, CB7L72R1, CB7P82R1, HY6U96R2, HY6Y52R2, HY7E87R1, SS7J91R3, SSCB7L48R, SSTL7G78R1,TL5S33R7, TL6VTTR1, TL7B51R1, TL7G20R3, TL7G78R3, TL7R87R1.     Sterilized Using Ethylene Oxide, Nonpyrogenic, Assembled in Mexico, Manufacturer Medtronic, Inc, Minneapolis, Mn 55432    Product is used by perfusionists as part of the extracorporeal circuit during cardiopulmonary bypass procedures, and is configured specifically as designated by each customer.
Medtronic is initiating an Urgent Medical Device Customer Notification.  We have confirmed that certain Medtronic Intersept Tubing Packs contain packaging trays that are susceptible to damage that can compromise product sterility.
Worldwide Distribution -- USA, including Puerto Rico, and the countries of Austria, Australia, Argentina, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Finland, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United Arab Emirates, and Vietnam.
Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971; b) list 11973 - software version 10.3; c) list 12391 - software version 11.3; d) list 20679 - Hospira MedNet Software e) list 20792 - Hospira MedNet Software;  Product Usage: The Plum A+ Infusion System is a dual-line volumetric infusion pump that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care
list numbers 11971, 11973, 12391, 20679, and 20792; all serial numbers
The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump.
Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software; Product Usage: The Plum A+3 is a dual-line triple channel volumetric infusion system that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care
list numbers 12348, 12618, and 20678; all serial numbers
Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.
Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90; ABBOTT LABORATORIES NORTH CHICAGO, IL 60064 U.S.A.
Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
Worldwide Distribution - USA including IL, IN, AR and GA.
Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length.    Oxygen therapy delivery system for adult patient.
FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the intended ventilation therapy.
Sanh Yuan Preserved Plum Candy (Sweet and Sour Prune), 5 oz (142g)
The manufacturer did not use lot number or code number
CHO Fuku Group Inc. is recalling Sanh Yuan Preserved Plum Candy (Sweet and Sour Prune) because of unacceptable levels of lead.
La Madeleine Potato Soup, 5 lb clear Cryovac pouches, 4 pouches per case.
All potato soup manufactured 08/09&10/2012.   Expiration dates Aug 21 - Oct 21, 2012
The potato in the potato soup is treated with sulfites.  Sulfites were not declared on the firm's product label.
Distributed in the states of FL, MA, CA, OR, NY, NC, MO, ID, IN, KY, PA, TX, OK, IL, GA, KS, and UT.
Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capillary action. The filled cuvette is inserted into the device where the contents of the cuvette are mixed through vibration. Within 90 seconds, the immunochemical reaction is completed and the turbidity is measured photometrically at 610 nm. The albumin concentration is proportional to the turbidity. When the end point is reached, the result is displayed in mg/L.   The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria.
See serial numbers of affected devices in attachment profided by firm.
Incorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made from April1 st 2011 and onwards. In addition, a warranty statement was missing in the analyzer package.
Nature's Plus GLUTEN Free SPIRU-TEIN HIGH PROTEIN ENERGY MEAL, S'mores (Flavor), 1.2 OZ. (34g) Packet, Display Box Product No. 95903, Individual Packet Product No. 45905, UPC Code 097467459052.  There are 8 foil packets per corrugated display box. --- Serving Size - 1 packet (1.2 oz.).
Lot /Batch Number 1243522,  Best By Date 06/2016
One lot of 1.2 oz. packets of Spiru-tein High Protein Energy Meal, S'mores flavor, is labeled as ''Gluten Free'' but actually contains gluten. Lot 1243522 of the product with Best Buy Date 06 2016 is being recalled.
Horiba Instruments, Inc dba Horiba Medical
Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.
ABX PENTRA AST CP, Part Number: A11A01629.   The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry.
Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST  (expected at 800 U/L and 1000 U/L) were recorded at 280 and 199 U/L without alarm.
PENTRA C200, Part Number: A11A01629.   The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and uring.
US Distribution only including the states of FL, KY and OK.
Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343   Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which was packaged as a 180 degree curve style introducer instead of a 90 degree curve style introducer as indicated on the labeling.
Worldwide Distribution--US (nationwide) including the states of AL, AZ, NC and TN.
Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130.   The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole.
Firm has  become aware of the potential for breakage of the pole clamp locking grids, or rasters, in the Space Pole Clamps.
Distributed  to CO, CA, CT, FL, GA, HI, IA, IN, NH, OR,  PA, TX, and WA.
Hemp Plus Granola.  The product is packaged in a 25 lb. container.  The UPC is 0 58449 88001 1.   The product is labeled in parts: ''***HempPlus Granola***INGREDIENTS: Organic rolled oats, organic evaporated cane juice, organic soybean oil, organic brown rice flour, organic flax seeds, organic hemp seed, organic oat syrup solids (organic oat syrups solids, tocopherol, sea salt, organic molasses***25 lb.***Nature's Path Foods, Blaine, WA 98230***www.naturespath.com***''.
Best Before 2013 June 12;  2013 June 13; 2013 June 14    002 12 261 02:59.  This number is explained as:    002: Internal code for Blaine production facility;  12 261: Internal code for year, product manufacturing date based on Julian        calendar date (for this case 2012, September 17);  02:59: product packaging time.
Undeclared almond.  Vanilla Almond Granola which contains almonds but it was mis-labeled as Hemp Plus Granola and almond was not declared on label.
Worldwide Distribution - USA including AR, GA, SC, TX, TN and internationally to France, United Arab Emirates, Australia, Brazil, Canada, Switzerland, China, Germany, Spain, United Kingdom, Italy, Japan, Sweden, Thailand, Turkey, Serbia, and South Africa.
Maquet Yuno Extension Table Device Maquet GmbH & Co. KG  Kehler Strabe 31  Baden-Wuerttemberg  76437 Rastatt,Germany     Used to support the lower extremities immediately before during and after surgery. The extension device is mounted to the YUNO operating table. The product may only be operated by medically trained staff within the OR environment.
Class I exempt Device Listing Number A922956
There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table.
Worldwide Distribution -- US (nationwide)
Companion External Battery, Part Number: 293001-001   The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.
Syncardia Systems is recalling the Companion External Batteries used with the Companion 2 Driver System because they may potentially be at risk of thermal events and/or other physical damage such as melting, charring and/or burning.