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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Class I Food Event

Event ID51893
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Feb-09
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmGiannios Candy Co Inc
CityStruthers
StateOH
CountryUS
Distribution PatternThe product was distributed in the states of OH, PA, MI, NY.
 

Associated Products

Product DescriptionMilk Chocolate Catalog # 111, Dark Chocolate Peanut Clusters Catalog # 112 & Peanut Butter Pieces Catalog # 107 individually wrapped. Date Codes 121401-130831
Code InfoPeanut Butter Pieces Catalog #107, Milk Chocolate Clusters Catalog #111 & Dark Chocolate Clusters Catalog #112 Date Codes 121401-130831
ClassificationClass I
Reason for RecallThis product is being recalled because it was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella
Product Quantity5,090 boxes/250 pieces
Recall NumberF-1031-2013

Class I Food Event

Event ID64092
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jan-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmHomestead Creamery
CityJamesport
StateMO
CountryUS
Distribution PatternThe product was distributed to stores in MO and an open farmer's market in gift baskets. Exact dates of the start of distribution are not clear. The plastic packaging film used to package the recalled product is supplied by: Specialty Foods, Roland Park, KS. The Annato cheese food coloring, cheese cultures and Rennet are supplied by, Dairy Connections, Madison, WI.
 

Associated Products

Product DescriptionHomestead Creamery Artisan Cheese, Flory's Favorite, whole raw jersey milk, packaged in 1-lb or 1/2-lb block/plastic packs.
Code Infolabel marked with: Packed On 210
ClassificationClass I
Reason for RecallThe raw milk cheese product may be contaminated with shiga-toxin e-coli.
Product Quantity4/20-lb blocks cut into smaller 1-lb and 1/2-lb packages
Recall NumberF-1009-2013

Class I Food Event

Event ID64199
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jan-13
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmWhole Foods Market
CityAustin
StateTX
CountryUS
Distribution PatternArkansas, California, Colorado, Connecticut, Florida, Idaho, Kansas, Louisiana, Maine, Massachusetts, Nevada , New Jersey, New Mexico, New York, Oklahoma, Rhode Island, Texas and Utah.
 

Associated Products

Product DescriptionWhole Foods Market Whole Catch Wild Alaskan Sockeye Smoked Salmon, Cold Smoked Sliced, Net Wt. 4 oz, Distributed by Whole Foods Market, Austin, TX 78703
Code InfoUPC code 0 99482 40880 0, Lot codes 7425A2298B and 7425A2297A. Sell by dates are applied at store level when product is thawed for sale and go 21 days out from date of thaw. Accordingly, the sell by dates should begin with 11/22/12 at the earliest and 2/15/13 at the latest.
ClassificationClass I
Reason for RecallThe product has the potential to contaminated with Listeria Monocytogenes.
Product Quantity6924 retail units
Recall NumberF-1005-2013

Class I Food Event

Event ID64292
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Feb-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmGoldCoast Salads
CityNaples
StateFL
CountryUS
Distribution PatternAL, FL, GA, MA, MD, NC, NJ, NY, PA, TN and VA
 

Associated Products

Product DescriptionGoldCoast Salads Blue Crab Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below)
Code Info8oz = UPC Code = 33555 00325 exp 01/31/2013 and exp 02/14/2013B 16oz = UPC Code 33555 00125 exp 01/31/2013 and exp 02/14/2013B
ClassificationClass I
Reason for RecallProduct may be contaminated with Listeria Monocytogenes
Product Quantity6,857 cases total
Recall NumberF-1032-2013
Product DescriptionGoldCoast Salads Marine Lobster Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below)
Code Info8oz = UPC Code = 33555 00234 exp 02/14/2013B 6oz = UPC Code = 33555 00124 exp 02/14/2013B
ClassificationClass I
Reason for RecallProduct may be contaminated with Listeria Monocytogenes
Product Quantity6,919 cases total
Recall NumberF-1033-2013
Product DescriptionGoldCoast Salads Lobster & Shrimp Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below)
Code Info8oz = UPC Code = 33555 00005 exp 02/23/13 L&S1 16oz = UPC Code = 33555 00004 exp 03/30/13 L&S1
ClassificationClass I
Reason for RecallProduct may be contaminated with Listeria Monocytogenes
Product Quantity2,284 cases total
Recall NumberF-1034-2013
Product DescriptionGoldCoast Salads Smoked Salmon Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below)
Code Info8oz = UPC Code = 33555 00328 exp 03/10/13 S2 16oz = UPC Code 33555 00128 exp 03/10/13 S2
ClassificationClass I
Reason for RecallProduct may be contaminated with Listeria Monocytogenes
Product Quantity1,567 cases Total
Recall NumberF-1035-2013

Class I Food Event

Event ID64331
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Feb-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSpecialty Commodities, Inc.
CityFargo
StateND
CountryUS
Distribution PatternCA, IL, MO, ND, NJ, OK, PA, WI
 

Associated Products

Product DescriptionEgyptian Parsley Flakes, Weight: 10kg Net.
Code InfoManufacturer's code: Batch No. 127, Lot#.: 214 Specialty Commodities' Lot numbers: SD28173, RE49421, SCS321167.
ClassificationClass I
Reason for RecallSpecialty Commodities was notified by a customer that they had found Parsley Flakes to be positive for Salmonella.
Product Quantity780 containers
Recall NumberF-1028-2013

Class I Food Event

Event ID64337
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmZip International Group
CityEdison
StateNJ
CountryUS
Distribution PatternNY
 

Associated Products

Product DescriptionBream Dry Salted Fish Net Wt.: about 14.2 oz Imported by Zip International Group LLC Product of Russia
Code Info835856001228; sell by 03/27/2013
ClassificationClass I
Reason for RecallNYSDAM sampling and analysis has revealed that Dry Salted Fish is uneviscerated.
Product Quantity5 boxes (77 lbs)
Recall NumberF-1007-2013

Class I Food Event

Event ID64345
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Feb-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmQtrade Teas And Herb
CityCerritos
StateCA
CountryUS
Distribution PatternNationwide in the US: CA, NY, PA, NJ, MO, MA, OH, RI, CO, NC. Worldwide in: Canada
 

Associated Products

Product DescriptionOrganic Lemon Grass Tea Bag Cut (TBC), Item#410. Packing Size: 25 kgs net double craft paper bags and double polyethylene bags each inner liner and repacked product packed in corrugated cartons with polyethylene inner liner. Organic Lemon Grass Tea Bag Cut (TBC) bulk sold in original, repacked cases, and as component of blended bulk tea products.
Code InfoLot#108
ClassificationClass I
Reason for RecallQTrade Teas & Herbs is recalling Organic Lemon Grass Tea Bag Cut (TBC) because it has the potential to be contaminated with Salmonella.
Product Quantity6,303.78 lbs
Recall NumberF-1026-2013

Class I Food Event

Event ID64359
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Feb-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmTeatulia
CityDenver
StateCO
CountryUS
Distribution PatternShipped to one distributor who sold it to 15 restaurants all in Colorado.
 

Associated Products

Product DescriptionSold as In-House brand iced tea: Garbanzo Mediterranean Grill Organic Lemongrass Ginger Green Tea, 3 oz. packages
Code InfoLot code #2234
ClassificationClass I
Reason for RecallTea received from bulk supplier may be contaminated with Salmonella.
Product Quantity14 Pounds of 3 Ounce packages, 32 packs per case
Recall NumberF-1025-2013

Class I Food Event

Event ID64360
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 FirmJs Pelmeni Ok, Inc.
CityBrooklyn
StateNY
CountryUS
Distribution PatternNew York, Massachusetts, Pennsylvania, New Jersey, and Illinois.
 

Associated Products

Product DescriptionPotato Dumplings, Net Weight 2 lb. (32 oz.), KEEP FROZEN, UPC 6 54368 10038 6, EST # A613069 --- JS Pelmeni OK - 667 Coney Island Ave., Brooklyn, NY 11218 - (718) 469-1490
Code InfoUPC 6 54368 10038 6 and no other coding
ClassificationClass I
Reason for RecallThe product contains undeclared milk and soy based on observations found during a joint inspection by the FDA and New York State Department of Agriculture & Markets.
Product Quantity
Recall NumberF-1029-2013
Product DescriptionPotato & Mushroom Dumplings, Net Weight 1 lb. (16 oz.), KEEP FROZEN, UPC 6 54368 10039 3 --- JS Pelmeni OK - EST # A615133 - 667 Coney Island Ave., Brooklyn, NY 11218 - (718) 469-1490
Code InfoUPC 6 54368 10039 3 and no other coding
ClassificationClass I
Reason for RecallThe product contains undeclared milk and soy based on observations found during a joint inspection by the FDA and New York State Department of Agriculture & Markets.
Product Quantity
Recall NumberF-1030-2013

Class I Food Event

Event ID64365
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAssociated Milk Producers, Inc
CityDawson
StateMN
CountryUS
Distribution PatternOne distributor in WI
 

Associated Products

Product DescriptionGFS Lemon Pulling, Net Wt. 113 oz (7 lb 1 oz) 3.20 kg UPC 93901-10676. Distributed by Gordon Food Service, Grand Rapids, MI 49548.
Code InfoLot # 3T12354C printed on the end of can
ClassificationClass I
Reason for RecallUndeclared Milk Allergen. GFS labeled Lemon Pudding may contain vanilla pudding which contains milk. The Lemon Pudding label does not list milk.
Product Quantity447 cases (6 cans per case)
Recall NumberF-1027-2013

Class I Food Event

Event ID64366
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Feb-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmMuffin Mam Inc (The)
CitySimpsonville
StateSC
CountryUS
Distribution PatternGA, NC, SC, PA, TN, VA and WV.
 

Associated Products

Product DescriptionThe Muffin Mam, Inc 24oz Strawberry Crème Cake, UPC 7-60366-00986-3
Code InfoAll Lot Codes
ClassificationClass I
Reason for RecallUndeclared Allergen: Eggs.
Product Quantity301,024 Units
Recall NumberF-1024-2013

Class II Biologics Event

Event ID39129
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-May-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternIL
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info011LQ56363
ClassificationClass II
Reason for RecallBlood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-0539-13

Class II Biologics Event

Event ID40856
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Sep-05
Initial Firm Notification of Consignee or Public FAX
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternSwitzerland.
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoC71385
ClassificationClass II
Reason for RecallBlood product, collected from a donor with non-confirmed repeat reactive HBsAg, was distributed..
Product Quantity1 Unit
Recall NumberB-0543-13

Class II Biologics Event

Event ID41055
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Oct-05
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternIowa
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoC72530
ClassificationClass II
Reason for RecallBlood product, which tested as CMV positive but labeled as CMV negative, was distributed.
Product Quantity1 Unit
Recall NumberB-0493-13

Class II Biologics Event

Event ID41270
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Nov-05
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternIowa
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoKN03020
ClassificationClass II
Reason for RecallBlood product, which did not meet acceptable product specifications, was distributed.
Product Quantity1 Unit
Recall NumberB-0546-13

Class II Biologics Event

Event ID42157
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-May-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmSiouxland Community Blood Bank
CitySioux City
StateIA
CountryUS
Distribution PatternIA, Austria
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info2025841
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-0625-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info2025841
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-0626-13

Class II Biologics Event

Event ID42486
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Jun-06
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAmerican National Red Cross (The)
CitySalt Lake City
StateUT
CountryUS
Distribution PatternUtah, Maryland, California.
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code Info020Q 10574 , 020Q 10575.
ClassificationClass II
Reason for RecallBlood products, which was collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity2 units
Recall NumberB-0374-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info020J 61790 , 020J 61792 , 020J 61796 , 020J 61797 , 020J 61799 , 020J 61801 , 020J 61804 , 020J 61607 , 020J 61811 , 020Q 10550 , 020Q 10551 , 020Q 10555 , 020Q 10556 , 020Q 10558 , 020Q 10562 , 020Q 10563 , 020Q 10564 , 020Q 10566, 020Q 10567, 020Q 10571 , 020Q 10574, 020Q 10575.
ClassificationClass II
Reason for RecallBlood products, which was collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity22 units
Recall NumberB-0375-13

Class II Biologics Event

Event ID42671
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jul-06
Initial Firm Notification of Consignee or Public Other
Recalling FirmLifeSouth Community Blood Centers, Inc.
CityDunwoody
StateGA
CountryUS
Distribution PatternGeorgia
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info71X45517-7
ClassificationClass II
Reason for RecallBlood product, with a low platelet count, was distributed
Product Quantity1
Recall NumberB-0638-13

Class II Biologics Event

Event ID43075
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Aug-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info11KS13328
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed
Product Quantity1 Unit
Recall NumberB-0634-13

Class II Biologics Event

Event ID43152
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Aug-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info11FY34707
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-0633-13

Class II Biologics Event

Event ID46543
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Nov-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info011LK58056
ClassificationClass II
Reason for RecallBlood products, manufactured from an apheresis unit with platelet yield that did not meet the criteria for a divided unit, were distributed.
Product Quantity1 Unit
Recall NumberB-0570-13

Class II Biologics Event

Event ID49819
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Aug-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPuget Sound Blood Center and Program
CitySeattle
StateWA
CountryUS
Distribution PatternCalifornia.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW141608213600
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who was taking the medication Finasteride, was distributed.
Product Quantity1 component
Recall NumberB-0544-13

Class II Biologics Event

Event ID49820
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Aug-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmPuget Sound Blood Center and Program
CitySeattle
StateWA
CountryUS
Distribution PatternAustria.
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoR305763
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1 component
Recall NumberB-0545-13

Class II Biologics Event

Event ID49821
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Jul-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmPuget Sound Blood Center and Program
CitySeattle
StateWA
CountryUS
Distribution PatternWashington.
 

Associated Products

Product DescriptionPlatelets
Code InfoW141608415198
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor in whom donor suitability was not adequately determined, was distributed.
Product Quantity1 component
Recall NumberB-0547-13

Class II Biologics Event

Event ID50020
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Sep-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross (The)
CitySaint Louis
StateMO
CountryUS
Distribution PatternIL
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info011LQ61233
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-0720-13
Product DescriptionPlasma Frozen
Code Info011LQ61233
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-0721-13

Class II Biologics Event

Event ID55399
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Feb-10
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc.
CityPortland
StateOR
CountryUS
Distribution PatternIllinois, Switzerland, and Germany,
 

Associated Products

Product DescriptionSource Plasma
Code Info0550856093, 0550841218, 0550840504, 0550839338, 0550837885, 0550837160, 0550835759, 0550835036, 0550833139, 0550832421, 0550831206, 0550830373, 0550829181, 0550827968.
ClassificationClass II
Reason for RecallBlood products, collected from a donor with an incomplete health assessment, were distributed.
Product Quantity14 components
Recall NumberB-0635-13

Class II Biologics Event

Event ID58358
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jan-11
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross (The)
CityPortland
StateOR
CountryUS
Distribution PatternOregon, Washington, Arizona, Virginia, and Alabama.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info021KS97435, 021KS97638, 021KS97647, 021KS97654, 021KS97722, 021KS97735, 021KS97737, 021KW88915, 021KW88933, 021KW88941, 021KW89609, 021KW89629, 021LH89688, 021LH89708, 021LH89774, 021LH89778, 021LH89787, 021LH89793, 021LK76002, 021LK76025, 021LL80496, 021LL80505, 021LL80557, 021LL80562, 021LL80931, 021LL81631, 021LS17820, 021LS17995, 021LS17996, 021LS18002, 021LS18022, 021LS18037, 021LS18046, 021LZ56619, 021LZ56651, 021LZ56661,
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity36 components
Recall NumberB-0713-13
Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info021LQ59071; 021LQ59071; 021LQ59673; 021LQ59673; 021LQ59915; 021LQ59915;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity6 components
Recall NumberB-0714-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info021LK76013
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity1 component
Recall NumberB-0715-13

Class II Biologics Event

Event ID58680
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Mar-11
Initial Firm Notification of Consignee or Public FAX
Recalling FirmPlasma Biological Services
CityAsheville
StateNC
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionSource Plasma
Code InfoAQ127299, AQ127044, AQ126535, AQ126248, AQ125780, AQ125488, AQ125001, AQ124734, AQ124452, AQ124190, AQ123836, AQ123592, AQ123299, AQ123099, AQ121609, AQ121437, AQ122999, AQ122800, AQ122357, AQ122177, AQ120700, AQ120518, AQ120089, AQ119847, AQ119412, AQ119174, AQ118720, AQ118548, AQ118133, AQ117865, AQ117303, AQ117035, AQ116499, AQ116305, AQ115865, AQ115663, AQ115241, AQ114875, AQ114657, AQ114225, AQ114058, AQ113693, AQ113481, AQ113182, AQ112979, AQ112578, AQ112351, AQ111961, AQ111781, AQ111445, AQ111237, AQ110882, AQ110649, AQ110308, AQ110096, AQ109672, AQ109498, AQ108918, AQ108557, AQ108262, AQ107942, AQ107742, AQ107373, AQ107106, AQ106812, AQ106520, AQ106321, AQ105992, AQ105636, AQ105224, AQ104971, AQ104693, AQ104514, AQ104204, AQ103961, AQ103674, AQ103449, AQ103194, AQ102985, AQ102708, AQ102486, AQ102174, AQ101814, AQ101168, AQ100806, AQ100690, AQ085468, AQ085211, AQ084888, AQ084672, AQ074311, AQ074134, AQ073725, AQ073565, AQ028245, AQ025877, AQ025243, AQ025074, AQ024728, AQ024419, AQ023985, AQ023894
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred, were distributed.
Product Quantity102 units
Recall NumberB-0637-13

Class II Biologics Event

Event ID59131
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jun-11
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBioLife Plasma Services L.P.
CityFayetteville
StateAR
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info10YARC6463; 10YARC6649; 10YARC7602; 10YARC7997; 10YARC8564; 10YARC8999; 10YARC9824; 10YARD0379; 10YARD0820; 10YARD1483; 10YARD2609; 10YARD2996; 10YARD3383; 10YARD3870; 10YARD4242; 10YARD4759; 10YARD5107; 10YARD5628; 10YARD1365; 10YARD1705; 10YARE1949; 10YARF0643; 10YARF1015; 11YARB3565; 11YARB4376; 10YARC9496; 10YARC9904; 10YARD0475; 10YARD0879; 10YARD1312; 10YARD1719; 10YARD2873; 10YARD3239; 10YARD3603; 10YARD4100; 10YARD4448; 10YARD4957; 10YARD5309; 10YARD5868; 10YARD6565; 10YARD6974; 10YARD7627; 10YARD7968; 10YARD8487; 10YARD9356; 10YARD9839; 10YARE0037; 10YARE0793; 10YARE1578; 10YARE2041; 10YARE2465; 10YARE2943; 10YARE3369; 10YARE4038; 10YARE4643; 10YARE4930; 10YARE5449; 10YARE6650; 10YARE7108; 10YARF0317; 11YARA0118; 11YARA0748; 11YARA1257; 11YARA2002; 11YARA2427; 11YARA2821; 11YARA3340; 11YARA3926; 11YARA4563; 11YARA4909; 11YARA5591; 11YARA6691; 11YARA7433; 10YARD7376; 10YARC7106; 10YARC8148; 10YARC9173; 10YARC9524; 10YARD0472; 10YARD3556; 10YARD4413; 10YARD4973; 10YARD8372; 10YARD9585; 10YARE3188; 10YARE6979; 10YARF0941; 11YARA9062; 11YARB0739; 11YARB1424; 10YARC9951; 10YARC9539; 10YARD0027; 10YARD1108; 10YARD1511; 10YARD2467; 10YARD5835; 10YARD6814; 10YARD7183; 10YARD8128; 10YARD8186; 10YARD9912; 10YARE0677; 10YARE4011; 10YARE4435; 11YARA0504; 10YARC9723; 10YARD1134; 10YARD1943; 10YARD5238; 10YARD5533; 10YARD6069; 10YARD6606; 10YARD8759; 10YARD9292; 10YARD9603; 10YARE0275; 10YARE0763; 10YARE1540; 10YARE1781; 10YARE2381; 10YARE2864; 10YARE3295; 10YARE4301; 10YARD1942; 10YARD2925; 10YARD3295; 10YARD3967; 10YARD4787; 10YARD5179; 10YARD5730; 10YARD6070; 10YARD6826; 10YARD9242; 10YARD9802; 10YARE0320; 10YARC6499; 10YARC6795; 10YARD1600; 10YARD1993; 10YARD2493; 10YARD2985; 10YARD3493; 10YARD3817; 10YARD4315; 10YARD4814; 10YARD5592; 10YARE2596; 10YARE3487; 10YARE4335; 10YARE5224; 10YARE6139; 10YARE6215; 11YARA0886; 11YARA1613; 11YARA2419; 11YARA2699; 11YARA3480; 11YARA3995; 11YARA4475; 11YARA4754; 11YARA5027; 11YARA5566; 11YARA5883; 11YARA6423; 11YARA6995; 11YARA7603; 11YARA8134; 11YARA8743; 11YARA9335; 11YARB0548; 11YARB1709; 11YARB2117; 11YARB2867; 10YARD1839; 10YARD2135; 10YARD2765; 10YARD3120; 10YARD3511; 10YARD3982; 10YARD4364; 10YARD4846; 10YARD5228; 10YARD5735; 10YARD6133; 10YARD6925; 10YARD7393; 10YARD7810; 10YARD8461; 10YARD9330; 10YARC6381; 10YARC6988; 10YARD6686; 10YARD7282; 10YARD7575; 10YARC6392; 10YARC6708; 10YARC7348; 10YARC7936; 10YARC8312; 10YARC8944; 10YARC9265; 10YARC9584; 10YARC9984; 10YARD0577; 10YARD0964; 10YARD4841; 10YARD5412; 10YARD5959; 10YARD6299; 10YARD6702; 10YARD7078; 10YARD7946; 10YARD8478; 10YARD8816; 10YARD9291; 10YARD9668; 10YARD0017; 10YARD1381; 10YARD1774; 10YARD2328; 10YARD2690; 10YARD3044; 10YARD4696; 10YARD4817; 10YARD5705; 10YARE6457; 10YARE6708; 10YARE7206; 10YARE7737; 10YARE8216; 10YARE8769; 10YARE9182; 10YARF0062; 10YARF0534; 10YARF1167; 11YARA0011; 11YARA0972; 11YARA1346; 11YARA1968; 11YARA2609; 11YARA2835; 11YARA4161; 11YARA4285; 11YARA4693; 11YARA5262; 11YARA5523; 11YARA6085; 11YARA6430; 11YARA6999; 11YARA7431; 11YARA7906; 11YARA8315; 11YARA8913; 10YARD1532; 10YARD2866; 10YARD3007; 10YARD3801; 10YARD3872; 10YARD4652; 10YARD4776; 10YARD5505; 10YARD5647; 10YARD6386; 10YARD7163; 10YARD7346; 10YARD8022; 10YARD8175; 10YARD8900; 10YARD9049; 10YARD9730; 10YARD9916; 10YARE0653; 10YARE0724; 10YARE1437; 10YARE1635; 10YARE2295; 10YARE2477; 10YARE3408; 10YARE4770; 10YARE5260; 10YARE6161; 10YARE6689; 10YARE8786; 10YARE9716; 10YARC9894; 10YARD0245; 10YARD0876; 10YARD1190; 10YARD1810; 10YARD2140; 10YARD2707; 10YARD3266; 10YARD3666; 10YARD4136; 10YARD4674; 10YARD5224; 10YARC9515; 10YARC9991; 10YARD1986; 10YARD2309; 10YARD3022; 10YARD3464; 10YARD2013; 10YARD2149; 10YARD2839; 10YARD3771; 10YARD4614; 10YARD5991; 10YARD6376; 10YARD7159; 10YARD7458; 10YARD8018; 10YARD9742; 10YARE0223; 10YARE0583; 10YARE5222; 10YARE5409; 10YARE8851; 10YARE9338; 10YARE9923; 10YARF0204; 11YARA9464; 11YARB1848; 11YARB2130; 10YARC5715; 10YARC6152; 10YARC6875; 10YARC7245; 10YARC7832; 10YARC8263; 10YARC8862; 10YARC9269; 10YARC9465; 10YARD0363; 10YARD0894; 10YARD1547; 10YARD2039; 10YARD3393; 10YARD3793; 10YARD4282; 10YARD5649; 10YARD6221; 10YARD6818; 10YARD7130; 10YARD7725; 10YARD8539; 10YARD8915; 10YARD9395; 10YARE5842; 10YARE6183; 10YARE6696; 10YARE7190; 10YARE7696; 10YARE8404; 10YARE8747; 10YARE9437; 10YARE9773; 10YARF0619; 10YARF0979; 11YARA0024; 11YARA0422; 11YARA1827; 11YARA2011; 11YARA2659; 11YARB0574; 10YARC5908; 10YARC6882; 10YARC5922; 10YARC6151; 10YARC6493; 10YARC7435; 10YARC8572; 10YARD1029; 10YARD5919; 10YARC6405; 10YARC6747; 10YARC7381; 10YARC7968; 10YARC8339; 10YARC8975; 10YARC9633; 10YARD0038; 10YARD0630; 10YARD0996; 10YARD2152; 10YARE3714; 10YARE4077; 10YARE4673; 10YARC9784; 10YARD0348; 10YARD0994; 10YARC9912; 10YARC9967; 10YARD0670; 10YARD1739; 10YARD2079; 10YARD3588; 10YARD4517; 10YARE5646; 10YARC9970; 10YARD0004; 10YARD0343; 10YARD2455; 10YARE6901; 10YARD1137; ; 10YARD3046; 10YARD3789; 10YARD4294; 10YARD1140; 10YARD1763; 10YARD2092; 10YARD2708; 10YARD3126; 10YARD3670; 10YARD4003; 10YARD5195; 10YARD6869; 10YARD7361; 10YARD9824; 10YARE0535; 10YARE1560; 10YARD1815; 10YARD6294; 10YARD6692; 10YARD7065; 10YARD7590; 10YARD1748; 10YARD2032; 10YARD2878; 10YARD4642; 10YARD5020; 10YARD7567; 10YARD8127; 10YARD8992; 10YARD9259; 10YARE1548;
ClassificationClass II
Reason for RecallBlood products, collected from donors with incomplete physical examination, were distributed.
Product Quantity437
Recall NumberB-0636-13

Class II Devices Event

Event ID61554
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Mar-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAdvanced Neuromodulation Systems Inc.
CityPlano
StateTX
CountryUS
Distribution PatternWorldwide Distribution - 53 consignees out of the US.
 

Associated Products

Product DescriptionAdvanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
Code InfoModel number 6788. All lots manufactured prior to 03/16/2012 are being recalled.
ClassificationClass II
Reason for RecallUnintended Fluid ingress into the device header has been shown.
Product Quantity388 units
Recall NumberZ-0894-2013

Class II Biologics Event

Event ID62670
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGenzyme Corporation
CityFramingham
StateMA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionGenzyme Thymoglobulin® [Anti-thymocyte Globulin (Rabbit)], 25 mg, for intravenous use only, Rx. NDC 58468-0080-01
Code InfoC0072C01 Feb 2013; C0062C01 Dec 2012; C0086C01 May 2013; C0094C01 Jul 2013; C0096C01 Aug 2013; C0098C01 Aug 2013; C0098C02 Aug 2013; C0098C03 Aug 2013; C0100C01 Aug-2013
ClassificationClass II
Reason for RecallAnti-Thymocyte Globulin (Rabbit) 25 mg, with an OOS assay result on the molecular size distribution stability test, was distributed.
Product Quantity9 units
Recall NumberB-0964-13

Class II Devices Event

Event ID62804
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOrthofix, Inc
CityLewisville
StateTX
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) Internationally to Australia, Hong Kong, Saudi Arabia, Korea, Turkey, Greece, Finland, South Africa, Spain, Singapore, Switzerland, Brazil, Germany, France, Japan, Netherlands, New Zealand, Israel, Canada and Mexico.
 

Associated Products

Product DescriptionOrthofix ISKD Limb Lengthener Sterile Rx Only, Orthofix Inc. Lewisville, TX 75056. ISKD - Intramedullary Skeletal Kinetic Distractor. The ISKD is intended for limb lengthening of the tibia and femur.
Code InfoAll serial numbers of the following Catalog Numbers: F12-255-305, F12-345-395NS, T12-245-295, F12-255-305NS, F12-345-425, T12-255-305, F12-255-335, F12-345-425NS, T12-255-305NS, F12-255-335NS, T10-215-265, T12-255-335, F12-300-350, T10-255-305, T12-255-335NS, F12-300-350NS, T10-255-335, T12-300-350, F12-300-380, T10-300-350, T12-300-350NS, F12-300-380NS, T12-215-265, T12-300-380, F12-345-395, T12-215-265NS, and T12-300-380NS
ClassificationClass II
Reason for RecallThere is a possibility that the ISKD limb lengthener may stop distracting post-operatively during treatment, which may result in premature bone consolidation (limb not achieving the desired length) leading to revision surgery to remove and/or replace the device.
Product Quantity1224 ISKD Limb Lengtheners
Recall NumberZ-0895-2013

Class II Drugs Event

Event ID63285
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDr. Reddy's Laboratories, Inc.
CityBridgewater
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionCitalopram tablets USP, 10mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-342-30
Code InfoLot #: C201028, Exp 12/13
ClassificationClass II
Reason for RecallChemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
Product Quantity27,805 bottles
Recall NumberD-178-2013
Product DescriptionCitalopram tablets USP, 20mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-343-30
Code InfoLot #: C201922, Exp 1/14
ClassificationClass II
Reason for RecallChemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
Product Quantity86, 093 bottles
Recall NumberD-179-2013
Product DescriptionCitalopram tablets USP, 40mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-344-30
Code InfoLot #: C108376, C108634, Exp 11/13
ClassificationClass II
Reason for RecallChemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
Product Quantity48, 754 bottles (C108376)/47,520 bottles (C108634)
Recall NumberD-180-2013

Class II Devices Event

Event ID63392
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Medical Systems (Cleveland) Inc
CityCleveland
StateOH
CountryUS
Distribution PatternWorldwide Distribution - USA ( nationwide) including the states of AK, AL, AR, AZ, CA, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, VA, WA, WV and WY, and the countries of Albania, Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Canada, China, Colombia, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Ghana, Gibraltar, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Venezuela, Viet Nam & Yemen.
 

Associated Products

Product DescriptionMx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Code Info1. Brilliance CT 16 slice (water): System Code #, 728245, Serial #s:2506, 2518, 2555, 2558, 2559, 2561, 2561, 2562, 2564, 2567, 2573, 2576, 2578, 2582, 2583, 2584, 2585, 2586, 2587, 2589, 2590, 2592, 2594, 2596, 2597, 3014, 3051, 3090, 3091, 3105, 3151, 3217, 3235, 3272, 3287, 3303, 3312, 3335, 3338, 3339, 3340, 3341, 3342, 3343, 3344, 3345, 3346, 3347, 3348, 3349, 3350, 3351, 3352, 3353, 3354, 3355, 3356, 3357, 3358, 3359, 3359, 3360, 3361, 3362, 3363, 3364, 3365, 3366, 3367, 3368, 3369, 3370, 3371, 3372, 3373, 3374, 3375, 3376, 3377, 3378, 3379, 3380, 3381, 3382, 3383, 3384, 3385, 3386, 3387, 3388, 3389, 3390, 3391, 3392, 3393, 3394, 3395, 3396, 3397, 3398, 3399, 3400, 3401, 3402, 3403, 3404, 3405, 3406, 3407, 3408, 3409, 3410, 3411, 3412, 3413, 3414, 3415, 3416, 3417, 3418, 3419, 3420, 3421, 3422, 3423, 3424, 3425, 3426, 3427, 3428, 3429, 3430, 3431, 3432, 3433, 3434, 3435, 3435, 3436, 3437, 3438, 3439, 3440, 3441, 3442, 3443, 3444, 3445, 3446, 3447, 3448, 3449, 3450, 3451, 3452, 3453, 3454, 3455, 3456, 3457, 3458, 3459, 3460, 3461, 3462, 3463, 3464, 3465, 3466, 3467, 3468, 3469, 3470, 3471, 3472, 3473, 3474, 3475, 3476, 3477, 3478, 3479, 3480, 3481, 3482, 3483, 3484, 3485, 3486, 3487, 3488, 3489, 3490, 3491, 3492, 3493, 3494, 3495, 3496, 3497, 3498, 3499, 3500, 3501, 3502, 3503, 3504, 3505, 3506, 3507, 3508, 3509, 3510, 3511, 3512, 3513, 3514, 3515, 3516, 3517, 5010, 5077, 5119, 6095, 9701, 9708, 9715, 9716, 9718, 9719, 9724, 9728, 9729, 9732, 9741, 9743, 9745, 9746, 9749, 9750, 9754, 9760, 9764, 9771, 9776, 9778, 9780, 9785, 9787, 9788, 9789, 9790, 9794, 9797, 9800, 9801, 9806, 9808, 9810, 9999 & 111111. 2. Brilliance CT 10 slice (water): System Code #, 728250, Serial #s: 2554, 2555, 2556, 2557, 2558, 2559, 2560, 2561, 2562, 2563, 2564, 2565, 2566, 2567, 2568, 2569, 2570, 2571, 2572, 2573, 2574, 2575, 2576, 2577, 2578, 2579, 2580, 2581, 2582, 2583, 2585, 2586, 2587, 2588, 2589, 2590, 2591, 2592, 2593, 2594, 2595, 2596, 2597, 2598, 9704, 9708, 9738 & 9741. 3. Brilliance CT 6 slice (water): System Code #, 728255, Serial #s: 2565, 9701, 9702, 9703, 9704, 9705, 9706, 9707, 9708, 9709, 9710, 9711, 9712, 9713, 9714, 9715, 9716, 9717, 9718, 9719, 9720, 9721, 9722, 9723, 9724, 9725, 9726, 9727, 9728, 9729, 9730, 9731, 9732, 9733, 9734, 9735, 9736, 9737, 9738, 9739, 9740, 9741, 9742, 9743, 9744, 9745, 9746, 9747, 9748, 9749, 9750, 9751, 9752, 9753, 9754, 9755, 9756, 9757, 9758, 9759, 9760, 9761, 9762, 9763, 9764, 9765, 9766, 9767, 9768, 9769, 9770, 9771, 9772, 9773, 9774, 9775, 9776, 9777, 9778, 9779, 9780, 9781, 9782, 9783, 9784, 9785, 9786, 9787, 9788, 9789, 9790, 9791, 9792, 9793, 9794, 9795, 9796, 9797, 9798, 9799, 9800, 9801, 9802, 9803, 9804, 9805, 9806, 9807, 9808, 9810 & 111111. 4. Mx8000 IDT 16 slice System Code #, 728120, Serial #, Serial #s: 1225, 2059, 2345, 2501, 2502, 2506, 2510, 2511, 2513, 2516, 2517, 2518, 2520, 2525, 2528, 2531, 2533, 2535, 2537, 2539, 2546, 2550, 3002, 3006, 3007, 3008, 3012, 3013, 3014, 3017, 3019, 3020, 3021, 3022, 3023, 3024, 3025, 3026, 3027, 3028, 3029, 3030, 3031, 3032, 3034, 3035, 3036, 3037, 3038, 3039, 3040, 3041, 3042, 3043, 3044, 3045, 3046, 3047, 3048, 3049, 3050, 3051, 3052, 3053, 3054, 3055, 3056, 3057, 3058, 3059, 3060, 3061, 3062, 3063, 3064, 3065, 3066, 3067, 3068, 3069, 3070, 3071, 3072, 3073, 3074, 3075, 3076, 3077, 3078, 3079, 3082, 3083, 3084, 3085, 3086, 3087, 3088, 3089, 3090, 3091, 3092, 3093, 3094, 3095, 3096, 3097, 3098, 3099, 3100, 3101, 3102, 3103, 3104, 3105, 3106, 3107, 3108, 3109, 3110, 3111, 3112, 3113, 3114, 3115, 3116, 3117, 3118, 3119, 3120, 3121, 3122, 3123, 3124, 3125, 3126, 3127, 3128, 3129, 3130, 3131, 3132, 3133, 3134, 3135, 3136, 3137, 3138, 3139, 3140, 3141, 3143, 3144, 3145, 3146, 3147, 3148, 3149, 3150, 3151, 3152, 3153, 3154, 3155, 3156, 3157, 3158, 3159, 3160, 3161, 3162, 3163, 3164, 3165, 3167, 3168, 3169, 3170, 3171, 3172, 3173, 3174, 3175, 3176, 3177, 3178, 3179, 3180, 3181, 3182, 3183, 3184, 3185, 3186, 3187, 3188, 3189, 3190, 3191, 3192, 3193, 3194, 3195, 3196, 3197, 3198, 3199, 3200, 3201, 3202, 3203, 3204, 3205, 3206, 3207, 3208, 3209, 3210, 3211, 3212, 3213, 3214, 3215, 3216, 3217, 3218, 3219, 3220, 3221, 3222, 3223, 3224, 3225, 3226, 3227, 3228, 3229, 3230, 3231, 3232, 3233, 3234, 3235, 3236, 3237, 3238, 3239, 3240, 3241, 3242, 3243, 3244, 3245, 3246, 3247, 3248, 3249, 3250, 3251, 3252, 3253, 3254, 3255, 3256, 3257, 3258, 3259, 3260, 3261, 3262, 3263, 3264, 3265, 3266, 3267, 3268, 3269, 3270, 3271, 3272, 3273, 3274, 3275, 3276, 3277, 3278, 3279, 3280, 3281, 3282, 3283, 3284, 3285, 3286, 3287, 3288, 3289, 3290, 3291, 3292, 3293, 3294, 3295, 3296, 3297, 3298, 3299, 3300, 3301, 3302, 3303, 3304, 3305, 3306, 3307, 3308, 3309, 3310, 3311, 3312, 3313, 3314, 3315, 3316, 3317, 3318, 3319, 3320, 3321, 3322, 3323, 3324, 3325, 3326, 3327, 3328, 3329, 3330, 3333, 3336, 3367, 3420, 3480, 4111, 4112, 4114, 4115, 4116, 4117, 4444, 4445, 4446, 4447, 4567, 4799, 5005, 5006, 5007, 5008, 5009, 5011, 5012, 5013, 5014, 5555, 5678, 8888, 9760, 9789, 9900, 9991, 9995, 9997, 9999, 11111, 80159 & 111111. 5. Mx8000 IDT 10 slice: System Code #, 728125, Serial #s: 1225, 1234, 2501, 2502, 2503, 2504, 2505, 2506, 2507, 2508, 2509, 2510, 2511, 2512, 2513, 2514, 2515, 2516, 2517, 2518, 2519, 2520, 2521, 2522, 2523, 2524, 2525, 2526, 2527, 2528, 2529, 2530, 2531, 2532, 2533, 2534, 2535, 2536, 2537, 2538, 2539, 2540, 2541, 2542, 2543, 2544, 2546, 2547, 2548, 2549, 2550, 2551, 2552, 3018, 9999 & 111111. 6. Mx8000 Quad: System Code #, 728200, Serial #s: 2008, 2009, 2011, 2014, 2017, 2022, 2023, 2025, 2027, 2029, 2030, 2031, 2032, 2034, 2035, 2037, 2038, 2041, 2042, 2044, 2045, 2046, 2047, 2048, 2050, 2051, 2055, 2056, 2058, 2059, 2061, 2062, 2063, 2064, 2065, 2068, 2073, 2074, 2075, 2080, 2081, 2084, 2085, 2086, 2089, 2092, 2093, 2095, 2096, 2099, 2100, 2101, 2102, 2103, 2104, 2105, 2109, 2116, 2123, 2125, 2126, 2127, 2128, 2129, 2131, 2132, 2134, 2135, 2136, 2137, 2138, 2139, 2140, 2141, 2142, 2150, 2151, 2152, 2155, 2156, 2158, 2159, 2161, 8118, 9124, 204935 & 2020-1. 7. Mx8000 Dual: System Code #, 728201, Serial #s: 4288, 9000, 9005, 9006, 9008, 9010, 9011, 9012, 9015, 9018, 9020, 9021, 9025, 9027, 9035, 9036, 9037, 9038, 9039, 9042, 9049, 9050, 9055, 9056, 9058, 9059, 9061, 9062, 9063, 9068, 9072, 9076, 9077, 9080, 9084, 9085, 9089, 9090, 9091, 9093, 9094, 9096, 9098, 9103, 9105, 9106, 9108, 9109, 9110, 9120, 9121, 9125, 9131, 9133, 9135, 9136, 9137, 9138, 9139, 9143, 9144, 9146, 9148, 9151, 9155, 9160, 9163, 9169, 9173, 9174, 9175, 9179, 9182, 9184, 9187, 9188, 9194, 9195, 9196, 9197, 9198, 9199, 9200, 9201, 9202, 9205, 9208, 9210, 9211, 9212, 9219, 9220, 9222, 9228, 9231, 9232, 9239, 9240, 9241, 9242, 9249, 9250, 9254, 9257, 9258, 9259, 9260, 9261, 9262, 9266, 9267, 9269, 9270, 9271, 9272, 9273, 9274, 9278, 9279, 9280, 9281, 9284, 9285, 9288, 9290, 9292, 9294, 9295, 9296, 9297, 9299, 9300, 9301, 9307, 9308, 9317, 9320, 9324, 9327, 9328, 9331, 9332, 9334, 9336, 9339, 9351, 9352, 9354, 9357, 9361, 9362, 9363, 9364, 9365, 9367, 9368, 9369, 9370, 9372, 9376, 9377, 9378, 9380, 9384, 9387, 9396, 9397, 9405, 9407, 9411, 9412, 9417, 9423, 9426, 9427, 9428, 9429, 9431, 9433, 9445, 9446, 9447, 9465, 9466, 9467, 9469, 9471, 9472, 9473, 9474, 9476, 9477, 9482, 9483, 9484, 9487, 9488, 9489, 9490, 9493, 9496, 9497, 9500, 9509, 9510, 9515, 9521, 9522, 9529, 9530, 9532, 9537, 9538, 9539, 9540, 9541, 9542, 9543, 9544, 9549, 9551, 9552, 9553, 9555, 9561, 9563, 9574, 9576, 9577, 9584, 9585, 9588, 9592, 9593, 9598, 9599, 9600, 9601, 9603, 9606, 225637, 226925, 235225, 238067, 999030, 9122A, 9347A, 9361-1 & 9586-1. 8. Mx8000 Dual exp: System Code #, 728130, Serial #, Serial #s: 2110, 3291, 6005, 8008, 8010, 8014, 8016, 8018, 8021, 8023, 8025, 8034, 8035, 8039, 8040, 8041, 8043, 8046, 8048, 8053, 8054, 8055, 8056, 8057, 8058, 8061, 8064, 8065, 8066, 8067, 8068, 8070, 8073, 8074, 8075, 8076, 8077, 8078, 8079, 8080, 8081, 8082, 8083, 8084, 8085, 8086, 8091, 8092, 8095, 8096, 8097, 8098, 8102, 8103, 8104, 8105, 8106, 8107, 8108, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, 8119, 8120, 8122, 8123, 8124, 8125, 8126, 8127, 8128, 8129, 8130, 8131, 8132, 8134, 8135, 8136, 8137, 8138, 8139, 8140, 8142, 8143, 8144, 8145, 8146, 8147, 8149, 8150, 8151, 8152, 8153, 8154, 8155, 8156, 8157, 8158, 8159, 8160, 8162, 8163, 8164, 8165, 8166, 8167, 8168, 8169, 8171, 8172, 8173, 8174, 8175, 8176, 8177, 8178, 8180, 8181, 8183, 8184, 8185, 8186, 8187, 8188, 8190, 8191, 8192, 8193, 8194, 8195, 8196, 8197, 8198, 8199, 8200, 8201, 8202, 8203, 8204, 8205, 8206, 8207, 8208, 8210, 8211, 8212, 8213, 8215, 8216, 8217, 8218, 8219, 8220, 8221, 8222, 8223, 8224, 8225, 8226, 8227, 8228, 8229, 8230, 8232, 8233, 8234, 8235, 8236, 8237, 8238, 8239, 8240, 8242, 8243, 8244, 8245, 8246, 8247, 8248, 8249, 8250, 8253, 8254, 8255, 8256, 8257, 8258, 8259, 8260, 8261, 8262, 8263, 8264, 8265, 8266, 8267, 8268, 8269, 8270, 8271, 8272, 8273, 8274, 8275, 8276, 8277, 8278, 8279, 8280, 8281, 8282, 8283, 8284, 8285, 8286, 8287, 8288, 8289, 8290, 8291, 8292, 8293, 8294, 8295, 8296, 8297, 8298, 8299, 8300, 8301, 8302, 8303, 8304, 8305, 8306, 8307, 8308, 8309, 8310, 8311, 8312, 8313, 8314, 8315, 8316, 8317, 8318, 8319, 8320, 8321, 8322, 8323, 8324, 8325, 8326, 8327, 8328, 8329, 8330, 8331, 8332, 8333, 8334, 8335, 8336, 8337, 8338, 8339, 8340, 8341, 8342, 8343, 8344, 8345, 8346, 8347, 8349, 8350, 8351, 8352, 8353, 8354, 8355, 8356, 8357, 8358, 8359, 8360, 8361, 8362, 8363, 8364, 8365, 8366, 8367, 8368, 8369, 8370, 8371, 8372, 8373, 8374, 8375, 8376, 8377, 8378, 8379, 8380, 8381, 8382, 8383, 8384, 8385, 8386, 8387, 8388, 8389, 8390, 8391, 8392, 8393, 8394, 8395, 8396, 8398, 8400, 8401, 8402, 8403, 8404, 8405, 8406, 8407, 8409, 8410, 8411, 8412, 8413, 8442, 9528, 80002, 80003, 80004, 80005, 80007, 80009, 80010, 80011, 80012, 80013, 80014, 80015, 80016, 80017, 80018, 80019, 80021 & 80022.
ClassificationClass II
Reason for RecallThe low contrast pins in the Image Quality (IQ) phantom deteriorates over time. This prevents the customers from doing the Daily Image Quality Checks as defined in the current Instructions for Use (IfU).
Product Quantity1,474 Units
Recall NumberZ-0786-2013

Class II Devices Event

Event ID63674
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Healthcare Inc.
CityAndover
StateMA
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide and the Foreign countries of: Austria, Canada, Belgium, China,Denmark, France, germany, Italy, Netherlands,New Zealand, Norway, Philippines, Portugual, SOuth Korea, Spain, Switzerland, Thailand, and UK.
 

Associated Products

Product DescriptionPhilips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system
Code InfoSystems with Eleva SW version 2.1.3
ClassificationClass II
Reason for RecallWhen the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.
Product Quantity551
Recall NumberZ-0884-2013

Class II Biologics Event

Event ID63752
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHCSC-Blood Center
CityBethlehem
StatePA
CountryUS
Distribution PatternPennsylvania
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW050912011395;
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed
Product Quantity1
Recall NumberB-0588-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW050912011395;
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed
Product Quantity1
Recall NumberB-0589-13

Class II Biologics Event

Event ID63753
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Nov-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmInterstate Blood Bank, Inc. of Wisconsin
CityMilwaukee
StateWI
CountryUS
Distribution PatternCalifornia; Germany,
 

Associated Products

Product DescriptionSource Plasma
Code Info12MKEC2429; 12MKEC1768; 12MKEC1541; YP037568; 12MKEC0329; YP037263; 12MKEB9768; 12MKEB9345; 12MKEB8835; 12MKEB8518; 12MKEB8146; 12MKEB7593; 12MKEB7276; 12MKEB6896; 12MKEB6468; 12MKEB5975; 12MKEB5649;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred, were distributed.
Product Quantity17
Recall NumberB-0590-13

Class II Biologics Event

Event ID63754
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Oct-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmUpstate New York Transplant Services
CityBuffalo
StateNY
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW280312701355;
ClassificationClass II
Reason for RecallBlood product, which did not meet acceptable product specifications, was distributed.
Product Quantity1
Recall NumberB-0591-13

Class II Biologics Event

Event ID63755
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Oct-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmSuncoast Communities Blood Bank, Inc.
CitySarasota
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW038612721688 Part A ; W038612721688 Part B;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity2
Recall NumberB-0592-13

Class II Biologics Event

Event ID63757
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCarter BloodCare
CityBedford
StateTX
CountryUS
Distribution PatternAustria; Texas
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW0352112740220;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred, were distributed
Product Quantity1
Recall NumberB-0593-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW0352112740220;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred, were distributed
Product Quantity1
Recall NumberB-0594-13

Class II Biologics Event

Event ID63764
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Sep-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmNew York Blood Center, Inc.
CityWestbury
StateNY
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW0470100844570; W047009516690;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred, were distributed.
Product Quantity2
Recall NumberB-0610-13

Class II Devices Event

Event ID63822
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Medical Systems (Cleveland) Inc
CityCleveland
StateOH
CountryUS
Distribution PatternWorldwide Distribution - USA including AK, AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, OA MA, MD MI, MN, MO, MS, NC, D, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV; Internationally to Canada and other countries..
 

Associated Products

Product DescriptionPhilips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244.
Code InfoBrilliance CT Big Bore - Model #728243 - Serial Numbers: 7006, 7007, 7008, 7009, 7013, 7014, 7015, 7016, 7017, 7018, 7019, 7020, 7021, 7022, 7023, 7024, 7025, 7026, 7027, 7028, 7029, 7030, 7031, 7032, 7033, 7034, 7035, 7036, 7037, 7038, 7039, 7040, 7041, 7042, 7043, 7044, 7045, 7046, 7047, 7048, 7049, 7050, 7051, 7053, 7054, 7055, 7056, 7057, 7058, 7059, 7060, 7061, 7062, 7063, 7064, 7065, 7066, 7067, 7068, 7069, 7070, 7071, 7072, 7073, 7074, 7075, 7076, 7077, 7078, 7079, 7080, 7081, 7082, 7083, 7084, 7085, 7086, 7087, 7088, 7089, 7090, 7091, 7092, 7093, 7094, 7095, 7096, 7097, 7098, 7099, 7100, 7101, 7102, 7103, 7104, 7105, 7106, 7107, 7108, 7109, 7110, 7111, 7112, 7113, 7114, 7115, 7116, 7117, 7118, 7119, 7120, 7122, 7123, 7124, 7125, 7126, 7127, 7128, 7129, 7130, 7131, 7132, 7133, 7134, 7135, 7136, 7137, 7138, 7139, 7140, 7141, 7142, 7143, 7144, 7145, 7146, 7147, 7148, 7149, 7150, 7151, 7152, 7153, 7154, 7156, 7157, 7158, 7159, 7160, 7161, 7162, 7163, 7164, 7165, 7166, 7167, 7168, 7169, 7170, 7171, 7173, 7174, 7175, 7177, 7178, 7179, 7181, 7183, 7184, 7185, 7186, 7187, 7188, 7189, 7191, 7192, 7193, 7194, 7195, 7196, 7197, 7198, 7199, 7201, 7202, 7203, 7204, 7205, 7206, 7207, 7208, 7209, 7210, 7211, 7212, 7213, 7214, 7215, 7216, 7217, 7218, 7219, 7220, 7221, 7222, 7223, 7224, 7225, 7226, 7227, 7228, 7229, 7230, 7231, 7232, 7233, 7234, 7235, 7236, 7237, 7238, 7239, 7240, 7241, 7242, 7243, 7245, 7246, 7247, 7248, 7249, 7250, 7251, 7253, 7254, 7255, 7256, 7257, 7258, 7259, 7260, 7261, 7262, 7263, 7265, 7266, 7267, 7269, 7270, 7272, 7273, 7274, 7275, 7276, 7277, 7278, 7279, 7280, 7281, 7282, 7283, 7284, 7285, 7286, 7287, 7288, 7289, 7290, 7291, 7292, 7293, 7294, 7295, 7296, 7297, 7299, 7300, 7302, 7304, 7305, 7306, 7307, 7308, 7309, 7310, 7311, 7312, 7313, 7314, 7315, 7316, 7317, 7319, 7320, 7321, 7322, 7323, 7324, 7325, 7326, 7327, 7328, 7329, 7330, 7331, 7332, 7333, 7334, 7335, 7336, 7337, 7338, 7339, 7340, 7341, 7342, 7343, 7344, 7345, 7346, 7347, 7348, 7349, 7350, 7351, 7352, 7353, 7354, 7355, 7356, 7357, 7358, 7359, 7360, 7361, 7362, 7363, 7364, 7365, 7366, 7367, 7368, 7369, 7370, 7371, 7372, 7373, 7374, 7376, 7377, 7378, 7379, 7381, 7382, 7385, 7387, 7388, 7389, 7391, 7392, 7393, 7394, 7395, 7397, 7398, 7399, 7400, 7401, 7403, 7404, 7405, 7406, 7409, 7410, 7411, 7412, 7413, 7414, 7415, 7416, 7417, 7418, 7419, 7420, 7421, 7422, 7423, 7424, 7425, 7426, 7428, 7429, 7431, 7432, 7433, 7434, 7435, 7436, 7437, 7438, 7440, 7441, 7442, 7443, 7444, 7445, 7446, 7447, 7448, 7449, 7450, 7451, 7454, 7455, 7456, 7457, 7459, 7462, 7463, 7464, 7465, 7466, 7467, 7468, 7469, 7470, 7471, 7472, 7473, 7474, 7475, 7476, 7477, 7478, 7479, 7480, 7481, 7482, 7483, 7484, 7485, 7487, 7488, 7489, 7490, 7491, 7492, 7493, 7494, 7495, 7496, 7497, 7498, 7499, 7500, 7501, 7502, 7503, 7504, 7505, 7506, 7507, 7508, 7509, 7511, 7512, 7513, 7515, 7516, 7517, 7518, 7519, 7521, 7522, 7523, 7524, 7526, 7527, 7528, 7530, 7531, 7532, 7534, 7535, 7537, 7539, 7540, 7542, 7544, 7545, 7547, 7548, 7549, 7550, 7551, 7552, 7553, 7554, 7555, 7556, 7558, 7559, 7560, 7561, 7562, 7564, 7565, 7566, 7568, 7569, 7573, 7574, 7577, 7578, 7579, 7580, 7581, 7582, 7584, 7585, 7588, 7589, 7590, 7591, 7592, 7593, 7596, 7597, 7598, 7599, 7601, 7602, 7603, 7605, 7608, 7609, 7611, 7612, 7613, 7615, 7616, 7617, 7618, 7620, 7622, 7623, 7624, 7626, 7627, 7628, 7629, 7630, 7634, 7635, 7637, 7638, 7639, 7640, 7641, 7642, 7643, 7644, 7645, 7646, 7647, 7648, 7649, 7650, 7652, 7655, 7656, 7657, 7658, 7659, 7661, 7662, 7663, 7665, 7666, 7667, 7671, 7672, 7673, 7674, 7675, 7677, 7678, 7679, 7680, 7681, 7682, 7684, 7685, 7686, 7687, 7689, 7690, 7691, 7693, 7695, 7696, 7698, 7699, 7700, 7701, 7702, 7703, 7704, 7705, 7706, 7707, 7709, 7715, 7716, 7718, 7720, 7724, 7725, 7727, 7729, 7730, 7731, 7735, 7736, 7737, 7739, 7740, 7741, 7743, 7744, 7745, 7749, 7750, 7751, 7752, 7753, 7754, 7755, 7757, 7758, 7759, 7761, 7762, 7763, 7765, 7768, 7769, 7770, 7774, 7775, 7776, 7777, 7779, 7782, 7783, 7784, 7785, 7786, 7787, 7788, 7791, 7793, 7794, 7795, 7796, 7797, 7799, 7800, 7801, 7802, 7803, 7806, 7807, 7808, 7810, 7811, 7812, 7814, 7815, 7818, 7820, 7823, 7824, 7827, 7828, 7833, 7834, 75000, 7536, 7541, 7688, 7595, 7572, 7636, 7268, 7614, 7190, 7529, 7600, 7402, 7710, 7571, 7654, 7252, 7632, 7453, 7244, 7486, 7533, 7557, 7538, 7607, 7708, 7052, 7660, 7407, 7384, 7576, 7318, 7427, 7390, 7546, 7668, 7651, 7587, 7697, 7200, 7172, 7121, 7375, 7396, 7408, 7586, 7452, 7514, 7683, 7631, 7510, 7380, 7543, 7430, 7621, 7301, 7528, 7383, 7155, 7520, 7439, 7610, 7619, 7180, 7386, 7525, 7570, 7271, 7694, 7653, 7575, 7458, 7676, 7583, 7182, 7176, 7669, and 7604.
ClassificationClass II
Reason for RecallSoftware anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Projection data set is used in the radiation therapy workflow, then this may result in unintended delivery of radiation to healthy tissue and/or failure to deliver radiation to the target lesion.
Product Quantity765 units
Recall NumberZ-0880-2013
Product DescriptionPhilips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.
Code InfoThe EBW Serial Numbers subject to software updates are as follows: 8222, 8235, 8270, 8838, 8841, 8862, 9014, 9019, 9127, 10331, 10348, 10402, 10705, 10749, 10827, 11002, 11362, 11365, 11588, 11597, 11652, 11693, 11704, 11724, 11725, 11828, 11857, 11861, 11945, 11949, 11950, 11951, 11952, 11953, 11954, 11955, 11956, 11957, and 11979.
ClassificationClass II
Reason for RecallSoftware anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Projection data set is used in the radiation therapy workflow, then this may result in unintended delivery of radiation to healthy tissue and/or failure to deliver radiation to the target lesion.
Product Quantity39 units
Recall NumberZ-0881-2013
Product DescriptionPhilips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Code InfoThe affected GEMINI systems are identified with the following Serial Numbers: GEMINI LXL Model # 882412, Serial Numbers: 14702 and 14707; GEMINI TF 16 Model #882470, Serial Numbers: 7129, 7121, 7123, 7128, 7096, 7133, 7185, 7187, 7226, and 7220; GEMINI TF 16, Model #882473, Serial Numbers: 7150, and and 7237;GEMINI TF 64, Model #882471, Serial Numbers: 7103, 7126, 7132, 7158, 7160, 7164, 7175, 7178, 7179, 7218, 7229, 7221, 7245, 7550, 7255, and 7256.
ClassificationClass II
Reason for RecallSoftware anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Projection data set is used in the radiation therapy workflow, then this may result in unintended delivery of radiation to healthy tissue and/or failure to deliver radiation to the target lesion.
Product Quantity30 units
Recall NumberZ-0882-2013
Product DescriptionPhilips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Code InfoThe affected GEMINI Big Bore system is identified with the following Serial Numbers: 9004, 9005, 9006, 9008 ,9009, 9010, 9011, 9012, 9013, 9014, 9014, 9016, 9017, 9018, 9019, 9020, 9021, 9022, 9023, 9201, 9202, 9203, 9204, 9205, 9205, 9206, 9207, 9208, 9209, 9210, 9213, 9214, 9215, 9216, 9217, 9218, 9219, 9220, and 9221.
ClassificationClass II
Reason for RecallSoftware anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Projection data set is used in the radiation therapy workflow, then this may result in unintended delivery of radiation to healthy tissue and/or failure to deliver radiation to the target lesion.
Product Quantity37
Recall NumberZ-0883-2013

Class II Food Event

Event ID63894
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Dec-12
Initial Firm Notification of Consignee or Public Visit
Recalling FirmProductos 2001 Inc.
CityHatillo
StatePR
CountryUS
Distribution PatternPR Only (retailers at the north side of the Island)
 

Associated Products

Product Description"***Productos 2001**Plantillas para Pastelillos-Empanadillas-Tacos-Cheese Dog y Otros (dough rounds for tacos and turnovers)***18 units***Keep refrigerated***NET WT. 28 oz***"
Code Infonone
ClassificationClass II
Reason for RecallUndeclared allergens: FD&C Yellow #5, Yellow# 6, Red #40.
Product Quantity3,925 packages (18 units each)
Recall NumberF-1023-2013

Class II Drugs Event

Event ID63926
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmedra Pharmaceuticals LLC
CityHorsham
StatePA
CountryUS
Distribution PatternNationwide and Puerto Rico.
 

Associated Products

Product DescriptionDextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09
Code InfoLot 238316, exp 01/31/2014
ClassificationClass II
Reason for RecallFailed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Product Quantity1,176 bottles
Recall NumberD-171-2013
Product DescriptionDextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09
Code InfoLot 220839, exp 11/30/2013
ClassificationClass II
Reason for RecallFailed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Product Quantity12,948 bottles
Recall NumberD-172-2013
Product DescriptionDextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-329-09
Code InfoLot 220843, exp 11/30/2013
ClassificationClass II
Reason for RecallFailed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Product Quantity10,968 bottles
Recall NumberD-173-2013

Class II Devices Event

Event ID63957
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmIntel-GE Care Innovations LLC
CityRoseville
StateCA
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionQuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.
Code InfoAll units of this model.
ClassificationClass II
Reason for RecallCare Innovations detected a software anomaly: During the engineering investigation into the cause of why a Wander Alert was not generated, a defect in the implementation of the Wander and Night Motion ADLs was discovered.
Product Quantity19 units
Recall NumberZ-0877-2013

Class II Drugs Event

Event ID64083
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira, Inc.
CityRocky Mount
StateNC
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionFurosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- NDC 0409-6102-04
Code Info18-099-DK
ClassificationClass II
Reason for RecallLack of Assurance of Sterility; possible loose crimp applied to fliptop vial
Product Quantity63,900 vials
Recall NumberD-169-2013

Class II Drugs Event

Event ID64106
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmWest-ward Pharmaceutical Corp.
CityEatontown
StateNJ
CountryUS
Distribution PatternGA
 

Associated Products

Product DescriptionIsoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100 tablets - NDC 61748-013-01, Mfd for: VersaPharm Incorporated Marietta, GA 30065-1505, Mfd by: West - Ward Pharmaceutical Corp.., Eatontown, NJ 07724
Code Info67079A; 67079B; 67079C
ClassificationClass II
Reason for RecallFailed Dissolution Specifications; 36 month stability timepoint
Product Quantity77531 bottles
Recall NumberD-174-2013

Class II Drugs Event

Event ID64107
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmWest-ward Pharmaceutical Corp.
CityEatontown
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionBelladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065 mg) with Phenobarbital (USP 16.2 mg) Tablets, packaged in a) 1000-count tablets per bottle (NDC 0143-1140-10; b) 5000-count tablets per bottle (NDC 143-1140-51); Rx only, Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724
Code InfoLot #: 69099A, 69099B, Exp 08/15
ClassificationClass II
Reason for RecallPresence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
Product Quantity6,511 bottles
Recall NumberD-170-2013

Class II Devices Event

Event ID64134
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionGE Healthcare Definium 5000 / 5220493 X-Ray System This expected use for this product is intended to take diagnostic radiographic exposures of the skull, spinal column, chest, extremities, abdomen and other body parts.
Code InfoDefinium Model 5000/5220493
ClassificationClass II
Reason for RecallIt was discovered GE Healthcare had become aware of a software issue associated with the user interface of Definium 5000.
Product Quantity312 installed in US
Recall NumberZ-0703-2013
Product DescriptionGE Healthcare Definium 5000/5220493-2 X-Ray System .This expected use for this product is intended to take diagnostic radiographic exposures of the skull, spinal column, chest, extremities, abdomen and other body parts.
Code Info Definium Model 5000/5220493-2
ClassificationClass II
Reason for RecallIt was discovered GE Healthcare had become aware of a software issue associated with the user interface of Definium 5000.
Product Quantity312 installed in US
Recall NumberZ-0704-2013

Class II Drugs Event

Event ID64198
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Dec-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmPacira Pharmaceuticals, Inc.
CitySan Diego
StateCA
CountryUS
Distribution PatternNationwide distribution: AZ, DC, FL, GA, MA, NJ, NY, OH, and TX.
 

Associated Products

Product DescriptionEXPAREL (bupivacaine liposome injectable suspension), 1.3%, 266 mg/20 mL (13.3 mg/mL) single use vials, INVESTIGATIONAL USE. For Infiltration Only. Not for any other route of administration. Manufactured by Paelra Pharmaceuticals. Inc., San Diego, California, USA
Code InfoLot #11-2005 Control #23542 Manufacture Date: 05Dec11 2011-L-009
ClassificationClass II
Reason for RecallSubpotent; bupivacaine
Product Quantity324 vials
Recall NumberD-168-2013

Class II Biologics Event

Event ID64205
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLions Eye Institute for Transplant & Research, Inc.
CityTampa
StateFL
CountryUS
Distribution PatternIndonesia; Egypt; Mexico; Saudi Arabia; Florida; Missouri; New Jersey; Dominican Republic
 

Associated Products

Product DescriptionCornea
Code Info2012010601; 2012032093; 2012042243; 2012042299; 2012053203; 2012053261; 2012064195; 2012074467; 2012074497; 2012074999; 2012085207; 2012096095; 2012106947; 2012107037; 2012107087; 2012107203; 2012107253; 2012128065; 2012128281; 2012128317; 2011127530; 2011127666; 2012010602; 2012032094; 2012042244; 2012042300; 2012053204; 2012053262; 2012064196; 2012074468; 2012074498; 2012075000; 2012085208; 2012096096; 2012106948; 2012107038; 2012107088; 2012107204; 2012107254; 2012117420; 2012128066; 2012128282; 2012031727; 2012021505; 2012021506; 2012021291; 2012021292; 2011127529; 2011127665
ClassificationClass II
Reason for RecallHuman Corneas, recovered from a donor whose donor screening may have been performed in a manner that did not determine the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Product Quantity49
Recall NumberB-0970-13

Class II Biologics Event

Event ID64208
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Dec-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services Heart of America Region
CityPeoria
StateIL
CountryUS
Distribution PatternIllinois, Oklahoma
 

Associated Products

Product DescriptionCryoprecipitated AHF, Pooled
Code Info22638; 22639; 22640; 22641; 22642; 22643; 22644; 22645; 22599; 22600; 22601; 22604; 22605; 22606; 22607; 22608; 22609; 22610; 22611; 22612; 22614; 22615; 22616; 22617; 22618; 22619; 22620; 22621; 22622; 22624; 22625; 22626; 22627; 22628; 22629; 22630; 22631; 22632; 22633; 22634; 22635; 22636; 22637; 22729; 22648; 22649; 22650; 22651; 22652; 22653; 22716; 22718; 22731; 22654; 22655; 22656; 22657; 22658; 22659; 22660; 22661; 22662; 22663; 22664; 22665; 22666; 22667; 22668; 22669; 22670; 22671; 22675; 22678; 22680; 22681; 22682; 22683; 22684; 22686; 22687; 22688; 22689; 22690; 22691; 22692; 22693; 22694; 22695; 22696; 22697; 22701; 22714; 22715; 22719; 22720; 22721; 22724; 22726; 22727; 22728; 22735; 22737; 22750; 22752; 22754; 22763; 22764; 22768; 22771; 22776; 22777; 22779; 22780; 22781; 22782
ClassificationClass II
Reason for RecallCryoprecipitated AHF, which failed to meet the minimum potency of 80IU of AHF (Factor VIII), was distributed.
Product Quantity115
Recall NumberB-0968-13
Product DescriptionCryoprecipitated AHF
Code Info40FC25610; 40FL47750; 40FL47755; 40GG25279; 40GT74300; 40GZ46302; 40K08469; 40LM12864; 40LT59262; 40LT59302; 40LT59322; 40LT59338; 40LX27007; 40LX27012; 40LZ36145
ClassificationClass II
Reason for RecallCryoprecipitated AHF, which failed to meet the minimum potency of 80IU of AHF (Factor VIII), was distributed.
Product Quantity15
Recall NumberB-0969-13

Class II Devices Event

Event ID64213
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jan-13
Initial Firm Notification of Consignee or Public Other
Recalling FirmElekta, Inc.
CityAtlanta
StateGA
CountryUS
Distribution PatternNationwide Distribution including TX
 

Associated Products

Product DescriptionElekta, Apex add-on Micro MLC, collimator for radiation therapy.
Code Info152652
ClassificationClass II
Reason for RecallIf the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions.
Product Quantity1
Recall NumberZ-0885-2013

Class II Devices Event

Event ID64226
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternNationwide Distribution including NM, WY, FL, MO, MA, and MI.
 

Associated Products

Product DescriptionGE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
Code InfoModel Number : 5271997
ClassificationClass II
Reason for RecallGE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.
Product Quantity9 units installed in US
Recall NumberZ-0761-2013

Class II Devices Event

Event ID64228
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmCellestis Inc
CitySanta Clarita
StateCA
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Ireland, Israel, Jordan, Luxembourg, Mexico, Netherlands, New Zealand, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, South Africa, Switzerland, and Turkey.
 

Associated Products

Product DescriptionVACUETTE Cellestis 1 ml QuantiFERON® - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.,1200 pcs. in total; Product Usage: QuantiFERON®-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood.
Code InfoCat # 0592-0201; Lot A111103N Exp 28 FEB, 2013
ClassificationClass II
Reason for RecallCellestis is recalling QuantiFERON® - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.
Product Quantity309,400 units
Recall NumberZ-0888-2013
Product DescriptionVacuette Cellestis 1 ml QuantiFERON® TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. greiner bio-one; 13x75 50pcs.,1200 pcs in total. Product Usage: QuantiFERON®-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood.
Code InfoCat # 0592-0501; Lot A111103M; Exp 28 FEB, 2013
ClassificationClass II
Reason for RecallCellestis is recalling QuantiFERON® - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.
Product Quantity29,690 units
Recall NumberZ-0889-2013

Class II Devices Event

Event ID64235
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMedical Components, Inc dba MedComp
CityHarleysville
StatePA
CountryUS
Distribution PatternUSA Nationwide Distribution including the state of PA.
 

Associated Products

Product DescriptionREF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits
Code InfoLots numbers MBKQ640, exp 05/2015; MBKZ720, exp 05/2015; MBLJ290, exp 06/2015; MBLR100, exp 07/2015; MBLZ350, exp 09/2015; and MBMG250, exp 10/2015.
ClassificationClass II
Reason for RecallThis recall is being initiated due to the affected product being packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.
Product Quantity785
Recall NumberZ-0898-2013

Class II Food Event

Event ID64245
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAptalis Pharma Us Inc
CityBirmingham
StateAL
CountryUS
Distribution PatternNationwide, Italy, Canada, and Brazil
 

Associated Products

Product DescriptionSourceCF(R) Pediatric Drops, Multivitamins with A, B, D, E and K Plus Zinc, 2 FL OZ. (60ML), NDC 66212-300-60, UPC 668212300600
Code Info1BA67, exp Mar 13; 1DC02, exp Jun 13; 2BA86, exp Apr 14; 2FA92, exp Aug13.
ClassificationClass II
Reason for RecallThe data suggests that the formulation does not support the shelf life of the product as labeled.
Product Quantity14439 units
Recall NumberF-1008-2013

Class II Devices Event

Event ID64250
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBaylis Medical Company Inc.
CityMississauga
StateON
CountryCA
Distribution PatternInternational distribution to the country of Australia.
 

Associated Products

Product DescriptionBMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined number of white shelf-boxes are then placed into shipping cartons (tertiary packaging). The BMC RF Cannula is intended for use in radiofrequency heat lesion procedures for relief of pain.
Code InfoDevice Model #: 1 PMF 16-145-10CS. Lot number: PFFB 190811.
ClassificationClass II
Reason for RecallA report of an event was received indicating that upon opening a box containing 10 sterile cannula by a nurse, the pouch package of 5 of the 10 individually packaged cannula had not been sealed along one edge. Thus the pouch was open and the device could fall out of the pouch and on to the floor when retrieved from the shelf box. The cannulas were not used on any patients, as the unsealed packages were identified prior to use.
Product Quantity1780
Recall NumberZ-0879-2013

Class II Devices Event

Event ID64265
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOrthofix, Inc
CityLewisville
StateTX
CountryUS
Distribution PatternWorldwidewide Distribution - USA Nationwide including Puerto Rico and the countries of: Australia, Lebanon, Germany, Spain, Sweden and Israel.
 

Associated Products

Product DescriptionFirebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for rod components to be connected side-to-side, or end-to-end and eliminate the need of rebuilding the entire system with a longer rod in order to include the new vertebral levels.
Code InfoCatalog Numbers: 52-6800 & 52-6700; All Lot Numbers
ClassificationClass II
Reason for RecallThere is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly (p/n 52-6800) & Axial Rod Connector (p/n 52-6700) may crack during final tightening. Orthofix Inc received six (6) customer complaints related to set screw cracking between November 15, 2010 and December 2012.
Product Quantity565 total (287 PN 52-6800 and 278 PN 52- 6700)
Recall NumberZ-0896-2013

Class II Biologics Event

Event ID64268
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Dec-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmIndiana Lions Eye and Tissue Transplant Bank
CityIndianapolis
StateIN
CountryUS
Distribution PatternSaudi Arabia; Indiana
 

Associated Products

Product DescriptionCornea
Code InfoCN100033OS; CN100033OD
ClassificationClass II
Reason for RecallHuman Corneas, recovered from a donor whose donor screening was performed in a manner that did not determine 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
Recall NumberB-0967-13

Class II Devices Event

Event ID64294
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Jan-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMedacta Usa Inc
CityCamarillo
StateCA
CountryUS
Distribution PatternNationwide Distribution including the states of ID, CO, TX, WI, NY, CT, WA, CA, UT, and AZ.
 

Associated Products

Product DescriptionVersafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136 (52mm), 01.26.10.0137 (54mm), 01.26.10.0138 (56mm), 01.26.10.0139 (58mm), 01.26.10.0140 (60mm), 01.26.10.0141 (62mm), 01.26.10.0142 (64mm). Designed for cementless use in total hip arthroplasty.
Code InfoReference Number Lot Number Reference Number Lot Number 01.26.10.0133: 095920, 096050, 096050A; 01.26.10.0138: 095925, 096055, 096055A; 01.26.10.0134: 095921, 096051, 096051A; 01.26.10.0139: 095926, 096056, 096056A; 01.26.10.0135: 095922, 096052, 096052A; 01.26.10.0140: 095927, 096057, 096057A; 01.26.10.0136: 095923, 096053, 096053A; 01.26.10.0141: 095928, 096058, 096058A; 01.26.10.0137: 095924, 096054, 096054A; 01.26.10.0142: 095929, 096059, 096059A.
ClassificationClass II
Reason for RecallMedacta USA is recalling Versafitcup Impacting Ring because the impaction ring may not fit properly in the implant shell in all cases. This could result in surgical delay potentially increasing possible complications under anesthesia, having to ream up to a larger shell size leaving less bone than planned and repositiong/removal of the shell after initial impaction.
Product Quantity293 units
Recall NumberZ-0878-2013

Class II Devices Event

Event ID64313
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Spine
CityAllendale
StateNJ
CountryUS
Distribution PatternNationwide Distribution including the states of AL, AZ, CA, CO, FL, GA, IA, IL,IN, KS, LA, MA, MD, MI, MO, MN, NC, NY. OH, OK, OR, PA, TN, TX, UT and WI.
 

Associated Products

Product DescriptionStryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial screws into the Ilium. This device is not intended to sustain or support life.
Code InfoCatalog Number: 48231326. Lot Number: 10G637; 10G638 and 10E852.
ClassificationClass II
Reason for RecallComplaints have been reported indicating that surgeons have experienced unthreading of the screwdrivers outer shafts during use.
Product Quantity46 units US
Recall NumberZ-0893-2013

Class II Devices Event

Event ID64316
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Feb-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmOculus Innovative Sciences Inc
CityPetaluma
StateCA
CountryUS
Distribution Pattern"Nationwide Distribution - One distributor in PA "
 

Associated Products

Product DescriptionAtrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, Professional Sample, Not for Sale. Pre-printed tube: MS31071, Shelf carton: PL51091-08 Atrapro Antipruritic HydroGel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis and atopic dermatitis.
Code InfoLot 12A0012, Exp 2/2013; Lot 12A0013, Exp 2/2013: Lot 12A1116, Exp 2.2013; Lot 12A1119, Exp 2/2013; Lot 12B1144, Exp 3/2013; Lot 12B1148, Exp 3/2013; Lot 12C1157, Exp 4/2013; Lot 12E190. Exp 6/2013; Lot 12E194, Exp 6/2013; Lot 12E198, Exp 6/2013; Lot 12E202. Exp 6/2013; Lot 12E208, Exp 6/2013; Lot 12E211, Exp 6/2013.
ClassificationClass II
Reason for RecallOut of specification result - stability test failure of free available chlorine (FAC) which functions as a preservative for the hydrogel. The 13 month test result obtained was 4 ppm FAC and the stability specification is >10 ppm FAC.
Product Quantity56,566 1.5 oz tubes
Recall NumberZ-0890-2013

Class II Devices Event

Event ID64322
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMc-NEIL-PPC, Inc.
CitySkillman
StateNJ
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionKY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.
Code InfoTube UPC: 380040085503 Case Code(s): 008550 V21, 008550 V00 Outer case UPC Code: 103800400855000215 Outer case UPC Code: 103800400855000000 Outer case Display UPC Code: 00380041153300
ClassificationClass II
Reason for RecallThis product is not cleared for marketing in the US.
Product Quantity1,185,664 units
Recall NumberZ-0873-2013
Product DescriptionKY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.
Code InfoCarton: 380040087149 Case Code: 008714 V05 Outer case UPC Code: 103800400871460055 Outer case Display UPC Code: 00380041153300
ClassificationClass II
Reason for RecallThis product is not cleared for marketing in the US.
Product Quantity750,264 units
Recall NumberZ-0874-2013
Product DescriptionKY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it. Distributed By: McNeil-PPC Inc.
Code InfoTube UPC: 380040088887 Case Code(s): 008888 V21, 008888 V00 Outer Case UPC: 103800400888840215, 103800400888840000
ClassificationClass II
Reason for RecallThis product is not cleared for marketing in the US.
Product Quantity425,304 units
Recall NumberZ-0875-2013

Class II Devices Event

Event ID64357
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmIntegra LifeSciences Corp.
CityPlainsboro
StateNJ
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide including Canada.
 

Associated Products

Product DescriptionIntegra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290) Product Usage: Endoscopic Instruments - For use by, or as directed by, a surgeon in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar Cable - Monopolar electrosurgical current can be used for coagulation and/or cutting as determined necessary and appropriate by the surgeon.
Code InfoAll lots distributed since 2004
ClassificationClass II
Reason for RecallIntegra has received complaint reports related to the electrical safety of the monopolar electrosurgical cables.
Product Quantity22,500
Recall NumberZ-0886-2013

Class II Food Event

Event ID64384
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Feb-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmKoda Farms Inc
CitySouth Dos Palos
StateCA
CountryUS
Distribution PatternCA and HI
 

Associated Products

Product DescriptionMochiko Blue Star Sweet Rice Flour; Net Wt. 50 lbs. (22.68 k) Koda Farms Milling, Inc. South Dos Palos, CA 93665
Code InfoProduct code 3F13 and 3F14 (produced January 13 and 1, 2013.
ClassificationClass II
Reason for RecallKoda Farms received a report from a customer that a hard yellow material was found in rice flour dough that had been manufactured using rice flour supplied by Koda Farms. The rice flour is believed to be the source of the foreign object.
Product Quantity878 x 50 lb. bags.
Recall NumberF-1022-2013

Class II Devices Event

Event ID64389
StatusOngoing
Product TypeDevices
Voluntary/Mandated
Recall Initiation Date19-Dec-12
Initial Firm Notification of Consignee or Public
Recalling FirmPhilips Medical Systems (Cleveland) Inc
CityCleveland
StateOH
CountryUS
Distribution PatternWorldwide Distribution - USA including AL, AR, CA, FL, GA, IL, IN, KY, MI, MS, NC, NJ, NV, NY, OH, PA, PR and VA.
 

Associated Products

Product DescriptionThe MX 16-Slice CT Scanner System can be used as a whole-body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
Code InfoSystem Code #, 728131, Serial #: EP16E090001, EP16E090002, EP16E090003, EP16E090004, EP16E090006, EP16E090007, EP16E090008, EP16E090009, EP16E090010, EP16E090011, EP16E090012,EP16E090013, EP16E090015, EP16E100001, EP16E100004, EP16E100006, EP16E100008, EP16E100010, EP16E100011, EP16E100012, EP16E100013, EP16E100015, EP16E100016, EP16E100017, EP16E100018, EP16E100019, EP16E100020, EP16E100021, EP16E100022, EP16E100023, EP16E100024, EP16E100025, EP16E100026, EP16E100027, EP16E100028, EP16E100029, EP16E100030, EP16E100031, EP16E100032, EP16E100033, EP16E100034, EP16E100035, EP16E100036, EP16E100037, EP16E100038, EP16E100039, EP16E100041, EP16E100043, EP16E100044, EP16E100045, EP16E100046, EP16E100047, EP16E100048, EP16E100049, EP16E100051, EP16E100052, EP16E100055, EP16E100056, EP16E100057, EP16E100058, EP16E100059, EP16E100060, EP16E100061, EP16E100062, EP16E100063, EP16E100067, EP16E100069, EP16E100070, EP16E100071, EP16E100072, EP16E100073, EP16E100074, EP16E100075, EP16E100076, EP16E100077, EP16E100078, EP16E100079, EP16E100080, EP16E100081, EP16E100082, EP16E100083, EP16E100084, EP16E100085, EP16E100086, EP16E100087, EP16E100088, EP16E100090, EP16E100091, EP16E100092, EP16E100093, EP16E100094, EP16E100095, EP16E100096, EP16E100099, EP16E100100, EP16E100101, EP16E100102, EP16E100103, EP16E100105, EP16E100106, EP16E100107, EP16E100108, EP16E100109, EP16E100110, EP16E100111, EP16E100112, EP16E100113, EP16E110003, EP16E110005, EP16E110006, EP16E110007, EP16E110008, EP16E110009, EP16E110011, EP16E110012, EP16E110013, EP16E110014, EP16E110015, EP16E110017, EP16E110018, EP16E110019, EP16E110020, EP16E110021, EP16E110023, EP16E110024, EP16E110025, EP16E110026, EP16E110027, EP16E110028, EP16E110029, EP16E110030, EP16E110031, EP16E110032, EP16E110033, EP16E110034, EP16E110035, EP16E110037, EP16E110038, EP16E110039, EP16E110042, EP16E110043, EP16E110044, EP16E110045, EP16E110046, EP16E110047, EP16E110048, EP16E110049, EP16E110050, EP16E110051, EP16E110052, EP16E110054, EP16E110055, EP16E110056, EP16E110057, EP16E110058, EP16E110060, EP16E110062, EP16E110063, EP16E110064, EP16E110067, EP16E110069, EP16E110070, EP16E110074, EP16E110075, EP16E110077, EP16E110078, EP16E110080, EP16E110083, EP16E110084, EP16E110085, EP16E110089, EP16E110090, EP16E110091, EP16E110092, EP16E110093, EP16E110095, EP16E110096, EP16E110097, EP16E110099, EP16E110100, EP16E110101, EP16E110102, EP16E110104, EP16E110105, EP16E110106, EP16E110107, EP16E110108, EP16E110109, EP16E110110, EP16E110111, EP16E110115, EP16E110117, EP16E110118, EP16E110119, EP16E120003, EP16E120004, EP16E120005, EP16E120006, EP16E120007, EP16E120008, EP16E120009, EP16E120010, EP16E120011, EP16E120013, EP16E120014, EP16E120015, EP16E120016, EP16E120017, EP16E120019, EP16E120021, EP16E120023, EP16E120024, EP16E120025, EP16E120026, EP16E120027, EP16E120029, EP16E120030, EP16E120031, EP16E120032, EP16E120033, EP16E120034, EP16E120035, EP16E120036, EP16E120037, EP16E120039, EP16E120040, EP16E120041, EP16E120042, EP16E120043, EP16E120044, EP16E120045, EP16E120046, EP16E120047, EP16E120048, EP16E120050, EP16E120051, EP16E120052, EP16E120055, EP16E120056, EP16E120058, EP16E120059, EP16E120060, EP16E120061, EP16E120063, EP16E120065, EP16E120067, EP16E120068, EP16E120070, EP16E120071, EP16E120072, EP16E120074, EP16E120075, EP16E120076, EP16E120078, EP16E120081, EP16E120083, EP16E120088, EP16E120089, EP16EB110003, EP16EB110004, EP16EB110005, EP16EB110006, P16C080001, P16C080002, P16C100001, P16C100002, P16C100003, P16C100004, P16C100005, P16C100007, P16C100008, P16C100009, P16C100010, P16C100011, P16C100012, P16C100013, P16C100014, P16C100015, P16C100017, P16C100018, P16C110001, P16C110002, P16C110003, P16C110004, P16C110005, P16C110006, P16C110007, P16C110008, P16C110011, P16C110012, P16C110013, P16C110014, P16C110015, P16C110016, P16C110017, P16C110018, P16C110019, P16C110020, P16C110021, P16C110022, P16C110023, P16C110024, P16C110025, P16C110026, P16C110027, P16C110028, P16C110029, P16C110030, P16C110031, P16C110032, P16C110033, P16C110034, P16C110035, P16C110036, P16C110037, P16C120001, P16C120002, P16C120003, P16C120006, P16C120007, P16C120008, P16C120009, P16C120011, P16C120012, P16C120014, P16C120016, P16C120017, P16C120018, P16C120019, P16C120020, P16C120021, P16C120022, P16C120023, P16C120024, P16C120025, P16C120026, P16C120027, P16C120029, P16C120030, P16E080007, P16E080008, P16E090002, P16E090003, P16E090004, P16E090005, P16E090006, P16E090008, P16E090009, P16E090010, P16E090011, P16E090012, P16E090013, P16E090014, P16E090015, P16E090016, P16E090017, P16E090018, P16E090019, P16E090020, P16E090021, P16E090024, P16E090025, P16E090026, P16E090027, P16E090028, P16EF80010, P16EM08003, P16EM09002, P16EM09003, P16EM09004 System Code #, 728132, Serial #: EP16E100005, EP16E100007, EP16E110066, EP16ER100003, EP16ER100004, EP16ER100005, EP16ER100007, EP16ER100008, EP16ER110003, EP16ER110004, EP16ER110005, EP16ER110006, EP16ER110007, EP16ER110008, EP16ER110009, EP16ER110010, EP16ER110011, EP16ER110012, EP16ER110013, EP16ER110014, EP16ER110015, EP16ER110016, EP16ER110017, EP16ER110018, EP16ER110019, EP16ER110020, EP16ER110021, EP16ER110022, EP16ER110023, EP16ER120005, EP16ER120006, EP16ER120007, EP16ER120008, EP16ER120009, EP16ER120010, EP16ER120011, EP16ER120012, EP16ER120013, EP16ER120015, EP16ER120016 , EP16ER120017, EP16ER120018
ClassificationClass II
Reason for RecallPhilips and Neusoft Medical Systems Co., Ltd. received a report from the field stating the four screws that secure the patient table top to the carrier became loose, which caused the table top to detach.
Product Quantity412 Units
Recall NumberZ-0899-2013

Class II Devices Event

Event ID64403
StatusOngoing
Product TypeDevices
Voluntary/Mandated
Recall Initiation Date21-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Medical Systems (Cleveland) Inc
CityCleveland
StateOH
CountryUS
Distribution PatternDistributed only in Ohio.
 

Associated Products

Product DescriptionIngenuity TF PET/CT Diagnostic imaging system
Code InfoModel # 882456, Serial # 2004.
ClassificationClass II
Reason for RecallIssues have been detected in the Ingenuity TF PET/CT currently running Ingenuity TF PET/CT system software version 4.0.0.26635 that if they were to re-occur, could cause a risk for patients.
Product Quantity1 Unit
Recall NumberZ-0897-2013

Class II Devices Event

Event ID64407
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAesculap, Inc.
CityCenter Valley
StatePA
CountryUS
Distribution PatternUSA Nationwide Distribution including the states of: AR, CA, FL, IN, IA, KS, MD, MN, MO, OR, TN, TX, VA and WA.
 

Associated Products

Product DescriptionAesculap Bipolar Generator Foot Pedal, Catalog No. GK226 Product Usage: Aesculaps Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery.
Code InfoManufacture date on the label on the bottom of the foot pedal - any product with manufactured dates between 45/10 and 31/12
ClassificationClass II
Reason for RecallAIC (USA) received a notification from Aesculap, AG (the manufacturer) regarding complaints that the bipolar energy did not stop after release of the foot pedal.
Product Quantity59
Recall NumberZ-0887-2013

Class II Devices Event

Event ID64434
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Feb-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmMyco Medical Supplies Inc
CityCary
StateNC
CountryUS
Distribution PatternWorldwide Distribution - USA including CA, FL, IL, MI, MO, NY, OH, PA, SC, TN, WI and Internationally to Canada
 

Associated Products

Product DescriptionTechnocut Plus,Sterile Single Use Safety Scalpel, Distributed by: Myco Medial Cary, NC 27513. The Technocut Plus Safety Scalpel is a surgical safety scalpel intended for use as a cutting device during surgical, pathology, and minor medical procedures.
Code InfoCatalogue number: 6008TR-10, 6008TR-11, 6008TR-12, 6008TR-15, 6008TR-20; Batch numbers: 1208235, 1210189, 1211305, 1208276, 1211213, 1208224, 1210105, 1212041, 1208307, 1211192, 1212052, 1210116.
ClassificationClass II
Reason for RecallPouch labeling/printing errors and defective packaging resulting in possible compromised sterility.
Product Quantity110,768 scalpels in individual pouches
Recall NumberZ-0891-2013

Class II Drugs Event

Event ID64441
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product Description0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
Code InfoLot 13-121-JT* * the lot number may be followed by 01
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.
Product Quantity56,854 Units
Recall NumberD-176-2013

Class III Biologics Event

Event ID54058
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Sep-09
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmTalecris Plasma Resources Inc
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code Info380098221, 380091801, 380095082, 380102319, 380093481, 380113918, 380106427, 380096985, 3800003417, 380100217, 380100491, 380111162, 380106940, 380107283, 380108885, 380111205, 380104488, 380105322, 380103028, 380098015, 380106785, 380099826, 380095696, 380092908, 380091944, 380108728, 380092169, 3800049989, 380111054, 380106540, 380104691, 380105648, 380097869, 3800024783, 380113213, 380114842, 380112449, 380104240, 380097106, 380107764, 380108063, 380111541, 38011917, 380100306, 3800007683, 380100117,380120861, 380114378, 380113395, 380112672, 380107722, 3800007855, 3800011972, 3800013705, 3800016966, 380112192, 380112456, 380113203, 380114527, 380107768, 380109650, 380109901, 380111431, 380106685, 3800014815, 3800011631, 3800011977, 3800016720, 3800018904, 3800023822, 3800025939, 3800032229, 380100438, 380113307, 3800012543, 380102704, 380102364, 380096979, 380093172, 380093149, 3800050812, 3800021421, 3800025602, 3800026282, 3800027849, 3800029571, 380120851, 380105380, 380100148, 380113303, 380120373, 380121848, 380109112, 3800005308, 3800007956, 3800009234, 3800011442, 3800013842, 3800014431, 3800014842, 3800009674, 3800010055, 3800012243, 3800015013, 3800015974, 3800019953, 3800031201, 3800031690, 3800032689, 3800034010, 3800027339, 3800038761, 3800049593, 3800050008, 3800046124, 3800046292, 3800026797, 380098580, 380093088, 380104542, 3800018583, 3800025291, 3800021451, 380103487, 380100121, 3800047949, 380112649, 380113562, 380114067, 380108072, 380109870, 380111125, 380105366, 380097323, 380097691, 380095356, 380114389, 380113356, 380112650, 380108073, 380106724, 380098847, 380095756, 380108332, 3800048043, 3800050794, 3800051176, 380096594, 380096304, 380094618, 380099701, 380100610, 380101245, 380095750, 380096876, 380092447, 380093902, 380108464, 380104116, 380093042, 380099135, 380111015, 380105336, 380094367, 380102766, 380106535, 380108169, 380108474, 380119567, 380120390, 380121675, 380122367, 380122968, 3800003310, 3800004240, 3800005911, 3800013330, 3800013741, 3800014428, 3800022854, 3800023632, 3800032531, 3800032875, 3800037703, 3800038998, 380119946, 380094573, 3800029145, 3800033519, 3800033279, 380108347, 380113921, 3800031199, 3800046063, 3800046430, 3800017959, 3800022312, 3800025391, 380121544, 380122993, 380119547, 380114690, 380120029, 380106994, 380101268, 380102156, 380098923, 380109155, 380120512, 380100255, 3800004674, 3800005989, 3800017209, 3800021157, 3800032180, 3800033354, 3800034693, 3800035637, 3800037716, 3800047796, 3800048468, 3800051159, 3800010767, 3800013181, 380120207, 380114458, 380103168, 380097717, 380096408, 380095394, 380094382, 380114235, 3800000123, 3800000417, 3800000981, 3800001636, 3800038505, 380093898, 380091968, 3800010998, 3800023288, 3800027237, 3800028021, 3800029166, 3800026415, 3800023268, 3800026655, 3800000722, 380114340, 380107809, 380120009, 380109232, 3800045559, 3800046191, 3800029104, 3800029586, 380111873, 3800010123, 380108414, 380109623, 380099740, 380103676, 380104547, 380093255, 380093384, 3800023434, 3800026668, 3800027875, 3800009759, 3800001623, 3800003078, 3800006285, 3800031822, 380112707, 380113135, 380113408, 380100421, 380123226, 380122692, 380121952, 380120067, 380119560, 380114735, 380113974, 380113327, 380109709, 380108825, 380108450, 380106663, 380105289, 380096101, 380109063, 380100370, 380093884, 380094507, 380092414, 380097673, 380097905, 3800002819, 3800003313, 3800004450, 380100432, 380100257, 3800006340, 3800022011, 3800024013, 3800027263, 3800032694, 380105630, 3800009451, 3800010848, 3800015541, 380102708, 380096955, 380102299, 380122899, 3800001593, 3800002317, 3800002576, 3800003362, 3800004559, 3800009384, 3800020839, 3800024103, 3800026542, 380109175, 380112934, 380113294, 380114085, 380106817, 380105403, 3800019184, 3800026148, 380096232, 380093309, 380096964, 380109263, 380119535, 380119747, 380104252, 3800002363, 3800003208, 3800008524, 3800009726, 3800010583, 380106875, 380113142, 380097456, 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3800006297, 3800020729, 3800003532, 3800020370, 3800021979, 3800001661, 3800003902, 3800004601, 3800009715, 3800013787, 380097907, 380101184, 380093018, 3800045295, 3800046167, 3800046727, 3800051036, 3800003093, 3800003548, 3800030580, 3800033552, 3800034032, 3800035313, 3800017454, 3800040701, 3800050649, 3800051165, 380097139, 380105827, 380099712, 3800000541, 3800001808, 3800004691, 3800009827, 3800010778, 3800013045, 3800016074, 3800017031, 3800020674, 3800022491, 3800023386, 3800025191, 3800025818, 3800030730, 380122472, 380121938, 380120336, 380120022, 380119554, 380114721, 380113594, 380112303, 380106858, 380106477, 380105858, 380097893, 380095966, 3800004382, 3800005198, 3800006073, 3800006671, 3800007952, 3800010682, 3800013789, 380101037, 380095159, 3800001139, 3800001805, 3800002293, 3800003291, 3800003802, 3800006273, 3800007134, 3800013051, 3800013929, 3800014208, 3800014995, 3800017183, 3800018369, 3800022185, 3800022322, 3800027985, 3800029557, 3800031524, 3800035039, 3800035366, 3800036903, 3800041037, 3800042330, 3800045645, 380123025, 380109000, 380105074, 3800003771, 3800004509, 380122754, 380122065, 380121768, 380119810, 380119498, 380113824, 380091846, 3800004101, 3800004639, 3800005978, 3800014628, 3800018619, 3800021927, 3800029307, 3800031076, 3800051161, 3800052951, 3800029564, 3800031104, 3800033126, 3800003298, 3800005677, 3800006022, 3800007636, 3800008655, 3800014643, 3800015337, 3800015700, 3800020529, 3800021541, 3800027204, 3800027525, 3800028783, 3800039694, 380091929, 380095065, 380092789, 380095949, 380114825, 380112881, 380100404, 380109718, 3800001157, 3800002229, 3800003775, 3800004117, 3800008431, 3800010742, 3800011279, 3800012357, 3800012981, 3800013436, 3800014381, 3800015040, 3800015985, 3800016381, 3800025113, 3800026718, 3800028751, 3800029300, 3800030163, 3800031262, 3800037416, 3800037982, 3800023923, 3800026264, 3800000956, 3800001193, 380109466, 3800025399, 3800025845, 3800016661, 3800029011, 3800046448, 3800041817, 3800042528, 3800018204, 3800018630, 3800022331, 3800023512, 380122874, 380113285, 380112629, 380113568, 380114327, 3800021211, 3800026112, 3800029590, 3800030181, 3800018317, 3800002424, 3800045808, 3800048347, 3800050892, 3800050637, 3800051794, 3800016991, 3800018078, 3800018463, 3800020310, 3800022466, 3800022903, 3800026943, 3800028995, 380122306, 380119037, 380107244, 380108638, 380109746, 380104557, 380102731, 380104925, 380106654, 3800027064, 3800023977, 3800018880, 3800013418, 3800001299, 380111578, 380106421, 380104603, 380100167, 380122743, 380114337, 380114569, 380120287, 380121041, 3800000551, 3800006642, 3800018358, 3800021679, 3800027206, 3800047667, 3800049368, 3800049572, 3800013559, 3800013753, 3800014569, 3800015821, 3800017524, 3800018589, 3800020809, 3800021000, 3800022128, 3800025529, 3800003318, 3800004083, 3800006636, 3800007814, 3800019017, 3800023825, 3800026651, 3800027220, 3800033759, 3800037916, 3800039530, 3800041000, 3800041900, 380120710, 380119042, 380113981, 380113342, 380111081, 380108914, 380095175, 3800039300, 3800039831, 3800040778, 3800041002, 3800048898, 3800050864, 3800001308, 3800001991, 3800002246, 3800002724, 3800003838, 3800014193, 3800019396, 3800021492, 3800027327, 3800014000, 3800014928, 380093333, 380093305, 380109378, 3800003705, 3800022472, 380102307, 3800007803, 3800008690, 380122720, 3800000162, 3800000498, 3800002406, 3800003221, 3800010056, 3800016684, 3800018215, 3800018804, 3800021477, 3800032224, 3800033224, 3800034050, 380122642, 380119788, 380113136, 380119501, 3800005791, 3800006714, 3800007891, 3800008828, 3800009185, 3800010127, 3800016806, 3800022277, 3800029831, 3800031298, 3800033391, 3800036801, 3800000257, 3800001246, 3800001483, 3800001950, 3800002884, 3800003406, 3800003648, 3800004087, 3800005330, 3800007577, 3800007810, 3800008516, 3800009837, 3800017393, 3800020678, 3800021031, 3800022192, 3800029446, 3800029806, 380109379, 3800001552, 3800002521, 380122586, 380120461, 380119408, 380107198, 380106629, 380099706, 380097696, 380095904, 380092913, 380096405, 3800013781, 3800017008, 3800018934, 3800029553, 3800046274, 3800048132, 380104883, 3800020929, 3800023838, 3800026562, 3800029453, 3800031757, 3800032130, 3800004058, 3800005976, 3800006885, 3800001595, 3800000385, 380122654, 380122425, 380121170, 380120396, 380120112, 380119491, 380114725, 380112062, 380111167, 380109724, 380108288, 380107377, 380099784, 380097897, 3800002831, 3800005837, 3800021079, 3800023287, 380122906, 380120772, 380114233, 380108388, 380106558, 380104838, 380103075, 380102247, 380101265, 380093319, 380121868, 380109029, 380109183, 380119153, 3800000825, 3800000887, 3800001494, 3800001573, 3800003309, 3800004071, 3800008868, 3800009479, 3800013364, 3800031564, 3800032080, 3800041765, 3800042033, 3800042896, 3800045810, 3800046149, 3800006337, 3800007912, 3800009254, 3800013537, 3800025126, 3800031817, 3800032615, 3800035438, 380122824, 380122600, 380121860, 380120538, 380104646, 380098385, 380097862, 380095819, 380092532, 380111092, 380108834, 380009254, 380121948, 380122695, 380119558, 380119777, 380114268, 380107045, 380108299, 380104677, 3800001615, 3800003126, 3800004173, 3800005883, 3800007744, 3800008670, 3800013343, 3800015755, 3800016586, 3800017229, 3800018365, 3800028081, 3800033296, 3800036504, 380120395, 380111980, 380106502, 380106168, 380094243, 3800049786, 3800049352, 3800048325, 3800052544, 3800039781, 3800039050, 3800032039, 3800029275, 3800020361, 3800018137, 3800017445, 3800016120, 3800014124, 3800013173, 380121301, 380119009, 380112643, 380112075, 380111315, 380111061, 380105344, 380097574, 380096619, 380092158, 380105467, 380105695, 380091941, 380092357, 380120105, 380100925, 380122195, 380111385, 380111183, 380097662, 380092988, 3800001358, 3800001807, 3800005343, 3800005663, 3800006929, 3800009456, 3800010400, 3800010710, 3800012427, 3800017481, 3800020063, 3800020761, 3800021148, 3800022176, 3800022530, 3800026657, 3800032064, 3800032342, 3800036465, 3800036815, 3800037574, 3800038599, 3800041886, 3800028671, 3800029238, 3800038983, 380096403, 380095290, 380094557, 3800001550, 3800001755, 3800003720, 3800004458, 3800009189, 3800014163, 380097892, 380097010, 380102415, 380105931, 380106901, 380095380, 380112135, 380112300, 380119566, 380121958, 380112920, 380108137, 380111568, 380106600, 380105294, 380102549, 380103609, 380104457, 380095066, 380094283, 380098958, 3800051414, 3800004098, 3800007779, 380114958, 3800007213, 3800015168, 3800013938, 380101675, 380094625, 3800010694, 3800012174, 3800013296, 3800013858, 3800014812, 3800018953, 3800023404, 3800032814, 3800035323, 3800040630, 3800042885, 3800047817, 3800049840, 3800050297, 3800052209, 3800052570, 3800053467, 380122348, 380121331, 380119050, 380114452, 380114275, 380111284, 380108745, 380107785, 380106890, 380106423, 380102330, 380097522, 380095362, 3800008264, 3800009377, 3800011310, 380114751, 380113226, 380112860, 380101322, 380098905, 380095180, 3800000548, 3800000746, 3800006705, 3800025195, 3800030235, 3800032262, 3800039198, 3800040049, 3800041150, 380122988, 380122557, 380113269, 380112156, 380109656, 3800023468, 3800041672, 380119489, 3800000289, 3800007545, 3800007898, 3800008531, 3800038149, 3800039649, 3800041865, 3800001616, 380112069, 3800032198, 3800039560, 3800040770, 3800015171, 3800018075, 3800024928, 3800027343, 380107152, 380094227, 380104769, 3800000535, 3800001798, 3800003269, 3800004199, 3800008662, 3800013816, 3800016734, 3800018494, 3800032191, 3800006702, 3800007411, 380097294, 380097633, 380104814, 380104396, 380104150, 3800021774, 3800053445, 380109136, 380109125, 380100215, 380093446, 3800013771, 3800029210, 3800001663, 380100129, 380100319, 380100017, 380109081, 3800005169, 380109082, 3800002318, 3800015549, 380109270, 380100045, 3800013069, 3800021361, 3800020342, 3800003066, 380100261, 3800006573, 3800003431, 380109064, 3800018177, 380109325, 380109224, 380109177, 380100043, 3800002379, 3800004129, 380100015, 380108916, 380106266, 380105351, 380104579, 380103078, 380095366, 380094444, 380091861, 380083526, 3800041225, 3800037690, 3800025512, 3800022884, 3800022295, 3800002826, 3800000922, 380122847, 380119993, 380119755, 380114970, 380112631, 380108899
ClassificationClass III
Reason for RecallBlood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity7066 units
Recall NumberB-0716-13

Class III Biologics Event

Event ID63763
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Nov-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center
CityDayton
StateOH
CountryUS
Distribution PatternOhio
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW035412052992; W035412053438;
ClassificationClass III
Reason for RecallBlood products, leukodepleted greater than three days after collection, were distributed.
Product Quantity2
Recall NumberB-0595-13
Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW035410040122; W035409008681; 3570639; 2455383; 2411381; 120869; 1252005; 1251925; 1249592;
ClassificationClass III
Reason for RecallBlood products, leukodepleted greater than three days after collection, were distributed.
Product Quantity9
Recall NumberB-0596-13

Class III Drugs Event

Event ID63821
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBayer Healthcare, LLC
CityMorristown
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionBronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24 coated caplets per blister pack, UPC 300240537879, b) 60 coated caplets per blister pack, UPC 300240537855, Bayer HealthCare LLC, Consumer Care, P.O. Box 1910, Morristown, NJ, 07962.
Code InfoLot #s: a) NAA0B3T, NAA0BDB, NAA0B3P, NAA0B3R, NAA0B3N, NAA070E, NAA070F, NAA03PX, NAA03B5, NAA03B6, NAA02LT. b) NAA0TF3, NAA0TF2, NAA0TF0, NAA0TF1, NAA0TET, NAA0TEW, NAA0TEX, NAA0HHL, NAA0HHK, NAA0HHN, NAA0HHH, NAA0DK5, NAA0DK4, NAA0DK3, NAA0CHE, NAA0CHD, NAA0B3L, NAA0B3K, NAA09XE, NAA09XB, NAA07H2, NAA09XD, NAA07H1, NAA09XA, NAA09XC, NAA07H3, NAA07H4, NAA05BB, NAA05BA, NAA07H0, NAA070D, NAA070C, NAA03PW, NAA05B9, NAA070B, NAA03B8, NAA03B7, NAA02N1, NAA02LW, 244511P, 244501P, 244481P, 244471P, 244491P, 244451P.
ClassificationClass III
Reason for RecallLabeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.
Product Quantity1,353,420 Blister Packs
Recall NumberD-177-2013

Class III Veterinary Event

Event ID63989
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Dec-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmADM Alliance Nutrition, Inc.
CityBluffton
StateIN
CountryUS
Distribution PatternIN and OH Only
 

Associated Products

Product DescriptionADM Alliance Nutrition Meat Goat Power 16%
Code InfoProduct #80865AZN24 Lot #BF23512
ClassificationClass III
Reason for RecallDuring an FDA inspection, the ADM Alliance Nutrition Meat Goat Power 16% (80865AZN), was run through the firm's mixer directly after lot # BF23512 of the recalled sheep feed. The Retention sample was found to have 46.4 ppm copper when the label states 25ppm-35ppm.
Product Quantity120-50lb bags
Recall NumberV-138-2013

Class III Cosmetics Event

Event ID64139
StatusOngoing
Product TypeCosmetics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Jan-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmProcter & Gamble Hair Care Llc
CityIowa City
StateIA
CountryUS
Distribution PatternDistribution was made to AR, AZ, AK, CA, CO, IA, IL, IN, KS, MI, MO, MN, NC, NE, NV, OR, TX, UT and WI.
 

Associated Products

Product Description3D White Arctic Fresh, 32 fl oz or 946 mL, whitening oral rinse, contains alcohol, distributed by Procter & Gamble, Cincinnati, OH.
Code InfoManufacturing Code: 22155395RF
ClassificationClass III
Reason for RecallRecalled products may have mixed during manufacturing process and products may appear cloudy and have sediment.
Product Quantity
Recall NumberF-1020-2013
Product DescriptionScope Mouthwash, original mint, 1.5 L or 50.7 fl oz., distributed by Procter & Gamble, Cincinnati, OH.
Code InfoManufacturing Code: 22195395ZB
ClassificationClass III
Reason for RecallRecalled products may have mixed during manufacturing process and products may appear cloudy and have sediment.
Product Quantity5988/6/1.5-L bottle/cases
Recall NumberF-1021-2013

Class III Devices Event

Event ID64303
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmUltradent Products, Inc.
CitySouth Jordan
StateUT
CountryUS
Distribution PatternUSA Nationwide Distribution including the states of CA, AZ, CO and WA.
 

Associated Products

Product DescriptionAvex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets.
Code InfoLot R131360
ClassificationClass III
Reason for RecallOrthodontic brackets distributed was incorrectly labeled.
Product Quantity124
Recall NumberZ-0876-2013

Class III Drugs Event

Event ID64317
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmActavis Pharmaceuticals
CityMorristown
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionbuPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217
Code InfoLot CB1D05A,
ClassificationClass III
Reason for RecallFailed Dissolution Specifications; 8-hours for the 18-month stability testing point.
Product Quantity14,856 bottles
Recall NumberD-175-2013

Class III Food Event

Event ID64347
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmWhole Foods Market
CityAustin
StateTX
CountryUS
Distribution PatternNationwide domestically and to Canada.
 

Associated Products

Product DescriptionWhole Foods Market Panettone Chocolate - 26.4 oz, 12 per case.
Code InfoLot codes: O 262, O 263 and O 264.
ClassificationClass III
Reason for RecallThe reason for the recall was that a small portion of the Whole Foods Market Cranberry Panettone was mispackaged in Whole Foods Market Panettone Chocolate boxes. Allergens are declared on both labels, but the only difference is that soy is in the 'may contains' statement on Whole Foods Market Cranberry Panettone box and on the Whole Foods Market Chocolate Panettone box, soy is declared in the 'contains' box.
Product Quantity1,035 cases (12,420 retail units)
Recall NumberF-1006-2013

Mixed Classification Food Event

Event ID64203
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jan-13
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmGiant Greens, Inc.
CityKent
StateWA
CountryUS
Distribution PatternProducts distributed in Alaska, Idaho, Oregon, Washington, and British Columbia, Canada.
 

Associated Products

Product DescriptionClover sprouts, product is packaged in a 4 oz or 5 oz. clamshell containers, and 1 lb. bag or 2 lb. tray. Product is sold under brand Sprouters Northwest. Clover Sprouts, 4oz container, has a UPC 8 15098 00201 6; Clover Sprouts, 5oz container, has a UPC 0 33383 70235 3; Clover Sprouts, 1 lb bag, has a UPC 0 79566 12351 5; Clover Sprouts, 2 lb tray, has a UPC 0 79566 12351 5; The Clover Sprouts, 4 oz., Sprouters Northwest brand is labeled in parts: "***CLOVER SPROUTS***Sprouters NORTHWEST***NET WT 4.0 oz***KEEP REFRIGERATED***DISTRIBUTED BY: SPROUTERS NORTHWEST, KENT, WA 98032***www.SproutersNorthwest.com***". The Clover Sprouts, 5 oz., Sprouters Northwest brand is labeled in parts: "***CLOVER ***Sprouters NORTHWEST, INC. KENT, WA 98032***NET WT 5.0 oz***KEEP REFRIGERATED***". The Clover Sprouts, 1 LB., Sprouters Northwest brand is labeled in parts: "***CLOVER SPROUTS***NET WT. 1 LB***KEEP REFRIGERATED***Sprouters NORTHWEST, KENT, WA 98032***". The Clover Sprouts, 2 LB., Sprouters Northwest brand is labeled in parts: "***Clover Sprouts***2 lb.*** Sprouters NORTHWEST, KENT, WA 98032***".
Code InfoThe Best by Dates are including all and up to 2/17/2013.
ClassificationClass I
Reason for RecallClover sprouts are recalled due to a potential contamination with Listeria monocytogenes.
Product Quantity14154/4 oz. Packages; 5130/5 oz. Packages; 24287/1 lb. Bags; and 552/2 lb. Trays
Recall NumberF-1010-2013
Product DescriptionBrocco Sprouts Sandwich Blend, packaged in a 4 oz. clamshell container, the UPC is 8 15098 00028 9. The product is labeled in parts: "***BROCCO SPROUTS SANDWICH BLEND***broccoli & clover sprouts***NET WT. 4.0 oz***DISTRIBUTED BY: BRASSICA PROTECTION PRODUCTS LLC, BALTIMORE, MD 21224***www.BroccoSprouts.com***"Growers***Sprouters Northwest (Kent, WA)***".
Code InfoThe Best by Dates are including all and up to 2/17/2013.
ClassificationClass I
Reason for RecallBrocco Sprouts Sandwich Blend are recalled due to a potential contamination with Listeria monocytogenes.
Product Quantity2306/4 oz. Packages
Recall NumberF-1011-2013
Product DescriptionSpicy Sprouts, packaged in a 4 oz. clamshell container or 85 gram package. The product is sold under Sprouters Northwest or LifeForce brand. The Sprouters Northwest, 4 oz., has UPC is 8 15098 00202 3. The LifeForce, 85 gram, has UPC 8 51042 00401 9. The Sprouters Northwest, 4 oz., is labeled in parts: "***SPICY SPROUTS***a blend of clover and radish sprouts***Sprouters NORTHWEST, INC.***KEEP REFRIGERATED***NET WT. 4.0 oz.***DISTRIBUTED BY: SPROUTERS NORTHWEST, INC., KENT, WA 98032***SproutersNorthwest.com***". The LifeForce, 85 gram, is labeled in parts: "***SPICY SPROUTS***a blend of clover and radish sprouts***LifeForce***KEEP REFRIGERATED***NET WT 85g***PRODUCED FOR: LIFE FORCE FOODS LLC, BALTIMORE, MD 21202***www.BroccoSprouts.com***".
Code InfoThe Best by Dates are including all and up to 2/17/2013
ClassificationClass I
Reason for RecallSpicy Sprouts are recalled due to a potential contamination with Listeria monocytogenes.
Product Quantity7212/4 oz. Packages and 420/85 gram Packages.
Recall NumberF-1012-2013
Product DescriptionAlfalfa sprouts, packaged in a 4 oz. clamshell container or 85 gram package. Product is sold under Sprouters Northwest or LifeForce brand. The Sprouters Northwest, 4oz., has UPC 8 15098 00108 8; The LifeForce, 85 gram, has UPC 8 51042 00402 6. The Sprouters Northwest, 4oz, is labeled in parts: "***ALFALFA SPROUTS***Sprouters NORTHWEST****KEEP REFRIGERATED***NET WT. 4.0 oz.***DISTRIBUTED BY: SPROUTERS NORTHWEST, KENT, WA 98032***www.SproutersNorthwest.com***". The LifeForce, 85 gram, is labeled in parts: "***ALFALFA SPROUTS***LifeForce foods***KEEP REFRIGERATED***NET WT 85g***PRODUCED FOR: LIFE FORCE FOODS LLC, BALTIMORE, MD 21202***www.BroccoSprouts.com***".
Code InfoThe Best by Dates are including all and up to 2/17/2013
ClassificationClass I
Reason for RecallAlfalfa sprouts are recalled due to a potential contamination with Listeria monocytogenes.
Product Quantity14562/4 oz. Packages and 3024/85 g. Packages
Recall NumberF-1013-2013
Product DescriptionBrocco sprouts is broccoli sprouts, packaged in a 4 oz. clamshell container or 85 gram package. The Brocco sprouts, 4oz., distributed BRASSICA, has UPC 8 15098 00025; The Brocco sprouts, 85 gram, produced for LIFE FORCE, has UPC 8 51042 00400 2. The Brocco sprouts, 4oz, is labeled in parts: "***BROCCO SPROUTS***broccoli sprouts***Keep Refrigerated***NET WT. 4.0 oz.***DISTRIBUTED BY: BRASSICA PROTECTION PRODUCTS LLC, BALTIMORE, MD 21224***Growers***Sprouters Northwest (Kent, WA)***www.BroccoSprouts.com***". The LifeForce, 85 gram, is labeled in parts: "***BROCCO SPROUTS***broccoli sprouts***Keep Refrigerated***NET WT 85 g***PRODUCED FOR: LIFE FORCE FOODS LLC, BALTIMORE, MD 21202***www.BroccoSprouts.com***".
Code InfoThe Best by Dates are including all and up to 2/17/2013
ClassificationClass I
Reason for RecallBrocco sprouts are recalled due to a potential contamination with Listeria monocytogenes.
Product Quantity792/4 oz. Packages and 528/85 g. Packages
Recall NumberF-1014-2013
Product DescriptionDeli sprouts is a mixture of Clover, Fenugreek, Lentils, an Radish sprouts. Product is packaged in a 4 oz. or 5 oz clamshell container. Product is sold under the Sprouters Northwest brand. The Deli sprouts, 4 oz., has UPC 8 79566 12305 4. The Deli sprouts, 5 oz., as UPC 0 79566 12360 7. The Deli sprouts, 4 oz., is labeled in parts: "***DELI SPROUTS***INGREDIENTS: CLOVER, FENUGREEK, LENTILS, AND RADISH***KEEP REFRIGERATED***NET WT. 4.0 oz.***DISTRIBUTED BY: SPROUTERS NORTHWEST, INC., KENT, WA 98032***www.SproutersNorwthest***". The Deli sprouts, 5 oz., is labeled in parts: "***DELI***INGREDIENTS: CLOVER, FENUGREEK, LENTILS, AND RADISH***KEEP REFRIGERATED***NET WT. 5 oz.***Sprouters NORTHWEST, INC. KENT, WA 98032***".
Code InfoThe Best by Dates are including all and up to 2/17/2013
ClassificationClass I
Reason for RecallDeli sprouts are recalled due to a potential contamination with Listeria monocytogenes.
Product Quantity294/4 oz. Packages; 174/5 oz. Packages.
Recall NumberF-1015-2013
Product Description3 Bean Munchies sprouts is a mixture of Green Peas, Cow Peas, Red Lentils and Garbanzo Beans. Product is packaged in a 4 oz clamshell container and sold under the Sprouters Northwest brand. Product has UPC 8 15098 00204 7. The 3 Bean Munchies sprouts, 4 oz., is labeled in parts: "***3 BEAN MUNCHIES***a blend of sprouts from green peas, cow peas, red and green lentils, and adzuki beans***KEEP REFRIGERATED***NET WT. 4.0 oz.***DISTRIBUTED BY: SPROUTERS NORTHWEST, INC., KENT, WA 98032***www.SproutersNorwthest***".
Code InfoThe Best by Dates are including all and up to 2/17/2013
ClassificationClass I
Reason for Recall3 Bean Munchies sprouts are recalled due to a potential contamination with Listeria monocytogenes.
Product Quantity1146/4 oz Packages
Recall NumberF-1016-2013
Product DescriptionMung Bean sprouts is packaged in a 8 oz clamshell container or 5 lb. bag and sold under the Sprouters Northwest or Life Force brand. The Life Force foods, 8 oz, has UPC 8 15098 00107 1; The Sprouters Northwest, 5 lb., has UPC 0 33383 70258 2. The Life Force foods, 8 oz., is labeled in parts: "***MUNG BEAN SPROUTS***KEEP REFRIGERATED***NET WT. 4 OZ.***MANUFACTURED FOR: BRASSICA SPROUT GROUP, BALTIMORE, MD 21202***www.broccosprouts.com***". The Sprouters Northwest, 5 lb., is labeled in parts: "***BEAN SPROUTS***KEEP REFRIGERATED***NET WT. 5 LBS***Sprouters NORTHWEST***KENT, WA 98032***".
Code InfoThe Best by Dates are including all and up to 2/17/2013
ClassificationClass I
Reason for RecallMung Bean sprouts are recalled due to a potential contamination with Listeria monocytogenes.
Product Quantity33774/8 oz. Packages and 416/5 lb. Bags
Recall NumberF-1017-2013
Product DescriptionWheatgrass is packaged in a pint or cup, 16 oz. bag, or 5 lb. Flat cardboard box and sold under the Sprouters Northwest brand. The Wheatgrass in a pint or cup has UPC 0 79566 12380 5; The wheatgrass in 16 oz. bag or 5 lb. Flat cardboard box does not have any UPC. The wheatgrass, Sprouters Northwest, pint or cup., is labeled in parts: "***Wheatgrass***CERTIFIED ORGANIC***Pint***Sprouters NORTHWEST, INC.***KENT, WA 98032***". The wheatgrass in 16 oz. bag is labeled in parts: "***ORGANIC WHEATGRASS***SKU# 16OZCW***Keep Refrigerated***Not For Retail Sales as Packaged***". The wheatgrass in 5 lb. Flat cardboard box is labeled in parts: "***Wheatgrass***1 Ea. 21"X21" Wheatgrass/case***Item 40019***".
Code InfoThe Best by Dates are including all and up to 2/17/2013
ClassificationClass II
Reason for RecallWheatgrass is recalled due to a potential contamination with Listeria monocytogenes.
Product Quantity3024/1 pint Packages; 888 cups; 63/16 oz. Bags; and 494/5 lbs. Flat boxes;
Recall NumberF-1018-2013
Product DescriptionOrganic Pea Shoots are packaged in a 3 oz. or 4 oz packages. Product is sold under the Life Force or Trader Joe's brand. The Life Force, 3 oz, has UPC 8 51042 00414 9. The Trader Joe's, 4 oz, has UPC 0092 7567. The Life Force, 3 oz, is labeled in parts: "***Organic Pea Shoots***Life Force foods***KEEP REFRIGERATED***NET WT. 3.0 oz***DISTRIBUTED BY: LIFEFORCE FOODS, LLC***BALTIMORE, MD 21202***". The Trader Joe's, 4 oz, is labeled in parts: "***ORGANIC PEA SHOOTS***TRADER JOE'S***PERISHABLE, KEEP REFRIGERATED***RINSE BEFORE USING***NET WT. 4 OZ***SKU# 92756***DIST. & SOLD EXCLUSIVELY BY: TRADER JOE'S, MONROVIA, CA 91016***".
Code InfoThe Best by Dates are including all and up to 2/16/2013
ClassificationClass II
Reason for RecallOrganic Pea Shoots are recalled due to a potential contamination with Listeria monocytogenes.
Product Quantity390/3 oz. Packages and 3180/4 oz. Packages
Recall NumberF-1019-2013

Mixed Classification Biologics Event

Event ID39130
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-May-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternMO, TX, CA
 

Associated Products

Product DescriptionCryoprecipitated AHF
Code Info011FS50120
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0540-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info011FS50120
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0541-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info011FS50120
ClassificationClass III
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0542-13

Mixed Classification Biologics Event

Event ID47035
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Dec-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross
CityPortland
StateOR
CountryUS
Distribution PatternCalifornia.
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info21FJ51269
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 component
Recall NumberB-0718-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info21FJ51269
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 component
Recall NumberB-0719-13

Mixed Classification Biologics Event

Event ID50296
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Oct-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CitySaint Louis
StateMO
CountryUS
Distribution PatternIL, NJ,
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info011KJ12276; 011KX08948
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity2 unit
Recall NumberB-0722-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info011KJ12276;011KX08948
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-0723-13

Mixed Classification Biologics Event

Event ID63730
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBlood Bank Of Delmarva, Inc
CityNewark
StateDE
CountryUS
Distribution PatternOhio; Indiana
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036911719674;
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-0644-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036911719674;
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0645-13
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