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U.S. Department of Health and Human Services

Enforcement Report - Week of October 2, 2013

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Class I Food Event

Event ID66167
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Aug-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmGarden-Fresh Foods, Inc.
CityMilwaukee
StateWI
CountryUS
Distribution Patternretail Spartan stores located in MI and Toledo, OH. Expanded recall: WI, MN, IA, IL, OH, IN, TX, FL, MA,MO, MI, PA, AZ, CA.
 

Associated Products

Product Descriptionspartan fresh selections american potato salad, Net Wt. 16 oz (1 LB) 454g. UPC 11213-90320.
Code InfoUse by 09/06/13/04
ClassificationClass I
Reason for RecallOne lot of Spartan Fresh Selections American Potato Salad has the potential to be contaminated with Listeria monocytogenes.
Product Quantitydo not know
Recall NumberF-1911-2013

Class I Food Event

Event ID66224
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Sep-13
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmKDK Management, Inc., dba Bubbles Baking Co.
CityVan Nuys
StateCA
CountryUS
Distribution PatternCA & Arizona
 

Associated Products

Product DescriptionFirst Street Blueberry Muffins (S 45395), 14 oz., 9 trays/case, UPC 0 4151210833 4
Code InfoLot Codes: 12355, 12361, 12365, 12365, 13013, 13007, 13008, 13022, 13029, 13030, 13031, 13001, 13032, 13038, 13039, 13042, 13049, 13050, 13051, 13058, 13059, 13063, 13064, 13070, 13073, 13079, 13084, 13085, 13086, 13091, 13093, 13094, 13098, 13099, 13102, 13105, 13107, 13114, 13115, 13116, 13122, 13123, 13124, 13128, 13129, 13130, 13134, 13140, 13142, 13143, 13151, 13152, 13152, 13154, 13156, 13157, 13162, 13163, 13165,13169, 13170, 13171, 13173, 13175, 13176, 13177, 13178, 13183, 13184, 13187, 13192, 13198, 132013,13200, 13199, 13210,13217, 13219, 13220,13221, 13233, 13235, 13237, 13239.
ClassificationClass I
Reason for RecallBubbles Baking Co. is recalling Blueberry muffins and Loaf cakes because they may contain undeclared milk and soy.
Product Quantity9,229 cases
Recall NumberF-1909-2013
Product DescriptionFirst Street Blueberry Muffins Loaf (S 45383), 16 oz., 12 trays/case, UPC 0 41512 10854 9.
Code InfoLot Codes: 12355, 12361, 12365, 12365, 13013, 13007, 13008, 13022, 13029, 13030, 13031, 13001, 13032, 13038, 13039, 13042, 13049, 13050, 13051, 13058, 13059, 13063, 13064, 13070, 13073, 13079, 13084, 13085, 13086, 13091, 13093, 13094, 13098, 13099, 13102, 13105, 13107, 13114, 13115, 13116, 13122, 13123, 13124, 13128, 13129, 13130, 13134, 13140, 13142, 13143, 13151, 13152, 13152, 13154, 13156, 13157, 13162, 13163, 13165,13169, 13170, 13171, 13173, 13175, 13176, 13177, 13178, 13183, 13184, 13187, 13192, 13198, 132013,13200, 13199, 13210,13217, 13219, 13220,13221, 13233, 13235, 13237, 13239.
ClassificationClass I
Reason for RecallBubbles Baking Co. is recalling Blueberry muffins and Loaf cakes because they may contain undeclared milk and soy.
Product Quantity9,229 cases total
Recall NumberF-1910-2013

Class I Food Event

Event ID66319
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Aug-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmIrene's Bakery & Gourmet Kitchen, Inc.
CityBensalem
StatePA
CountryUS
Distribution PatternLocal and nationwide wholesale distributors and retail markets.
 

Associated Products

Product DescriptionIrene's Black & White Cookies, 8 oz. (226.4g) All Natural. Ingredients: Sugar, wheat flour, water, eggs, canola oil, unmodified food starch, corn syrup, vegetable fat, cocoa powder processed with alkali, mono and diglycerides, sea salt, sodium acid pyrophosphate, sodium bicarbonate, mono calcium phosphate, soy lecithin, natural flavors. May contain traces of tree nuts. Manufactured by Irene's Bakery and Gourmet Kitchen, Bensalem, PA.
Code Infoactual date code information are not available. Two-week expiration dates are assigned by the retail store upon receipt of shipment from the manufacturer.
ClassificationClass I
Reason for RecallUndeclared whey powder (milk allergen) sub-ingredient of chocolate confectionery coating used in manufacturing of Black & White Cookies.
Product Quantity2008 packages (87 cases of 24 or 16 eight oz. packages/case)
Recall NumberF-1946-2013

Class II Biologics Event

Event ID44064
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jan-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBlood Bank of San Bernardino and Riverside Counties
CitySan Bernardino
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoGP30924
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-2191-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoGP30924
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-2192-13

Class II Biologics Event

Event ID45178
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Feb-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmHemaCare Corporation
CityVan Nuys
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells
Code Info4035495
ClassificationClass II
Reason for RecallBlood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-2403-13

Class II Biologics Event

Event ID46664
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Nov-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHemaCare Corporation
CityVan Nuys
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells
Code Info3051339
ClassificationClass II
Reason for RecallBlood products, collected from a donor during a deferral period for travel to a malarial endemic area, were distributed.
Product Quantity1 unit
Recall NumberB-2047-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info5082472; 3052917
ClassificationClass II
Reason for RecallBlood products, collected from a donor during a deferral period for travel to a malarial endemic area, were distributed.
Product Quantity2 units
Recall NumberB-2048-13
Product DescriptionFresh Frozen Plasma
Code Info3051339; 5082472; 3052917
ClassificationClass II
Reason for RecallBlood products, collected from a donor during a deferral period for travel to a malarial endemic area, were distributed.
Product Quantity3 units
Recall NumberB-2049-13

Class II Biologics Event

Event ID47085
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jan-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBlood Systems, Inc.
CityScottsdale
StateAZ
CountryUS
Distribution PatternAZ
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info101976580; 101976580
ClassificationClass II
Reason for RecallBlood products, collected from a donor taking the drug Avodart, were distributed.
Product Quantity2
Recall NumberB-2158-13

Class II Biologics Event

Event ID49222
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Aug-08
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBioLife Plasma Service, LP
CityVan Nuys
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info07KPT16024; 07KPT15990
ClassificationClass II
Reason for RecallBlood products which tested negative for all viral markers, were collected from a donor who subsequently tested positive for hepatitis C (HCV) by NAT.
Product Quantity2
Recall NumberB-2152-13

Class II Biologics Event

Event ID50441
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Oct-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSan Diego Blood Bank
CitySan Diego
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW044208304007
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom hemoglobin screening test was not performed, were distributed.
Product Quantity1 unit
Recall NumberB-2082-13

Class II Biologics Event

Event ID51464
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Feb-09
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternMultiple states within the U.S. Firm could not provide specifics.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoKS31583; KS32243; KS32648; GF62856; KS26788; KS26831; KS26878; KS26880; KS26895; KS27908; KS27987; KS30757; KS32556
ClassificationClass II
Reason for RecallBlood products, possibly contaminated with air during collection, were distributed.
Product Quantity13 Units
Recall NumberB-2054-13
Product DescriptionRed Blood Cells
Code InfoKS32438; KS32530; KS32527; KX17484; KX17483; KX17479; KX17475; KX17468; KX17467; KX17464; KS32596; KS32597; KS32598; KS32601; KS32610; KS32595; KS32604; KS32629; KS32628; KS32626; KS32624; KS32621; KS32643; KS32632; KS32642; KS32552; KS32528; KS32553; KS32658; KX17465; KX17470; KS32638; KS32582; KS32607; KS32654; FG12509; KS32635; KS32531; KS32604; KS32610; KS32519; KS32643; KX17454; KX17457; KX17461
ClassificationClass II
Reason for RecallBlood products, possibly contaminated with air during collection, were distributed.
Product Quantity45 Units
Recall NumberB-2055-13
Product DescriptionPlasma Frozen
Code InfoKS26450; KS32618; KS26812 ;KS26795; KS27370; KS27371; KS27883; KS30126 ;KS26778; KS26831; KS31365; KS30245; KS26824; KS31331; KS26776; KS26787; KS26788 ;KS26791; KS26850; KS26852; FG10087; KS32472; KS32625
ClassificationClass II
Reason for RecallBlood products, possibly contaminated with air during collection, were distributed.
Product Quantity23 Units
Recall NumberB-2056-13
Product DescriptionPlasma Frozen Cryo Reduced
Code InfoKS31255; FZ85831; KS31581; KS32483; KS32655; KS36252; KS32652; KS32538; KS32530; KS32547; FX20623; KS28912; KS29917; KS32635; KS27597; KS27917; FX20723; KS28903; KS30221; KS30217; FZ85566; KS31545; KS31543; KS31553; KS30131; KS32532; KS32597; KS31562; KS31546; KS32253; KS31860; KS31557; KS31651; KS32255; KS30140; KS30222; FZ85830; KS31238
ClassificationClass II
Reason for RecallBlood products, possibly contaminated with air during collection, were distributed.
Product Quantity38 Units
Recall NumberB-2057-13
Product DescriptionCryoprecipitated AHF
Code InfoFZ85867; KS31542; KS31546; KS31548; KS29887; KS31562; KS29999; KS29996; KS30008; KS30162; KS32397; KS32434; KS32442; FZ85860; KS32453; KS32476; KS32495; KS32439; KS32456; KS32455; KS32448; KS32457; KS32608; FX20688; FX20623; FX20672; FX20739; KS27597; KS27618; KS27604; KS27609; GJ87542; KS27803; KS27919; KS27989; KS27987; FG07159; FG07161; KS30000; KS30214; KS30217; KS30819; KS31047; GG54598; GG54596; KS32653; KS31129; KS32680; KS32657; KS27376; GG64591; KS28900; KS28905; KS28912; KS30004; KS30135; KS30222; KS31238; KS31255; KS31554; KS31561; KS32435; KS32451; KS32604; KS32607; KS32652; KS32632; KS32635; KS27619; KS27602; FL65947; KB27889; KS28813; KS2816; FZ85866; KS31451; FZ85830; KS32393; KS32498; KS32492; KS32568; KS32549; FX20670; KS27614; KS30959; KS31133; FZ85855; KS32542; GJ87649; GJ87625; GJ87548; KS29998; KS32556; KS30002; KS30140; KS30144; KS30221; KS30219; KS32398; KS32440; KS30131; KS32392; KX17478; KX17475; KS32637; KS32640; KS32643; KS28911; KS32648; KS32441; KS27591; KS27596; KS27816; FG07165; KS27592; KS28917; KS28903; KS27585; KS27605; KS32533; KS32630; KS32654; KS27908; FL56930; KS27917; KS32432; KS32482; KX17477; KX17473; KX17470; KS30008; KS31451; FZ85830; KS32383; KS32485; KS32498; KS32492; KS32558; KS32549; FL58955; KS27892; KS27908; KS30214; KS32442
ClassificationClass II
Reason for RecallBlood products, possibly contaminated with air during collection, were distributed.
Product Quantity145 Units
Recall NumberB-2058-13

Class II Biologics Event

Event ID59134
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Jun-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHemaCare Corporation
CityVan Nuys
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW313711006151; W313711006151; W313711006151; W313711007011; W313711007011
ClassificationClass II
Reason for RecallBlood products, collected from donors who reported travel to malarial endemic areas, were distributed.
Product Quantity5 units
Recall NumberB-2059-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW313711006529; W313711006529; W313711006529; W313711006773; W313711006773; W313711006773.
ClassificationClass II
Reason for RecallBlood products, collected from donors who reported travel to malarial endemic areas, were distributed.
Product Quantity6 units
Recall NumberB-2060-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW313711135113; W313711118495; W313711124899; W313711125072.
ClassificationClass II
Reason for RecallBlood products, collected from donors who reported travel to malarial endemic areas, were distributed.
Product Quantity4 units
Recall NumberB-2061-13

Class II Devices Event

Event ID64236
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSynthes USA HQ, Inc.
CityWest Chester
StatePA
CountryUS
Distribution PatternWorldwide Distribution - USA including CO, PA, TN, VA, TN, WA, and internationally to Czech Republic.
 

Associated Products

Product DescriptionSynthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The Oracle Spacer is indicated as a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial and total vertebrectomy procedures or the treatment of tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of the collapsed vertebral body. The Slap Hammer, 03.809.690, is a dual sided device with two separate attachment options. The Slap Hammer allows a user (surgeon) to remove a previously placed trial implants.
Code InfoPart number 03.809.690, Lot Number 6723847
ClassificationClass II
Reason for RecallThis recall is being initiated in response to complaints received where it was reported that the proximal end of the Slap Hammer broke during use.
Product Quantity27
Recall NumberZ-2282-2013

Class II Devices Event

Event ID65009
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSynthes USA HQ, Inc.
CityWest Chester
StatePA
CountryUS
Distribution PatternNationwide Distribution including CA,and VA. .
 

Associated Products

Product DescriptionSynthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus.
Code InfoPart Number 241.267, lot number 8037923
ClassificationClass II
Reason for RecallRecall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276).
Product Quantity2
Recall NumberZ-2278-2013

Class II Devices Event

Event ID65348
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmInvacare Corporation
CityElyria
StateOH
CountryUS
Distribution PatternWorldwide Distribution - USA including 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, VT, WA, WI, WV, and WY. Internationally to Canada, Australia, Bermuda, Brazil, China, Costa Rica, Germany, France, United Kingdom, Guam, Hong Kong, Israel, India, Kuwait, New Zealand, Puerto rico, Qatar, Saudi Arabia, Singapore, Thailand, Trinidad, Tobago, and South Africa.
 

Associated Products

Product DescriptionInvacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.
Code InfoThe following Joystick model numbers and respective part numbers are affected by this recall: CSPJ, 1121239; SPJPLUS, 1127291; SPJAP, 1136937; SPJAPM, 1136938; CMPJM6, 1164361; CMPM6U, 1644361; MPJM6, 1136885; MPJM6U, 1136885; 1558M6, 1136887; 1558MM6, 1136887; 1500M6, 1136889; PACM6, 1136888; PACM6, 1167927; PSRM6, 1139941; PSRM6, 1140046; PSRM6, 1140047; PSRM6, 1140048; PSRM6, 1144844; PSRM6, 1144845; and PSFM6, 1139944. The following Power Wheelchair model numbers (affected date ranges are included in the 1525712 6-3-13 001C model numbers FINAL xlsx document) are affected by this recall: M61UKRD; 3GAR; 3GARBASE; 3GAR-CG; 3GRX; 3GRXBASE; 3GRX-CG; 3GSEAT-CG; 3GSTRX-TS; 3GTQ3; 3GTQ3-CG; 3GTQ3-MCG; 3GTQ3V; 3GTQ-CG; 3GTQ-MCG; 3GTQSE; 3GTQSEBASE; 3GTQSE-CG; 3GTQSE-PTO; 3GTQSP; 3GTQSPBASE; 3GTQSP-TS; FDX; FDX-CG; FDX-MCG; M41BB; M41RB; M41RBCN; M51 PBLUEBASE; M51 PREDBASE; M51BB; M51-CG; M51CGBB; M51CGRB; M51P; M51PBB; M51PBLUEBASE; M51PR; M51PRB; M51PREDBASE; M51RB; M51RBCN; M51SEAT-CG; M61; M61 PBLUE; M61 PRED ; M61 ; KRDBASE; M61(1144227); M61FBLUE; M61FRAD; M61FRED; M61R; M61RB(1144227); M61RBCN; M61RED; M61SEAT; M61UK; M61UK REDBASE; M61UKRD; M61UKRDBASE; M71; M71JR; M71R; M71SEAT; M71-TS; M91; M91-C; M91-M; M91R; M91-R; M91SEAT; M91-TS; M94; M94-C; PTBASE; PTORB; PWORBITS; R51; R51LXP; TDX3; TDX3BASE; TDX3-PS; TDX3SE; TDX3SEBASE; TDX3SE-PS; TDX3SE-TS; TDX3-TS; TDX4; TDX4BASE; TDX4-PS; TDX4-TS; TDX5; TDX5BASE; TDX5-PS; TDX5-TS; TDXSC; TDXSC2-CG; TDXSCSEAT; TDXSCV; TDXSEAT; TDXSI; TDXSI-2; TDXSI-2-S; TDXSI-CG; TDXSI-HD; TDXSI-HD-S; TDXSISEAT; TDXSISEAT-HD; TDXSIV; TDXSIV-2; TDXSIV-2-S; TDXSIV-HD; TDXSIV-HD-S; TDXSP; TDXSPBASE; TDXSP-CG; TDXSP-CG-GT; TDXSP-GT; TDXSP-MCG; TDXSP-MCG-GT; TDXSPREE; TDXSPREE-CG; TDXSPREESEAT; TDXSPSEAT; TDXSR; TDXSR-CG; TDXSR-CG-HD; TDXSR-HD; TDXSR-MCG; TDXSR-MCG-HD; TDXSRSEAT; TDXSRV; and TDXSRV-HD.
ClassificationClass II
Reason for RecallUnintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks.
Product Quantity166,230
Recall NumberZ-2270-2013

Class II Biologics Event

Event ID65528
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBlood Systems, Inc. dba United Blood Services Texas
CityEl Paso
StateTX
CountryUS
Distribution PatternTX
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW041112066647F; W041112054611T
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to a malaria endemic area, were distributed.
Product Quantity2 units
Recall NumberB-1636-13

Class II Biologics Event

Event ID65534
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jun-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmOneBlood, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW036811019372
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-2270-13
Product DescriptionFresh Frozen Plasma
Code InfoW036811019372
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-2271-13

Class II Biologics Event

Event ID65535
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jun-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmOneBlood, Inc.
CityLantana
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionRed Blood Cells
Code Info2077018
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2268-13
Product DescriptionPlatelets
Code Info2077018
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2269-13

Class II Biologics Event

Event ID65536
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-May-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCentral Blood Bank
CityPittsburgh
StatePA
CountryUS
Distribution PatternPA
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW085313001566-part 1; W085313001566-part 2
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity2 units
Recall NumberB-1635-13

Class II Biologics Event

Event ID65611
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-May-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmLifeSource
CityRosemont
StateIL
CountryUS
Distribution PatternPennsylvania
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW288613000541;
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-2383-13

Class II Biologics Event

Event ID65613
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-May-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmThe Blood Center
CityNew Orleans
StateLA
CountryUS
Distribution PatternLouisiana
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW067113021623;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1
Recall NumberB-2365-13
Product DescriptionFresh Frozen Plasma
Code InfoW067113021623;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1
Recall NumberB-2366-13
Product DescriptionPlatelets
Code InfoW067113021623;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1
Recall NumberB-2367-13

Class II Biologics Event

Event ID65623
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Mar-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBlood Centers of the Pacific - Irwin Center
CitySan Francisco
StateCA
CountryUS
Distribution PatternAustria; California
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW117008118113;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1
Recall NumberB-2368-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW117008118113;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1
Recall NumberB-2369-13

Class II Biologics Event

Event ID65625
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-May-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeShare Blood Centers
CityBeaumont
StateTX
CountryUS
Distribution PatternTexas
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036513027187;
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2377-13
Product DescriptionFresh Frozen Plasma
Code InfoW036513027187;
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2378-13

Class II Biologics Event

Event ID65636
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-May-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmKnoxville Plasma Corporation
CityKnoxville
StateTN
CountryUS
Distribution PatternTennessee; California
 

Associated Products

Product DescriptionSource Plasma
Code InfoTQ215673; TQ213787;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity2
Recall NumberB-2379-13

Class II Biologics Event

Event ID65638
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Bank of Erie County
CityErie
StatePA
CountryUS
Distribution PatternPennsylvania
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW045613002185;
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-2380-13

Class II Biologics Event

Event ID65639
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Apr-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services Heart of America Region
CityPeoria
StateIL
CountryUS
Distribution PatternIllinois
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW204013801547A; W204013801547B; W204013801539; W204013801551A; W204013801551B; W204013801551C;
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity6
Recall NumberB-2381-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW204013801543;
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity1
Recall NumberB-2382-13

Class II Devices Event

Event ID65883
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMicrogenics Corp
CityFremont
StateCA
CountryUS
Distribution PatternUS Distribution including the states of DC, MA, NJ, TX. FL, CA, WA, NY, TX, CT, KY, LA, AR, TN, AL, GA, CT, VA, NC, KS, MD, OH and IL
 

Associated Products

Product DescriptionDRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by: Microgenics Corporation, 46360 Fremont Blvd. Fremont, CA 94538 The DRI Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme intended for the qualitative and semi-quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine with either 300 ng/mL or 150 ng/mL as a cutoff calibrator. The assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirm analytical result.
Code InfoPart no. 0055, lot number 60053405, Exp 2/29/2016; Part No. 0056, lot number 60053396, Exp 2/29/2016; Part No. 10014593, lot number 60112588, Exp 2/29/2016; - not distributed Part number #l40-20, lot number 24215M500, Exp 8/13/14.
ClassificationClass II
Reason for RecallSurveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an unexpected decreasing change in the reaction rate, indicating a faster than expected reagent degradation.
Product Quantity1473 units in distribution.
Recall NumberZ-2267-2013

Class II Drugs Event

Event ID65889
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCore Pharma Llc
CityMiddlesex
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionPyridostigmine Bromide Tablets, USP Rx Only 100 Tablets, Manufactured and Distributed by: CorePharma, LLC Middlesex, NJ 08846 NDC 64720-128-10 NDC 64720-128-10
Code Info109497; Exp. 12/15
ClassificationClass II
Reason for RecallFailed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing.
Product Quantity960 bottles
Recall NumberD-1062-2013

Class II Devices Event

Event ID65922
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Aug-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Medical Division of Stryker Corporation
CityPortage
StateMI
CountryUS
Distribution PatternWorldwide Distribution - USA including MI, WI, VA and internationally to Canada.
 

Associated Products

Product DescriptionThe FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes. It can be operated by the patient or the caregiver to adjust the height and surface contour of the bed. The bed includes movable and latchable siderails. The FL23SE Bed is intended for use with patients for procedures, therapy, recovery in healthcare environments, and to transport patients between bays and procedural rooms. The FL23SE Bed is intended for use with patients for procedures, therapy, recovery in healthcare environments, and to transport patients between bays and procedural rooms.
Code InfoModel Numbers: FL23SE with nurse call option: OL235017 & OL235018 List of Affected Devices: J60267 J60425 J60009 J60001 J60094 J60095 J60096 J60348 J60349 J60350 J60351 J60352 J60353 J60354 J60360 J60361 J60362 J60363 J60364 J60365 J60366 J60367 J60368 J60369 J60370 J60371 J60372 J60373 J60374 J60375 J60376 J60377 J60378 J60379 J60380 J60381 J60382 J60383 J60384 J60385 J60386 J60387 J60388 J60389 J60390 J60391 J60392 J60393 J60394 J60395 J60396 J60397 J60398 J60399 J60400 J60401 J60402 J60403 J60404 J60405 J60512
ClassificationClass II
Reason for RecallThe nurse call cable (Part Number: QDF23-0571) on the FL23SE Bed is located right under the opening of the bed head box. If an accessory (i.e. IV pole) is inserted into this slot, the circuit directing the nurse call system can be damaged.
Product Quantity61 units
Recall NumberZ-2283-2013

Class II Devices Event

Event ID65981
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTerumo Cardiovascular Systems Corporation
CityElkton
StateMD
CountryUS
Distribution PatternNationwide Distribution including WA, IN, OK, TX, MI, CA, NY, CT, AZ, FL, WV, NC, VA, PA, TN, GA, AL, MA, SC, OH, MS, MO, SD, WI, AR, AND NV.
 

Associated Products

Product DescriptionTerumo® Pall AL6X Arterial Blood Line Filter, labeled in part ***Terumo Cardiovascular Systems Corporation Elkton, MD 21921***, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit Single/Sterile Terumo® Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 40 microns in size, including gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris from the arterial line and where the flow rate will not exceed 8 liters per minute. Cardiovascular Procedure (Convenience) Kit that includes the Terumo® Pall AL6X Arterial Filter: The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed. The sterile cardiovascular procedure kit is intended to be used one time for periods up to 6 hours.
Code InfoRecalled filters sold singly are identified with Part Number AL6X with the following lot codes: MM19, MN23, NC15, ND01, ND08, ND29, NE11, NE18, NE25, NF09, NF31, PA23, PD05, PE02, PF14, PF21, PG04, PG11, PG18, PG25, PH09, PH16, PH30, PK06, PK13, PL24, PM01, PM08, PM22, PM29, PN12, PN26, PP17, PP31, QA07, QA14, QA21, QC04, QC25, QD11, QD18, QD25, QE08, QE15, QE22, QE29, QF06, QF28, MM26, NL12, NM24, NP12, and PA30; Affected filters, also Part # AL6X, packaged within Terumo Cardiovascular Convenience Kits are identified with the following lot codes: PN19, QA14, QC11R, QD04, QE15, QF06, QF13, NM31, NP05, PC20, PD05, QF28, QC04, PD26, PG04, PE23R, PK13, PK20, QA21, QC11, QC11A, QD11, QE01, PL17, QE08, NK08, PG25, PN26, QC18, NN07, NN07R, PA16, PA16R, PC27, PC27R, PF07, PL24, PD12, PE09, PE30, PH09, PL10, PE23, PF14, PG18, PK06, PM01, PM22, PN12, QA02, QA28, QC25, QD25, NK01, NK08R, PH23, PH16, PL10A, PM15, PP10, PP17, QD18, QE22, NM17, NM17A, PC06, PC06R, PE09R, QE01A, QE15A, QE15T, QE15TA, QE15TC, QF13T, QF20, QF20T, NA10R, NA17R, ND14, ND28, ND28T, NE11T, NE18, NF23, NG06, NG20, NH11, NH18, NK15, NL12, NL26, NM03, NM10, NM24, NN14, NN28, NP12, PA30, PC13, PD19, PE16, PF07A, PF21, PK27, PK27A, PL04, PM08, PP03, QA14T, QE29, QF28T, QF28TA, PG11, PH30, PH30A, PN26A, QA07, NH25, NK29, PE02, PF29, PN19, QG17, PK13A, QD11A, MN22, NE25, NF31, PM29, PA09, QG03, PA02, PH23T, PG11T, QC18R, QF06A, PH09T, PH09TA, QF13TA, QF20TA, and QF20TC
ClassificationClass II
Reason for RecallMedical device used in cardiovascular procedures is defective.
Product Quantity15,817 filters
Recall NumberZ-2261-2013

Class II Devices Event

Event ID65992
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternWorldwide Distribution - All states in continental USA including DC except AK, AZ, RI and WY. and the countries of : AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEANON, MARINIQUE, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE,SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, LUXEMBOURG, PORTUGAL, VIETNAM and URUGUAY.
 

Associated Products

Product DescriptionGE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2. GE Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T. The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. IT is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including but not limited to head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used
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ClassificationClass II
Reason for RecallGE Healthcare has recently become aware of a potential safety issue due to non-unique series identifiers embedded in image headers of certain GE MR Products. For ClariView and Screen Save from GVTK (Gems Visualization ToolKit) Viewer, the MR Product can generate image headers with non-unique series identifiers, which when exported to some PACS systems, results in the series being associated with the incorrect study on the PACS. The intended study will not have the correct series listed and an unintended study will have it listed instead. In all cases, patient identifying annotation remains correct. The issue may result in an incorrect diagnosis from the study with mixed patient data, if the series protocol and anatomy on the studies are similar, and the annotation is not noticed.
Product Quantity1,246 (521 US and 725 OUS)
Recall NumberZ-2266-2013

Class II Devices Event

Event ID65996
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmElekta, Inc.
CityAtlanta
StateGA
CountryUS
Distribution PatternNationwide Distribution including AK, CA, CO, CT, FL, IL, IN, MI, MN, MO, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, WA and Puerto Rico.
 

Associated Products

Product DescriptionMonaco RTP System Radiation treatment planning
Code InfoVersions 3.10.00 and later
ClassificationClass II
Reason for RecallUpgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values.
Product Quantity45
Recall NumberZ-2276-2013

Class II Devices Event

Event ID65998
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmElekta, Inc.
CityAtlanta
StateGA
CountryUS
Distribution PatternDistributed in Puerto Rico and the states of AK, AZ, CA, CO, CT, FL, IL, IN, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, and WA.
 

Associated Products

Product DescriptionMonaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.
Code InfoAll versions of Monaco
ClassificationClass II
Reason for RecallPatient needs to be positioned as indicated by the treatment plan.
Product Quantity72
Recall NumberZ-2277-2013

Class II Devices Event

Event ID66049
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Aug-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMaquet Cardiovascular Us Sales, Llc
CityWayne
StateNJ
CountryUS
Distribution PatternWorldwide Distribution, including Nationwide (US) and foreign countries.
 

Associated Products

Product DescriptionQUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
Code InfoQUADROX-iD Adult catalog number HMOD 70000, lot # 70081567 QUADROX-i Adult catalog number VKMO 70000, lot # 70082663 QUADROX-i Adult catalog number VKMO 71000, lot # 70083974
ClassificationClass II
Reason for RecallThe manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product which may not meet specifications for bond strength on the inlet and/or outlet connector.
Product Quantity1,182 units
Recall NumberZ-2262-2013

Class II Devices Event

Event ID66051
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Aug-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMaquet Cardiovascular Us Sales, Llc
CityWayne
StateNJ
CountryUS
Distribution PatternWorldwide Distribution - USA including NY and PA and internationally to Australia, Brazil, Canada, Germany, Hong Kong, Japan, Sweden.
 

Associated Products

Product DescriptionTEGRIS system Four labels of the Tegris System include: Emergency button (1703.72) MAQUET GmbH & Co. KG Kehler-Strabe 31 Baden-Wuerttemberg 76437 Rastatt, Germany Touch screen (elo) Elo TouchSystems 301 Constitution Drive Menlo Park, CA 94025 www.elotouch.com Manufacturer: Tyco Electronics Brand Name: Elo Touch Systems Made in China Tegris system (1703.01) MAQUET GmbH & Co. KG Kehler Strabe 31 76437 Rastatt, Germany OR Table Module (1703.71) MAQUET GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt, Germany Designed to be used as the central operating system in an operating room. The integration system has two main functions. -recording and distribution of images and videos -interaction with medical and non-medical devices. The system has a modular design and comprises the basic units as well as s various optional modules,which may be used or integrated in conjunction with the basic unit. TEGRIS is operated using a touchscreen. Medical devices that can be operated by TEGRIS include OR tables an OR lights. In the case of OR tables and OR lights, the main functions of these devices may be separated, e.g. adjustment of OR tables or switching the OR lights on.off. TEGRIS has no effected on the primary operating functions of the original control device. TEGRIS does not provide any other functions in addition to these primary operating functions. The purpose of TEGRIS namely the central operation of these various devices, is dependant on the individual devices. Please refer to the operating instructions of the individual devices for instructions. The integrated surgical safety checklist is a raft and must be modified to meet local requirements and approved by the User. TEGRIS is intended for short-term use pursuant to Appendix IX of the Directive 93/42/EEC of medical products in medical rooms in accordance with Group 1 and 2 VDR 0100-710, providing, among other things, protection against electric shock and connections for potential equalization lines. Intended for the following users: medical experts
Code InfoClass 1 exempt Device Listing #D122038 Tegris Base System 1703.01X0 OR TAblet Module 1703.71A0 Secondary 19" touchscreen - part number 1707.05A0 The above product is affected only when used in combination with Tegris base system 1703.01X0 OR Table Control 1703.71A0
ClassificationClass II
Reason for RecallMAQUET has identified a potential issue that might occur because of the lack of an emergency stop button on a secondary touch screen display on the TEGRIS System.
Product Quantity21 units
Recall NumberZ-2275-2013

Class II Devices Event

Event ID66063
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmEndoplus, Inc.
CityMundelein
StateIL
CountryUS
Distribution PatternDistributed in the states of FL, TX, and VA.
 

Associated Products

Product DescriptionENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the laparoscopic during laparoscopic surgery.
Code InfoItem: 346VA; Lot Numbers: D3, E3, F3
ClassificationClass II
Reason for RecallMultiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.
Product Quantity81 units
Recall NumberZ-2264-2013
Product DescriptionENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the laparoscopic during laparoscopic surgery.
Code InfoItem: 345VA; Lot Number: F3
ClassificationClass II
Reason for RecallMultiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.
Product Quantity9 units
Recall NumberZ-2265-2013

Class II Devices Event

Event ID66070
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Aug-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmBecton Dickinson & Company
CityFranklin Lakes
StateNJ
CountryUS
Distribution PatternWorldwide Distribution - USA including FL, VA, TX, NY, IL, AZ, MI, RI, NJ, SC, MO, TN, CA, MN, UT, GA, NE, OH, MD, PA, MT and internationally to Brazil, Australia, Canada, and Puerto Rico..
 

Associated Products

Product DescriptionBD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.
Code Info510K K925902 D041521 Catalog Number: 405198 Lots 8310086 9246684 0035495 0053165 0056608 0056607 0096757 0120074 0126127 0152581 0242475 0258468 0258469 0258472 0291220 0291221 0291223 0291224 0278495 0291218 0291219 0291222 0291226 0291227 0291228 0336391 0336393 0336396 0336400 1005321 1006136 1033177 1033178 1094304 1209634 1210646 1213990 1213993 1276782 1307383 2032802 2033712 2060835 2065940 2084318 2121011 2122467 2205098 2212313 2276066 3038272 3042376 3063436 3063440 3085498 3085001 3085003 3085005 3123462 3123246 3184092 Catalog Number 405291 Lots 0154661 0174905 0252565 0279140 0301813 0347866 1012200 1035046 1063738 1095340 1124755 1180073 1213029 1262268 1273795 1312116 1320204 1356378 2041210 2058524 2083246 2135469 2158092 2170207 2194139 2205106 2223162 2223337 2250088 2286395 2303137 2303141 2334338 2334339 2355389 2355391 3057376 3120039 Catalog Number 405807 Lots GD873422 GD874743 GD875419 GD876029 GD876912 GD879577 GD881128 GD883033 Catalog Number 405823 Lots GD877068 GD882951 GD884312 GD885491 GD886192 GD887893 GD889527 B01F223D B01F243D B01G057D B01G196D Catalog Number 406078; Lots GD876003 GD877787 GD881169 GD883017 GD883660 GD885202 GD886283 GD888677 GD890442 B01F054D B02F156D B02F178D B03F074D B03F241D Catalog number 406084 Lots B03F090D B06F326D GD875369 GD880427 GD883025 GD888255 B05G087D Catalog # 406119 Lots GD873364 GD875625 GD877878 GD879015 GD881813 GD885129 GD889782 B02F051D B02F096D B01F135D B03F222D Catalog # 406121 Lots GD887596 GD889618 Catalog # 406156 Lots GD887778 GD889733 GD889980 GD890178 B02F214D B02F292D B02G157D B03F292D B03G158D B04F238D B05F241D
ClassificationClass II
Reason for RecallBD has received several reports indicating that the plunger of the 7 mL BD Epilor plastic BD Luer-Lok Loss of Resistance Syringe may stall or stick within the syringe preventing the user from detecting a loss of resistance upon entering the epidural space.
Product Quantity1,335,885 units
Recall NumberZ-2274-2013

Class II Food Event

Event ID66102
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Aug-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmGourmet Express Marketing, Inc.
CityAddison
StateIL
CountryUS
Distribution PatternUS: Nationwide (IL, IN, MI, MO, NY, OH)
 

Associated Products

Product DescriptionBreaded, frozen shrimp packaged in plastic bags labeled in part: BREADED SHRIMP; NET WEIGHT; 2.0 LBS or 3 LBS
Code InfoLot Code: 6483004
ClassificationClass II
Reason for RecallPackages of breaded shrimp failed to declare shellfish (shrimp) and wheat allergens.
Product Quantity856 lbs in 2 and 3 lbs units
Recall NumberF-1913-2013

Class II Food Event

Event ID66140
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Aug-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmBlythedale Farm Inc.
CityCorinth
StateVT
CountryUS
Distribution PatternVT, NH, CT, RI, ME, NY, MA, DC, IL, CA
 

Associated Products

Product DescriptionBlythedale Farm Vermont Brie, 7 oz. wrapped disc in plastic cup UPC Code: 762713669010
Code InfoBest Buy or Sell By date prior to October 19
ClassificationClass II
Reason for RecallInadequate pasteurization
Product Quantity11,678 units
Recall NumberF-1955-2013
Product DescriptionBlythedale Farm Farmstead Brie, 1 lb white wrapped disc UPC Code:
Code InfoBest Buy or Sell By date prior to October 19
ClassificationClass II
Reason for RecallInadequate pasteurization
Product Quantity143 units
Recall NumberF-1956-2013
Product DescriptionBlythedale Farm Camembert Vermont, 7 oz wrapped disc in plastic cup UPC Code: 762713669027
Code InfoBest Buy or Sell By date prior to October 19
ClassificationClass II
Reason for RecallInadequate pasteurization
Product Quantity9, 078 units
Recall NumberF-1957-2013

Class II Devices Event

Event ID66150
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Aug-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCareFusion 303, Inc.
CitySan Diego
StateCA
CountryUS
Distribution PatternNationwide Distribution including CA
 

Associated Products

Product DescriptionSmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The SmartSite Low Sorbing set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a 1.2 micron filter, needleless SmartSite connector, low sorbing tubing segment, pinch clamps, and luer connectors.
Code InfoLot Number 13016314
ClassificationClass II
Reason for RecallCareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number 13016314, because of an incorrect filter was assembled on this lot. The correct filter is a 1.2 micron filter (blue color) but a 0.2 micron filter (clear color) may have been added instead.
Product Quantity600 units
Recall NumberZ-2279-2013

Class II Devices Event

Event ID66151
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Aug-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCareFusion 303, Inc.
CitySan Diego
StateCA
CountryUS
Distribution PatternClass II Recall - United States ***Center Recommended Depth - Consumers/Users**
 

Associated Products

Product DescriptionSmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.
Code InfoLot Numbers 13015883 and 13025342.
ClassificationClass II
Reason for RecallCareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber.
Product Quantity15860 units
Recall NumberZ-2285-2013

Class II Devices Event

Event ID66152
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Aug-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCareFusion 303, Inc.
CitySan Diego
StateCA
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionCareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein. The CareFusion Gravity Set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a check valve, injection ports, 4-way stopcock, anti-siphon valve, roller clamp and tubing.
Code InfoLot Numbers: 12086930, 12106215, 13016408, 13016834, 13025446, and 13025672.
ClassificationClass II
Reason for RecallCareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date. The affected lot numbers of the Gravity Set are labeled with a 5 year expiration instead of three (3) years.
Product Quantity2,850 units
Recall NumberZ-2281-2013

Class II Food Event

Event ID66174
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Aug-13
Initial Firm Notification of Consignee or Public Visit
Recalling FirmSnoqualmie Falls Candy Factory, LLC
CitySnoqualmie
StateWA
CountryUS
Distribution Patterndistributed in WA.
 

Associated Products

Product DescriptionPecan Brittle's label is read in parts: "***PECAN BRITTLE***INGREDIENTS: Sugar, corn syrup, pecans, brown sugar, butter (cream, salt), baking soda, salt. NO PRESERVATIVES ADDED***Net Wt. 8 oz.***www.snofallscandy.com***Toll Free 1-888-636-CANDY***".
Code Infofirm did not provide
ClassificationClass II
Reason for RecallFinished product labels declared butter or cream but milk is not listed.
Product QuantityUnknown
Recall NumberF-1950-2013
Product DescriptionAlmond Brittle's label is read in parts:"***ALMOND BRITTLE***INGREDIENTS: Sugar, corn syrup, almonds, brown sugar, butter (cream, salt), baking soda, salt. NO PRESERVATIVES ADDED***Net Wt. 8 oz.***www.snofallscandy.com***Toll Free 1-888-636-CANDY***".
Code Infofirm did not provide
ClassificationClass II
Reason for RecallFinished product labels declared butter or cream but milk is not listed.
Product QuantityUnknown
Recall NumberF-1951-2013
Product DescriptionCoconut Peanut Brittle's label is read in parts:"***COCONUT PEANUT BRITTLE***INGREDIENTS: Coconut (preserved with sodium metabisulfate), peanuts, white sugar, glucose, water, butter (cream, salt), vanilla, salt***Net Wt. 8 oz.***www.snofallscandy.com***Toll Free 1-888-636-CANDY***".
Code Infofirm did not provide
ClassificationClass II
Reason for RecallFinished product labels declared butter or cream but milk is not listed.
Product QuantityUnknown
Recall NumberF-1952-2013
Product DescriptionCoconut Brittle's is labeled in parts: "***COCONUT BRITTLE***INGREDIENTS: Coconut (preserved with metabisulfate), white sugar, glucose, butter (cream, salt), vanilla, salt***".
Code Infofirm did not provide
ClassificationClass II
Reason for RecallFinished product labels declared butter or cream but milk is not listed.
Product QuantityUnknown
Recall NumberF-1953-2013

Class II Food Event

Event ID66187
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Aug-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMothers Milk Bank
CitySan Jose
StateCA
CountryUS
Distribution PatternProduct was distributed to 6 hospitals in Honolulu and California.
 

Associated Products

Product DescriptionHuman breast milk, pasteurized, 4 oz, in bottles; Pasteurized Human Milk,Hospital Grade Milk. Mother's Milk Bank 751 S. Bascom Abe.San Jose, CA 95128
Code InfoBatch number SC1308067; 001-071, Expiry 2/2/14
ClassificationClass II
Reason for RecallHuman Breast milk was collected from a donor that tested reactive for Hepatitis B in a screening test.
Product Quantity70 x 4 oz. bottles
Recall NumberF-1949-2013

Class II Devices Event

Event ID66211
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Aug-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmStryker Endoscopy
CitySan Jose
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY and internationally to Australia, Canada, Chile, China, Argentina, Guam, Taiwan, India, Japan, Korea, Latin America, Philippines, Mexico, New Zealand, Hong Kong, Singapore, and Switzerland.
 

Associated Products

Product DescriptionStryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model number 0240-095-200, manufactured by Stryker Endoscopy San Jose The intended use of the Stryker Vision Mount is to hold and position an LCD monitor. The Stryker Vision Mounting Arm can be used with any Stryker flat panel display and is It is compatible with Stryker Carts (0240099001, 0240099011 or 0240099020). It is indicated for use in a surgical operating room environment and is exposed to environmental conditions associated with the storage and shipping of the product. It is not intended to enter the sterile field. The Stryker Vision Mount does not deliver to and/or extract from the patient any energy or material. It does not process any biological materials, as it is not intended to be sterilized by the user. The Stryker Vision Mount is only used to display surgical images and video and does not sustain or support life.
Code InfoModel number 0240-095-200, all serial numbers.
ClassificationClass II
Reason for RecallWhen positioning the display located on top of the video cart, it is possible for the user to apply excessive force and push the display up and out of the mounting arm. This can result in the display falling upon the user/patient.
Product Quantity14271 units
Recall NumberZ-2271-2013

Class II Devices Event

Event ID66234
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Sep-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSmiths Medical ASD, Inc.
CitySaint Paul
StateMN
CountryUS
Distribution PatternWorldwide Distribution - USA including AZ, AR, CA, GA, IL, IN, KY, MD, MA, MI, NV, NJ, NY, NC, OH, OR, PA, RI, SC, TN, TX, VA, WA, WV, WY. Internationally to DENMARK, BELGIUM CANADA.
 

Associated Products

Product DescriptionSmith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, Rx Only PORT-A-CATH® and PORT-A-CATH® II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications, fluids, and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein.
Code Info1991524 1997100 2033224 2051222 2116286 2183921 2192487 2210967 2229821 2237453
ClassificationClass II
Reason for RecallSmiths Medical is conducting a voluntary recall of PORT-A-CATH® and PORT-A-CATH® II Implantable Venous and Arterial Access Systems and Introducer Sets. Smiths Medical has become aware of a small number of customer reports regarding the introducer sheath and the introducer opening being too small for the width of the catheter with the use of these Sets. Smiths Medical has received no reports of serious injury or death related to this issue.
Product Quantity190
Recall NumberZ-2268-2013
Product DescriptionSmiths Medical, Deltec: REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access System. REF 21-8052-24 & REF 21-8053-24 , Port-A-Cath II Dual-Lumen, Polysulfone /Titanium Venous Access System. Sterile EO, Rx Only. PORT-A-CATH® and PORT-A-CATH® II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications, fluids, and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein.
Code Info21-8011-24: 1971567 1979805 1984078 1997124 2006124 2038001 2090898 2151160 2196530 2216256 2249695 21-8052-24: 1971572 2012472 2022904 2067947 2080704 2146472 2168988 2196532 2207404 2237458 2249696 2269178 2282158 21-8053-24: 2168989 2249697
ClassificationClass II
Reason for RecallSmiths Medical is conducting a voluntary recall of PORT-A-CATH® and PORT-A-CATH® II Implantable Venous and Arterial Access Systems and Introducer Sets. Smiths Medical has become aware of a small number of customer reports regarding the introducer sheath and the introducer opening being too small for the width of the catheter with the use of these Sets. Smiths Medical has received no reports of serious injury or death related to this issue.
Product Quantity372
Recall NumberZ-2269-2013

Class II Devices Event

Event ID66247
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Aug-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSteris Corporation
CityMentor
StateOH
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including the states of AK, CO, FL, GA, HI, ID, IL, KS, LA, MD, MN, MO, MT, NE, NM, OH, PA, SC, UT, & WY and the countries of Australia, Canada & Spain.
 

Associated Products

Product DescriptionReliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com. The intended use of the REPS is washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-critical devices.
Code InfoModel #'s: MB30001, MB30002, MB30003, MB000077, MB000078, MB000079, MB000080 and MB000081. Serial number range 3625606001 - 3608912002
ClassificationClass II
Reason for RecallThe air pipe that delivers unfiltered ambient air from the procedure room into the water bottle on the listed FUJINON G5 & G8 type flexible GI endoscopes does not connect to the main air/water channel within the light guide (LG) connection head and, as a result, the air pipe does not receive forced flow during the Reliance EPS processing cycle.
Product Quantity266 units
Recall NumberZ-2263-2013

Class II Food Event

Event ID66255
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Sep-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmRestaurant Depot
CityCollege Point
StateNY
CountryUS
Distribution PatternNY, NJ, CT, RI, MA, PA, MD, VA
 

Associated Products

Product DescriptionJAMES FARM brand CUT GREEN BEANS (EJOTES CORTADOS), FRESH FROZEN, NET WT. 32 OZ. (2 LBS.) 907 g, UPC 7 60695 01004 2, PRODUCT OF POLAND -- Distributed by RD/JET, LLC 15-24 132nd Street, College Point, NY 11356 --- Product is harvested, sorted, graded, washed, cut/processed and blanched before snap freezing and packing. The cut green beans are instantly quick frozen (IQF) and packaged in a pre-printed sealed plastic bag, 2 lbs. of product per bag, 12 - 2 lbs. bags per master carton.
Code InfoLots: L6X 0424130911RY, Best before 04/24/2015; L1X 0404130814RY, Best before 04/04/2015; L1X 0404130815RY, Best before 04/04/2015; L1Y 0311132059RY, Best before 03/11/2015
ClassificationClass II
Reason for RecallThe product was found to be contaminated with Listeria monocytogenes based on private laboratory testing.
Product QuantityPotentially 35,896 lbs.
Recall NumberF-1945-2013

Class II Food Event

Event ID66271
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Sep-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmMaplehurst Bakeries, Inc.
CityBrownsburg
StateIN
CountryUS
Distribution PatternMI and OH.
 

Associated Products

Product DescriptionMeijer 8 Inch Carrot Uniced Split Cake Layers (product is packed in bulk cartons of 24 units/paper bags lined with flexible blue plastic liner).
Code InfoSKU: 00569, Lot Codes: 3221G00569, 3221H00569, 3221I00569 Shelf life (Exp. Date): Best if Used Before: 2/5/2014
ClassificationClass II
Reason for RecallProduct was found to contain foreign material, flexible plastic.
Product Quantity1561 cases with 24 cakes/case (37464 individual cakes)
Recall NumberF-1912-2013

Class II Food Event

Event ID66326
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Sep-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmThe Dannon Company, Inc
CityWest Jordan
StateUT
CountryUS
Distribution PatternArizona, California, Colorado, Nevada, Utah, Washington, and Wyoming. 324 cases were distributed to govt/military/VA consignees. No foreign consignees.
 

Associated Products

Product DescriptionDannon ACTIVIA® LIGHT Nonfat Yogurt Strawberry-Banana & Peach Flavor, 12 PACK of 4oz cups, Form fill seal 4oz cup
Code InfoUPC 36632 02764 With the following expiration codes: Expiration code of PLT 49-64 SEP 24 2013 WJ, Expiration code of PLT 49-64 SEP 29 2013 WJ, Expiration code of PLT 49-64 OCT 08 2013 WJ
ClassificationClass II
Reason for RecallDannon Company is recalling certain lots of ACTIVIA® LIGHT Nonfat Yogurt Strawberry/Banana & Peach Flavors due to the potential for mold.
Product Quantity6045 cases
Recall NumberF-1954-2013

Class II Drugs Event

Event ID66330
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Aug-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmWalgreens Co
CityDeerfield
StateIL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionWalgreens Progesterone in Ethyl Oleate 50 mg per mL Injection, 10 mL vial, Inject 1 mL Intramuscularly as directed by physician, Walgreens Specialty Pharmacy, Fresco, TX.
Code InfoLot #: P50EO07121390A, Exp 1/12/14
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Walgreens Specialty Pharmacy is recalling one lot of Progesterone in Ethyl Oleate sterile injection due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.
Product Quantity298 vials
Recall NumberD-1063-2013

Class II Food Event

Event ID66332
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Sep-13
Initial Firm Notification of Consignee or Public Visit
Recalling FirmSemifreddi's Inc.
CityAlameda
StateCA
CountryUS
Distribution PatternProducts were delivered to retail stores/cafes/restaurants throughout California and to AZ, CO, NE, NJ, NY, OR and WA
 

Associated Products

Product DescriptionAlmond Biscotti, 1 oz. and 0.5 oz. wrapped in plastic, with "Enjoy By dates prior to 091614, manufactured by Semifreddi's Inc, Alameda, CA. Product size and UPC codes 0.5 oz., case of 100 units 758843915936, 1.0 oz., box of 4 units 758843915738 , 1.0 oz., box of 12 units 758843915950, 1.0 oz., case of 50 units 758843915752,
Code InfoWith "Enjoy By" dates prior to 091614
ClassificationClass II
Reason for RecallSemifreddi's Almond Biscotti and Semifreddi's Chocolate Dipped Almond Biscotti are being recalled due to undeclared allergens, milk and soy; butter did not list milk as a subingredient; lecithin did not list soy as a subingredient.
Product QuantityUnknown
Recall NumberF-1947-2013
Product DescriptionChocolate Dipped Almond Biscotti, in various sizes, wrapped in plastic, with "Enjoy By" dates prior to 091614, manufactured by Semifreddi's Inc, Alameda, CA. Product Size and UPC codes: 0.65 oz., case of 100 units 758843915943 0.89 oz., tub of 22 units 758843916001 1.3 oz., box of 4 units 758843915745 1.3 oz., box of 12 units 758843915967 1.3 oz., case of 50 units 758843915905
Code Info with Enjoy By date prior to 091614
ClassificationClass II
Reason for RecallSemifreddi's Almond Biscotti and Semifreddi's Chocolate Dipped Almond Biscotti are being recalled due to undeclared allergens, milk and soy; butter did not list milk as a subingredient; lecithin did not list soy as a subingredient.
Product QuantityUnknown
Recall NumberF-1948-2013

Class II Devices Event

Event ID66355
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Aug-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMedtronic Xomed, Inc.
CityJacksonville
StateFL
CountryUS
Distribution PatternNationwide Distribution (US), including the states of CA, NE, GA, and IL.
 

Associated Products

Product DescriptionUniversal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Code InfoREF: 1150000 Lot: 0207029284
ClassificationClass II
Reason for RecallOne lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
Product Quantity60
Recall NumberZ-2284-2013

Class II Food Event

Event ID66369
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Sep-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Nut Company
CitySylmar
StateCA
CountryUS
Distribution PatternCA, AZ, & WA
 

Associated Products

Product DescriptionFancy Mixed Nuts (25lbs), Mixed Nuts (25lbs), and Super King Fancy Mixed Nuts (25lbs)
Code InfoFancy Mixed Nuts: LOT2013.09.09 Mixed Nuts: LOT2013.09.12 Super King Fancy Mixed Nuts: LOT2013.08.23
ClassificationClass II
Reason for RecallAmerican Nuts is recalling Mixed Nuts because they may contain undeclared wheat allergen.
Product Quantity111 cases
Recall NumberF-1944-2013

Class II Food Event

Event ID66395
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Sep-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTaylor Farms Retail, Inc.
CitySalinas
StateCA
CountryUS
Distribution PatternOne account in Canada.
 

Associated Products

Product DescriptionSensations Asian Supreme Salad Kit; 220 g/7.8 oz. Product os USA/Produit des E. U. A. Taylor Farms, Salinas, CA 93901
Code InfoBest Before 2013 SE 26; Batch number WO2013252
ClassificationClass II
Reason for RecallCanadian product only - Sensations Spinach salad kit was packed in Sensations Asian Supreme Salad kit. The spinach kit contains feta cheese and milk is not listed on the ingredient statement as the source of the cheese as required by FALCPA.
Product Quantity749 cases, 6 x 7.8 oz bags per case.
Recall NumberF-1958-2013

Class III Biologics Event

Event ID43057
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Sep-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmInternational BioResources, LLC
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code Info368010172
ClassificationClass III
Reason for RecallBlood product, collected from a donor whose arm check and general appearance inspection were not documented, was distributed.
Product Quantity1
Recall NumberB-2160-13

Class III Biologics Event

Event ID44365
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Oct-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityToledo
StateOH
CountryUS
Distribution PatternOH
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info50LH79006
ClassificationClass III
Reason for RecallBlood products, which should have been quarantined pending an investigation, were distributed.
Product Quantity1 component
Recall NumberB-1909-13

Class III Biologics Event

Event ID46553
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Dec-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBlood Systems, Inc.
CityScottsdale
StateAZ
CountryUS
Distribution PatternAZ
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info103043006
ClassificationClass III
Reason for RecallBlood product, possibly contaminated with P.acne, was distributed.
Product Quantity1
Recall NumberB-2159-13

Class III Biologics Event

Event ID48862
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Jul-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmChildrens Hospital Los Angeles
CityLos Angeles
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionBlood and blood products for reprocessing
Code InfoW070008001819
ClassificationClass III
Reason for RecallBlood products, collected from a donor who was previously deferred, were distributed.
Product Quantity1
Recall NumberB-2157-13

Class III Biologics Event

Event ID49278
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jun-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternNY & PA
 

Associated Products

Product DescriptionRed Blood Cells
Code Info01KG99432, 01KG99431, 01KG99434, 01KG99435, 01KG99438, 01KG99460, 01KG99447, 01KG99445, 01KG99458, 01KG99453, 01KG99457, 01KG99451, 01KG99441, 01KG99456, 01KG99433, 01KG99436, 01GE72762, 01GE72764, 01GE72763, 01FM61959;01FM61955;01FM61962;01FM61968;01FM61970;01FM61960;01FM61963;01FM61965;01FM61966;01FM61971;01FM61972
ClassificationClass III
Reason for RecallBlood products, for which the West Nile Viral testing performed was incomplete, were distributed.
Product Quantity30
Recall NumberB-2162-13
Product DescriptionRed Blood Leukocytes Reduced
Code Info01GH15013, 01GH15012, 01GQ29464, 01GQ29427, 01GQ29454, 1GQ29460, 01GQ29461, 01GQ29463, 01GQ29465, 01GQ29467, 01GQ29469, 1GQ29474, 01GQ29453, 01GQ29458, 01GQ29468, 01KT32514, 01KT32524, 01KT32520, 01KT32524, 01KT32539, 01KT32530, 01KT32546, 01KT32536, 01KT32538, 01KT32543, 01KT32547, 01KT32541, 01KT325519, 01KT32544, 01KT32521, 01KT32528, 01KT32532, 01KT32522, 01FM62000, 01FM61998, 01GE72771, 01GT29616, 01GT29609, 01GT29610, 01GT29613, 01GT29614, 01GT29615, 01GT29590, 01KM53768, 01KM53770, 01KM53766, 01KM53776, 01KM53761, 01KM53764, 01KM53765, 01KM53775, 01KM53791, 01KM53774, 01KM53767, 01KM53769, 01KM53762 01KJ89623
ClassificationClass III
Reason for RecallBlood products, for which West Nile Viral testing was incomplete, were distributed.
Product Quantity57
Recall NumberB-2163-13
Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info01GQ29427 bag1 & bag2, 01GQ29429 bag 1 & bag2, 01GQ29430 bag2 , 01KG99421 bag1, 01KG99425 bag1, 01KG99422 bag1, 01KG99420 bag1, 01KG99423 bag1 & bag2, 01KG99424 bag 1 & bag 2, 01GQ29434 bag1, 01GQ29426 bag1 & bag2, 01GQ29435 bag1, and 01GQ29436 bag1
ClassificationClass III
Reason for RecallBlood products, for which West Nile Viral testing was incomplete, were distributed.
Product Quantity18
Recall NumberB-2164-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info01GT29616 , 01GT29611 , 01GT29462 , 01GT29617 , 01GT29607, 01GQ29457
ClassificationClass III
Reason for RecallBlood products, for which West Nile Viral testing was incomplete, were distributed.
Product Quantity6
Recall NumberB-2165-13
Product DescriptionPlatelets Leukocytes Reduced
Code Info01W51941
ClassificationClass III
Reason for RecallBlood products, for which West Nile Viral testing was incomplete, were distributed.
Product Quantity1
Recall NumberB-2166-13
Product DescriptionPlasma Frozen within 24 hours (FP24)
Code Info01KG99436, 01KG99447, 01KG99458, 01KG99446, 01KG99460, 01KT32538, 01KT32537, 01KT32524, 01KT32522, 01KT32546, 01KT32541, 01KT32511, 01KT32553, 01KT32518, 01KT32530, 01GE72773, 01GE72771, 01GE72769, 01FM61970, 01FM61967, 01FM61966, 01FM61963, 01FM62201, 01FM62202, 01FM61961, 01FM61665, 01FM61972, 01FM61997, 01FM61998, 01FM62000, 01FM62205, 01FM61965, 01FM61968, 01GH15015, 01GH15014, 01GQ29463, 01GQ29461, 01GQ29467, 01GQ29469, 01GQ29451, 01GT29591, 1GT29612, 01GH15018
ClassificationClass III
Reason for RecallBlood products, for which West Nile Viral testing was incomplete, were distributed.
Product Quantity43
Recall NumberB-2167-13

Class III Biologics Event

Event ID65612
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-May-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Center Hammond Laboratory (the)
CityHammond
StateLA
CountryUS
Distribution PatternLouisiana
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW067113050945;
ClassificationClass III
Reason for RecallBlood product, labeled with an incorrect expiration date and product code, was distributed.
Product Quantity1
Recall NumberB-2357-13

Class III Devices Event

Event ID66209
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Sep-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHoriba Instruments, Inc dba Horiba Medical
CityIrvine
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA including the country of Canada.
 

Associated Products

Product DescriptionABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone mineralization, in blood coagulation and in transmission of nerve impulses. Calcium is present in plasma in three forms: free, bound to proteins or complexed with anions as phosphate, citrate and bicarbonate. Under physiological conditions, calcium balance is determined by the relationship between calcium intake and calcium absorption and excretion. Urinary excretion is an important determinant of calcium retention in the body. Decreased total calcium levels can be associated with diseases of the bone apparatus (especially osteoporosis), kidney diseases (especially under dialysis), defective intestinal absorption and hypoparathyroidism. Increased total calcium can be measured in hyperparathyroidism, malignant diseases with metastases and sarcoidosis. Calcium measurements also help in monitoring of calcium supplementation mainly in the prevention of osteoporosis.
Code InfoLot/Serial #(s): 014664503
ClassificationClass III
Reason for RecallHORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect calcium results when using the ABX PENTRA CALCIUM CP reagent.
Product Quantity2,658 units ( 1240 US 1418 OUS )
Recall NumberZ-2280-2013

Class III Food Event

Event ID66302
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Aug-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmShenandoah Growers, Inc.
CityHarrisonburg
StateVA
CountryUS
Distribution PatternProduct was distributed to PA, VA and MD.
 

Associated Products

Product DescriptionFresh Herbs Everyday Basil, Shenandoah Growers brand, packaged in .75 oz; 2 oz.; and 2.5 oz. in 3 count and 6 count cardboard sleeves and labeled in part ***Shenandoah Growers Inc., Harrisonburg, Va 22802***
Code InfoLots: 50 143233; 50 243233; 50343233; and 50 443233
ClassificationClass III
Reason for RecallFresh basil may be adulterated with pesticides.
Product Quantity200 lbs
Recall NumberF-1914-2013
Product DescriptionBasil, fresh, Giant brand, packaged in 2.5 oz. package and labeled in part ***Distributed by FoodHold USA Landover, MD 20785***
Code InfoLots: 50 143233; 50 243233; 50343233; and 50 443233
ClassificationClass III
Reason for RecallFresh basil may be adulterated with pesticides.
Product Quantity200 lbs total
Recall NumberF-1915-2013

Mixed Classification Biologics Event

Event ID65530
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOneBlood, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternSwitzerland; FL
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW036809267543
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2248-13
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036809818928
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2249-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036809267543
ClassificationClass III
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2250-13

Mixed Classification Biologics Event

Event ID65624
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jun-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmOneBlood, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternSwitzerland; Florida; New York
 

Associated Products

Product DescriptionCryoprecipitated AHF
Code Info2642211; W036808137145; W036809172740;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity3
Recall NumberB-2370-13
Product DescriptionPlatelets Leukocytes Reduced
Code InfoW036809154256;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2371-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036808137145; W036809172740; W036809154256;
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity3
Recall NumberB-2372-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036809154256; W036809154710;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-2373-13
Product DescriptionRed Blood Cells
Code Info2642211; W036808137145; W036809172740; W036810117211;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity4
Recall NumberB-2374-13
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036809819555; W036810813443;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-2375-13
Product DescriptionFresh Frozen Plasma
Code InfoW036809154710; W036810117211;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-2376-13
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