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U.S. Department of Health and Human Services

Enforcement Report - Week of September 11, 2013

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Class I Food Event

Event ID63799
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Nov-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmThe Warrell Corporation
CityCamp Hill
StatePA
CountryUS
Distribution PatternProduct was distributed to retailers in DE, FL, GA, MD, MO, NH, NJ, NY, PA, VA, and WV.
 

Associated Products

Product DescriptionChocolate covered raisinsin 4 oz flexible bags labeled in part "***Pennsylvania Dutch Candies***Chocolate Covered Raisins***NET WT 4 OZ (113g)***Packed for Pennsylvania Dutch Candies Camp Hill, PA***Manufactured In A Facility That Also Processes Peanuts***".
Code InfoLot Code: 4832B
ClassificationClass I
Reason for RecallChocolate Covered Peanuts were mislabeled with Chocolate Covered Raisins label; therefore Peanut Allergen is not identified. Affected consignees were contacted in November, 2012.
Product Quantity51 cases/12-4 oz bags per case
Recall NumberF-1864-2013

Class I Food Event

Event ID65032
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Feb-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSaratoga Therapeutics, LLC
CityNorth Wales
StatePA
CountryUS
Distribution PatternProduct was sold through physicians offices and via internet sales to consumers located nationwide and in Canada.
 

Associated Products

Product DescriptionebA*(TM) Multivitamin Supplement, 180 tablets in plastic bottles, Distributed by Saratoga Therapeutics, LLC, North Wales, PA.
Code InfoLot number 0912164, exp 12/12 and 1110354, exp 10/14
ClassificationClass I
Reason for RecallThe recall was initiated due to discovery of the presence of milk components (milk protein(s) and lactose) despite labeling that incorrectly states it is free of milk components.
Product Quantity890 bottles
Recall NumberF-1876-2013

Class I Drugs Event

Event ID65130
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-May-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBeamonstar Products
CityQueen Creek
StateAZ
CountryUS
Distribution PatternUS states nationwide and international.
 

Associated Products

Product DescriptionSexVoltz All Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 and 12 capsule bottles, Manufactured For: BeaMonstar Products, Queen Creek, AZ
Code InfoAll lots of product distributed and sold from January 2012 to May 7, 2013 SKUs: 626570609490, 827912089028, 626570617877, 626570615316, 626570623588
ClassificationClass I
Reason for RecallMarketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug
Product Quantity673,851 capsules
Recall NumberD-929-2013
Product DescriptionVelextra All-Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 & 12 capsule bottles, Manufactured For: BeaMonstar Products Queen Creek, AZ
Code InfoAll lots of product distributed and sold from January 2012 to May 7, 2013. SKUs: SKUs 626570613855, 626570619055, 626570617860, 626570617563
ClassificationClass I
Reason for RecallMarketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug
Product Quantity145,632 capsules
Recall NumberD-930-2013

Class I Food Event

Event ID65497
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jun-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTerrafina
CityBronx
StateNY
CountryUS
Distribution PatternNY, NJ, FL
 

Associated Products

Product Description1) terrafina Natural Roasted Salted Pistachios, Net wt. 2.25 oz(63g) UPC 847938032112, 2) terrafina Natural Roasted Salted Pistachios, Net wt. 10 oz (283g) UPC 8497938103218, 3) terrafina Natural California Salted Pistachios, Net wt. 13 oz (368g) UPC 847938063215, 4) terrafina Natural California Salted Pistachios, Net wt. 18 oz (510 g) UPC 847938032150, 5) terrafina Natural California Salted Pistachios, Net wt. 20 oz (568g) UPC 847938073214), 6) terrafina Natural Roasted Salted Pistachios, Net wt. 7 oz (198g) UPC 847938003211.
Code InfoItem numbers: 1) 3211 with Best before 10/1/2013 to 11/30/13, 2) 9321 with Best before 10/1/2013 to 11/30/13, 3) S321 with Best before 10/1/2013 to 11/30/13, 4) M321 with Best before 10/1/2013 to 11/30/13, 5) L321 with Best before 10/1/2013 to 11/30/13, 6) R321 with Best before 10/1/2013 to 11/30/13
ClassificationClass I
Reason for RecallPotential Salmonella contamination.
Product Quantity3500 pounds
Recall NumberF-1791-2013
Product Description1) terrafina Natural Roasted Unsalted Pistachios, Net wt. 10 oz (283g) UPC 847938103201, 2) terrafina Natural California Unsalted Pistachios, Net wt. 13 oz (368g) UPC 847938063208, 3) terrafina Natural California Unsalted Pistachios, Net wt. 18 oz (510g) UPC 847938032051, 4) terrafina Natural California Unsalted Pistachios, Net wt. 20 oz (567 g) UPC 847938073207, 5) terrafina Natural California Unsalted Pistachios, Net wt. 7 oz (198g) UPC 847938003204.
Code InfoItem numbers: 1) 9320 with Best before 7/1/2013 to 1/31/14, 2) S320 with Best before 7/1/2013 to 1/31/14, 3) M320 with Best before 7/1/2013 to 1/31/14, 4) L320 with Best before 7/1/2013 to 1/31/14, 5) R320 with Best before 7/1/2013 to 1/31/14
ClassificationClass I
Reason for RecallPotential Salmonella contamination.
Product Quantity5250 pounds
Recall NumberF-1792-2013

Class I Food Event

Event ID65906
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Aug-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmZip International Group LLC.
CityEdison
StateNJ
CountryUS
Distribution PatternNY
 

Associated Products

Product DescriptionBaltic Sprats in Spicy Brine Net Wt. 15.8 oz. Prod. of Latvia Distributed by Zip International Group LLC 160 Raritan Center Parkway Unit #6 Edison NJ 08837 T 732-225-3600 UPC 4750217602547
Code Info12-10-2013
ClassificationClass I
Reason for RecallBaltic Sprats in Spicy Brine may be contaminated with Listeria monocytogenes.
Product Quantity50 cases
Recall NumberF-1865-2013

Class I Food Event

Event ID65956
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Aug-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmDove Chocolate Discoveries Llc
CityMount Arlington
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionDove Chocolate Discoveries Fruit Collection Dark Chocolate - Covered Cranberries, Blueberries, Cherries Net Wt. 18 oz. Distributed by Dove Chocolate Discoveries, LLC A subsidiary of Mars, Incorporated Hackettstown, NJ 07840-1503 USA Item #3265D Each 18 oz box of mislabeled Fruit Collection contains two clear 8 oz polypropylene bags, labeled DK CINN ALMOND .
Code Infolot code 317DAIDS01 Each 18 oz box of mislabeled Fruit Collection contains two clear 8 oz polypropylene bags, labeled DK CINN ALMOND . The interior polypropylene bags are stamped with lot code 308 BC4CP02 which reflects the co-packer of the 8 oz bags (Cano acquired by Coregistics, Wheeling, IL 60090).
ClassificationClass I
Reason for RecallCinnamon Dusted Dark Chocolate Almonds (Item Number: 3059D) were packaged in boxes labeled Fruit Collection (Item Number: 3265D), a mix of Dark Chocolate-Covered Cranberries, Blueberries, and Cherries.
Product QuantityEighteen boxes
Recall NumberF-1871-2013

Class I Food Event

Event ID66085
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Aug-13
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmConagra Inc
CityOmaha
StateNE
CountryUS
Distribution PatternDistribution was made to: Alabama, Alaska, Arizona, California, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Michigan, Missouri, Montana, Nebraska, Nevada, New Mexico, North Carolina, Ohio, Oregon, South Carolina, Tennessee, Utah, Virginia, Washington, West Virginia and Wyoming.
 

Associated Products

Product DescriptionKroger Break 'N Bake Chocolate Chip Cookie Dough, refrigerated dough, packaged in 16.0 oz. plastic package.
Code InfoDate code: 24NOV13C21
ClassificationClass I
Reason for RecallPeanut Butter Cup Cookie Dough (refrigerated) is packaged in Chocolate Chip Cookie Dough packaging. Peanuts or peanut butter are not listed on the ingredient list or allergen statement.
Product Quantity1,073 /8/16 oz package/cases
Recall NumberF-1866-2013

Class II Biologics Event

Event ID38573
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Jun-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTri-Counties Blood Bank dba UBS- Central Coast
CitySanta Barbara
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoFZ84753; FZ67148
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity2 units
Recall NumberB-1848-13

Class II Biologics Event

Event ID43282
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Oct-06
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSouthern California Permanente Medical Group Blood Donor Center
CityIrvine
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoKX01047
ClassificationClass II
Reason for RecallBlood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-1684-13
Product DescriptionFresh Frozen Plasma
Code InfoKX01047
ClassificationClass II
Reason for RecallBlood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-1685-13

Class II Biologics Event

Event ID52869
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Mar-09
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCsl Plasma
CityDayton
StateOH
CountryUS
Distribution PatternIL, Germany
 

Associated Products

Product DescriptionSource Plasma
Code Info4080307345, 4080304707, 4080302925, 4080302592, 4080301045, 4080300255, 4080299405, 4080298897, 4080297920, 4080297374, 4080296503, 4080294636, 4080293921, 4080292719, 4080291766, 4080290587, 4080289563, 4080288528, 4080287610, 4080286781, 4080285527, 4080284898, 4080283608, 4080282639, 4080281633, 4080280750, 4080279432, 4080278202, 4080277455, 4080276135, 4080275539, 4080274005, 4080273426, 4080272017, 4080271214, 4080269965, 4080269311, 4080267965, 4080267509, 4080265741, 4080265152, 4080263595, 4080263070, 4080261722, 4080261025, 4080259133, 4080257782, 4080257083, 4080255635, 4080254972, 4080253554, 4080252990, 4080251596, 4080250968, 4080249611, 4080248202, 4080247456, 4080246108, 4080245334, 4080244206, 4080243261, 4080242314, 4080241356, 4080240241, 4080239230, 4080238501, 4080237421, 4080236454, 4080235314, 4080234406, 4080233427, 4080230677, 4080229940, 4080228753, 4080226819, 4080225993, 4080225136, 4080224240
ClassificationClass II
Reason for RecallBlood products, collected from a donor who did not have a complete physical examination, were distributed.
Product Quantity78 units
Recall NumberB-2278-13

Class II Biologics Event

Event ID52874
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-May-08
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCSL Plasma, Inc.
CityDayton
StateOH
CountryUS
Distribution PatternIllinois, Germany
 

Associated Products

Product DescriptionSource Plasma
Code Info4080230278, 4080227918, 4080221282, 4080216664, 4080215290, 4080214606, 4080213281, 4080212687, 4080207359, 4080206207, 4080202459, 4080201975, 4080199969, 4080197473, 4080196893, 4080180169, 4080170428, 4080167977, 4080167627
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity19 units
Recall NumberB-2277-13

Class II Biologics Event

Event ID55593
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Feb-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCsl Plasma Inc
CityTempe
StateAZ
CountryUS
Distribution PatternIllinois, Germany, Switzerland.
 

Associated Products

Product DescriptionSource Plasma
Code Info0481339420 0481187078 0481187843 0481190303 0481193163 0481194078 0481196270 0481197223 0481199788 0481201648 0481203129 0481204842 0481206527 0481208049 0481209704 0481211349 0481215561 0481216908 0481222347 0481224106 0481225744 0481232998 0481234244 0481238148 0481238941 0481241888 0481243843 0481245817 0481247374 0481249476 0481252118 0481253347 0481255700 0481256776 0481259566 0481260471 0481263204 0481264353 0481269330 0481270059 0481275956 0481277763 0481281134 0481286536 0481287435 0481293164 0481294166 0481296600 0481297433 0481299805 0481300688 0481306049 0481306855 0481309181 0481310231 0481312385 0481313382 0481315586 0481316355 0481318776 0481319628 0481322889 0481323890 0481336417 0481338013
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 Quantity65 units
Recall NumberB-2039-13

Class II Devices Event

Event ID64937
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDePuy Spine, Inc.
CityRaynham
StateMA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) including AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV and WY; and internationally to: Algeria, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, France, Germany, Hong Kong, India, Israel, Italy, Latvia, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UAE and UK.
 

Associated Products

Product DescriptionCONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.
Code InfoHPBBZP, HPDBFZ
ClassificationClass II
Reason for RecallDuring injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.
Product Quantity3896 units (Overall quantity distributed appears greater than quantities manufactured due to the distribution pathways)
Recall NumberZ-2132-2013
Product DescriptionCONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures
Code InfoHPBB0K, HPBB3C,HPCB7J, HPDBD6, HPBB0L,HPBB3D,HPCB7W,HPDBF0, HPBB0M,HPBB3F,HPDBBC,HPDBG4, HPBB0N,HPBBWH,HPDBBD,HPDBGB, HPBB0P,HPBBWJ,HPDBBK,HPDBGC,HPBB0T,HPBBWL,HPDBBL,HPDBGJ, HPBB19,HPBBZ8,HPDBBY,HPDBGM,HPBB27,HPBBZD,HPDBCD,HPDBGN, HPBB29,HPBBZN,HPDBCF, HPDBGY,HPBB2B,HPCB7B,HPDBD0,HPBB2C, HPCB7C,HPDBD3,HPBB2G,HPCB7H,HPDBD4
ClassificationClass II
Reason for RecallDuring injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.
Product Quantity3896 units (Overall quantity distributed appears greater than quantities manufactured due to the distribution pathways)
Recall NumberZ-2133-2013
Product DescriptionCONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.
Code InfoHPBB0B, HPBBWM, HPCB75, HPCCBN, HPBB0R, HPBBWP, HPCB7D, HPDBBV, HPBB28, HPBBZ7, HPCB7F, HPDBCG, HPBB2D, HPBBZF, HPCB7T, HPDBD1, HPBB2F, HPBCKH, HPCB7V, HPDBD5, HPBB4R, HPBDL9, HPCB8G, HPDBF9, HPBBV1, HPCB67, HPCBLC, HPDBGH, HPBBWG, HPCB68, HPCBM1, HPDBGK, HPBBWK, HPCB74, HPCCBM, HPDBGL
ClassificationClass II
Reason for RecallDuring injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.
Product Quantity3896 units (Overall quantity distributed appears greater than quantities manufactured due to the distribution pathways)
Recall NumberZ-2134-2013

Class II Biologics Event

Event ID65016
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jan-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmOneBlood / dba CBCF
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW036812635828- part A; W036812635828- part B
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity2 units
Recall NumberB-1898-13

Class II Biologics Event

Event ID65294
StatusCompleted
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Feb-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Center of the Ozarks
CitySpringfield
StateMO
CountryUS
Distribution PatternSwitzerland; North Carolina; Austria; Missouri; Arkansas
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045112354865; W045112346756; W045111266101; W045110206835; W045110186065; W045110168815; W045110128425; W045109111941;
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity8 units
Recall NumberB-2173-13
Product DescriptionRed Blood Cells
Code Info7042343; 7022228; 6955463
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity3 units
Recall NumberB-2174-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW045112354865; W045112346756; W045111266101; W045110206835; W045110186065; W045110168815; W045110128425; W045109111941; 7042343; 7022228; 6955463
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity11 units
Recall NumberB-2175-13

Class II Biologics Event

Event ID65305
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-May-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionRed Blood Cells
Code Info2436253
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2155-13

Class II Biologics Event

Event ID65307
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-May-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLake Worth
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionPlatelets
Code Info2559582
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity1 unit
Recall NumberB-2170-13
Product DescriptionRed Blood Cells
Code Info2559582; 2366969; 2251960
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity3 units
Recall NumberB-2171-13
Product DescriptionFresh Frozen Plasma
Code Info2559582; 2551960;
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity2 units
Recall NumberB-2172-13

Class II Biologics Event

Event ID65323
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFlorida's Blood Centers - Lake Park
CityPalm Beach Gardens
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW038113040525
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-2156-13

Class II Food Event

Event ID65325
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-May-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmContoocook Creamery
CityContoocook
StateNH
CountryUS
Distribution PatternNH only. No foreign distribution.
 

Associated Products

Product DescriptionButter (salted). 8oz round clear plastic tub and 5 gallon pail. UPC Code 7 93573 09802 3.
Code InfoN/A
ClassificationClass II
Reason for RecallElevated coliform and standard plate count.
Product Quantityquantity unknown
Recall NumberF-1859-2013

Class II Biologics Event

Event ID65336
StatusCompleted
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Jan-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmData Innovations, Inc.
CitySouth Burlington
StateVT
CountryUS
Distribution PatternNationwide.
 

Associated Products

Product DescriptionData Innovations Instrument Manager Software Any version of Instrument Manager using the Roche Cobas e411 (rche411) driver versions 8.00.0001 or v8.00.002
Code Info Roche Cobas e411 (rche411) driver versions 8.00.0001 or v8.00.002
ClassificationClass II
Reason for RecallLaboratory software, with a defect or glitch, was distributed.
Product Quantity1
Recall NumberB-2265-13

Class II Biologics Event

Event ID65340
StatusCompleted
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmData Innovations, Inc.
CitySouth Burlington
StateVT
CountryUS
Distribution PatternNationwide; Canada
 

Associated Products

Product DescriptionData Innovations Instrument Manager software Model - Versions 8.12.01
Code InfoSoftware Version: 8.12.01
ClassificationClass II
Reason for RecallLaboratory software, with a defect or glitch, was distributed.
Product Quantity1
Recall NumberB-2299-13

Class II Biologics Event

Event ID65346
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOneBlood, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code Info2565869;
ClassificationClass II
Reason for RecallBlood products, collected from an inelgibile donor, were distributed.
Product Quantity1 unit
Recall NumberB-2230-13
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code Info2922847;
ClassificationClass II
Reason for RecallBlood products, collected from an inelgibile donor, were distributed.
Product Quantity1 unit
Recall NumberB-2231-13
Product DescriptionRed Blood Cells
Code Info2565869; 2514057;
ClassificationClass II
Reason for RecallBlood products, collected from an inelgibile donor, were distributed.
Product Quantity2 units
Recall NumberB-2232-13

Class II Biologics Event

Event ID65454
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Apr-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeShare Blood Centers
CityShreveport
StateLA
CountryUS
Distribution PatternLouisiana; Texas
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036513020524; W036512129435; W036512096702
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity3 units
Recall NumberB-2267-13

Class II Devices Event

Event ID65485
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGenzyme Corporation, A Sanofi Company
CityWoburn
StateMA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.
 

Associated Products

Product DescriptionLeGoo® Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula Pouch Product Number: CS-25 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
Code InfoAll lot codes
ClassificationClass II
Reason for RecallProduct contains particulates (fibers)
Product Quantity30 units
Recall NumberZ-2139-2013
Product DescriptionLeGoo® Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch Product Number: CS-50 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
Code InfoAll lot codes
ClassificationClass II
Reason for RecallProduct contains particulates (fibers)
Product Quantity65 units
Recall NumberZ-2140-2013
Product DescriptionLeGoo® Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch Product Number: CS-100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
Code InfoAll lot codes
ClassificationClass II
Reason for RecallProduct contains particulates (fibers)
Product Quantity100 units
Recall NumberZ-2141-2013
Product DescriptionLeGoo® Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula Product Number: PV-50 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
Code InfoAll lot codes
ClassificationClass II
Reason for RecallProduct contains particulates (fibers)
Product Quantity5 units
Recall NumberZ-2142-2013
Product DescriptionLeGoo® Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula Product Number: PV-100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
Code InfoAll lot codes
ClassificationClass II
Reason for RecallProduct contains particulates (fibers)
Product Quantity45 units
Recall NumberZ-2143-2013
Product DescriptionLeGoo® Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula Product Number: PV-250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
Code InfoAll lot codes
ClassificationClass II
Reason for RecallProduct contains particulates (fibers)
Product Quantity250 units
Recall NumberZ-2144-2013
Product DescriptionLeGoo® Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch Product Number: LG50 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
Code InfoAll lot codes
ClassificationClass II
Reason for RecallProduct contains particulates (fibers)
Product Quantity660 units
Recall NumberZ-2145-2013
Product DescriptionLeGoo® Endovascular Occlusion Gel- 1.0 mL LeGoo with 3 Cannula Pouch Product Number: LG100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
Code InfoAll lot codes
ClassificationClass II
Reason for RecallProduct contains particulates (fibers)
Product Quantity994 units
Recall NumberZ-2146-2013
Product DescriptionLeGoo® Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch Product Number: LG250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
Code InfoAll lot codes
ClassificationClass II
Reason for RecallProduct contains particulates (fibers)
Product Quantity181 units
Recall NumberZ-2147-2013
Product DescriptionLeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
Code InfoAll lot codes
ClassificationClass II
Reason for RecallProduct contains particulates (fibers)
Product Quantity448 units
Recall NumberZ-2148-2013
Product DescriptionLeGoo Internal Vessel Occluder .5mL Product Number: 10-0050 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
Code InfoAll lot codes
ClassificationClass II
Reason for RecallProduct contains particulates (fibers)
Product Quantity776 units
Recall NumberZ-2149-2013
Product DescriptionLeGoo Internal Vessel Occluder 1mL Product Number: 10-0100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
Code InfoAll lot codes
ClassificationClass II
Reason for RecallProduct contains particulates (fibers)
Product Quantity652 units
Recall NumberZ-2150-2013
Product DescriptionLeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
Code InfoAll lot codes
ClassificationClass II
Reason for RecallProduct contains particulates (fibers)
Product Quantity331 units
Recall NumberZ-2151-2013
Product DescriptionLeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
Code InfoAll lot codes
ClassificationClass II
Reason for RecallProduct contains particulates (fibers)
Product Quantity308 units
Recall NumberZ-2152-2013
Product DescriptionLeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
Code InfoAll lot codes
ClassificationClass II
Reason for RecallProduct contains particulates (fibers)
Product Quantity37 units
Recall NumberZ-2153-2013
Product DescriptionLeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
Code InfoAll lot codes
ClassificationClass II
Reason for RecallProduct contains particulates (fibers)
Product Quantity110 units
Recall NumberZ-2154-2013
Product DescriptionLeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
Code InfoAll lot codes
ClassificationClass II
Reason for RecallProduct contains particulates (fibers)
Product Quantity220 units
Recall NumberZ-2155-2013
Product DescriptionLeGoo Endovascular Occlusion Gel 2.5 mL Product Number: LG250IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
Code InfoAll lot codes
ClassificationClass II
Reason for RecallProduct contains particulates (fibers)
Product Quantity100 units
Recall NumberZ-2156-2013

Class II Biologics Event

Event ID65537
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Apr-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross, Penn-Jersey Region
CityPhiladelphia
StatePA
CountryUS
Distribution PatternPennsylvania; New Jersey
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info022LL72748; 022LL72748;
ClassificationClass II
Reason for RecallBlood product, mislabeled as leukoreduced, was distributed.
Product Quantity2 units
Recall NumberB-2273-13

Class II Biologics Event

Event ID65538
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-13
Initial Firm Notification of Consignee or Public Other
Recalling FirmBlood Systems, Inc. dba United Blood Services Texas
CityEl Paso
StateTX
CountryUS
Distribution PatternSwitzerland
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW041111105120G;
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity1 unit
Recall NumberB-1831-13

Class II Biologics Event

Event ID65599
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Apr-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmUniversity Of Miami Miller School of Medicine Tissue Bank
CityMiami
StateFL
CountryUS
Distribution PatternMississippi; Puerto Rico; Maryland; Florida; Guatemala; New York
 

Associated Products

Product DescriptionBone
Code Info0111510146; 0111510147; 0111510148; 0111510131; 0111510132; 0111510133; 0111510134; 0111510135; 0111510136; 0111510137; 0111510138; 0111510139; 0111510140; 0111510066; 0111510068; 0111510070; 0111510071; 0111510072; 0111510073; 0111510074; 0111510075; 0111510076; 0111510077; 0111510078; 0111510079; 0111510080; 0111510081; 0111510082; 0111510083; 0111510091; 0111510096; 0111510097; 0111510098; 0111510099; 0111510100; 0111510101; 0111510102; 0111510103; 0111510104; 0111510105; 0111510106; 0111510107; 0111510108; 0111510109; 0111510110; 0111510111; 0111510112; 0111510113; 0111510114; 0111510115; 0111510121; 0111510123; 0111510150; 0111510152; 0111510153; 0111510154; 0111510119; 0111510149; 0112840072; 0112840073; 0112840074; 0112840075; 0112840076; 0112840077; 0112840078; 0112840080; 0112840081; 0112840086; 0112840082; 0112840085;
ClassificationClass II
Reason for RecallHuman tissue allografts, associated with positive culture results, were distributed.
Product Quantity70 bone allografts
Recall NumberB-2183-13

Class II Food Event

Event ID65811
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jul-13
Initial Firm Notification of Consignee or Public Visit
Recalling FirmTortilleria Lupita, Inc.
CityOklahoma City
StateOK
CountryUS
Distribution PatternOK
 

Associated Products

Product DescriptionTortillas Lupita Flour Tortillas, Net Wt. 23oz, Manufactured By Tortilleria Lupita, 235 SW 25th St., Oklahoma City, OK 73109
Code InfoAll product still on the retail store shelf.
ClassificationClass II
Reason for RecallThe product is being recalled for undeclared soy lecithin and soybean oil.
Product Quantity154 cases
Recall NumberF-1863-2013

Class II Devices Event

Event ID65823
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jun-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmStelkast Co
CityMcmurray
StatePA
CountryUS
Distribution PatternNationwide Distribution including TX, VA, OK, and PA
 

Associated Products

Product DescriptionSC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.
Code InfoPart number SC2316-3-5 with lot number 22389-111609. Part number SC2316-4-5 with lot number 22587-111609. Part number SC2316-5-5 with lot number 23214-111609.
ClassificationClass II
Reason for RecallThe firm became aware of an incident relating to a breach of sterility in the sterility barrier packaging of SC2316, Distal Femoral Augment with Screw.
Product Quantity11
Recall NumberZ-2136-2013

Class II Devices Event

Event ID65868
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics
CityTarrytown
StateNY
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) Puerto Rico and internationally to Argentina, Austria, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hungary, Indonesia, Italy, Kazakhstan, Lithuania, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, South Africa, South Korea, Thailand, Turkey, Uruguay, Vatican City, and Vietnam.
 

Associated Products

Product DescriptionADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or unit package: Level 1: 2 x 0.5 g; Level 2: 2 x 0.5 g; Level 3: 2 x 0.5 g; Level 4: 2 x 0.5 g -- Siemens Healthcare Diagnostics, Inc. Tarrytown, NY 10591 --- System Information: The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use. For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA® Chemistry systems.
Code InfoLots 1MD014 (exp. date 5/01/2013), 1BD063 (exp. 5/01/2013), 2GD014 (exp. 10/01/2014)
ClassificationClass II
Reason for RecallSiemens confirmed that the ADVIA® Chemistry Systems HbA1c method exhibits a positive bias of up to 12% for patient and CAP survey samples due to over-recovery when using A1c_3 Calibrator lots 1MD014, 1BD063, and 2GD014. The established ranges of CAP Survey Samples GH2-04, GH2-05 and GH2-06 and IFCC sample recoveries use ± 7% from the established mean as their acceptance criteria. This is the criterion that was used during testing to confirm the customer complaints. Depending upon quality control limits this issue may not have been detected..
Product QuantityUS: 1546 units; Foreign: 518 units
Recall NumberZ-2135-2013

Class II Devices Event

Event ID65919
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBoston Scientific Corporation
CityMaple Grove
StateMN
CountryUS
Distribution PatternWorldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV,NH,NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC,SC, TN, TX, UT, VA, WA, WV, and WI. Internationally to Algeria, Finland, Japan, Spain, Australia, France, Latvia, Sweden, Austria, Germany, Netherlands, Switzerland, Belgium, Great Britain, Norway, Taiwan, Brazil, Greece, Panama, Turkey, Canada, Hong Kong, Poland, Unit.Arab Emir., China, India, Russian Fed., Colombia, Ireland, Saudi Arabia, Czech Republic, Israel, South Africa, Denmark, Italy, and South Korea.
 

Associated Products

Product DescriptionBoston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae. 1) 4.00mm x 15mm Small Peripheral Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #001BPM4015140F0, Catalogue # BPM4015140F & UPN # M001PCBM4015140F0, Catalogue # PCBM4015140F. 2) 4.00mm x 15mm Small Peripheral Cutting BalloonTM Over-the-Wire Microsurgical Dilatation Device, UPN # M001PCBO4015140F0, Catalogue # PCBO4015140F.
Code InfoUPN # 001BPM4015140F0, Catalogue #BPM4015140F. Lot#'s 15778169, 15735527, 15774378, 15788826, 15812347, 15824636, 15825277, 15836626, 15873338, 15891705, 15931291, 15945240, 16057260. UPN# M001PCBM4015140F0, Catalogue #PCBM4015140F, Lot #15756145. UPN # M001PCBO4015140F0, Catalogue #PCBO4015140F, Lot #'s 15688199, 15992736, 16066536, 16141255.
ClassificationClass II
Reason for RecallBoston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilation Devices. Boston Scientific has determined that users may experience significant difficulty or inability to remove the protector cap from the device which may result in damage to the device.
Product Quantity1,331
Recall NumberZ-2137-2013
Product DescriptionBoston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #H749CBM3400150 Catalogue # CBM340015 & UPN# H749RB4400150 Catalogue # RB440015 2) 4.00mm x 15mm FlextomeTM Cutting BalloonTM Over-the-Wire Microsurgical Dilatation Device, UPN # H749CBO3400150, Catalogue # CBO340015 The Flextome Cutting Balloon Device is indicated for dilatation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered. In addition, the target lesion should possess the following characteristics: " Discrete (< 15 mm in length), or tubular (10 to 20 mm in length) " Reference vessel diameter (RVD) of 2.00 mm - 4.00 mm " Readily accessible to the device " Light to moderate tortuosity of proximal vessel segment " Nonangulated lesion segment (< 45°) " Smooth angiographic contour " Absence of angiographically visible thrombus and/or calcification.
Code InfoUPN # Catalogue # Lot # H749CBM3400150 CBM340015 15777251, 15898645, 16125358. H749RB4400150 RB440015 15780571. H749CBO3400150 CBO340015 15854224.
ClassificationClass II
Reason for RecallBoston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilation Devices. Boston Scientific has determined that users may experience significant difficulty or inability to remove the protector cap from the device which may result in damage to the device.
Product Quantity340
Recall NumberZ-2138-2013

Class II Drugs Event

Event ID65959
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Aug-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTeva Pharmaceuticals USA, Inc.
CitySellersville
StatePA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionCARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11
Code InfoLot 31314458B, 31314459B exp.08/14, 31315794 exp. 10/14, 31315982B exp.11/14
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
Product Quantity780 vials
Recall NumberD-928-2013

Class II Devices Event

Event ID66029
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Aug-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMicroAire Surgical Instruments, LLC
CityCharlottesville
StateVA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and internationally to Australia, Ireland, Canada, Netherlands, Sweden, Japan, and United Kingdom.
 

Associated Products

Product DescriptionSteinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-509 1620-509 1640-509 1620-609 1648-509 1620-709 1648-509T 1624-109 1648-609 1624-509 1648-609T 1624-509T 1628-509 1632-509 1632-609 A smooth or threaded wire / pin that may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Code InfoProduct # Lot Number 1620-109 0213216244 1620-109 0213216804 1620-109 0313217447 1620-109 0413219296 1620-109 0413219479 1620-109 0613222208 1620-509 0213216077 1620-509 0213216598 1620-509 0213216740 1620-509 0313217912 1620-509 0313217980 1620-509 0413219446 1620-509 0413219514 1620-509 0513220340 1620-509 0613222209 1620-509 0613222677 1620-509 0613222950 1620-609 0213216021 1620-609 0213216987 1620-609 0313218036 1620-609 0413218860 1620-709 0313217801 1620-709 0413218861 1620-709 0513220659 1620-709 0613222204 1620-709 0613222465 1620-709 0613223531 1620-709 0713224375 1624-109 0213216721 1624-109 0313218583 1624-109 0413219836 1624-109 0413219934 1624-109 0613222761 1624-109 0713223840 1624-509 0213216018 1624-509 0213217203 1624-509 0313217576 1624-509 0313218461 1624-509 0413219480 1624-509T 0213215841 1628-509 0213217207 1628-509 0413219845 1628-509 0513220335 1628-509 0513220422 1628-509 0613222210 1632-509 0213216079 1632-509 0213216820 1632-509 0313218668 1632-509 0313218715 1632-509 0513220951 1632-509 0613222467 1632-509 0613223364 1632-609 0413219600 1636-509 0313218458 1636-509 0413218937 1640-509 0213216975 1640-509 0213216985 1640-509 0313217640 1640-509 0313217911 1640-509 0413219741 1640-509 0413219936 1640-509 0513220770 1648-509 0213216078 1648-509T 0213216803 1648-609 0213216295 1648-609 0513221947 1648-609T 0413220144
ClassificationClass II
Reason for RecallA medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility
Product Quantity15786 total units
Recall NumberZ-2158-2013
Product DescriptionKirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-509 1620-509 1640-509 1620-609 1648-509 1620-709 1648-509T 1624-109 1648-609 1624-509 1648-609T 1624-509T 1628-509 1632-509 1632-609 A smooth or threaded wire / pin that may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Code InfoProduct # Lot Number 1600-020 0213215913 1600-020 0413220145 1600-020 0513220342 1600-020 0513220769 1600-020 0513220952 1600-020 0513221114 1600-020 0513221302 1600-020 0513221825 1600-020 0613222383 1600-020 0613222462 1600-021 0213216019 1600-021 0213217287 1600-021 0413218802 1600-021 0413219838 1600-021 0513220423 1600-021 0513220876 1600-021 0513221009 1600-021 0513221948 1600-021 0613222759 1600-022 0213215911 1600-022 0213216599 1600-022 0213217105 1600-022 0313217635 1600-022 0313217978 1600-022 0313218584 1600-022 0413218936 1600-022 0413219297 1600-022 0413219980 1600-022 0513220829 1600-022 0513221303 1600-022 0613222034 1600-022 0613222678 1600-022 0613223243 1600-022 0713223715 1600-023 0213216601 1600-023 0213217285 1600-023 0313217910 1600-023 0313218074 1600-023 0313218484 1600-023 0413218804 1600-023 0413219743 1600-023 0413220193 1600-023 0513220503 1600-023 0513221006 1600-023 0513221626 1600-023 0613222540 1600-023 0613222904 1600-023 0613223365 1600-023 0713223833 1600-428 0213217031 1600-428 0313217802 1600-428 0413218859 1600-428 0513220955 1600-428 0513221177 1600-428 0513221823 1600-435 0213216017 1600-435 0213216556 1600-435 0313217847 1600-435 0313218304 1600-435 0313218674 1600-435 0413219524 1600-435 0513220338 1600-435 0513220771 1600-435 0513221437 1600-435 0613222206 1600-435 0613222830 1600-445 0213216300 1600-445 0213217030 1600-445 0313217486 1600-445 0313217982 1600-445 0313218460 1600-445 0413218932 1600-445 0413219482 1600-445 0413220192 1600-445 0513220767 1600-445 0513221373 1600-445 0513221949 1600-445 0613222384 1600-445 0613222829 1600-445 0613223467 1600-454 0213216405 1600-454 0213216976 1600-454 0213217206 1600-454 0313217485 1600-454 0313218485 1600-454 0413219153 1600-454 0413219846 1600-454 0513221175 1600-462 0213216245 1600-462 0213216743 1600-462 0213217289 1600-462 0313218035 1600-462 0313218589 1600-462 0413219157 1600-462 0413219981 1600-462 0513220875 1600-462 0513221558 1600-462 0613222281 1600-462 0613222902 1600-462 0613223525 1600-462T 0213217106 1600-462T 0413219602 1600-462T 0513221557 1600-628 0213216299 1600-628 0213216404 1600-628 0213217108 1600-628 0313217913 1600-628 0313218671 1600-628 0413219298 1600-628 0513221436 1600-635 0213216081 1600-635 0213216555 1600-635 0213217142 1600-635 0313217846 1600-635 0313218459 1600-635 0413219158 1600-635 0413219525 1600-635 0513220425 1600-635 0513220954 1600-635 0513221729 1600-635 0613222381 1600-635 0613222869 1600-635 0613223527 1600-645 0213216080 1600-645 0213216451 1600-645 0213216984 1600-645 0313217353 1600-645 0313217848 1600-645 0313218076 1600-645 0313218305 1600-645 0313218669 1600-645 0313218716 1600-645 0413219160 1600-645 0413219448 1600-645 0413219742 1600-645 0413219951 1600-645 0413220146 1600-645 0513220590 1600-645 0513220953 1600-645 0513221372 1600-645 0513221561 1600-645 0513221822 1600-645 0613222033 1600-645 0613222463 1600-645 0613222541 1600-645 0613222953 1600-645 0613223244 1600-645 0713223634 1600-645T 0213216742 1600-645T 0313218704 1600-645T 0413219599 1600-645T 0413219841 1600-645T 0613222203 1600-654 0213216746 1600-654 0213217104 1600-654 0313217803 1600-654 0313218585 1600-654 0413219516 1600-654 0413220142 1600-654 0513220336 1600-654 0513221624 1600-654 0613222464 1600-662 0213216400 1600-662 0213216517 1600-662 0213217005 1600-662 0213217205 1600-662 0313217759 1600-662 0313218160 1600-662 0313218673 1600-662 0413219098 1600-662 0413219603 1600-662 0413219974 1600-662 0513220657 1600-662 0513221435 1600-662 0513221728 1600-662 0613222123 1600-662 0613222760 1600-662 0613223180 1600-662 0713224021 1600-662T 0213216741 1600-662T 0213217204 1600-662T 0313218037 1600-662T 0313218283 1600-662T 0313218706 1600-662T 0413218858 1600-662T 0413219447 1600-662T 0413219839 1600-662T 0513220341 1600-662T 0613222382 1600-662T 0613222680 1600-662T 0613223281 1600-935 0213216729 1600-935 0313217478 1600-935 0313218281 1600-935 0413218862 1600-935 0513220660 1600-9355 0213216016 1600-9355 0413219601 1600-935T 0213217288 1600-945 0213216020 1600-945 0213216726 1600-945 0213217208 1600-945 0313218075 1600-945 0313218703 1600-945 0413219154 1600-945 0413219840 1600-945 0513220424 1600-945 0513220702 1600-945 0513221176 1600-945 0613222279 1600-945 0613222881 1600-945 0613223477 1600-9455 0213216727 1600-9455 0213217143 1600-9455 0613222278 1600-9455 0613222380 1600-954 0313217578 1600-954 0313218705 1600-954 0413219844 1600-954 0513220339 1600-954 0513220570 1600-9545 0313217371 1600-9545 0513220337 1600-9545 0513220877 1600-9545 0513221007 1600-962 0213216298 1600-962 0213216747 1600-962 0213217107 1600-962 0313217909 1600-962 0313218297 1600-962 0413219159 1600-962 0413219935 1600-962 0513220701 1600-962 0513221174 1600-962 0613222205 1600-962 0613222679 1600-962 0613223088 1600-9625 0213216596 1600-9625 0313218284 1600-9625 0413219295 1600-9625 0513220703 1600-9625 0513221005 1600-9625 0513221623 1600-9625 0613222280 1600-962T 0213216553 1600-962T 0313217649 1600-962T 0313217845 1600-962T 0313218280 1600-962T 0313218672 1600-962T 0413219740 1600-962T 0413219843 1600-962T 0413220143 1600-962T 0513220571 1600-962T 0513220874 1600-962T 0513221218 1600-962T 0613222207 1604-145 0213216554 1604-145 0213216988 1604-145 0313218670 1604-145 0413219097 1604-145 0413219837 1604-145 0513220334 1604-145 0513220504 1604-145 0513221820 1604-145 0613223277 1604-145 0613223362 1604-145 0713223841 1604-154 0413219984 1604-162 0213216745 1604-162 0313217579 1604-162 0313218667 1604-162 0313218714 1604-162 0413218801 1604-162 0413218857 1604-162 0413219842 1604-162 0513221173 1604-162 0613222212 1604-162 0613222282 1604-162 0613222675 1604-162 0613222832 1604-162 0713223956
ClassificationClass II
Reason for RecallA medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility
Product Quantity15786 total units
Recall NumberZ-2159-2013

Class II Veterinary Event

Event ID66042
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jun-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmWedgewood Village Pharmacy, Inc.
CitySwedesboro
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionPentosan Polysulfate Sodium (K9) 150 mg/ml aqueous solution for injection, for Veterinary Use only 10 mL Sterile amber vials Refrigerated Storage required. Item Code PENTOS-INJ007VC This preparation is dispensed with a prescription label, so each vial would be individually labeled with specific information containing not only the drug name, strength, etc. but also the patient name, prescriber name, and directions for use.
Code InfoLot number 20130618@409, Beyond Use Date 12/15/2013
ClassificationClass II
Reason for RecallRoutine endotoxin testing of this batch indicated that the finished injection solution contained a concentration of endotoxins exceeding established endotoxin concentration limits. A second sample tested from this same lot confirmed the higher than expected endotoxin concentration.
Product Quantity34 units
Recall NumberV-312-2013

Class II Devices Event

Event ID66048
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Aug-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmElekta, Inc.
CityAtlanta
StateGA
CountryUS
Distribution PatternNationwide distribution: AL, CT, FL, GA, IA, MS, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA and Puerto Rico.
 

Associated Products

Product DescriptionDMLC IV-ERGO - Beam shaping block for Radiation Therapy.
Code InfoEM-042, EM7-004, EM-046, EM-060, EM-047, EM-029, EM7-003, EM7-002, EM7-008, EM-062, EM-063, EM3-004, 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116068, 116013, 116046
ClassificationClass II
Reason for RecallClinical mistreatment may occur when there are errors in the clinical work flow.
Product Quantity31
Recall NumberZ-2157-2013

Class II Food Event

Event ID66146
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Aug-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmThe Seafood Exchange Of Fla
CityRaleigh
StateNC
CountryUS
Distribution PatternTX
 

Associated Products

Product DescriptionH-E-B Jumbo Butterfly Shrimp-10.5 oz Box, 20 units per case
Code InfoProduct marked with "BEST BY 23APR2014"
ClassificationClass II
Reason for RecallCartons of this product have been found to contain coconut shrimp. Coconut is not listed as an ingredient.
Product Quantity190 cases delivered to H-E-B warehouses
Recall NumberF-1870-2013

Class III Biologics Event

Event ID40401
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Jun-05
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBiomat USA, Inc.
CityMesa
StateAZ
CountryUS
Distribution PatternSpain
 

Associated Products

Product DescriptionSource Plasma
Code Info0210062043 0210062481 0210063444 0210063852 0210064554 0210064603 0210065081 0210065608 0210065837 0210066266 0210066480 0210067362 0210067724 0210067973 0210068300 0210068633 0210068854 0210069332 0210069618 0210070022 0210070334 0210070650 0210070994 0210071289
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate were not adequately determined, were distributed.
Product Quantity24 units
Recall NumberB-2197-13

Class III Biologics Event

Event ID43117
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPresbyterian Intercommunity Hospital, Inc. Blood Bank
CityWhittier
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code Info5304596
ClassificationClass III
Reason for RecallBlood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-2279-13

Class III Biologics Event

Event ID43119
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPresbyterian Intercommunity Hospital, Inc. Blood Bank
CityWhittier
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code Info3593691
ClassificationClass III
Reason for RecallBlood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-2239-13

Class III Biologics Event

Event ID43121
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPresbyterian Intercommunity Hospital, Inc. Blood Bank
CityWhittier
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code Info5304297
ClassificationClass III
Reason for RecallBlood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-2240-13

Class III Biologics Event

Event ID43179
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPresbyterian Intercommunity Hospital, Inc. Blood Bank
CityWhittier
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code Info3595085
ClassificationClass III
Reason for RecallBlood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-2246-13

Class III Biologics Event

Event ID43182
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPresbyterian Intercommunity Hospital, Inc. Blood Bank
CityWhittier
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code Info3593691
ClassificationClass III
Reason for RecallBlood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-2245-13

Class III Biologics Event

Event ID43747
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Nov-06
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSouthern California Permanente Medical Group Blood Donor Center
CityLos Angeles
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoKP29367
ClassificationClass III
Reason for RecallBlood product, collected from a donor who did not meet acceptance criteria, was distributed.
Product Quantity1 unit
Recall NumberB-1679-13

Class III Biologics Event

Event ID44528
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Feb-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDepartment of the Navy
CitySan Diego
StateCA
CountryUS
Distribution PatternNew Jersey
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW021607000599
ClassificationClass III
Reason for RecallBlood product, which did not meet the minimum requirement for Red Blood Cell recovery, was distributed.
Product Quantity1 unit
Recall NumberB-2280-13

Class III Biologics Event

Event ID45175
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Sep-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSan Diego Blood Bank
CitySan Diego
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoKP75541
ClassificationClass III
Reason for RecallBlood product, collected from a donor whose body temperature was not documented, was distributed.
Product Quantity1 unit
Recall NumberB-2244-13

Class III Biologics Event

Event ID52892
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Dec-08
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmOctapharma Plasma, Inc.
CityCharlotte
StateNC
CountryUS
Distribution PatternAustria
 

Associated Products

Product DescriptionSource Plasma
Code Info0460054624, 0460054375, 0460053765, 0460053046, 0460052681, 0460052248, 0460050883, 0460050587, 0460050160, 0460049586, 0460049195, 0460048781, 0460048529, 0460047982, 0460047459, 0460047069, 0460046603, 0460046302, 0460045817, 0460045407, 0460044919, 0460044525, 0460044162, 0460043473, 0460043099, 0460042359, 0460041692, 0460041247, 0460040232, 0460039929, 0460038722, 0460038262, 0460037878, 0460036800, 0460036262, 0460035913, 0460035198, 0460034855, 0460034484, 0460033826, 0460033566, 0460033193, 0460032009, 0460031674, 0460031243, 0460030874, 0460030294, 0460030010, 0460029419, 0460028966, 0460028569, 0460027866, 0460027348, 0460026653, 0460026242, 0460025627, 0460025140, 0460024799, 0460024343, 0460024005, 0460023658, 0460023224, 0460022865, 0460022451, 0460022161, 0460021763, 0460021229, 0460020986, 0460020604, 0460020401, 0460020029, 0460019816, 0460019201, 0460018801, 0460018337, 0460018128, 0460017835, 0460017479, 0460017179, 0460016789, 0460016454, 0460016212, 0460015933, 0460015577, 0460014957, 0460014733, 0460014319, 0460014032, 0460013752, 0460013536, 0460013227, 0460013029, 0460012708, 0460012455, 0460012125, 0460011882, 0460011605, 0460011399, 0460011066, 0460010860, 0460010491, 0460010215, 0460009837, 0460009607, 0460009151, 0460008935, 0460008547, 0460008336, 0460008015, 0460007838, 0460007385, 0460006986, 0460006733, 0460006373, 0460006126, 0460005737, 0460005614, YA181580, YP197658, YP180952, YP180872, YP180664, YP180584, YT102264, YT102246, YT102201, YT102185, YT102164, YT102147, YT102093
ClassificationClass III
Reason for RecallBlood products, collected from a deferred donor, were distributed.
Product Quantity130 units
Recall NumberB-2247-13

Class III Biologics Event

Event ID64847
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Mar-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmUniversity Of Miami Miller School of Medicine Tissue Bank
CityMiami
StateFL
CountryUS
Distribution PatternFlorida and Texas
 

Associated Products

Product DescriptionBone
Code InfoUBO008514008211; UBO008514008011; UBO008514008111
ClassificationClass III
Reason for RecallHuman tissue allografts, mislabeled with extended expiration dates, were distributed.
Product Quantity3
Recall NumberB-2266-13

Class III Biologics Event

Event ID65368
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Sep-12
Initial Firm Notification of Consignee or Public Other
Recalling FirmSanofi Pasteur, Inc.
CitySwiftwater
StatePA
CountryUS
Distribution PatternMultiple U.S. States
 

Associated Products

Product DescriptionTyphoid Vi Polysaccharide Vaccine
Code InfoE12871; E12881; G04811; G05071; G05081; G11301
ClassificationClass III
Reason for RecallLots of Typhim Vi (Typhoid Vi Polysaccharide Vaccine), with potentially low antigen content, were distributed.
Product Quantity6 Lots
Recall NumberB-2189-13

Class III Biologics Event

Event ID65517
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jun-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmEye Bank Of Wisconsin, Inc.
CityMadison
StateWI
CountryUS
Distribution PatternWisconsin; West Virginia
 

Associated Products

Product DescriptionCornea
Code InfoCW101654OD; CW101654OS
ClassificationClass III
Reason for RecallHuman Corneas, recovered from a donor whose plasma dilution was not properly evaluated, were distributed.
Product Quantity2 corneas
Recall NumberB-2272-13

Class III Biologics Event

Event ID65525
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jun-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmInternational Sight Restoration, Inc.
CityTampa
StateFL
CountryUS
Distribution PatternEgypt; Florida
 

Associated Products

Product DescriptionCornea
Code Info20130076OD; 20130076OS
ClassificationClass III
Reason for RecallHuman corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Product Quantity2 corneas
Recall NumberB-2275-13

Class III Biologics Event

Event ID65527
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Mar-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmImmucor Inc
CityNorcross
StateGA
CountryUS
Distribution PatternNationwide; Worldwide
 

Associated Products

Product DescriptionReagent Red Blood Cells
Code InfoN338; N339; N340; N341; R276; R277ZA; R278; CW249ZA; CW249ZB; CW250ZA; CW250ZB
ClassificationClass III
Reason for RecallCapture-R Ready plates, with higher rates of equivocal and unexpected positive reactions, were distributed.
Product Quantity11
Recall NumberB-2276-13

Class III Biologics Event

Event ID65595
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMerck Sharpe & Dohme Corp
CityWest Point
StatePA
CountryUS
Distribution PatternMultiple U.S. States
 

Associated Products

Product DescriptionMeasles, Mumps and Rubella Virus Vaccine Live
Code Info0851AA
ClassificationClass III
Reason for RecallM-M-R II (Measles, Mumps and Rubella Virus Vaccine Live)was inadvertently distributed.
Product Quantity1 Batch; 39,340 vials
Recall NumberB-2190-13

Class III Food Event

Event ID65873
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Aug-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmLa Terra Fina USA, Inc.
CityUnion City
StateCA
CountryUS
Distribution PatternCA, CO, TX, IN..
 

Associated Products

Product DescriptionChunky Spinach Artichoke and Parmesan Dip: Gluten Free, Trans Fat Free. Net WT. 10 oz., (.625 lb,284g Made with real cream cheese. Plastic square tub La Terra Fina Union City, CA 94587
Code InfoBest By SEP-02-2013
ClassificationClass III
Reason for RecallOne lot Spinach Artichoke & Parmesan dip contains the ingredient and nutrition information for Caramelized onion dip. Both dips have the same allergens statement - Milk, Soy and Egg.
Product Quantity1130 cases (6/10 oz tubs per carton)
Recall NumberF-1869-2013

Class III Devices Event

Event ID65923
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Aug-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCopan Italia
CityBrescia
State
CountryIT
Distribution PatternWorldwide Distribution - USA (nationwide) including Oregon and California, and internationally to: France, Belgium, Italy, Denmark, Norway, Switzerland, Romania, Finland, Germany, South Africa, Canada, Ireland, UK, Sweden and Japan.
 

Associated Products

Product DescriptionWASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog number: W086 WASP is a fully automated system used to process microbiological specimens in liquid phase for the investigation of infectious microbes.
Code InfoSerial Numbers: W086-61-084/106/115/119/134/136; W086-050-179; W086-61-087/109/125/127/130/133; W086-050-144/151/153/157/170/171/181/184; W086-61-088/097/100/117; W086-050-177/178/183; W086-61-093; W086-050-143/155; W086-61-096; W086-050-164/169/159/175; W086-61-103/137/141/142; W08661-104/114118/128/138; W086050-182; W08661 111; W08661 113; W08661 124; W08661129/140; W086050150/152/154/185; W08661 139; W086050 147; W08661 110; W086050160/161/162; W086050 180; W086050 187.
ClassificationClass III
Reason for RecallThe recall of the WASP (Walk Away Specimen Process) instrument was initiated because Copan Italia SpA has upgraded the software concerning the broth inoculation table feature. The upgrade has been considered necessary from the manufacturer in order to eliminate the very low risk of rotation of the broth table when the door is open.
Product Quantity63 units
Recall NumberZ-2131-2013

Class III Food Event

Event ID66003
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jul-13
Initial Firm Notification of Consignee or Public Visit
Recalling FirmThrive Foods LLC
CityAmerican Fork
StateUT
CountryUS
Distribution PatternThe product was distributed nationwide, in all U.S. states, and in Canada (Wade & Sandy Pierson Company Name: In Case Of , #102 127 Commercial Drive , Calgary AB T3Z 2A7 Canada, Tel. 403-381-0005). The product was not distributed to the U.S. Defense Supply Center, VA or other Federal Government Agency Sales/distribution center.
 

Associated Products

Product DescriptionTHRIVE 6 Grain Pancake Mix; There are two unit sizes: (1) 4 lb. #10/gallon can (6.03x 7.02) (the "Gallon Cans"); and (2) 1.17 lb. Pull-Top Pantry Cans (4.01x 5.08) (the "Pantry Cans"). Both units are packaged in metal cans. The Pantry Can has a metal pull-top lid and the Gallon Can has a metal lid that must be opened by a can opener. (1) The Gallon Cans may be ordered as single units or in six (6) can cases. (2) The Pantry Cans may be ordered as single units or in ten (10) can cases.
Code InfoCatalog numbers: (1) Gallon Cans - 21110; (2) Pantry Cans - 22110 Website ID numbers: (1) Gallon Cans - 660 (2) Pantry Cans - 584 Identified using Canning dates: 2009 - 07/15/09, 08/25/09, 09/25/09, 11/23/09, 12/15/09; 2010 - 02/13/10, 03/04/10, 03/10/10, 03/11/10, 04/06/10, 04/12/10, 04/23/10, 04/24/10, 05/10/10, 06/16/10, 06/17/10, 06/30/10, 07/14/10, 08/26/10, 08/27/10, 08/30/10, 08/31/10, 09/20/10, 09/27/10, 09/28/10, 10/07/10, 10/08/10, 10/19/10, 10/20/10, 10/23/10, 10/30/10, 11/10/10, 11/29/10, 12/03/10, 12/14/10, 12/28/10; 2011 - 01/03/11, 01/04/11, 01/13/11, 03/21/11, 05/06/11, 05/23/11, 06/15/11, 06/16/11, 06/26/11, 07/20/11, 07/25/11, 10/17/11, 10/18/11, 10/31/11, 11/16/11, 11/21/11, 11/30/11, 12/15/11, 12/21/11, 12/29/11; 2012 - 01/13/12, 01/25/12, 02/06/12, 02/07/12, 02/13/12, 03/15/12, 03/26/12, 04/16/12
ClassificationClass III
Reason for RecallThrive Foods is recalling certain lots of its 64 and 72 ounce cans of THRIVE 6 Grain Pancake Mix because this product contains ingredients that react over time and increase the pressure inside the can, which may cause cans to expand or bulge and increase the risk of sudden release of the pancake mix when the can is opened and could pose the risk of injury.
Product QuantityGallon Cans - 100,116 cans; Pantry Cans - 4,219 cans
Recall NumberF-1867-2013

Class III Food Event

Event ID66011
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Aug-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmJustin'S Nut Butter
CityBoulder
StateCO
CountryUS
Distribution PatternNationwide. No foreign, military, gov't, VA distribution.
 

Associated Products

Product DescriptionMaple Almond Butter 16 oz Jar (Unit USPC 894455000322, Case USPC 894455002135)
Code InfoLot Code 188 (Best By Date 07/07/14) Lot Code 190 (Best By Date 07/09/14) Lot Code 191 (Best By Date 07/10/14)
ClassificationClass III
Reason for RecallJusti's has initiated a voluntary recall of certain lots of its Maple Almond Butter 16oz jars and its Chocolate Hazelnut Butter 16oz jars due to the presence of foreign metallic fragments in unpackaged nut butter.
Product Quantity5,649 master cases (6 jars per master case)
Recall NumberF-1874-2013
Product DescriptionChocolate Hazelnut Butter 16oz Jar (Unit UPC 894455000490, Case UPC 894455000612)
Code InfoLot Code 191 (Best By Date 07/10/14) Lot Code 192 (Best By Date 07/11/14)
ClassificationClass III
Reason for RecallJustin's has initiated a voluntary recall of certain lots of its Maple Almond Butter 16oz jars and its Chocolate Hazelnut Butter 16oz jars due to the presence of foreign metallic fragments in unpackaged nut butter.
Product Quantity1,512 master cases (6 jars per master case)
Recall NumberF-1875-2013

Class III Food Event

Event ID66018
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Aug-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmPotters Fine Foods, LLC
CityMadison
StateWI
CountryUS
Distribution PatternIL, NY, NC, WI.
 

Associated Products

Product DescriptionPotter's Crackers, Classic White, Net Wt 5 ounces, UPC 6 80569 15877 2, Potters Fine Foods LLC, 100 S. Baldwin, Madison WI 53703., Ingredients, Wheat Flour, Milk, Butter, Cracked Wheat, Sugar, Crystal Salt, Baking Powder, Black Pepper. Allergen Information: wheat, dairy & tree nuts.
Code Info10-10-13
ClassificationClass III
Reason for RecallPotters Fine Foods LLC are recalling Potter's Crackers Classic White because of cross contamination with a Basil Walnut Presto Cracker dough. Even though there is an allergen statement on the Classic White tag for tree nuts, we initiated a voluntary recall. All 109 packages were accounted for.
Product Quantity109 containers.
Recall NumberF-1868-2013

Class III Food Event

Event ID66035
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Jul-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmGreenland Trading Corp
CityPaterson
StateNJ
CountryUS
Distribution PatternCT, FL, MA, NJ & NY
 

Associated Products

Product DescriptionEl Basham Weight 400 g Ingredients: Natural Apricot Juice, Glucose, Sugar, Oil. Made by: For the Owner of the Trade Mark ABU Ode h Bros Co. Amok St. Aman -Jordan Tel +962 6 4914961 Fax +962 6 4907878 Remaining information is in Arabic.
Code InfoNone listed in Attachment B. However, the outside markings on the label has an expiration date code 6/2012-6/2014 (Attachment #2 2 of 2 and in Memorandum Report dated June 14, 2013.
ClassificationClass III
Reason for RecallKamar Deen AL Basham Apricot Dried Paste does not declare product identity in English.
Product Quantity100 cases (20 units each)
Recall NumberF-1872-2013

Class III Food Event

Event ID66109
StatusOngoing
Product TypeFood
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 FirmCrown Pacific Int'L Llc
CityHilo
StateHI
CountryUS
Distribution PatternOne distributor in both CO and VA
 

Associated Products

Product DescriptionHawaii Fresh Sweet Basil Hawaii Fresh Thai Basil product of the USA Crown Pacific International, Inc. Hilo, HI
Code Infono code informtion
ClassificationClass III
Reason for RecallState of Hawaii Issued a Cease and Desist Order to grower of basil for positive sample results for pesticides not allowed on basil.
Product Quantity56 boxes of sweet basil (14, 15 or 16 lbs per box); 16 boxes of Thai basil (15 or 16 lbs per box)
Recall NumberF-1873-2013

Mixed Classification Biologics Event

Event ID38803
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Mar-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityCleveland
StateOH
CountryUS
Distribution PatternOhio, Switzerland
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info42FT70229, 42FT70233, 42FT70246, 42FT70255, 42FT70267, 42FT70306, 42FX56668, 42FX56674, 42FX56676, 42FX56684, 42FX56690
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the units, were distributed.
Product Quantity11 units
Recall NumberB-2241-13
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code Info42FT70246, 42FT70255, 42FT70306, 42FX56668, 42FX56674, 42FX56684, 42FX56690
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the units, were distributed.
Product Quantity7 units
Recall NumberB-2242-13
Product DescriptionRecovered Plasma
Code Info42FT70229, 42FT70246, 42FT70255, 42FT70267, 42FT70306, 42FX56668, 42FX56674, 42FX56676, 42FX56684, 42FX56690
ClassificationClass III
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the units, were distributed.
Product Quantity10 units
Recall NumberB-2243-13

Mixed Classification Biologics Event

Event ID65308
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036812427152
ClassificationClass III
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity1 unit
Recall NumberB-2168-13
Product DescriptionRed Blood Cells
Code InfoW036812427152
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity1 unit
Recall NumberB-2169-13

Mixed Classification Biologics Event

Event ID65329
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-May-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCarter BloodCare
CityBedford
StateTX
CountryUS
Distribution PatternSwitzerland, TX
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW035213107399T
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2153-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW035213107399T
ClassificationClass III
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2154-13

Mixed Classification Biologics Event

Event ID65345
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOneBlood / dba CBCF
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036812575466;
ClassificationClass II
Reason for RecallBlood products, collected from an inelgible donor, were distributed.
Product Quantity1 unit
Recall NumberB-2226-13
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036812845514;
ClassificationClass II
Reason for RecallBlood products, collected from an inelgible donor, were distributed.
Product Quantity1 unit
Recall NumberB-2227-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036812575466;
ClassificationClass III
Reason for RecallBlood products, collected from an inelgible donor, were distributed.
Product Quantity1 unit
Recall NumberB-2228-13
Product DescriptionRed Blood Cells
Code Info2466267; 1748931;
ClassificationClass II
Reason for RecallBlood products, collected from an inelgible donor, were distributed.
Product Quantity2 units
Recall NumberB-2229-13

Mixed Classification Biologics Event

Event ID65403
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-May-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmOneBlood, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternSwitzerland; Florida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036813010029;
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity1 unit
Recall NumberB-2223-13
Product DescriptionRed Blood Cells
Code Info2438324; 2685776; W036809266093; W036810226326;
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity4 units
Recall NumberB-2224-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036809266093; W036810226326; W036813010029;
ClassificationClass III
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity3 units
Recall NumberB-2225-13

Mixed Classification Biologics Event

Event ID65521
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jun-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmInternational Sight Restoration, Inc.
CityTampa
StateFL
CountryUS
Distribution PatternEgypt; Lebanon; Argentina; Mexico; Romania; South Africa; Iraq
 

Associated Products

Product DescriptionCornea
Code Info20130020OD; 20130020OS; 20130040OD; 20130040OS; 20130040ODSW; 20130040OSSW; 20130073OD; 20130073OS; 20130077OD; 20130077OS
ClassificationClass III
Reason for RecallHuman corneas, recovered from donors whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Product Quantity10 corneas
Recall NumberB-2281-13
Product DescriptionCornea
Code Info20120136OD; 20120136OS
ClassificationClass II
Reason for RecallHuman corneas, recovered from donors whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Product Quantity2 corneas
Recall NumberB-2282-13

Mixed Classification Biologics Event

Event ID65529
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOneBlood / dba CBCF
CityLauderhill
StateFL
CountryUS
Distribution PatternIllinois; Florida; New York
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW036809286286;
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity1 unit
Recall NumberB-2293-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036809286286;
ClassificationClass III
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity1 unit
Recall NumberB-2294-13
Product DescriptionCryoprecipitated AHF, Pooled
Code InfoW036809813030;
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity1 unit
Recall NumberB-2295-13
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