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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Class I Food Event

Event ID64666
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Mar-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNuGo Nutrition HQ
CityOakmont
StatePA
CountryUS
Distribution PatternNationwide and Canada.
 

Associated Products

Product DescriptionNuGo Free Dark Chocolate Trail Mix Bar, 1.59 oz (45g) Non-Dairy
Code InfoBest By date ending in 2012 and 2013 UPC code 691535453012 (box) UPC code 69153545301 (bar)
ClassificationClass I
Reason for RecallProduct may contain undeclared milk product
Product Quantity
Recall NumberF-1824-2013
Product DescriptionNuGo Free Dark Chocolate Crunch, 1.59 oz (45g) Non-Dairy
Code InfoBest By date ending in 2012 and 2013 UPC code 69153545102 (box) UPC code 69153545101 (bar)
ClassificationClass I
Reason for RecallProduct may contain undeclared milk product
Product Quantity
Recall NumberF-1825-2013
Product DescriptionNuGo Free Carrot Cake, 1.59 oz (45g) Non-Dairy
Code InfoBest By 2012 and 2013 UPC 69153545502 (box) UPC 69153545501 (bar)
ClassificationClass I
Reason for RecallProduct may contain undeclared milk product
Product Quantity
Recall NumberF-1826-2013
Product DescriptionNuGo Dark Chocolate Chocolate Chip 1.59 oz (45g) Non-Dairy
Code Info Best By date ending in 2012 and 2013 UPC 69153552102 (box) UPC 69153552101 (bar)
ClassificationClass I
Reason for RecallProduct may contain undeclared milk product
Product Quantity
Recall NumberF-1827-2013
Product DescriptionNuGo Dark Mocha, 1.59 oz (45g) Non-Dairy
Code InfoBest By date ending in 2012 and 2013 UPC code 69153552302 (box) UPC code 69153552301 (bar)
ClassificationClass I
Reason for RecallProduct may contain undeclared milk product
Product Quantity
Recall NumberF-1828-2013
Product DescriptionNuGo Dark Mint Chocolate Chip, 1.59 oz (45g) Non-Dairy
Code InfoBest By date ending in 2012 and 2013 UPC 69153552502 (box) UPC 69153552501 (bar)
ClassificationClass I
Reason for RecallProduct may contain undeclared milk product
Product Quantity
Recall NumberF-1829-2013
Product DescriptionNuGo Dark Peanut Butter Cup, 1.59 oz (45g) Non-Dairy
Code InfoBest By date ending in 2012 and 2013 UPC 69153552702 (box) UPC 69153552701 (bar)
ClassificationClass I
Reason for RecallProduct may contain undeclared milk product
Product Quantity
Recall NumberF-1830-2013
Product DescriptionNuGo Dark Pretzel 1.59 oz (45g) Non-Dairy Non-Dairy
Code Info Best By date ending in 2012 and 2013 UPC 69153552902 (box) UPC 69153552901 (bar)
ClassificationClass I
Reason for RecallProduct may contain undeclared milk product
Product Quantity
Recall NumberF-1831-2013
Product DescriptionNuGo Slim Crunchy Peanut Butter, 1.59 oz (45g) Non-Dairy
Code InfoBest By date ending in 2012 and 2013 UPC 69153520702 (box) UPC 69153520701 (bar)
ClassificationClass I
Reason for RecallProduct may contain undeclared milk product
Product Quantity
Recall NumberF-1832-2013
Product DescriptionNuGo Slim Espresso, 1.59 oz (45g) Non-Dairy
Code InfoBest By date ending in 2012 and 2013 UPC 69153520902 (box) UPC 69153520901 (bar)
ClassificationClass I
Reason for RecallProduct may contain undeclared milk product
Product Quantity
Recall NumberF-1833-2013

Class I Food Event

Event ID65645
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jul-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmWhole Foods Market
CityAustin
StateTX
CountryUS
Distribution PatternRetail Stores Nationwide
 

Associated Products

Product DescriptionCrave Brothers Les Freres cheese sold with labeling as: Les Freres, Crave Brothers Les Freres, Les Freres Wash Rind Product of USA, Crave Bros Les Freres, Crave Brothers Les Freres Cheese by Pound, Les Freres Crave Brothers, and Les Freres Crave Brothers PO-RK. Cheese was cut and wrapped.
Code InfoAll best by dates for the following list of PLUs: Les Freres - PLU #299682, Crave Brothers Les Freres - PLU #299682, Les Freres Wash Rind Product of USA - PLU #294473, Crave Bros Les Freres - PLU #294473, Crave Brothers Les Freres Cheese by Pound - PLU #294473, Les Freres Crave Brothers - PLU #294473, and Les Freres Crave Brothers PO-RK - PLU #294473.
ClassificationClass I
Reason for RecallWhole Foods Market announces that it is recalling Crave Brothers Les Freres cheese in response to a recall by the Crave Brothers Farmstead Cheese Company of Waterloo, Wisconsin. The cheese is being recalled because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. To date, one illness and one death have been reported.
Product QuantityUnknown
Recall NumberF-1834-2013

Class I Devices Event

Event ID65777
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Spine
CityAllendale
StateNJ
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionStryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.
Code InfoK093670 Catalog numbers: Small - 48551044 Medium - 48551045 Large - 48551046 Large Long - 48551047 Mini- 48551048 All lots of the above
ClassificationClass I
Reason for RecallStryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.
Product Quantity1536 units (US) 880 (Foreign)
Recall NumberZ-1976-2013

Class II Biologics Event

Event ID39149
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Systems, Inc.
CityScottsdale
StateAZ
CountryUS
Distribution PatternArizona
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info103081478
ClassificationClass II
Reason for RecallBlood product, with positive bacterial detection testing, was distributed.
Product Quantity1 unit
Recall NumberB-2062-13

Class II Biologics Event

Event ID39150
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Systems, Inc.
CityScottsdale
StateAZ
CountryUS
Distribution PatternArizona
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code Info103697958
ClassificationClass II
Reason for RecallBlood product, with positive bacterial detection testing, was distributed.
Product Quantity1 unit
Recall NumberB-2063-13

Class II Biologics Event

Event ID39151
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-May-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Systems, Inc.
CityScottsdale
StateAZ
CountryUS
Distribution PatternArizona
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info108021563(Part A); 108021563(Part B)
ClassificationClass II
Reason for RecallBlood Products, which were contaminated with Corynebacterium species, were distributed.
Product Quantity2 units
Recall NumberB-2064-13

Class II Biologics Event

Event ID39155
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jul-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBlood Systems, Inc.
CityScottsdale
StateAZ
CountryUS
Distribution PatternArizona
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info108012740(Part A)
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-2050-13

Class II Biologics Event

Event ID39156
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Aug-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBlood Systems, Inc.
CityScottsdale
StateAZ
CountryUS
Distribution PatternArizona
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info108024925(Part A)
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-2051-13

Class II Biologics Event

Event ID40787
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Sep-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHemaCare Corporation
CitySherman Oaks
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info4067666
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-1787-13

Class II Biologics Event

Event ID41367
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Dec-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityTucson
StateAZ
CountryUS
Distribution PatternArizona
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info007GE26161
ClassificationClass II
Reason for RecallBlood product, collected from a donor who gave history which warranted deferral, was distributed.
Product Quantity1 unit
Recall NumberB-2010-13

Class II Biologics Event

Event ID41639
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jan-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCSL Plasma Inc
CityBoca Raton
StateFL
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code Info0480908143; 0480907970; 0480907276; 0480906431; 0480906175
ClassificationClass II
Reason for RecallBlood products, collected from a donor who did not have a complete physical examination, were distributed.
Product Quantity5 units
Recall NumberB-2004-13

Class II Biologics Event

Event ID41720
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Feb-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTri-counties Blood Bank
CityPhoenix
StateAZ
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoFZ65185
ClassificationClass II
Reason for RecallBlood product, which failed to meet the minimum specification for product volume, was distributed.
Product Quantity1 unit
Recall NumberB-1849-13

Class II Biologics Event

Event ID43672
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Oct-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmPlasmaCare Inc
CityColumbus
StateOH
CountryUS
Distribution PatternOH
 

Associated Products

Product DescriptionSource Plasma
Code Info2040055458, 2040053823, 2040052644
ClassificationClass II
Reason for RecallBlood products, collected from a donor who did not have a complete physical examination, were distributed.
Product Quantity3 units
Recall NumberB-2009-13

Class II Biologics Event

Event ID43981
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Oct-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHoxworth Blood Center University of Cincinnati Medical Center
CityCincinnati
StateOH
CountryUS
Distribution PatternOH
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info2819133; 2815693; 1696707
ClassificationClass II
Reason for RecallBlood products, with a low volume, were distributed.
Product Quantity3 units
Recall NumberB-2002-13
Product DescriptionFresh Frozen Plasma
Code Info2815693
ClassificationClass II
Reason for RecallBlood products, with a low volume, were distributed.
Product Quantity1 unit
Recall NumberB-2003-13

Class II Biologics Event

Event ID45172
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Sep-07
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSouthern California Permanente Medical Group Blood Donor Center
CityIrvine
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoKJ43504I; KJ43504II
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity2 units
Recall NumberB-1695-13

Class II Drugs Event

Event ID64102
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFresenius Kabi USA LLC (FK USA)
CitySchaumburg
StateIL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionIRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7.
Code InfoLot #: 872CZ00101, Exp 12/13
ClassificationClass II
Reason for RecallCrystallization: Active pharmaceutical ingredient is precipitating in product solution.
Product Quantity23,672 vials
Recall NumberD-915-2013

Class II Biologics Event

Event ID64999
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Feb-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmDepartment of Air Force - BB/HT
CityLackland A F B
StateTX
CountryUS
Distribution PatternTX
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW001313200265
ClassificationClass II
Reason for RecallBlood product, which did not meet the acceptable product specifications for release, was distributed.
Product Quantity1 unit
Recall NumberB-1731-13

Class II Biologics Event

Event ID65001
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Apr-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternSD
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW044113009725
ClassificationClass II
Reason for RecallBlood product, which did not meet the acceptable product specifications for release, was distributed
Product Quantity1 unit
Recall NumberB-1730-13

Class II Biologics Event

Event ID65010
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Mar-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmOneBlood / dba CBCF
CityLauderhill
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW036813047271
ClassificationClass II
Reason for RecallBlood product, which did not meet acceptable product specifications, was distributed.
Product Quantity1 unit
Recall NumberB-1733-13

Class II Biologics Event

Event ID65014
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Mar-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Systems, Inc.
CityLas Vegas
StateNV
CountryUS
Distribution PatternNV
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW041912047393C- part 3
ClassificationClass II
Reason for RecallBlood products, which did not meet acceptable product specifications, were distributed.
Product Quantity1 unit
Recall NumberB-1896-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW041912047393C-part 1; W041912047393C-part 2
ClassificationClass II
Reason for RecallBlood products, which did not meet acceptable product specifications, were distributed.
Product Quantity2 units
Recall NumberB-1897-13

Class II Biologics Event

Event ID65024
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Mar-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmDepartment of Army US Army Blood Bank Center
CityFort Hood
StateTX
CountryUS
Distribution PatternAfghanistan
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW012012003060
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-1899-13

Class II Food Event

Event ID65116
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-May-13
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmGalveston Shrimp Company, Inc.
CityGalveston
StateTX
CountryUS
Distribution PatternAll product was distributed in Texas.
 

Associated Products

Product DescriptionTexas Wild UPC 51/60 BSO Shrimp Headless Shell-on IQF, Wild Caught, Product of the USA 20 # Net Weight, Galveston Shrimp Co., Galveston, TX 77550
Code InfoUPC 27241-45551, lot number 379B
ClassificationClass II
Reason for RecallForeign Material
Product Quantity
Recall NumberF-1836-2013
Product DescriptionTexas Wild UPC 41/50 BSO, Shrimp Headless Shell-on, IQF Wild Caught, Product of the USA 20# Net Weight, Galveston Shrimp Co., Galveston, Texas 77550
Code InfoUPC 27241-72010, lot number 379B
ClassificationClass II
Reason for RecallForeign Material
Product Quantity
Recall NumberF-1837-2013
Product DescriptionTexas Wild UPC 31/40 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA 20# Net Weight, Galveston Shrimp Co., Galveston, Texas 77550
Code InfoUPC 27241-45530; 27241-45536 and 27241-45531 , lot number 379B
ClassificationClass II
Reason for RecallForeign Material
Product Quantity
Recall NumberF-1838-2013
Product DescriptionTexas Wild UPC, 26/30 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, Texas 77550
Code InfoUPC 27241-72005 lot number 379B
ClassificationClass II
Reason for RecallForeign Material
Product Quantity
Recall NumberF-1839-2013
Product DescriptionTexas Wild UPC 16/25 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550
Code InfoUPC 27241-45519 lot number 379B
ClassificationClass II
Reason for RecallForeign Material
Product Quantity
Recall NumberF-1840-2013
Product DescriptionTexas Wild UPC, 16/20 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550
Code InfoUPC 27241-45516 lot number 379B
ClassificationClass II
Reason for RecallForeign Material
Product Quantity
Recall NumberF-1841-2013
Product DescriptionTexas Wild UPC, 16/20 WSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550
Code InfoUPC 27241-45416 lot number H143
ClassificationClass II
Reason for RecallForeign Material
Product Quantity
Recall NumberF-1842-2013
Product DescriptionTexas Wild UPC, 10/15 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550
Code InfoUPC 27241-45512 and 27241-45510 lot number 379B
ClassificationClass II
Reason for RecallForeign Material
Product Quantity
Recall NumberF-1843-2013
Product DescriptionTexas Wild UPC, 10/15 WSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550
Code InfoUPC 27241-45410 and 27241-45412 lot number H143
ClassificationClass II
Reason for RecallForeign Material
Product Quantity
Recall NumberF-1844-2013

Class II Biologics Event

Event ID65206
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-May-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternFlorida; New York
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info2629093;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2101-13
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code Info2928447;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2102-13

Class II Biologics Event

Event ID65220
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Apr-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternMichigan; Florida
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW036812440893; W036811187949; W036811102262;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity3
Recall NumberB-2104-13
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036812843172; W036811804772;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-2105-13
Product DescriptionFresh Frozen Plasma
Code InfoW036812440893; W036811187949; W036811102262;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity3
Recall NumberB-2106-13

Class II Biologics Event

Event ID65222
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Apr-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLake Worth
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells
Code Info2423919;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2110-13
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code Info2918705;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2111-13

Class II Biologics Event

Event ID65249
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBloodSource, Inc.
CityMather
StateCA
CountryUS
Distribution PatternAustria; New York
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoLE33722;
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed
Product Quantity1
Recall NumberB-2112-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoLE33722;
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed
Product Quantity1
Recall NumberB-2113-13

Class II Biologics Event

Event ID65266
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Apr-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmDCI Biologicals Temple Terrace, LLC
CityTemple Terrace
StateFL
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code InfoTT0155293; TT0155522
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity2 units
Recall NumberB-2146-13

Class II Biologics Event

Event ID65267
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Apr-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center of Carolinas
CityCharlotte
StateNC
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW227012072941
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2144-13
Product DescriptionFresh Frozen Plasma
Code InfoW227012072941
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2145-13

Class II Biologics Event

Event ID65268
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Apr-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasma Biological Services
CityOwensboro
StateKY
CountryUS
Distribution PatternTN
 

Associated Products

Product DescriptionSource Plasma
Code InfoBQ128259
ClassificationClass II
Reason for RecallBlood product, collected from a donor who was previously deferred, was distributed.
Product Quantity1 unit
Recall NumberB-2143-13

Class II Biologics Event

Event ID65279
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Apr-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmNorthern California Community Blood Bank
CityEureka
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW149513934295- part 1; W149513934295-part 2; W149513934326- part 1; W149513934326- part 2; W149513934326- part 3
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity5 units
Recall NumberB-2133-13

Class II Devices Event

Event ID65413
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jun-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmZimmer, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the country of Japan.
 

Associated Products

Product Description00597001101 Femur CR PRECOAT FEM COMP SIZE AML, Rx, Sterile; 00597001102 Femur CR PRECOAT FEM COMP SIZE AMR, Rx, Sterile; 00597001201 Femur CR PRECOAT FEM COMP SIZE BML, Rx, Sterile; 00597001202 Femur CR PRECOAT FEM COMP SIZE BMR, Rx, Sterile. Used in total knee arthroplasty and indicated for patients with severe pain.
Code InfoREF 00597001101, all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-1998-2013
Product Description00597001131 Femur CR PRC SURF HDN FEM CO-NID AML, Rx, Sterile; 00597001132 Femur CR PRC SURF HDN FEM CO-NID AMR, Rx, Sterile; 00597001231 Femur CR PRC SURF HDN FEM CO-NID BML, Rx, Sterile; 00597001232 Femur CR PRC SURF HDN FEM CO-NID BMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Infoall codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-1999-2013
Product Description00597201101 Femur CR POROUS FEM COMP SIZE AML Rx, Sterile; 00597201102 Femur CR POROUS FEM COMP SIZE AMR Rx, Sterile; 00597201201 Femur CR POROUS FEM COMP SIZE BML Rx, Sterile; 00597201202 Femur CR POROUS FEM COMP SIZE BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2000-2013
Product Description65597201131 Femur CR POR FEM SURF HDN HATCP AML Rx, Sterile; 65597201132 Femur CR POR FEM SURF HDN HATCP AMR Rx, Sterile; 65597201231 Femur CR POR FEM SURF HDN HATCP BML Rx, Sterile; 65597201232 Femur CR POR FEM SURF HDN HATCP BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355
Recall NumberZ-2001-2013
Product Description00597201131 Femur CR POR SURF HDN FEM CO-NID AML Rx, Sterile; 00597201132 Femur CR POR SURF HDN FEM CO-NID AMR Rx, Sterile; 00597201231 Femur CR POR SURF HDN FEM CO-NID BML Rx, Sterile; 00597201232 Femur CR POR SURF HDN FEM CO-NID BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2002-2013
Product Description65597201101 Femur CR POR FEM HATCP SIZE AML Rx, Sterile; 65597201102 Femur CR POR FEM HATCP SIZE AMR Rx, Sterile; 65597201201 Femur CR POR FEM HATCP SIZE BML Rx, Sterile; 65597201202 Femur CR POR FEM HATCP SIZE BMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2003-2013
Product Description00597601201 Femur CRA PRECOAT FEM COMP SIZE B/L Rx, Sterile; 00597601202 Femur CRA PRECOAT FEM COMP SIZE B/R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2004-2013
Product Description00595601201 Femur CR-FLEX OPT FEM B-L Rx Sterile; 00595601202 Femur CR-FLEX OPT FEM B-R Rx Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Infoall codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2005-2013
Product Description00595001201 Femur CR-FLEX PCT FEM B-L Rx, Sterile; 00595001202 Femur CR-FLEX PCT FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355
Recall NumberZ-2006-2013
Product Description00595201201 Femur CR-FLEX POR FEM B-L Rx, Sterile; 00595201202 Femur CR-FLEX POR FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2007-2013
Product Description65595201201 Femur CR-FLEX POR HATCP FEM B-L Rx, Sterile; 65595201202 Femur CR-FLEX POR HATCP FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2008-2013
Product Description00597001303 Femur CR PRC FEM COMP SIZE CML Rx, Sterile; 00597001304 Femur CR PRC FEM COMP SIZE CMR Rx, Sterile; 00597001403 Femur CR PRC FEM COMP SIZE DML Rx, Sterile; 00597001404 Femur CR PRC FEM COMP SIZE DMR Rx, Sterile; 00597001503 Femur CR PRC FEM COMP SIZE EML Rx, Sterile; 00597001504 Femur CR PRC FEM COMP SIZE EMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355
Recall NumberZ-2009-2013
Product Description00597001333 Femur CR PRC SURF HDN FEM CO-NID CML Rx, Sterile; 00597001334 Femur CR PRC SURF HDN FEM CO-NID CMR Rx, Sterile; 00597001433 Femur CR PRC SURF HDN FEM CO-NID DML Rx, Sterile; 00597001434 Femur CR PRC SURF HDN FEM CO-NID DMR Rx, Sterile; 00597001533 Femur CR PRC SURF HDN FEM CO-NID EML Rx, Sterile; 00597001534 Femur CR PRC SURF HDN FEM CO-NID EMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2010-2013
Product Description00597201303 Femur CR POR FM COMP SIZE CML Rx, Sterile; 00597201304 Femur CR POR FM COMP SIZE CMR Rx, Sterile; 00597201403 Femur CR POR FM COMP SIZE DML Rx, Sterile; 00597201404 Femur CR POR FM COMP SIZE DMR Rx, Sterile; 00597201503 Femur CR POR FM COMP SIZE EML Rx, Sterile; 00597201504 Femur CR POR FM COMP SIZE EMR Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2011-2013
Product Description00597201333 Femur CR POR SURF HDN FEM CO-NID CML, Rx, Sterile; 00597201334 Femur CR POR SURF HDN FEM CO-NID CMR, Rx, Sterile; 00597201433 Femur CR POR SURF HDN FEM CO-NID DML, Rx, Sterile; 00597201434 Femur CR POR SURF HDN FEM CO-NID DMR, Rx, Sterile; 00597201533 Femur CR POR SURF HDN FEM CO-NID EML, Rx, Sterile; 00597201534 Femur CR POR SURF HDN FEM CO-NID EMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2012-2013
Product Description65597201333 Femur CR POR FEM SURF HDN HATCP CML, Rx, Sterile; 65597201334 Femur CR POR FEM SURF HDN HATCP CMR, Rx, Sterile; 65597201433 Femur CR POR FEM SURF HDN HATCP DML, Rx, Sterile; 65597201434 Femur CR POR FEM SURF HDN HATCP DMR, Rx, Sterile; 65597201533 Femur CR POR FEM SURF HDN HATCP EML, Rx, Sterile; 65597201534 Femur CR POR FEM SURF HDN HATCP EMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2013-2013
Product Description00587806126 Patella MICRO POROUS PAT 26MM X 10MM, Rx, Sterile; 00587806129 Patella MICRO POROUS PAT 29MM X 10MM, Rx, Sterile; 00587806132 Patella MICRO POROUS PAT 32MM X 10MM, Rx, Sterile; 00587806135 Patella MICRO POROUS PAT 35MM X 10MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2014-2013
Product Description00597206126 Patella ALL POLY PAT COMP MICRO 26DIA, Rx, Sterile; 00597206129 Patella ALL POLY PAT COMP MICRO 29DIA, Rx, Sterile; 00597206132 Patella ALL POLY PAT COMP MICRO 32DIA, Rx, Sterile; 00597206135 Patella ALL POLY PAT COMP MICRO 35DIA, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2015-2013
Product Description00595202010 Articular Surface XLPE CR ART SURF 1,2/PUR 10, Rx, Sterile; 00595202012 Articular Surface XLPE CR ART SURF 1,2/PUR 12, Rx, Sterile; 00595202014 Articular Surface XLPE CR ART SURF 1,2/PUR 14, Rx, Sterile; 00595202017 Articular Surface XLPE CR ART SURF 1,2/PUR 17, Rx, Sterile; 00595202020 Articular Surface XLPE CR ART SURF 1,2/PUR 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2016-2013
Product Description90595202017 Articular Surface XLPE CR ART SURF AE12/PUR 17, Rx, Sterile; 90595202020 Articular Surface XLPE CR ART SURF AE12/PUR 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2017-2013
Product Description00597002009 Articular Surface CR ART SURF 12/PURPLE 9, Rx, Sterile; 00597002010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile; 00597002012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, Sterile; 00597002014 Articular Surface CR ART SURF 12/PURPLE 14, Rx, Sterile; 00597002017 Articular Surface CR ART SURF 12/PURPLE 17, Rx, Sterile; 00597002020 Articular Surface CR ART SURF 12/PURPLE 20, Rx, Sterile; 00597002023 Articular Surface CR ART SURF 12/PURPLE 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2018-2013
Product Description90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM, Rx, Sterile; 90597002010 Articular Surface CR ART SURF 12/PURPLE 10MM, Rx, Sterile; 90597002012 Articular Surface CR ART SURF 12/PURPLE 12MM, Rx, Sterile; 90597002014 Articular Surface CR ART SURF 12/PURPLE 14MM, Rx, Sterile; 90597002017 Articular Surface CR ART SURF 12/PURPLE 17MM, Rx, Sterile; 90597002020 Articular Surface CR ART SURF 12/PURPLE 20MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2019-2013
Product Description00597202009 Articular Surface CR ART SURF 12/PURPLE 09, Rx, Sterile; 00597202010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile; 00597202012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, Sterile; 00597202014 Articular Surface CR ART SURF 12/PURPLE 14, Rx, Sterile; 00597202017 Articular Surface CR ART SURF 12/PURPLE 17, Rx, Sterile; 00597202020 Articular Surface CR ART SURF 12/PURPLE 20, Rx, Sterile; 00597202023 Articular Surface CR ART SURF 12/PURPLE 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2020-2013
Product Description00597602010 Articular Surface AC ART SURF 12/PUR 10, Rx, Sterile; 00597602012 Articular Surface AC ART SURF 12/PUR 12, Rx, Sterile; 00597602014 Articular Surface AC ART SURF 12/PUR 14, Rx, Sterile; 00597602017 Articular Surface AC ART SURF 12/PUR 17, Rx, Sterile; 00597602020 Articular Surface AC ART SURF 12/PUR 20, Rx, Sterile; 00597602023 Articular Surface AC ART SURF 12/PUR 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2021-2013
Product Description00595203110 Articular Surface XLPE CR ART SURF 3,4/SYEL 10, Rx, Sterile; 00595203112 Articular Surface XLPE CR ART SURF 3,4/SYEL 12, Rx, Sterile; 00595203114 Articular Surface XLPE CR ART SURF 3,4/SYEL 14, Rx, Sterile; 00595203117 Articular Surface XLPE CR ART SURF 3,4/SYEL 17, Rx, Sterile; 00595203120 Articular Surface XLPE CR ART SURF 3,4/SYEL 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2022-2013
Product Description90595203117 Articular Surface XLPE CR ART SURF AE34/STYEL 17, Rx, Sterile; 90595203120 Articular Surface XLPE CR ART SURF AE34/STYEL 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2023-2013
Product Description00597003109 Articular Surface CR ART SURF 34/STRIPE YEL 9, Rx, Sterile; 00597003110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx, Sterile; 00597003112 Articular Surface CR ART SURF 34/STRIPE YEL 12, Rx, Sterile; 00597003114 Articular Surface CR ART SURF 34/STRIPE YEL 14, Rx, Sterile; 00597003117 Articular Surface CR ART SURF 34/STRIPE YEL 17, Rx, Sterile; 00597003120 Articular Surface CR ART SURF 34/STRIPE YEL 20, Rx, Sterile; 00597003123 Articular Surface CR ART SURF 34/STRIPE YEL 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2024-2013
Product Description90597003109 Articular Surface CR ART SURF 34/STR YEL 09MM, Rx, Sterile; 90597003110 Articular Surface CR ART SURF 34/STR YEL 10MM, Rx, Sterile; 90597003112 Articular Surface CR ART SURF 34/STR YEL 12MM, Rx, Sterile; 90597003114 Articular Surface CR ART SURF 34/STR YEL 14MM, Rx, Sterile; 90597003117 Articular Surface CR ART SURF 34/STR YEL 17MM, Rx, Sterile; 90597003120 Articular Surface CR ART SURF 34/STR YEL 20MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2025-2013
Product Description00597203109 Articular Surface CR ART SURF 34/STRIPE YEL 09, Rx, Sterile; 00597203110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx, Sterile; 00597203112 Articular Surface CR ART SURF 34/STRIPE YEL 12, Rx, Sterile; 00597203114 Articular Surface CR ART SURF 34/STRIPE YEL 14, Rx, Sterile; 00597203117 Articular Surface CR ART SURF 34/STRIPE YEL 17, Rx, Sterile; 00597203120 Articular Surface CR ART SURF 34/STRIPE YEL 20, Rx, Sterile; 00597203123 Articular Surface CR ART SURF 34/STRIPE YEL 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2026-2013
Product Description00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603112 Articular Surface AC ART SURF 34/STRIPED YEL 12, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2027-2013
Product Description00595204110 Articular Surface XLPE CR ART SURF 5-6/STRGRN 10, Rx, Sterile; 00595204112 Articular Surface XLPE CR ART SURF 5-6/STRGRN 12, Rx, Sterile; 00595204114 Articular Surface XLPE CR ART SURF 5-6/STRGRN 14, Rx, Sterile; 00595204117 Articular Surface XLPE CR ART SURF 5-6/STRGRN 17, Rx, Sterile; 00595204120 Articular Surface XLPE CR ART SURF 5-6/STRGRN 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2028-2013
Product Description90595204117 Articular Surface XLPE CR ART SURF AE56/STGRN 17, Rx, Sterile; 90595204120 Articular Surface XLPE CR ART SURF AE56/STGRN 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2029-2013
Product Description00597004109 Articular Surface CR ART SURF 56/STRIPE GREEN 9, Rx, Sterile; 00597004110 Articular Surface CR ART SURF 56/STRIPE GREEN 10, Rx, Sterile; 00597004112 Articular Surface CR ART SURF 56/STRIPE GREEN 12, Rx, Sterile; 00597004114 Articular Surface CR ART SURF 56/STRIPE GREEN 14, Rx, Sterile; 00597004117 Articular Surface CR ART SURF 56/STRIPE GREEN 17, Rx, Sterile; 00597004120 Articular Surface CR ART SURF 56/STRIPE GREEN 20, Rx, Sterile; 00597004123 Articular Surface CR ART SURF 56/STRIPE GREEN 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2030-2013
Product Description90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx, Sterile; 90597004110 Articular Surface CR ART SURF AE56/STR GRN 10MM, Rx, Sterile; 90597004112 Articular Surface CR ART SURF AE56/STR GRN 12MM, Rx, Sterile; 90597004114 Articular Surface CR ART SURF AE56/STR GRN 14MM, Rx, Sterile; 90597004117 Articular Surface CR ART SURF AE56/STR GRN 17MM, Rx, Sterile; 90597004120 Articular Surface CR ART SURF AE56/STR GRN 20MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2031-2013
Product Description00597204109 Articular Surface CR ART SURF 56/STRIPE GRN 9, Rx, Sterile; 00597204110 Articular Surface CR ART SURF 56/STRIPE GRN 10, Rx, Sterile; 00597204112 Articular Surface CR ART SURF 56/STRIPE GRN 12, Rx, Sterile; 00597204114 Articular Surface CR ART SURF 56/STRIPE GRN 14, Rx, Sterile; 00597204117 Articular Surface CR ART SURF 56/STRIPE GRN 17, Rx, Sterile; 00597204120 Articular Surface CR ART SURF 56/STRIPE GRN 20, Rx, Sterile; 00597204123 Articular Surface CR ART SURF 56/STRIPE GRN 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2032-2013
Product Description00597604110 Articular Surface AC ART SURF 56/STRIPED GRN 10, Rx, Sterile; 00597604112 Articular Surface AC ART SURF 56/STRIPED GRN 12, Rx, Sterile; 00597604114 Articular Surface AC ART SURF 56/STRIPED GRN 14, Rx, Sterile; 00597604117 Articular Surface AC ART SURF 56/STRIPED GRN 17, Rx, Sterile; 00597604120 Articular Surface AC ART SURF 56/STRIPED GRN 20, Rx, Sterile; 00597604123 Articular Surface AC ART SURF 56/STRIPED GRN 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2033-2013
Product Description00597101101 Provisional CR PROV FRM COMP SIZE AML, Rx, Sterile; 00597101102 Provisional CR PROV FRM COMP SIZE AMR, Rx, Sterile; 00597101201 Provisional CR PROV FRM COMP SIZE BML, Rx, Sterile; 00597101202 Provisional CR PROV FRM COMP SIZE BMR, Rx, Sterile; 00597101303 Provisional CR PROV FRM COMP SIZE CML, Rx, Sterile; 00597101304 Provisional CR PROV FRM COMP SIZE CMR, Rx, Sterile; 00597101403 Provisional CR PROV FRM COMP SIZE DML, Rx, Sterile; 00597101404 Provisional CR PROV FRM COMP SIZE DMR, Rx, Sterile; 00597101503 Provisional CR PROV FRM COMP SIZE EML, Rx, Sterile; 00597101504 Provisional CR PROV FRM COMP SIZE EMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2034-2013
Product Description00595501201 Provisional CR-FLEX FEM PROV SZ B-L, Rx, Sterile; 00595501202 Provisional CR-FLEX FEM PROV SZ B-R, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2035-2013
Product Description00598706201 Provisional CRA FEM PROV/CUT GDE SZ BML, Rx, Sterile; 00598706202 Provisional CRA FEM PROV/CUT GDE SZ BMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2036-2013
Product Description00597106126 Provisional ALL POLY PAT PROV MICRO SZ 26, Rx, Sterile; 00597106129 Provisional ALL POLY PAT PROV MICRO SZ 29, Rx, Sterile; 00597106132 Provisional ALL POLY PAT PROV MICRO SZ 32, Rx, Sterile; 00597106135 Provisional ALL POLY PAT PROV MICRO SZ 35, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2037-2013
Product Description00597106126 Provisional MIC POROUS PAT PROV 26MMX10MM, Rx, Sterile; 00597106129 Provisional MIC POROUS PAT PROV 29MMX10MM, Rx, Sterile; 00597106132 Provisional MIC POROUS PAT PROV 32MMX10MM, Rx, Sterile; 00597106135 Provisional MIC POROUS PAT PROV 35MMX10MM, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2038-2013
Product Description00597502010 Provisional AC ART SURF PROV 12/PUR 10, Rx, Sterile; 00597502012 Provisional AC ART SURF PROV 12/PUR 12, Rx, Sterile; 00597502014 Provisional AC ART SURF PROV 12/PUR 14, Rx, Sterile; 00597502017 Provisional AC ART SURF PROV 12/PUR 17, Rx, Sterile; 00597502020 Provisional AC ART SURF PROV 12/PUR 20, Rx, Sterile; 00597502023 Provisional AC ART SURF PROV 12/PUR 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2039-2013
Product Description00597503110 Provisional AC ARTSURF PROV 34/STRIPE YEL10, Rx, Sterile; 00597503112 Provisional AC ARTSURF PROV 34/STRIPE YEL12, Rx, Sterile; 00597503114 Provisional AC ARTSURF PROV 34/STRIPE YEL14, Rx, Sterile; 00597503117 Provisional AC ARTSURF PROV 34/STRIPE YEL17, Rx, Sterile; 00597503120 Provisional AC ARTSURF PROV 34/STRIPE YEL 20, Rx, Sterile; 00597503123 Provisional AC ARTSURF PROV 34/STRIPE YEL 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2040-2013
Product Description00597504110 Provisional AC ART SURF PROV 56/STR GRN 10, Rx, Sterile; 00597504112 Provisional AC ART SURF PROV 56/STR GRN 12, Rx, Sterile; 00597504114 Provisional AC ART SURF PROV 56/STR GRN 14, Rx, Sterile; 00597504117 Provisional AC ART SURF PROV 56/STR GRN 17, Rx, Sterile; 00597504120 Provisional AC ART SURF PROV 56/STR GRN 20, Rx, Sterile; 00597504123 Provisional AC ART SURF PROV 56/STR GRN 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2041-2013
Product Description00597102010 Provisional CR ART SURF PROV 12/PURPLE 10, Rx, Sterile; 00597102012 Provisional CR ART SURF PROV 12/PURPLE 12, Rx, Sterile; 00597102014 Provisional CR ART SURF PROV 12/PURPLE 14, Rx, Sterile; 00597102017 Provisional CR ART SURF PROV 12/PURPLE 17, Rx, Sterile; 00597102020 Provisional CR ART SURF PROV 12/PURPLE 20, Rx, Sterile; 00597102023 Provisional CR ART SURF PROV 12/PURPLE 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2042-2013
Product Description00597103110 Provisional CR ART SURF PROV 34/STR YEL 10, Rx, Sterile; 00597103112 Provisional CR ART SURF PROV 34/STR YEL 12, Rx, Sterile; 00597103114 Provisional CR ART SURF PROV 34/STR YEL 14, Rx, Sterile; 00597103117 Provisional CR ART SURF PROV 34/STR YEL 17, Rx, Sterile; 00597103120 Provisional CR ART SURF PROV 34/STR YEL 20, Rx, Sterile; 00597103123 Provisional CR ART SURF PROV 34/STR YEL 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2043-2013
Product Description00597104110 Provisional CR ART SURF PROV 56/STR GRN 10, Rx, Sterile; 00597104112 Provisional CR ART SURF PROV 56/STR GRN 12, Rx, Sterile; 00597104114 Provisional CR ART SURF PROV 56/STR GRN 14, Rx, Sterile; 00597104117 Provisional CR ART SURF PROV 56/STR GRN 17, Rx, Sterile; 00597104120 Provisional CR ART SURF PROV 56/STR GRN 20, Rx, Sterile; 00597104123 Provisional CR ART SURF PROV 56/STR GRN 23, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Code Info all codes
ClassificationClass II
Reason for RecallZimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.
Product Quantity192,355 all devices
Recall NumberZ-2044-2013

Class II Biologics Event

Event ID65437
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifeNet Health
CityVirginia Beach
StateVA
CountryUS
Distribution PatternMassachusetts
 

Associated Products

Product DescriptionCardiac Tissue, Non-valved
Code Info083696HV02
ClassificationClass II
Reason for RecallCardiac pulmonary patch, recovered from a donor and not tested using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, was distributed.
Product Quantity1 allograft
Recall NumberB-2097-13

Class II Devices Event

Event ID65552
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jun-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmInvacare Corporation
CityElyria
StateOH
CountryUS
Distribution PatternNationwide distribution: USA including states of: CA, FL, IN, MN, NJ, NY, OH, RI, SC, SD, TX, and VA.
 

Associated Products

Product DescriptionCHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in person. Recliner provides heat and massage after surgery.
Code InfoThe following model numbers are affected by this recall: 54PGS636-7JM; 56PLV04-TRL4LJM; 59PT09-F7CJM; 68PT96-TS7JM; 86PT26-TS7JM3; 54PLV04-TRL4LJM; 56PSR20-TS7JM; 59PT19-TFS7PJM3; 85PSR12-TS7JM3; 86PT45-T7KJM; 54PSR20-TS7JM; 56PT21-TS7JM; 65PEV943X-TS7JM3; 85PSR30-TS7JM3; 89PCHA06-TFS7HJM; 54PT26-TS7CJM3; 56PT26-TS7CJM3; 65PFS26-TS7JM; 85PSU103-TS7JM; 89PEV921X-TFS7HPJM3; 54PT45-NJM 56PT45-NJM 65PSH12-S7JM 85PT09-TS7JM3 89PFS04-TFS7HPJM3; 54PT45-TNJM; 56PT45-RNJM; 65PT09-TS7JM; 85PT19-T7JM; 89PFS13-TFS7HPJM3; 54PT45-TS7JM; 58PCHA06-TFS7HJM; 65PT21-TS7JM; 85PT26-TS7JM3; 89PFS15-TFS7HPJM; 54PT56-T7JM; 59PGS493-TFS7HPJM; 66PCHA04-TS7JM; 86PCHA06-TS7JM; 89PFS26-TFS7HPJM3; 54PT96-TS7JM3; 59PGS493-TFS7HPJM3; 66PEV923X-TS7JM3; 86PSU103-TS7JM; 89PFS32-TFS7HPJM3; 56PGS636-7JM; 59PSR12-FS7JM3; 66PFS26-TS7JM; and 86PT09-TS7JM3.
ClassificationClass II
Reason for RecallThere is a possibility of elevated temperatures in the seat pad. In addition, the hospital cord set does not agree with the labeling (information in manual).
Product Quantity285 units
Recall NumberZ-1980-2013

Class II Drugs Event

Event ID65559
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-May-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMedicis Pharmaceutical Corp
CityScottsdale
StateAZ
CountryUS
Distribution PatternNationwide, Great Britain, Mexico, Russia and The Ukraine.
 

Associated Products

Product DescriptionCLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit, Distributed by OMP, Inc., Long Beach, CA 90806, Kit is comprised of: Daily Care Foaming Cleanser (Salicylic Acid 2%) NDC 62032-111; Pore Therapy (Salicylic Acid 2%) NDC 62032-110 and Therapeutic Lotion (Benzoyl Peroxide 5%) NDC 562032-113). Product under recall is the Pore Therapy (Salicylic Acid 2%), NDC 62032-110.
Code InfoLot #11L1074, Exp 07/14
ClassificationClass II
Reason for RecallcGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles labeled as CLENZIderm M.D. Pore Therapy
Product Quantity2491 Kits
Recall NumberD-916-2013

Class II Drugs Event

Event ID65606
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-May-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmEarthlabs, Inc. DBA Wise Woman Herbals
CityCreswell
StateOR
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionEyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and distributed by: Wise Woman Herbals, Creswell, OR
Code InfoLot# 10010 Best used by: 07/14/13 Lot# 10285 Best used by: 02/16/14 Lot# 10640 Best used by: 11/09/14 Lot# 11107 Best used by: 09/16/15 Lot# 11408 Best used by: 05/04/16 Lot# 11711 Best used by: 11/23/16 Lot# 12088 Best used by: 09/04/17 Each lot number has various sizes Product numbers - 1EDCO, 2EDCO, 4EDCO, 8EDCO, 16EDCO, 32EDCO 1 (indicates package size) ED (indicates Eyebright) CO (indicates compound (blended from other finished products) Container sizes - Stock: 1 oz., 2 oz., 4 oz. Non-stock: 8 oz., 16 oz., 32 oz.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility; Lack of Assurance of Sterility; product not manufactured under sterile conditions as required for ophthalmic drug products
Product Quantity581x1oz bottles, 263x2 oz bottles, 20x4 oz bottles, 2x8 oz bottles, 1x16 oz bottle, 1x32 oz bottle
Recall NumberD-912-2013

Class II Food Event

Event ID65608
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jun-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmHarmony Chai
CityEastsound
StateWA
CountryUS
Distribution PatternRetail stores, one farmers' market in Washington State, and two internet customers in Washington State
 

Associated Products

Product DescriptionAcidified Tea in a glass bottle with a multi-colored, stick-on label that reads in part: " HARMONY Chai concentrated Fresh brewed on Orcas Island, WA Black Spiced Chai 22oz. (650 ml)***Ingredients: water, Organic Raw Sugar, Black Tea, cloves, cinnamon, Ginger, secret spices, citric Acid***7 05105 01311 4***" There is also a larger size with the same labeling except: "*** 64oz. (1892.70ml)***7 05105 01301 5***"
Code Info22 oz. Black Spiced Chai: 7 05105 01311 4 64 oz. Black Spiced Chai: 7 05105 01301 5 The recall involved all lot codes.
ClassificationClass II
Reason for RecallProduct not properly processed
Product Quantitynot availble
Recall NumberF-1846-2013
Product DescriptionAcidified Tea in a glass bottle with a multi-colored, stick-on label that reads in part: " HARMONY Chai Decaffeinated Fresh brewed on Orcas Island, WA Rooibos Chai 22oz. (624,25ml)***Ingredients: water, Organic Raw Sugar, Rooibos Tea, cloves, cinnamon, Ginger, secret spices, citric Acid***7 94504 02431 9***" There is also a larger size with the same labeling except: "*** 64oz. (1892.70ml)***7 05105 01301 5***"
Code Info22 oz. Rooibos Chai: 7 94504 02431 9 64 oz. Rooibos Chai: 7 05105 01301 5 The recall involved all lot codes.
ClassificationClass II
Reason for RecallProduct not properly processed
Product Quantitynot available
Recall NumberF-1847-2013

Class II Devices Event

Event ID65644
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMedtronic MiniMed
CityNorthridge
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and the countries of Australia, Bermuda, Brazil, Canada, Chile, Columbia, Ecuador, El Salvador, Germany, Japan, Mexico, Netherland, Paraguay, Puerto Rico, Singapore, Uruguay and Venezuela.
 

Associated Products

Product DescriptionMedtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Medtronic Paradigm series insulin infusion pumps. The two reservoirs are identical except for barrel length and as a result, maximum insulin capacity. The MMT-326A holds a maximum of 1.8ml of insulin whereas the longer MMT-332A reservoir can hold up to 3.0ml of insulin. Both reservoirs are supplied sterile and are labeled for single use. Typically, the reservoir is replaced every tow or three days at the time of infusion set replacement. The Paradigm reservoirs have a shelf life of three years post sterilization. Product Quantity Distributed (Int) 669,672 units
Code InfoMMT-326A Lot Numbers: H8437486 H8441420 H8442973 H8451531 H8486688 H8489386 H8485398 H8500423 H8500472 H8503728 H8512826 H8503372 H8510440 H8539013 H8627745 MMT-332A Lot Numbers: H8416432 H8420977 H8422490 H8424676 H8452933 H8455959 H8457716 H8459557 H8461538 H8463297 H8464121 H8467888 H8469703 H8471745 H8473271 H8476270 H8478398 H8473106 H8492449 H8491921 H8494645 H8496561 H8509305 H8512566 H8515317 H8517079 H8521052 H8541843 H8584244 H8603292 H8604958 H8635301
ClassificationClass II
Reason for RecallMedtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3.0mL) used with Medtronic Paradigm insulin pumps because they may have increased risk for leaking. A leak in the reservoir may result in delivery of less insulin than intended. In addition, if there is a leaky reservoir and an insulin blockage occurs in the infusion set, the pump may not alarm to notify users.
Product Quantity669,672 units
Recall NumberZ-1986-2013

Class II Devices Event

Event ID65678
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAtrium Medical Corporation
CityHudson
StateNH
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionPleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the insertion of thoracic catheters.
Code InfoPart Number: 17100: 10734588, 10734583, 10728237, 10728236, 10728235, 10728234, 10736244, 10736243, 10736242, 10736238, 10734590, 10734589, 10736245, 10852352, 10847222, 10847218, 10842301, 10842299, 10842297, 10840114, 10834292, 10829188, 10852337, 10852334, 10834291, 10834286, 10834284, 10860795, 10857119, 10857111, 10864592, 10864104, 10856867, 10875059, 10875046 , 10871063, 10871059, 10868989, 10879191, 10879190, 10889037, 10887634, 10887292, 10884093, 10879192, 10891329, 10884084;Part Number: 17150: 10728238, 10734584, 10823084, 10800926, 10827874, 10827874, 10834299, 10857110, 10881097, 10874228, 10867130; Part Number 17200: 10728239, 10734585, 10794372, 10802727, 10802725, 10820803, 10825183, 10834338, 10852339, 10864105, 10884087
ClassificationClass II
Reason for RecallIndividual component's IFUs are not included with the kit.
Product Quantity6,516 units
Recall NumberZ-1987-2013

Class II Food Event

Event ID65704
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Apr-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPacific Pure Aid
CitySilverton
StateOR
CountryUS
Distribution PatternCA, NJ, KY, OH, and IL Foreign - France, Ireland, Australia, England, and Hungry
 

Associated Products

Product DescriptionRoasted Red Bell Pepper Plus Powder 50 lb carton
Code InfoProduct # 68237; Lot # 2193 expiration date January 11, 2013 Lot # 2215 expiration date February 2, 2013 Lot numbers runs for a 24 hour period. The first number is the year; the last three numbers are the Julian date for the day the product was manufactured.
ClassificationClass II
Reason for RecallThe product contained gluten and is sold as gluten free.
Product Quantity59 - 50 lb cartons
Recall NumberF-1816-2013
Product DescriptionFried Onion Powder 44.092 lb carton
Code InfoProduct # DA 10686; Lot # 2171 best-by date June 19, 2013 Lot # 2178 best-by date June 26, 2013 Lot numbers runs for a 24 hour period. The first number is the year; the last three numbers are the Julian date for the day the product was manufactured.
ClassificationClass II
Reason for RecallThe product contained gluten and is sold as gluten free.
Product Quantity477 containers each weighing 44.092 lbs
Recall NumberF-1817-2013
Product DescriptionThai Chili Flake
Code InfoProduct # 68200; Lot # 2179 best-by date June 27, 2013 Lot numbers runs for a 24 hour period. The first number is the year; the last three numbers are the Julian date for the day the product was manufactured.
ClassificationClass II
Reason for RecallThe product contained gluten and is sold as gluten free.
Product Quantity23 containers at 40 lbs each
Recall NumberF-1818-2013

Class II Devices Event

Event ID65738
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Jul-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmSmith & Nephew Inc
CityMemphis
StateTN
CountryUS
Distribution PatternInternational only: Germany, France, United Arab Emirates, and United Kingdom.
 

Associated Products

Product DescriptionGENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic
Code InfoLot Number 12LM03798
ClassificationClass II
Reason for RecallThe products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts).
Product Quantity9 units
Recall NumberZ-1996-2013

Class II Food Event

Event ID65740
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmZip International Group LLC.
CityEdison
StateNJ
CountryUS
Distribution PatternIN, ND & NY
 

Associated Products

Product DescriptionMarmalade Fonariky Net 105.8 oz (3 kg) Product of Russia upc 460161417406
Code InfoNet Wt. 105.8 oz.product code SS Lot number 24
ClassificationClass II
Reason for RecallMarmalade contains undeclared colors and dyes.
Product Quantity15 cartons
Recall NumberF-1813-2013

Class II Devices Event

Event ID65745
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jul-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAspen Surgical Products, Inc.
CityCaledonia
StateMI
CountryUS
Distribution PatternWorldwide Distribution - US Nationwide in the state of Florida and in the countries of , Netherlands, and Reditch Worcestershire England
 

Associated Products

Product DescriptionDistributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile, Box 1000 pouches 5 strips /pouch, Pouch , 5 strips 6 mm X100 mm Sterile EO Product Number: 40-2893: Wound Closure Strips , Sterile (1,000pouches/box) Rx; Pouch Label: Wound Closure Strips 6 mm X100 mm, 1/4" X 4 ", Rx Product Usage: intended for skin closure and closure support for sutures and staples
Code Info Product 40-2894: Lot Numbers/Expiration Date Lot Numbers/Expiration 2690-090730 2014-07 2690-111128 2016-11 2690-091207 2014-12 2690-111205 2016-12 2690-100309 2015-03 2690-29661 2017-01 2690-100407 2015-04 2690-29775 2017-01 2690-100429 2015-04 2690-120307 2017-03 2690-100505 2015-05 2690-120410 2017-03 2690-100603 2015-06 2690-120425 2017-04 2690-100607 2015-06 2690-120517 2017-05 2690-100615 2015-06 2690-120803 2017-08 2690-100617 2015-06 2690-120822 2017-08 2690-100709 2015-07 2690-120917 2017-09 2690-100728 2015-07 2690-121019 2017-10 2690-101001 2015-10 2690-121106 2017-10 2690-101101 2015-11 2690-121105 2017-11 2690-101117 2015-11 2690-121128 2017-11 2690-101221 2015-12 2690-130107 2018-01 2690-110121 2016-01 2690-130103 2018-01 2690-110201 2016-02 2690-130109 2018-01 2690-110217 2016-02 2690-130215 2018-02 2690-110223 2016-02 2690-130307 2018-03 2690-110310 2016-03 2690-130213 2018-02 2690-110328 2016-03 2690-130306 2018-03 2690-110415 2016-04 2690-130403 2018-04 2690-110426 2016-04 2690-130409 2018-04 2690-110511 2016-02 2690-130415 2018-04 2690-120804 2017-08 " Product 39-0058 (outside USA): Lot Numbers/ Expiration Date 11305 2016-05 11731 2017-03 11974 2017-08 12353 2018-04 " Product 40-2893 (outside USA): Lot Numbers/ Expiration Date 10425 2014-11 10504 2014-07 10727 2015-02 11178 2015-10 11179 2015-12 11260 2016-01 11261 2016-02 11558 2016-07
ClassificationClass II
Reason for RecallAspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sampling indicated the product may not be sterile. Using the recalled product could lead to infection which may require further treatment including the use of antibiotics. There have been no reports of injuries or illnesses as of 7/18/2013.
Product Quantity3286 boxes ( 6,353,000)
Recall NumberZ-1988-2013

Class II Drugs Event

Event ID65756
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jul-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmVistaPharm, Inc.
CityLargo
StateFL
CountryUS
Distribution PatternNationwide.
 

Associated Products

Product DescriptionNystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
Code InfoLot # 240200, 243000, 244800, 245600, 250800 and 253600. Exp 06/13.
ClassificationClass II
Reason for RecallFailed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
Product Quantity1,707,050 cups / 5ml ea.
Recall NumberD-913-2013

Class II Food Event

Event ID65765
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling Firm Plum Inc
CityEmeryville
StateCA
CountryUS
Distribution PatternNationwide and Bermuda.
 

Associated Products

Product DescriptionPlum Organics Mighty 4 Essential nutrition blend; Kale, Strawberry, Amaranth, Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case USPC: 846675003409; Case USPC: 00846675003522 Distributed by Plum Inc., Emery ville, CA.
Code InfoItem 3522 6-Mar-14 7-Mar-14 23-Mar-14 24-Mar-14 25-Mar-14 4-Apr-14 5-Apr-14 6-Apr-14 9-Apr-14 10-Apr-14 11-Apr-14 12-Apr-14 13-Apr-14 18-Apr-14 19-Apr-14 5-May-14 10-May-14 11-May-14 18-May-14 19-May-14 20-May-14 26-May-14 30-May-14 5-Jul-14 6-Jul-14
ClassificationClass II
Reason for RecallIntermittent ineffective hermetic seal on pouch package leading to potential spoilage after thermal processing of acidified product .
Product Quantity81,347 cases, total of all varieties
Recall NumberF-1819-2013
Product DescriptionPlum Organics Mighty 4 Essential nutrition blend; Spinach, Kiwi, Barley, Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case USPC: 846675003447; Case UPC: 00846675003560 Distributed by Plum Inc., Emeryville, CA.
Code InfoItem 3560 8-Mar-14 11-Mar-14 19-Mar-14 20-Mar-14 21-Mar-14 22-Mar-14 31-Mar-14 1-Apr-14 7-Apr-14 8-Apr-14 9-Apr-14 23-Apr-14 24-Apr-14 25-Apr-14 27-Apr-14 28-Apr-14 29-Apr-14 4-May-14 14-May-14 15-May-14 16-May-14 17-May-14 25-May-14 26-May-14 28-Jun-14 29-Jun-14 30-Jun-14.
ClassificationClass II
Reason for RecallIntermittent ineffective hermetic seal on pouch package leading to potential spoilage after thermal processing of acidified product .
Product Quantity81, 347 cases, total number for all varieties.
Recall NumberF-1820-2013
Product DescriptionPlum Organics Mighty 4 Essential nutrition blend; Sweet Potato Blueberry Millet , Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case USPC: 846675003416; Case USPC:00846675003539 Distributed by Plum Inc., Emeryville, CA.
Code InfoItem 3539 6-Mar-14 12-Mar-14 25-Mar-14 26-Mar-14 27-Mar-14 2-Apr-14 3-Apr-14 4-Apr-14 21-Apr-14 22-Apr-14 23-Apr-14 2-May-14 3-May-14 4-May-14 12-May-14 13-May-14 20-May-14 21-May-14 22-May-14 23-May-14 29-May-14 31-May-14 6-Jul-14 7-Jul-14 8-Jul-14 9-Jul-14 10-Jul-14 14-Jul-14 15-Jul-14.
ClassificationClass II
Reason for RecallIntermittent ineffective hermetic seal on pouch package leading to potential spoilage after thermal processing of acidified product .
Product Quantity81,347 cases. total number for all varieties
Recall NumberF-1821-2013
Product DescriptionPlum Organics Mighty 4 Essential nutrition blend; Purple Carrot Berry Quinoa, Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case USPC: 846675003430; Case UPC: 00846675003553. Distributed by Plum Inc., Emeryville, CA.
Code InfoItem 3553 12-Mar-14 13-Mar-14 14-Mar-14 27-Mar-14 28-Mar-14 29-Mar-14 30-Mar-14 19-Apr-14 20-Apr-14 26-Apr-14 29-Apr-14 1-May-14 8-May-14 9-May-14 20-May-14 23-May-14 24-May-14 25-May-14 13-Jul-14 14-Jul-14.
ClassificationClass II
Reason for RecallIntermittent ineffective hermetic seal on pouch package leading to potential spoilage after thermal processing of acidified product .
Product Quantity81,347 cases, total for all varieties
Recall NumberF-1822-2013
Product DescriptionPlum Organics Mighty 4 Essential nutrition blend; Pumpkin Pomegranate Quinoa, Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case UPC: 846675003454 Case USPC: 00846675003577 Distributed by Plum Inc., Emeryville, CA.
Code InfoItem 3577 11-Mar-14 12-Mar-14 15-Mar-14 16-Mar-14 17-Mar-14 18-Mar-14 25-Apr-14 26-Apr-14 27-Apr-14 5-May-14 6-May-14 7-May-14 8-May-14 26-May-14 27-May-14 28-May-14 31-May-14 3-Jun-14 6-Jun-14 11-Jun-14 12-Jun-14 11-Jul-14 12-Jul-14 23-Mar-14 7-Apr-14 10-Apr-14 11-Apr-14 19-May-14.
ClassificationClass II
Reason for RecallIntermittent ineffective hermetic seal on pouch package leading to potential spoilage after thermal processing of acidified product .
Product Quantity81,347 cases; total for all varieties.
Recall NumberF-1823-2013

Class II Devices Event

Event ID65785
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGyrus Medical, Inc
CityOsseo
StateMN
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, FL, GA, IL, IN, KS,KY, MD, MA, MI, MN, MS, MO, NY, NC, OH, PA, SD, TN, TX, VA and WI., and the countries of BRAZIL, CHINA, AUSTRALIA, CHINA, GERMANY and INDIA.
 

Associated Products

Product DescriptionGYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.
Code InfoREF 3740 150080AC 258624MC G166568CC 381809KD 408020AE JF480565 NY492562 REF 3740PK 128971JB 226730IC 226742IC 226743IC 431894CE 431895CE G128677JB REF 94201PK 102290EB 147428AC 167021CC 198596GC 204439HC 204451HC 249022KC 278142BD 320659DD 344712FD 363953ID 373761JD 389095MD 418231BE G386412KD G461037EE JF493195
ClassificationClass II
Reason for RecallOn April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study conducted as part of a new market submission. The study found that one of 60 Dissector units that underwent 3 year accelerated aging failed the dye penetration test indicating that the seal on sterile packaging was compromised. The dissector products are labeled with a 3 year shelf life.
Product Quantity1140
Recall NumberZ-1983-2013

Class II Devices Event

Event ID65797
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternUS Distribution in the state of CT.
 

Associated Products

Product DescriptionThe Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combination of a cardiac dedicated nuclear imaging subsystem and LightSpeed GE CT subsystem. This system is intended for cardiac Nuclear Medicine (NM) diagnostic imaging applications, head and body CT diagnostic imaging applications, as well as attenuation correction and anatomical localization. The Discovery product is a SPECT-CT system. It consists of two back-to-back gantries, the NM Gantry, carrying solid state Cadmium Zinc Telluride (CZT) detectors, the CT Gantry, a single patient table, power distribution unit (PDU), NMV integrated power supply (IPS) , two operator consoles with two acquisition systems (Nuclear and CT), interconnecting cables and associated accessories (ECG gating, etc.).
Code InfoPart numbers H3000SA UFC Cardiac SPECT System, H3001JA UFC Gantry, H3001JE UFC VCT Connecting Kit, H3001JF DISCOVERY NMV/CT 570C Connecting Kit.
ClassificationClass II
Reason for RecallGE Healthcare has recently become aware of an incident where the wrong part of the patient body was scanned during a CT standalone exam with the Discovery NM/CT 570c
Product Quantity10 Systems
Recall NumberZ-1967-2013

Class II Devices Event

Event ID65798
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBoston Scientific CRM Corp
CitySaint Paul
StateMN
CountryUS
Distribution PatternUS distribution in the state of Tennessee.
 

Associated Products

Product DescriptionBoston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
Code InfoSerial # 108063
ClassificationClass II
Reason for RecallBoston Scientific CRM manufacturing quality system recently discovered test artifacts (related to shock charge time) in a small number of implantable defibrillators (ENERGEN DR ICD model E143) which require further investigation. While these devices successfully passed all manufacturing tests and met all requirements, they showed a slightly longer charge time than other devices during a manufacturing test.
Product Quantity1 (4 devices were implanted and are not part of this action)
Recall NumberZ-1979-2013

Class II Food Event

Event ID65825
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jul-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmJohnson Brothers Liquor Company, Inc
CitySaint Paul
StateMN
CountryUS
Distribution PatternAL, AZ, GA, IN,KY, MI, MO , NE, NV, NC, OH, SC.
 

Associated Products

Product DescriptionEvviva Fresh Peach Spumante, UPC 84279-99137
Code InfoUPC 84279-99137
ClassificationClass II
Reason for RecallEvviva Fresh Peach Spumante and Evviva Strawberry Spumante are being recalled because they contain coloring ingredients not permitted for use in the United States.
Product Quantity1750 cases (12 bottles/case)
Recall NumberF-1814-2013
Product DescriptionEvviva Strawberry Spumante, UPC 84279-99138
Code InfoUPC 84279-99138
ClassificationClass II
Reason for RecallEvviva Fresh Peach Spumante and Evviva Strawberry Spumante are being recalled because they contain coloring ingredients not permitted for use in the United States.
Product Quantity1750 cases (12 bottles/case)
Recall NumberF-1815-2013

Class II Devices Event

Event ID65832
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBeckman Coulter Inc.
CityBrea
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA and the country of Canada.
 

Associated Products

Product DescriptionHemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.
Code InfoPart Number 395067. All in-date lots (42 lots total). Lot Number: Manuf. Date: Exp. Date: M207143 27Jul2012 01/31/2014 M208454 21Sep2012 02/28/2014 M210079 19Oct2012 03/31/2014 M211100 30Nov2012 05/31/2014 M212122 20Dec2012 06/30/2014 M212203 17Jan2013 06/30/2014 M301418 22Feb2013 & 28Feb2013 07/31/2014 M202086 24Feb2012 07/31/2013 M203081 16Mar2012 07/31/2013 M203081A 23Mar2012 07/31/2013 M203262 06Apr2012 08/31/2013 M203098 13Apr2012 08/31/2013 M203098A 20Apr2012 08/31/2013 M203098B 25Apr2012 08/31/2013 M203080 27Apr2012 10/31/2013 M203080A 04May2012 10/31/2013 M203080B 11May2012 10/31/2013 M204276 18May2012 09/30/2013 M205199 12May2012 09/30/2013 M205288 22May2012 11/30/2013 M206021 06June2012 11/30/2013 M206166 18June2012 12/31/2013 M207072 05July2012 12/31/2013 M207143 27July2012 01/31/2014 M206259 26June2012 12/31/2013 M207332 30July2012 01/31/2014 M208345 22Aug2012 01/31/2014 M208272 24Aug2012 02/28/2014 M208454 06Sep2012 02/28/2014 M209135 19Sep2012 03/31/2014 M210079 04Oct2012 03/31/2014 M210169 27Oct2012 04/30/2014 M211100 10Nov2012 05/31/2014 M211078 01Dec2012 05/31/2014 M212122 12Dec2012 06/30/2014 M212203 03Jan2013 06/30/2014 M301324 16Jan2013 07/31/2014 M301418 11Feb2013 07/31/2014 M302410 27Feb2013 08/31/2014 M303157 15Mar2013 09/30/2014 M303223 26Mar2013 09/30/2014 M304130 09Apr2013 09/30/2014
ClassificationClass II
Reason for RecallBeckman Coulter has received a customer complaint that suggests trending of positive results has increased from approximately 4% to 1 0%. As a result of our investigation, Beckman Coulter has confinned an increase in sensitivity at the borderline positive level. " This testing also demonstrated that the issue does not affect results reported as negative.
Product Quantity68,116 units
Recall NumberZ-1997-2013

Class II Devices Event

Event ID65833
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmZimmer, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including the states of CT, FL, GA, IL, IN, KS, KY, MA, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VI, and WI, and the countries of Singapore, Canada, Mexico, Arab Emirates, Saudi Arabia, and Hong Kong.
 

Associated Products

Product DescriptionMoore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bone cement.
Code Info25621400 203600 25711600 203800 25621300 25621500 203700 206500 26601000 60025547 25003900 60016485 60028037 60028040 60028041 60028042 60016492 60028045 60016487 60028036 60028038 60028039 60028043 60034329 60034330 60039203 60038245 60043146 60039161 60039170 60039173 25209700 60039184 60039186 60039201 60039207 60016491 60028044 60039214 60039217 60039218 60039220 60039222 60039223 60039224 60034328 60039158 60039199 60039216 223900 365036 365034 365037 60016497 60039221 60043147 60039166 60039168 60039182 60039183 60039209 60039219 60057784 60039213 60063014 60064868 60063150 60064885 60057785 60064862 60064867 60064886 60064888 60063042 60076067 60076073 60079812 60064887 60083643 60076089 60095965 60095967 60096024 60095966 60095988 60095986 60095978 60095989 60118708 365491 365488 365452 365495 365487 365455 365468 365460 365459 60096023 365469 365610 365470 365609 365476 365473 365483 365611 60187598 365608 60233503 366219 60278488 60293376 60301903 60301909 60301910 366367 366361 60293345 366362 366366 366371 366365 366359 366370 60335336 366368 60335394 366364 60331363 366369 366360 366440 60370153 366363 60323737 60441602 60459779 60501809 60506751 60553757 60532130 60609997 60610068 60506791 60717634 60717637 60717636 60750867 60750869 60823726 60834952 60845453 60933807 60940767 60979560 60990032 60659033 61199167 61496604 61501406 61582442 61582445 61582447 61582449 61582444 61599941 61496594 61658306 60750868 369883 61748928 61783682 61748929 61783684 61815823 61817989 61859934 61927043 61938355 61964729 62051548 62211964 62200345 62200346 62197219 62278696 62258850 62273053 62330362 62330364 62322473 62330365
ClassificationClass II
Reason for RecallZimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a single packaging tray configuration, which consists of an inner and outer sterile tray, did not pass the established requirements for seal integrity and seal strength. Specifically, there was approximately 2% of either the inner or outer tray that did not pass the established requirements for seal integrity and seal strength.
Product Quantity1,710 units are in distribution
Recall NumberZ-1981-2013

Class II Devices Event

Event ID65834
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jul-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlue Belt Technologies MN
CityPlymouth
StateMN
CountryUS
Distribution PatternWorldwide Distribution and US Nationwide in the states of: CA and PA. United Kingdom.
 

Associated Products

Product DescriptionBlue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.
Code InfoLot: D130432, expires February 2018
ClassificationClass II
Reason for RecallBlue Belt Technologies is recalling sterile Monitor Drapes used with their Navio PFS system during orthopedic knee surgery. The drapes are used to cover the Navio PFS system computer monitor and arm assembly and provide a sterile barrier in the surgical suite. The defect is evident when the computer monitor is being draped. The front section of the drape separates from the rest of the drape at the bond joint.
Product Quantity60 cartons (20 pieces/carton) 40 in EU, 20 in US.
Recall NumberZ-1995-2013

Class II Devices Event

Event ID65839
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Healthcare Inc.
CityAndover
StateMA
CountryUS
Distribution PatternUS Nationwide Distribution including Puerto Rico
 

Associated Products

Product DescriptionPhilips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing, or lying in the prone or supine positions. Not intended for mammography.
Code InfoSystem Code - 712001
ClassificationClass II
Reason for RecallThe Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU does not provide tolerance levels for several generator values as required by 1020.30(h)(3).
Product Quantity240 systems US -- 1 system within Puerto Rico
Recall NumberZ-1964-2013

Class II Food Event

Event ID65845
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Jul-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSensoryEffects Powder Systems
CityDefiance
StateOH
CountryUS
Distribution PatternProduct was shipped to the following states: KY, MN, SD, WA. Product was also shipped to Canada.
 

Associated Products

Product DescriptionMaple flavored lipid-based inclusions. Maple NT-RF and Maple NT-MF, NET WT: 50 lbs, Ingredients: Sugar, vegetable oil (palm, palm kernel), wheat flour, cocoa powder, glucose, extractives of foenugreek, maple sugar, caramel color, soy lecithin. SensoryEffects® , 136 Fox Run Dr., Defiance, OH 43512
Code InfoItem code 20526 Maple NT-RF lot 2013-36707 and Item code 20525 Maple NT-MF lot 2013-36708
ClassificationClass II
Reason for RecallThe firm was notified by a customer that a random sample from lot 2013-36707 tested positive for Salmonella.
Product QuantityLot 2013-36707  120/50 lb boxes. Lot 2013-36708  247/50 lb boxes
Recall NumberF-1848-2013

Class II Devices Event

Event ID65855
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmEndogastric Solutions Inc
CityRedmond
StateWA
CountryUS
Distribution PatternDistributed nationwide and Italy.
 

Associated Products

Product DescriptionEndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.
Code InfoUN-EXPIRED devices with Expiration dates (8/31/2013, 11/30/2013, 12/31/2013, and 1/31/2014) and following LOT numbers: 401132, 401147, 401152, 401156, 401159, 401167, 401207, 401214, 401219, 401220, 401225, 401227, 401230, 401233, 401236, 401246, 401248, 401251, 401257, 401258, 401259, 401267, 401269, 401271, 401274, and 401276. EXPIRED devices with Expired dates (1/31/2013, 2/28/2013, 3/31/2013 4/30/2013, 5/31/2013, 6/30/2013, and 7/31/2013) and following LOT numbers: 400923, 400927, 400934, 400937, 400940, 400943, 400949, 400961, 400963, 400973, 400976, 400979, 400980, 400981, 400984, 400986, 400992, 400994, 400997, 400998, 401004, 401005, 401009, 401012, 401016, 401017, 401024, 401026, 401029, 401056, 401058, 401059, 401060, 401061, 401062, 401063, 401065, 401072, 401074, 401076, 401079, 401084, 401085, 401092, 401094, 401107, 401114, 401115, 401121, 401129, and 401130.
ClassificationClass II
Reason for RecallEndogastric Solutions, Inc. has received a limited number of reports relating to the loss of tissue mold control when operating the R2001 or R2002 EsophyX2 device. In one case, surgical intervention was necessary to remove the device.
Product Quantity5192 units in the US and 41 units outside the US
Recall NumberZ-1982-2013

Class II Devices Event

Event ID65862
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide in the states of AL, AK, AR, CA, CO, CT, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, MD, MA, NMI, MN, MS, MO, NE, NV,NH,NJ, NM, NY, NC,ND, OH, OK OR, PA,SC, SD, TN, TX, UT, VA, WA, WV, WI, WY and the countries of CANADA, FRANCE GERMANY, GREAT BRITAIN ITALY, PANAMA, SAUDI ARABIA.
 

Associated Products

Product DescriptionGE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
Code InfoFMI# 10879: CRT Monitor Suspension Supporting Hardware Serial # 00000002608GQ8 00000002734GQ2 00000002735GQ9 00000002736GQ7 00000002838GQ1 00000003208GQ6 00000003209GQ4 00000004078GQ2 00000004079GQ0 00000004083GQ2 00000004084GQ0 00000004086GQ5 00000004087GQ3 00000004102GQ0 00000004103GQ8 00000004104GQ6 00000004105GQ3 00000004106GQ1 00000004107GQ9 00000004109GQ5 00000004873GQ6 00000004874GQ4 00000004875GQ1 00000004876GQ9 00000004878GQ5 00000004881GQ9 00000004882GQ7 00000005522GQ8 00000005523GQ6 00000005524GQ4 00000005525GQ1 00000005527GQ7 00000005528GQ5 00000005529GQ3 00000005530GQ1 00000005885GQ9 00000005886GQ7 00000005887GQ5 00000006565GQ6 00000006566GQ4 00000006742GQ1 00000006743GQ9 00000006744GQ7 00000006745GQ4 00000006746GQ2 00000006747GQ0 00000006748GQ8 00000006752GQ0 00000006753GQ8 00000006755GQ3 00000006756GQ1 00000006757GQ9 00000006758GQ7 00000007111GQ8 00000007112GQ6 00000007113GQ4 00000007114GQ2 00000007115GQ9 00000007116GQ7 00000007117GQ5 00000007118GQ3 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00000984821WK9 00000984822WK7 00000984824WK3 00000984825WK0 00000984826WK8 00000984827WK6 00000984828WK4 00000984829WK2 00000984830WK0 00000984831WK8 00000984832WK6 00000984833WK4 00000984834WK2 00000985547WK9 00000985548WK7 00000985549WK5 00000985550WK3 00000985945WK5 00000985946WK3 00000985947WK1 00000985948WK9 00000985949WK7 00000985950WK5 00000985951WK3 00000985952WK1 00000985953WK9 00000985954WK7 00000985955WK4 00000985956WK2 00000986944WK7 00000986945WK4 00000987213WK6 00000987214WK4 00000987215WK1 00000987216WK9 00000987217WK7 00000987218WK5 00000987219WK3 00000987220WK1 00000987222WK7 00000987223WK5 00000987224WK3 00000987225WK0 00000987226WK8 00000987231WK8 00000987233WK4 00000987234WK2 00000987238WK3 00000987245WK8 00000987253WK2 00000987254WK0 00000987321WK7 00000987323WK3 00000987332WK4 00000987333WK2 00000987336WK5 00000987337WK3 00000987338WK1 00000988559WK1 00000988560WK9 00000988561WK7 00000988562WK5 00000988563WK3 00000988564WK1 00000988565WK8 00000988566WK6 00000988567WK4 00000988568WK2 00000988569WK0 00000988570WK8 00000988571WK6 00000988572WK4 00000988573WK2 00000988574WK0 00000988575WK7 00000988576WK5 00000988577WK3 00000988578WK1 00000988579WK9 00000988580WK7 00000988581WK5 00000989367WK8 00000989369WK4 00000989371WK0 00000989372WK8 00000989375WK1 00000989376WK9 00000989378WK5 00000989379WK3 00000989380WK1 00000989381WK9 00000989382WK7 00000989383WK5 00000989384WK3 00000989386WK8 00012966GP8000 00000002609GQ6 00000004108GQ7 00000009899GQ6 00000009902GQ8 00000009908GQ5 00000013252GP2 00000013555GP8 00000013847GP9 00000014154GP9 00000006749GQ6 00000010410GP9 00000989377WK7 00000006754GQ6 00000008891GP4 00000012812GP4 00000012841GP3 00000013546GP7 00000984815WK1 00000984823WK5 00000989368WK6 00000989370WK2 00000006759GQ5 00000013557GP4 00000012957GP7
ClassificationClass II
Reason for RecallGE Healthcare has recently become aware of a potential safety issue involving the overhead Video Monitor Suspension involving Precision 500D Systems. There is a potential for the locking nut to loosen out of the Video Monitor Suspension yoke which could result in impact. This will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing and a screw in the absence of the locking-nut. To date, no complaint or injury has been reported due to this issue.
Product Quantity445 (421 US, 24 OUS)
Recall NumberZ-1989-2013

Class II Devices Event

Event ID65866
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Aug-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGetinge USA Inc
CityRochester
StateNY
CountryUS
Distribution PatternWorldwide Distribution - USA and the country of Canada.
 

Associated Products

Product DescriptionGetinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 14623. Getinge Assure AccuFast Biological Indicators (BIs) are designed for biological testing of 121°C, 132°C, 134°C and 135°C steam sterilization cycles. The AccuFast BI is a self-contained biological indicator containing Geobacillus stearothermophilus inoculated on a paper carrier and placed in a plastic vial with a small glass ampule containing sterile culture medium. After activation, the plastic vial serves as a culture tube. The chemical indicator on the label changes from blue to black when exposed to steam, distinguishing exposed from unexposed units. This indicator does not indicate adequate sterilization.
Code InfoLOT SR-430 (Expiration 02/06/2014)
ClassificationClass II
Reason for RecallAccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viability. This could result in a false negative (or pass) when exposed to sub-lethal sterilization parameters.
Product QuantityCatalog # 61301606636: 78 Packs (3900 BIs); Catalog # 61301606637: 43 Packs (4300 BIs)
Recall NumberZ-1994-2013

Class II Devices Event

Event ID65869
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSorin Group USA, Inc.
CityArvada
StateCO
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionEdwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.
Code InfoModel S099B
ClassificationClass II
Reason for RecallSorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch.
Product Quantity18,927 packs
Recall NumberZ-1985-2013

Class II Devices Event

Event ID65888
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Communications
CityFlower Mound
StateTX
CountryUS
Distribution PatternWorldwide Distributio: US natiowide and to the country of Canada.
 

Associated Products

Product DescriptionStryker Visum 300 Ceiling-mounted Exam Light.
Code InfoProduct sold under the following part numbers: 0682001410A, 0682001410B, 0682001410C, 0682001410D, 0682001410E, 0682001410F, 0682001410G, and 0682001410H and shipped prior to February 28, 2013.
ClassificationClass II
Reason for RecallPotential incomplete final weld on the drop tube flange.
Product Quantity1,375 units
Recall NumberZ-1992-2013

Class II Devices Event

Event ID65908
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Aug-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmMedicel Ag
CityWolfhalden
State
CountryCH
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionProduct Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a STAAR Surgical Collamer® nanoFLEX or Afinity IOLs, through surgical procedure in a human eye.
Code InfoItem number 37-0000-08 Lot number of the recalled products: LOT121402
ClassificationClass II
Reason for RecallThe firm initiated this recall of one lot (121402) of nanoPOINT Injectors after they noticed that Tyvek lids might have been damaged and, therefore, the stability of the sterile barrier might be negatively affected.
Product Quantity68 boxes or 680 units
Recall NumberZ-1984-2013

Class II Food Event

Event ID65971
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Aug-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmMariposa Baking Co.
CityOakland
StateCA
CountryUS
Distribution Patternone distributor in CA. Number of retail locations forthcoming.
 

Associated Products

Product DescriptionPenguinos - four cream filled chocolate cupcakes: gluten, wheat & dairy free & vegan; 4 x 2.2oz cupcakes, net wt 8.8 oz. Ingredients: organic unrefined cane sugar, filtered water, expeller pressed canola oil, rice flour, cocoa powder, tapioca starch, potato starch, Ener-G egg Replacer, gluten free rice milk, organic palm oil shortening, salt, baking soda, natural vanilla, powder, cocoa butter, xanthan gum, natural flavors (gluten free and began) baking powder, pure vanilla extract. Mariposa Baking Co., 5427 Telegraph Ave., D3, Oakland, Ca 94609
Code InfoLot 73-39 (on outer case) Julian date 17913 printed on plastic film of individually wrapped cupcake. If frozen, expiry date of 9/28/13.
ClassificationClass II
Reason for RecallMariposa Baking received a complaint from consumer who found a piece of coconut in a cupcake. Coconut is not an ingredient of the product and was not listed on the ingredient label
Product Quantity48 cases (48 cupcakes per case)
Recall NumberF-1812-2013

Class III Biologics Event

Event ID40040
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Apr-05
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBiomat USA, Inc.
CityPhoenix
StateAZ
CountryUS
Distribution PatternSpain
 

Associated Products

Product DescriptionSource Plasma
Code Info0230045965, 0230046276
ClassificationClass III
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity2 units
Recall NumberB-2053-13

Class III Biologics Event

Event ID40045
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Apr-05
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBiomat USA, Inc.
CityPhoenix
StateAZ
CountryUS
Distribution PatternCA, Spain
 

Associated Products

Product DescriptionSource Plasma
Code Info0230005934 0230006594 0230007010 0230007704 0230008026 0230008774 0230009105 0230009716 0230010053 0230010737 0230011090 0230011783 0230012190 0230012866 0230013242 0230013874 0230014166 0230014835 0230015137 0230015838 0230016157 0230016877 0230017197 0230017916 0230018140 0230018821 0230019107 0230019832 0230020173 0230020889 0230021231 0230022001 0230022295 0230023406 0230023699 0230024368 0230024663
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor with a history of living with someone who is HIV positive, were distributed.
Product Quantity37 units
Recall NumberB-2052-13

Class III Biologics Event

Event ID41722
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Mar-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTri-counties Blood Bank
CityPhoenix
StateAZ
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoGW79769; GW79769
ClassificationClass III
Reason for RecallBlood products, were not quarantined or measured to confirm an acceptable RBC volume, were distributed.
Product Quantity2 units
Recall NumberB-1850-13

Class III Biologics Event

Event ID42016
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Mar-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTri-counties Blood Bank
CityPhoenix
StateAZ
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoFZ66520; FZ66520
ClassificationClass III
Reason for RecallBlood products, quality control and distribution of products that did not meet specifications, were distributed.
Product Quantity2 units
Recall NumberB-1851-13

Class III Biologics Event

Event ID42060
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Apr-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTri-counties Blood Bank
CitySan Luis Obispo
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionCryoprecipitated AHF, Pooled
Code InfoLF38077; LF38078; LF38079; LF38080; LF38081; LF38082; LF38084; LF38085
ClassificationClass III
Reason for RecallBlood products, which were not frozen within 1 hour of production, were distributed.
Product Quantity8 units
Recall NumberB-1852-13

Class III Biologics Event

Event ID42243
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Jun-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTri-counties Blood Bank
CitySan Luis Obispo
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoGW81381
ClassificationClass III
Reason for RecallBlood product, during irradiation process was out of storage greater than 30 minutes, was distributed.
Product Quantity1 unit
Recall NumberB-1853-13

Class III Biologics Event

Event ID42768
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Aug-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionCryoprecipitated AHF
Code Info2109548
ClassificationClass III
Reason for RecallBlood product was not frozen in required time, was distributed.
Product Quantity1 unit
Recall NumberB-1385-13

Class III Biologics Event

Event ID43967
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Dec-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Bank Of San Bernardino and Riverside Counties
CitySan Bernardino
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoGS89507;GS90434;GS90437;GS90439;GS90441;GS90445;GS88058;GS90444;GS90446
ClassificationClass III
Reason for RecallBlood products, for which storage condition was outside the acceptable range, were distributed.
Product Quantity9 units
Recall NumberB-2036-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoGS89507;GS89508;GS89768;GS89768;GS90434;GS90435;GS88058;GS90435;GS90436;GS90436;GS90439;GS90440;GS88056;GS88056;GS88058;GS90437;GS90443;GS90446;GS90449;GS89768;GS90445;GS90445;GS90446;GS90451
ClassificationClass III
Reason for RecallBlood products, for which storage condition was outside the acceptable range, were distributed.
Product Quantity24 units
Recall NumberB-2037-13

Class III Biologics Event

Event ID46128
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Nov-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBlood Bank of San Bernardino and Riverside Counties
CitySan Bernardino
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoGW82775; GW82775; GW82775; GW82775
ClassificationClass III
Reason for RecallBlood products, not prepared in accordance with specifications, were distributed.
Product Quantity4 units
Recall NumberB-2006-13

Class III Biologics Event

Event ID65000
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Apr-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmMedic Inc
CityKnoxville
StateTN
CountryUS
Distribution PatternSwitzerland
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW071212065186
ClassificationClass III
Reason for RecallBlood product, which did not meet the acceptable product specifications, was distributed.
Product Quantity1 unit
Recall NumberB-1732-13

Class III Biologics Event

Event ID65219
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Mar-13
Initial Firm Notification of Consignee or Public Other
Recalling FirmAmerican National Red Cross
CityColumbus
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info16GY41376;
ClassificationClass III
Reason for RecallBlood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-2103-13

Class III Biologics Event

Event ID65265
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Apr-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Systems Inc
CityScottsdale
StateAZ
CountryUS
Distribution PatternIL, AZ
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW0410130357788; W041013044809A; W041013044904C; W0410130449068; W0410130499779; W041013049992B
ClassificationClass III
Reason for RecallBlood products, collected using an expired blood collection set, were distributed.
Product Quantity6 units
Recall NumberB-2147-13

Class III Biologics Event

Event ID65507
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLife Technologies Holdings Pte Ltd
CitySingapore
State
CountrySG
Distribution PatternDE,. IL, MA, MN,NE, OR.
 

Associated Products

Product DescriptionApplied BioSystems (AB) Hi-Di Formamide, 5 ml used with the Hi-DI Formamide 3500 Dx Series. In-Vitro Diagnostic Part Number: 4404307
Code InfoLot Number: 1302029
ClassificationClass III
Reason for RecallInjection solvent for use with genetic analyzers, stored in warehouse at improper temperatures, was distributed.
Product Quantity1 Bottle
Recall NumberB-2151-13

Class III Drugs Event

Event ID65663
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStayma Consulting Service, LLC.
CitySuwanee
StateGA
CountryUS
Distribution PatternNationwide.
 

Associated Products

Product DescriptionDuet DHA Balanced, 1) 30 count tablet blister cards and 5 count softgels blister cards combination pack (NDC 44118-775-30 and NDC 44118-800-30) 2) physician samples (carton contain 7 envelopes each with one 5 count tablet blister card and 5 softgels (NDC 44118-800-05) Rx only, Manufactured for Eckson Labs, Wilmington, DE
Code Info1) NDC 44118-775-30, Lots 12120001, exp. 10/14 and 12120002, exp. 10/14; NDC 44118-800-30, Lots 12120001, exp 10/14 and 12080002, exp 8/14 2) Physician Samples: NDC 44118-800-05, Lot 12080001 exp. 8/14 and 12120002, exp. 10/14
ClassificationClass III
Reason for RecallSubpotent; Beta carotene (Vitamin A)
Product Quantity1) 12,278 and 28476; 2) 23740
Recall NumberD-894-2013
Product DescriptionDuet DHA 400, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Rx only, Manufactured for Eckson Labs, Wilmington, DE (NDC 44118-807-30) --- Also Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-807-30)
Code InfoNDC 44118-807-30 Lots 40614, exp. 9/14 and 40614A, exp. 9/14 NDC 76331-807-30 lot 39736A, exp. 3/2014, and lot 41667, exp. 12/2014
ClassificationClass III
Reason for RecallSubpotent; Beta carotene (Vitamin A)
Product Quantity1,460 and 2,990
Recall NumberD-895-2013
Product DescriptionDuet DHA 400 ec, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Rx only, Manufactured for Eckson Labs, Wilmington, DE (NDC 44118-809-30) and Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-809-30)
Code InfoNDC 44118-809-30; Lot 40614B, exp. 9/14 and NDC 76331-809-30; lot 39736A, exp. 3/2014,
ClassificationClass III
Reason for RecallSubpotent; Beta carotene (Vitamin A)
Product QuantityNDC 44118-809-30; 747 and NDC 76331-807-30; 1493
Recall NumberD-896-2013
Product DescriptionNataChew, 1) one 90-count bottle of multi-vitamin tablets (imprinted 902), (NDC 44118-902-90) and 2) physician samples containing nine bottles with 5 multi-vitamin tablets (imprinted 902) (NDC 44118-902-05), Manufactured for Eckson Labs, Wilmington, DE
Code Info1) Lot 41065, exp 10/14 and 41099, exp 9/14 NDC 44118-902-90 2) Lot 41065A, exp. 9/14 NDC 44118-902-05
ClassificationClass III
Reason for RecallSubpotent; Beta carotene (Vitamin A)
Product Quantity1) 4546 bottles and 2) 1349 bottles
Recall NumberD-897-2013
Product DescriptionDuet DHA 430, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Manufactured for W.H. Nutritionals, Wilmington, DE --- NDC 76331-808-30
Code InfoNDC 76331-808-30; lot 39736A, exp. 3/14 and lot 41667, exp. 12/14
ClassificationClass III
Reason for RecallSubpotent; Beta carotene (Vitamin A)
Product Quantity2985
Recall NumberD-898-2013
Product DescriptionDuet DHA 430 ec, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-810-30)
Code InfoNDC 76331-810-30; Lot 39736A, exp. 3/14
ClassificationClass III
Reason for RecallSubpotent; Beta carotene (Vitamin A)
Product Quantity1492
Recall NumberD-899-2013
Product DescriptionNata Komplete, containing one 30-count bottle of multi-vitamin tablets (imprinted 909), Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-909-30) and physician samples of nine bottles of 5-multi-vitamin tablets (NDC 76331-909-05 )
Code InfoNDC 76331-909-30; Lot 40186, exp 5/14 NDC 76331-909-05; Lot 40186, exp. 5/14 (physician samples)
ClassificationClass III
Reason for RecallSubpotent; Beta carotene (Vitamin A)
Product Quantity1974 and 3967 physician samples
Recall NumberD-900-2013

Class III Drugs Event

Event ID65676
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBraintree Laboratories Inc.
CityHolbrook
StateMA
CountryUS
Distribution PatternNationwie
 

Associated Products

Product DescriptionBraintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) NDC 52268-523-02
Code InfoLot 3013002 Exp. 08/14
ClassificationClass III
Reason for RecallDefective Container; Small micro fracture observed in the 2-Liter bottle at the fill line resulting in a small leak when patient reconstitutes the bulk powder
Product Quantity10,362 kit cartons
Recall NumberD-911-2013

Class III Food Event

Event ID65820
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jul-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmGreen Core
CityJacksonville
StateFL
CountryUS
Distribution PatternVA, TN, GA, NC, SC, FL
 

Associated Products

Product DescriptionOkami Fully Cooked Wild-Caught Lobster Roll with Avocado, in a 7oz plastic tray with lid, to be stored less than or equal to 40 degrees F.
Code Info07/15/13 thru 07/19/13 UPC's: 663603141428
ClassificationClass III
Reason for RecallThe product was misbranded. Raw lobster meat (instead of cooked lobster meat) was used.
Product Quantity233 individual packs
Recall NumberF-1845-2013

Class III Drugs Event

Event ID65840
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Aug-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNovartis Consumer Health
CityLincoln
StateNE
CountryUS
Distribution PatternNationwide, Canada, and Panama.
 

Associated Products

Product DescriptionMaalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN 02243496, UPC 0 58478 44872 5.
Code InfoLot #: 10097345, Exp 08/13; 10104668, Exp 01/14; 10114317, Exp 03/14; 10120624, Exp 07/14
ClassificationClass III
Reason for RecallLabeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Product Quantity117,816 bottles
Recall NumberD-902-2013
Product DescriptionMaalox Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wild Berry flavor, packaged in a) 50-count (UPC 0 58478 44825 1), b) 100-count (UPC 0 58478 44826 8) and c) 145-count (UPC 0 58478 44836 7) tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238290.
Code InfoLot #: a) 10095538, Exp 07/13; 10099449, Exp 09/13; 10104663, Exp 01/14; 10111110, Exp 02/14; 10114312, Exp 04/14; 10120619, Exp 07/14; b) 10095537, Exp 07/13; 10099451, Exp 09/13; 10104664, Exp 01/14; 10111112, Exp 02/14; 10114313, Exp 04/14; 10120620, Exp 07/14; c) 10095528, Exp 07/13; 10106998, Exp 01/14; 10120618, Exp 07/14
ClassificationClass III
Reason for RecallLabeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Product Quantity112,728 bottles
Recall NumberD-903-2013
Product DescriptionMaalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Wild Berry flavor, 65-count tablets per bottle, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-62791-65, UPC 3 0067-0376-65 9.
Code InfoLot #: 10093113, Exp 06/13; 10097332, Exp 08/13; 10101258, Exp 10/13; 10104632, Exp 12/13; 10108852, Exp 01/14; 10104633, 10110688, Exp 02/14; 10111944, Exp 03/14; 10114325, Exp 05/14; 10120609, 10120610, Exp 07/14; 10123084, Exp 09/14
ClassificationClass III
Reason for RecallLabeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Product Quantity410,220 bottles
Recall NumberD-904-2013
Product DescriptionMaalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, packaged in a) 35-count (NDC 0067-6279-35) (UPC 3 0067-0343-35 4); b) 65-count (NDC 0067-6279-65) (UPC 3 0067-0343-65 1); and c) 90-count (NDC 0067-6279-90) (UPC 3 0067-0343-90 3) tablets per bottle, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622.
Code InfoLot #: a) 10090971, Exp 08/13; 10101253, Exp 09/13; 10102751, Exp 11/13; 10104624, Exp 01/14; 10108954, 10108955, Exp 02/14; 10111942, 10111943, Exp 03/14, 10117575, Exp 04/14; b) 10095525, Exp 07/13; 10097329, Exp 08/13; 10099437, 10101254, Exp 09/13; 10101255, 10102752, Exp 10/13; 10104625, 10104626, Exp 11/13; 10104627, 10109871, 10110711, 10109182, Exp 01/14; 10109872, 10110003, Exp 02/14; 10111941, Exp 03/14; 10115413, 10116855, Exp 04/14; 10118565, 10118566, Exp 06/14; 10120611, 10120612, Exp 07/14; 10123086, Exp 08/14; c) 10093109, 10093111, 10093112, Exp 06/13; 10095529, 10095540, Exp 07/13; 10097330, 10097331, Exp 08/13; 10099438, 10099439, 10099440, Exp 09/13; 10101256, 10101257, Exp 10/13; 10102753, 10102754, 10104628, Exp 11/13; 10104629, Exp 12/13; 10104630, 10104631, 10108289, 10108290, Exp 01/14; 10107564, 10109868, 10110004, 10110005, Exp 02/14; 10111938, 10111939, 10113621, 10113622, 10114320, 10114321, Exp 03/14; 10114322, 10114323, 10116852, Exp 04/14; 10116853, Exp 05/14; 10118563, 10118564, Exp 06/14; 10120613, 10120614, Exp 07/14; 10123087, 10123088, 10123089, Exp 08/14; 10126000, 10126001, 10126002, Exp 09/14; 10128831, 10128833, Exp 10/14
ClassificationClass III
Reason for RecallLabeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Product Quantity3,451,224 bottles
Recall NumberD-905-2013
Product DescriptionMaalox Extra Strength Antacid (calcium carbonate) chewable tablets,1000 mg, Wild Berry flavor, packaged in a) 35-count (UPC 0 58478 44829 9) and b) 65-count (UPC 0 58478 44842 8) tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238291.
Code InfoLot #: a) 10095535, Exp 07/13; 10101288, Exp 10/13; 10104665, Exp 01/14; 10111114, Exp 02/14; 10114314, Exp 04/14; 10120621, Exp 07/14; b) 10095536, Exp 07/13; 10101289, Exp 10/13; 10104666, Exp 01/14; 10111116, Exp 02/14; 10114315, Exp 04/14; 10120622, Exp 07/14
ClassificationClass III
Reason for RecallLabeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Product Quantity149,616 bottles
Recall NumberD-906-2013
Product DescriptionMaalox, Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wintergreen flavor, 50-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238290, UPC 0 58478 44824 4.
Code InfoLot #: 10095534, Exp 07/13; 10114311, Exp 04/14
ClassificationClass III
Reason for RecallLabeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Product Quantity46,680 bottles
Recall NumberD-907-2013
Product DescriptionMaalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 600 mg/60 mg, Wild Berry flavor, 35-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN 02243496, UPC 0 58478 44840 4.
Code InfoLot #: 10093133, Exp 06/13; 10099452, Exp 09/13; 10104667, Exp 12/13; 10110926, Exp 02/14; 10114316, Exp 04/14; 10120623, Exp 07/14; 10123098, Exp 09/14
ClassificationClass III
Reason for RecallLabeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Product Quantity129,048 bottles
Recall NumberD-908-2013
Product DescriptionMaalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Mint flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 80000899, UPC 0 58478 10091 3.
Code InfoLot #: 10107000, Exp 07/13; 10114319, Exp 01/14
ClassificationClass III
Reason for RecallLabeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Product Quantity23,856 bottles
Recall NumberD-909-2013
Product DescriptionMaalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Cherry flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 80000899, UPC 0 58478 10090 6.
Code InfoLot #: 10114318, Exp 01/14
ClassificationClass III
Reason for RecallLabeling: Incorrect or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Product Quantity11,760 bottles
Recall NumberD-910-2013

Class III Drugs Event

Event ID65851
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Aug-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAbbVie Inc.
CityNorth Chicago
StateIL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionMavik® trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories, North Chicago, IL 60064, USA
Code InfoLot 22033GY
ClassificationClass III
Reason for RecallLabeling: Incorrect Package Insert; product packaged with outdated version of the insert
Product Quantity704 bottles
Recall NumberD-901-2013

Class III Devices Event

Event ID65879
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmConvatec Inc.
CitySkillman
StateNJ
CountryUS
Distribution PatternUS Nationwide Distribution
 

Associated Products

Product DescriptionConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.
Code InfoFlexi-Seal Signal FMS Kit - ICC Code: 418000 SAP Code #1262167 Lot# 12-FM-01 and Lot# 12-FM-02.
ClassificationClass III
Reason for RecallConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number convention was duplicated on the packaging.
Product Quantity22,896 units
Recall NumberZ-1990-2013
Product DescriptionConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.
Code InfoFlexi-Seal Signal + ICC Code 418000; SAP Code# 1705108, Lots 12-FM-01 and 12-FM-02.
ClassificationClass III
Reason for RecallConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number convention was duplicated on the packaging.
Product Quantity22,896 units
Recall NumberZ-1991-2013

Class III Drugs Event

Event ID66032
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBracco Diagnostics Inc
CityMonroe Township
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionTagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc. Lake Success, NY 11042 Tel: 1-516-333-8230 1-800-544-4624 NDC 32909-814-53
Code InfoLot #65846
ClassificationClass III
Reason for RecallFailed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
Product Quantity3,096 bottles
Recall NumberD-914-2013

Class III Food Event

Event ID66034
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmS & M International Inc
CityBayonne
StateNJ
CountryUS
Distribution PatternNY
 

Associated Products

Product DescriptionGrove Grow Notes Dried Mushroom, Net Wt. 200g/7 oz. packaged in plastic tray in plastic bag. UPC 6949682800734 Product of China Product label is in Chinese
Code InfoUPC 6949682800734
ClassificationClass III
Reason for RecallGrove Grow Notes Dried Mushrooms contain undeclared sulfites at a level of 59 ppm.
Product Quantity100 packages
Recall NumberF-1835-2013

Mixed Classification Biologics Event

Event ID65013
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Mar-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmInland Northwest Blood Center
CitySpokane
StateWA
CountryUS
Distribution PatternSwitzerland; WA; CA
 

Associated Products

Product DescriptionCryoprecipitated AHF
Code InfoW068513390157Z
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-1735-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW0685133202186; W068513390157Z
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-1736-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW0685133202186; W068513390157Z
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed
Product Quantity2 units
Recall NumberB-1737-13

Mixed Classification Biologics Event

Event ID65221
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHCSC-Blood Center
CityBethlehem
StatePA
CountryUS
Distribution PatternPennsylvania
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW050912006948;
ClassificationClass III
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2107-13
Product DescriptionFresh Frozen Plasma
Code InfoW050912006948;
ClassificationClass III
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2108-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW050912005655;
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2109-13

Mixed Classification Biologics Event

Event ID65250
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Apr-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternTennessee; Florida
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036813013386; W036812634195;
ClassificationClass III
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-2114-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036813013386; W036812634195; W036812449727;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity3
Recall NumberB-2115-13
Product DescriptionFresh Frozen Plasma
Code InfoW036812449727;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2116-13
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036812851617; W036812841109;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-2117-13
Product DescriptionRed Blood Cells
Code Info2468490;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2118-13

Mixed Classification Biologics Event

Event ID65251
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Apr-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLake Worth
StateFL
CountryUS
Distribution PatternSwitzerland; Florida
 

Associated Products

Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036811804654;
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity1
Recall NumberB-2119-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036811057950;
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity1
Recall NumberB-2120-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036809182342;
ClassificationClass III
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity1
Recall NumberB-2121-13
Product DescriptionRed Blood Cells
Code InfoW036809182342; 1700651;
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity2
Recall NumberB-2122-13
Product DescriptionFresh Frozen Plasma
Code InfoW036811057950; 1700651;
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity2
Recall NumberB-2123-13
Product DescriptionPlatelets
Code Info1700651;
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity1
Recall NumberB-2124-13

Mixed Classification Biologics Event

Event ID65276
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Apr-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternSwitzerland, FL, NY
 

Associated Products

Product DescriptionPlatelets Irradiated
Code Info2030388
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2134-13
Product DescriptionPlatelets
Code Info2236855
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2135-13
Product DescriptionPlatelets Pooled Leukocytes Reduced Irradiated
Code InfoW036809820065
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2136-13
Product DescriptionCryoprecipitated AHF
Code Info2236855; W036809257757
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-2137-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036809257757
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2138-13
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036810808509
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2139-13
Product DescriptionRed Blood Cells
Code Info2030388; 2236855; 2326541; W036809346298; W036810169486; W036810134483
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity6 units
Recall NumberB-2140-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036809257757; W036809346298; W036810134483
ClassificationClass III
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity3 units
Recall NumberB-2141-13
Product DescriptionFresh Frozen Plasma
Code Info2030388; 2326541; W036810271097
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity3 units
Recall NumberB-2142-13

Mixed Classification Biologics Event

Event ID65278
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Apr-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternTennessee; Switzerland; Florida; California
 

Associated Products

Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036810818581; W036812840236; W036812850369
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity3 units
Recall NumberB-1945-13
Product DescriptionFresh Frozen Plasma
Code InfoW036810100975; W036812477893; W036812632589
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity3 units
Recall NumberB-1946-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036810100975; W036812373201
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity2 units
Recall NumberB-1947-13
Product DescriptionRed Blood Cells
Code InfoW036811019911; W036812477893; W036812632589
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity3 units
Recall NumberB-1948-13
Product DescriptionPlatelets Pooled Leukocytes Reduced Irradiated
Code InfoW036811804717; W036811808529; W036811826757
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity3 units
Recall NumberB-1949-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036811019911; W036811164080; W036812373201
ClassificationClass III
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity3 units
Recall NumberB-1950-13
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