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U.S. Department of Health and Human Services

Enforcement Report - Week of January 16, 2013

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Class I Biologics Event

Event ID63120
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTissue Banks International
CitySan Rafael
StateCA
CountryUS
Distribution PatternAllograft products were released for distribution to 6 consignees in US. located in CA, MD and PA.
 

Associated Products

Product DescriptionBone, Human Tissue allograft; CeSpace (Brand for Aesculap, Inc.); Prepared by Aesculap, Inc., Center Valley, PA and distributed by TBI National Processing Center, San Rafael, CA
Code InfoCL1202013057; CL1202013061; CL1202013064; CL1202013068; CL1202013071; CL1202013075; CL1202013079; CL1202013084; CL1202013077; CL1202013083; CL1202013056; CL1202013058; CL1202013059; CL1202013060; CL1202013062; CL1202013063; CL1202013065; CL1202013066; CL1202013067; CL1202013069; CL1202013070; CL1202013072; CL1202013073; CL1202013074; CL1202013076; CL1202013078; CL1202013080; CL1202013081; CL1202013082; CL1202013085; CL1202013086; CL1202013006; CL1202013004
ClassificationClass I
Reason for RecallHuman tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.
Product Quantity33
Recall NumberB-0162-13
Product DescriptionTendon, Human Tissue allograft; TranZgraft (brand for TBI); Product is prepared and distributed by TBI/Tissue Banks International, San Rafael, CA
Code InfoCL1202013007; CL1202013008; CL1202013009; CL1202013010; CL1202013003
ClassificationClass I
Reason for RecallHuman tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.
Product Quantity5
Recall NumberB-0163-13

Class I Biologics Event

Event ID63229
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jul-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmMusculoskeletal Transplant Foundation
CityEdison
StateNJ
CountryUS
Distribution PatternAK, AZ, CA, MI, PA. TX
 

Associated Products

Product DescriptionTendon
Code Info06711073061037; 06711073061038; 06711073061043; 06711073061027; 06711073061031; 06711073061041; 06711073061040; 06711073061028; 06711073061039; 06711073061029; 00311087151038; 00311087151045;0311087151039; 00311087151046; 00311087151047; 00311087151040; 00311087151042; 00311087151049
ClassificationClass I
Reason for Recall.Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.
Product Quantity18 units
Recall NumberB-0164-13
Product DescriptionBone
Code Info06711073061066; 06711073061059; 06711073061067; 06711073061073; 06711073061065; 06711073061060; 06711073061061; 06711073061062; 06711073061072; 06711073061069; 06711073061070; 06711073061071; 06711073061051; 06711073061052; 06711073061053; 06711073061054; 06711073061068; 06711073061056; 06711073061057; 06711073061058; 06711073061055; 06711073061064; 06711073061063; 00311087151030; 00311087151031; 00311087151032; 00311087151033; 00311087151034
ClassificationClass I
Reason for RecallHuman tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.
Product Quantity28 units
Recall NumberB-0165-13

Class I Food Event

Event ID63425
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmWhole Foods Market Brand 365, Llc
CityAustin
StateTX
CountryUS
Distribution PatternKY
 

Associated Products

Product DescriptionKentucky Bleu cheese was sold in the Louisville, KY, Whole Foods Market store, and was cut and packaged in clear plastic wrap. It was sold with a Whole Foods Market scale label reading 'Kenny's Farmhouse Cheese KY BL.
Code InfoThe Kenny's Farmhouse Cheese KY BL has a PLU of 209578 and includes all 'sell by' dates, which are noted on the scale label.
ClassificationClass I
Reason for RecallWhole Foods Market announces that it is recalling Kenny's Farmhouse Cheese KY BL sold in its Louisville, KY store and Blue Kentucky Rose Kenny's cheese sold in its Nashville, TN store. These cheeses are being recalled because they have 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, no illnesses have been reported. This recall is in response to a recall by Kenny's Farmhouse Cheese of Austin, Kentucky.
Product Quantity1.21 lbs
Recall NumberF-0868-2013
Product DescriptionThe Blue Kentucky Rose cheese sold in the Nashville, TN, Whole Foods Market store was cut and packaged in clear plastic wrap. It was sold with a Whole Foods Market scale label reading 'Blue Kentucky Rose Kenny's.
Code InfoThe Blue Kentucky Rose Kenny's had a PLU of 71113 and includes all sell by dates, which are noted on the scale label.
ClassificationClass I
Reason for RecallWhole Foods Market announces that it is recalling Kenny's Farmhouse Cheese KY BL sold in its Louisville, KY store and Blue Kentucky Rose Kenny's cheese sold in its Nashville, TN store. These cheeses are being recalled because they have 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, no illnesses have been reported. This recall is in response to a recall by Kenny's Farmhouse Cheese of Austin, Kentucky.
Product Quantity0 lbs - it was found that the TN store never received the recalled lots
Recall NumberF-0869-2013

Class I Food Event

Event ID63735
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Nov-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling Firm Maplehurst Deli-Bake South Inc
CityCarrollton
StateGA
CountryUS
Distribution PatternFL & GA
 

Associated Products

Product DescriptionPublix 7 Yellow Special Blend Layers, Net Wt. 14.25 lbs. (24 count), frozen in bulk paper cartons to be frosted and sold individually at the retail stores.
Code InfoLot numbers: 2311B00610, 2311B00611, 23110C00611, Lot 231C00610 and 2311A00611.
ClassificationClass I
Reason for RecallProduct sample was found to be positive for Listeria monocytogenes.
Product Quantity859 cases (24 units per case)
Recall NumberF-0871-2013
Product DescriptionPublix 7 Chocolate Split Layers, Net Wt. 12.75 lbs. (24 count), frozen in bulk paper cartons to be frosted and sold individually at the retail stores.
Code InfoLot numbers: 2311B00610, 2311B00611, 23110C00611, Lot 231C00610 and 2311A00611.
ClassificationClass I
Reason for RecallProduct sample was found to be positive for Listeria monocytogenes.
Product Quantity
Recall NumberF-0872-2013

Class I Food Event

Event ID63747
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmMichael's Seafood Inc. DBA Michael's Gourmet & Delicacies
CityMiami
StateFL
CountryUS
Distribution PatternProducts was distributed in Florida.
 

Associated Products

Product DescriptionAlaskan Wild Smoked Sockeye Salmon in vacuum packed plastic package, labeled in part: MICHAEL'S WILD SOCKEYE SMOKED SALMON***INGREDIENTS: WILD ALASKAN SOCKEYE SALMON, SALT, SUGAR, NATURAL HARDWOOD SMOKE.***KEEP FROZEN UNTIL USE/THAWED UNDER REFRIGERATION IMMEDIATELY BEFORE USE.***DISTRIBUTED BY: MICHAEL'S SEAFOOD INC. 500 NE 185TH STREET, MIAMI FL 33179.***READY TO EAT WITHIN 3 DAYS AFTER OPENING OR BEFORE SELL BY DATE.***
Code InfoBatch #1443
ClassificationClass I
Reason for RecallMichael's Gourmet Delicacies, Miami, FL is recalling their Alaskan Wild Smoked Sockeye Salmon, Batch #1443 (4oz., 8 oz., 16 oz. and Trimmings) after a sample of 4 oz. Smoked Sockeye Salmon tested positive for Listeria Monocytogenes.
Product Quantity2,440 pieces and 250 lbs. of Trimmings
Recall NumberF-0866-2013

Class I Food Event

Event ID63750
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Nov-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCapital City Fruit Co.
CityNorwalk
StateIA
CountryUS
Distribution PatternThe product was distributed to IA, MO, NE, MN and WI.
 

Associated Products

Product DescriptionCherry tomatoes packaged in 1 pint clear, plastic clamshells. The clamshells are packaged either 9/1-pint clamshells or 12/1-pint clamshells per case.
Code InfoP96290001 date code: 4604 P96330002 date code: 4605 P96477001 date code: 4606 P96368001 date code: 4605 P96500001 date code: 4701 P96313001 date code: 4604 P96330007 date code: 4605 P96290006 date code: 4604 P96500006 date code: 4701
ClassificationClass I
Reason for RecallThe recalled cherry tomatoes are associated with the Rio Queen Citrus, Inc. recall received on November 12, 2012 and used in the packaging of certain lots of Capital Brand Clamshell Cherry tomatoes have the potential to be contaminated with Salmonella.
Product Quantity283/9/1-pint clamshell cases and 190/12/1-pint clamshell cases
Recall NumberF-0867-2013

Class I Food Event

Event ID63928
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Dec-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmUdi's Healthy Foods,Granola & Gluten Free
CityDenver
StateCO
CountryUS
Distribution PatternUS Distribution: 5 direct accounts in WA, CA, CO with subaccount distribution to WA, CA, CO, NV, UT, MT, ID, and OR.
 

Associated Products

Product DescriptionUdi's gluten free au naturel granola in 12 ounce clear plastic bag, UPC 6-98997-80615-8, best by 041913 12265 1.
Code InfoUPC 6-98997-80615-8 Best by 041913 122565 1
ClassificationClass I
Reason for RecallProduct may contain undeclared almonds.
Product Quantity3510 - 12 ounce bags shipped (585 cases)
Recall NumberF-0864-2013

Class I Food Event

Event ID63980
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Dec-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmMultiexport Foods, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternAlabama, Arkansas, Alaska, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Montana, Missouri, Mississippi, Nebraska, North Carolina, New Hampshire, New Jersey, New York, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Washington, Virginia, Wisconsin and West Virginia
 

Associated Products

Product DescriptionProduct labeled in part: ***PARAMOUNT RESERVE***PRODUCT OF CHILE FARM RAISED ATLANTIC SALMON PACKED BY: ALIMENTOS MULTIEXPORT S.A. *** DISTRIBUTED BY MULTIEXPORT FOODS INC. 703 WATERFORD WAY (NW 62ND AVE) SUITE 510, MIAMI, FL 33126***
Code InfoTwin Pack 12 oz = 931-59733-2, 933-59753-1, 933-59754-2, 875-701413-1, and 890-701413-1 // 12oz UPC 6 88264 86705 0 ===================================== 1.25 lb Pack = 870-701342-1, 873-701342-1, 870-701344-1, 873-701360-1, 870-701364-1, 873-701364-1, 900-701344-1, 873-701344-1, 873-701360-1, 886-701413-1, 900-701413-1, 873-701344-1, and 870-701360-1 // 1.25 lb UPC 6 88264 86664 0
ClassificationClass I
Reason for RecallThe firm initiated the recall based on positive results for Listeria monocytogenes obtained from a composite sample tested by a private laboratory.
Product Quantity
Recall NumberF-0875-2013

Class I Food Event

Event ID63998
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmUnited National Foods (Unfi)
CityAurora
StateCO
CountryUS
Distribution PatternDistributed to UNFI distribution centers located in WA, CA, CO, and TX.
 

Associated Products

Product DescriptionKinnikinnick Pie Crust Glutent Free (frozen) weight 290 g/ 10 oz Qty/Pkg: 2, UPC 620133006229, Kinnikinnick Foods 10940 120 Street, Edmonton, AB Canada.
Code InfoUS distribution: BB2013NO30; BB2013DE12; BB2013DE13; BB2013DE14; BB2013DE17.
ClassificationClass I
Reason for RecallUNFI Aurora, Colorado is recalling certain Kinnikinnick Pie Crusts (frozen) because they were notified by the manufacturer, Kinnikinnick Foods (Alberta, Canada) that the products contain eggs and are not identified in the finished product labeling.
Product Quantity56 x 10 oz packages
Recall NumberF-0865-2013

Class II Biologics Event

Event ID42599
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jun-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBiomat USA, Inc.
CitySalt Lake City
StateUT
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info0630000144, 0630000390
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a piercing within one year of donation, were distributed.
Product Quantity2 units
Recall NumberB-0322-13

Class II Biologics Event

Event ID42601
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jun-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBiomat USA, Inc.
CitySalt Lake City
StateUT
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info0630000313
ClassificationClass II
Reason for RecallBlood product, collected from a donor who received a piercing within one year of donation, was distributed.
Product Quantity1 unit
Recall NumberB-0323-13

Class II Biologics Event

Event ID42750
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jun-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBiomat USA, Inc.
CitySalt Lake City
StateUT
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info0630001318
ClassificationClass II
Reason for RecallBlood product, collected from a donor who received a piercing within one year of donation, was distributed.
Product Quantity1 unit
Recall NumberB-0324-13

Class II Biologics Event

Event ID42877
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jul-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Center of the Ozarks
CitySpringfield
StateMO
CountryUS
Distribution PatternAustria
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info6702463
ClassificationClass II
Reason for RecallBlood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Product Quantity1 Unit
Recall NumberB-0204-13

Class II Biologics Event

Event ID49158
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-May-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBiomat USA, Inc.
CityLogan
StateUT
CountryUS
Distribution PatternAustria
 

Associated Products

Product DescriptionSource Plasma
Code Info8160052763, 8160051047, 8160050780, 8160050356, 8160048823, 8160048574, 8160046973, 8160044948, 8160044626, 8160044266, 8160044047, 8160043643, 8160043634, 8160042902, 8160042819, 8160039198, 8160039056, 8160037466, 8160036624, 8160036207, 8160034821, 8160034135, 8160033992, 8160033693, 8160033432, 8160032439
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tattoo within one year of donation, were distributed.
Product Quantity26 units
Recall NumberB-0325-13

Class II Biologics Event

Event ID49910
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Aug-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPuget Sound Blood Center
CitySeattle
StateWA
CountryUS
Distribution PatternWashington
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW141608084774
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Product Quantity1 unit
Recall NumberB-0218-13

Class II Biologics Event

Event ID50250
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-May-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomat USA, Inc.
CityLos Angeles
StateCA
CountryUS
Distribution PatternCalifornia, Spain
 

Associated Products

Product DescriptionSource Plasma
Code Info0420047676, 0420047864, 0420049894, 0420058168
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tattoo within one year of donation, were distributed.
Product Quantity4 units
Recall NumberB-0326-13

Class II Biologics Event

Event ID50662
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Nov-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code InfoI52016184, I52016394, I52018262, I52018570, I52018970, I52019242, I52019495, I52019724, I52022606, I52020929, I52021091, I52021531, I52021688
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity13 units
Recall NumberB-0044-13

Class II Biologics Event

Event ID50671
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Nov-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPuget Sound Blood Center and Program
CitySeattle
StateWA
CountryUS
Distribution PatternWashington
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW141608653413
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Product Quantity1 unit
Recall NumberB-0219-13

Class II Biologics Event

Event ID50672
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Nov-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPuget Sound Blood Center and Program
CitySeattle
StateWA
CountryUS
Distribution PatternWashington
 

Associated Products

Product DescriptionPlatelets Pooled
Code InfoW141608253881
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Product Quantity1 unit
Recall NumberB-0216-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW141608253881
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Product Quantity1 unit
Recall NumberB-0217-13

Class II Biologics Event

Event ID50954
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Jun-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code Info366114186, 366112717, 366111503, 366113827, 366110539, 366110229, 366109212, 366102779, 366101468, 366100729, 366099619, 366098290, 366096881, 366096418, 366094371, 366093295, 366091439, 366091305, 366087915, 366087494, 366086570, 366084819, 366084594, 366083584, 366083319, 366081603, 366081414, 366080176, 366079795, 366077808, 366077428, 366076904, 366075364, 366074966, 366074174, 366073803, 366073008, 366072170, 366071460, 366071145, 366070369, 366068705, 366068050, 366067625, 366065135, 366065088, 366049285, 366048534, 366048220, 366047767, 366046406, 366045572, 366044844, 366044738, 366043964, 366043723, 366043313, 366042910, 366042564, 366041779, 366041598, 366040691, 366040325, 366039315, 366038536, 366037633, 366037133, 366036815, 366036174, 366036017, 366034409, 366034140, 366032820, 366032471, 366031837, 366031504, 366030946, 366030561, 366030071, 366029625, 366029090, 366028713, 366028238, 366027747, 366027321, 366026861, 366025865, 366025246, 366024526, 366024038, 366023589, 366023138, 366022682, 366022179, 366021714, 366021250, 366020842, 366020279, 366019308, 366018970, 366018247, 366017925, 366016988, 366016619, 366015248, 366014789, 366014164, 366013846, 366013044, 366010830, 366010513, 366009717, 366009311, 366008834, 366008231, 366007661, 366007316, 366006344, 366005384, I52062487, I52062224, I52061675, I52061454, I52060803, I52060608, I52059995, I52059786, I52058636, I52058376, I52057692, I52057317, I52048664, I52048466, I52047404, I52047110, I52046647, I52046418, I52043742, I52043708,366111027
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity139 units
Recall NumberB-0205-13

Class II Biologics Event

Event ID52276
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Mar-09
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionSource Plasma
Code Info3750018826; 3750018468; 3750018140; 3750017888; 3750017558; 3750017267; 3750016872; 3750016618; 3750016294; 3750016103; 3750015912; 3750015355; 3750015165; 3750014628; 3750014478; 3750013901; 3750019392; 3750019209; 3750013791; 3750013274; 3750012705; 3750012296; 3750011663; 3750011357; 3750010704; 3750010364; 3750009783; 3750009359;3750008672; 3750008402
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was permanently deferred, were distributed.
Product Quantity30
Recall NumberB-0207-13

Class II Biologics Event

Event ID53059
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jan-09
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomat USA, Inc.
CityAmarillo
StateTX
CountryUS
Distribution PatternSpain
 

Associated Products

Product DescriptionSource Plasma
Code Info0020185088, 0020184599, 0020184373, 0020184089, 0020183872
ClassificationClass II
Reason for RecallBlood products, which were not quarantined subsequent to receiving information regarding high risk behavior, were distributed.
Product Quantity5 units
Recall NumberB-0146-13

Class II Biologics Event

Event ID61707
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Mar-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDelta Blood Bank
CityStockton
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW128711240444
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Product Quantity1 unit
Recall NumberB-0199-13

Class II Devices Event

Event ID61718
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Howmedica Osteonics Corp.
CityMahwah
StateNJ
CountryUS
Distribution PatternNationwide distribution, including the states of NY, NJ, CA and FL.
 

Associated Products

Product DescriptionAccolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.
Code InfoCatalog Number: 6021-2530 Lot #40264005 Catalog Number: 6021-3535 Lot #40163005. This lot was not received in the US.
ClassificationClass II
Reason for RecallStryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix.
Product Quantity6021-2530- four units; 6021-3535-
Recall NumberZ-0656-2013

Class II Devices Event

Event ID62121
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Mar-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMaquet Cardiovascular, LLC
CityWayne
StateNJ
CountryUS
Distribution PatternWorldwide Distribution - USA including ID and Fl and Internationally to United Arab Emirates, France, Luxembourg, Poland, Spain, Sweden, Germany, Italy, Netherlands, Republic of China, Spain, Sweden, and Thailand
 

Associated Products

Product DescriptionCARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.
Code Info510K K112372 Device Listing Number D132687 US Customer IABPs CA202159K1 CA202167K1 CA203492L1 CA203494L1 International Customer IABPs CA203486L1 CA202155K1 CA202161K1 CA203487L1 CA203490L1 CA203507L1 CA204330L1 CA204328L1 CA203505L1 International Company Owned IABPs CA204327L1 CA202150K1 CA203506L1 CA204324L1 CA204326L1 CA202163K1 CA202169K! CA203497L1 CA203498L1 CA203496L1 CA203503L1 CA203488L1 CA203493L1 CA203508L1 CA204337L1 CA203502L1
ClassificationClass II
Reason for RecallIn the Cardiosave Intra-aortic Balloon Pump, there is a possibility that the coiled cord assembly, a prominent connector cord between the Cardiosave IABP housing and the dual display head which secured atop the IABP may fail as a result of mishandling.
Product Quantity29 units (total)
Recall NumberZ-0662-2013

Class II Devices Event

Event ID62950
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmZoll Circulation, Inc.
CitySunnyvale
StateCA
CountryUS
Distribution PatternWorldwide distribution.
 

Associated Products

Product DescriptionAutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.
Code Infoall
ClassificationClass II
Reason for RecallComplaints associated with an unexpected stop in AutoPulse compressions.
Product Quantity3881 in US, 1846 ROW.
Recall NumberZ-0658-2013

Class II Devices Event

Event ID63030
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Medical Systems North America Co. Phillips
CityBothell
StateWA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and the countries of Japan and Malaysia.
 

Associated Products

Product DescriptionPhilips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
Code Info1)Philips brand FRx Model Number 861304 under 510(k) K050004, sold nationally and Internationally, Serial numbers range from BO4L-00001 through B12F-00286 and represents 181,226 devices; 2) Laerdal brand FRx Model Number 861305 unfrt 510(k) K050004, sold nationally and Internationally, serial numbers range from B04L-00013 through B12E-04135 and represents 20,372 devices. Please note the serial number range represents first and last serial number for each model. Serial numbers are not continguous.
ClassificationClass II
Reason for RecallPhilips determined that it is important to clarify information in the Owner's Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305), OnSite (models M5066A and M5067A), or HeartStart Home (model M5068A) automated external defibrillators (AEDs) shipped between December 2005 and July 2012. Philips had determined there is a need to emphasize the importance of all owners contacting their local Philips representative if an affected FRx or HS1 AED has emitted a pattern of triple chirps. If the device is emitting a pattern of triple chirps, it is a signal that the defibrillator's behavior needs to be investigated by Philips.
Product Quantity201,598
Recall NumberZ-0642-2013
Product DescriptionPhilips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
Code InfoHS1 product family all start with A in the serial number and break down into 3 catalog numbers - M5066A, M5067A and M5068A: 1) M5066A (referred to as Onsite or HS1), Philips brand, 510 (k) = K020715, sold nationally and internationally, serial numbers range from A021-00038 through A12E-03490, with 306,108 total devices. 2) M5067A, Philips brand 510(k) = K040904, sold nationally and internationally, serial numbers range from A05C-00727 through A12D-01406, with 978 total devices. 3) M5068A, Philips brand 510(k) = K020715, sold nationally and internationally, serial numbers range from A021J-00207 through A12E-01900, with 22,760 total devices 4) M5066A, Laerdal brand, 510 (k) = K020715, sold internationally, serial numbers range from A021-00036 through A12D-02148, with 60,433 total devices. 5) M5067A, Laerdal brand, sold as Home device- cleared for OTC on initial 510(k) = K040904, serial numbers range from A021-00133 through A11B-00970, with 8659 total devices. 6) M5068A, Laerdal brand, 510(k) = K020715, sold internationally, serial numbers range from A02K-00172 through A11H-00868, with 5217 total devices. Please note the serial number range represents first and last serial number for each model. Serial numbers are not continguous. Laerdal is a distribution partner in EU and Canada, sold internationally
ClassificationClass II
Reason for RecallPhilips determined that it is important to clarify information in the Owner's Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305), OnSite (models M5066A and M5067A), or HeartStart Home (model M5068A) automated external defibrillators (AEDs) shipped between December 2005 and July 2012. Philips had determined there is a need to emphasize the importance of all owners contacting their local Philips representative if an affected FRx or HS1 AED has emitted a pattern of triple chirps. If the device is emitting a pattern of triple chirps, it is a signal that the defibrillator's behavior needs to be investigated by Philips.
Product QuantityEstimate 613,000 devices shipped
Recall NumberZ-0643-2013

Class II Devices Event

Event ID63226
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Mar-12
Initial Firm Notification of Consignee or Public
Recalling FirmSurgical Tissue Network, Inc.
CityOrlando
StateFL
CountryUS
Distribution PatternWorldwide Distribution including Turkey, Greece, & Mexico.
 

Associated Products

Product DescriptionUltrafill DBM labeled in part: ***TISSUENET***Sterilized by T10^6 (r)***Description: UltraFill DBM***Size: 1cc***Product Code: RT53001***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***FOR INTERNATIONAL USE ONLY***See Package Insert for Additional Information*** TissueNet's Porcine DBM product line is used as a bone void filler
Code InfoProduct Code: RT53001 Tissue ID: TN29041-11-0072 Through TN29041-11-0081; and TN29041-11-0083 through TN29041-11-0119
ClassificationClass II
Reason for RecallSurgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates.
Product Quantity25 units
Recall NumberZ-0651-2013
Product DescriptionUltraFill DBM labeled in part: ***TISSUENET***Sterilized by T10^6 (r)***Description: UltraFill DBM***Size: 5cc***Product Code: RT53005***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***FOR INTERNATIONAL USE ONLY***See Package Insert for Additional Information*** TissueNet's Porcine DBM product line is used as a bone void filler.
Code InfoProduct Code: RT53005 Tissue ID: TN48005-11-0021 through TN48055-11-0059; TN48055-11-0070 through TN48055-11-0075; TN58063-11-0101 through TN58063-11-0142; TN61039-11-0031 through TN61039-11-0097; TN70037-11-0017 through TN70037-11-0018; TN70037-11-0020 through TN70037-11-0037; TN74060-11-0021 through TN74060-11-0047; TN74060-11-0050 through TN74060-11-0056
ClassificationClass II
Reason for RecallSurgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates.
Product Quantity208 units
Recall NumberZ-0652-2013
Product DescriptionUltraFill DBM labeled in part: ***TISSUENET***Sterilized by T10^6 (r)***Description: UltraFill DBM***Size: 10cc***Product Code: RT53010***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***FOR INTERNATIONAL USE ONLY***See Package Insert for Additional Information*** TissueNet's Porcine DBM product line is used as a bone void filler.
Code InfoProduct Code: RT53010 Tissue ID: 07-175-330 through 07-175-359; TN61032-11-0017 through TN61032-11-0041; TN62034-11-0001 through TN62034-11-0024; TN62053-11-0155 through TN62053-11-0209; TN67049-11-0291 through TN67049-11-0316; TN70037-11-0020 through TN70037-11-0037; TN74060-11-0021 through TN74060-11-0047; TN74060-11-0050 through TN74060-11-0056
ClassificationClass II
Reason for RecallSurgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates.
Product Quantity160 units
Recall NumberZ-0653-2013

Class II Devices Event

Event ID63231
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMerit Medical Systems, Inc.
CityChester
StateVA
CountryUS
Distribution PatternDistributed in Mississippi and New Jersey.
 

Associated Products

Product DescriptionMerit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F. Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.
Code InfoTray and Kit - K12T-03162B & K12T-02641F/ Lots #T243169, Exp. 2012-12, T276753, Exp. 2013-04, T282465, Exp. 2013-02, T259844, Exp. 2013-02, T265274, Exp. 2013-02, Chloride Injection Lot 05-201-JT
ClassificationClass II
Reason for RecallCustom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because one confirmed customer report where four separate particulate issues were identified in four individual flexible containers. The particular matter may result acutely in local inflammation, phlebitis and/or generalized low-level allergic response to the particulate and/or embolize to other organs in the body.
Product Quantity422 total kits/trays
Recall NumberZ-0663-2013

Class II Biologics Event

Event ID63326
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells
Code Info2723207;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0281-13
Product DescriptionFresh Frozen Plasma
Code Info2723207;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0282-13
Product DescriptionPlatelets Pooled Leukocytes Reduced Irradiated
Code Info2930687;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0283-13

Class II Devices Event

Event ID63355
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Communications, Inc.
CityFlower Mound
StateTX
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and Internationally to Australia, Japan, Taiwan, Canada, United Kingdom, France, Netherlands, Spain, Mexico, India, Korea, Singapore, New Zealand, Hong Kong, Philippines and Brazil.
 

Associated Products

Product Description(l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker Flat Panel & Navigation Arm The Spring Arm Circlip is part of the Stryker Spring Arm used in multiple configurations as a component of the (1)Visum Halogen Surgical Light, (2)Visum LED Surgical Light, and (3)Stryker Flat Panel & Navigation Arm. The Spring Arm that is subject to this field action suspends loads, is a conduit for power/data, and facilitates multi-directional movement. The Spring Arms that have been identified within scope are replacement parts that have potentially been serviced incorrectly.
Code InfoCode Number and Product Name: 0682000112-SPRING ARM, LIGHT 12-18KG, 0682000211 - FLAT PANEL SPRING ARM, ONDAL SUSPENSION, 15-21KG, 0682000212 - FLAT PANEL SPRING ARM, ONDAL SUSP., 12-18KG, 0682000226 - SPRING ARM,3.5-7KG,NAVIGATION, 0682000228 - SPRING ARM, LIGHT 9-15KG, 0682001062 - PKG EDS LIGHT SUSPENSION CENTRAL AXIS 5P/FP, 0682001270 - 9-POLE SPRING ARM, AC 2000,15-21 KG, 0682001274 - 5-POLE SPRING ARM AC 2000 15-21 KG, 0682400034 - FLAT PANEL SPRING ARM, EDS SUSPENSION, 15-21KG, 0682400059 - UNIVERSAL YOKE SPRING ARM RETROFIT KIT, 06824000591 - UNIVERSAL YOKE & SPRING ARM RETROFIT KIT, INT, 0682400151 - LOW CEILING SPRING ARM, 5P SIDE MOUNT, 0682400152 - LOW CEILING SPRING ARM, 9P SIDE MOUNT, 0682400169 - 5-POLE SPRING ARM AC 2000 9-15KG, CARDINAL, 0682400207 - STANDARD SPRING ARM WITH BEARING, 5P, 0682400208 - STANDARD SPRING ARM WITH BEARING, 9P, and 0682400365 - FLAT PANEL SPRING ARM WITH ERA ADAPTER BEARING.
ClassificationClass II
Reason for RecallStryker has become aware that there is a low likelihood of incomplete engagement of the Spring Arm Circlip during service or replacement of the Spring Arm. If the Spring Arm Circlip is not fully seated, the Spring Arm could separate and fall along with the surgical lights or monitors mounted to the end of the Spring Arm. To date, there have been no serious injuries reported from the incomplete engagement of the Spring Arm Circlip.
Product QuantityUnited States: 1,082 units and Outside United States: 199 units
Recall NumberZ-0657-2013

Class II Biologics Event

Event ID63398
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPuget Sound Blood Center and Program
CitySeattle
StateWA
CountryUS
Distribution PatternWashington; California
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW141610180553;
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0262-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW141610178698;
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0263-13
Product DescriptionRed Blood Cells
Code InfoW141610173064;
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0264-13

Class II Biologics Event

Event ID63414
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Sep-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeShare Blood Centers
CityShreveport
StateLA
CountryUS
Distribution PatternArkansas
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036512094817
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Product Quantity1 unit
Recall NumberB-0197-13

Class II Biologics Event

Event ID63416
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Sep-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeShare Blood Centers
CityLake Charles
StateLA
CountryUS
Distribution PatternLouisiana, Texas
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036512045868
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-0313-13
Product DescriptionFresh Frozen Plasma
Code InfoW036512045868
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-0314-13

Class II Devices Event

Event ID63559
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Sep-12
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
 

Associated Products

Product DescriptionThe TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the knob of the inserter shaft allowing the lateral grasping arms to secure the implant. Once the implant is inserted and its position confirmed radiographically, the inserter is removed from the implant by turning the shaft knob counterclockwise to loosen the lateral grasping arms from the implant.
Code InfoPart number: 96-701-10001; Lot numbers: " 61946711, 61946712, 61991588, 62000412,
ClassificationClass II
Reason for RecallZimmer Spine, Inc. is initiating a voluntary medical device correction to the Surgical Technique (L1607) for the TM Ardis Inserter because Zimmer has received complaints reporting difficulty in turning the implant release knob after final positioning of the TM Ardis interbody spacer implant. There has been two reports where the inserter instrument was inadvertently removed from the patient with the implant still engaged. The correction includes revised directions explaining the technique to remove the implant from the inserter.
Product Quantity170
Recall NumberZ-0659-2013

Class II Food Event

Event ID63826
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Dec-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmLifevantage Corp
CitySandy
StateUT
CountryUS
Distribution PatternSale of products through a network of independent distributors, preferred customers and end consumers in the United States, Japan, Australia and Mexico. Sales also directly to end consumers for personal consumption in Canada. Independent distributors consume the product themselves and in some cases sell the product or provide the product gratis to those potentially interested in LifeVantage. Preferred customers purchase the products on a monthly, auto-ship basis directly from Life Vantage. Other end consumers purchase directly from LifeVantage via the website and are assigned to a distributor.
 

Associated Products

Product DescriptionProtandim is packaged in a 90cc cylindrical blue bottle with a silver cap and contains thirty caplets per bottle. Label has a blue background with multi-colored print and pictorial stating in part:Lifevantage PROTANDIM *the Nrf2 Synergizer Dietary Supplement I 30 Caplets.
Code InfoLot # / Expiration Date: 12-0258 / 7/2/2015;12-0259 / 7/3/2015; 12-0292 / 7/9/2015; 12-0294 / 7/11/2015; 12-0295 / 7/12/2015; 12-0304 / 7/18/2015; 12-0306 / 8/16/2015; 12-0307 / 8/17/2015; 12-0373 / 8/21/2015; 12-0382 / 9/21/2015.
ClassificationClass II
Reason for RecallPossible inclusion of small metal fragments embedded within the tablets of Protandim Dietary Supplement.
Product Quantity247,896 bottles
Recall NumberF-0876-2013

Class II Devices Event

Event ID63829
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHoriba Instruments, Inc dba Horiba Medical
CityIrvine
StateCA
CountryUS
Distribution PatternNationwide in the US, including the states of CA, MI, IN, FL, and GA.
 

Associated Products

Product DescriptionABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Code InfoLot/Serial# PML0937
ClassificationClass II
Reason for RecallHoriba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient that is stored in the ML database. This issue occurs in a very rare sequence of specific events. The affected software versions are Versions 9.0.1, 9.0.2, 8.0x and below.
Product Quantity10 units
Recall NumberZ-0645-2013

Class II Devices Event

Event ID63842
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Nov-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmApplied Medical Resources Corp
CityRancho Santa Margarita
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and France.
 

Associated Products

Product DescriptionLaparoscope, general&plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
Code InfoLot Number: 1179107
ClassificationClass II
Reason for RecallApplied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the blade to remain exposed after shield deployment. Further use of any affected product should cease immediately. The affected model number is CTB71, and the affected lot is 1179107.
Product Quantity72 units
Recall NumberZ-0644-2013

Class II Devices Event

Event ID63850
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomet, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternWorldwide Distribution -- US (nationwide) including the countries of , Canada, Japan, Argentina, Australia ,Netherlands, Europe and Chile.
 

Associated Products

Product DescriptionPT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Code InfoPart 113950 Lot 093540, 093550,093570,093580,093590,093600,093610,093620,093720, 093730,093740,093760,093770,093780,282590,282600,282620,282630, 282680,282700,282710,489160,489180,489200,489210,489770,489780, 489790,714480,714550,714570,714700,714730,722210,722250,722280, 984770,984780,984790,984800,984810,984820,984830,984840, and 984850
ClassificationClass II
Reason for RecallBiomet is recalling Part Number PT-113950 PT Hybrid Glenoid Post, following an investigation which identified that the male thread of the post may be oversized. This oversized condition can vary in degree and may lead to the following three events: 1) If the PT Hybrid Glenoid Post is not fully seated into the Hybrid Base and the implant construct is implanted, then a gap of 1-3 mm will be present. 2) If excessive torque is applied to assemble the post into the base, the PT Hybrid Glenoid Post drive tip could break off. 3) The PT Hybrid Glenoid Post may not thread at all into the Hybrid Glenoid Base, which would prevent assembly of the two implant components.
Product Quantity1050
Recall NumberZ-0660-2013

Class II Devices Event

Event ID63877
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAdvanced Sterilization Products
CityIrvine
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and internationally to the following countries: AR, CO, TW, SI, AU, MX, MY, HU, PH, BE, FR, DE, IE, IT, ES, NO, CH, and GB.
 

Associated Products

Product DescriptionSTERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD NX Cassettes are only used in conjunction with the STERRAD NX Sterilization system.
Code InfoLot # 11J037, 11L038, 11J033
ClassificationClass II
Reason for RecallAdvanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it does not have adequate data to support the entire duration of the product's labeled shelf-life.
Product Quantity12,280 units
Recall NumberZ-0661-2013

Class II Devices Event

Event ID63892
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics, Inc.
CityNewark
StateDE
CountryUS
Distribution PatternDistributed in the states of CA, FL, IL, KS, MA, MI, MN, MS, NM, NY, NC, OH, OR, PA, TN, TX, UT, and WA.
 

Associated Products

Product DescriptionEmit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended for use in the quantitative analysis of Phenobarbital in human serum or plasma.
Code InfoEmit(R) 2000 Phenobarbital Assay (OSR4D229) lots 1237 and 1264 and/or Syva(R) Emit(R) Phenobarbital Assay (4D019UL), lots E1, E2, and E3.
ClassificationClass II
Reason for RecallFirm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and the Syva(R) Emit(R) 2000 Phenobarbital (4D019UL) lots E1, E2, and E3 as an application if the AU(R) System is used, the issue may be experienced. Firm has found that within-run imprecision of the recalled lots frequency of outliers that differ from the expected value by 20%. This is an expansion of the recall initiated in July, 2012 to include additional lots.
Product Quantity1979 cartons
Recall NumberZ-0664-2013

Class II Devices Event

Event ID63896
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCalifornia Medical Laboratories Inc
CityCosta Mesa
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA including AZ, FL, CA, LA, CO, and MS. Internationally to Canada, Israel, Greece, Hong Kong, India, Ireland, Jordan, Lebanon, Malaysia, Netherlands, Russia, Saudi Arabia, South Africa and Spain.
 

Associated Products

Product DescriptionSterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.
Code InfoCatalog No: SU-12202 Lot No: S112462, S111480
ClassificationClass II
Reason for RecallCalifornia Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.
Product QuantityS112462=995 units & S111480 1430 units
Recall NumberZ-0649-2013
Product DescriptionRigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction Wands are indicated for use to remove excess fluid from the surgical field.
Code InfoCatalog No: SU-12202NS Lot No: S112468N, S120196N, S120197N
ClassificationClass II
Reason for RecallCalifornia Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.
Product QuantityS112468N=1000 units, S120196N=1400 units, & S120197N=1200 units
Recall NumberZ-0650-2013

Class II Food Event

Event ID63932
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Dec-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmDawn Food Products, Inc.
CityJackson
StateMI
CountryUS
Distribution PatternDistribution Centers in GA, IL, Ca, TX,
 

Associated Products

Product DescriptionSam's Club Artisan Fresh Miniature Candy Cookie Carton 504 Count , 28.35 lb (12.89 kg)
Code Info2 348 18 2 349 18
ClassificationClass II
Reason for RecallOuter case of Sam's Artisan Fresh Miniature Candy Cookie contained White Chocolate Macadamia Nut Cookie and separate labels matching the White Chocolate Macadamia Nut Cookies.
Product Quantity1650 cases
Recall NumberF-0862-2013

Class II Devices Event

Event ID63938
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmConcentric Medical Inc
CityMountain View
StateCA
CountryUS
Distribution PatternUS (nationwide) including the states of CA, FL, GA, OR and TN.
 

Associated Products

Product DescriptionFlowGate Balloon Guide Catheter, Manufactured by Concentric Medical, Mountain View, CA. FlowGate Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A balloon is flush mounted on the distal end. FlowGate Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.
Code InfoCatalog number 90253, lot # 36140; Catalog number 90254, lot numbers 36009, 36135.
ClassificationClass II
Reason for RecallFirm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration.
Product Quantity13 units
Recall NumberZ-0655-2013

Class II Food Event

Event ID63944
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Dec-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmS & M International Inc
CityBayonne
StateNJ
CountryUS
Distribution PatternNortheast
 

Associated Products

Product DescriptionYangsheng Duck Eggs Cooked Salted Duck Eggs Content:6 pieces Net Wt. 12.69 oz (360g) S & M (USA0 ENTERPRISE CORP. RED. B/T YUOXIU Bldg. 160-174 Lockhart Road, Man Chai, HK Distributed by: S & M INT'L. INC 100 Pulaski Street, Bayonne NJ 07002 UPC 6949682803568
Code InfoLot #YS12-02C
ClassificationClass II
Reason for RecallCooked Salted Duck Eggs have the potential to be contaminated with C. botulinum.
Product Quantity200 CASES (24 individual packages of 6 eggs each)
Recall NumberF-0863-2013

Class III Biologics Event

Event ID41848
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Mar-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomat USA, Inc.
CitySalt Lake City
StateUT
CountryUS
Distribution PatternSpain
 

Associated Products

Product DescriptionSource Plasma
Code Info0440061470
ClassificationClass III
Reason for RecallBlood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-0318-13

Class III Biologics Event

Event ID41850
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Mar-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomat USA, Inc.
CityTaylorsville
StateUT
CountryUS
Distribution PatternSpain
 

Associated Products

Product DescriptionSource Plasma
Code Info0440060645
ClassificationClass III
Reason for RecallBlood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-0319-13

Class III Biologics Event

Event ID41852
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Mar-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomat USA, Inc.
CityTaylorsville
StateUT
CountryUS
Distribution PatternSpain
 

Associated Products

Product DescriptionSource Plasma
Code Info0440062579
ClassificationClass III
Reason for RecallBlood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-0320-13

Class III Biologics Event

Event ID41854
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Mar-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomat USA, Inc.
CityTaylorsville
StateUT
CountryUS
Distribution PatternSpain
 

Associated Products

Product DescriptionSource Plasma
Code Info0440062480
ClassificationClass III
Reason for RecallBlood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-0321-13

Class III Biologics Event

Event ID42448
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jun-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternIowa; Pennsylvania; CSL fractionator.
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoLX51298
ClassificationClass III
Reason for RecallBlood products, collected from a donor who disclosed taking Dapsone, were distributed.
Product Quantity1 Unit
Recall NumberB-0201-13
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoLP46813
ClassificationClass III
Reason for RecallBlood products, collected from a donor who disclosed taking Dapsone, were distributed.
Product Quantity1 Unit
Recall NumberB-0202-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoLX51298
ClassificationClass III
Reason for RecallBlood products, collected from a donor who disclosed taking Dapsone, were distributed.
Product Quantity1 Unit
Recall NumberB-0203-13

Class III Biologics Event

Event ID56479
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Mar-10
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionSource Plasma
Code Info3960036260, 3960040395, 3960045419, 3960044791, 3960049126, 3960038309, 3960041518, 3960042604, 3960044381, 3960045946, 3960049362, 3960041668, 3960036528, 3960037383, 3960039345, 3960040984, 3960046561, 3960047630, 3960038635, 3960039269, 3960037127, 3960038858, 3960042900, 3960048564, 3960037839, 3960040945, 3960043000, 3960036786, 3960037820, 3960043349, 3960043948, 3960044834, 3960036398, 3960038024, 3960038438, 3960049641, 3960046652, 3960036766, 3960037199, 3960036246, 3960038727, 3960039751, 3960046557, 3960047168, 3960048574, 3960041287, 3960035846, 3960037530, 3960041029, 3960041529, 3960042520, 3960048748, 3960040882, 3960048088, 3960038704, 3960039209, 3960039132, 3960043247, 3960046343, 3960040957, 3960036795, 3960046690, 3960047822, 3960048229, 3960048016, 3960043208, 3960038207, 3960038817, 3960039478, 3960039839, 3960044368, 3960045996, 3960039230, 3960042516, 3960043563, 3960048652, 3960049172, 3960048237, 3960038729, 3960039044, 3960041088, 3960042104, 3960043206, 3960040371, 3960047916, 3960049402, 3960040124, 3960041779, 3960043161, 3960046220, 3960036695, 3960048310, 3960036017, 3960037050, 3960039042, 3960040085, 3960040718, 3960043135, 3960049163, 3960038158, 3960041166, 3960043249, 3960038300, 3960039363, 3960039358, 3960043694, 3960046521, 3960037131, 3960037657, 3960039186, 3960036240, 3960042874, 3960037096, 3960043815, 3960044337, 3960045634, 3960035655, 3960038822, 3960038549, 3960039822, 3960040428, 3960040548, 3960041023, 3960041688, 3960042726, 3960037849, 3960047692, 3960044851, 3960040355, 3960039942, 3960040810, 3960037790, 3960036830, 3960037494, 3960040527, 3960040631, 3960045772, 3960046192, 3960047675, 3960047339, 3960040297, 3960045482, 3960036191, 3960036780, 3960038795, 3960040431, 3960045591, 3960046667, 3960049120, 3960049455, 3960045541, 3960039029, 3960038867, 3960048833, 3960049470, 3960040956, 3960041983, 3960042480, 3960036045, 3960042149, 3960044233, 3960038012, 3960042637, 3960046030, 3960042652, 3960041375, 3960036848, 3960043788, 3960048104, 3960048401, 3960039737, 3960040131, 3960040738, 3960043455, 3960040497, 3960037877, 3960038276, 3960040235, 3960042244, 3960043998, 3960037067, 3960039071, 3960041330, 3960044783, 3960048955, 3960039192, 3960040484, 3960046664, 3960039630, 3960045926, 3960047655, 3960048082, 3960049595, 3960041751, 3960042316, 3960042771, 3960048807, 3960036910, 3960039341, 3960039853, 3960040854, 3960038085, 3960040676, 3960044210, 3960044843, 3960049007, 3960049339, 3960047965, 3960037172, 3960040614, 3960038116, 3960038504, 3960039464, 3960036568, 3960039075, 3960037662, 3960038044, 3960037202, 3960038776, 3960041161, 3960042321, 3960046384, 3960039759, 3960040352, 3960043534, 3960042855, 3960040452, 3960037534, 3960036301, 3960039302, 3960041776, 3960046549, 3960038714, 3960042327, 3960041548, 3960039002, 3960037848, 3960040657, 3960036179, 3960037717, 3960047360, 3960044622, 3960048305, 3960047331, 3960037241, 3960049465, 3960049791, 3960048597, 3960037370, 3960040682, 3960048222, 3960048558, 3960042222, 3960042860, 3960043277, 3960036382, 3960040003, 3960040999, 3960037149, 3960037431, 3960040055, 3960040730, 3960043774, 3960044274, 3960045914, 3960036742, 3960037144, 3960039295, 3960048466, 3960041513, 3960041840, 3960043942, 3960047520, 3960048138, 3960042885, 3960045786, 3960035973, 3960036633, 3960037018, 3960039652, 3960049604, 3960041596, 3960043597, 3960044840, 3960047359, 3960048241, 3960042177, 3960048027, 3960038110, 3960040809, 3960044150, 3960048967, 3960038741, 3960036030, 3960037057, 3960041862, 3960041532, 3960044618, 3960043126, 3960043777, 3960036814, 3960039981, 3960041961, 3960040668, 3960041704, 3960038958, 3960039988, 3960039679, 3960047802, 3960035821, 3960037509, 3960039276, 3960039684, 3960049496, 3960041851, 3960042492, 3960046095, 3960045638, 3960048300, 3960048886, 3960049359, 3960037012, 3960044400, 3960040377, 3960040913, 3960037448, 3960038442, 3960045781, 3960041870, 3960038783, 3960042832, 3960047388, 3960038813, 3960037899, 3960039051, 3960039757, 3960040099, 3960042938, 3960044634, 3960047064, 3960037434, 3960041857, 3960044571, 3960049806, 3960038580, 3960039977, 3960044075, 3960047197, 3960047890, 3960048460, 3960048884, 3960038805, 3960039457, 3960040792, 3960042513, 3960047394, 3960040481, 3960043571, 3960040285, 3960047494, 3960049376, 3960038669, 3960041173, 3960039076, 3960044652, 3960048212, 3960038638, 3960039701, 3960043853, 3960039562, 3960042188, 3960042654, 3960043846, 3960046060, 3960046539, 3960048643, 3960039880, 3960040177, 3960045757, 3960036279, 3960040232, 3960039468, 3960040059, 3960041464, 3960049041, 3960039032, 3960040655, 3960042284, 3960035840, 3960036525, 3960041885, 3960043005, 3960044063, 3960044568, 3960047814, 3960047971, 3960048265, 3960040600, 3960043399, 3960040964, 3960040538, 3960046659, 3960042645, 3960040351, 3960046530, 3960047557, 3960037006, 3960048394, 3960040135, 3960042457, 3960042881, 3960037721, 3960039313, 3960038374, 3960039233, 3960047765, 3960040684, 3960047658, 3960048270, 3960044241, 3960036548, 3960038566, 3960039556, 3960039939, 3960041586, 3960041965, 3960043016, 3960047185, 3960045394, 3960037846, 3960038816, 3960045022, 3960046055, 3960043626, 3960045478, 3960046929, 3960047626, 3960037635, 3960045574, 3960038615, 3960039151, 3960040769, 3960042236, 3960046401, 3960037189, 3960048148, 3960049392, 3960037709, 3960040047, 3960045877, 3960046920, 3960048350, 3960035984, 3960037105, 3960036792, 3960045547, 3960045938, 3960047888, 3960040822, 3960041887, 3960037783, 3960045918, 3960039455, 3960038499, 3960038881, 3960039353, 3960038659, 3960038290, 3960043447, 3960038216, 3960038914, 3960039498, 3960039906, 3960040742, 3960041762, 3960042184, 3960043123, 3960037644, 3960038187, 3960040562, 3960046936, 3960048819, 3960042170, 3960044129, 3960044360, 3960049065, 3960047568, 3960035850, 3960039654, 3960043157, 3960045569, 3960037351, 3960038701, 3960039911, 3960046082, 3960035445, 3960036062, 3960042426, 3960044872, 3960047774, 3960038429, 3960039493, 3960040075, 3960039725, 3960040071, 3960040876, 3960041893, 3960043582, 3960039099, 3960040092, 3960046701, 3960048783, 3960041013, 3960037648, 3960038261, 3960039647, 3960040224, 3960038340, 3960038046, 3960038524, 3960039027, 3960041506, 3960037528, 3960040550, 3960036983, 3960039598, 3960040194, 3960041621, 3960041579, 3960045431, 3960038963, 3960040593, 3960040976, 3960042267, 3960038593, 3960046481, 3960048363, 3960047089, 3960047544, 3960045909, 3960048260, 3960048805, 3960039289, 3960040168, 3960043798, 3960044239, 3960045227, 3960037714, 3960040479, 3960041758, 3960045040, 3960047797, 3960042196, 3960037194, 3960038182, 3960038788, 3960041213, 3960043540, 3960044324, 3960045375, 3960037081, 3960038305, 3960039877, 3960043603, 3960046216, 3960048194, 3960046052, 3960041436, 3960039887, 3960037500, 3960036483, 3960037138, 3960039272, 3960041695, 3960043164, 3960043008, 3960048462, 3960038051, 3960037088, 3960048775, 3960045511, 3960048093, 3960048746, 3960038745, 3960043806, 3960035828, 3960038630, 3960044838, 3960048209, 3960047552, 3960046550, 3960046987, 3960036097, 3960037626, 3960037989, 3960040763, 3960041181, 3960044116, 3960039224, 3960043870, 3960049675, 3960038650, 3960047515, 3960048874, 3960035709, 3960041573, 3960042174, 3960038088, 3960036854, 3960038344, 3960038930, 3960040334, 3960043945, 3960045474, 3960046032, 3960041897, 3960042939, 3960036113, 3960043758, 3960043243, 3960040430, 3960037995, 3960035436, 3960040660, 3960037703, 3960041217, 3960036425, 3960035708
ClassificationClass III
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity628 units
Recall NumberB-0301-13

Class III Biologics Event

Event ID59696
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jun-11
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Centers of the Pacific
CitySan Francisco
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW117011433853, W117011433861, W117011433878, W117011433887
ClassificationClass III
Reason for RecallBlood products, collected using scales that did not meet the acceptable quality control specifications, were distributed.
Product Quantity4 units
Recall NumberB-0214-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW117011433855
ClassificationClass III
Reason for RecallBlood products, collected using scales that did not meet the acceptable quality control specifications, were distributed.
Product Quantity1 unit
Recall NumberB-0215-13

Class III Biologics Event

Event ID63415
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Aug-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeShare Blood Centers
CityShreveport
StateLA
CountryUS
Distribution PatternLouisiana
 

Associated Products

Product DescriptionCryoprecipitated AHF, Pooled
Code InfoW036512061595
ClassificationClass III
Reason for RecallBlood product, which reached an unacceptable temperature during storage, was distributed.
Product Quantity1 unit
Recall NumberB-0198-13

Class III Devices Event

Event ID63852
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Nov-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmSiemens Healthcare Diagnostics
CityTarrytown
StateNY
CountryUS
Distribution PatternWorldwide Distribution - USA including CA, GA, IL, IN, MI, MN, NY, and Puerto Rico. Internationally to Agentina, Bolivia, Brazil, Canada, Chile, Guatemala, South Korea, Philippines, Paraguay, Taiwan, and Uraguay,
 

Associated Products

Product DescriptionImmunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.
Code InfoLots 969 and 970
ClassificationClass III
Reason for RecallThe recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H) lot 035 calibrator vials are not affected. The darker yellow calibrator vials yield a 15-20% lower dose values compared to the target values. This may result in out of range (+2 SD) controls.
Product QuantityLot 969=33 units (29 units foreign) Lot 970=7 units (42 units foreign)
Recall NumberZ-0646-2013
Product DescriptionImmunoradiometric assay.
Code InfoLots 831 and 832
ClassificationClass III
Reason for RecallThe recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H) lot 035 calibrator vials are not affected. The darker yellow calibrator vials yield a 15-20% lower dose values compared to the target values. This may result in out of range (+2 SD) controls.
Product QuantityLot 831=19 units (all foreign consignees) and Lot 832=2 units (all foreign consignees)
Recall NumberZ-0647-2013
Product DescriptionImmunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.
Code InfoLots 742 and 743
ClassificationClass III
Reason for RecallThe recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H) lot 035 calibrator vials are not affected. The darker yellow calibrator vials yield a 15-20% lower dose values compared to the target values. This may result in out of range (+2 SD) controls.
Product QuantityLot 742= 8 units all foreign consignees) Lot 743=7 units (all foreign consignees)
Recall NumberZ-0648-2013

Class III Food Event

Event ID63883
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Dec-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmMeijer Distribution, Inc
CityGrand Rapids
StateMI
CountryUS
Distribution Pattern199 Meijer stores located in Illinois, Indiana, Kentucky, Michigan, and Ohio may have received product from Meijer distribution centers.
 

Associated Products

Product DescriptionMarkets of Meijer 16oz Redskin Peanuts
Code InfoLot 07 2234; Sell by date 12/20/2012 Lot 08 2279; Sell by date 1/1712013 Lot 07 2318; Sell by date 5/3/2013 lot 07 2340; Sell by date 5/3/2013 UPC 8-8692619797-6
ClassificationClass III
Reason for RecallSodium was not correctly stated on the label.
Product Quantity15336 units
Recall NumberF-0861-2013

Class III Devices Event

Event ID63941
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics, Inc.
CityNewark
StateDE
CountryUS
Distribution PatternNationwide Distribution to the following states: AL, AR, CA, CO, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NY, OH, PA, TN, TX and WI.
 

Associated Products

Product DescriptionSiemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(R) tox(TM) Serum Barbiturate and Benzodiazepine Assays as a reference for the semi-quantitative analis of barbiturates and benzodiazepines in human serum.
Code InfoLot D1
ClassificationClass III
Reason for RecallIncorrect expiration date was assigned to the D1 lot of Emit(R) tox(TM) Serum Calibrators. The correct expiration date is 2013-12-31. The incorrect assigned expiration date is 2014-12-31.
Product Quantity1,998 cartons
Recall NumberZ-0665-2013

Class III Food Event

Event ID63965
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Oct-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmNew B.C.N. Trading Inc
CitySouth Plainfield
StateNJ
CountryUS
Distribution PatternCT, FL, NJ, NY, PA, & VA
 

Associated Products

Product DescriptionAsian Boy (EBQ) Tapioca Stick 3.5 oz (100g) New B.C.N. Trading Inc. 701 Hadky South Plainfield, NJ 07080 MINH NGUYET TRADING CO., LTD. BIN CHANH -HOCHIMINH CITY VIETNAM UPC 627404021822
Code InfoUPC 627404021822
ClassificationClass III
Reason for RecallTapoica stick contains undeclared sulfites.
Product Quantity71 cases (50 retail units per carton)
Recall NumberF-0870-2013

Mixed Classification Food Event

Event ID63792
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Aug-12
Initial Firm Notification of Consignee or Public Visit
Recalling FirmPastry Food Products Inc.
CitySan Juan
StatePR
CountryUS
Distribution PatternPuerto Rico only
 

Associated Products

Product DescriptionTRIGAL***Empanadillas de Pizza (Pizza turnovers)***12 ct***Pastry Foods Inc., Rio Piedras, PR
Code Infonone
ClassificationClass II
Reason for RecallUndeclared milk as the source of cheese.
Product Quantity120 packages of 12 units each
Recall NumberF-0873-2013
Product DescriptionTRIGAL***Pastelillos Coctel de Pizza (Pizza Mini turnovers)***12 ct***Pastry Foods Inc., Rio Piedras, PR
Code Infonone
ClassificationClass I
Reason for RecallUndeclared milk
Product Quantity12 packages of 12 units each
Recall NumberF-0874-2013

Mixed Classification Biologics Event

Event ID63327
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternTennessee; Switzerland; Florida
 

Associated Products

Product DescriptionCryoprecipitated AHF, Pooled
Code InfoW036811822350;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0275-13
Product DescriptionFresh Frozen Plasma
Code Info2243062;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0276-13
Product DescriptionCryoprecipitated AHF
Code InfoW036809216741; 2479070;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-0277-13
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036810821967; W036809821585; W036809813222; 2911209;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity4
Recall NumberB-0278-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036811262717; W036810243696; W036810039414; W036809359200; W036809216741; 2479070;
ClassificationClass III
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity6
Recall NumberB-0279-13
Product DescriptionRed Blood Cells
Code InfoW036811262717; W036810039414; W036809359200; W036809216741; 2243062; 2479070; W036810243696;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity7
Recall NumberB-0280-13

Mixed Classification Devices Event

Event ID63809
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics Inc
CityNorwood
StateMA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,
 

Associated Products

Product DescriptionSiemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 Chek-Stix® Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX® positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
Code InfoCarton/Bottle Lot Number: C9093061B P9093061B C9094081B P9094081B C0097091B P0097091B C0100101C P0100101C C0103042F P0103042F C0106062B P0106062B C91 01022D P91 01022D CP9105052B P9105052B C9108092A P9108092A
ClassificationClass III
Reason for RecallWhen these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25°C (77°F).
Product Quantity7865
Recall NumberZ-0635-2013
Product DescriptionSiemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with the CLINITEK ATLAS® Automated urine Chemistry Analyzer and CLINITEK ATLAS® 10 reagent Pak, CLINITEK ATLAS® Positive and Negative Control Strips provide defined results for color, clarity, glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes. Each CLINITEK ATLAS Positive Control Strip is a firm plastic strip to which are affixed seven separate analyte areas.
Code InfoCarton/Bottle Lot Number: S9093061A P9093061A S9094081A P9094081A S0097091C P0097091C S9093061A P9093061A S9094081A P9094081A S0097091C P0097091C S0100101B P0100101B S0103042A P0103042A S0103042H P0103042H S0106062A P0106062A S9101022A P9101022A S9101022B P9101022B S9105052A P9105052A
ClassificationClass III
Reason for RecallWhen these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25°C (77°F).
Product Quantity6466
Recall NumberZ-0636-2013
Product DescriptionSiemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix® Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX® positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
Code InfoCarton/Bottle Lot Number: C9093061C P9093061C C9094081J P9094081J C0100101D P0100101D C0097091E P0097091E C9101022E P9101022E C0099091D P0099091D C0100101E P0100101E C9101022H P9101022H C9101022J P9101022J C0103042B P0103042B C0103042G P0103042G C0106062D P0106062D C9105052C P9105052C
ClassificationClass III
Reason for RecallWhen these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25°C (77°F).
Product Quantity16711
Recall NumberZ-0637-2013
Product DescriptionSiemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) Catalog Number: 1360L Chek-Stix® Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX® positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
Code InfoCarton/Bottle Lot Number: C9094081C P9094081C C0100101A P0100101A C9101022C P9101022C
ClassificationClass III
Reason for RecallWhen these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25°C (77°F).
Product Quantity700
Recall NumberZ-0638-2013
Product DescriptionSiemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix® Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX® positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
Code InfoCarton/Bottle Lot Number: CP0099091B P0099091B C0100101G P0100101G C0103042E P0103042E
ClassificationClass III
Reason for RecallWhen these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25°C (77°F).
Product Quantity325
Recall NumberZ-0639-2013
Product DescriptionSiemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix® Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX® positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
Code InfoCarton/BottleLot Number: C0099091A P0099091A C0100101 H P0100101 H C0103042C P0103042C
ClassificationClass II
Reason for RecallWhen these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25°C (77°F).
Product Quantity1130
Recall NumberZ-0640-2013
Product DescriptionSiemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix® Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX® positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
Code InfoCarton/Bottle Lot Number: C0099091C P0099091C C0100101F P0100101F C9101022I P9101022I C0103042D P0103042D C0106062E P0106062E
ClassificationClass III
Reason for RecallWhen these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25°C (77°F).
Product Quantity4642
Recall NumberZ-0641-2013
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