Tri-Counties Blood Bank dba UBS- Central Coast
Red Blood Cells Leukocytes Reduced Irradiated
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood products, collected from a donor who were previously deferred, were distributed.
Blood products, collected from a donor in which donor suitability were not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, with discrepancies documented on the irradiator worksheet, were documented.
Blood Bank of San Bernardino and Riverside Counties
Blood product, which was not quarantined after the donor provided information of a possible blood exposure, was distributed.
Blood products, which were possibly contaminated with Propionibacterium species, were distributed.
Blood product, prepared without the appropriate amount of RBC additive, was distributed.
Vitae Cockatiel with Sunflower, 2lbs and 4lbs
Merit Bird Company is recalling  Vitae brand bird food because it has the potential to be contaminated with Salmonella.  Vitae brand bird food contains parsley that has been recalled by Specialty Commodities due to Salmonella.
Unted States Nationwide, and Worldwide to Algeria, Argentina, Australia, Bangladesh, Brazil, Cambodia, Canada, Chile, Colombia, Ecuador, Egypt, France, Germany, Guatemala, Hong Kong, India, Italy, Japan, Libya, Malaysia, Mexico, Pakistan, Peru, Philippines, Puerto Rico, Russia,  South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.
Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000
Respironics is recalling the Esprit Ventilator because the power to the Esprit Display's Backlight is interrupted, causing the GUI to flicker or go dark and making the display unreadable.
Worldwide Distribution - USA Nationwide and the countries of Canada, Europe, Asia, Japan.
Benchmark XT/LT and Discovery XT   Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS.    Product Usage:  Usage:  The Benchmark product lines are intended to automatically stain histological or cytological specimens on microscope slides with specific immunohistochemistry or in situ hybridization reagents for in vitro diagnostic use. The Discovery Systems are research use only instruments with similar functionality.
BenchMark XT Instruments-S/N: 711869-712465; BenchMark LT instruments-S/N: 610321-610345.  Discovery XT Instruments-S/N: 610321-610345.
Ventana Medical System is initiating the recall of the BenchMark and DISCOVERY series instruments because there is a possibility that the heating element could separate from the underside of the heater cap and cause a non-staining or inconsistent staining event.  Additionally, the system may not detect this anomaly and therefore it may not generate an error message for the slide position.
Blood products, collected from a donor whose suitability to donate were not adequately determined, were distributed.
Blood products, collected from a donor, whose suitability to donate were not adequately determined, were distributed.
Blood products, collected from a donor who was deferred for specific high risk behavior, were distributed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Blood products, collected from donors who did not have a complete physical examination, were distributed.
Hoxworth Blood Center University of Cincinnati Medical Center
0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hospira, Inc. Lake Forest, IL 60045 --- NDC 0409-7984-23
Lot Number 05-201-JT, Expiration Date 1MAY2013
Presence of Particulate Matter; product may contain fibrous material
Brewtech Dried Brewers Yeast, manufactured by International Ingredient Corporation, P.O. Box 26377, St. Louis, MO 63026 sold in 50 lb. bags, 2000 lb. bulk totes, and 2205 lb. bulk totes.
The product has the potential to be contaminated with salmonella.
AL, CO, FL, GA, IN, KY, MD, MA, MI, MN, MO, NY, NC, OH, OK, PA, SC, VA, Canada, Costa Rica, Japan, Lebanon, Latvia, Poland, Russia, Sweden, Singapore, Slovenia, Taiwan
Premium Edge Finicky Adult Cat Formula, 6 lb. bags &18 lb. bags, Premium Edge Pet Foods P.O. Box 156 Meta, MO 65058.
Production Codes: NGF0802, Best By: 15-Aug-2013, 16-Aug-2013 (6 lb. bags) and Production Codes: NGF0703, Best By: 10-Jul-2013(18 lb. bags).
Product may contain low thiamine levels (vitamin B1).
Premium Edge Senior Cat Hairball Management Formula, 6 lb. and 18 lb. bags, Premium Edge Pet Foods P.O. Box 156 Meta, MO 65058.
Production Codes: NGS0101, Best By: 03-Jan-2014, 04-Jan-2014 and Production Codes: NGS0702, Best By: 10-Jul-2013.
Premium Edge Kitten Formula, 6 oz. samples, 6 lb. and 18 lb. bags, Premium Edge Pet Foods P.O. Box 156 Meta, MO 65058.
Production Code: MKT0901; Best Before: 26-Sept-2013, 29-Sept-2013, 30-Sept-2013 and 02-Oct-2013
Diamond Naturals Kitten Formula, 6 oz. samples and 6 lb. bags, Proudly made by Diamond Pet Foods, Meta, MO 65058 USA.
Production Codes: MKT0901, Best By: 30-Sept-2013
4health All Life Stages Cat Formula, 5 lb. and 18 lb. bags, Distributed By: Tractor Supply Company, 200 Powell Place, Brentwood, TN 37027.
Production Codes: NGF0802, Best By: 14-Aug-2013 and 18-Aug-2013.
Nutra Gold Indoor Kitten Formula, 3 Kilogram and l Kilogram
Production Code: MKT0901, Best By: 26-Sep-2014 and 26-Mar-2014.
Bravo! Raw Food Diet Chicken Blend for Dogs and Cats, 2lb. tube, frozen    Product Code: 21-102
Batch ID Code / Production Code Date 6_14_12 on white tag attached to the bottom of the plastic film tube.  Expanded Recall: Best Used By 3_21_15.
Bravo! Raw Food Diet Chicken Balance  For Dog and Cats, 5 lb bags, frozen   Product Code: 21-405
Best Used By'' dates of 3_6_15 and 3_12_15 imprinted on the side of the plastic casing.
Potential for Product  to be contaminated with salmonella
Bravo!.Raw Food Diet Beef Blend Burgers  For Dog and Cats, 5 lb bags, frozen   Product Code: 51-508
Best Used By 3_21_15 and 3_22_15 imprinted on the back panel of the plastic bag.   (Batch ID and Use by Dates are the same)
Nationwide and Canada via wholesale distribution and internet sales to consumers
Garbanzo Iced Lemon Grass Ginger Tea 3 oz foil portion packs
Recall is being conducted based on a finding of possible contamination by the supplier of the firms lemongrass.
Long Life Premium Organic Green Tea with Lemongrass, packages of 18 tea bags, (27 grams/.95 ounces)
Lot number 2165 --  UPC 713757555302   Expiration 6/13/14 (may or may not be printed on the product packaging)
Recall is being conducted based on a finding of possible contamination by the supplier of the firm's lemongrass.
Product was distributed to retail feed stores located in WA and ID.
Showmaster S-Series Show Lamb Feed (BW). Cargill Animal Nutrition, General Office, Minneapolis, MN 55440.  UPC 7 22304 28992 8  50 lb bag
38306326464, 38306726610, and 38307426757 Lot code consists of four components: 38 - 3 - 063 - 26464  38= location code 38 = Burlington, WA  3 = year (2013)  063 = julian date code (63rd day of the year = March 4th)  26464 = represents the production run and is sequential run number from the batching system and matches up to the production records.
The animal feed was manufactured with the incorrect concentration of sodium molybdate (molybdenum) thereby having an excessive amount of molybdenum.
US Distribution including the states of  AL, AR, CA, FL, GA, IL, KS, LA, MA, MD, NY, OK, PA, RI, TX, VA, and WA.
Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack.  The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England   Product is used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.
Use of affected lots may give false indication of susceptibility to Nitrofurantoin.
Fresenius Medical Care Holdings, Inc. dba Renal Solutions
USA Nationwide Distribution in the states of CA, MA, and NY.
2008 MeDS Pump, Venofer(R) Pump   Product Usage:  The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer, in conjunction with hemodialysis, is prescribed by a physician.
Product is being recalled because the combination of the current 50 mg vial, the 2008 MeDS pump, and the 2008 MeDS pump tubing Set for CombiSet Bloodlines can lead to a situation where Venofer(R) delivery does not meet dosage accuracy requirements.  This may lead to a slight over or under delivery of Venofer(R) that does not pose an acceptable risk to the patient.     Please note that this recall does not affect the CombiSet Bloodlines or 50 mg Venofer(R) vials.  The 50 mg Venofer(R) vial can continue to be used for manual drug delivery via syringe.
Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmaceuticals, LLC, Schaumburg, IL, 60173, NDC 63323-064-50
Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.
Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA
Lot #CABDAHAC:39,  Exp. Date: 5/8/2013; Lot #CABDAGAC:58,  Exp. Date: 4/13/2013; Lot #CABDAHAC:77,  Exp. Date: 4/8/2013; Lot #CABDBIAC:86,  Exp. Date: 4/19/2013; Lot #CABDCFAC:29,  Exp. Date: 4/26/2013; Lot #CABDAEAD:26,  Exp. Date: 5/3/2013; Lot #CABDAEAC:47,  Exp. Date: 5/5/2013; Lot #CABDAEAC:58,  Exp. Date: 5/5/2013; Lot #CABDAFAC:46,  Exp. Date: 5/6/2013; Lot #CABDAIAC:46,  Exp. Date: 5/9/2013; Lot #CABDBCAC:94,  Exp. Date: 5/13/2013; Lot #CABDCCAC:26,  Exp. Date: 5/23/2013; Lot #CABDCFAC:81,  Exp. Date: 5/26/2013; Lot #CABDABAD:05,  Exp. Date: 5/30/2013; Lot #CABDAFAC:47,  Exp. Date: 5/6/2013; Lot #CABDAGAC:43,  Exp. Date: 5/7/2013; Lot #CABDBDAC:69,  Exp. Date: 5/14/2013; Lot #CABDBIAC:77,  Exp. Date: 5/19/2013; Lot #CABDCHAC:19,  Exp. Date: 5/28/2013; Lot #CABDAHAD:21,  Exp. Date: 6/5/2013; Lot #CABDCFAC:17,  Exp. Date: 5/26/2013; Lot #CABDAHAD:00,  Exp. Date: 6/5/2013; Lot #CABDBCAC:47,  Exp. Date: 5/13/2013; Lot #CABDCBAC:97,  Exp. Date: 5/22/2013; Lot #CABDAGAC:08,  Exp. Date: 5/7/2013; Lot #CABDBCAC:15,  Exp. Date : 5/13/2013; Lot #CABDBDAC:17,  Exp. Date: 5/14/2013; Lot #CABDCIAC:42,  Exp. Date : 5/29/2013; Lot #CABDBEAC:44,  Exp. Date: 5/15/2013; Lot #CABDCBAC:79,  Exp. Date: 5/22/2013; Lot #CABDCIAC:00,  Exp. Date : 5/29/2013; Lot #CABDAHAD:82,  Exp. Date : 6/5/2013; Lot #CABDCBAC:31,  Exp. Date: 5/22/2013; Lot #CABDCIAB:68,  Exp. Date: 4/28/2013; Lot #CABDCJAB:59,  Exp. Date: 4/29/2013; Lot #CABDDBAB:93,  Exp. Date: 5/1/2013; Lot #CABCCGBC:92,  Exp. Date: 2/24/2013; Lot #CABCCGBC:49,  Exp. Date: 3/26/2013; Lot #CABCCIBC:39,  Exp. Date: 3/23/2013; Lot #CABCDBBC:71,  Exp. Date: 3/1/2013; Lot #CABDACAB:56,  Exp. Date: 4/2/2013; Lot #CABDACAB:76,  Exp. Date: 4/2/2013; Lot #CABDACAB:89,  Exp. Date: 4/2/2013; Lot #CABDADAB:69,  Exp. Date: 4/3/2013; Lot #CABDADAB:93,  Exp. Date: 4/3/2013; Lot #CABDADAB:54,  Exp. Date: 4/3/2013; Lot #CABDAEAB:96,  Exp. Date: 4/4/2013; Lot #CABDAHAB:00,  Exp. Date: 4/7/2013; Lot #CABDAHAB:59,  Exp. Date: 4/7/2013; Lot #CABDAHAB:18,  Exp. Date: 4/7/2013; Lot #CABDAJAB:30
Lack of Assurance of Sterility; product linked to adverse event reports of endophthalimitis eye infections and FDA inspection findings resulted in concerns regarding quality control processes
Community Blood Centers of South Florida, Inc.
Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood product, not labeled with a tag indicating that it contained anti-D, was distributed.
Amer.  National Red Cross-Greater Chesapeake & Potomac Reg.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
Blood product, collected from a donor who was allowed to donate without a current physical, was distributed.
Blood Centers of the Pacific - Irwin Center
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
American Red Cross Blood Services Tennessee Valley Region
Blood products, collected using an inadequate reagent to perform the arm scrub, were distributed.
Lifesouth Community Blood Centers - Montgomery Region
Blood product, labeled with an extended expiration date, was distributed.
Blood products, labeled leukoreduced which had not undergone leukoreduction, were distributed.
Lifesouth Community Blood Centers, Inc. - Mobile Region
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, collected without the performance of a WBC count during instrument re-validation, were distributed.
Blood products, collected in an expired triple transfer pack, were distributed.
LifeSouth Community Blood Centers Inc - Birmingham Region
Blood product, with platelet count below the specified minimum requirement, was distributed.
Wellmont Health System Dba Marsh Regional Blood Center
Nationwide.  Product was also available for sale via internet
Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York
Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibutramine and phenolphthalein, two active ingredients that were once marketed in the U.S. but removed due to safety reasons, making this product an unapproved new drug.
ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by: Rugby Laboratories, Inc., Duluth, Georgia 30097, NDC 0536-3086-41, UPC 3 0536-3086-41 9.
Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 bottle labeled as Rugby label Enteric Coated Aspirin 81 mg Tablets actually contained Acetaminophen 500 mg Tablets.
Worldwide distribution: US Nationwide (including PR and USVI), and countries of: Israel, Argentina, Brazil, France, Mexico, Saudi Arabia, Beirut, China, Korea, San Salvador, Honduras, Canada, Australia, Switzerland, Germany, Arab Emirates, UK, Belgium, Egypt, Spain, France, Italy, Iran, Lebanon, Jordan, Iraq, Canary Islands.
Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15. 8 mm). Item codes starting with 00-1181-05, 00-1181-10 and 00-1181-15. ZIMMER Compression Hip Screw, orthopedic implant.
Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.
Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150).   ZIMMER Compression Hip Screw, orthopedic implant.
VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), diameters (12.7 mm and 15.8 mm) and short thread, standard thread and large thread. Item codes starting with 00-1193-005, 00-1193-010 and 00-1193-015.  Versa-Fx Femoral Fixation System, orthopedic implant.
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low profiles, several holes/length combinations (2/54, 3/70, 4/86, 5/102, 6/118) and several angles (130, 135, 140, 145 and 150). Item codes starting with 00-1193-130, 00-1193-135, 00-1193-140, 00-1193-145, 00-1193-150.  Orthopedic implant.
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5/102 and 6/118), different degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-194-130, 00-1194-135, 00-1194-140, 00-1194-145, 00-1194-150). Orthopedic implant.
Nationwide Distribution including the states of AK. AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MD, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI SC, SD, TN, TX, UT, VA, VT, WA WI and WV.
Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm   Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column Volar Distal Radius Plate and 1.2 Nm Torque Limiting Attachment. The US Technique guide lists 1.2Nm TLA as an option for use with the 2.4mm Variable Angle LCP (VA-LCP) Two-Column (Standard & Narrow) Volar Distal Radius Plate. The potential exists for the VA locking screw to be driven through the 2.4mm VA-LCP Two Column Volar Distal Radius Plate when used with a 1.2Nm Torque Limiting Attachment. If a screw passes through the VA-LCP plate, additional medical intervention during the index procedure could be needed.
Worldwide distribution: US (nationwide) including PR and countries of: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic Korea, Saudia Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, and United Kingdom.
Dimension Vista 500 and Dimension Vista 1500  System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6.    In vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric, and integrated ion-selective multisensory technology for clinical use.
Dimension Vista 500 Siemens material numbers: 10284473 (domestic), and 10488224 (international), Dimension Vista 1500 Siemens material numbers: 10444801 (domestic) and 10444802 (international).
Siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems using software versions 3.5.1 and 3.6. Under specific rare conditions which require a system reset, there is a potential for a sample to be dispensed into an aliquot well that has previously been used for a QC or calibrator product from a Vista vial. If two samples are dispensed into the same aliquot well, the first sample will always be QC or calibrator from a Vista vial. Patient sample will never be dispensed into an aliquot well that contains another patient sample. The possible combinations are 1.) patient sample dispensed on QC or calibrator from a Vista vial, 2) QC from a Vista vial or any other sample container dispensed on QC or calibrator from a Vista vial, and 3) Calibrator from a Vista vial or any other sample container dispensed on QC or calibrator from a Vista vial.
Worldwide Distribution - USA Nationwide including Puerto Rico and the countries of:  Albania, Afghanistan, Algeria, Argentina, Austria, Bangladesh, Belgium, Bolivia, Bosnia- Herzegovinia, Brazil, Bulgaria, Camaroon, Canada, Canary Islands, Chile, China, Colombia, Coast Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Honduras, Hungary, India,  Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Nicaragua, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, Spain, South Africa, Rep. of Korea (S), Sweden, Switzerland, Syria, Taiwan, Thailand, The Netherlands, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, Uruguay, White Russia, Venezuela, and Vietnam.
PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D); and in the IMMULITE 2000/2000XPi Systems Analyzers, Catalog Numbers L2KPS2, L2KPS6, L2KPTS2(D) and L2KPTS6(D).  IVD Immunoassay kits in the following sizes: 100, 200, 500 and 600 test kits;  For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi Systems Analyzers. PMA # P930027/ Device Listing # D002374.   Product Usage:  For the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients. For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and the IMMULITE 2000/ 2000 XPI Systems Analyzers
Product Code/Lot # LKPS1 424, Expiration Date 2013-08-31;  Product Code/Lot # LKPS1 425, Expiration Date 2013-10-31;  Product Code/Lot # LKPS1 426, Expiration Date 2013-10-31;   Product Code/Lot # LKPS5 424, Expiration Date 2013-08-31;   Product Code/Lot # LKPS5 425, Expiration Date 2013-10-31;  Product Code/Lot # LKPS5 426, Expiration Date 2013-10-31;  Product Code/Lot # LKPTS1(D) D0104, Expiration Date 2013-08-31;  Product Code/Lot # L2KPS2 379, Expiration Date 2013-07-31;  Product Code/Lot # L2KPS2 380, Expiration Date 2013-08-31;  Product Code/Lot # L2KPS2 381, Expiration Date 2013-10-31;  Product Code/Lot # L2KPS2 382, Expiration Date 2013-10-31;  Product Code/Lot # L2KPS2 383, Expiration Date 2013-10-31;  Product Code/Lot # L2KPS2 384, Expiration Date 2013-10-31;  Product Code/Lot # L2KPS6 379, Expiration Date 2013-07-31;  Product Code/Lot # L2KPS6 380, Expiration Date 2013-08-31;  Product Code/Lot # L2KPS6 381, Expiration Date 2013-10-31;  Product Code/Lot # L2KPS6 382, Expiration Date 2013-10-31;  Product Code/Lot # L2KPS6 383, Expiration Date 2013-10-31;  Product Code/Lot # L2KPS6 384, Expiration Date 2013-10-31;  Product Code/Lot # L2KPTS2(D) D107, Expiration Date 2013-07-31;  Product Code/Lot # L2KPTS2(D) D108, Expiration Date 2013-10-31;  Product Code/Lot # L2KPTS2(D) D109, Expiration Date 2013-10-31;   Product Code/Lot # L2KPTS6(D) D107, Expiration Date 2013-07-31;  Product Code/Lot # L2KPTS6(D) D108, Expiration Date 2013-10-31;  Product Code/Lot # L2KPTS6(D) D109, Expiration Date 2013-10-31.
Customers complained of a positive bias in patient results on the IMMULITE/ IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi PSA assay when compared against the  IMMULITE /IMMULITE 1000 3rd Generation PSA assay. Siemens has confirmed an overall average positive bias of approximately 20% to 23% across the assay range relative to the WHO 96/670 with the IMMMULITE Systems PSA Assay. This positive bias is observed in patient values and the Siemens Tumor Marker controls (TMCO).  Other commercially available controls may show this bias.
Synthes Trauma Nail System. The devices are indication for bone fixation.
Trauma Ex Nails, all lot numbers up to and including lot # 7072305 and Trochanteric Fixation Nails, all lot numbers up to and including lot # 7060897
Recall was initiated due to the possibility that the outer pouch was compromised.  The product is packaged in two pouches; a sterile, internal pouch within an external pouch.  It is the outer, external pouch that may be compromised.
Worldwide distribution: US (nationwide) including states of:US states: AZ, CA, FL, GA, IL, MD, NJ, NY, OK,  PA, TN, TX,and WA ; and countries of: Spain, France, Japan. International: Spain, France, Japan.
Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.
The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 40mm implants, due to an off-center cannulation hole at the proximal end of the bone screw. There is a potential risk that when the screw is mated to a polyaxial screwdriver, the guide wire may not pass through the screwdriver.
Worldwide Distribution - USA (nationwide) including the countries of Singapore, Brazil, Taiwan, Australia, Canada, Germany(with further distribution to UAE, Austria, Belgium, Switzerland, Czech Republic, Denmark, Spain, Finland, France, Greece, Israel, Italy, Malta, Norway, Portugal, Sweden and South Africa,
00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor  Rx, Non sterile (sterilize before use)   The Glenosphere Distractor must be able to attach, connect, or mate with the Glenosphere and remove it without dislodging or loosening the base plate from the glenoid, or damaging the glenoid. Pulling the trigger releases a weight inside the Distractor. This force is transmitted to the bottom of the glenosphere dislodging it from the base plate.
Zimmer is initiating a lot specific recall of the Trabecular Metal'' Reverse Glenosphere Distractor due to the potential of the device not functioning properly should it be utilized without proper lubrication. As a result, there is a potential for the device to fail to provide impact to the Glenosphere when the trigger is pulled. In addition, there is a potential for the foot of the device to fracture during use which may result in the device being unable to remove the Glenosphere. There have been 17 reported complaints of the device failing to provide impact and 8 reported complaints of the foot fracturing. In the U.S.,these devices were distributed between March 13, 2006 and March 22, 2013.
D'Aqui Manufacturing Products, Corp., Dba Postres de Aqui
Tres Leches cake sold under the following brand names: 1) ''****Tres Leches***Postres D'Aqui***D'Aqui Manufacturing Products Corp***Peso Neto 3oz***''; 2) ''****Tres Leches***Fresh Star***Distribuido por Karelly's Food***PO Box 634 Sabana Seca PR 00952***Peso Neto 3 oz***''
Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT,  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, WA, WI, WV, and the countries of Dubai, Arab Emirates, Quebec, Canada, Japan, and Ireland.
DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx Only  2) REF 28-0214 Hi-Flow Insufflation Tubing Rx Only   3) REF 28-0216 Tubing, Insuf w/.3 Micr Filter Rx Only   4) REF 28-0217 Insufflation Tubing, Laparoscopic Rx Only   5) REF 28-0208 Insufflation Tubing w/Vent Rx Only   6) REF 28-0212H Heated Hi-Flow Insufflation Tubing Rx Only.    Used during laparoscopic surgical procedures to aid in the insufflation of the abdomen.
All Lots of the Insufflation Tubing Sets are as follows:  REF 28-0206 Insufflation Tubing, Laparoscopic, Lot #29074214;  REF 28-0214 Hi-Flow Insufflation Tubing Lot #3194170;  REF 28-0216 Tubing, Insuf w/.3 Micr Filter Lot #29074249;  REF 28-0217 Insufflation Tubing, Laparoscopic Lot #32305010; DeRoyal REF 28-0208 Insufflation Tubing w/Vent Lot #29314302; DeRoyal REF 28-0212H Heated Hi-Flow Insufflation Tubing  Lot #29000354.
506,632 sets in US; 17,854 sets International
DeRoyal Industries is recalling their product Insufflation Tubing Sets due to materials incompatibility which could possibly result in occlusion at or near the filter housing which could prevent the flow of gas through the device.
USA Nationwide Distribution in the states AR, MD, NJ, NY, PA, and WV.
Mc Kesson Anesthesia-Rx  Model Number 8.0.2 & 8.0.1 with RapiDispense   Product Usage:  Automated anesthesia cart that monitors and controls the dispensing of medications, narcotics and supplies during surgical procedures.
Model Number (software version)  8.0.2 & 8.0.1 with RapiDispense
The firm issued a clinical alert after users reported an issue where the Anesthesia-Rx system was interrupted ANF became temporarily unavailable during use.
USA Nationwide Distribution in the states of DE, IA, MN, and NC.
HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests.
Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA.
Worldwide Distribution - US Distribution only to AR., and the countries of Australia, Germany and Japan.
BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. The Frameless Radiosurgery Components are a device used for fixation, localization and repositioning of the patient's: head and neck; and head, neck, and shoulders, in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures.
The Frameless SRS QA Target Pointer - Pointer Cap with the engraved cross hairs may become loose even when only a moderate force is applied to the Pointer Cap.
Worldwide Distribution-USA (nationwide) and  Puerto Rico and the country of Canada.
PrepStain AG.   For use in the screening and detection of cervical cancer.
PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.
PrepStain Tecan US-I.   For use in the screening and detection of cervical cancer.
PrepStain Tecan US-II.   For use in the screening and detection of cervical cancer.
Worldwide Distribution - USA (nationwide) including the countries through Stryker Distribution: Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Latvia, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Spain, Sweden, Switzerland, United Kingdom, Argentina, Australia, Brazil, Jordan, Kingdom of Saudi Arabia, Kuwait, Latin America (others), New Zealand, Russia, Singapore, South Africa, and United Arabian Emirates.
Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc),  397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015 (15 cc) HydroSet Injectable HA Bone Substitute Sterile R/EO, nonpyrogenic,  Product of Ireland   Stryker Injectable Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton. The powder is mixed with the sodium phosphate/PVP solution provided in the kit and loaded into the empty cement delivery syringe to be applied directly to the site for void filling or augmentation.
Stryker received reports of the desiccant bag in the kit leaking silica gel granulate.  This could increase exposure to anesthesia during surgical delay up to 60 minutes or inadvertent implantation of silica gel granulate which could cause  foreign body reaction  including inflammation and might lead to the need for revision surgery.
US Distribution including the states of  PA, NJ, DC, VA, MD and DE.
Axiom Artis systems. C-arm angiographic x-ray system   x-ray, angiographic system.
The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that may involve  incorrect channel nuts being used.
US Distribution to the state of Tennessee only.
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox. Stem dia. 12 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
The trial stems were manufactured using the wrong design.
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001, prox. Stem dia. 14 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002, prox. Stem dia. 16 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem dia. 18 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox. Stem dia. 20 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, prox. Stem dia. 22.5 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006, prox. Stem dia. 25 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/12, Stem size 0, prox. Stem dia. 12 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/14, Stem size 01, prox. Stem dia. 14 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, prox. Stem dia. 16 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/18, Stem size 03, prox. Stem dia. 18 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/20, Stem size 04, prox. Stem dia. 20 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/22, Stem size 05, prox. Stem dia. 22.5 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem dia. 25 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/12, Stem size S-0, prox. Stem dia. 12 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/14, Stem size S-1, prox. Stem dia. 14 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2, prox. Stem dia. 16 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/18, Stem size S-3, prox. Stem dia. 18 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4, prox. Stem dia. 20 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/22, Stem size S-5, prox. Stem dia. 22.5 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6, prox. Stem dia. 25 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Micro Therapeutics Inc, Dba Ev3 Neurovascular
US Distribution including the states of AZ, KY, MO, NC, GA, WI, OR, FL, NY, CA, IL, TN, NV, TX, CO, MA, IA, UT and VA.
Pipeline Embolization Device (PED)   The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.
Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (PED) because the Instructions For Use (IFU) do not include the following contraindication:  Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location.  Additionally, the designation of aspirin and clopidogrel was missing from the following contraindication ''Patients in whom dual antiplatelet therapy (aspirin and clopidorel) is contraindicated.''
Worldwide Distribution - USA including Puerto Rico and the states of AZ, CA, FL, GA, IL, IN, KY, MA, MI, MS, NE, NM, NY, OH, PA, TN, TX, UT, VA, WA, WI and WV., and the countries of Spain, Singapore, South Africa, Canada, Libya,Pakistan and Cayman Islands.
Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware.    The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open during neurosurgery.
Catalog Number R2383 and as a component of catalog number R2385, including all lot numbers date codes going back to January 2006.
As a result of complaint investigations it was identified that there is a potential that the Leyla Ball Joint Clamp (R2383) may not provide the level of stability needed to maintain retraction in all cases.
Medtronic Inc. Cardiac Rhythm Disease Management
Worldwide Distribution - USA Nationwide CA, IL, LA, MI and the country of CANADA
Medtronic Custom Perfusion System.  Model Numbers:  1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9.   Sterilized by Ethylene Oxide, Do no Reuse.        Product Usage:  This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.
Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B.  The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.
Medtronic Custom Perfusion System with Carmeda BioActive Surface.  Model Numbers:  CB1D82R12 and CB5N73R7.   Sterilized by Ethylene Oxide, Do no Reuse.      Product Usage:  Usage:  This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.
Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin).  Model Numbers:  TL4X17R8, TL5D01R, TL5D02R, TL5D02R3, TL5D02R5, and TL6A65R7.   Sterilized by Ethylene Oxide, Do no Reuse.      Product Usage:  Usage:  This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.
Worldwide Distribution - US Nationwide in the country Virgin Islands
SARKEN STAT! Multi-Drug Test Panel   Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Manufacturer's Product Number HMO-W264    Lot Number  F2290966    Expiration Date:  02/2014
These products are being recalled because they were distributed without adequate labeling and instructions for use.  Inadequate labeling could lead to misuse of the Test Kits and incorrect test results.
Manufacturer's Product Number DOA-254    Lot Number  DOA2050035  DOA2090666  DOA2110059  DOA2120771    Expiration Date:  02/2014  07/2014  08/2014  10/2014
SARKEN STAT! 1- Panel Test Kit-THC   Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
SARKEN STAT! 1- Panel Test Kit-COC   Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Manufacturer's Product Number DCO-114    Lot Number  COC2010004  COC2110076    Expiration Date:  12/2013  09/2014
SARKEN STAT! 1- Panel Test Kit-mAMP   Product Usage:  Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Manufacturer's Product Number DMA-114    Lot Number  MET2100027    Expiration Date:  08/2014
SARKEN STAT! 1- Panel Test Kit-OPI   Product Usage:  Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Manufacturer's Product Number DOP-114    Lot Number  OPI2100003    Expiration Date:  09/2014
Worldwide Distribution - USA Nationwide in the states of NJ, IN, PA, FL, OH, MN, MO, CA, AL, NE MI, LA. and countries of:Argentina, China, South Africa, Pakistan, Spain, Switzerland, Italy, Algeria, Croatia, Turkey, Canada, Germany, France, Poland, Japan, Russian Federation. Lebanon, Egypt, Slovakia, Latvia, Kenya, Brazil, Kuwait, Saudi Arabia, Greece, Belgium, Taiwan, Portugal.
PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT, TT-S s/n 1001-1083.     Product Usage:  The intended use of the SIEMENS branded, ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
ONCOR, PRIMUS and ARTISTE Lican systems with tabletop component: Tabletop, 550TxT, TT-A    08632296*  Tabletop, 550TxT, TT-S    10046140
Siemens has become aware of a customer complaint concerning the rail threaded holes of the 550TxT treatment tabletop.  Due to a manufacturing error, the screws holding the side rails in position on the tabletop might break off.
Internationally Distributed in China only.
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLATE,   SHORT  RIGHT  11 HOLES   178 MM LENGTH  STERILE   RX ONLY    Product Usage:  Usage:  The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including: Comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions.
Zimmer is initiating a lot specific voluntary recall of the Distal Medial Humeral Locking Plate, Short due to the incorrect information  printed on the Chinese label. The original label indicates that implants are RIGHT sided, but the Chinese label indicates that the implants are LEFT sided.
Worldwide Distribution - USA (nationwide) and the countries of  Austria, Australia, Belgium, Bosnia - Herzegovina, China, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Ireland, Iraq, Israel, Italy, Japan, Kenya, Republic of Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Martinique, Malaysia, Netherlands, Norway, New Zealand, Philippines, Poland, Portugal, Romania, Russian Republic, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom and Vietnam.
ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 .   The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts.
Domestic: 950 units; Foreign: 3369 units
The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer.  When the optics cover is raised, it is supported by two gas struts (SMN 10309266) attached to the cover on the left and right sides.  Over time, it is possible that these struts may lose their effectiveness and fail to support the optics cover in the open position.  This could cause the cover to fall during maintenance procedures.
Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Vial, Rx only, Manufactured in the USA for Nexus Pharmaceuticals Inc, Lincolnshire, IL 60069,  NDC 14789-300-02
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.
AZ, CA, HI, IL, IN, LA, MI, MO, NE, NV, OH, OK, TX, VA, Washington D.C., and WI
Trois Comtois Morbier Cheese labeled as follows: Morbier Raw Milk PLU 293358; Morbier AOC Le Trois PLU 293608; Morbier Raw Milk French Cheese PLU 293358; and Morbier Les Trois Comtois PLU 293608, Whole Foods Market
All best buy dates sold at Whole Food Market Stores in Louisiana, Oklahoma, Texas, Ohio, Virginia, Washington D.C., Illinois, Indiana, Michigan, Missouri, Nebraska, Wisconsin, California, Hawaii, Arizona, Nevada (Reno Store Only)
The product has the potential to be contaminated with Listeria monocytogenes.  This recall is in response to the Trois Comtois in Poligny, France recall.
NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.
Under certain circumstances, the Left eye image may be saved as the Right eye image.
Morbier Les 3 Comtois, 11 lb. wheel; packaged in a cardboard case; one per case; refrigerated
FDA analysis of Morbier Semi-Soft Cheese (prior to entry) revealed the presence of Listeria Monocytogenes.  Les 3 Comtois is recalling the cheese from the same lot that was allowed entry and further distributed in the US.
OLA Buffer For Laboratory Use;  Contents: 1 tube with buffered solution containing   MgCl2 (80 M) and KCL (300 M. 10.0ml.)  PN: 50003300;  Store at d - 15C.        Product Usage:  General Purpose Reagent for laboratory use.
The package insert for FG OLA Buffer, GPR displayed the wrong concentration of M instead of the correct mM unit.
Worldwide Distribution - USA Nationwide including Puerto Rico and the countries of:  ANDORRA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BRAZIL, BULGARIA, CANADA, CHILE, COLOMBIA, CZECH REPUBLIC, ESTONIA, FINLAND, GERMANY, HONG KONG, INDIA, INDONESIA, IRAQ, ITALY, JAPAN, KUWAIT, MALAYSIA, Norway, OMAN, PALESTINIAN TERRITORY, OCCUPIED, POLAND, PORTUGAL, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, and UNITED KINGDOM.
GE Ultrasound ViewPoint 6.     Product Usage:  ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation of medical reports primarily for diagnostic ultrasound. ViewPoint provides the user the ability to including images, drawings, and charts into medical reports. ViewPoint is designed to accept, transfer, display, calculate, store and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint displays to the user, can be used for diagnostic purposes. ViewPoint is intended for professional use only. ViewPoint is not intended to be used as an automated diagnosis system.
software versions 6.2, 6.2.1, 6.3, and 6.3.1
GE has recently become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (PIV) for venous flow measurements associated with obstetric reporting of the GE ViewPoint 6 system.  The ViewPoint calculated Doppler PIV for veins could be incorrect.  An incorrect calculation of the ductus venosus PIV could lead to false high risk for trisomy 13, 18, and 21, which potentially results in an inaccurate consultation of the patient.
ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
Lot Number(s): GDA 048, GDA050, GDA 051, GDA 063
Internal Roche inspections have revealed that after the lancet is used for a finger stick, the needle may not fully retract back within the lancet drum or back into the cap. This allows the needle to protrude inside the cap or outside of the cap of the ACCU-CHEK FastClix lancing device.
USA Nationwide Distribution in the states of FL, GA, NC, OH, KY, NJ, ID, IN, and MN.
Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right   Product Usage:  Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the distal radius and other small bones.
The possibility exists that 2.4 mm VA-LCP 2 column distal radius plates from a specific lot are etched with ''R'' for right plate when they should be etched with ''L'' for left plate.
USA Nationwide Distribution in the states of:  FL. OH, TX, & VA
Stryker  1) Asnis III Cannulated Screw REF 604640  4.0x40mm TL 13.5mm    2) Asnis III Cannulated Screw REF 604642S  4.0x42mm TL 14mm, sterile    Product Usage:  The Asnis III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
Catalog # 604640, Lot Code R11428 21 units    Catalog # 604642S, Lot Code R09071  1 unit
Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot R11482, was incorrect.
''***Que sos VACA NEGRA***CAP AEZ***Libre DE Lactose y Hormona R-BST***Quesos Vaca Negra, Carr 492 km 0.1, Hatillo, PR***''
Positive test results for Generic E. coli
Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument.
Stryker Orthopaedics has received complaints associated with cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument.
small independent retail stores in Michigan
Cardboard BIN LABEL: 03808  LOT #: 09000101, MELON CANTALOUPE..., 80-90 CT , 07/22/13   cantaloupes themselves are not labeled.
Lot 09000101, 07/22/13 on cardboard bin (box)
Heeren Brothers Produce is recalling Athena cantaloupes distributed to small independent grocers in Michigan July 23-26, after routine testing by FDA found product contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections in young children, the elderly or others with weak immune systems.  Healthy individuals may suffer short-term symptoms, such as high fever, severe headache, stiffness, nausea, abdominal pain or diarrhea.  Listeria can cause miscarriages and stillbirths in pregnant women.
Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only,  1000 count bottles, Manufactured in Czech Republic by: Teva Czech Industries, sro, Opava komanov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-467-03
Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10 mg due to the potential of some tablets not conforming to weight specification.
Worldwide Distribution - USA Nationwide in the states of CA, FL, GA, IN, IA, MO, NV, NJ, NY, PA, SC, TN, TX, WA. and the country of CANADA.
3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns/box).   Product Usage:  Stainless Steel Crowns are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth.
Product Code 902150 (Kit)  Lot codes N492036, N500930 (not distributed)  and N495695    Product Code 900114 (Refill)   Lot Codes N486012, N497616 (not distributed)  and N483920
3M ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) because these products have been manufactured with the incorrect marginal contour edge.
SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M).   Use to aspirate bone morrow.
SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval.
USA Nationwide Distribution in the state of Florida
SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage)   Product Usage:  Is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level
Ref. No. CL1012-05   Size  10mm x 12mm x 5mm, Ref. No. CL1012-06   Size 10mm x 12mm x 6mm,  Ref. No. CL1012-07   Size 10mm x 12mm x 7mm,  Ref. No. CL1012-08   Size 10mm x 12mm x 8mm,  Ref. No. CL1012-09   Size 10mm x 12mm x 9mm,  Ref. No. CL1012-10   Size 10mm x 12mm x 10mm,  Ref. No. CL1014-05   Size 12mm x 14mm x 5mm,  Ref. No. CL1014-06   Size 12mm x 14mm x 6mm,  Ref. No. CL1014-07   Size 12mm x 14mm x 7mm,  Ref. No. CL1014-08   Size 12mm x 14mm x 8mm,  Ref. No. CL1014-09   Size 12mm x 14mm x 9mm, and  Ref. No. CL1014-10   Size 12mm x 14mm x 10mm.
The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to initial product marketing.
Worldwide Distribution - US  Nationwide including the states of   AZ, CA, CO, DE, FL, GA, MO, MS, NC, NH, NY, PA and TX., and the countries of  Canada, Australia, China, Czech Republic, France, Germany, Greece, Italy, Netherlands, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates and United Kingdom.
Philips Easy Upgrade DR, Code No: 712086   This system is used for making X-Ray exposures for diagnostics.
The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.
Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Block and Infiltration Only, 50 Cartridges per box - 1.7 mL minimum each,  NDC #s: a) Octocaine 100, Mfr'ed for Septodont, Louisville, CO, 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada N1R6X3, 0362-9023-05; b) Superdent, Dist by: Darby Dental Supply Co., Jericho, NY 11753, Made in Canada,  66467-9730-5; and c) Dist by: IQ Dental, 353 Rt 46 W, Bldg C Unit 120, Fairfield, NJ, 07004, made in Canada, 42756-1030-5; Manufactured by: by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada N1R6X3.
Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine 100, and 2% Xylocaine Dental, may be subpotent for the epinephrine component.
Sparhawk Laboratories, Inc. Atropine Sulfate 1/120 Injectable Solution, each mL of sterile solution contains 0.54 mg. atropine sulfate, packaged in 100-ml. vials, RX, Manufactured for Sparhawk Laboratories, Inc., Lenexa, KS.
The lot failed stability at the 12-mo. testing interval (low).
Class II  Recall - Worldwide Distribution - US including the states of  CA, HI, IL, MN, NC, NJ, OH, PA, TX, UT and VA.
E-Z Clean Disposable Laparoscopic Electrode Model Number 0100L and 0100LS.  Expiration dates of 05/2018 to 07/2018. Sterile.  RX ONLY. This product is packaged individually in a chevron Tyvek - polyester peel pouch, 6 pouches per box.   The E-Z Clean laparoscopic electrode is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during laparoscopic surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.
Megadyne Medical Products is recalling certain lots of E-Z Clean, L-Wire laproscopic Electrode Standard Stem and Split Stem due to potential breach of insulation.
Sour Cherry Crostata, 1 pie Net. Wt. 1 lb. 6 oz (624 g)    Whole Foods Market Inc., Emeryville, CA 94608
All units with sell by date prior to 8/14/13 and pack date prior to 8/10/13.
~110-120 units a week, both varieties. 19 weeks of production for ~2280 individual crostatas.
Egg wash is used on the product and is not listed on the ingredient list or allergen statement.
Blueberry Crostata, 1 pie Net. Wt. 1 lb. 6 oz (624 g)    UPC: 0216733009993    Whole Foods Market Inc., Emeryville, CA 94608
~110-120 units per week. 19 weeks of product - 2280 total units
Nature's Earthly Choice Organic Quinoa  Distributed by Nature's Earthly Choice Eagle, ID 83616  Product of Bolivia    a) Net Wt 2 lbs. - UPC 897034002267  b) Net Wt 4 lbs.-  UPC 897034002021    packaged in re-sealable bags
Nature's Earthly Choice Organic Quinoa may contain sand and grit.
Worldwide Distribution - USA Nationwide including DC and PR except ND and the countries of: ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOSNIA-HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, CHANA, GREECE, HONDURAS, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, MALAYSIA, MEXICO, MOROCCO, NEPAL, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PANAMA, PARAGUAY, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAK IA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNSIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, BOLIVIA, HONG KONG, JAMAICA, PHILIPPINES, SOUTH KOREA, TRINIDAD TOBAGO, URUGUAY, VENEZUELA.
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000.   Product Usage:  The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients.
GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/or Tram Module.    ECG and Respiration signal noise caused by DASH, PDM, and/or Tram ECG cable connector movement may result in reduced ECG, Respiration and arrhythmia detection performance.
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)    Product Usage:  The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes.
GE Healthcare, TRAM MODULE, High-acuity patient monitoring.    Product Usage:  The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another.
Product was distributed to the following states: IL, IN, MI and OH.
Buurma Farms Cilantro, fresh, 4 oz bunch, #4889 UPC 0 33383 80104 9
The firm was notified by one of their customers of a positive Listeria monocytogenes results they received from the Michigan Department of Agriculture.
See's retail store and Licensees in US and Hong Kong and Taiwan and mail order  US only.
See's Candies, Van Doren Dark Chocolate Blueberries; 8 oz. clear plastic packages.    See's Candies Inc./See's Candy Shops Inc:  South San Francisco, CA 94080/Los Angeles, CA 90016
8 oz UPC: 737666094479.    Stock boxes SKU 9458. These are ~ 3.78 lb boxes sent to stores where they are packed into 8 oz bags.  KSU 9447 - 1- lb.cases of 8oz x 20 bags sent to licensees.
Investigation into a consumer complaint revealed that ''milk: had been erroneously omitted from the ingredient statement of Dark Chocolate covered Blueberries.
Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA,  NDC 0409-3795-01
Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.
buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.
Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets (XL) 300 mg, because another lot was shown to have similar failing results for dissolution at the 8-hour timepoint.
Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL 60045, USA,  NDC 0409-3213-12
Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.
AZ, CA, CO, FL, GA, IL, KY, MN, MO, MS, NC, NH, NY, PA, TX, VA and WA.
Daily Chef, Tropical Fruit & Nut Blend, 44oz plastic bags, Distributed by SAMs West, Inc., Bentonville, AR 72716.