GFKWMV;GFKXMW; GFLCNS; GFLDJG; GFLFPV; GFLGJT; GFLHQF; GFLJHW; GFLKKC; GFMDZG; GFMGBS; GFMGTN; GFMHXS; GFMJMT; GFMKHX; GFMMBQ; GFMMWS; GFMPJS; GFMQFC; GFMRMP; GFMSVC; GFMVBP; GFMPDV; GFYBVS; GFYCYF; GFYFDR; GFYGLW; GFYGYN; GFYJFM; GFYJTT; GFYKZL; GFYLYK; GFYNZL; GFZHLG; GFZJGY; GFZKMW; GFZLNH; GFZMJH; GFZNFN; GFZPFH; GFZPVM; GFZQPL; GFZRGV; JBBRWK; JBBZYZ
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood Bank Of San Bernardino and Riverside Counties
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood and Blood Products for Reprocessing.
Blood products collected from a donor who was previously permanently, were distributed.
Hoxworth Blood Center University of Cincinnati Medical Center
Blood products, collected from a donor taking the medication Azathioprine, were distributed.
Blood products, collected from a donor with a history of incarceration, were distributed.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood product, which did not have the required volume of red blood cells, was distributed.
Blood product, in which routine testing was performed, interpreted and/or documented incorrectly, was distributed.
Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood product, which did not meet the acceptable product specifications, was distributed.
Blood product, which was outside the acceptable quality control ranges, was distributed.
Blood Bank Of San Bernardino And Riverside Counties
Red Blood Cells Leukocytes Reduced Irradiated
Blood products, collected from a donor who warranted deferral due to travel to a malaria endemic area, were distributed.
Blood product, which tested negative for viral markers, but was collected from a donor who subsequently tested positive for hepatitis B surface antigen (HBsAg), was distributed.
Blood Bank of San Bernardino and Riverside Counties
California, Florida, Washington, D.C., Austria
Blood and Blood Products for Reprocessing
Blood products, released from quarantine prior to post leukoreduction, were distributed.
Blood Products, which were contaminated with Corynebacterium species, were distributed.
Blood products,  without any coolant in the shipping container, were distributed.
Blood products, collected from a donor whose suitability to donate were not adequately determined, were distributed.
Blood products, which did not meet the acceptable product specifications, were distributed.
Southern California Permanente Medical Group Blood Donor Center
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Blood products, collected from a donor taking the medication Proscar, were distributed.
Blood products, collected from a donor whose physical was improperly documented, were distributed.
Blood products, collected from a donor with polycythemia, were distributed.
Worldwide Distribution--USA (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Belgium, Brazil, canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Saudi, South Africa, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Eon Mini - 3788 (IPG),    Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back, surgery syndrome, intractable low back and leg pain.
Multiple lots recalled are the ones with supplier's inner battery lots of 326-508
As part of St. Jude Medical's routine tracking and product monitoring, they have received a total of 214 reports, out of 34,617 Eon Mini IPGs, that lost the ability to communicate or recharge due to an inner battery weld issue resulting in loss of pain relief and subsequent explant.  Explant surgery, as with any surgery, presents a risk to patient health. Adverse events associated with an unplanned surgery may be comparable to adverse events associated with planned operations, and may include pain, scarring, and infection, as well as complications from anesthesia.  Product investigation and analysis conducted by St. Jude Medical as a result of reports of the inability to communicate or recharge the Eon Mini IPG has identified weld cracks in the IPG's inner battery as the cause of this issue. Prior analysis had indicated that moisture was the cause of weld cracking. However, with the occurrence of additional weld cracks, the firm's investigation has determined that the current weld cracks are not attributed to moisture within the battery.  Thorough analysis of the cracked batteries and review of the battery manufacturing processes has identified a need to more frequently maintain and replace certain tools during the internal battery welding process by a St. Jude Medical supplier in order to assure complete alignment between the welding apparatus and the battery. It is important to note that the battery is contained within the hermetically-sealed IPG case and cannot leak electrolyte outside the IPG casing.
Worldwide Distribution - USA (nationwide) and internationally to Australia, Belgium, Brazil, Chile, France, Germany, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands, Philipines, Singapore,  South Africa, Spain, Switzerland, Thailand, Turkey, and United Kingdom.
Leica ASP6025 Vacuum Tissue Processor   The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens.
The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the Ready To Use (RTU) bottles from other suppliers than Leica. In case of a pressure failure of the device in combination with a bottle with incorrect dimensions, overflow can cause contamination of reagents. Additionally, the current instructions for use does not highlight the importance to check the filling levels of all reagent bottles (RTU and system bottles) prior to every process run.   Without this important information, risk of tissue damage or loss is possible. Therefore the missing information will be distributed to all customers by a Field Service Notice.
Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA
Marketed Without an Approved NDA/ANDA; product contains analogues of sildenafil and tadalafil which are active pharmaceutical ingredients in FDA-approved drugs used to treat erectile dysfunction (ED) making this product an unapproved new drug.
Worldwide Distribution-USA (nationwide) and the countries of  Belgium, Canada, and Saudi Arabia.
Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc.    Dilation of airway tree.
Product code: BC0524A; All lots manufactured after March 1, 2011
Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc.    Dilation of airway tree.
Product code: BC0724A; All lots manufactured after March 1, 2011
Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc.    Dilation of airway tree.
Product code: BC8524A; All lots manufactured after March 1, 2011
Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc.    Dilation of airway tree.
Product code: BC1040A; All lots manufactured after March 1, 2011
Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc.    Dilation of airway tree.
Product code: BC1240A; All lots manufactured after March 1, 2011
Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc.    Dilation of airway tree.
Product code: BC1440A; All lots manufactured after March 1, 2011
Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc.    Dilation of airway tree.
Product code: BC1640A; All lots manufactured after March 1, 2011
Blood products, collected from a donor who was not deferred after testing reactive for HTLV-I/II, were distributed.
Community Blood Centers of South Florida, Inc.
Blood products, collected from a donor who lived in an area considered endemic for malaria and had a piercing within 12 months of donation, were distributed.
US distribution in states of: CO, DC, MA and TX.
Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number:  11-80009 Rev. B   The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients
Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm screws.
Blood products, collected from a donor who had recently visited a malarial endemic region, were distributed.
Blood product, collected from a donor who had recently visited a malarial endemic region, was distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
US distributions to states of: KS and TX.
S-LIFT Slap Hammer, Part Number: 11-50204, Revision A   The slap hammers are used primarily to remove trial instruments that are used to estimate sizes of intervertebral body fusion devices intended to promote fusion. These devices were used in conjunction with lumbar intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients.
Platelets Pheresis Leukocytes Reduced Washed
Blood product, with a volume significantly higher than the usual and expected amount, was distributed.
Nationwide Distribution including Nebraska and Virginia.
Custom Spine ISSYS LP Inverted Screw System.  8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile.  Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ  07054 USA.  TEL: 973-808-0019   The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine for pedicular and non-pedicular fixation.
On March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were found to be out of specification.  The screw length was 5 mm shorter in length than the required specification for the screw size. The product is laser marked 8.5mm X 45mm, but its length measured 40mm.
Distribution to CA, GA, MN, NC, UT and the District of Columbia.
uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 Terra Bella Ave., Suto A. Mountain View, CA 94043 USA. The product is a single reagent cartridge run on an automated system and each assay performed on a single disposable chip using microfluidic electrophoretic separation. The reagent cartridge contains various buffers and antibodies.
Product fails to meet the accuracy at the low end of the measuring range.
Antibody Screening Cells, misbranded with incorrect Antigen Profile, were distributed.
Worldwide Distribution - USA including AL, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.  Internationally to: Australia, Austria, Belguim, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zeland,Norway, Poland  Singapore, South Africa, Switzerland, Turkey, and United Kingdom.
HeartWare Ventricular Assist System   For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.
US product: Model 1400, 1401US, 1403US, 1404 International: Model 1400, 1401XX, 1407XX, 1408  ALL HEARTWARE CONTROLLER SERIAL NUMBERS
Potential to electrostatic discharged (ESD)
Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only.  Manufactured by VistaPharm, Inc., Birmingham, AL 35242.  Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC  28092 USA
Failed Impurity/Degradation Specification; ''Related Compound C''
USA, Canada, Germany, Israel, Poland, Spain, Brazil, Japan, Singapore, Thailand, and Vietnam.
Micro SSP'' Allele Specific HLA Class I DNA Typing Tray B*38/39, Catalog Identification: SSPR1-16   Micro SSP'' Allele Specific HLA Class I DNA Typing Tray  B*38/39 Catalog Identification: SSPR1-16  Article Number: SSP_DNAT_PI Rev 18  Lot number: 002, batches 001-003    510(K) Number : BK960062
Micro SSP'' Allele Specific HLA Class I DNA Typing Tray B*38/39 Catalog Identification: SSPR1-16  Article Number: SSP_DNAT_PI Rev 18  Lot number: 002, batches 001-003
Micro SSP Allele Specific HLA Class I DNA Typing Trays (B*38/39), manufactured with an incorrect primer, were distributed.
Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Worldwide Distribution, including Nationwide (US) and the countries of China, Italy, Japan, Canada, Turkey, United Kingdom, Singapore, Israel, and the Netherlands.
AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is for in vitro diagnostic use only.
The recall was initiated because Beckman Coulter has identified a software error on AU5800 analyzers with the Automation Ready (AR) Sampler Kit.  This software error results in the failure of the concentrated wash solution pump to stop, creating an overflow or leak on each analyzer unit.
Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet.  Physician Sample 7 Tablets bottle, Rx only,  Mfd by:  Novartis Pharma Stein AG, Stein, Switzerland, NDC 0078-9420-07
Failed Impurities/Degradation Specifications: unspecified degradation product
CA, CT, FL, ID, IL, IA, ME, MA, MI, MN, MO, MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SD, TN, TX, VT, VA, WA, WV, WI.
OSKRI, Coconut Bar Dark Chocolate, Net Wt. 1.9 oz ( 53g), UPC 6 66016 30070 3.    Ingredients: Coconuts 55%, Rice Syrup, Dark Chocolate 20% ( Sugar, Cocoa Butter, Chocolate, Soy Lecithin, Natural Vanilla).
OSKRI Corp is recalling Coconut Bar Dark Chocolate, Coconut Bar Dark Chocolate Minis, Fig Dark Chocolate Bars and Almond Dark Chocolate Bars because of undeclared milk.
OSKRI, Fig Dark Chocolate Bar, Net Wt 1.9 oz (53g) UPC 6 66016 30030 7.   Ingredients: Figs 80%, dark chocolate 20% ( sugar, cocoa butter, pure chocolate, soy lecithin, natural vanilla).
OSKRI, Almond Dark Chocolate Bars, Net Wt 1.9 oz (53g), UPC 6 66016 30042 0.   Ingredients: Almonds 32%, Rice syrup, Rice Crisp, Dark Chocolate 10% ( sugar, chocolate liquor, coco butter, soy lecithin, natural vanilla).
OSKRI, Coconut Bar Dark Chocolate Minis, Net Wt .88 oz (25g), UPC 6 66016 40031.    Ingredients: Coconuts , Rice Syrup, Dark Chocolate  ( Sugar, Cocoa Liquor,Cocoa Butter,  Chocolate, Soy Lecithin,  Vanilla).
Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.
Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525   EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121C, 132C, 134C and 135C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.
Affected Biological Indicator Lot No.: S-444
Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Code T40360EZ   EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121C, 132C, 134C and 135C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.
EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400   EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121C, 132C, 134C and 135C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.
Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code 61301606638   The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers.
Affected Biological Indicator Lot No.:121101-447 and 121101-444
Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Product Code 61301606639   The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers.
Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, Distributor Product Code SRSP/25   The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 1132 (27270 and 3 minutes at 11357275re-vacuum steam sterilizers.
Affected Biological Indicator Lot No.:130301
Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR   SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132C (270F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome
Affected Biological Indicator Lot No.:130401
Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE   SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132C (270F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome.
US Distribution including the states of  CA, IN, NJ and OK.
Siemens Luminos dRF Fluoroscopic X-Ray system   Fluoroscopic X-Ray system
Model number 10094200, serial numbers 4024, 4077, 4043 and 4051
Siemens became aware of an unintended behavior when using the Luminos dRF with software version VD10A.  The possibility exists that a software error may occur causing the table to tilt into an upright position and may collide with the floor.  Four consignees were notified of this recall by Update Instruction XP067/12/S -- all four units have been corrected.
Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV. Manufactured by Medica Medizintechnik GmbH, Hochdorf, Germany. The product is indicated for powered exercise equipment intended for medical purposes.
An anomaly in the firmware that may cause Omnicycle Elite to operate at a speed other than what was previously set when in reverse mode.
El Campestre Brand Ceviche Mixto, 2/5 lbs bulk containers into 1/10lbs carton. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton.    Labeling reads in part:''CEVICHE MIXTO***NET WT..10 LBS***DIST.BY EL CAMPESTRE DIST TEL (562) 505-7247***''.
Product is not coded with lot numbers.   Expiration date 06/01/13
El Campestre initiated this recall due to the following reason: undeclared allergens: eggs, soy, wheat, and crab extract.
El Campestre Brand Seafood Ranchero. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton.    Labeling reads in part:''SEA FOOD RANCHERO***NET WT..10 LBS***DIST.BY EL CAMPESTRE DIST TEL (562) 505-7247***''.
El Campestre Brand Ceviche De Basa. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton.    Labeling reads in part:''EL CAMPESTRE CEVICHE DE BASA***NET WT.10 LBS***Manufactured by: El Campestre Compton, CA 90221 (310) 764-2461***''.
El Campestre initiated this recall due to the following reason: mislabeling: does not contain Basa fish, it contains Swai fish.
El Campestre Brand Ceviche Mixto De Basa.   Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton.    Labeling reads in part:''EL CAMPESTRE CEVICHE MIXTO DE BASA***NET WT.10 LBS***Manufactured by: El Campestre Compton, CA 90221 (310) 764-2461***''.
El Campestre Brand Ceviche De Camaron.   Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton.    Labeling reads in part:''EL CAMPESTRE CEVICHE DE CAMARON***NET WT.10 LBS***Manufactured by: El Campestre Compton, CA 90221 (310) 764-2461***''.
El Campestre initiated this recall due to the following reason: mislabeling: Shrimp not listed in English, but the whole shrimp are visible.
El Campestre Brand Camaron Aquachile. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton.    Labeling reads in part:''EL CAMPESTRE CAMARON AGUACHILE***NET WT.10 LBS***Manufactured by: El Campestre Compton, CA 90221 (310) 764-2461***''.
El Campestre initiated this recall due to the following reason: shrimp are not listed in English, but the whole shrimp are visible.
Mesa Laboratories, Inc., Bozeman Manufacturing Facility
Worldwide Distribution: US (nationwide) and countries of: Australia, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Egypt, Greece, India,Israel, Japan, Jordan, Malaysia, Mexico, Milanese, Netherlands, Peru, Portugal, Pozan, Romania, Spain, Sweden, Taiwan, Thailand, United Kingdom, and Uruguay.
Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM.    Intended for use in determining the efficacy of steam sterilization processes.
Lot No S-444 Manufacture Date 2013 January 21 Expiration Date 2015 January 21;   Lot No S-445 Manufacture Date 2013 February 15 Expiration Date 2015 February 15 ;    Lot No S-447 Manufacture Date 2013 March 18 Expiration Date 2015 March 18.
Mesa EZTest , Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.
Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM.   Intended for use in determining the efficacy of steam sterilization processes.
Lot No SR-444 Manufacture Date 2013 January 21 Expiration Date 2015 January 21;   Lot No SR-445 Manufacture Date 2013 February 15 Expiration Date 2015 February 15.    Lot No SR-447 Manufacture Date 2013 March 18 Expiration Date 2015 March 18.
Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.
US Distribution including the states of AR, CA, FL, NJ, NY, OK, and TX
Exactech Articulated Driver    A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
When torque is applied to the Articulated Driver at the maximum angle, the cross pin may shift out of position, potentially leading to disassembly of the instrument.
Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. Internationally to Canada, Japan, Mexico, Chile, and Uruguay.
AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag   AIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Bioscience AIA Analyzers for lab analysis of various immunoassays.
Visual inspection of the pipette tips indicated that some of the tips were not uniform in size/length which was causing error messages on the analyzers.
Arm & Hammer Baking Soda  a) Net Wt. 1 LB. (454 g) UPC 3320001130  b) Net Wt. 8 oz. (277 g) UPC 3320001110  Church & Dwight, Co. Inc. 469 N. Harrison Street Princeton, NJ 08543-5297 USA
Church and Dwight Co., Inc. has initiated a recall for Sodium Bicarbonate, USP produced by the Old Fort, OH Sodium Bicarbonate Production facility due to metal and other contamination.
Worldwide Distribution-USA including the states of FL, GA, ID, KS, KY, MI, MO, NV, NY, OH, OK, PA, TN, TX, VA, and WA and the countries of AUSTRALIA, CANADA, ENGLAND, GERMANY, INDIA, COUNTY CORK, IRELAND, and TURKEY.
LPS Lower Extremity Dovetail Intercalary component.   Intended for use in replacement of the mid-shaft portion of the femur.
CATALOG NO. : Part Number:  1987-19-055 and lot numbers:130896, 132131, 132133, 209461, 209466, 219843, 232972, 295965, 310189, 336843, 349283, 352878, 374125, 379089, A1TAR1, A2AGN1, A2AGS1, A2AGT1, A2AGV1, B2VAL1, B43G11, B43G1A, B43G1B, B43G1C, B43G1D, B69HV1, B69HVA, BK1BB1, BW7DX1, BW7DX1A, E3SJD1, and EN4KJ1.   In certain documentation, these alphanumeric lot numbers may appear with three zeros at the end (e.g. A1TAR1 may appear as A1TAR1000).
The LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the female component when exposed to certain physiological loads.
Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP 16.2 mg, Hyoscyamine Sulfate 0.1037 mg,  Atropine Sulfate 0.0194 mg,  Scopolamine Hydrobromide 0.0065 mg  30-count bottle (NDC 54868-0031-04), Rx only, Repackaged and distributed by Physicians Total Care, Inc. Tulsa, OK 74146.
Lot# 6GP2; Exp 10/14   West-Ward Lot /WWCN 67331A
Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.
US Distribution only including the states of  PA, OH, UT, CA, NY, MO, and TX.
syngo Dynamics Information System (sDIS) versions 9.5 and VA10A.   The syngo Dynamics system is intended for the acceptance, transfer, display, storage, archive, and manipulation of digital medical images, including quantification and reportgeneration.    syngo Dynamics is not intended to be used for reading mammography images.
Siemens initiate this recall due to a potential issue when using the sDIS matching rules of the syngo Dynamics Information System version 9.5 or VA10A with modality device configured to end study at association close. Images or DICOM SR objects sent from a modality device to syngo Dynamics may not be saved when the modality is configured at syngo Dynamics to end study at association close, and when sDIS matching rules are in effect. The risk is that a study may be missing some of its images and/or DICOM SR objects and there is no indication to the user that images and/or SR objects are missing from the study.
US Distribution including the states of AL, CA, CT, DE, FL, HI, IA, IL, IN, LA, MA, MD, ME, MI, MN, NC, NJ, NY, PA, SD, TX and  WA.
The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.
The devices secondary audio signal fails to activate.
BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252; kits are labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle Sparks, MD 21152 USA, 800-638-8663, www.bd.com/ds***   The Affirm VPIII Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Candida species,
In vitro diagnostic test kit may exhibit invalid internal negative control results.
1. Esh Foods, L.L.C., located at 58 Hatville Rd; Gordonville, PA 17529  tel # 717-768-8542 Contact: David Esh   2. Landis Foods, located at 679 Hartman Station Road, Lancaster, PA 17602 Tel 717-397-5382 Contact: Lloyd Miller    3. Soup R Salads, located at 2268 Old Philadelphia Pike, Lancaster, PA 17602 Tel # 717-295-3105 Contact: Steve Shenk.    Additional quantities (approximately 140 lbs)  were sold to customers from the on-site retail counter at Fisher's Homestyle Salads, LLC.
Fisher's Homestyle Salads LLC***New England Clam Chowder*** packaged in 5 lb and 10 lb plastic containers.
No sell-by or expiration date code information was included on the package. A 7-day sell-by date was estimated as 7/4/13.
1) Milk not listed in ingredient statement, but listed in allergen warning statement and as a subingredient of sodium caseinate. 2) Undeclared corn  3) Undeclared crab, lobster and shrimp; allergen statement lists ''crustacean shellfish products''
Fisher's Homestyle Salads LLC***Cheddar Potato Soup w/Bacon*** packaged in 5 lb and 10 lb plastic containers.
No sell-by or expiration date code information was included on the package. A 10-day sell-by date was estimated as 7/8/13.
1) Milk not listed as source of cream, cheese, or butter 2) Undeclared corn
Fisher's Homestyle Salads LLC***Broccoli Cheese Soup*** packaged in 5 lb and 10 lb plastic containers.
1) milk not lsited as source of cream, cheese, or butter
Fisher's Homestyle Salads LLC***Crab & Shrimp Salad*** packaged in 5 lb and 10 lb plastic containers.
1) Undeclared corn 2) undeclared whiting, cod, and/or bream; pollock and whitefish listed in ingredient statement  3) undeclared wheat  4) undeclared Red 40  5) undeclared crab - crab in name of product
Fisher's Homestyle Salads LLC***Gourmet Crab Cakes*** packaged in 6-piece (36 oz) and 12-piece (72 oz) styrofoam trays.
No sell-by or expiration date code information was included on the package. A 7-day sell-by date was estimated as 7/1/13.
1) undeclared fish 2) undeclared soy lecithin - soy flour listed in ingredient statement  3) undeclared wheat
US Distribution including the states of  IL, KY and TN.
GAMMA3 System Long Nail Kit, R2.0, Ti, Left   Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA    A single use device intended for the temporary fixation, correction of stabilization of the right femur. The kit consists of intramedullary nail and set screw. The kit is used in combination with lag screw and (distal) locking screws and end cap as well.
Catalog Number- 33250400S Catalog Number 33250360S
Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails.
DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg and phenylephrine HCl 5 mg) liquicaps and NyQuil Sinex NightTime Sinus Relief (acetaminophen 325 mg, doxylamine succinate 6.25 mg, and phenylephrine HCl 5 mg) liquicaps Combopack, each 48-count liquicaps per carton contains 32 DayQuil Sinex DayTime Liquicaps and 16 NyQuil Sinex NightTime Liquicaps per carton, Made In Canada, Dist. by Procter & Gamble, Cincinnati, OH 45202, UPC 3 23900 01454 1.
Unit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomplete blister card cuts, and missing or incorrectly placed liquicaps within the blisters.
Lehman's Hot Veggie Mix, packaged in 12/16-oz jars per case, distributed by Lehman's, Kidron, OH 44636
The pH levels of these products are not accurately measured due to the use of outdated buffers and pH levels do not meet process specifications.
Nationwide Distribution, including the states of:  AK, AR, AZ, CA, CO, DC, DE, FL, GA, ID, IN, MA, MD, MO, NH, NJ, OH, OR, SC, TN, WA, and WV.
Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3.  The application stores patient information in a database, and it may analyze and/or display the data in different formats for evaluation by healthcare professionals for informational purposes.
Notes associated with prescription are not printed to the prescription or to the patient chart.
Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900   Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix; Axon and Synapse Systems are indicated for the following: -Degenerative Disk Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); -Spondylolisthesis; -Spinal Stenosis; -Fracture/dislocation; -Atlantoaxial fracture with instability; -Occipitocervical dislocation; -Revision of previous cervical spine surgery; and -Tumo
Part Number SD389.477, Lot Number 6913900
A complaint was received from the field, that the drill guide was etched incorrectly, 12mm etch instead of 18mm drill guide.  The firm identified that this constituted a field action and retrospectively reported this action.
US Distribution including the states of  CA, MN, NC and TN.
Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599   Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
It was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Clamp and what was called for in the Bill of Materials.  Following a detailed investigation, it was determined that the incorrect insert was used which indicates that the device is MR Safe, when it is actually MR Conditional.
ME, VA.  Product sold only in two LL Bean stores.  No online sales.
LL Bean Balsam Pine Moisturizing Lotion, 16 oz plastic bottle with pump. UPC 5DC6550000
LL Bean Sea Spray Moisturizing Lotion, 16 oz plastic bottle with pump. UPC 5DC6520000
LL Bean Lemon Verbena Hand and Body Lotion, 16 oz plastic bottle with pump. UPC 5DC6560000, Item Number: 5DC6560
ViSi Mobile Monitor, Catalog No. 92-10010   The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound.
ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014   The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
Products were directly distributed in Oregon and Washington.
Penny's Garlic Hummus 12 oz has UPC 7 49404 83061 4; Harbor Greens Garlic Hummus 8 oz has UPC 7 49404 802123;  Tacoma Boys Garlic Hummus 8 oz has UPC 7 49404 902120;    The 1 Gallon hummus does not have any brand name and does not have any UPC.
486/8 oz packages; 1338/12 oz packages; and 12/1 gallon containers
Garlic Hummus is recalled due to a potential contamination with Listeria monocytogenes.
PENNY'S CREAMY HUMMUS 12 oz has UPC 7 49404 90971 6; PENNY'S SALSA Creamy Original Hummus 25 LB  has no UPC.
864/12 oz packages and 16/25 lb containers
Creamy Hummus is recalled due to a potential contamination with Listeria monocytogenes.
Penny's Hummus De Gallo 12 oz has  UPC 7 49404 32368 0; Harbor Greens Hummus De Gallo 8 oz has UPC  7 49404 8061609;  Tacoma Boys Hummus De Gallo 8 oz has UPC 7 49404 90676 6.
1080/12 oz. packages and 324/ 8 oz packages
Hummus De Gallo is recalled due to a potential contamination with Listeria monocytogenes.
Penny's Roasted Red Pepper Hummus 12 oz has UPC 7 49404 51848 2; Harbor Greens Roasted Red Pepper Hummus 8 oz has  UPC  7 49404 80414 1;  Tacoma Boys Roasted Red Pepper Hummus 8 oz has UPC 7 49404 90414 8;  Roasted Red Pepper Hummus (no brand name) 1 gallon has No UPC.
10/1 gallon containers; 396/8 oz packages; 1014/12 oz packages
Roasted Red Pepper Hummus is recalled due to a potential contamination with Listeria monocytogenes.
Penny's Jalapeno Hummus 12 oz UPC 7 49404 91368 3; Harbor Greens Jalapeno Hummus 8 oz UPC  7 49404 80313 7;  Tacoma Boys Jalapeno Hummus 8 oz UPC 7 49404 90313 4.
444/12 oz packages and 369/8 oz packages
Jalapeno Hummus is recalled due to a potential contamination with Listeria monocytogenes.
Penny's Black Bean Hummus 12 oz has UPC 7 49404 70200 3; Harbor Greens Black Bean Hummus 8 oz has UPC  7 49404 80515 5;  Tacoma Boys Black Bean Hummus 8 oz has UPC 7 49404 90515 2.
Black Bean Hummus is recalled due to a potential contamination with Listeria monocytogenes.
Harbor Greens Sun-Dried Tomato Hummus 8 oz has UPC  7 49404 80717 3; Tacoma Boys Sun-Dried Tomato Hummus 8 oz has UPC 7 49404 90717 0.
Sun-Dried Tomatoes Hummus is recalled due to a potential contamination with Listeria monocytogenes.
Vegetable tray 8 oz UPC 7 49404 98020 3; Ingredients:  Carrot Sticks, Celery, Grape Tomatoes, Creamy Hummus.    Penny's Salsa Inc. Snack Pack 8 oz has UPC 07494041923606.  Ingredient: W/Hummus, Celery, Carrots, Tomato.    Both of these products contain the same ingredients in the same amount.  The hummus is in a 1.5 oz container, labeled Made in the Pacific North West.
Vegetable Trays and Snack Pack, 8 oz, are recalled because they contain 1.5 oz cups of hummus.  The hummus is recalled due to a potential contamination with Listeria monocytogenes.
Vegetable tray 8 oz UPC 7 49404 30002 5; Ingredients:  Carrot Sticks, Pretzels, Grapes, Creamy Hummus.    Penny's Salsa Inc. Snack Pack w/Hummus Grapes, Carrots and Pretzels 8 oz UPC 07494041923679.    Both of these products contain the same ingredients in the same amount.  Each contains a 1.5 oz package of hummus labeled Made in the Pacific North West.
The product was distributed to Kentucky, Maryland, Pennsylvania, Ohio, Virginia, Washington D.C. and New Jersey.
Pimento Cheese, packaged in 7 oz. plastic containers, and labeled in part ***Made by Whole Foods Market, Landover, MD 20785***UPC: 000000234801
Pimento cheese was mislabeled with an ingredient list, which did not declare the presence of mayonnaise, containing egg sub-ingredient.
Worldwide Distribution - US Distribution including the states AK, AZ, AR, CA, CO, CT, DE, FL, GA, IL, LA, MD, MI, MN, MO, NE, NV, NM, NY, NC, OH, OR, PA, SC, SD, TN,TX, VA, WA and WI., and the countries of  ALGERIA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRIL, CANADA, CHINA, COLOMBIA, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, INDIA, IRAQ, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF MOLDOVA, NETHERLANDS, NORWAY, POLAND, ROMANIA, RUSSIAN FEDERATION, KINGDOM OF SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA.
GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM.   The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal; and Intraoperative (abdominal, PV and neurological).
GE Healthcare has recently become aware that during use of the Voluson E6 or E8 systems, that an error message Out of Memory can be displayed which could cause the system to freeze. This is an intermittent behavior that also requires a certain workflow. This issue can be resolved by rebooting the system.
Worldwide Distribution -  USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, DE, FL, GA, ID, IL , IA, MD, MA, MI, MS, MO, NJ, NM, NY, NC, OH, PA, RI, SC, TN,TX, UT,VT, VA and WI., and the countries of  ARAB EMIRATES, AUSTRALIA, AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, HONG KONG, INDIA, ITALY, JAPAN, NETHERLANDS,NEW ZEALAND, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SINGAPORE,SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND and UNITED EMIRATES.
GE Healthcare,  LOGIQ e Ultrasound System.   The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.
GE Healthcare became aware of a potential issue associated with the LOGIQ e system. Image data from one patient has the potential to be linked to the patient ID of another patient.
PERFECT 3000 CHOCOLATE POWDER, FORMULA # 3098.  The product is loose powder packaged in bulk drum.
Firm had distributed the bulk product in violation of the Consent Decree for Permanent Injunction (12-CV-3468).
PERFECT 3000 VANILLA POWDER, FORMULA # 3101.  The product is loose powder packaged in bulk drum.
CA, FL, GA, IL, IN, MO, NC, NY, OH, OK, PA, TX, UT, WI, and WY
10-inch Supreme Chocolate Layered Cake; 12 units per shipping case
Foreign Material Contamination - Ball point pen
Hummus is packed in 1.5 oz plastic portion cups with foil peel lids, 100 cups in a case.   The product labeled in parts: ''***HUMMUS***1.5 oz*** KEEP REFRIGERATED***
Hummus, 1.5 oz. plastic portion cups with foil peel lids, is recalled due to a potential to be contaminated with Listeria monocytogenes.
Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Prasco Laboratories, Mason OH, 45040, USA, Mfd by: Torrent Pharmaceuticals Ltd., Indrad-382 721, Dist. Mehsana India, NDC 66993-463-30
Defective Container; This action is being taken as a precautionary measure due to the product being re-packaged in the U.S. using a filler material that (removes or blocks) less moisture than what is approved in the application.
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation, Deerfield, IL  60015, Product L5B4826, NDC 0941-0409-07
Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.
Ohio, Michigan, Minnesota, West Virginia, Kentucky, Pennsylvania, Illinois, and Indiana
WHOLEY Shrimp, Farm Raised,  Cooked, Peeled Deveined, Tail on, Ingredients:  Shrimp, Salt and Sodium Tripolyphosphate...,    ,Net Wt 1 LB (16 oz) , 399103 UPC Number: 094776074556; Product of Indonesia
Lipari Foods of Warren, MI is recalling Wholey peeled, cooked, tail-on 31/40 count shrimp, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.