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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Class I Drugs Event

Event ID62836
StatusCompleted
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Dec-11
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBody Basics Inc
CityCanoga Park
StateCA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionActra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA
Code InfoLot number 008A, expiration date Dec 2014, UPC code 830733002016
ClassificationClass I
Reason for RecallMarketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction
Product Quantity30,000 capsules
Recall NumberD-265-2013

Class I Food Event

Event ID63060
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Aug-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmBrand New Energy, LLC
CityBurbank
StateCA
CountryUS
Distribution PatternID, NY, KS, CO,
 

Associated Products

Product DescriptionEphBurn 25, 90 count bottle with red capsules
Code Infoall lot codes, no UPC codes
ClassificationClass I
Reason for RecallBrand New Energy is recalling all lot codes of EphBurn 25 because it may contain ephedrine alkaloids, making it an unapproved drug.
Product Quantity1000 units
Recall NumberF-1325-2013

Class I Drugs Event

Event ID63432
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Oct-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionLactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7929-09.
Code InfoLot # :12-160-JT*, Exp 12/01/13
ClassificationClass I
Reason for RecallNon-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.
Product Quantity136,224 flexible containers
Recall NumberD-263-2013

Class I Drugs Event

Event ID63684
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Mar-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmThe Menz Club, LLC
CityRidgeland
StateMS
CountryUS
Distribution PatternUtah
 

Associated Products

Product DescriptionBlue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS
Code InfoNone
ClassificationClass I
Reason for RecallMarketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of sildenafil, the active ingredient in a FDA approved product used for erectile dysfunction, making it an unapproved new drug
Product Quantity50,000 capsules
Recall NumberD-266-2013

Class I Drugs Event

Event ID64197
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jan-13
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionLactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA; NDC 0409-7929-09.
Code InfoLot #: 05-019-JT*, Exp 05/01/13; lot number * may be followed by 01, 90, or 91.
ClassificationClass I
Reason for RecallNon-Sterility: Confirmed customer complaint of product contaminated with mold.
Product Quantity143,136 flexible containers
Recall NumberD-262-2013

Class I Devices Event

Event ID64308
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Howmedica Osteonics Corp.
CityMahwah
StateNJ
CountryUS
Distribution PatternUSA Nationwide Distribution
 

Associated Products

Product DescriptionShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting.
Code InfoCatalog No: TR7100-L and TR7100-R Lot Code: All
ClassificationClass I
Reason for RecallWith regard ShapeMatch Cutting Guides using MRI Imaging, Stryker Orthopaedics has become aware that there are potential issues associated with internal processes for planning cases and producing ShapeMatch Cutting Guides.
Product Quantity7868 units
Recall NumberZ-1052-2013

Class I Devices Event

Event ID64624
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifescan Inc
CityMilpitas
StateCA
CountryUS
Distribution PatternUSA Nationwide Distribution
 

Associated Products

Product DescriptionAll OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ Starter kits - Meter; Verio IQ Warranty Meter. Product Usage: The OneTouch® VerioIQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The system is intended to be used by a single patient and should not be used for testing multiple patients. The OneTouch® VerioIQ Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.
Code InfoPart numbers: Verio IQ Systems Kits: 022 267-01, 022 267-01, 022 267-03; Verio IQ Starter Kits: 022 268 01, 022 268-02; Verio IQ Warranty Kits: 022 275 01, 022 275 02. All lots and serial numbers
ClassificationClass I
Reason for RecallThe Verio IQ meter will shut off and revert to set up mode at glucose values above 1023 instead of displaying EXTREME HIGH GLUCOSE.
Product QuantityUS 710,413
Recall NumberZ-1074-2013

Class I Devices Event

Event ID64728
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCarefusion Corporation
CitySan Diego
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and the countries of Australia and China.
 

Associated Products

Product DescriptionAlaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
Code Infounit model 8015 with software version 9.12
ClassificationClass I
Reason for RecallThe recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached.
Product Quantity9,241 units
Recall NumberZ-1098-2013

Class I Food Event

Event ID64738
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Mar-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPublix Super Markets, Inc.
CityLakeland
StateFL
CountryUS
Distribution PatternAL, FL, GA, SC, and TN
 

Associated Products

Product DescriptionPublix Deli Tri Fruit and Grain Salad with red rice, red wheat, quinoa, apricots, cranberry and raisins 12oz. In a clear plastic container.
Code InfoItem code 04459, UPC Code: 041415396623 Use by dates of 04/15/2013, 04/14/2013 and 04/17/2013
ClassificationClass I
Reason for RecallProduct may be adulterated with Listeria monocytogenes.
Product Quantity772
Recall NumberF-1315-2013

Class I Food Event

Event ID64836
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Apr-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmLittle Mermaid Smokehouse
CityNorth Hollywood
StateCA
CountryUS
Distribution PatternCalifornia.
 

Associated Products

Product DescriptionLittle Mermaid Brand Smoked Herring.
Code InfoNo codes. Products sold prior to 04/04/2013.
ClassificationClass I
Reason for RecallDuring an inspection by FDA, it was found that the Little Mermaid Smoked Herring and Little Mermaid Pickled Herring were uneviscerated. The firm initiated the recall due to potential for Clostridium botulinum.
Product Quantityapproximately 12.81 lbs
Recall NumberF-1316-2013
Product DescriptionLittle Mermaid Brand Pickled Herring.
Code InfoNo codes. Products sold prior to 04/04/2013.
ClassificationClass I
Reason for RecallDuring an inspection by FDA, it was found that the Little Mermaid Smoked Herring and Little Mermaid Pickled Herring were uneviscerated. The firm initiated the recall due to potential for Clostridium botulinum.
Product Quantityapproximately 44.5 lbs
Recall NumberF-1317-2013

Class II Biologics Event

Event ID39102
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jul-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBlood Center of Central Iowa (The)
CityDes Moines
StateIA
CountryUS
Distribution PatternIA
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoKX17959
ClassificationClass II
Reason for RecallBlood product, which were collected from a donor who traveled to malarial endemic areas, was distributed.
Product Quantity1 unit
Recall NumberB-0928-13

Class II Biologics Event

Event ID39707
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jan-05
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross
CityBoise
StateID
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info20FY02601
ClassificationClass II
Reason for RecallBlood product, collected from a donor, whose screening/donor record was incomplete, was distributed.
Product Quantity1 unit
Recall NumberB-0916-13

Class II Biologics Event

Event ID40646
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jul-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBioLife Plasma Services L.P.
CityIndependence
StateMO
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info05IMOA0697; 05IMOA0914; 05IMOA1311; 05IMOA1588; 05IMOA2057; 05IMOA2312; 05IMOA2669; 05IMOA2996; 05IMOA3358; 05IMOA3582; 05IMOA4007; 05IMOA4251; 05IMOA4655; 05IMOA4877; 05IMOA5269; 05IMOA5536; 05IMOA5997; 05IMOA6209; 05IMOA6648; 05IMOA6944; 05IMOA7372; 05IMOA7650; 05IMOA8410; 05IMOA9490; 05IMOA9751; 05IMOB1163; 05IMOB2262; 05IMOB2549; 05IMOB3013; 05IMOB3290; 05IMOB3698; 05IMOB3976; 05IMOB4378; 05IMOB4683
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a piercing within 12 months of the donation, were distributed.
Product Quantity34 units
Recall NumberB-0933-13

Class II Biologics Event

Event ID41200
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Dec-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center of the Ozarks
CitySpringfield
StateMO
CountryUS
Distribution PatternAR
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info6625084
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to malarial endemic areas, was distributed.
Product Quantity1 unit
Recall NumberB-0929-13

Class II Biologics Event

Event ID42233
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Apr-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiouxland Community Blood Bank
CitySioux City
StateIA
CountryUS
Distribution PatternIA, SC
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info2026818(Part A); 2026818(Part B)
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity2 units
Recall NumberB-0985-13

Class II Biologics Event

Event ID42652
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Jun-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info011GF52924
ClassificationClass II
Reason for RecallBlood product, collected from a donor for whom the acceptance criteria for hematocrit was not met, was distributed.
Product Quantity1 Unit
Recall NumberB-0717-13

Class II Biologics Event

Event ID43899
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Nov-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmThe Blood Alliance, Inc.
CityJacksonville
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info5828716
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-0920-13

Class II Biologics Event

Event ID47612
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Feb-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternIowa
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoLX71193
ClassificationClass II
Reason for RecallBlood product, collected from a donor possibly at increased risk for Creutzfeldt-Jakob Disease (CJD), was distributed.
Product Quantity1 Unit
Recall NumberB-0898-13

Class II Biologics Event

Event ID47983
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Feb-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternKS, MO, IN, Austria
 

Associated Products

Product DescriptionRed Blood Cells
Code Info0301805; 0429177
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity2 units
Recall NumberB-0534-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info0328053; 0357685; 1336389; W045004001160; W045005025891; W045006037539
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity6 units
Recall NumberB-0535-13
Product DescriptionPlatelets
Code Info0301805; 0429177
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity2 units
Recall NumberB-0536-13
Product DescriptionFresh Frozen Plasma
Code Info0301805; 0328053; 1336389; 0429177; W045004001160
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity5 units
Recall NumberB-0537-13

Class II Biologics Event

Event ID48309
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Apr-08
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternSwitzerland
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoLX73700
ClassificationClass II
Reason for RecallBlood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Product Quantity1 Unit
Recall NumberB-0897-13

Class II Biologics Event

Event ID48851
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-May-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternIowa
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoLF41206
ClassificationClass II
Reason for RecallBlood products, collected from a donor taking the drug Finasteride, were distributed.
Product Quantity1 Unit
Recall NumberB-0899-13
Product DescriptionPlasma Frozen
Code InfoLF41206
ClassificationClass II
Reason for RecallBlood products, collected from a donor taking the drug Finasteride, were distributed.
Product Quantity1 Unit
Recall NumberB-0900-13

Class II Biologics Event

Event ID49615
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Aug-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPuget Sound Blood Center
CitySeattle
StateWA
CountryUS
Distribution PatternWashington.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW141608134016; W141608530989.
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to a malaria risk area, were distributed.
Product Quantity2 components
Recall NumberB-0488-13
Product DescriptionPlatelets Pooled Leukocytes Reduced Irradiated
Code InfoW141608530989.
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to a malaria risk area, were distributed.
Product Quantity1 component
Recall NumberB-0489-13

Class II Biologics Event

Event ID50275
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Sep-08
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmFlorida's Blood Centers, Inc.
CityOrlando
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info6229009; 5790237
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity2 units
Recall NumberB-1029-13
Product DescriptionCryoprecipitated AHF, Pooled
Code Info5801688
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity1 unit
Recall NumberB-1030-13

Class II Biologics Event

Event ID50385
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Sep-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info01Q17523
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred after disclosing high risk behavior, were distributed.
Product Quantity1 component
Recall NumberB-0905-13
Product DescriptionPlatelets Leukocytes Reduced
Code Info01Q17523
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred after disclosing high risk behavior, were distributed.
Product Quantity1 component
Recall NumberB-0906-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info01Q17523
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred after disclosing high risk behavior, were distributed.
Product Quantity1 component
Recall NumberB-0907-13

Class II Biologics Event

Event ID50673
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Dec-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLane Memorial Blood Bank
CityEugene
StateOR
CountryUS
Distribution PatternOregon.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW137508106942; W137508109801
ClassificationClass II
Reason for RecallBlood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
Product Quantity2
Recall NumberB-0954-13

Class II Biologics Event

Event ID51354
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Feb-09
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionSource Plasma
Code Info366062470; 366062795; 366063446; 366064187; 366064521; 366065712; 366066099; 366066772; 366067065; 366067722; 366068450; 366068703; 366076202; 366076635; 366080733; 366081890; 366083409; 366084655; 366090123; 366091038; 366091463; 366092776; 366093045; 366095359; 366095840; 366097361; 366098260; 366099750; 366100248
ClassificationClass II
Reason for RecallBlood products collected from a donor whose scheduled physical exam had not been performed, were distributed.
Product Quantity29 units
Recall NumberB-0911-13

Class II Biologics Event

Event ID58204
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jan-11
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBiomat USA, Inc.
CityLos Angeles
StateCA
CountryUS
Distribution PatternSpain, California.
 

Associated Products

Product DescriptionSource Plasma
Code Info0330236642; 0330228719; 0330229933; 0330230273; 0330230666; 0330230927; 0330231306; 0330231587; 0330232281; 0330233802; 0330234079; 0330247656; 0330247936; 0330248371; 0330248613; 0330249830; 0330250077; 0330228457; 0330250432; 0330250747; 0330251105; 0330251416; 0330251837; 0330252104; 0330252656; 0330253001; 0330253386; 0330253625; 0330254070; 0330254320; 0330254818; 0330255188.
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity32 units
Recall NumberB-0951-13

Class II Drugs Event

Event ID63819
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTeva Pharmaceuticals USA, Inc.
CitySellersville
StatePA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionCopaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single use PRE-FILLED syringes and 33 Alcohol Preps (swabs) per box, Marketed by: TEVA Neuroscience, Inc., Kansas City, MO 64131; Distributed by: TEVA Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 68546-317-30
Code InfoLot P53847, Exp 01/14
ClassificationClass II
Reason for RecallPresence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system.
Product Quantity6,692 boxes
Recall NumberD-249-2013

Class II Devices Event

Event ID63856
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmIntegra LifeSciences Corp.
CityPlainsboro
StateNJ
CountryUS
Distribution PatternDistributed in the states of IL, ID, LA, MA, NJ, NY, OH, PA, and SD.
 

Associated Products

Product DescriptionIntegra XKnife® Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2. Intended for use in stereotactic and non-stereotactic (frameless stereotactic), collimated beam, computer planned, linear accelerator (Linac) based treatment.
Code InfoSoftware Versions 5.0.1 and 5.0.2.
ClassificationClass II
Reason for RecallDepending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. occurs if a beam plan is transmitted from XKnife using DICOM-RT.
Product Quantity11 XKnife V5.0.1 and 1 XKnife V5.0.2
Recall NumberZ-1103-2013

Class II Devices Event

Event ID63945
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAbbott Laboratories, Inc
CityIrving
StateTX
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and Internationally to Internationally distributed to Argentina, Australia, Austria, Bahamas, Brunei, Canada, Chile, Curacao, Denmark, France, Germany, Greece, Ireland, Italy, Lebanon, Mexico, Netherlands, Norway, Oman, Paraguay, Portugal, Puerto Rico, Russia, Saudi Arabia, Serbia, South Korea, Spain, Switzerland, Turkey, and United Kingdom.
 

Associated Products

Product DescriptionClinical Chemistry Phenobarbital, list number 1E08
Code InfoLot Numbers 52803UN12, 62299UN12, and 85773UN12
ClassificationClass II
Reason for RecallAbbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to imprecision issues which increase with the age of the reagent lot. The imprecision of the Phenobarbital assay is d 7% Total CV%; however, internal testing confirmed CVs up to approximately 12% for in-date reagent lots over five months old. Although lot 52803UN12 is now expired, it exhibited similar imprecision issues. As a precaution, future replacement lots will have reduced dating until root cause is identified and preventive measures are implemented.
Product Quantity1289
Recall NumberZ-1118-2013

Class II Biologics Event

Event ID64023
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHoxworth Blood Center UC Medical Center
CityCincinnati
StateOH
CountryUS
Distribution PatternOH
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW037712008772; W037712008772; W037711175343; W037711175343; W037711138674; W037711138674;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity6 units
Recall NumberB-0939-13

Class II Biologics Event

Event ID64027
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Nov-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBloodCenter of Wisconsin, Inc
CityMilwaukee
StateWI
CountryUS
Distribution PatternWI
 

Associated Products

Product DescriptionFresh Frozen Plasma (Apheresis)
Code InfoW036312246748
ClassificationClass II
Reason for RecallBlood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-0869-13

Class II Food Event

Event ID64048
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Dec-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMiami Growers Inc.
CityJersey City
StateNJ
CountryUS
Distribution PatternNY, NJ, and PA
 

Associated Products

Product DescriptionSiya Green Mukwhas Net Wt. 200 gm (7 oz) Distributed by: Miami Growers, Inc. 80 Broadway, Jersey City, NJ 07306 Phone: 201-985-9322, Fax: 201-985-9569 Email: miamigrowers@yahoo.com Visit us: www.miamigrowersinc.com A Product of India
Code InfoAll lots
ClassificationClass II
Reason for RecallSiya Brand Green Mukwhas contain unapproved and undeclared colors.
Product Quantity1000 units (Approximately)
Recall NumberF-1326-2013

Class II Biologics Event

Event ID64050
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternMichigan; Florida
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code Info2192852;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-1000-13
Product DescriptionPlatelets Irradiated
Code Info2192852;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-1001-13
Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info2192852;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-1002-13

Class II Biologics Event

Event ID64143
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Nov-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCoffee Memorial Blood Center
CityAmarillo
StateTX
CountryUS
Distribution PatternTennessee; Korea, Republic Of(South)
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW067312012405;
ClassificationClass II
Reason for RecallBlood product, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity1 unit
Recall NumberB-1018-13

Class II Biologics Event

Event ID64144
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Dec-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045011091969;
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to malarial endemic areas, was distributed.
Product Quantity1 unit
Recall NumberB-1028-13

Class II Devices Event

Event ID64229
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmEdwards Lifesciences, LLC
CityIrvine
StateCA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including the states of AR, CA, FL, HI, ID, IN, KS, KY, LA, MA, MI, MN, MO, NC, ND, NM, NV, NY, OH, OK, PA, SD, TN, TX, VA, WA, and WI and country of: Europe.
 

Associated Products

Product DescriptionPressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260, PXVP0826, PXVP0827, PXVP2284AT3, PXVP23X3AT3, T398807D, T100605B, T001762A, T391T00A, VP2. Blood sampling system used on patients requiring periodic withdrawal of blood samples.
Code Info59184554, 59187809, 59191725, 59221801, 59227844, 59238613, 59326333, 59356987, 59401041, 59222349, 59227178, 59234808, 59284693, 59328047, 59270408, 59284617, 59276238, 59401734, 59270380, 59319038, 59306624, 59390840, 59195810, 59331224, 59397181, 59291446, 59272771.
ClassificationClass II
Reason for RecallThe device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples.
Product Quantity30,467
Recall NumberZ-1146-2013

Class II Devices Event

Event ID64395
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmEndogastric Solutions Inc
CityRedmond
StateWA
CountryUS
Distribution PatternNationwide Distribution including NC, VA, WI, TN, KY, IN, FL, MI, IA, IL, TX, LA, AR, HI, CA, NV, OR, and WA,
 

Associated Products

Product DescriptionEndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in part "EsophyX2 2-LINK Device Qty: (1) Fastener Delivery System ***" Designed for the treatment of Gastroesophageal Reflux Disease (GERD), with erosive and non-erosive esophagitis
Code InfoLots 401378, 401392, 401409, and 401416 Additional lots manufactured from 11/26/12 to 12/07/12 had a stop ship issued issued on 11/21/12 and the product was placed in quarantine (it was not distributed). This represents an additional 175 units from a total of 187 units manufactured during this time period. 12 units were used for bench testing. The lot numbers of units in quarantine are 401432, 401434, 401436, and 401441.
ClassificationClass II
Reason for RecallEsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.
Product Quantity190
Recall NumberZ-1136-2013

Class II Food Event

Event ID64446
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Jan-13
Initial Firm Notification of Consignee or Public letter
Recalling FirmL. K. Bowman, Incorporated
CityNottingham
StatePA
CountryUS
Distribution PatternProduct was distributed to one firm in Utah, USA.
 

Associated Products

Product DescriptionCanned mushrooms, #10 cans (Brites, not labeled)
Code InfoLot 11 363 A 895BD
ClassificationClass II
Reason for RecallSome isolated spoilage was found in this lot of #10 cans.
Product Quantity3,480
Recall NumberF-1327-2013

Class II Devices Event

Event ID64460
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRoche Diagnostics Operations, Inc.
CityIndianapolis
StateIN
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).
Code Infopart number 05060311001, 05060303001
ClassificationClass II
Reason for RecallRoche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or quality standards.
Product QuantityBoth devices 4467
Recall NumberZ-1113-2013
Product DescriptionCoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT").
Code Infocatalog number 05530199160
ClassificationClass II
Reason for RecallRoche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or quality standards. Errors have been confirmed with the EAN 13 barcodes which should not be used for patient or operator identification.
Product Quantity4467 both devices
Recall NumberZ-1114-2013

Class II Devices Event

Event ID64478
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifescan Inc
CityMilpitas
StateCA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, 10, IL, IN, KS, KY, LA, MA, MD, ME, Ml, MN, MO, MS, MT, NC, NO, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SO, TN, TX, UT, VA, VI, VT, WA, WI,WV, and WY, and the countries of Russia and Ukraine.
 

Associated Products

Product DescriptionLifeScan brand OneTouch® Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.
Code Info2AA2G01, Exp. Date: 7-31-2014; 2AA2G02, Exp. Date: 7-31-2014; 2AA2G03, Exp. Date: 8-31-2014; 3AA2G04, Exp. Date: 12-31-2014; 3AA2G05, Exp. Date: 12-31-2014
ClassificationClass II
Reason for RecallWhen OneTouch® Ultra and OneTouch® Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial label even though the system is working properly.
Product Quantity132,301 units total
Recall NumberZ-1129-2013
Product DescriptionLifeScan brand OneTouch® Select Control Solution, Part Number/Model #: 02168902. Testing of Blood Glucose Levels.
Code Info2AA2101, Exp. Date: 9-30-2014; 2AA2102, Exp. Date: 10-31-2-14
ClassificationClass II
Reason for RecallWhen OneTouch® Ultra and OneTouch® Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial label even though the system is working properly.
Product Quantity132,301 units total
Recall NumberZ-1130-2013

Class II Devices Event

Event ID64486
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Feb-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmBacterin International, Inc.
CityBelgrade
StateMT
CountryUS
Distribution PatternUSA Nationwide Distribution
 

Associated Products

Product DescriptionOsteoSelect DBM Putty Product Usage: Orthopedic bone filler
Code InfoB100164 and B110115
ClassificationClass II
Reason for RecallThe firm's retesting procedure was not validated.
Product Quantity165
Recall NumberZ-1138-2013

Class II Devices Event

Event ID64499
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNipro Diagnostics, Inc.
CityFt Lauderdale
StateFL
CountryUS
Distribution PatternNationwide Distribution only in NY.
 

Associated Products

Product DescriptionDuane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.
Code InfoFinished Good (FG) Kit Lot# KL01009-3TI, TRUEtrack Test Strip Lot# RL3435; FG Kit Lot# KL01009-12TI, TRUEtrack Test Strip Lot# RL3435; FG Kit Lot# KL01233-4TI, TRUEtrack Test Strip Lot# RL3476; FG Kit Lot# KM0548TI, TRUEtrack Test Strip Lot# RM3547; FG Kit Lot# KM0645TI, TRUEtrack Test Strip Lot# RM3562; FG Lot# KM0692TI, TRUEtrack Test Strip Lot# RM3562.
ClassificationClass II
Reason for RecallMeter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.
Product Quantity1,627 Kits
Recall NumberZ-1140-2013

Class II Devices Event

Event ID64538
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmElana, Inc.
CityColumbia
StateMD
CountryUS
Distribution PatternDistributed in the states of Pennsylvania, Texas, and New York.
 

Associated Products

Product DescriptionElana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.
Code InfoModel 280, S/N 776, S/N 706, S/N 758
ClassificationClass II
Reason for RecallDistribution of an unapproved device into interstate commerce.
Product Quantity3 devices
Recall NumberZ-1143-2013

Class II Devices Event

Event ID64547
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Medical Systems (Cleveland) Inc
CityCleveland
StateOH
CountryUS
Distribution PatternWorldwide Distribution - (USA) Nationwide Distribution including the states of AL, AR, AZ, CA, FL, GA, IA, IN, LA, MI, MN, MO, NC, NJ, NY, OH, OK, OR, PA, TN, TX, WA, WI & WV. and the countries of Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Monaco, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand & United Kingdom
 

Associated Products

Product DescriptionIntellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.
Code InfoModel #881001, Serial #s: 79916, 79932, 79933, 79935, 79936, 79937, 79939, 79940, 79943, 80071, 80914, 80916, 80925, 80926, 80928, 80932, 80939, 80963, 80965, 80977, 80979, 80994, 80995, 81004, 81006, 81008, 81010, 81026, 81027, 81028, 81034, 81035, 81036, 81039, 81063, 81065, 81076, 81079, 81081, 81085, 81089, 81097, 81098, 81108, 81110, 81117, 81119, 81127, 81130, 81132, 81133, 81150, 81153, 81154, 81160, 81161, 81163, 81165, 81169, 81172, 81173, 81174, 81175, 81178, 81179, 81182, 81183, 81184, 81187, 81189, 81190, 81192, 81194, 81196, 81200, 82001, 82002, 82003, 82004, 82006, 82007, 82008, 82009, 82010, 82011, 82012, 82013, 82014, 82015, 82016, 82017, 82018, 82019, 82020, 82021, 82022, 82023, 82024, 82025, 82026, 82027, 82028, 82029, 82030, 82031, 82032, 82033, 82034, 82035, 82036, 82037, 82038, 82050, 82051, 82052, 82053, 82054, 82055, 82056, 82057, 82058, 82059, 82060, 82061, 82062, 82063, 82064, 82065, 82066, 82067, 82068, 82069, 82070, 82071, 82072, 82073, 82074, 82084, 82086, 82087, 82088, 82089, 82090, 82091, 82092, 82095, 82097, 82098, 82099, 82100, 82101, 82102, 82103, 82104, 82105, 82106, 82107, 82108, 82109, 82110, 82112, 82116, 82118, 82120, 82121, 82123, 82125, 82126, 82128, 82129, 82130, 82131, 82132, 82133, 82138, 82142, 82143, 82144, 82146, 82148, 82201, 82202, 82203, 82236, 82238, 82240, 82241, 82250, 82251, 85005, 85006, 85007, 85008, 85009, 85010, 85011, 85014, 85025, 85026, 85027, 85028, 85029, 85031, 85032, 85033, 85040, 85041, 85042, 85043, 85044, 85046, 85047, 85049, 85050, 85066, 85067, 85068, 85069, 85080, 85081, 85082, 85083, 85084, 85086, 85088, 85090, 85096, 85103, 85104, 85105, 85106, 85107, 85108, 85110, 85117, 85141, 85143, 85144, 85145, 85149, 85164, 85165, 85167, 85168, 85169, 85170, 85171, 85172, 85174, 85175, 85176, 85177, 85178, 85179, 85180, 85213, 85214, 85215, 85216, 85217, 85218, 85219, 85238, 85239, 85243, 85244, 85245, 85246, 85247, 85248, 85249, 85250, 85252, 85253, 85254, 85255, 85257, 85260, 85296, 85299, 85300, 85302, 85305, 85306, 85307, 85308, 85309, 85312, 85315, 85316, 85317, 85319, 85320, 85322, 85329, 85330, 85332, 85333, 85334, 85335, 85337, 85338, 85355, 85373, 85475, 95001, 95007, 95008, 95009, 820001, 822002, 822003, 822004, 822005, 822009, 822017, 850004, 850015, 920003 & 950001.
ClassificationClass II
Reason for RecallPhilips was notified of a problem using the IntelliSpace Portal with software version 4.0.2 with the URL PACS integration. Philips was informed that when loading a study to an analysis application while using URL PACS integration configuration, after another study was opened by a review application, the Analysis monitor is updated with the study of the current patient, but the Review monitor continues to display the study from the previous patient. If the issues were to re-occur, it could pose a risk for the patient.
Product Quantity313 units
Recall NumberZ-1102-2013

Class II Devices Event

Event ID64568
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmInstrumentation Industries Inc
CityBethel Park
StatePA
CountryUS
Distribution PatternWorldwide Distribution - USA including AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV. Shipped internationally to Canada, Ireland, Hong Kong, the Netherlands, New Zealand, and Thailand.
 

Associated Products

Product DescriptionInstrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/Inline Filter; and BE 183-R Regulator The BE 183-SUR and BE 183-SU Manual Jet Ventilators are designed to provide transtracheal ventilation in specific emergency situations of upper airway obstructions.
Code InfoBE 183-2 -- lot numbers P0911307, P1109307, P1117907, P1210807, P1216107, P0112208, P0203508, P0208308, P0220008, P0313608, P0503608, P0510108, P0712408, P0816308, P0911708, P1008408, P0115009, P0203009, P0313109, P0603709, P0619009, P0806309, P0903509, P0905109, P0912309, P1005709, P1107809, P1205709, P1214309, P0111410, P0210810, P0212510, P0300210, P0314310, P0400710, P0404510, P0701210, P0705410, P0715010, P0816310, P0715010R10, P0705410R10, P1001810, P1011610, P1114810, P1204810, P1207310, P0109811, P0211311, P0404611, P0504911, P0603911, P0706511, P0801811, P0811811, P0818511, P0900611, P0908411, P0917111, P1008111, P1012211, P1113911, P1207111, P0107712, P0118212, P0211712, P0308512, P0409012, P0412912, P0802012, and P0813612; BE 183-R -- P0904007, P1015407, P1118107, P1209207, P0205608, P0208208, P0415408, P0509608, P0503008, P0517408R, P1215508, P0200709, P0308109, P0614909, P0712009, P0806409, P0903309, P1101909, P1101909R10, P0303710, P0409910, P0615710, P0710710, P0714510, P0814310, P0907010, P1214710, P0208711, P0208711R11, P1214710R11, P0716411, P0718111, P0807511, P0812211, P0816111, P0819511, P0914111, P1000511, P1015011, P1217911, P0117112, P0211312, P0313612, P0605312, P0709612, and P0807812; BE183-SU -- P0914607, P1015607, P1016907, P1119007, P1201807, P1211307, P0108808, P0112408, P0203008, P0208608, P0306908, P0313508, P0404908, P0510008, P0708808, P0806508, P0915908, P1020008, P1104508, P1109108, P1211608, P0102809, P0203109, P0208109, P0214609, P0302209, P0504909, P0603609, P0617209, P0618909, P0703509, P0804609, P0812609, P1005209, P1110009, P1221709, P0104510, P0108110, P0307110, P0411910, P0603510, P0616210, P0813510, P0912310, P1000910, P1017410, P0111111, P0207611, P0209411, P0216411, P0300611, P0309411, P0515711, P0619111, P0707411, P0717311, P0804011, P0809611, P0815311, P0901611, P0905011, P0915611, P1014511, P1103511, P1112811, P1116411, P1201911, P1213511, P1216511, P0103312, P0106212, P0114112, P0207712, P0211112, P0216312, P0320512, P0402512, P0408912, P0416912, P0509212, and P0513212; BE 183 SU-12 -- no lot numbers assigned; BE 183-SUR -- P0908607, P1006707, P1010807R, P1101207, P1117507, P1117707, P1210307, P1212007, P0103208, P0110308, P0116508, P0203208, P0214908, P0221508, P0317708, P0409808, P0409908, P0418308, P0508508, P0513308, P0601308, P0606608, P0704008, P0808108, P0606608R, P0814308, P0907308, P0916208, P1011108, P1016908, P1201708, P1208508, P0102409, P0113809, P0203709, P0102409R09, P0304509, P0405109, P0413009, P0501209, P0612709, P0709109, P0803109, P0910909, P1009609, P1106609, P1111509, P1206809, P1218009, P0114410, P0203010, P0304310, P0408410, P0500610, P0509410, P0607410, P0705710, P0711810, P0500610R10, P0805110, P0903110, P0909710, P1014710, P1102910, P0104411, P0116011, P0201211, P0206711, P0211011, P0219311, P0302911, P0308311, P0312211, P0400211, P0413811, P0506511, P0605911, P0609411, P0703111, P0708011, P0807911, P0809511, P0813811, P0819311, P0901311, P0905311, P0907511, P0912211, P1002711, P1018011, P1102911, P1104011, P1110711, P1207011, P0107812, P0115812, P0208312, P0210912, P0305212, P0309312, P0315812, P0400912, P0407212, P0417012, P0601712, P0701712, and P0712412; and BE 183 SUR-12 -- P1012107, P1102507, P1116107, P0319008, P1113408, P0201409, and P0703911.
ClassificationClass II
Reason for RecallFirm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use.
Product Quantity2998
Recall NumberZ-1125-2013

Class II Food Event

Event ID64572
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Mar-13
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmLa Preferida Inc
CityChicago
StateIL
CountryUS
Distribution PatternNationwide (AL, CA, CO, FL, GA, IA, IL, IN, MA, MI, MN, MO, NE, OH, PA, TN, TX, and WI)
 

Associated Products

Product DescriptionMetal cans; labeled as containing 29 oz of pinto beans packed in water and salt
Code InfoUPC: 071524020034; Producty Code: PINTO LP; Best By Date: 01/03/2015; Lot Code: 3003; Time Code: All Time Codes
ClassificationClass II
Reason for RecallSome cans may not have been fully processed which could result in product contamination by spoilage organisms or by pathogens, which could lead to illness if consumed.
Product Quantity4,734 cases (57,040 cans)
Recall NumberF-1323-2013

Class II Devices Event

Event ID64577
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOrtho-Clinical Diagnostics
CityRochester
StateNY
CountryUS
Distribution PatternWorldwide Distribution- USA (nationwide) including Puerto Rico and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Republic of Panama, Singapore, Spain, and Venezuela.
 

Associated Products

Product DescriptionVITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System Refurbished, Product Code 6801890. Intended for use in the measurement of a variety of chemistry analytes.
Code InfoVITROS 5,1 FS Chemistry System Serial Numbers: 34000119 through 34002273; VITROS 5,1 FS Chemistry System Refurbished Serial Numbers: 34000133, 34001240, 34000193, 34001243, 34000212, 34001248, 34000316, 34001251, 34000318, 34001274, 34000337, 34001297, 34000360, 34001311, 34000420, 34001317, 34000451, 34001345, 34000478, 34001378, 34000495, 34001389, 34000497, 34001390, 34000529, 34001396, 34000538, 34001422, 34000552, 34001472, 34000557, 34001504, 34000596, 34001569, 34000601, 34001572, 34000631, 34001589, 34000642, 34001610, 34000799, 34001633, 34000805, 34001668, 34000833, 34001809, 34000851, 34001840, 34000893, 34001850, 34000947, 34001897, 34001172, 34001218
ClassificationClass II
Reason for RecallOrtho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS® Systems may be out of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an internal evaluation in its manufacturing facility, it was discovered that an extension spring had insufficient force. If the extension spring does not provide sufficient force, MicroSlides may not be properly positioned within the MicroSlide incubator which has the potential to cause imprecise results. Extension springs are just one component in the slide alignment assembly. OCD's evaluation determined that the probability of an out of specification extension spring alone adversely affecting results is unlikely.
Product QuantityVITROS 5,1 FS: USA: 670 units, Foreign: 1249 units; VITROS 5,1 FS Refurbished: USA: 52 units, Foreign: 2 units
Recall NumberZ-1106-2013
Product DescriptionVITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. Intended for use in the measurement of a variety of chemistry analytes.
Code InfoSerial Numbers 46000108 through 46000217
ClassificationClass II
Reason for RecallOrtho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS® Systems may be out of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an internal evaluation in its manufacturing facility, it was discovered that an extension spring had insufficient force. If the extension spring does not provide sufficient force, MicroSlides may not be properly positioned within the MicroSlide incubator which has the potential to cause imprecise results. Extension springs are just one component in the slide alignment assembly. OCD's evaluation determined that the probability of an out of specification extension spring alone adversely affecting results is unlikely.
Product QuantityUSA: 58 units, Foreign: 103 units
Recall NumberZ-1107-2013
Product DescriptionVITROS 5600 Integrated System, Product Code 6802413. Intended for use in the measurement of a variety of chemistry analytes.
Code InfoSerial Numbers 56000118 through 56001583
ClassificationClass II
Reason for RecallOrtho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS® Systems may be out of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an internal evaluation in its manufacturing facility, it was discovered that an extension spring had insufficient force. If the extension spring does not provide sufficient force, MicroSlides may not be properly positioned within the MicroSlide incubator which has the potential to cause imprecise results. Extension springs are just one component in the slide alignment assembly. OCD's evaluation determined that the probability of an out of specification extension spring alone adversely affecting results is unlikely.
Product QuantityUSA: 775 units, Foreign: 800 units
Recall NumberZ-1108-2013

Class II Devices Event

Event ID64596
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics, Inc.
CityNewark
StateDE
CountryUS
Distribution PatternDistributed within the US to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
 

Associated Products

Product DescriptionSiemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product.
Code InfoCatalog Number KC460, SMN 10472284, lot 2KD052, exp 5/1/14 and Catalog Number KC460A, SMN 10476471, lot 2KD053, exp 5/1/14.
ClassificationClass II
Reason for RecallSiemens has confirmed complaints of low QC and patient recovery with the Dimension Vista(R) LOCI(R) Digoxin(DIGXN) Flex(R) reagent cartridge when calibrating DIGXN with either Drug 4 Cal (KC460) lot 2KD052 or Drug 4 Cal (KC460A) lot 2KD053. Internal testing has shown an average 15% low bias in the therapeutic range of 0.9 to 2.0 ng/mL.
Product Quantity1,638
Recall NumberZ-1151-2013

Class II Devices Event

Event ID64610
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics, Inc
CityEast Walpole
StateMA
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D.
Code InfoReady Pack Lot Number: 134009 Kit Lot Number/Exp. Date: 88766009 4/28/2013 88786009 4/28/2013 89198009 4/28/2013 Ready Pack Lot Number: 134010 Kit Lot Number/Exp. Date: 90671010 6/2/2013 92212010 6/2/2013 Ready Pack Lot Number: 134011 Kit Lot Number/Exp. Date: 92395011 8/12/2013 94660011 8/12/2013 95016011 8/12/2013 95313011 8/12/2013
ClassificationClass II
Reason for RecallNegative bias in patient samples for Vitamin D
Product Quantity3871
Recall NumberZ-1119-2013
Product DescriptionADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the quantitative determination of Vit D.
Code InfoReady Pack Lot Number: 134009 Kit Lot Number/Exp. Date: 88767009 4/28/2013 88787009 4/28/2013 Ready Pack Lot Number: 134010 Kit Lot Number/Exp. Date: 90253010 6/2/2013 91934010 6/2/2013 Ready Pack Lot Number: 134011 Kit Lot Number/Exp. Date: 92396011 8/12/2013 93363011 8/12/2013 95088011 8/12/2013
ClassificationClass II
Reason for RecallNegative bias in patient samples for Vitamin D
Product Quantity4133
Recall NumberZ-1120-2013
Product DescriptionADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For use in the quantitative determination of Vit D.
Code InfoLot Number: C3410 Kit Lot Number/Exp. Date: 95197A10 8/16/2013 95031A10 8/16/2013 94607A10 8/16/2013 94155A10 8/16/2013
ClassificationClass II
Reason for RecallNegative bias in patient samples for Vitamin D
Product Quantity372 pk Cals
Recall NumberZ-1121-2013
Product DescriptionADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For use in the quantitative determination of Vit D.
Code InfoLot Number: C3410 Kit Lot Number/Exp. Date: 95010A10 8/16/2013
ClassificationClass II
Reason for RecallNegative bias in patient samples for Vitamin D
Product Quantity107 6pk Cals
Recall NumberZ-1122-2013

Class II Food Event

Event ID64626
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Feb-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmZumbro River Brand, Inc
CityAlbert Lea
StateMN
CountryUS
Distribution PatternVT and Canada
 

Associated Products

Product DescriptionIdeal Protein, Sea Salt & Vinegar Ridges, 7 packets Net WT 1.4 oz (40 g) each. Total net weight 9.9 oz (280 g). Distributed by Laboratories C.O.P Inc., 60 Jean-Proulx St Gatieau QC Canada J8Z 1W1
Code InfoSS & Vinegar USA Lot Numbers 10723 18821 10821 22923 10822 23021 10823 23022 10921 23023 10922 23121 10923 23122 14922 32322 15522 32323 15523 32421 15621 32422 15622 32423 15623 32521 15721 32522 15722 32523 18523 18721 18722 18723 SS & Vinegar Canada Lot Numbers 10923 28922 11021 28923 11022 29021 14521 29022 14522 29023 14523 29023 14621 14922 18323 18421 18422 18423 18521 18522 28723 28821 28822 28823 28921
ClassificationClass II
Reason for RecallDakota Specialty Milling informed Zumbro River Brand (ZRB) that they are recalling Multigrain Whole Meal Flour Blend 100 (Multigrain Flour) because of a potential contamination with fine wire pieces. This Multigrain Flour is a component in an extruded base called Whey multigrain Ridges, so these fine wire pieces could be contained in the Whey Muligrain Ridges. The fine wire is too thin to be detected by metal detection, therefore ZRB is recalling the products made with the recalled Multigrain Flour which include Sea Salt & vinegar Ridges and BBQ Ridges (USA & Canada).
Product Quantity58,610 lbs
Recall NumberF-1319-2013
Product DescriptionIdeal Protein, BBQ Ridges, 7 packets Net WT 1.4 oz (40 g) each. Total net weight 9.9 oz (280 g). Distributed by Laboratories C.O.P Inc., 60 Jean-Proulx St Gatieau QC Canada J8Z 1W1
Code InfoBBQ USA Lot Numbers 10123 19023 10221 23122 10222 23123 10223 23221 10321 23222 10322 23223 10323 23321 15723 32621 15821 32622 15822 33021 15823 33022 15921 33121 15922 33122 18823 33221 18921 18922 18923 19021 19022 BBQ Canada Lot Numbers 10323 10421 10622 11622 11623 11721 19023 19121 19122 19123 19221 19222 23321 23322 23323 23421 23422 23423
ClassificationClass II
Reason for RecallDakota Specialty Milling informed Zumbro River Brand (ZRB) that they are recalling Multigrain Whole Meal Flour Blend 100 (Multigrain Flour) because of a potential contamination with fine wire pieces. This Multigrain Flour is a component in an extruded base called Whey multigrain Ridges, so these fine wire pieces could be contained in the Whey Muligrain Ridges. The fine wire is too thin to be detected by metal detection, therefore ZRB is recalling the products made with the recalled Multigrain Flour which include Sea Salt & vinegar Ridges and BBQ Ridges (USA & Canada).
Product Quantity56,842 lbs
Recall NumberF-1320-2013

Class II Devices Event

Event ID64641
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMaquet Cardiovascular, LLC
CityWayne
StateNJ
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide and the following countries: Australia, Austria, Belarus, Belgium, Canada, Columbia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Iceland, Iran, Ireland, Italy, Jordan, Kazakhstan, Korea, Kuwait, Luxembourg, The Netherlands, Norway, Oman, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates and the United Kingdom.
 

Associated Products

Product DescriptionMAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).
Code InfoCatalog Number: 70104.8012 Cardiohelp-i. Multiple serial numbers.
ClassificationClass II
Reason for RecallIt has come to the attention of MAQUET that there have been episodes of brief unexpected shutdown, followed by an automatic device restart of the human machine interface (touch screen) of the CARDIOHELP device. The human machine interface (HMI) is the central display of the CARDIOHELP device, where measured values, settings and alarms are displayed and adjusted/confirmed, with the exception of blood flow which is set by a separate rotary knob located at the front of the device.
Product Quantity154 units affected
Recall NumberZ-1149-2013

Class II Devices Event

Event ID64646
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSynvasive Technology Inc
CityEl Dorado Hills
StateCA
CountryUS
Distribution PatternUSA Distribution in the state of IN
 

Associated Products

Product DescriptionThe Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.
Code InfoBiomet Product code: 506076, Lot 829182. Synvasive Part Number: 11-3629.
ClassificationClass II
Reason for RecallBiomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
Product Quantity100 kits
Recall NumberZ-1127-2013

Class II Devices Event

Event ID64653
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCarefusion Corporation
CitySan Diego
StateCA
CountryUS
Distribution PatternWorldwide Distribution USA Nationwide and the countries of Australia and Canada.
 

Associated Products

Product DescriptionAlaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System
Code Infonot available
ClassificationClass II
Reason for RecallThe recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software version 9.12. Automating infusion pump parameter input from either the electronic medical record (EMR) or the Alaris Auto-ID module for a continuous infusion with a bolus dose option may result in a loss of information from the Guardrails Data set while programming a bolus dose.
Product Quantity4,090 total units
Recall NumberZ-1112-2013

Class II Devices Event

Event ID64669
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Mar-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmSmith & Nephew Inc
CityMemphis
StateTN
CountryUS
Distribution PatternNationwide Distribution including CA, FL, GA, MA, MI, NC, SC, OH, and MO.
 

Associated Products

Product DescriptionTRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery
Code InfoLot Number 12FM12182
ClassificationClass II
Reason for RecallOne batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter).
Product Quantity23 units
Recall NumberZ-1132-2013

Class II Devices Event

Event ID64671
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAlere San Diego, Inc.
CitySan Diego
StateCA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of Canada, South Africa, Netherlands, Italy, Brazil, Singapore, Russia, Hong Kong, Argentina, South Korea, Philippines, El Salvador, Indonesia, and Trinidad.
 

Associated Products

Product DescriptionAlere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
Code InfoLot/Unit Codes: 274351A, 274351B, 274352B, 274353A, 290243A, 290244A, 290641A, 290641B, 290642A, 290643A, 290643B, 290644A, 290644B, 290645A, 290645B, 290646A, 290647A, 290648A, 293669A, 293670A, 293671A, 293672A, 293673A, 296635A, 296636A, 296637A, 296638A, 296639A, 296639B, 296640A, 296641A, 296642A, 297311B, 297313A, 297313B.
ClassificationClass II
Reason for RecallThe recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT AST cassette, and it has the potential for humidity changes to impact results for certain analytes on the Alere Cholestech LDX System.
Product Quantity38,571 kits
Recall NumberZ-1139-2013

Class II Drugs Event

Event ID64676
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Mar-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmPrecision Dose Inc.
CitySouth Beloit
StateIL
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionChildren's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC 68094-650-62), Pkg. By: Precision Dose, Inc., S. Beloit, IL 61080.
Code InfoLot #: 101456, Exp 05/13; 101488, Exp 06/13: 101499, 101503, Exp 07/13; 101537, 101552, 101554, Exp 08/13; 101611, 101616, 101623, Exp 10/13; 101630, Exp 11/13; 101754, Exp 03/14
ClassificationClass II
Reason for RecallLabeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose.
Product Quantity9,268 cases
Recall NumberD-250-2013

Class II Devices Event

Event ID64679
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Mar-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmBiomet U.K., Ltd.
CityBridgend, South Wales
State
CountryGB
Distribution PatternWorldwide Distribution - USA (nationwide), Europe, Japan, Australia, Canada, Singapore, South Africa, and Costa Rica.
 

Associated Products

Product DescriptionREF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in REF 32-422763 Oxford Mlcroplasty Knee System Tibial instrument Tray small surgical hammer supplied with the Oxford Partial Knee Microplasty Instrument set, used for impacting implants.
Code Info32-422760 ( sold as part of instrument set 32-422763 ) ZB100901,ZB110201,ZB110301,ZB110302,ZB110303, ZB110304,ZB110601,ZB110602,ZB110701,ZB111201, ZB111202,ZB120201,ZB120202,ZB120701,ZB120801, ZB120802,ZB121102,ZB121103
ClassificationClass II
Reason for RecallInvestigation of complaints found excessive use of the instrument could result in cracking on the weld between the head and the handle, which could lead to part of the head becoming detached from the handle.
Product Quantity430
Recall NumberZ-1124-2013

Class II Devices Event

Event ID64683
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmVital Images, Inc.
CityMinnetonka
StateMN
CountryUS
Distribution PatternWorldwide Distribution - USA including AL, AR, CA, CO, IA, MI,MN, MO, NY, NC, OH, OR, PA, TX, and UT. Internationally to AUSTRIA, BELGIUM, CANADA, CHINA, COLOMBIA, GEORGIA, JAPAN, KOREA, MACEDONIA, NETHERLANDS, POLAND, PORTUGAL, RUSSIAN FEDERATION, SINGAPORE, SWEDEN, SWITZERLAND, TURKEY, UKRAINE, UNITED KINGDOM.
 

Associated Products

Product DescriptionVitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and subsequent versions of VitreaWorkstation, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite, through version 6.4. Vitrea® CT Multi-Chamber Cardiac Functional Analysis provides a variety of tools for working with clinical CT images of the coronary arteries, heart, and surrounding tissue.
Code InfoSerial Number EMC1112028 EMC1112027 EMC1103020 VMC1302077 VMC1202027 VMC1202028 VMC1202029 VMC1109012 MCH1006002 VMC1109008 VMC1202017 VMC1202026 VMC1202025 VMC1202032 VMC1202019 VMC1202037 VMC1202022 VMC1202023 VMC1202024 VMC1202020 VMC1202021 VMC1105013 VMC1105014 VMC1105015 VMC1109011 VMC1211048 VMC1211049 VMC1202038 VMC1211043 VMC1211044 VMC1211046 VMC1211047 VMC1211045 VMC1302064 VMC1302065 VMC1211040 VMC1302050 VMC1302051 VMC1202018 VMC1109005 VMC1302076 VMC1302075 VMC1109010 VMC1109009 VMC1202034 VMC1202031 VMC1012011 EMC1012014 EMC1012015 EMC1101016 VMC1202033 VMC1202030 EMC1203036 VMC1202015 VMC1109004 VMC1202035 VMC1111013 VMC1211041 EMC1203033 EMC1209041 EMC1203037 VMC1109006 EMC1211043 VMC1109007 EMC1211044 VMC1202039 VMC1202036 VMC1109003 VMC1211042 EMC1212047 EMC1203035 EMC1109025 EMC1203031 EMC1302049 EMC1212048 EMC1201029 EMC1212045 EMC1201030 EMC1110026 VMC1108016 EMC1107022 MCH1006011 EMC1206039 EMC1101017 MCH1006001 EMC1203034 EMC1103018 EMC1103019 EMC1107023 EMC1203032 VMC1202016 EMC1108024 EMC1209042 EMC1206038 EMC1212046 EMC1012011 VMC1201014 EMC1105021
ClassificationClass II
Reason for RecallVital Images has made a decision to perform a field correction to the Vitrea CT Multi-Chamber Cardiac Functional Analysis application. Vital Images has identified a defect in which numerical values may be incorrect in the Results Table under the Cardiac Analysis portion of the user interface.
Product Quantity102
Recall NumberZ-1144-2013

Class II Devices Event

Event ID64693
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmToshiba American Medical Systems Inc
CityTustin
StateCA
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionAplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.
Code InfoItem numbers: TUS-A300/Wl and TUS-A500/Wl
ClassificationClass II
Reason for RecallToshiba Medical Systems has received reports of startup issues with the Toshiba TUS-500 and TUS-300 ultrasound systems. The startup issue is predominant when attempting to bring the system up from standby mode when the system is used remotely. It has been determined that this may potentially cause damage to the system.
Product Quantity233 units
Recall NumberZ-1104-2013

Class II Devices Event

Event ID64698
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSr Instruments Inc
CityTonawanda
StateNY
CountryUS
Distribution PatternUSA Distribution in the state of Texas.
 

Associated Products

Product DescriptionSR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patient Lifters. Model# FG3105 Patient Scales. Product Usage: The FG3105 Scale is designed for Joerns Healthcare for use in portable patient weighing systems. The scale is designed to be connected between the patient hoist mechanism and patient sling apparatus. The scale is not intended to be used for patient transport.
Code InfoSerial numbers: 1005 thru 1780, 1785 thru 1809, 1866 thru 1868 and 1870 thru 1875.
ClassificationClass II
Reason for RecallSR Instruments Inc. is implementing a field correction for the Joerns Healthcare Patient Lifts after they received two incident reports regarding two field failures of a tensile type load cell involving the FG3105 Patient Scale. The failures resulted in patient falls.
Product Quantity806 patient scales
Recall NumberZ-1128-2013

Class II Devices Event

Event ID64700
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAdvanced Sterilization Products
CityIrvine
StateCA
CountryUS
Distribution PatternNationwide Distribution-USA including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.
 

Associated Products

Product DescriptionEVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
Code InfoSerial Numbers: 5041110197 5041110198 5041110205 5041110200 5041110206 5041110203 5041110207 5041110208 5041110211 5041110210 5041110216 5041110209 5041110225 5041110220 5041110218 5041110227 5041110219 5041110229 5041110212 5041110215 5041110223 5041110224 5041110221 5041110214 5041110226 5041120061 5041120065 5041120057 5041120064 5041120059 5041120069 5041120063 5041120072 5041120074 5041120066 5041120068 5041120070 5041120073 5041120076 5041120078 5041120079 5041120075 5041120077 5041120080 5041120084 5041120092 5041120096 5041120094 5041120071 5041120086 5041120089 5041120090 5041120088 5041120093 5041120095 5041120098 5041120103 5041120101 5041120091 5041120097 5041120104 5041120062 5041120105 5041120099 5041120085 5041120102 5041120108 5041120060 5041120107 5041120100 5041120106 5041120087 5041120116 5041120114 5041120113 5041120112 5041120111 5041120081 5041120067 5041120109 5041120118 5041120123 5041120110 5041120119 5041120125 5041120126 5041120117 5041120129 5041120132 5041120115 5041120127 5041120131 5041120121 5041120122 5041120130 5041120124 5041120133 5041120139 5041120136 5041120140 5041120137 5041120138 5041120157 5041120158 5041120159 5041120160 5041120161 5041120162 5041120163 5041120164 5041120165 5041120148 5041120149 5041120152 5041120153 5041120154 5041120155 5041120151 5041120150 5041120120 5041120169 5041120168 5041120176 5041120172 5041120141 5041120156 5041120142 5041120147 5041120146 5041120171 5041120145 5041120175 5041120181 5041120170 5041120173 5041120177 5041120183 5041120180 5041120182 5041120197 5041120179 5041120178 5041120190 5041120193 5041120184 5041120191 5041120196 5041120199 5041120192 5041120201 5041120203 5041120200 5041120194 5041120174 5041120198 5041120195 5041120185 5041120213 5041120206 5041120214 5041120208 5041120209
ClassificationClass II
Reason for RecallAdvanced Sterilization Products (ASP) has determined that a limited number of EVOTECH ECRs manufactured between 2011 and 2012 did not receive sufficient High Potential (HIPOT) DC voltage testing.
Product Quantity273 units
Recall NumberZ-1123-2013

Class II Devices Event

Event ID64708
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Apr-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Healthcare Inc.
CityAndover
StateMA
CountryUS
Distribution PatternWorldwide Distribution including USA (nationwide)
 

Associated Products

Product DescriptionPhilips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray systems or sub-systems, each with a continuously rotating x-ray tube and multi-row detectors enclosed by a gantry. X-ray transmission data acquired and taken at different angles can be reconstructed into cross-sectional images. Each device also includes signal analysis and display equipment, patient and equipment supports, components, and accessories.
Code InfoGemini Dual, Gemini 16 Power, Gemini GXL, Gemini LXL, Gemini TF 16, Gemini TF Base/Ready, Gemini TF 64, Gemini TF Big Bore, Precedence SPECT/CT, Brilliance CT (6, 10,16, 16P, 40, 64, and Big Bore), Brilliance iCT, Brilliance iCT SP
ClassificationClass II
Reason for RecallPhilips Healthcare discovered the customer was performing CTDI measurements for facility accreditation and received results that were 15 to 25% higher than Philips protocol parameters stated.
Product Quantity2089 US 4036 ROW
Recall NumberZ-1003-2013

Class II Devices Event

Event ID64712
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAccuray Incorporated
CitySunnyvale
StateCA
CountryUS
Distribution PatternWorldwide distribution, including Nationwide in the US and the countries of Korea, Myanmar, Canada, Belgium, England, Czech Republic, Finland, France, Germany, Greece, India, Italy, Poland, Russia, Spain, Switzerland, Turkey, Columbia, Mexico, Japan and Saudi Arabia.
 

Associated Products

Product DescriptionAccuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment.
Code InfoAll units of these models.
ClassificationClass II
Reason for RecallA defect on the master-side connector block of the pneumatic tool changer could introduce a tilt in the collimator housings, resulting in a potential shift to the central axis of the radiation beam. The issue could pose significant clinical impact to plans created using the smallest collimators.
Product Quantity176 units
Recall NumberZ-1126-2013

Class II Devices Event

Event ID64723
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHoriba Instruments, Inc dba Horiba Medical
CityIrvine
StateCA
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionHORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. Used to measure absorbance and ion electrodes.
Code InfoModel Numbers: P400ISE110EN02 and P400ISE110US02. All Serial Numbers. Versions 5.0.7 and below
ClassificationClass II
Reason for RecallHORIBA Medical is informing all ABX PENTRA 400 Analyzer with I.S.E. Module customers that there are no Linearity Limit Flags for the I.S.E. assays currently programmed into the ABX PENTRA 400 Analyzer software. All other assays run on this analyzer do have Linearity Limit Flags to alert the user to values that fall below or above the validated linearity range for each assay.
Product Quantity905 units
Recall NumberZ-1141-2013

Class II Devices Event

Event ID64734
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDeGotzen
CityOlgiate Olona Varese
State
CountryIT
Distribution PatternUS (nationwide)
 

Associated Products

Product DescriptionDeGotzen XRay unit XGenus Dental X-ray unit.
Code Info766471
ClassificationClass II
Reason for RecallIt was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification
Product Quantity159 units
Recall NumberZ-1020-2013

Class II Devices Event

Event ID64737
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions USA, Inc
CityMalvern
StatePA
CountryUS
Distribution PatternWorldwide Distribution - USA including the states of AL, CA, CO, DC, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MO, NC, NE, NH, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WI, WV, and WY. and the countries of Canada and Australia.
 

Associated Products

Product DescriptionSiemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system syngo(R) Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration, as well as multiple interfaces for patient registration, order entry, and external billing modules. It is not intended to treat disease or administer any medicinal substances or drugs. There is no contact between device and patient. syngo(R) Workflow SLR can be used as a separate RIS, interfacing to a Hospital Information System (HIS) or Picture Archiving and Communication Systems (PACS
Code InfoModel numbers 10558922, 10558933 and 10558980 with software version VA31A SP1/SP2/SP3
ClassificationClass II
Reason for RecallUnder certain conditions, when using the Search functionality, the potential exists for the wrong patient's Interactive Documents to display when viewing a signed report in the single patient view. This can occur when the Interactive Document is viewed or auto displayed, dismissed by the user, and then a different patient and signed exam is selected in single patient view. The Notes Viewer will display Interactive Document notes for the previously selected patient. The problem is when a signed report is selected, the internal list of selected exams is not being reset. The potential for a safety issue occurs when the Radiologist selects a signed report for a patient and then selects a signed report for a different patient. If the Radiologist is performing an addend on the second signed report and bases the addend on information from the incorrect note, this could then contribute to an incorrect diagnosis if this is not recognized by the Radiologist. Furthermore, if the Radiologist creates and saves a new note, the note could be saved against the previously selected patient.
Product Quantity37
Recall NumberZ-1105-2013

Class II Devices Event

Event ID64747
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmEdwards Lifesciences, LLC
CityDraper
StateUT
CountryUS
Distribution PatternNationwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.
 

Associated Products

Product DescriptionEdwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
Code InfoModels 9100CR23, all lot numbers.
ClassificationClass II
Reason for RecallHoles in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers.
Product Quantity5,472 units
Recall NumberZ-1134-2013
Product DescriptionEdwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
Code InfoModels 9100CR26, all lot numbers.
ClassificationClass II
Reason for RecallHoles in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers.
Product Quantity6,117 units
Recall NumberZ-1135-2013

Class II Devices Event

Event ID64748
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jan-12
Initial Firm Notification of Consignee or Public Visit
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternWorldwide Distribution -- USA, including all states except ME, and the U.S. Virgin Islands; and, the countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, MALAYSIA, NETHERLAND, NEW ZEALAND, NORWAY, PHILIPPINES,S QATAR, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
 

Associated Products

Product DescriptionGE Healthcare Muse v7 cardiology information system. Model number 2026443-001: MUSE 7.0 app cd, Model Number 2026443-015: MUSE 7.0.2 app cd, Model number 2026443-017: MUSE 7.1 app cd, Model number 2026443-029:MUSE 7.1.1 A app cd, and Model Number 2026443-031: MUSE 7.1.1 app cd. Intended to store, access and manage cardiovascular information on adult and pediatrics patients.
Code InfoSerial Number SBP05450003GA SBP05450009GA SBP05500067GA SBP06100195GA SBP06110200GA SBP06110203GA SBP06160274GA SBP06170288GA SBP06180296GA SBP06180306GA SBP06180308GA SBP06190316GA SBP06190326GA SBP06190329GA SBP06190330GA SBP06200371GA SBP06200377GA SBP06230507GA SBP06230512GA SBP06250577GA SBP06260614GA SBP06260619GA SBP06280624GA SBP06280626GA SBP06280629GA SBP06280637GA SBP06280653GA SBP06290744GA SBP06290748GA SBP06290758GA SBP06290768GA SBP06300778GA SBP06300789GA SBP06310812GA SBP06310814GA SBP06330820GA SBP06330824GA SBP06330838GA SBP06330841GA SBP06330853GA SBP06330873GA SBP06330878GA SBP06340958GA SBP06340959GA SBP06360974GA SBP06360979GA SBP06360983GA SBP06361019GA SBP06371040GA SBP06371055GA SBP06371058GA SBP06371061GA SBP06391095GA SBP06391100GA SBP06411137GA SBP06411147GA SBP06421164GA SBP06421167GA SBP06421169GA SBP06421171GA SBP06421183GA SBP06421189GA SBP06431228GA SBP06441246GA SBP06441251GA SBP06441277GA SBP06441279GA SBP06441282GA SBP06441296GA 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ClassificationClass II
Reason for RecallGE Healthcare conducted a recall on the Muse v7 because incorrect medications were displayed on the MUSE, which could result in incorrect treatment.
Product Quantity963
Recall NumberZ-1133-2013

Class II Devices Event

Event ID64755
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmIntuitive Surgical, Inc.
CitySunnyvale
StateCA
CountryUS
Distribution PatternWorldwide Distribution.-USA (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.
 

Associated Products

Product DescriptionIS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from contamination.
Code InfoModel number 550516-05
ClassificationClass II
Reason for RecallRevised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.
Product Quantity1642 customers
Recall NumberZ-1109-2013
Product DescriptionIS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000. Arm drapes protect equipment from contamination.
Code InfoModel number 550650-05 (P8)
ClassificationClass II
Reason for RecallRevised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.
Product Quantity1642 customers
Recall NumberZ-1110-2013

Class II Devices Event

Event ID64770
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTransonic Systems Inc
CityIthaca
StateNY
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide including the states of AZ, CA, FL, GA, NM, NY, TX, VA and WA and countries of Netherlands, Canada and Russia.
 

Associated Products

Product DescriptionHCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.
Code InfoLot numbers: 102810, 010311 and 111810.
ClassificationClass II
Reason for RecallTransonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.
Product Quantity195 units total (140 units Domestic, 55 units Foreign)
Recall NumberZ-1147-2013

Class II Devices Event

Event ID64781
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAdvanced Sterilization Products
CityIrvine
StateCA
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionEVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
Code InfoBatch Numbers: 5041090177 5041090127 5041090131 5041110307 5041120049 5041120065 5041120076 5041100256 5041110157 5041120133 5040107029 5041110264 5041110265 5041110280 5041100218 5041100219 5041110018 5041110143 5041110079 5041110329 5041110212 5041120155 5041100250 5041110080 5041110174 5041110330 5041110203 5041090103 5041090110 5041100103 5041100104 5041100142 5041090184 5041090185 5041120120 5041120070 5041120073 5041120080 5040107087 5041110158 5041100189 5041100186 5041110189 5041080029 5041080063 5041120034 5041080028 5041080060 5041080064 5041100145 5041100146 5041100151 5041100268 5041120081 5040107065 5041120087 5041120116 5041110111 5041110113 5040107115 5041070037 5041110121 5041110140 5041090067 5041090167 5041090168 5041120154 5041090179 5041110177 5041110112 5041110129 5041110130 5041090069 5041110271 5041070036 5041070044 5041070045 5041090034 5041090054 5041090147 5041100192 5041090203 5041100214 5041100265 5041110186 5041110187 5041100067 5041100071 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ClassificationClass II
Reason for RecallAdvanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because they have received reports of smoke emanating from the system due to a circuit board malfunction that may occur in the Channel Control Manifold sub-assembly.
Product Quantity761 units
Recall NumberZ-1150-2013

Class II Devices Event

Event ID64782
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmEdwards Lifesciences, LLC
CityDraper
StateUT
CountryUS
Distribution PatternUSA Nationwide Distribution including the states of: FL, MA, MI, NY, PA, TX.
 

Associated Products

Product DescriptionEdwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin-coated blood path is desired. The femoral arterial cannulae are wire-reinforced, thin-wall cannulae.
Code InfoModel DIIFEMII018A, Lot 59337174
ClassificationClass II
Reason for RecallTwo unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach.
Product Quantity379 units
Recall NumberZ-1111-2013

Class II Food Event

Event ID64798
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Mar-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTristar Food Wholesale Co Inc
CityJersey City
StateNJ
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionFructus Lycii (400g). Dried Medlar (Net Wt: 14.11 oz (400G). Ingredients: Dried Medlar. Distributed Exclusively By: Tristar Food Wholesale Company Inc. 115 Amity Street, Jersey City NJ 07304, USA. Product of P.R.C. UPC: 6931653102466
Code InfoItem #: 60025 - Dried Medlar (Net Wt: 14.11 oz (400G). UPC: 6931653102466
ClassificationClass II
Reason for RecallThe product contains undeclared sulfites (as a preservative).
Product Quantity19 cartons (each carton containst 50 400 g plastic bags)
Recall NumberF-1322-2013

Class II Devices Event

Event ID64810
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSynvasive Technology Inc
CityEl Dorado Hills
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and countries of: Austria, Australia, Belgium, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Panama, Spain, Sweden, Switzerland, Tunisia, United Kingdom and Yemen.
 

Associated Products

Product DescriptionProduct is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as a total knee replacement.
Code InfoLots Numbers included in Recall: 1X311,01251,16325,15023,15024,1Y224,23326,0X401,26385,1Y174, 17151,0Y280,17150,22028,28114,19071,23372,23346,23504,23505, 25134,25341,2W223,2X105,26001,2W573,2W574,24348,25304, 25333,26068,26165,27015,27016,29392,PD4647
ClassificationClass II
Reason for RecallVarious reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors include: (1) The pouch says oscillating saw blade when it actually contains a reciprocating saw blade; (2) The box bar code date does not match the human readable expiration date; and (3) The label incorrectly states use with Zimmer/Synthes handset and not the Zimmer Universal Power System.
Product Quantity3442 units per the part numbers listed
Recall NumberZ-1115-2013

Class II Drugs Event

Event ID64835
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPfizer Inc.
CityNew York
StateNY
CountryUS
Distribution PatternNationwide and PR
 

Associated Products

Product DescriptionLevoxyl (levothyroxine sodium) tablets, USP 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles ( NDC 60793-850-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Code InfoLot # a) 66675B, Exp. 10/13; b) 66852B Exp. 10/13; 67138B, Exp. 02/14
ClassificationClass II
Reason for RecallChemical contamination: emission of strong odor after package was opened..
Product Quantity23210 bottles
Recall NumberD-251-2013
Product DescriptionLevoxyl (levothyroxine sodium) tablets, USP 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles ( NDC 60793-851-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Code InfoLot # a) 66730B, 66853B, Exp. 01/14; b) 66731B, 67116B, Exp. 11/13, 66856B, Exp. 12/13; 67341B, Exp, 02/14
ClassificationClass II
Reason for RecallChemical contamination: emission of strong odor after package was opened.
Product Quantity29613 bottles
Recall NumberD-252-2013
Product DescriptionLevoxyl (levothyroxine sodium) tablets, USP 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles ( NDC 60793-852-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Code InfoLot # a) 66369B, Exp. 10/13; 66679B, Exp. 11/13; 66850B, Exp. 12/13; b) 66676B, 66732B, Exp. 12/13; 67136B, Exp. 03/14
ClassificationClass II
Reason for RecallChemical contamination: emission of strong odor after package was opened.
Product Quantity37809 bottles
Recall NumberD-253-2013
Product DescriptionLevoxyl (levothyroxine sodium) tablets, USP 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles ( NDC 60793-853-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Code InfoLot # a) 66619B, Exp. 11/13; 67010B, Exp. 01/14; b) 66733B, Exp. 11/13; 67441B, Exp. 01/14
ClassificationClass II
Reason for RecallChemical contamination: emission of strong odor after package was opened..
Product Quantity26447 bottles
Recall NumberD-254-2013
Product DescriptionLevoxyl (levothyroxine sodium) tablets, USP 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles ( NDC 60793-854-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Code InfoLot # a) 66897B, Exp. 12/13; b) 67137B, Exp.02/14
ClassificationClass II
Reason for RecallChemical contamination: emission of strong odor after package was opened..
Product Quantity18195 bottles
Recall NumberD-255-2013
Product DescriptionLevoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles ( NDC 60793-855-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Code InfoLot # a) 67343B, Exp. 01/14; b) 66902B, Exp. 12/13
ClassificationClass II
Reason for RecallChemical contamination: emission of strong odor after package was opened.
Product Quantity9213 bottles
Recall NumberD-256-2013
Product DescriptionLevoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles ( NDC 60793-856-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Code InfoLot # a) 66373B, Exp. 10/13; 66851B, Exp. 12/13; b)66792B, Exp. 12/13; 67349B, Exp. 03/14
ClassificationClass II
Reason for RecallChemical contamination: emission of strong odor after package was opened
Product Quantity37891 bottles
Recall NumberD-257-2013
Product DescriptionLevoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles ( NDC 60793-857-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Code InfoLot # a) 67013B, Exp. 01/14; b) 66900B, Exp. 01/14
ClassificationClass II
Reason for RecallChemical contamination: emission of strong odor after package was opened.
Product Quantity7901 bottles
Recall NumberD-258-2013
Product DescriptionLevoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles ( NDC 60793-858-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Code InfoLot # a) 66375B, Exp. 10/13; 66719B, Exp. 01/14; b) 66904B, Exp. 01/14
ClassificationClass II
Reason for RecallChemical contamination: emission of strong odor after package was opened.
Product Quantity36045 bottles
Recall NumberD-259-2013
Product DescriptionLevoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles ( NDC 60793-859-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Code InfoLot # a) 67507B, Exp. 02/14; b) 67508B, Exp. 02/14
ClassificationClass II
Reason for RecallChemical contamination: emission of strong odor after package was opened.
Product Quantity10121 bottles
Recall NumberD-260-2013
Product DescriptionLevoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles ( NDC 60793-860-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Code InfoLot # a) 66671B, Exp. 11/13; 67512B, Exp. 02/14 b) 66739B Exp. 11/13; 67513B Exp. 02/14
ClassificationClass II
Reason for RecallChemical contamination: emission of strong odor after package was opened.
Product Quantity14464 bottles
Recall NumberD-261-2013

Class II Devices Event

Event ID64840
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAcist Medical Systems
CityEden Prairie
StateMN
CountryUS
Distribution PatternNationwide Distribution including the states of AL, AK, AZ, AR, CA, CO, CT, DC, GA, HI, ID, IL, IN, IA, KS, KY, MD,MI, MN, MS, MO, NV, NH, NJ, NM, NY,NC, OR, OK, OH, PA, TN, TX, VA and WA.
 

Associated Products

Product DescriptionACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
Code Info23884007, 23884008, 23884009
ClassificationClass II
Reason for RecallACIST Medical Systems is issuing a voluntary recall notice for three specific lots of BT2000 Automated Manifold Kits. For these specific lots, ACIST has received field reports related to ingress of air into the manifold body. This has been detected by the Air Column Detect Sensor halting the injection, and normally replacement of the BT2000 Automated Manifold Kit is necessary in order to proceed with the injection. To date, there has been no evidence or report of any air injection to a patient, injury or adverse health consequence associated with this issue.
Product Quantity6640 units
Recall NumberZ-1145-2013

Class II Devices Event

Event ID64841
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and Internationally to Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.
 

Associated Products

Product DescriptionThe GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.
Code InfoList Numbers: 13000, 13100, 13150
ClassificationClass II
Reason for RecallDuring infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
Product Quantity1) List Number 13000: 25,119 pumps; 2) List Number 13100: 185 pumps; 3) List Number 13150: 13,497 pumps
Recall NumberZ-1116-2013
Product DescriptionThe GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.
Code InfoList Numbers: 13086, 13087, 13088
ClassificationClass II
Reason for RecallDuring infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
Product Quantity1) List Number 13086: 286 pumps; 3) List Number 13087: 45,376 pumps; 4) List Number 13088: 23,492 pumps
Recall NumberZ-1117-2013

Class II Devices Event

Event ID64848
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHeritage Labs International LLC
CityOlathe
StateKS
CountryUS
Distribution PatternNationwide Distribution including the states of AL, CA, GA, IL, IN, KY, MA, MD, NC, NY, OK and VA.
 

Associated Products

Product DescriptionHeritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which hold support supplies for health care providers when treating patients. Bag #3 contains 5 different blood collection tubes (5 each) and 2 different gauge needles--all for drawing blood. One of the tubes is the recalled BD blue top citrate tube (5 tubes). These tubes were manufactured by BD, Franklin Lakes, NJ. The kit is used by health care providers when treating patients.
Code InfoLot A2376-12307, exp 2/28/2013 and Lot A2376-12272, exp 4/30/2013
ClassificationClass II
Reason for RecallThe product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results.
Product Quantity25 kits
Recall NumberZ-1131-2013

Class II Devices Event

Event ID64884
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Oct-11
Initial Firm Notification of Consignee or Public Visit
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternWorldwide Distribution - Nationwide Distribution including the states of FL, IL, IN, LA, MI, MN, NJ, NM, NY, OH, PR, SC, TX and VA and the countries of Vietnam, Latvia, Italy, Israel, Indonesia, Hong Kong, United Kingdom, Finland, Spain, Czech Republic, Canada, Bahrain and Australia.
 

Associated Products

Product DescriptionGE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System.
Code InfoSerial Number 00000000321WVO 00000000353WV3 00000000000000 00000000346WV7 00000000292WW3 00000000327WV7 00000000333WV5 00000000325WV1 00000000298WV0 00000000301WV2 00000000271WV7 00000000250WV1 00000000251WV9 00000000332WV7 00000000263WV4 00000000275WV8 00000000335WV0 00000000249WV3 00000000303WV8 00000000331WV9 00000000255WV0 00000000337WV6 00000000359WV0 00000000362WV4 00000000352WV5 00000000318WV6 00000000324WV4 00000000355WV8 00000000354WV1 00000000329WV3 00000000274WV1 00000000267WV5 00000000305WV3 00000000322WV8 00000000317WV8 00000000132WV1 00000000280WV8 00000000026WV5 00000000254WV3 00000000420WV0 00000000297WV2 00000XXX299WV8 00000000257WV6 00000000357WV4 00000000253WV5 00000000339WV2 00000000265WV9 00000000252WV7
ClassificationClass II
Reason for RecallAs part of GE Innova IQ table introduction, a label was designed to be affixed on the front Cover of the Gantry Pivot section. This safety label is missing on systems manufactured between March 2010 and July 2011. In the situation a staff member (doctor, nurse, operator, anesthetist, etc&) stands in the region between the C-arm gantry pivot and the head section of the table, there is a risk of collision or jam when the head section of the table moves toward the C-arm gantry pivot. To date no collision or injury has been reported related to this condition.
Product Quantity48
Recall NumberZ-1142-2013

Class II Food Event

Event ID64899
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Apr-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmTwo Chefs On A Roll, Inc
CityCarson
StateCA
CountryUS
Distribution PatternCA, WA, AZ, IL, PA
 

Associated Products

Product DescriptionTrader Joe's Hummus Dip Size: 16 oz., 12 units/case, SKU 20411. Size: 7 oz, 24 units/case, SKU 15735.
Code Info16oz Sell By Dates: 04/26/13, 05/01/13, 05/03/13 7oz Sell by date: 05/01/13
ClassificationClass II
Reason for RecallTwo Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment.
Product Quantity3269 units
Recall NumberF-1329-2013
Product DescriptionTrader Joe's Three Layer Hummus Dip 12 oz., 12 units/case, SKU 80867.
Code InfoSell By Dates: 04/22/13, 04/27/13, 04/28/13, 05/02/13.
ClassificationClass II
Reason for RecallTwo Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment.
Product Quantity758 units
Recall NumberF-1330-2013
Product DescriptionTrader Joe's Mediterranean Hummus 16 oz., 12 units/case, SKU 90642.
Code InfoSell By Dates: 04/25/13, 04/29/13, 05/03/13, 05/06/13.
ClassificationClass II
Reason for RecallTwo Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment.
Product Quantity4855 units
Recall NumberF-1331-2013
Product DescriptionTrader Joe's Spicy Hummus Dip 7 oz., 24 units/case, SKU 38056.
Code InfoSell By Dates: 04/30/13.
ClassificationClass II
Reason for RecallTwo Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment.
Product Quantity559 units
Recall NumberF-1332-2013
Product DescriptionTrader Joe's Roasted Garlic Hummus Dip 7 oz., 24 units/case, SKU 20648.
Code InfoSell By Dates: 04/26/13, 05/02/13.
ClassificationClass II
Reason for RecallTwo Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment.
Product Quantity1349 units
Recall NumberF-1333-2013
Product DescriptionTrader Joe's Tomato Basil Hummus Dip 7 oz., 24 units/case, SKU 21953.
Code InfoSell By Dates: 04/30/13, 05/01/13.
ClassificationClass II
Reason for RecallTwo Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment.
Product Quantity497 units
Recall NumberF-1334-2013
Product DescriptionTrader Joe's Chunky Olive Hummus 7 oz., 24 units/case, SKU 75347.
Code InfoSell By Dates: 04/28/13.
ClassificationClass II
Reason for RecallTwo Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment.
Product Quantity377 units
Recall NumberF-1335-2013
Product DescriptionTrader Joe's Mediterranean Hummus Snack Pack with Pita Chips 8 oz., 24 units/case, SKU 97136.
Code InfoSell By Dates: 04/25/13, 04/26/13, 04/29/13, 05/01/13, 05/02/13, 05/03/13, 05/06/13
ClassificationClass II
Reason for RecallTwo Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment.
Product Quantity953 units
Recall NumberF-1336-2013
Product DescriptionTrader Joe's Hummus Salad Dressing 12 oz., 12 units/case, SKU 96752.
Code InfoSell By Dates: 05/14/13, 05/18/13, 05/20/13, 05/21/13, 05/22/13, 05/25/13.
ClassificationClass II
Reason for RecallTwo Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment.
Product Quantity608 units
Recall NumberF-1337-2013

Class II Devices Event

Event ID64900
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide including the states of: AK, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IL, IN, IA, LA, MD, MI, ,N, ,S, MO, MT, NJ, NM, NY, NC, OH, OK, PA, SC, SD, TN,TX, UT, VA, WA, WI. and the countries of : AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA, BRAZIL, CANADA, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUADELOUPE, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KOREA, LIBYA, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, POLAND, QATAR, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TURKEY and UNITED ARAB EMIRATES.
 

Associated Products

Product DescriptionGE Healthcare, AW Server. Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.
Code InfoMfg Lot or Serial # 00000267104GE8 00000276601GE2 00000211976GE6 00000223238GE7 00000257702GE1 00000183554HP5 00000248244GE6 000001010056GS 00000256021GE7 00000240706GE2 00000223235GE3 00000218205GE3 00000216337GE6 00000266111GE4 00000223234GE6 00000276603GE8 00000275004GE0 00000183573HP5 00000183555HP2 00000235884GE4 00000240705GE4 00000222533GE2 00000218207GE9 00000257708GE8 00000275003GE2 00000261642GE3 00000214206GE5 00000214821GE1 00000266112GE2 00000217429GE0 00000240703GE9 00000257707GE0 00000219371GE2 00000235886GE9 00000217427GE4 00000216338GE4 00000183518HP0 00000271798GE1 00000214817GE9 00000216334GE3 00000235885GE1 00000183570HP1 00000216331GE9 00000183568HP5 00000267105GE5 00000217428GE2 00000211978GE2 000001010012GS 00000240704GE7 00000229339GE7 00000216340GE0 00000266110GE6 00000267106GE3 00000260456GE9 00000222536GE5 00000261644GE9 00000214818GE7 00000183562HP8 00000229342GE1 00000276070GE0 00000235883GE6 00000257711GE2 00000257706GE2 00000222535GE7 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00000E11026001 00000E11026004 0000AA11157010 0000AA11157007 00000V11136007 00000LFB441084 00000G10363001 000001010038GS 000001010047GS 00000M12067010 00000A12034001 00000LCEFC4168 00000Z10335003 00000E11026005 00000P11244001 0000AD11138005 000001010026GS 00000Z10335004 00000K11230001 00000P10312001 0000AB10329001 00000Y11013007 000001010013GS 0000AB10329003 00000Z10335008 000001010061GS 00000Y11013008 00000J11056003 000001010001GS 00000B12048006 00000M12067009 000001010002GS 00000P10312002 00000P10347009 00000E11026008 00000P10347011 000001010027GS 00000J11056002 00000E11026002 00000E11026009 00000V11136005 00000F11206002 00000Y11013003 00000P11244013 00000J11056004 00000J11056001 0000ZA11257002 00000K11152002 000001010059GS 00000P11244012 00000E11301009 00000B12002001 00000183514HP9 0000AB10329002 000001010016GS 00000Z10335006 00000M11284013 000001010022GS 00000K11199001 00000C11263003 000001010017GS 00000B12048001 00000M12067002 00000M12067006 00000Q11340004 00000Z10335010 000001010018GS 00000L327C4AD6 00000183531HP3 00000V11185001 00000LE23E90E2 00000LE23E90CA 00000LE23E9026 00000A11096006 00000F10363001 00000LE23E8FDA 00000LE23E65BA 00000LCEFC3016 0000AD11087003 000001010044GS 000001010043GS 000001010042GS 00000K12010004 00000E11301007 00000LE23E65AE 00000L327C4A0E 0000AD12016001 00000LE23E9072 00000M11284001 00000E11301010 00000L3FE006EE 00000U11318007 00000A11096002 0000AD11138002 000001010004GS 00000P10347007 00000L11074007 0000AB11054004 0000AD11087001 00000L11074003 0000AD11104001 00000U11318003 000001010003GS 00000L11074009 0000AB11054002 0000AD11104003 0000AD11104002 00000L11071009 00000A11096004 00000B12048004 00000L11074002 0000AB11054005 000001010005GS 00000B12048010 00000J11056005 00000A12038003 00000M11284002 00000L11074004 00000A12159010 00000V11185002 00000267110GE5 00000P10312008 00000P10347003 00000L11074006 00000Q11340003 0000AA11157004 00000A11096003 00000E11301008 00000M11284006 00000S12045001 00000L11074010 00000M11284008 000001010041GS 00000L8B2FAE2A 00000H12118001 00000P10312010 00000V11136003 00000B12048009 00000Q11340002 00000E11301001 00000F11206003 000001010024GS 00000B12048007 00000Y11013001 00000Z10335002 000001010040GS 00000B12048008 00000Q11340001 0000AM11360001 00000M12067007 00000P10347005 00000P11244008 000001010045GS 0000AM11360002 0000AX11314004 00000Q11333002 00000B12002006 00000A11096009 00000P10347010 0000AB11054003 00000Y11013009 00000M11284005 0000AD11104004 0000AD11104005 00000L7B3745A8 USE152PED2 000001010023GS
ClassificationClass II
Reason for RecallGE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the AW Server. After starting the Results Viewer with the selected series of a patient, the pixel and certain annotation data from a different patient is displayed in one of the viewports. This occurs on an occasional basis, when multiple users are simultaneously accessing the Results Viewer.
Product Quantity429
Recall NumberZ-1137-2013

Class II Food Event

Event ID64911
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Apr-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmFresh And Easy
CityEl Segundo
StateCA
CountryUS
Distribution PatternCA, AZ, NV
 

Associated Products

Product DescriptionFresh & Easy Organic 100% Apple Juice from concentrate, 64 oz, 8 units/case. UPC/Barcode: 50513790021007 ORIN: 100012615 SPORIN: 100012623
Code InfoLot Code: 3690430491, expiration 2/18/2014. Lot Code: 3690430701, expiration 3/11/2014.
ClassificationClass II
Reason for RecallFresh and Easy is recalling Fresh & Easy Organic Apple Juice because it may be contaminated with patulin.
Product Quantity173 cases
Recall NumberF-1328-2013

Class III Biologics Event

Event ID42667
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Feb-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternNC; Switzerland
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoLT86807
ClassificationClass III
Reason for RecallBlood products, collected from a donor with a history of surgery within the previous 12 months, were distributed.
Product Quantity1 unit
Recall NumberB-0921-13

Class III Biologics Event

Event ID51461
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Jan-09
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionSource Plasma
Code Info366069668; 366069758; 366073001; 366073218; 366074209; 366074669; 366076781; 366078067; 366077956; 366078753; 366080353; 366080627; 366090190; 366090845; 366091600; 366092375; 366093080; 366094375; 366095054; 366095887; 366096690; 366097611; 366098270; 366099479; 366100192; 366100940; 366101921; 366102505; 366103910; 366104561; 366105398; 366106316; 366107116; 366107615; 366108885; 366109347; 366110249; 366110696; 366113832; 366113299; 366111436.
ClassificationClass III
Reason for RecallBlood products collected from a donor who was previously deferred for unsuitable lab test results, were distributed.
Product Quantity41 units
Recall NumberB-0912-13

Class III Biologics Event

Event ID58427
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Mar-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionSource Plasma
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3600094329, 3600095392, 3600097605, 3600099406, 3600124129, 3600108683, 3600114341, 3600115938, 3600094866, 3600106673, 3600107210, 3600097527, 3600121328, 3600121731, 3600122521, 3600127015, 3600100319, 3600141990, 3600143420, 3600147438, 3600145871, 3600154975, 3600127105, 3600137475, 3600144331, 3600146108, 3600146896, 3600100977, 3600113301, 3600125463, 3600104211, 3600110998, 3600110004, 3600129610, 3600104104, 3600109740, 3600096510, 3600100943, 3600106115, 3600137092, 3600139389, 3600146175, 3600099118, 3600100065, 3600148798, 3600155111, 3600094811, 3600096465, 3600097255, 3600097529, 3600099880, 3600106569, 3600111080, 3600113399, 3600118664, 3600103587, 3600102194, 3600133717, 3600150758, 3600131339, 3600091581, 3600113002, 3600113340, 3600131293, 3600150456, 3600156017, 3600123153, 3600128489, 3600129693, 3600112108, 3600100827, 3600108469, 3600142042, 3600112068, 3600155279, 3600156769, 3600111135, 3600149939, 3600095362, 3600095389, 3600100009, 3600102146, 3600099050, 3600104118, 3600106446, 3600110962, 3600114969, 3600102639, 3600103021, 3600092963, 3600098846, 3600099124, 3600100819, 3600102149, 3600108275, 3600110633, 3600112249, 3600114492, 3600118394, 3600119852, 3600122728, 3600123165, 3600123910, 3600125086, 3600125596, 3600127537, 3600129608, 3600130555, 3600133004, 3600133811, 3600138320, 3600138747, 3600140579, 3600142078, 3600152359, 3600156804, 3600108990, 3600129345, 3600138591, 3600143385, 3600144709, 3600153064, 3600125030, 3600148348, 3600094817, 3600113737, 3600114950, 3600135532, 3600091872, 3600112833, 3600113177, 3600098924, 3600100918, 3600091653, 3600092603, 3600108279, 3600128194, 3600131362, 3600140823, 3600150954, 3600131367, 3600144426, 3600149573, 3600127040, 3600155961, 3600096666, 3600097808, 3600146948, 3600094621, 3600097229, 3600108957, 3600110094, 3600110643, 3600146278, 3600118627, 3600120841, 3600122041, 3600123183, 3600124377, 3600100777, 3600118607, 3600120281, 3600122033, 3600143514, 3600119494, 3600150141, 3600142205, 3600092948, 3600095029, 3600107582, 3600130530, 3600133770, 3600119640, 3600120341, 3600123905, 3600126585, 3600138889, 3600089513, 3600094034, 3600095079, 3600096095, 3600097978, 3600099000, 3600102030, 3600103020, 3600103617, 3600105833, 3600107543, 3600101016, 3600135148, 3600150644, 3600155157, 3600155979, 3600156730, 3600099376, 3600102156, 3600136835, 3600137464, 3600139140, 3600141523, 3600142207, 3600150031, 3600132662, 3600105867, 3600102674, 3600111702, 3600107616, 3600099095, 3600099397, 3600103980, 3600105873, 3600122196, 3600123347, 3600124430, 3600106030, 3600127426, 3600105887, 3600119657, 3600129878, 3600132128, 3600100801, 3600096417, 3600125501, 3600141098, 3600105262, 3600092876, 3600102042, 3600117215, 3600119292, 3600123913, 3600135628, 3600140800, 3600097288, 3600120376, 3600120769, 3600095979, 3600106266, 3600141179, 3600146169, 3600149336, 3600141085, 3600106538, 3600104212, 3600104157, 3600105920, 3600124486, 3600129681, 3600098954, 3600100042, 3600146159, 3600101743, 3600105871, 3600113268, 3600119302, 3600107129, 3600110575, 3600125010, 3600125412, 3600127222, 3600129349, 3600129675, 3600136806, 3600138011, 3600138621, 3600140891, 3600141472, 3600102070, 3600096077, 3600106405, 3600107504, 3600110072, 3600097606, 3600107211, 3600118766, 3600124442, 3600129581, 3600131747, 3600132432, 3600143561, 3600144844, 3600146181, 3600147510, 3600147967, 3600123915, 3600138102, 3600093901, 3600111089, 3600123318, 3600121462, 3600095869, 3600151752, 3600108963, 3600118604, 3600122036, 3600123204, 3600125498, 3600112796, 3600118481, 3600124053, 3600138820, 3600143051, 3600128224, 3600132440, 3600137113, 3600147575, 3600099407, 3600110063, 3600111060, 3600114353, 3600114837, 3600100985, 3600122073, 3600094996, 3600105829, 3600106953, 3600104011, 3600105914, 3600110948, 3600096177, 3600146090, 3600110597, 3600117934, 3600121280, 3600124062, 3600097803, 3600153508, 3600132874, 3600135136, 3600147646, 3600129806, 3600096444, 3600099409, 3600101472, 3600108272, 3600108765, 3600113746, 3600106198, 3600122434, 3600120817, 3600124143, 3600110043, 3600125494, 3600128390, 3600092535, 3600094338, 3600096516, 3600099422, 3600112647, 3600116851, 3600117968, 3600118383, 3600119502, 3600147527, 3600102153, 3600105284, 3600096456, 3600124983, 3600102920, 3600106121, 3600107206, 3600097206, 3600118319, 3600128404, 3600102082, 3600121315, 3600127128, 3600130207, 3600131364, 3600135672, 3600141621, 3600137311, 3600127225, 3600097587, 3600093235, 3600093885, 3600094943, 3600097176, 3600100686, 3600101046, 3600103870, 3600106189, 3600118683, 3600122070, 3600122598, 3600123267, 3600124418, 3600126072, 3600128332, 3600128682, 3600124960, 3600095893, 3600096644, 3600104163, 3600093526, 3600108376, 3600114928, 3600124048, 3600125556, 3600129433, 3600100780, 3600109714, 3600100051, 3600103990, 3600118498, 3600117874, 3600124286, 3600093952, 3600094613, 3600095379, 3600106142, 3600123246, 3600124406, 3600099023, 3600100997, 3600101479, 3600103104, 3600105300, 3600107438, 3600119318, 3600103599, 3600138898, 3600113283, 3600131616, 3600145884, 3600093946, 3600095085, 3600097234, 3600100060, 3600096475, 3600111014, 3600122865, 3600124126, 3600124525, 3600129589, 3600133792, 3600136106, 3600137317, 3600139566, 3600139974, 3600141225, 3600142498, 3600143540, 3600145452, 3600147038, 3600147481, 3600148884, 3600106590, 3600107592, 3600109691, 3600125182, 3600130439, 3600139613, 3600140817, 3600141609, 3600142971, 3600096488, 3600100037, 3600106560, 3600137287, 3600149987, 3600103583, 3600139865, 3600143047, 3600127866, 3600129849, 3600135228, 3600136432, 3600138846, 3600140519, 3600137205, 3600103075, 3600140705, 3600141208, 3600118583, 3600120590, 3600128219, 3600148383, 3600135329, 3600137089, 3600141798, 3600112743, 3600122152, 3600123327, 3600127249, 3600129664, 3600148093, 3600099348, 3600092957, 3600106040, 3600111628, 3600095005, 3600097247, 3600103621, 3600129793, 36001.50690, 3600149358, 3600123236, 3600104144, 3600148186, 3600122839, 3600129699, 3600135299, 3600136443, 3600118333, 3600126081, 3600096440, 3600097627, 3600097576, 3600101548, 3600098753, 3600100724, 3600102795, 3600144338, 3600146142, 3600148859, 3600111726, 3600095018, 3600095864, 3600099416, 3600095888, 3600098622, 3600147198, 3600099070, 3600101847, 3600149087, 3600154509, 3600153195, 3600098571, 3600100935, 3600116091, 3600146294, 3600146688, 3600154599, 3600156021, 3600089455, 3600146050, 3600147506, 3600144385, 3600096421, 3600100874, 3600106034, 3600114489, 3600140978, 3600121278, 3600123037, 3600124119, 3600125541, 3600120894, 3600106041, 3600095386, 3600096477, 3600112784, 3600113391, 3600114976, 3600115978, 3600140701, 3600153151, 3600102046, 3600118666, 3600130265, 3600134819, 3600143438, 3600147028, 3600118489, 3600122913, 3600123300, 3600145843, 3600129896, 3600137237, 3600145402, 3600096434, 3600097153, 3600119505, 3600136301, 3600149348, 3600149850, 3600132961, 3600092971, 3600091605, 3600132240, 3600128589, 3600096018, 3600099080, 3600126398, 3600130274, 3600131294, 3600129399, 3600142146, 3600146701, 3600108964, 3600116069, 3600117222, 3600118302, 3600121527, 3600123095, 3600123894, 3600126090, 3600129370, 3600131322, 3600143038, 3600146130, 3600098553, 3600099841, 3600114486, 3600112666, 3600102114, 3600095694, 3600097194, 3600107502, 3600109898, 3600150878, 3600152183, 3600153023, 3600106999, 3600132228, 3600139368, 3600143792, 3600147766, 3600118387, 3600136304, 3600145444, 3600156424, 3600122173, 3600094770, 3600096999, 3600112306, 3600113424, 3600117153, 3600132193, 3600121639, 3600148163, 3600149596, 3600150124, 3600096997, 3600100006, 3600092547, 3600112007, 3600146801, 3600149875, 3600151887, 3600096136, 3600142164, 3600147170, 3600150706, 3600151390, 3600155249, 3600107558, 3600108762, 3600124394, 3600125521, 36001399Q3, 3600141151, 3600142466, 3600122140, 3600123207, 3600138875, 3600142085, 3600119510, 3600128309, 3600116220, 3600095989, 3600106512, 3600139493, 3600139830, 3600142361, 3600146396, 3600147183, 3600122012, 3600121694, 3600103899, 3600100880, 3600097822, 3600106601, 3600121345, 3600108466, 3600111621, 3600113110, 3600118695, 3600108463, 3600110997, 3600112028, 3600113296, 3600097301, 3600124134, 3600142159, 3600106143, 3600099010, 3600141212, 3600143790, 3600138615, 3600110039, 3600111042, 3600094842, 3600136558, 3600137243, 3600125472, 3600102159, 3600106243, 3600106577, 3600128406, 3600130474, 3600105884, 3600110107, 3600120898, 3600093964, 3600097292, 3600102635, 3600128410, 3600093922, 3600097802, 3600109004, 3600103603, 3600121747, 3600126146, 3600137329, 3600143543, 3600122081, 3600133652, 3600138804, 3600139851, 3600142413, 3600146334, 3600147635, 3600153159, 3600156036, 3600106392, 3600116361, 3600118617, 3600124365, 3600129796, 3600132860, 3600146064, 3600153523, 3600105288, 3600106613, 3600109947, 3600120876, 3600095070, 3600098849, 3600100758, 3600104027, 3600111064, 3600114435, 3600099813, 3600094819, 3600095910, 3600096993, 3600108926, 3600122189, 3600101562, 3600112941, 3600121444, 3600123050, 3600125353, 3600129892, 3600135199, 3600102713, 3600107624, 3600103993, 3600110477, 3600111149, 3600124196, 3600125058, 3600126111, 3600102081, 3600109750, 3600102010, 3600110592, 3600117207, 3600119665. 3600118669, 3600131346, 3600090964, 3600097057, 3600107031, 3600113727, 3600116085, 3600123289, 3600131282, 3600133702, 3600148551, 3600138789, 3600148551, 3600146683, and 3600147263
ClassificationClass III
Reason for RecallBlood products, collected from a donor, whose suitability to donate were not adequately determined, were distributed.
Product Quantity1116 units
Recall NumberB-0986-13

Class III Biologics Event

Event ID64038
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmKapiolani Medical Center for Women and Children
CityHonolulu
StateHI
CountryUS
Distribution PatternHawaii
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW0888412535911;
ClassificationClass III
Reason for RecallBlood product, which label was applied to blood unit with incorrect or missing information, was distributed.
Product Quantity1 unit
Recall NumberB-0694-13

Class III Biologics Event

Event ID64140
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Dec-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBergen Comm Reg Blood Center
CityParamus
StateNJ
CountryUS
Distribution PatternNew Jersey
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code InfoW065612041135;
ClassificationClass III
Reason for RecallBlood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-1050-13

Class III Biologics Event

Event ID64142
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Sep-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmMeek Blood Center
CityAbilene
StateTX
CountryUS
Distribution PatternTexas
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW141412018769;
ClassificationClass III
Reason for RecallBlood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-1009-13

Class III Drugs Event

Event ID64325
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLupin Pharmaceuticals Inc.
CityBaltimore
StateMD
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionSuprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 68180-202-03.
Code InfoLot #s: MSA 2021A, MSA 2024A, MSA 2025A, Exp July 2014
ClassificationClass III
Reason for RecallDiscoloration; Product may not meet specifications for color description once reconstituted.
Product Quantity64,368 bottles
Recall NumberD-264-2013

Class III Biologics Event

Event ID64632
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBD Biosciences, Systems & Reagents
CitySan Jose
StateCA
CountryUS
Distribution PatternCA, GA, NC, NY, PA, OR, TX, OK, MO, VA, MI, NJ, CT, UT and to Australia, Canada, Belgium, China, India, South Korea, Taiwan.
 

Associated Products

Product DescriptionBD HLA-B27 Kit; 510(k) BK050073; Manufactured by BD Biosciences 2350 Qume Drive San Jose, CA 95131
Code InfoModel number 340183; Lot numbers 3029914 and 3035581
ClassificationClass III
Reason for RecallCertain lots of HLA-B27 FITC/CD3 PE reagent contained in the HLA-B27 kit, contaminated with CD4 PE, were distributed.
Product Quantity2
Recall NumberB-1367-13

Class III Food Event

Event ID64735
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Mar-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNestle Puerto Rico Inc
CityCatano
StatePR
CountryUS
Distribution PatternProduct was distributed in Puerto Rico only (wholesalers and distributors).
 

Associated Products

Product DescriptionGERBER® Pure Water (1 Plastic Gallon)
Code InfoManufactured- 2/20/13 - 3/22/13- 3.79L (1 Gallon) 1304948683, 1305048682, 1305048683, 1305148682, 1305348683, 1305648682, 1305648683, 1305748682, 1306048682, 1306348681, 1306548682, 1306648681, 1306748682, 1307048682, 1307348681
ClassificationClass III
Reason for RecallAn audit to the purified water supplier revealed deficiencies related to the Ozone purification system and particulates, the analytical results show that mold was found on one of the batches
Product Quantity12,948 - (3 gallons cases)
Recall NumberF-1324-2013

Class III Veterinary Event

Event ID64777
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Mar-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmWilbur Ellis Co
CityVancouver
StateWA
CountryUS
Distribution PatternDistributed in Oregon
 

Associated Products

Product DescriptionMesserle & Sons Dewormer Mineral. Product is Type B medicated mineral premix (dewormer), formulated to contain fendendazole. The product is labeled in parts: "***Messerle & Sons Dewormer Mineral***MEDICATED***ACTIVE DRUG INGREDIENTS Fenbendazole***4540 g/ton***Manufactured by: Wilbur-Ellis Company P.O Box 407 Clackmas, OR 97015***Net Weight 50 lbs***".
Code InfoMESRL003 03/2010; Lot 644370; Expiration date: September 2014
ClassificationClass III
Reason for RecallMesserle & Sons Dewormer Mineral is recalled because Fenbendazole drug concentration was exceeded the AV allowed.
Product Quantity1950 lbs.
Recall NumberV-145-2013

Class III Devices Event

Event ID64790
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAlere San Diego, Inc.
CitySan Diego
StateCA
CountryUS
Distribution PatternNationwide Distribution including TN, WA, UT, KS, KY, MN, GA, MA, PA, NY, VT, and the Dist. of Columbia
 

Associated Products

Product DescriptionIMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the diagnosis of infectious Mononucleosis.
Code InfoThe affected control lot number is 11030386. Lot/Unit Codes: MON1040008 & MON1040016.
ClassificationClass III
Reason for RecallAlere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.
Product Quantity78 kits
Recall NumberZ-1148-2013

Class III Food Event

Event ID64793
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Mar-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmDPI Specialty Foods West, Inc.
CityOntario
StateCA
CountryUS
Distribution PatternDistributed within the state of California.
 

Associated Products

Product DescriptionHumboldt Fog (brand) Cypress Grove Chevre, Aged Goat Milk Cheese. Packaged in 7oz (random weight) and 5 oz (random weight). Cypress Grove Chevre # 213146 7oz (random weight) Cypress Grove Chevre # 35363 5oz (random weight) Products are random (various) weight. The 7 oz is packed 6 packs per case. The 5 oz is packed 8 packs per case.
Code InfoThe sell by dates on the product are between 12/14/12 and 04/28/13. Item numbers: 35363 (5 oz) and 213146 (7 oz) LOT #s 24694 24519 24521 24969 24709 25198 25108 25455 25229 23986 25701 27477 25616 25959 28278 27694 27798 25958 26444 26279 26555 26457 28345 26771 26911 26815 26931 26895 27140 26659 29345 27474 29451 29509 27865 29866 28435 28599 28429 28828 28974 29048 29350 28973
ClassificationClass III
Reason for RecallDPI Specialty Foods has been notified that some Cypress Grove Humboldt Fog Goat Cheese was labeled with incorrect ingredients. This product is produced with pasteurized goat milk, and was labeled as containing cultured raw cow's milk.
Product Quantity2116 cases
Recall NumberF-1318-2013

Class III Drugs Event

Event ID64846
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmActavis South Atlantic LLC
CitySunrise
StateFL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionbuPROPion 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.
Code InfoLot #: CC1D11A, CC1D12A, CC1D17A, CC1D18A, CD1D05A, CD1D07A, CD1D08A, CD1D14A, CD1D15A, CD1D16A, CE1D08A, Exp 03/13; CE1D03A, CE1D04A, CE1D07A, CE1D06A, CE1D05A, CE1D13A, CE1D14A, CE1D15A, Exp 04/13; CF1D01A, CE1D24A, CF1D02A, Exp 05/13; CH1D08A, CH1D09A, Exp 07/13; CJ1D01A, CH1D11A, CH1D10A, CJ1D09A, CJ1D02A, CJ1D10A Exp 08/13; CL1D05A, CL1D06A, CK1D05B, CK1D06A, Exp 10/13; CL1D08A, CM1D01A, CM1D02A, Exp 11/13
ClassificationClass III
Reason for RecallFailed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.
Product Quantity555,672 bottles
Recall NumberD-248-2013

Mixed Classification Biologics Event

Event ID39139
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Mar-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center of the Ozarks
CitySpringfield
StateMO
CountryUS
Distribution PatternMO and Austria
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info6753448
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity1 Unit
Recall NumberB-0925-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info6753448
ClassificationClass III
Reason for RecallBlood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity1 Unit
Recall NumberB-0926-13

Mixed Classification Biologics Event

Event ID39644
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Feb-05
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmNew York Blood Center, Inc.
CityNew York
StateNY
CountryUS
Distribution PatternNew Jersey, California, New York, Switzerland
 

Associated Products

Product DescriptionRed Blood Cells
Code Info6238785, 6238816, 6238935, 6238937 and 6238958.
ClassificationClass II
Reason for RecallBlood products, collected from donors in which donor suitability was not adequately determined, were distributed.
Product Quantity5
Recall NumberB-0781-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info6238820, 6238843, 6238848, 6238859, 6238873, 6238883 6238900, 6238913,, and 6238918.
ClassificationClass II
Reason for RecallBlood products, collected from donors in which donor suitability was not adequately determined, were distributed.
Product Quantity9
Recall NumberB-0782-13
Product DescriptionPlatelets
Code Info6238918, 6238913, 6238909, 6238900, 6238820, 6238816, 6238873, 6238848 and 6238843.
ClassificationClass II
Reason for RecallBlood products, collected from donors in which donor suitability was not adequately determined, were distributed.
Product Quantity9
Recall NumberB-0783-13
Product DescriptionFresh Frozen Plasma
Code Info6238918, 6238913, 6238900, 6238883, 6238820, 6238816, 6238859, 6238873, 6238848, 6238843.
ClassificationClass II
Reason for RecallBlood products, collected from donors in which donor suitability was not adequately determined, were distributed.
Product Quantity10
Recall NumberB-0784-13
Product DescriptionRed Blood Cells Irradiated
Code Info6238945
ClassificationClass II
Reason for RecallBlood products, collected from donors in which donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0785-13
Product DescriptionPlasma for Further Manufacturing
Code Info6238935, 6238909, 6238785, 6238937,6238945, 6238958
ClassificationClass III
Reason for RecallBlood products, collected from donors in which donor suitability was not adequately determined, were distributed.
Product Quantity6
Recall NumberB-0786-13

Mixed Classification Biologics Event

Event ID50330
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Sep-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross (The)
CityFarmington
StateCT
CountryUS
Distribution PatternNE
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info033GM37984; 033GM55654; 033GW23732; 033GW54331; 033GM57596; 033GM59812
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity6 units
Recall NumberB-0548-13
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code Info033GM57596;033GM55654
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-0549-13
Product DescriptionFresh Frozen Plasma
Code Info033GM57596;033GW54331;033GM55654
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity3 units
Recall NumberB-0550-13
Product DescriptionPlatelets Leukocytes Reduced
Code Info033GM35609
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0551-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info033GM37984
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0552-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info033FP63417P1;033FP63417P2
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-0553-13
Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info033FE00104B2;033FE00104B1
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-0554-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info033GM35609
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0555-13

Mixed Classification Biologics Event

Event ID64141
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (the)
CityCharlotte
StateNC
CountryUS
Distribution PatternSouth Carolina; California
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info012GE28907;
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-1003-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info012GE28907; 012GH80270;
ClassificationClass III
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-1004-13
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