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U.S. Department of Health and Human Services

Enforcement Report - Week of February 27, 2013

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Class I Devices Event

Event ID63783
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDePuy Orthopaedics, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternWorldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, FL, GA, ID, IL, MA, MD, MI, MN, NC, NM, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI, and WV and the countries of Holland, Australia, Austria, South Africa and Canada including Veteran Administration hospitals.
 

Associated Products

Product DescriptionLPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
Code InfoPart number: 198720018 and Lot numbers: 123506, 123507, 156208, 188414, 202951, 212351, B34GC1000, B4EGN1000, B4SBM1000, B5SHY1000, DH8F91000, DH8F9A000, DH8F9B000, DH8F9C, and FE5LL1.
ClassificationClass I
Reason for RecallDePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.
Product Quantity162 total units (US) and 102 units total (OUS)
Recall NumberZ-0828-2013
Product DescriptionLPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
Code InfoPart number: 198720020 and Lot numbers: 140576, 156212, 156213, 156214, 162644, 188411, 202954, 156214A, 202954A, B34GD1000, B4SBN1000, B4SBNA000, B4SBNB000, B4SBNC000, B5RAW1000, B5RAWA000, C3RHJ1000, C74JX1000, C74JXA, E18N61000, E3PKV1000, EF8GB1000, and FL2WB1.
ClassificationClass I
Reason for RecallDePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.
Product Quantity162 total units (US) and 102 units total (OUS)
Recall NumberZ-0829-2013
Product DescriptionLPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
Code InfoPart number: 198720024 and Lot numbers: 113812, 123509, 140578, 156210, 171659, 171660, 171661, 171662, 171663, 123509A, B34GE1000, B34GEA000, B4EGR1000, B4EGRA000, B4EGRB000, B4XFL1000, B4XFLA000, B5SH11000, B5SH1A000, B5SH1B, C74J11000, D14KG1000, E4RF21000, EN8CY1000, EN8CYA000, FC1MB1, and FC1MBA.
ClassificationClass I
Reason for RecallDePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.
Product Quantity162 total units (US) and 102 units total (OUS)
Recall NumberZ-0830-2013
Product DescriptionLPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
Code InfoPart number: 198720028 and Lot numbers: 123510, 156211, 212355, B34GG1000, B4TH51000, B5RAX1000, B5RAXA000, B5RAXB000, CC3KX1000, CC3KXA000, E4RF31000, E4RF3A000, E55HV1, and EN4KN1000.
ClassificationClass I
Reason for RecallDePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.
Product Quantity162 total units (US) and 102 units total (OUS)
Recall NumberZ-0831-2013

Class I Drugs Event

Event ID63899
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMylan Institutional, Inc. (d.b.a. UDL Laboratories)
CityRockford
StateIL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionHydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 blistered tablets per carton, Rx only; Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, Pkg by & Distributed by UDL Laboratories, Inc., Rockford, IL 61103; NDC 51079-254-21.
Code InfoLot #: 3037841, 3040859, 3042573, Exp 12/13
ClassificationClass I
Reason for RecallSuperpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Product Quantity3,407 cartons
Recall NumberD-166-2013

Class I Drugs Event

Event ID63942
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Dec-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmP & J Trading Co
CityFullerton
StateCA
CountryUS
Distribution PatternNationwide and Korea
 

Associated Products

Product DescriptionSLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19685 Varda Ave., Buena Park, CA.
Code InfoThere are no manufacturing codes associated with the product.
ClassificationClass I
Reason for RecallMarketed Without an Approved NDA/ANDA: All lots of the dietary supplement Slimdia Revolution are being recalled because they contain sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.
Product Quantityunknown
Recall NumberD-165-2013

Class II Biologics Event

Event ID39104
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Apr-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternPA, IL, Switzerland
 

Associated Products

Product DescriptionCryoprecipitated AHF
Code InfoJ65110
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-0315-13
Product DescriptionFresh Frozen Plasma
Code InfoJ62864
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-0316-13
Product DescriptionRecovered Plasma
Code InfoJ65110
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-0317-13

Class II Biologics Event

Event ID39637
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Jan-05
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeServe Blood Center
CitySioux City
StateIA
CountryUS
Distribution PatternIA, MO, FL, VA, Austria
 

Associated Products

Product DescriptionCryoprecipitated AHF
Code Info1933200
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-0465-13
Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info1944382; 1944382
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity2 units
Recall NumberB-0466-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info1879895;1888158;1933200
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity3 units
Recall NumberB-0467-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info1879895;1888158;1933200
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity3 units
Recall NumberB-0468-13

Class II Biologics Event

Event ID40103
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Apr-05
Initial Firm Notification of Consignee or Public FAX
Recalling FirmZLB Bioplasma, Inc.
CityFt. Collins
StateCO
CountryUS
Distribution PatternNC, Switzerland
 

Associated Products

Product DescriptionSource Plasma
Code Info7050250350; 7050249999; 7050249438; 7050248725; 7050248427; 7050247466; 7050246334; 7050245972; 7050244385; 7050247190; 7050242563; 7050232066; 7050231322; 7050230879; 7050230716; 7050213765; 7050213142; 7050255690; 7050212544; 7050212340; 7050211828; 7050211268; 7050209821; 7050209506; 7050209329
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a body piercing within 12 months of donating, were distributed.
Product Quantity25 units
Recall NumberB-0647-13

Class II Biologics Event

Event ID40148
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Apr-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifeServe Blood Center
CitySioux City
StateIA
CountryUS
Distribution PatternFL, IA
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info1978331;1978331
ClassificationClass II
Reason for RecallBlood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Product Quantity2 units
Recall NumberB-0642-13

Class II Biologics Event

Event ID41943
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Mar-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info11KJ01769
ClassificationClass II
Reason for RecallBlood product, labeled as leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed.
Product Quantity1 Unit
Recall NumberB-0624-13

Class II Biologics Event

Event ID41984
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Apr-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternGeorgia
 

Associated Products

Product DescriptionRed Blood Cells
Code Info11FV46850
ClassificationClass II
Reason for RecallBlood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Product Quantity1 Unit
Recall NumberB-0172-13

Class II Biologics Event

Event ID42559
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jun-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross
CityPortland
StateOR
CountryUS
Distribution PatternCalifornia.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info21GS28030.
ClassificationClass II
Reason for RecallBlood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Product Quantity1 component
Recall NumberB-0573-13

Class II Biologics Event

Event ID43300
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Oct-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternIL, PA, IA, MS, MO
 

Associated Products

Product DescriptionCryoprecipitated AHF
Code InfoGX06871, GX06874
ClassificationClass II
Reason for RecallBlood products, collected from donors whose arm scrubs were performed using expired cleanser, were distributed.
Product Quantity2 units
Recall NumberB-0328-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoGX06872, GX06874, GX06873, GX06870, GX06868, GX06865, GX06864, GX06869, GX06866, GX06878, GX06871
ClassificationClass II
Reason for RecallBlood products, collected from donors whose arm scrubs were performed using expired cleanser, were distributed.
Product Quantity11 units
Recall NumberB-0329-13

Class II Biologics Event

Event ID47978
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Mar-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmLifeServe Blood Center
CitySioux City
StateIA
CountryUS
Distribution PatternIA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info2156722
ClassificationClass II
Reason for RecallBlood component, processed from Whole Blood stored at room temperature for more than 8 hours after collection, was distributed.
Product Quantity1 unit
Recall NumberB-0582-13

Class II Biologics Event

Event ID49874
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Aug-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternArkansas
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info011FY45853
ClassificationClass II
Reason for RecallBlood product, collected from a donor who did not respond to questions regarding increased risk for vCJD, was distributed.
Product Quantity1 Unit
Recall NumberB-0641-13

Class II Biologics Event

Event ID51366
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Dec-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomat USA, Inc.
CityLos Angeles
StateCA
CountryUS
Distribution PatternCalifornia, Spain, and Japan.
 

Associated Products

Product DescriptionSource Plasma
Code Info0130050140, 0130050770, 0130051035, 0130051507, 0130051813, 0130052248, 0130052469, 0130052924, 0130053200, 0130053717 0130053996, 0130054472, 0130054718, 0130055393, 0130055563 0130056309, 0130056624, 0130057132, 0130060275, 0130060649 0130057551, 0130058315, 0130058656, 0130059009, 0130061052, 0130061496, 0130061916, 0130062474, 0130062881
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
Product Quantity29 components
Recall NumberB-0464-13

Class II Biologics Event

Event ID51468
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-May-08
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 Info357109561; 357109081; 357107957; 357107354; 357106112; 357105645; 357104501; 357103958; 357102687; 357094085; 357093564; 357092426; 357091898; 357088997; 357088620; 357087454; 357086940; 357085683; 357085329; 357084251; 357083744; 357082438; 357082275; 357079741; 357079241; 357069722; 357069025; 357067946; 357078368; 357077347; 357076795; 357075138; 357073684; 357073023; 357071708; 357071129; 357070173; 357067075; 357065733; 357065067; 357063857; 357063168; 357061847; 357061391; 357060172; 357059540; 357058141; 357057634; 357056451; 357053823; 357052475; 357051952; 357035559; 357034481; 357034101; 357032979; 357032189; 357032103; 357110528; 357109873; 357107140; 357106296; 357103735; 357102870; 357101841; 357101557; 357100375; 357099094; 357098357; 357097748; 357096607; 357095849; 357095093; 357094461; 357093271; 357092588; 357091765; 357091125; 357089884; 357089236; 357088373; 357087824; 357085970; 357085476; 357084246; 357083805; 357079589; 357079041; 357069225; 357068756; 357067668; 357078158; 357077103; 357076502; 357075340; 357074393; 357066473; 357065819; 357064887; 357064147; 357062804; 357062109; 357060993; 357060299; 357059329; 357058634; 357057353; 357056578; 357053556; 357052720; 357051849; 357051103; 357049781; 357049065; 357048070; 357055649; 357054284; 357047050; 357045719; 357045000; 357044024; 357043219; 357042254; 357041576; 357039063; 357037951; 357037024; 357036399; 357035266; 357034687; 357033895; 357033279; 357031976; 357031440; 357030441; 357024472; 357024415; 357110220; 357109701; 357108651; 357107982; 357106937; 357106248; 357105201; 357104524; 357103487; 357102807; 357101811; 357101174; 357100182; 357099056; 357098052; 357097411; 357096439; 357095568; 357094744; 357094100; 357093083; 357092453; 357091425; 357090791; 357089806; 357089172; 357086455; 357085853; 357084856; 357084256; 357083275; 357082495; 357081800; 357081175; 357080241; 357069988; 357069505; 357068406; 357067861; 357077752; 357077180; 357076030; 357075594; 357074024; 357073349; 357072279; 357071597; 357066370; 357065602; 357064570; 357063871; 357062720; 357062036; 357060878; 357060195; 357059019; 357058339; 357057168; 357056488; 357053271; 357052643; 357051455; 357050796; 357049626; 357048984; 357047804; 357055683; 357047066; 357045916; 357045219; 357044151; 357043446; 357042354; 357041674; 357040729; 357040096; 357039104; 357038016; 357037065; 357036449; 357035507; 357034902; 357033976; 357033385; 357032516; 357031468; 357060732; 357055380; 357055212; 357038647; 357076091; 357074481; 357072414; 357071896; 357066409; 357065901; 357064615; 357064174; 357062272; 357060538; 357059826; 357058647; 357057962; 357056110; 357052955; 357052294; 357051109; 357050411; 357049362; 357048621; 357047561; 357054857; 357047368; 357046004; 357045493; 357044221; 357043743; 357042369; 357041698; 357040653; 357040069; 357039085; 357037754; 357036972; 357036130; 357035421; 357034572; 357033912; 357033059; 357051278; 357050537; 357049489; 357048781; 357047670; 357055507; 357046882; 357044083; 357040638; 357040081; 357038272; 357038538; 357024411; 357091656; 357090309; 357089977; 357088644; 357088327; 357086915; 357086331; 357085071; 357084462; 357083540; 357082833; 357082072; 357081399; 357080487; 357079783; 357069973; 357069427; 357068419; 357078388; 357077672; 357076733; 357076015; 357074282; 357073553; 357072464; 357071780; 357070731; 357070219; 357066637; 357065765; 357064848; 357064127; 357063019; 357062268; 357061060; 357060542; 357059258; 357058572; 357057371; 357056705; 357053527; 357052798; 357051706; 357051020; 357049913; 357049200; 357048038; 357055856; 357054196; 357047234; 357046115; 357045399; 357044288; 357043628; 357042592; 357041923; 357040958; 357040218; 357039277; 357038171; 357037252; 357036603; 357035669; 357035011; 357034169; 357033513; 357032688; 357031569; 357030789; 357030160; 357029440; 357028910; 357028181; 357027643; 357026952; 357026473; 357025814; 357025371; 357024741; 357023802; 357023223; 357022808; 357022303; 357021934; 357021417; 357021034; 357018253; 357018228
ClassificationClass II
Reason for RecallBlood products, collected from a donor who may have received a body piercing within 12 months of donating, were distributed.
Product Quantity368
Recall NumberB-0650-13

Class II Biologics Event

Event ID60488
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Oct-11
Initial Firm Notification of Consignee or Public FAX
Recalling FirmDCI Biologicals LLC
CityGallup
StateNM
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code InfoSS0028297, SS0028810, SS0029396, SS0029992, SS0030710, SS0031173, SS0032411, SS0032571, SS0033526, SS0034910, SS0033790, SS0035135, SS0040286, SS0040977, SS0041971, SS0042322, SS0046118, SS0046508, SS0049341, SS0054262, SS0054851, SS0055786, SS0056509
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of high-risk behavior, were distributed.
Product Quantity23 units
Recall NumberB-0399-13

Class II Devices Event

Event ID62334
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHill-Rom, Inc.
CityBatesville
StateIN
CountryUS
Distribution PatternWorldwide Distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY; and CANADA LOCATIONS: AB, BC, MB, NB, NS, ON, and SK.
 

Associated Products

Product DescriptionLiko Overhead Rail System Product Usage - The Overhead Rail System allows overhead lifts to be mounted to the ceiling allowing versatility for use in lifting situations. It can be used with different Liko ceiling lifts.
Code InfoThe Liko Overhead Rail System components are not serialized and have been distributed since the early 1980's to the present.
ClassificationClass II
Reason for RecallLiko/Hill-Rom to date has received two reports from facilities alleging that the overhead rail system has failed to the extent that the overhead rails have fallen down while in use in high humidity (swimming pool) areas. Analysis of the incidents suggest that the components (hardware) used to secure the rail to the ceiling had corroded and may be unsuitable for environments with an atmosphere containing chlorine.
Product Quantity3816 in total
Recall NumberZ-0872-2013

Class II Devices Event

Event ID63692
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Sustainability Solutions
CityTempe
StateAZ
CountryUS
Distribution PatternDistributed in Arizona and New Jersey.
 

Associated Products

Product DescriptionStryker Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system. PUMPKIT (Pump Kit), and RSP159-01 - AC Power Adaptor.
Code Info108851407, 108851408, 108870192, 108874144, 108883271, 108886340, and 108888023.
ClassificationClass II
Reason for RecallReports that the AC Power Adaptor may not operate due to wires coming loose in the unit.
Product Quantity1,311
Recall NumberZ-0840-2013

Class II Devices Event

Event ID63933
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHealthtronics, Inc.
CityAustin
StateTX
CountryUS
Distribution PatternCA, CO, FL, GA, NC, NJ, OH, TX, and WI. No international distribution.
 

Associated Products

Product DescriptionHealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L, Endocare, Inc., a wholly owned subsidiary of HealthTronics, Inc., 9825 Spectrum Dr. Building 3, Austin, TX 78717 The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical System. The CryoCare Surgical System is intended for use in surgical procedures in the arrears of general surgery, dermatology, neurology, thoracic surgery, pulmonary surgery,
Code InfoLot 10180, Expiration date on box is 2105-07. Model Number R3.8L
ClassificationClass II
Reason for RecallThe Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date.
Product Quantity50 units
Recall NumberZ-0825-2013

Class II Devices Event

Event ID64076
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmInternational Technidyne Corp.
CityEdison
StateNJ
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and Internationally to Bermuda, Canada, Chile, Denmark, Germany,Italy,Latvia, Lithuania, Malaysia, Phillipines, South Africa, Spain, Switzerland, Taiwan, and United Arab Emirates.
 

Associated Products

Product DescriptionPro Time Microcoagulation System/ Pro Time 3 Cuvette International Technidyne Corporation 23 Nevsky Street Edison, NJ 08820 The Pro Time Microcoagulation System is a portable batter operated instrument with a disposable cuvette for quantitative determination of prothrombin time from fingerstick whole blood or anticoagulant free venous whole blood.
Code InfoPro3-25 A2K3C001 1/31/2013 A2K3C002 1/31/2013 A2P3C003 1/31/2013 A2P3C004 1/31/2013 A2K3C005 1/31/2013 A2K3C006 1/31/2013 A2K3C007 1/31/2013 A2K3C008 1/31/2013 A2K3C009 1/31/2013 A2K3C011 1/31/2013 A2K3C013 1/31/2013 A2K3C015 1/31/2013 A2K3C016 1/31/2013 A2K3C017 1/31/2013 A2K3C018 1/31/2013 A2K3C019 1/31/2013 A2K3C020 1/31/2013 A2K3C021 1/31/2013 A2K3C022 1/31/2013 A2K3C023 1/31/2013 2K3C024 1/31/2013 A2K3C025 1/31/2013 A2K3C026 1/31/2013 A2K3C027 1/31/2013 B2K3C028 2/28/2013 B2K3C030 2/28/2013 B2K3C031 2/28/2013 B2K3C032 2/28/2013 B2K3C033 2/28/2013 B2K3C034 2/28/2013 B2K3C035 2/28/2013 B2K3C036 2/28/2013 B2K3C037 2/28/2013 B2K3C038 2/28/2013 B2K3CO39 2/28/2013 B2K3C040 2/28/2013 B2K3C041 2/28/2013 B2K3C042 2/28/2013 B2K3C043 2/28/2013 B2K3C044 2/28/2013 B2K3C045 2/28/2013 B2K3C046 2/28/2013 C2K3C048 3/31/2013 C2K3C049 3/31/2013 C2K3C050 3/31/2013 C2K3C051 3/31/2013 C2K3C052 3/31/2013 C2K3C053 3/31/2013 C2K3C054 3/31/2013 C2K3C055 3/31/2013 C2K3C056 3/31/2013 C2K3C058 3/31/2012 C2K3C059 3/31/2013 C2K3C061 3/31/2013 D2K3C078 4/30/2013 M1K3C474 12/31/2012 M1K3C475 12/31/2012 M1K3C477 12/31/2012 M1P3C478 12/31/2012 M1P3C479 12/31/2012 M1P3C480 12/31/2012 M1P3C481 12/31/2012 M1P3C482 12/31/2012 PRO3-4 A2K3H015 1/31/2013 B2K3H029 2/28/2013 B2K3H033 2/28/2013 B2K3H047 2/28/2013 C2K3H049 3/31/2013 C2K3H055 3/31/2013 C2K3H057 3/31/2013 PRO3-50 B2P3C029 2/28/2013 B2P3C030 2/28/2013 B2O3C033 2/28/2013 C2P3C057 3/31/2013
ClassificationClass II
Reason for RecallSome Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothrombin Time/International Normalized Ratio (PT/INR) results.
Product Quantity11742 boxes US (25 cuvettes per box); 22,968 boxes OUS (25 cuvettes per box)
Recall NumberZ-0837-2013

Class II Devices Event

Event ID64158
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCodman & Shurtleff, Inc.
CityRaynham
StateMA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.
 

Associated Products

Product DescriptionNEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code InfoAll unexpired lots
ClassificationClass II
Reason for RecallSterility of device may be compromised due to lack of packaging integrity
Product Quantity867 units
Recall NumberZ-0842-2013
Product DescriptionNEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code InfoAll unexpired lots
ClassificationClass II
Reason for RecallSterility of device may be compromised due to lack of package integrity
Product Quantity19 units
Recall NumberZ-0843-2013
Product DescriptionNEUROPATH 6Fx90 GUIDING CATH HH Product Code: GHH60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code InfoAll unexpired lots
ClassificationClass II
Reason for RecallSterility of device may be compromised due to lack of package integrity
Product Quantity56 units
Recall NumberZ-0844-2013
Product DescriptionNEUROPATH 5Fx100 GUIDING CATH HH Product Code: GHH51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code InfoAll unexpired lots
ClassificationClass II
Reason for RecallSterility of device may be compromised due to lack of package integrity
Product Quantity50 units
Recall NumberZ-0845-2013
Product DescriptionNEUROPATH 5Fx100 GUIDING CATH HH Product Code: GMC51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code InfoAll unexpired lots
ClassificationClass II
Reason for RecallSterility of device may be compromised due to lack of package integrity
Product Quantity234 units
Recall NumberZ-0846-2013
Product DescriptionNEUROPATH 6Fx100 GUIDING CATH MPD Product Code: GMD60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code InfoAll unexpired lots
ClassificationClass II
Reason for RecallSterility of device may be compromised due to lack of package integrity
Product Quantity867 units
Recall NumberZ-0847-2013
Product DescriptionNEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code InfoAll unexpired lots
ClassificationClass II
Reason for RecallSterility of device may be compromised due to lack of package integrity
Product Quantity273 units
Recall NumberZ-0848-2013
Product DescriptionNEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code InfoAll unexpired lots
ClassificationClass II
Reason for RecallSterility of device may be compromised due to lack of package integrity
Product Quantity266 units
Recall NumberZ-0849-2013
Product DescriptionNEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code InfoAll unexpired lots
ClassificationClass II
Reason for RecallSterility of device may be compromised due to lack of package integrity
Product Quantity32 units
Recall NumberZ-0850-2013
Product DescriptionNEUROPATH 6Fx100 GUIDING CATH MC Product Code: GCB61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code InfoAll unexpired lots
ClassificationClass II
Reason for RecallSterility of device may be compromised due to lack of package integrity
Product Quantity34 units
Recall NumberZ-0851-2013
Product DescriptionNEUROPATH 6Fx100 GUIDING CATH S2 Product Code: GSM61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code InfoAll unexpired lots
ClassificationClass II
Reason for RecallSterility of device may be compromised due to lack of package integrity
Product Quantity129 units
Recall NumberZ-0852-2013
Product DescriptionNEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code InfoAll unexpired lots
ClassificationClass II
Reason for RecallSterility of device may be compromised due to lack of package integrity
Product Quantity5 units
Recall NumberZ-0853-2013
Product DescriptionNEUROPATH 5Fx90 GUIDING CATH MCV Product Code: GCB50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code InfoAll unexpired lots
ClassificationClass II
Reason for RecallSterility of device may be compromised due to lack of package integrity
Product Quantity5 units
Recall NumberZ-0854-2013
Product DescriptionNEUROPATH 5Fx90 GUIDING CATH MPC Product Code: GMC50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code InfoAll unexpired lots
ClassificationClass II
Reason for RecallSterility of device may be compromised due to lack of package integrity
Product Quantity202 units
Recall NumberZ-0855-2013
Product DescriptionNEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code InfoAll unexpired lots
ClassificationClass II
Reason for RecallSterility of device may be compromised due to lack of package integrity
Product Quantity1548 units
Recall NumberZ-0856-2013
Product DescriptionNEUROPATH 5Fx90 GUIDING CATH MPD Product Code: GMD50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code InfoAll unexpired lots
ClassificationClass II
Reason for RecallSterility of device may be compromised due to lack of package integrity
Product Quantity202 units
Recall NumberZ-0857-2013
Product DescriptionNEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code InfoAll unexpired lots
ClassificationClass II
Reason for RecallSterility of device may be compromised due to lack of package integrity
Product Quantity46 units
Recall NumberZ-0858-2013
Product DescriptionNEUROPATH 5Fx90 GUIDING CATH ST Product Code: GST50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code InfoAll unexpired lots
ClassificationClass II
Reason for RecallSterility of device may be compromised due to lack of package integrity
Product Quantity46 units
Recall NumberZ-0859-2013
Product DescriptionNEUROPATH 6Fx90 GUIDING CATH ST Product Code: GST60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code InfoAll unexpired lots
ClassificationClass II
Reason for RecallSterility of device may be compromised due to lack of package integrity
Product Quantity268 units
Recall NumberZ-0860-2013
Product DescriptionNEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code InfoAll unexpired lots
ClassificationClass II
Reason for RecallSterility of device may be compromised due to lack of package integrity
Product Quantity141 units
Recall NumberZ-0861-2013
Product DescriptionNEUROPATH 6Fx90 GUIDING CATH MCV Product Code: GCB60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code InfoAll unexpired lots
ClassificationClass II
Reason for RecallSterility of device may be compromised due to lack of package integrity
Product Quantity10 units
Recall NumberZ-0862-2013
Product DescriptionNEUROPATH 6Fx90 GUIDING CATH S2 Product Code: GSM60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code InfoAll unexpired lots
ClassificationClass II
Reason for RecallSterility of device may be compromised due to lack of package integrity
Product Quantity64 units
Recall NumberZ-0863-2013
Product DescriptionNEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code InfoAll unexpired lots
ClassificationClass II
Reason for RecallSterility of device may be compromised due to lack of package integrity
Product Quantity25
Recall NumberZ-0864-2013
Product DescriptionNEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code InfoAll unexpired lots
ClassificationClass II
Reason for RecallSterility of device may be compromised due to lack of package integrity
Product Quantity522 units
Recall NumberZ-0865-2013

Class II Devices Event

Event ID64185
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmIntegra LifeSciences Corp.
CityPlainsboro
StateNJ
CountryUS
Distribution PatternWorldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA & WI. Internationally to Belgium.
 

Associated Products

Product DescriptionMAYFIELD® Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar Drive, Building A, Cincinnati, OH 45227 The MAYFIELD® Base Units are intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.
Code InfoModel # A3101 Base Units Serial No's: SB120016, SB120017, SB120019, SB120020, SB120021, SB120022, SB120023, SB120024, SB120025, SB120026, SB120027, SB120028, SB120029, SB120030, SB120031, SB120032, SB120134, SB120036, SB120037, SB120038, SB120040, SB120042, SB120043, SB120044, SB120045, SB120049, SB120050, SB120051, SB120052, SB120053, SB120054, SB120055, SB120056, SB120057, SB120058, SB120059, SB120060, SB120061, SB120062, SB120063, SB120064, SB120065, SB120066, SB120067, SB120068, SB120069, SB120070, SB120071, SB120072, SB120073, SB120074, SB120075, SB120076, SB120077, SB120078, SB120079, SB120080, SB120081, SB120082, SB120083, SB120084, SB120085, SB120086, SB120087, SB120088, SB120089, SB120090, SB120091, SB120092, SB120093, SB120094, SB120095, SB120096, SB120097, SB120098, SB120099, SB120100, SB120107, SB120108, SB120109, SB120111, SB120112, SB120113, SB120114, SB120115, SB120116, SB120117, SB120118, SB120119, SB120120, SB120121, SB120122, SB120129, SB120131, SB120138 & SB120141.
ClassificationClass II
Reason for RecallIntegra determined there is a possibility that the Base Units may break during use.
Product Quantity96 units
Recall NumberZ-0869-2013

Class II Food Event

Event ID64187
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jan-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmBimbo Bakeries Usa
CityHorsham
StatePA
CountryUS
Distribution PatternProducts were to distributed to grocery outlets within the US in AL, FL, GA, LA, MS, NC, SC, and TN.
 

Associated Products

Product DescriptionThomas' Bagels, 1 lb 4 oz packages; EVERYTHING, ONION, BLUEBERRY, PLAIN, CINNAMON RAISIN, HEARTY GRAINS 100% WHOLE WHEAT, CINNAMON SWIRL and HONEY WHEAT varieties.
Code InfoBest buy dates (month and day) "JAN 18" to and including "JAN 27" found on the lock tab bag closures in the following states: AL, FL, GA and TN.
ClassificationClass II
Reason for RecallThe firm found metal fragments in two packages of product.
Product Quantity418,356 packages
Recall NumberF-1001-2013
Product DescriptionSara Lee Deluxe Bagels, 20 oz packages; BLUEBERRY, PLAIN, CINNAMON RAISIN,and HONEY WHEAT varieties.
Code InfoBest buy dates (month and day) "JAN 18" to and including "JAN 27" found on the lock tab bag closures in the following states: AL, FL, GA, LA, MS, NC, SC and TN.
ClassificationClass II
Reason for RecallThe firm found metal fragments in two packages of product.
Product Quantity57,492 packages
Recall NumberF-1002-2013
Product DescriptionPublix Premium Bagels, 20 oz packages; ORIGINAL, MULTI-GRAIN, and CINNAMON RAISIN SWIRL varieties.
Code InfoBest buy dates (month and day) "JAN 18" to and including "JAN 27" found on the lock tab bag closures in the following states: AL, FL, SC and TN.
ClassificationClass II
Reason for RecallThe firm found metal fragments in two packages of product.
Product Quantity34,020 packages
Recall NumberF-1003-2013
Product DescriptionWeight Watchers 6 Original Bagels, 15 oz packages
Code InfoBest buy dates (month and day) "JAN 18" to and including "JAN 27" found on the lock tab bag closures in the following states: AL, FL, GA, NC, SC and TN.
ClassificationClass II
Reason for RecallThe firm found metal fragments in two packages of product.
Product Quantity4,032 packages
Recall NumberF-1004-2013

Class II Devices Event

Event ID64201
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Healthcare Inc.
CityAndover
StateMA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and Internationally to ALGERIA, ANGOLA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BULGARIA, COLOMBIA, CROATIA (LOCAL NAME HYVATSKA), CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, ESTONIA, FINLAND, FRANCE, GABON, GERMANY, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN (ISLAMIC REPUBLIC OF), IRAQ, IRELAND, ISRAEL, ITALY, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MALAYSIA, MALTA, MAURITIUS, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PALESTINE, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA (SLOVAK REPUBLIC), SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, AND VIET NAM.
 

Associated Products

Product DescriptionPhilips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation
Code InfoSerial number range: USO1100100 - USO1100372, USN1100376 - USN1100960, USD1100961 - USD1101095, US11201096 - US11201186, US21201187 - US21201239, US31201240 - US31201537, US41201538 - US41201585, US51201586 - US51201721, US61201722 -US61201924, US71201925 - US71202048, US81202049 - US81202168, US91202169- US91202514, USO1202515 - USO1202990, USN1202991 - USN1203537, USD1203538- USD1203968, US11303969 - US11303972
ClassificationClass II
Reason for RecallPhilips HeartStart XL+ Defibrillator/Monitor may become locked out of clinical use
Product Quantity3785 units
Recall NumberZ-0871-2013

Class II Devices Event

Event ID64202
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jan-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMerit Medical Systems, Inc.
CitySouth Jordan
StateUT
CountryUS
Distribution PatternWorldwide Distribution - USA including the states of NJ, FL, GA, MO, AZ, UT and the country of Denmark
 

Associated Products

Product DescriptionMerit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
Code InfoLot numbers H399931S1; H411376; H399938S1; H411373; H399940S1; H411374; H399942S1; H411375; H399948S1; H411380; H399950S1; H411377; H39952S1; H411378; H39953S1; H411379.
ClassificationClass II
Reason for RecallMerit Medical Systems is recalling certain lots of ReSolve Biliary Locking Drainage Catheters due to a consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
Product Quantity387 units
Recall NumberZ-0866-2013

Class II Devices Event

Event ID64204
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCarefusion 303 Inc
CitySan Diego
StateCA
CountryUS
Distribution PatternNationwide Distribution including the states of AK, CA, CO, IL, MO, NV, NY, TX and UT.
 

Associated Products

Product DescriptionCareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.
Code InfoLot number 12055225
ClassificationClass II
Reason for RecallCareFusion is recalling the SmartSite® Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . The separation may be observed at priming or observed during use. If a separation between the drip chamber and tubing occurs, this could cause a delay in treatment.
Product Quantity5,050 units
Recall NumberZ-0832-2013

Class II Biologics Event

Event ID64210
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCryoLife, Inc.
CityKennesaw
StateGA
CountryUS
Distribution PatternTennessee; Missouri; Kentucky; Texas
 

Associated Products

Product DescriptionVascular Graft
Code Info9887377; 9887385; 9887396; 9887480
ClassificationClass II
Reason for RecallHuman Tissues, recovered from a donor whose donor eligibility determination did not identify if the donor was free from risk factors for and clinical evidence of, infection due to relevant communicable disease agents, were distributed.
Product Quantity4
Recall NumberB-0768-13

Class II Devices Event

Event ID64215
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmVascular Solutions, Inc.
CityMaple Grove
StateMN
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide including the states of AL, AZ, AR, CA, CO, CT, DE, CD, FL, GA, HI, ID, IL ,IN, IA, KY, LA, ME, MD, MA, MI,MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT VA, WA, WV, WI, WY and AUSTRIA, CANDA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, ISRAEL,. ITALY, MEXICO, NETHERLANDS, NORWAY, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED KINGDOM.
 

Associated Products

Product DescriptionVascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324, 5325, 5329, 5332, 5336, 5340, and 5341. Product Usage: The SuperCross catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents
Code Info559450, 551750, 552370, 552761, 552840, 552954, 553267, 553647, 553931, 554269, 554270, 554413. 555958, 557192, 557824, 558222, 558894, 559827, 560215, 551751, 552371, 552841, 553090, 553218, 553434, 553529, 554029, 554268, 554271, 555759, 555953, 557251, 559570, 559981, 560253, 560079, 560080, 554123, 556182, 558905, 560114, 554210, 555991, 556842, 557253, 554209, 555223, 555992, 556536, 556747, 557124, 558327, 558991, 560115, 561206, 554208, 555490, 555993, 556674, 556843, 558018, 558798, 559707, 560433, 561207, 554040, 555007, 555224, 555358, 558542, 560434, 561459, 554122, 555008, 555225, 555994, 558992, 561208, 560221, 560222, 560223, 560995, 560996.
ClassificationClass II
Reason for RecallVascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross microcatheters. A potential for surface contamination on aged catheters was observed during in-house testing.
Product Quantity4731
Recall NumberZ-0868-2013

Class II Biologics Event

Event ID64217
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Dec-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmHeartland Lions Eye Bank
CityKansas City
StateMO
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionCornea
Code InfoPH109275OS; PH109275OD
ClassificationClass II
Reason for RecallHuman Corneas, recovered in a manner that increased the risk of the introduction, transmission, or spread of communicable disease, were distributed.
Product Quantity2
Recall NumberB-0838-13

Class II Food Event

Event ID64243
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Jan-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTumalo Farms LLC
CityBend
StateOR
CountryUS
Distribution PatternWA and OR only
 

Associated Products

Product DescriptionA soft brie-style cheese called Jewell. Ingredients: Certified organic cows' milk, Pasteurized farmstead goats' milk, cultures, rennet and salt. (information obtained from firm's web site)
Code InfoPackages are labeled with a "born on date" along with the weight of the package. The cheeses range in weight. The package also contains a packaged date which represents the date shipped.
ClassificationClass II
Reason for RecallImproperly pasteurized.
Product Quantity222 - 6 oz pucks
Recall NumberF-0999-2013
Product DescriptionA soft chevre-style cheese. Label reads in part, "*** TUMALO FARMS Artisan Cheeses of Central Oregon Chevita This fresh and mild, soft, white cheese has a great tangy finish www.tumalofarms.com *** Ingredients . Pasteurized Goats' Milk, Culture, Rennet and Salt."
Code InfoProduct is coded with a "born on date" and weight (individual cheese packages are different weight. The product also has a packaged date, which is the same as the ship date. there are 2 born on dates - 1/10/13 and 1/24/13
ClassificationClass II
Reason for RecallImproperly pasteurized.
Product QuantityFrom production date 1/10/13 10 - 4 oz tubs and 4-2 lb tubs; from production date 1/24/13 3 4 oz tubs and 8 2 lb tubs
Recall NumberF-1000-2013

Class II Devices Event

Event ID64246
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAnsell Healthcare Products LLC
CityIselin
StateNJ
CountryUS
Distribution Pattern.Nationwide Distribution including the states of AL, AZ, CA, CO, DE, FL, GA, IA, IN, IL, KS, KY, LA, MI, MN, MO.MS, NC, NH, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, WI and UT.
 

Associated Products

Product DescriptionLifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).
Code InfoZero Regular 10-Ct: SKU# 0-70907-20510-5 Master Case: 30070907205106.
ClassificationClass II
Reason for RecallOut of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condom (regular) product. The condom has met or exceeded test and quality standards required by the Food and Drug Administration. However, we are experiencing a number of complaints concerning the difficulty in unrolling and subsequent breakage, and so we are asking to have all products returned.
Product Quantity469,134 units
Recall NumberZ-0838-2013

Class II Devices Event

Event ID64248
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmConMed Corporation
CityUtica
StateNY
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia.
 

Associated Products

Product DescriptionELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.
Code InfoBeginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].
ClassificationClass II
Reason for RecallConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.
Product QuantityDomestic Distribution: 97,450 units; Foreign Distribution: 6,800 units
Recall NumberZ-0826-2013
Product DescriptionELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION 525 FRENCH RD., UTICA, NY 13502-5994 USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.
Code InfoBeginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].
ClassificationClass II
Reason for RecallConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.
Product QuantityDomestic Distribution: 97,450 units; Foreign Distribution: 6,800 units
Recall NumberZ-0827-2013

Class II Devices Event

Event ID64288
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMaquet Cardiovascular Us Sales, Llc
CityWayne
StateNJ
CountryUS
Distribution PatternWorldwide Distribution-USA including the states of AZ, CO, FL, TN, and TX and the countries of Australia, Canada, Czech Republic, Dubai/Bahrain/Kuwait/Lebanon/Saudi Arabia/Yemen, France, Germany, Hong Kong, Italy, Japan, Netherlands, Singapore, South Africa, Sweden, Switzerland, Thailand, Turkey, and UK.
 

Associated Products

Product DescriptionMaquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants.
Code InfoUS Distribution Part number 701017471 Lot numbers 92046825 92065723 92076940 OUS Distribution Part Number Lot Numbers 701002797 92050616 701002797 92052823 701002797 92052913 701002797 92058153 701002797 92063518 701002797 92068260 701002797 92069267 701002797 92072177 701002797 92075413 701002797 92077862 701005092 92081862 701005092 92049129 701005092 92070554 701005093 92049130 701005093 92056899 701005093 92065588 701005093 92069429 701005093 92070553 701005093 92071852 701005093 92073598 701005093 92076875 701017471 92076940 701046644 92063587 701050978 92047882 701050978 92053930 701050978 92054156 701050978 92056171 701050978 92056804 701050978 92065094 701050978 92067382 701050978 92068224 701050978 92069286 701050978 92071806
ClassificationClass II
Reason for RecallELS 15 Fr Cannula could potentially contain an occluded arterial lumen.
Product Quantity41 units - US Distirbution; 216 units - OUS Distribution
Recall NumberZ-0839-2013

Class II Devices Event

Event ID64319
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmVarian Medical Systems, Inc. Oncology Systems
CityPalo Alto
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide
 

Associated Products

Product DescriptionVarian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
Code InfoH480044 , H481353 , H482733 , H484585 , H485948 , H480045 , H481354 , H482734 , H484634 , H486024 , H480105 , H481433 , H482765 , H484673 , H486032 , H480106 , H481436 , H482827 , H484677 , H486093 , H480159 , H481437 , H482858 , H484680 , H486094 , H480160 , H481451 , H482859 , H484745 , H486095 , H480247 , H481452 , H482860 , H484746 , H486114 , H480301 , H481453 , H482888 , H484747 , H486140 , H480373 , H481454 , H482889 , H484753 , H486209 , H480374 , H481460 , H482897 , H484830 , H486291 , H480378 , H481461 , H483087 , H484842 , H486369 , H480379 , H481462 , H483204 , H484856 , H486385 , H480408 , H481483 , H483345 , H484950 , H486412 , H480409 , H481532 , H483350 , H484951 , H486442 , H480410 , H481533 , H483351 , H48SOOS , H486473 , H480422 , H481581 , H483352 , H485006 , H486486 , H480471 , H481582 , H483353 , H485090 , H486498 , H480477 , H481601 , H483354 , H485091 , H486499 , H480493 , H481627 , H483406 , H485113 , H486543 , H480566 , H481639 , H483442 , H485127 , H486579 , H4806Sl , H481685 , H483452 , H485143 , H486580 , H480692 , H481766 , H483592 , H485144 , H486615 , H480725 , H481781 , H483617 , H485145 , H486616 , H480764 , H481807 , H483666 , H485162 , H486688 , H480765 , H481815 , H483695 , H485244 , H486689 , H480766 , H481834 , H483696 , H485268 , H486694 , H480794 , H481857 , H483698 , H485308 , H486703 , H480808 , H481879 , H483723 , H485321 , H486716 , H480819 , H481923 , H483724 , H485322 , H486759 , H480820 , H481924 , H483725 , H485359 , H486760 , H480821 , H482166 , H483732 , H485442 , H486858 , H480917 , H482167 , H483733 , H485471 , H486859 , H480918 , H482168 , H483757 , H485481 , H486860 , H481054 , H482181 , H483758 , H485536 , H486861 , H481057 , H482182 , H483759 , H485537 , H486885 , H481112 , H482191 , H483767 , H485541 , H486895 , H481114 , H482192 , H483768 , H485557 , H486896 , H481119 , H482193 , H483840 , H485573 , H486938 , H481120 , H482194 , H483841 , H485580 , H486939 , H481133 , H482243 , H483871 , H485581 , H486941 , H481138 , H482244 , H483872 , H485582 , H486957 , H481154 , H482246 , H483943 , H485592 , H487011 , H481155 , H482266 , H483967 , H485595 , H487012 , H481164 , H482267 , H483968 , H485628 , H487277 , H481165 , H482323 , H483969 , H485689 , H487278 , H481166 , H482367 , H483993 , H485694 , H487279 , H481168 , H482385 , H484008 , H485706 , H487302 , H481171 , H482386 , H484023 , H485729 , H487428 , H481172 , H482387 , H484056 , H485776 , H487512 , H481196 , H482388 , H484153 , H485777 , H487513 , H481206 , H482391 , H484154 , H485792 , H487580 , H481207 , H482579 , H484168 , H485800 , H487621 , H481208 , H482580 , H484169 , H485890 , H487639 , H481211 , H482581 , H484274 , H485891 , H487698 , H481218 , H482638 , H484367 , H485892 , H487700 , H487771 , H48A323 , H48B875 , H48C805 , H487772 , H48A398 , H48B887 , H48C806 , H487775 , H48A462 , H48B898 , H48C807 , H487778 , H48A474 , H488899 , H48C808 , H487895 , H48A482 , H48B900 , H48C809 , H487950 , H48AS12 , H48C084 , H48C854 , H487980 , H48AS13 , H48C085 , H48C8SS , H487999 , H48ASSS , H48C086 , H48C866 , H488005 , H48AS87 , H48C116 , H48C881 , H488029 , H48AS90 , H48C120 , H4800Sl , H4880SS , H48AS91 , H48C121 , H480113 , H488102 , H48AS92 , H48C134 , H480118 , H488163 , H48AS93 , H48C135 , H480171 , H488210 , H48AS94 , H48C136 , H48D177 , H488211 , H48AS95 , H48C137 , H48D179 , H488229 , H48A612 , H48C138 , H48D187 , H488237 , H48A614 , H48C173 , H48D211 , H488238 , H48A713 , H48C174 , H48D235 , H488243 , H48A760 , H48C176 , H48D315 , H488249 , H48A762 , H48C212 , H48D316 , H488291 , H48A816 , H48C252 , H48D317 , H488311 , H48A818 , H48C253 , H48D318 , H488312 , H48A890 , H48C278 , H480319 , H488483 , H48A918 , H48C316 , H480320 , H489074 , H48A920 , H48C356 , H480321 , H489079 , H48A956 , H48C367 , H480347 , H489095 , H48A971 , H48C373 , H480349 , H489096 , H48A986 , H48C399 , H480353 , H489114 , H48A987 , H48C434 , H480354 , H489379 , H48B109 , H48C441 , H48D356 , H489417 , H48B138 , H48C442 , H48D394 , H489431 , H488216 , H48C443 , H48D397 , H489432 , H48B2S9 , H48C448 , H48DS17 , H489433 , H48B293 , H48C450 , H48DS24 , H489792 , H48B294 , H48C474 , H48D654 , H489793 , H48B295 , H48C475 , H48D688 , H489794 , H48B331 , H48C476 , H48D689 , H489819 , H48B332 , H48CSS7 , H48D690 , H489953 , H488333 , H48CSS8 , H480758 , H489996 , H48B334 , H48CSS9 , H48D956 , H48A029 , H48B399 , H48CS60 , H480957 , H48A083 , H48B471 , H48CS61 , H48D988 , H48A084 , H48B472 , H48CS75 , H48D992 , H48A085 , H48B480 , H48CS76 , H480993 , H48Al47 , H48BS86 , H48C661 , H48E031 , H48A148 , H48BS87 , H48C688 , H48E069 , H48A149 , H488588 , H48C689 , H48E106 , H48A150 , H48BS89 , H48C715 , H48El39 , H48A202 , H48B602 , H48C717 , H48E143 , H48A224 , H488605 , H48C795 , H48El52 , H48A225 , H488691 , H48C796 , H48El53 , H48A226 , H48B692 , H48C797 , H48E154 , H48A229 , H48B693 , H48C798 , H48El59 , H48A230 , H48B694 , H48C799 , H48E422 , H48A243 , H488787 , H48C800 , H48E423 , H48ES68 , H48F073 , H48FS17 , H48F927 , H48ES90 , H48F074 , H48FS18 , H48F939 , H48ES91 , H48F075 , H48FS19 , H48F944 , H48ES92 , H48F076 , H48FS23 , H48F948 , H48ES93 , H48F077 , H48FS24 , H48F980 , H48ES95 , H48F078 , H48FS34 , H48F993 , H48E609 , H48F079 , H48FS36 , H48F994 , H4BE677 , H48F083 , H4BF537 , H48G020 , H48EB16 , H48F084 , H48FS44 , H48G021 , H48E883 , H4BF085 , H48FS45 , H48G039 , H48E884 , H48F086 , H48FS46 , H48G041 , H48E885 , H48F089 , H48FS47 , H48G109 , H48E888 , H48F120 , H48FS48 , H48Gll7 , H48E890 , H48F131 , H48FS49 , H48G123 , H48E892 , H48F132 , H48FSSO , H48G153 , H48E893 , H48F134 , H48F568 , H48G154 , H48E894 , H48F135 , H48FS92 , H48Gl84 , H48E908 , H48F136 , H48F606 , H48G185 , H48E909 , H48F137 , H48F609 , H48G228 , H48E913 , H48F138 , H48F623 , H48G229 , H48E914 , H4BF156 , H48F624 , H48G230 , H48E915 , H48F166 , H48F637 , H48G235 , H48E916 , H48F167 , H4BF647 , H4BG236 , H4BE917 , H4BF168 , H4BF648 , H48G238 , H4BE918 , H4BF169 , H48F649 , H48G241 , H48E919 , H4BF170 , H48F697 , H48G242 , H48E920 , H48F184 , H48F698 , H48G246 , H48E921 , H48F185 , H48F713 , H48G247 , H4BE922 , H48F194 , H48F714 , H4BG249 , H4BE932 , H48F195 , H48F715 , H4BG250 , H4BE933 , H48F196 , H48F760 , H48G275 , H48E944 , H4BF197 , H48F761 , H48G276 , H48E945 , H48F199 , H48F777 , H48G277 , H4BE946 , H48F219 , H48F779 , H48G278 , H48E947 , H4BF268 , H48F780 , H48G279 , H48E948 , H48F312 , H48F791 , H4BG280 , H48E952 , H48F315 , H48F792 , H48G281 , H48E954 , H48F316 , H48F796 , H48G282 , H48E957 , H48F317 , H4BF824 , H48G283 , H4BE964 , H48F318 , H48FB25 , H48G284 , H48E966 , H4BF331 , H48F826 , H48G285 , H4BE989 , H4BF332 , H48F827 , H48G286 , H48E990 , H48F333 , H48F828 , H48G289 , H48E991 , H4BF354 , H48F829 , H48G290 , H48E992 , H48F394 , H48F835 , H4BG291 , H48E994 , H48F395 , H48F836 , H48G292 , H48E996 , H48F399 , H48F837 , H48G293 , H48F002 , H48F400 , H48F843 , H48G294 , H48F013 , H48F426 , H48F844 , H48G295 , H48F014 , H48F468 , H48FB45 , H48G296 , H48F016 , H48F469 , H48F852 , H48G363 , H4BF017 , H48F470 , H48F854 , H48G405 , H4BF018 , H48F490 , H48FBS6 , H48G413 , H48F025 , H48FS06 , H48F859 , H48G414 , H48F028 , H48FS07 , H48F865 , H48G487 , H481328 , H482681 , H484368 , H485893 , H487736 , H48A244 , H48B816 , H48C801 , H48E425 , H48F029 , H48FS08 , H48F922 , H483654 , H481329 , H482682 , H484435 , H485894 , H487737 , H48A245 , H48B818 , H48C802 , H48ES66 , H48FOS8 , H48FS09 , H48F925 , H48F393 , H481352 , H482732 , H484495 , H485895 , H487739 , H48A246 , H48B819 , H48C803 , H48ES67 , H48F072 , H48F516 , H48F926 , H482411 , H480974 , H48G246 , H480803 , H48B712 , H487089 , H482936 , H48A812 , H487040 , H48F730 , H48G585 , H486116 , H480875 , H482412 , H482384 , H48G247 , H481184 , H480536 , H481835 , H48F478 , H48F246 , H481005 , H48F731 , H48G586 , H48C095 , H480876 , H484904 , H487981 , H487466 , H48E426 , H48A712 , H481836 , H48F479 , H48F443 , H483856 , H48F733 , H48G587 , H48C096 , H48E762 , H48F345 , H487982 , H487782 , H48E427 , H480535 , H48B845 , H480323 , H48F444 , H48G405 , H48C540 , H48G588 , H48C097 , H48E763 , H483697 , H48B252 , H487798 , H48E441 , H484052 , H48F053 , H480324 , H481289 , H481828 , H48C541 , H48G589 , H48C098 , H48E764 , H48F765 , H48F338 , H48G414 , H48E514 , H48F615 , H480971 , H480325 , H481290 , H481829 , H484381 , H48G590 , H48C099 , H48F240 , H487773 , H48F352 , H481315 , H48E517 , H48F617 , H485963 , H486683 , H481291 , H481830 , H488320 , H48G591 , H48C100 , H48F241 , H48G267 , H48F353 , H481316 , H489872 , H48F724 , H482203 , H480262 , H481292 , H481831 , H487595 , H48G592 , H48C101 , H48F326 , H48F355 , H488452 , H481334 , H48F727 , H486934 , H48A254 , H481293 , H480873 , H48F833 , H48GS93 , H48C102 , H48F327 , H482935 , H48A911 , H481335 , H48F729 , H48B366 , H48G584 , H482201 , H480874 , H48F834 , H485100 , H48C103 , H483509 , H485125 , H48C104 , H482381 , H484280 , H480346 , H48A295 , H48B057 , H48G002 , H48E984 , H48F483 , H482383 , H48F942 , H487212 , H48C105 , H486701 , H482164 , H481510 , H48A296 , H48E537 , H48G004 , H48E985 , H48F484 , H483649 , H485896 , H480107 , H48F754 , H48E973 , H486370 , H482289 , H48A184 , H482196 , H48G006 , H48E986 , H483374 , H480830 , H481063 , H480920 , H48F755 , H48E974 , H483506 , H482807 , H480556 , H484018 , H48G007 , H48E987 , H483375 , H483615 , H48A395 , H482793 , H48F756 , H48E975 , H485400 , H487623 , H480557 , H484019 , H484624 , H48E988 , H483376 , H485821 , H48G198 , H480051 , H48F757 , H48E976 , H48B549 , H48E962 , H480558 , H484020 , H480933 , H48F790 , H487866 , H480004 , H481077 , H480052 , H48F758 , H486927 , H483964 , H48E977 , H486581 , H48F526 , H480934 , H48F186 , H487867 , H48F428 , H481078 , H480053 , H484497 , H480692 , H484903 , H48E978 , H48F054 , H480348 , H48F868 , H480530 , H488820 , H48F595 , H482263 , H480054 , H484498 , H480693 , H486069 , H48E979 , H48F059 , H480349 , H481837 , H480055 , H484499 , H488056 , H486071 , H48E980 , H487776 , H482382 , H481838
ClassificationClass II
Reason for RecallVarian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where the calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Convolution 11.0 algorithm (PBC 11.0) is used.
Product Quantity1168 units
Recall NumberZ-0867-2013

Class II Devices Event

Event ID64321
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGreiner Bio-One North America, Inc.
CityMonroe
StateNC
CountryUS
Distribution PatternUS Nationwide Distribution in the states of FL, IL, KY, NY, NC, PA, OH, TX, VA
 

Associated Products

Product DescriptionVACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.
Code InfoLot No. 12H27
ClassificationClass II
Reason for RecallThe VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.
Product Quantity192,000 pieces (192 cases)
Recall NumberZ-0835-2013

Class II Devices Event

Event ID64328
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmElekta, Inc.
CityAtlanta
StateGA
CountryUS
Distribution PatternNationwide Distribution-including the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI.
 

Associated Products

Product DescriptionMonaco RTP System. Radiation treatment planning.
Code InfoVersions 3.20.00 and 3.20.01
ClassificationClass II
Reason for RecallThe beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.
Product Quantity13
Recall NumberZ-0841-2013

Class II Devices Event

Event ID64329
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMedrad Inc
CityIndianola
StatePA
CountryUS
Distribution PatternWorldwide Distribution including USA nationwide.
 

Associated Products

Product DescriptionMEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.
Code InfoCatalog number AVA 500 HCS/3010903 - Lot numbers D72211, DA82711, DA93131, D101091, D101681, D110591, D111961, D113341A, D120731, D101641, D82741, D93131, DA101091, DA101691, D110601, D111991, D113351, D120831A, D72251, D83011, D93151, D101101, D101701, D110611, D112061, D113351A, D120741, D72261, DA83021, DA93151, DA101101, DA101721, D110621, D112131, D113461, D120761, D72281, DA83031, DA93221, D101111, D101721, D110631, D112131A, D113461A, D120771, D72291, D83041, D93231, DA101111, D101731, D110661, D112341, D113471, D120831, D72651, DA83121, D93411, D101121, D101741, D110731, D112341A, D113471A, D120861, D72671, D83151, DA93411, DA101121, D101861, D110741, D112351, D113491, DA72681, D83651, D93421, D101131, DA101861, D110751, D112351A, D113501, DA72691, D90021, DA93421, DA101131, D101881, D110871, D112361, D120161, D72751, D90541, D93431, D101171, DA101881, D110881, D112361A, D120161A, D120891, D90561, DA93431, D101301, DA101901, D110901, D112411, D120171, D80221, D90611, D93561, D101311, D101911, D111201, D112411A, D120171A, DA80231, DA90631, D93631, DA101441, DA101931, D111221, D112421, D120181, DA80241, D90821, DA93631, D101441, D101931, D111231, D112421A, D120311, D80281, DA90831, DA100141, D101461, D101951, D111241, D112431, D120311A, D80391, D90981, D100151, DA101461, DA101951, D111261, D112431A, D120321, DA80561, D91031, D100181, D101471, D101971, D111261A, D112441, D120321A, D80631, DA91041, DA100191, DA101481, D102111, D111291, D112441A, D120331, DA80641, DA91061, DA100321, D101481, D102141, D111291A, D112481, D120341, D80871, D91071, D100331, DA101511, DA102141, D111301, D112481A, D120371, D80981, D91181, DA100341, D101511, D102151, D111301A, D112491, D120371A, DA81281, D91191, D100351, D101531, DA102151, D111311, D112501, D120381, DA81421, D91281, DA100461, DA101531, D102351, D111311A, D112621, D120381A, D81471, D91331, D100561, D101541, DA102351, D111321, D112621A, D120391, D81541, D91351, D100671, D101551, D102811, D111321A, D112631, D120451, DA81821, D91381, DA100671, DA101551, D102821, D111361, D112631A, D120511, D81971, D91561, DA100691, D101581, D102921, D120861A, D112641, D120521, D81991, D91901, D100691, DA101581, D103361, D111351, D112721, D120521A, DA82031, D92061, D100711, D101591, D103401, D111371, D112791, D120531, D82131, D92091, DA100711, DA101601, D103481, D111371A, D113071, D120541, D82141, D92111, DA100741, D101601, D103631, D111381, D113081, D120541A, D82171, D120881, D100751, D101611, D103611, D111711, D113111, D120551, D82181, D92501, D101021, D101621, D103571, D111721, D113111A, D120591, D82191, D92521, DA101021, DA101621, D103621, D111731, D113291, D120601, DA82201, DA92781, D101031, D101631, D110181, D111751, D113291A, D120671, D120881A, D92791, D101041, D101651, D110191, D111861, D113321, D120671A, D82241, D93081, DA101041, DA101651, D110321, D111871, D113321A, D120681, DA82251, D93091, D101061, D101661, D110331, D111891, D113331, D120681A, D82671, D93101, DA101061, D101671, D110351, D111921, D113331A, D120691, D82701, D93111, D101071, DA101671, D110541, D111921A, D113341, and D120721.
ClassificationClass II
Reason for RecallBayer is initiating this recall because in certain packages within the affected lots, the seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package, resulting in a potential breach of the sterility of this accessory.
Product Quantity832,175
Recall NumberZ-0870-2013

Class II Food Event

Event ID64349
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Feb-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNestle USA
CitySolon
StateOH
CountryUS
Distribution PatternProduct was shipped to the following states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI & WY.
 

Associated Products

Product DescriptionLean Cuisine Culinary Collection Mushroom Mezzaluna Ravioli ravioli filled with portobello & button mushrooms, romano & ricotta cheeses in a creamy marsala wine sauce with spinach & red peppers no preservatives, NET WT 8 5/8 oz (244g) 0 13800 58358 1 DISTRIBUTED BY: NESTLE' USA, INC., SOLON, OH 44139
Code InfoLot 2311587812 Best Before Dec2013 and Lot 2312587812 Best Before Dec2013, UPC Code 13800-58358
ClassificationClass II
Reason for RecallThe firm received complaints of small fragments of glass that were found inside the ravioli portion of the entrée.
Product Quantity41,818 cs/12/8 5/8 oz packages
Recall NumberF-0998-2013

Class III Biologics Event

Event ID42235
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-May-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSiouxland Community Blood Bank
CitySioux City
StateIA
CountryUS
Distribution PatternSD
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info2045397
ClassificationClass III
Reason for RecallBlood product, stored at an unacceptable temperature, was distributed.
Product Quantity1 unit
Recall NumberB-0583-13

Class III Biologics Event

Event ID47084
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jan-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmInternational BioResources, LLC
CityFort Worth
StateTX
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionSource Plasma
Code Info364009860; 364008845; 364007371; 364000437
ClassificationClass III
Reason for RecallBlood product, collected from a donor whose donor suitability was not adequately determined, was distributed.
Product Quantity4 units
Recall NumberB-0643-13

Class III Biologics Event

Event ID47102
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Dec-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmLifeServe Blood Center
CitySioux City
StateIA
CountryUS
Distribution PatternIA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info2150235
ClassificationClass III
Reason for RecallBlood product, exposed to unacceptable shipping temperatures, was distributed.
Product Quantity1 unit
Recall NumberB-0581-13

Class III Biologics Event

Event ID52271
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Sep-08
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
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364045246; 364047527; 364048938; 364045450; 364046890; 364047534; 364048190; 364052291; 364053394; 364054129; 364058230; 364054660; 364051686; 364055198; 364057711; 364058257; 364049127; 364048975; 364048538; 364048374; 364050575;
ClassificationClass III
Reason for RecallBlood product, collected from a donor whose donor suitability was not adequately determined, was distributed.
Product Quantity840 units
Recall NumberB-0639-13

Class III Biologics Event

Event ID53334
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Mar-09
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAmerican National Red Cross (The)
CityLittle Rock
StateAR
CountryUS
Distribution PatternAR
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Washed
Code Info55R77401
ClassificationClass III
Reason for RecallBlood product, for which the red cell count and hematocrit were outside the acceptable range, was distributed.
Product Quantity1 unit
Recall NumberB-0338-13

Class III Biologics Event

Event ID61564
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Feb-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross (The)
CityFarmington
StateCT
CountryUS
Distribution PatternCT, NY
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info033KX34123, 033KX34094, 033KX34095, 033KX34096, 033KX34097, 033KX34098, 033KX34099, 033KX34101, 033KX34102, 033KX34103, 033KX34104, 033KX34105, 033KX34106, 033KX34107, 033KX34124, 033KX34125, 033KX34126, 033KX34127, 033FN44900, 033FN44901, 033FN44890, 033FN44891, 033FN44893, 033FN44894, 033FN44895, 033FN44897, 033FN44898, 033FN44899, 033FN44879, 033FN44880, 033FN44881, 033FN44882, 033FN44883, 033FN44884, 033FN44885, 033FN44886, 033FN44887, 033FN44888, 033FN44889, 033KX34131, 033KX34132, 033KX34133, 033KX34134, 033KX34136, 033KX34138, 033KX34139, 033KX34140, 033KX34141, 033KX34129, 033KX34130, 033FN44851, 033FN44852, 033FN44853, 033FN44854, 033FN44855, 033FN44856, 033FN44857, 033FN44858, 033FN44859, 033FN44860, 033FN44862, 033FN44863, 033FN44864, 033FN44866, 033FN44868, 033FN44869, 033FN44870, 033FN44871, 033FN44873, 033FN44874, 033FN44875, 033FN44876, 033FN44878, 033KX34142, 033KX34143, 033KX34144, 033KX34145, 033KX34146, 033FN44847, 033FN44849, 033FN44850, 033KX34108, 033KX34109, 033KX34110, 033KX34111, 033KX34112, 033KX34113, 033KX34114, 033KX34115, 033KX34116, 033KX34117, 033KX34118, 033KX34119, 033KX34120, 033KX34121, 033KX34122, 033FN44903, 033FN44905, 033FN44906, 033FN44907, 033FN44908, 033FN44909, 033FN44910, 033FN44911, 033FN44912, 033FN44914
ClassificationClass III
Reason for RecallBlood products, for which the scale and Hemocue used during collection failed quality control testing, were distributed.
Product Quantity106 units
Recall NumberB-0403-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info033KX34128, 033FN44892, 033FN44865, 033FN44846, 033FN44902, 033FN44913, 033FN44915
ClassificationClass III
Reason for RecallBlood products, for which the scale and Hemocue used during collection failed quality control testing, were distributed.
Product Quantity7 units
Recall NumberB-0404-13

Class III Drugs Event

Event ID64137
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmProcter & Gamble Hair Care Llc
CityIowa City
StateIA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionCrest PRO-HEALTH CPC Antigingivitis/Antiplaque Oral Rinse, 250 mL (8.4 fl oz),Dist. by Procter & Gamble, Cincinnati, OH 45202 NDC 37000-452-02
Code Info22155395UA Expires: 07/2014
ClassificationClass III
Reason for RecallCross Contamination with Other Products: Product was mixed with another type of mouth wash.
Product Quantity71,040 bottles
Recall NumberD-167-2013

Class III Biologics Event

Event ID64193
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Dec-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmHemacare Corporation
CityVan Nuys
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW313712022984
ClassificationClass III
Reason for RecallBlood product, collected from a donor with an initially positive test for syphilis, was distributed.
Product Quantity1
Recall NumberB-0891-13

Class III Devices Event

Event ID64307
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAnimas Corporation
CityWest Chester
StatePA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including Washington, DC, Puerto Rico, US Virgin Island and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and the countries of Austria, Australia, Bermuda, Canada, New Zealand, Czech Republic, Italy, France, Finland, Hungary, Israel, United Kingdom, Spain, Sweden, Norway, Denmark, Germany, Mexico and Ireland.
 

Associated Products

Product DescriptionAnimas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcutaneous infusion of insulin.
Code InfoAll Animas 2020, IR1250 and IR1200 Pump Models - Part Numbers 101370-00, 101371-00, 101372-00, 101374-00, 101375-00, 100380-00, 100381-00, 100382-00, 100384-00, 100385-00, 100450-00, 100210-00, 100211-00, 100212-00, 100250-00, 100251-00, 100252-00, 100200-00, 100201-00, 100202-00, 100170-00, 100171-00 and 100172-00.
ClassificationClass III
Reason for RecallDue to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on January 1, 2016, and will result in a call service alarm that is displayed on the pump display.
Product Quantity37,998
Recall NumberZ-0836-2013

Mixed Classification Biologics Event

Event ID48236
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Apr-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternOK, TX
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info011KJ12464
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0605-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info011KJ12464
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-0606-13

Mixed Classification Biologics Event

Event ID48858
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-May-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CitySaint Louis
StateMO
CountryUS
Distribution PatternIL and MO
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info011KC32262; 011KC34046
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-0577-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info011KC32262; 011KC34046
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-0578-13

Mixed Classification Biologics Event

Event ID49198
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Jun-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternTX and MO
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info011GJ87885
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0607-13
Product DescriptionRed Blood Cells
Code Info011GJ87885
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-0608-13
Product DescriptionCryoprecipitated AHF
Code Info011GJ87885
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-0609-13

Mixed Classification Biologics Event

Event ID50328
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Sep-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross (The)
CityDedham
StateMA
CountryUS
Distribution PatternCA, MA, NH, VT
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info004KM33220;004KM61922;004KM69676;004KQ32543;004KT69103
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity5 units
Recall NumberB-0574-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info004KM69676
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0575-13
Product DescriptionPlasma Frozen
Code Info004KT69103
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0576-13

Mixed Classification Biologics Event

Event ID60141
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Oct-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNew York Blood Center, Inc.
CityNew York
StateNY
CountryUS
Distribution PatternNY, NJ, PA, CA, NC
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW047011056156, W047011326288, W047011330978, W047011334076, W047011337255, W047011337381, W047011351793, W047011338532, W047011342807, W047011336499, W047011342268, W047011333963, W047011336452, W047011349758, W047011335665, W047011333350, W047011333374, W047011333379, W047011333639, W047011333978, W047011334415, W047011334422, W047011334456, W047011334645, W047011333639, W047011336682, W047011337465, W047011337580, W047011338365, W047011337942, W047011339511, W047011339543, W047011339863, W047011339875, W047011341197, W047011341225, W047011341577, W047011341654, W047011341697, W047011341943, W047011342052, W047011342061, W047011342456, W047011342822, W047011344129, W047011344906, W047011345097, W047011345107, W047011345129, W047011345528, W047011345752, W047011346513, W047011347560 (2 units), W047011347841, W047011351263, W047011326528
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity57 units
Recall NumberB-0514-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW047011326254, W047011326489, W047011339265, W047011339427
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity4 units
Recall NumberB-0515-13
Product DescriptionCryoprecipitated AHF
Code InfoW047011330978, W047011333350, W047011333374, W047011333379, W047011333639, W047011334645, W047011333639, W047011337580, W047011339543, W047011342822, W047011344906, W047011345097
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity12 units
Recall NumberB-0516-13
Product DescriptionRecovered Plasma
Code InfoW047011326288, W047011330967, W047011330978, W047011336499, W047011326528, W047011332975, W047011333350, W047011333374, W047011333379, W047011333639, W047011334415, W047011334456, W047011337580, W047011339543, W047011341943, W047011342456, W047011342822, W047011347560
ClassificationClass III
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity18 units
Recall NumberB-0517-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW047011325144 (2 units), W047011341398 (2 units), W047011326254, W047011329482 (2 units), W047011348802 (2 units), W047011326489, W047011332206
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity11 units
Recall NumberB-0518-13
Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW047011325181 (2 units), W047011333860 (2 units), W047011343932 (2 units), W047011350111 (2 units)
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity8 units
Recall NumberB-0519-13
Product DescriptionPlasma Frozen within 24 hours (FP24)
Code InfoW047011056156, W047011336625, W047011336682, W047011338416, W047011339863, W047011342052, W047011342061
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity7 units
Recall NumberB-0520-13
Product DescriptionCryoprecipitated AHF, Pooled
Code InfoW047011328328, W047011328374, W047011341225, W047011351793, W047011467903, W047011467980
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity6 units
Recall NumberB-0521-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW047011332975, W047011333909, W047011336625 (2 units), W047011338416, W047011338548, W047011342870
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity7 units
Recall NumberB-0522-13
Product DescriptionFresh Frozen Plasma
Code InfoW047011336452
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0523-13
Product DescriptionPlasma Cryoprecipitate Reduced
Code InfoW047011342870, W047011345097
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-0524-13
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