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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Class I Food Event

Event ID50900
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Jan-09
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmTropical Nut & Fruit Inc
CityColumbus
StateOH
CountryUS
Distribution PatternThe recalled product was sold in Tropical's Outlet Store in Columbus, OH.
 

Associated Products

Product DescriptionGranulated Peanuts in 1 lb plastic bags.
Code InfoLot #'s 8148B, 8168B, 8288B & 8289B
ClassificationClass I
Reason for RecallThe product is being recalled because it was manufactured using peanut products recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
Product Quantity390/1 lb bags and 416/30 lb cases
Recall NumberF-1037-2013

Class I Food Event

Event ID51892
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Feb-09
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmBA Sweetie Candy Co
CityBrooklyn
StateOH
CountryUS
Distribution PatternThe product was distributed to one customer in Ohio.
 

Associated Products

Product DescriptionB. A. Sweetie Double Dip Peanuts in plastic bags 2 lb, UPC 0 17598 90687 4, 5 lb, UPC 0 17598 00687 1; & Dave's Market Chocolate Double Dip Peanuts in plastic bags, 4 oz, UPC 017598 70687 0
Code InfoNo code.
ClassificationClass I
Reason for RecallProduct is being recalled because it was manufactured using peanut products recalled by Peanut Corporation of America. The peanut products has the potential to be contaminated with Salmonella
Product Quantity168/4 oz plastic bags
Recall NumberF-1038-2013
Product DescriptionB. A. Sweetie Chocolate Bridge Mix in plastic bags 2 lb, UPC 0 17598 90609 6, 5 lb, UPC 0 17598 00609 3; & Dave's Markets Chocolate Bridge Mix in plastic bags, 4 oz, UPC 017598 70609 2.
Code InfoNo code.
ClassificationClass I
Reason for RecallProduct is being recalled because it was manufactured using peanut products recalled by Peanut Corporation of America. The peanut products has the potential to be contaminated with Salmonella
Product Quantity72 bags
Recall NumberF-1039-2013
Product DescriptionSugar Free/ NSA Chocolate Bridge Mix in plastic bags 2 lb, UPC 0 17598 94258 2, 5 lb, UPC 017598 04258 9
Code InfoAll codes.
ClassificationClass I
Reason for RecallProduct is being recalled because it was manufactured using peanut products recalled by Peanut Corporation of America. The peanut products has the potential to be contaminated with Salmonella
Product Quantity
Recall NumberF-1040-2013
Product DescriptionSweetie Sugar Free/ NSA Chocolate Peanuts in plastic bag 2 lb, UPC 0 17598 94259 9, 5 lb, UPC 0 17598 04259 6
Code InfoNo code.
ClassificationClass I
Reason for RecallProduct is being recalled because it was manufactured using peanut products recalled by Peanut Corporation of America. The peanut products has the potential to be contaminated with Salmonella
Product Quantity
Recall NumberF-1041-2013

Class I Food Event

Event ID51893
StatusTerminated
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 ID51895
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Feb-09
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmGorant Candies Inc A Division of Carlton Cards Retail Inc
CityYoungstown
StateOH
CountryUS
Distribution PatternProduct was distributed to wholesalers and retailers throughout the continental US and to Canada. US states product was distributed to includes: AL, AR, AZ, CA, CT, DE, FL, GA, IA, IL, IN, KY, MA, MD, MI, MS, NC, NE, NH, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI.
 

Associated Products

Product DescriptionChocolate bridge mix in 10 oz, 3 oz, and 3.5 oz bags
Code InfoSweet Sentiments: UPC-765915043329, 765915043534; Code date-09 AL 19, 09 AL 21, Gorant: UPC-765915043299, 765915017832, 765915047433, 765915046788, 765915047693; Code date-08 NO 23, 09 DE 15, 09 DE 16, 07 OC 17, 09 MA 30
ClassificationClass I
Reason for RecallThe product is being recalled because it was manufactured using peanuts that were recalled by Peanut Corporation of America because of their potential to be contaminated with Salmonella.
Product Quantity14762 pounds
Recall NumberF-1042-2013
Product DescriptionMilk Chocolate Peanuts in 10 oz, 3 oz, and 5 oz bags
Code InfoSweet Sentiments: UPC-765915043367, 765915043527; Code date: 09 AL 21, Gorant: UPC-765915043282, 765915043435, 765915047457, 765915047709, 765915045125, 765915046771; Code Date: 09 MA 30, 09 AL 15, 09 MA 25,
ClassificationClass I
Reason for RecallThe product is being recalled because it was manufactured using peanuts that were recalled by Peanut Corporation of America because of their potential to be contaminated with Salmonella.
Product Quantity17380 pounds
Recall NumberF-1043-2013
Product DescriptionNo Sugar Added Milk Chocolate Peanuts in 10 oz and 3 oz bags
Code Info765915026179, 765915043773, 765915047549, 765915047594. Date code: 09 AU 12, 09 DE 12, 11-15-08,
ClassificationClass I
Reason for RecallThe product is being recalled because it was manufactured using peanuts that were recalled by Peanut Corporation of America because of their potential to be contaminated with Salmonella.
Product Quantity1287 pounds
Recall NumberF-1044-2013
Product DescriptionNo Sugar Added Bridge Mix in 12 oz bags
Code InfoUPC: 765915026209, 765915047624. Date code: 09 DE 01.
ClassificationClass I
Reason for RecallThe product is being recalled because it was manufactured using peanuts that were recalled by Peanut Corporation of America because of their potential to be contaminated with Salmonella.
Product Quantity1536 pounds
Recall NumberF-1045-2013

Class I Devices Event

Event ID64136
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAd-Tech Medical Instrument Corporation
CityRacine
StateWI
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide including the states of CA, GA, LA, MA, MD, MI, MN, NH, PA, RI, TX, UT, WI and the countries of: Australia, CANADA, ENGLAND, JAPAN, KOREA, and SWITZERLAND.
 

Associated Products

Product DescriptionMacro Micro Subdural Electrode Product Usage: The AD-TECH Subdural Electrodes are intended for temporary (<30 days) use with recording, monitoring and stimulation equipment, for the recording, monitoring and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.
Code InfoREF numbers (catalog numbers): EG10A-SP10N-000, EG34B-SP10X-000, EGD7A-MP12N-000, EGE4A-SP10N-000, EGE4A-SP10X-000, QG10B-SP10X-000, QG10C-SP10N-000, QG10D-SP10N-000, QG11A-SP10X-000, QG16A-SP10X-000, QG17A-SP10X-000, QG18A-SP10N-000, QG18A-SP10X-000, QG20B-SP10N-000, QG20B-SP10X-000, QG20C-SP10N-000, QG20C-SP10X-000, QG20D-SP10X-200, QG20E-SP10X-000, QG20F-SP10X-000, QG24A-SP10N-000, QG26A-SP10N-000, QG32A-SP10X-000, QG32B-SP10X-000, QG36A-SP10N-000, QG36A-SP10X-000, QG36B-SP10N-000, QG44A-SP10X-000, QG53A-SP10X-000, QG66A-SP85N-000, QG69A-SP10N-000, QG88A-SP10X-000, QG96A-SP10N-000, QG96A-SP10X-000, QG96C-SP10X-000, QG96D-SP10X-000, QGC6A-SP07N-000, QGC8A-SP10N-000, QGC8A-SP10X-000, QGC8B-SP10X-000, QGC8C-SP10X-000, QGC8D-SP10N-000, QGC8E-SP10X-000, QGC8F-SP10X-000, QS20A-SP10N-000, QS40B-SP10X-000, Lot numbers: 208140314, 208140343, 208140344, 208140353, 208140354, 208140362, 208140369, 208140374, 208140381, 208140382, 208140387, 208140390, 208140395, 208140398, 208140399, 208140414, 208140417, 208140421, 208140431, 208140443, 208140445, 208140450, 208140452, 208140453, 208140458, 019020, 208140356R, 208140357R, 208140452R, C010180001, C702201001, C703160006, C704040001, C800250002, C800350004, C801240003, C802220003, C802220005, C802220006, C805210003, C805210004, C908221002, G012111001, G012140002, G015020002, G016240001, G017250004, G017250005, G017250006, G018011001, G018011002, G018011003, G019021002, G019021003, G019150003, G112270004, G114160001, G114160002, G115080002, G115170004, G115280005, G119020004, G211220001, G608060002, G704150001, G805270001, G900211002, G903011001, G903080003, S903080004, S905280003.
ClassificationClass I
Reason for RecallThe microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of abrading the cortical surface, and may have remaining pieces which may fracture and remain in the cortical tissue with the electrode is explanted.
Product Quantity115
Recall NumberZ-0892-2013

Class I Food Event

Event ID64232
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOcean Beauty Seafoods, LLC
CityMonroe
StateWA
CountryUS
Distribution PatternWhole Market Foods in Seattle, WA
 

Associated Products

Product DescriptionCold-smoked salmon in a vacuum packed, clear plastic bag. Product labeled: Csea brand Cold Smoked Smoked Sockeye Trim, 2 lb., Ingredients: Sockeye Salmon, Salt, and Natural Hardwood Smoked Produced by Ocean Beauty Seafoods, LLC KEEP REFRIGERATED AT 38 DEG OR BELOW"
Code Info7425A2297A, 7425A2298A and 7425A2298B
ClassificationClass I
Reason for RecallA surveillance sample was found positive for Listeria monocytogenes.
Product Quantity336 pounds (2 pound packages)
Recall NumberF-1036-2013

Class I Food Event

Event ID64282
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Dec-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmMkg Provisions Inc
CityMiami
StateFL
CountryUS
Distribution PatternFL and IL
 

Associated Products

Product DescriptionUpRiver brand Cold Smoke Atlantic Salmon Pre-sliced Vacuum Packed, 4 oz..
Code InfoBatch #911
ClassificationClass I
Reason for RecallResults from the company lab samples revealed that some of the samples contained Listeria monocytogenes.
Product Quantity1,020 lbs Total
Recall NumberF-1047-2013
Product DescriptionUpRiver brand Cold Smoke Atlantic Salmon Balik Cut Sides Vacuum Packed
Code InfoBatch #911
ClassificationClass I
Reason for RecallResults from the company lab samples revealed that some of the samples contained Listeria monocytogenes.
Product Quantity1,020 lbs total
Recall NumberF-1048-2013
Product DescriptionCold Smoke Atlantic Salmon Nordic Choice Pre-sliced Vacuum Packed
Code InfoBatch #1478-69441
ClassificationClass I
Reason for RecallResults from the company lab samples revealed that some of the samples contained Listeria monocytogenes.
Product Quantity3,425 lbs total
Recall NumberF-1049-2013
Product DescriptionCold Smoke Atlantic Salmon Trimmings Vacuum Packed
Code InfoBatch #1478-69441 and #911
ClassificationClass I
Reason for RecallResults from the company lab samples revealed that some of the samples contained Listeria monocytogenes.
Product Quantity3,425 lbs total
Recall NumberF-1050-2013

Class I Food Event

Event ID64369
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Feb-13
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmDecoty Coffee Company, Inc
CitySan Angelo
StateTX
CountryUS
Distribution PatternMainly in TX but internet sales were nationwide.
 

Associated Products

Product DescriptionTaco Seasoning, Net Wt. 1.25 lb and 5.75 lb. Distributed by Decoty Coffee Company, San Angelo, TX 76903, 800-588-8001. The products come in 1.25lb and 5.75lb sizes and are distributed in plastic spice containers with resealable lids.
Code InfoThe item code numbers are 71400 and 71410 with lot numbers from 010111 through 021313.
ClassificationClass I
Reason for RecallDeCoty Coffee Company of San Angelo, Texas is recalling its 1.25lb and 5.75lb of DeCoty Taco Seasoning because it contains an undeclared ingredient, Soy. People who have an allergy or severe sensitivity to Soy run the risk of a life threatening or serious allergic reaction if they consume these items.
Product Quantity205 of the 1.25 lb and 310 of the 5.75 lb
Recall NumberF-1058-2013

Class I Food Event

Event ID64419
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Feb-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmHerbalife International Of America Inc
CityTorrance
StateCA
CountryUS
Distribution PatternWorldwide distribution
 

Associated Products

Product DescriptionHERBALIFE Formula 1 Instant Healthy Meal, Nutritional Shake Mix ( Vanilla Dream) Packets; net WT 1.83 oz/52 g; packaged as 12 packets in a cardboard carton; just add water; single serve powder in a packet;
Code InfoLot #'s 133405G10; 133407G10; 133407C10; 133408C10; 133408G10; 133409C10; 133409G10; 133411L10; 133410L10; 133410J10;133412L10; 133410M11; 133410K07; 133411M11; 133412M11; 133418R10; Catalogue #2797; NNPart #'s: 68-00033; 68-00037; 68-00032; 68-00031; 68-00092.
ClassificationClass I
Reason for RecallHerbalife of America Inc is initiating this recall due to trace amounts of an undeclared milk protein allergen.
Product Quantity5,928 (2,732 cartons and3,196 IBP Kits)
Recall NumberF-1059-2013

Class I Food Event

Event ID64442
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Feb-13
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmBruce Foods Corp
CityNew Iberia
StateLA
CountryUS
Distribution PatternVA, MN, IN
 

Associated Products

Product DescriptionFood Club(R) MEXICAN STYLE ENCHILADA SAUCE, RED, NET WT 10 OZ (284g), DISTRIBUTED BY TOPCO ASSOCIATES LLC, 7711 GROSS POINT RD., SKOKIE, IL 60077 UPC: 036800292208
Code InfoGES 462449, Best Before Date: 12/03/2016
ClassificationClass I
Reason for RecallUndeclared soy and wheat: One can of product labeled as containing red enchilada sauce, was found to contain green enchilada sauce which contains wheat and soy.
Product Quantity141 cases of 12 units
Recall NumberF-1055-2013

Class II Biologics Event

Event ID40172
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-May-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CitySaint Louis
StateMO
CountryUS
Distribution PatternMO
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info011GF47386
ClassificationClass II
Reason for RecallBlood product, manufactured from a unit of whole blood lacking hematocrit documentation, was distributed.
Product Quantity1 unit
Recall NumberB-0221-13

Class II Biologics Event

Event ID40232
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-May-05
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Bank of Lancaster County Medical Society
CityLincoln
StateNE
CountryUS
Distribution PatternNE, FL
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info6519597; 6519597
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity2 units
Recall NumberB-0273-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info6032691; 6032687; 6032679; 6032689; 6519587
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity5 units
Recall NumberB-0274-13

Class II Biologics Event

Event ID40629
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Aug-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center of the Ozarks
CitySpringfield
StateMO
CountryUS
Distribution PatternMO
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info9917207
ClassificationClass II
Reason for RecallBlood product, which did not meet acceptable product specifications, was distributed.
Product Quantity1 unit
Recall NumberB-0357-13

Class II Biologics Event

Event ID42790
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Aug-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross (The)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis)
Code Info01FH11831, 01FH13343, 01KK20799, 01KK22605, 01KK23536, 01KM37179, 01KX97207, 01Q92728
ClassificationClass II
Reason for RecallBlood products, which did not meet the minimum requirement for total hemoglobin, were distributed.
Product Quantity8 units
Recall NumberB-0041-13

Class II Biologics Event

Event ID43004
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Sep-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternIlinois
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoLX28135
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-0742-13

Class II Biologics Event

Event ID43008
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Aug-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)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info01FP43191
ClassificationClass II
Reason for RecallBlood product, which did not meet acceptable product specifications, was distributed.
Product Quantity1
Recall NumberB-0741-13

Class II Biologics Event

Event ID43678
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Oct-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross
CityPortland
StateOR
CountryUS
Distribution PatternOregon.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info021LL14609.
ClassificationClass II
Reason for RecallBlood product, collected from a donor who lived in a country endemic for malaria, was distributed. .
Product Quantity1 component
Recall NumberB-0732-13

Class II Biologics Event

Event ID43835
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Dec-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternIowa
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoLT37295
ClassificationClass II
Reason for RecallBlood product, positive for the JKb-antigen but labeled as JKb-antigen negative, was distributed.
Product Quantity1 Unit
Recall NumberB-0711-13

Class II Biologics Event

Event ID44371
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Feb-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternIowa
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoLC83075
ClassificationClass II
Reason for RecallBlood product, positive for the E-antigen but labeled as E-antigen negative, was distributed.
Product Quantity1 Unit
Recall NumberB-0743-13

Class II Biologics Event

Event ID44496
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Jan-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternNY, MD, and PA
 

Associated Products

Product DescriptionPlatelets
Code Info01Q99477;01Q99514
ClassificationClass II
Reason for RecallBlood products, possibly contaminated with air during collection, were distributed.
Product Quantity2
Recall NumberB-0737-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info01Q99451; 01Q99454; 01Q99477; 01Q99489; 01Q99497; 01Q99519; 01Q99522; 01Q99528; 01Q99531; 01Q99548; 01Q99552
ClassificationClass II
Reason for RecallBlood products, possibly contaminated with air during collection, were distributed.
Product Quantity11
Recall NumberB-0738-13
Product DescriptionPlasma Frozen
Code Info01Q99451;01Q99454;01Q99497
ClassificationClass II
Reason for RecallBlood products, possibly contaminated with air during collection, were distributed.
Product Quantity3
Recall NumberB-0739-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info01Q99487;01Q99492
ClassificationClass II
Reason for RecallBlood products, possibly contaminated with air during collection, were distributed.
Product Quantity2
Recall NumberB-0740-13

Class II Biologics Event

Event ID45105
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Aug-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternIowa
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoP40172 Part A ; P40172 Part B
ClassificationClass II
Reason for RecallBlood products, for which the required quality control testing was not performed, were distributed.
Product Quantity2 Units
Recall NumberB-0712-13

Class II Biologics Event

Event ID45357
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Sep-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternIowa
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoLE99344
ClassificationClass II
Reason for RecallBlood product, positive for the c-antigen but labeled as c-antigen negative, was distributed.
Product Quantity1 Unit
Recall NumberB-0744-13

Class II Biologics Event

Event ID46133
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Oct-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center of the Ozarks
CitySpringfield
StateMO
CountryUS
Distribution PatternNorth Carolina; Missouri;
 

Associated Products

Product DescriptionRed Blood Cells
Code Info6798040
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity1 Unit
Recall NumberB-0745-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info6819346
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity1 Unit
Recall NumberB-0746-13

Class II Biologics Event

Event ID46636
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Nov-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 Info21LY18474
ClassificationClass II
Reason for RecallBlood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Product Quantity1 component
Recall NumberB-0735-13

Class II Biologics Event

Event ID49793
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Aug-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityCleveland
StateOH
CountryUS
Distribution PatternOH, NJ, GA, MO, NC, MI, SC, IN, and CA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info42FE10146; 42FG38598; 42L54257; 42GX05663; 42GS32747; 42FE10012; 42FE10015; 42FE10144; 42FE10145; 42FE10019; 42FE10140; 42FE10148; 42FG38588; 42FG38596; 42FY87647; 42GX05665; 42L54010; 42L54256; 006LV50469; 006LP45246; 006FY93535; 006GS40395; 006LH17884; 006GT77083; 006GE34211; 006LV50477; 006LP45421; 006LQ04192; 006LV50512; 006LV50488; 006LV50506; 006LH17880; 006LY83121; 006LY83089; 006LY83117; 42FE10019; 42FE10140; 42FE10148; 42FG38588; 42FG38596; 006FY92834; 006FC59395; 42FW52035; 42FG38596; 42FG38597;42M35638; 42GT24395; 42GS33656; 42GM06234; 42GM06237; 42GM06238; 42W53470; 42GM06233; 42M35638; 006FE32665; 006GV77287; 42FY81647; 42GX05665; 42L54010; 42L54256
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity51 units
Recall NumberB-0527-13
Product DescriptionPlasma Frozen
Code Info42FE10144; 42FG38596; 42GX05663; 42CX05665; 42L54010
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity5 units
Recall NumberB-0528-13
Product DescriptionRed Blood Cells
Code Info42FG38734
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity1 unit
Recall NumberB-0529-13
Product DescriptionCryoprecipitate AHF, Pooled
Code Info006L16589
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity1 unit
Recall NumberB-0530-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info006FE32995
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity1 unit
Recall NumberB-0531-13
Product DescriptionPlasma Frozen within 24 hours after Phlebotomy (FP24)
Code Info42FZ62526; 42FG38596; 42FZ31978; 006LV50504; 006LV50477; 006LH16787; 006FY92533; 006LT83833; 006FY93230; 006GV77545; 006GE03248; 006FC59791; 006FC59790; 006GX88824; 006GX88853; 006FE31590; 006FE31591; 006GX88583; 006FR07331; 006FR07309; 006FY91374; 006GX88558; 006FY91468; 006LT84124; 006FY91564; 006FY83209; 006LS18607; 006GP95732; 006FE32997; 006FC60183; 006LH16761; 006LQ04205; 006LT84139; 006FY92525; 006FR07284; 006GT77323; 006GW55916; 006LP45234; 006GE34230; 006FY93228; 006GT77327; 006FC60177; 006LT84391; 006FY92828; 006LT84147; 006LP43762; 006FR07279; 006FY91552; 006FY91461; 006FY91322; 006FE30810; 006GT76431; 006GL03267; 006FY91566
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity54 units
Recall NumberB-0532-13

Class II Biologics Event

Event ID56583
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jul-09
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionSource Plasma
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ClassificationClass II
Reason for RecallBlood products, collected from donors who did not have a complete physical exam, were distributed.
Product Quantity3124 units
Recall NumberB-0751-13

Class II Food Event

Event ID60188
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Oct-11
Initial Firm Notification of Consignee or Public Visit
Recalling FirmTortilleria Provincia
CityBowling Green
StateKY
CountryUS
Distribution PatternThe product was only distributed in the state of Kentucky.
 

Associated Products

Product DescriptionYellow Corn Tortillas in 5 lb clear flexible plastic bags with green and yellow printing. Tortilleria Provincia 1200 B Clay Street Bowling Green, KY 42101
Code InfoManufacture dates from 09/19/2011 through 10/19/2011 and all expiration dates between 10/19/2011 and 11/19/2011.
ClassificationClass II
Reason for RecallDuring an FDA inspection at the firm, it was discovered that the firm uses, FD&C Yellow #5, in the manufacture of their tortillas. However, FD&C Yellow #5 is not listed in the ingredient statement.
Product Quantity60-70 cases ( 6 pkgs/case)
Recall NumberF-1046-2013

Class II Drugs Event

Event ID63522
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionHEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045, NDC 0409-1555-54
Code InfoLot # 10-199-JT Exp. 10/13
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.
Product Quantity11,412 bags
Recall NumberD-184-2013

Class II Biologics Event

Event ID63571
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Sep-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center
CityDayton
StateOH
CountryUS
Distribution PatternOH
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW035412060950
ClassificationClass II
Reason for RecallBlood product, collected from a donor who had a previous history of travel to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-0359-13

Class II Biologics Event

Event ID63572
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Sep-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers Inc
CityHuntsville
StateAL
CountryUS
Distribution PatternAL
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW1151122758236- part 1; W1151122758236- part 2
ClassificationClass II
Reason for RecallBlood products, which were not quarantined subsequent to receiving post donation illness information, were distributed.
Product Quantity2 units
Recall NumberB-0448-13

Class II Biologics Event

Event ID63573
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Sep-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers, Inc.
CityGainesville
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW115112327021R
ClassificationClass II
Reason for RecallBlood product, labeled leukoreduced but was not tested to verify the White Blood Cell count, was distributed.
Product Quantity1 unit
Recall NumberB-0447-13

Class II Biologics Event

Event ID63575
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Oct-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers Inc - Birmingham Region
CityBirmingham
StateAL
CountryUS
Distribution PatternAL
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW115112282932C
ClassificationClass II
Reason for RecallBlood product, which did not meet acceptable product specifications, was distributed.
Product Quantity1 unit
Recall NumberB-0446-13

Class II Biologics Event

Event ID63576
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Sep-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers, Inc.
CityGainesville
StateFL
CountryUS
Distribution PatternAL,FL
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW115112277608P- part 1; W115112277608P-part 2
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications for release, were distributed.
Product Quantity2 units
Recall NumberB-0480-13

Class II Biologics Event

Event ID63578
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Sep-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers, Inc.
CityGainesville
StateFL
CountryUS
Distribution PatternAL
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW115112277116S
ClassificationClass II
Reason for RecallPlatelet, with a low platelet count, was distributed.
Product Quantity1 unit
Recall NumberB-0481-13

Class II Biologics Event

Event ID63579
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLane Memorial Blood Bank
CityEugene
StateOR
CountryUS
Distribution PatternTennessee; Oregon
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW137512105036; W137512107334
ClassificationClass II
Reason for RecallBlood products, collected from a donor who had traveled to a malarial endemic area, were distributed.
Product Quantity2 units
Recall NumberB-0477-13

Class II Biologics Event

Event ID63591
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmD. D. Eisenhower Army Med. Ctr. - Blood Bank
CityFort Gordon
StateGA
CountryUS
Distribution PatternNJ, FL
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW010712004910;
ClassificationClass II
Reason for Recall
Product Quantity
Recall NumberB-0478-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW010712004910
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-0479-13

Class II Devices Event

Event ID63671
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Healthcare Inc.
CityAndover
StateMA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Canada, Chile, Czech republic, Estonia,France, Germany, Hungary, Inida, Ireland, Italy, Japan, Libyan Arab Jamahari, Mexico, Netherlands, New Zealand, Norway , Oman, Panama, Peru, Poland, Qatar, Reunion, Russia, Saudi Arabia, South Africa, South Korea,Spain, Sweden, Swizerland, Thailand, UAE, and the UK.
 

Associated Products

Product DescriptionPhilips Digital Diagnost Stationary radiographic system
Code InfoAll Digital Diagnost systems with Eleva software version 3.0.x
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 Quantity360
Recall NumberZ-0900-2013

Class II Drugs Event

Event ID63706
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Nov-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBristol Myers Squibb Manufacturing Company
CityHumacao
StatePR
CountryUS
Distribution PatternLA, TN, CA
 

Associated Products

Product DescriptionABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35
Code Info2E69023A, Exp. FEB 28 2015
ClassificationClass II
Reason for RecallCGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed.
Product Quantity21 blister packs
Recall NumberD-181-2013

Class II Devices Event

Event ID64000
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBeckman Coulter Inc.
CityBrea
StateCA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Austria, Brazil, China, Czech Republic, France, Germany, Hungary, India, Ireland, Israel, Italy, Korea Republic, Malaysia, Netherlands, Russian Federation, Spain, Switzerland, Taiwan, Turkey, United Kingdom, and Viet Nam.
 

Associated Products

Product DescriptionBeckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.
Code InfoAll serial numbers / Multiple manufacture dates. Part# Item# ================ A94907 AU5811-02 A94912 AU5821-02 A94917 AU5831-02 A94922 AU5841-02 A94908 AU5811-03 A94913 AU5821-03 A94918 AU5831-03 A94923 AU5841-03 A94909 AU5811-04 A94914 AU5821-04 A94919 AU5831-04 A94924 AU5841-04 A94910 AU5811-06 A94915 AU5821-06 A94920 AU5831-06 A94925 AU5841-06
ClassificationClass II
Reason for RecallDue to a software data storage limitation which only occurs under certain conditions, measurements of the Reagent Blank (RB) or Calibration (CAL) sample results are not saved and the software reverts to a previously stored, acceptable RB/CAL result.
Product Quantity28 in U.S.; 4 Canada; 318 to other foreign countries.
Recall NumberZ-0913-2013

Class II Drugs Event

Event ID64001
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product Description 0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7984-23,
Code InfoLot Number 02-117-JT Exp. 02/13
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: There is the potential for solution to leak from the administrative port to the fill tube seal.
Product Quantity325,056 bags
Recall NumberD-183-2013

Class II Devices Event

Event ID64071
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternWorldwide Distribution - USA including the states of AR, CA, CO, FL, GA, IL IN, IA, LA, MD, MA, MI, MN, MO, NJ, NM, NY, NC, OH, OK, PA, PR, SC, SD, TN, TX and VA. and the countries of ALGERIA, AUSTRALIA, AUSTRIA, ARGENTINA, BELARUS, CANADA, CHINA, CHILE, EGYPT CZECH REPUBLIC, FRANCE, FINLAND, GERMANY, GABON, HONG KONG, INDIA, IRELAND, ITALY KENYA, KOREA, JAPAN, MEXICO, NIGERIA, PHILIPPINES, PORTUGAL REPUBLIC OF MALTA, RUSSIAN FEDERATION SAUDI ARABIA, SPAIN SWITZERLAND, TURKEY, TAIWAN, TUNISIA, UNTIED KINGDOM and VENEZUELA.
 

Associated Products

Product DescriptionGE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast, easy, volume visualization of three dimensional structures imaged with a computed tomography (CT) or magnetic resonance (MR) system. It is dedicated to clinical and diagnostic applications in radiology, surgery, and treatment planning.
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NE651510 NP384112 41018DCS01 53004DCS01 05004DCS01 00192ADW12 70772ADW01 38824624IISOCC
ClassificationClass II
Reason for RecallIncorrect views and measurements possible. GE Healthcare became aware of multiple potential safety issues involving the Advantage workstation, Volume Viewer Plus and Volume Analysis.
Product Quantity363
Recall NumberZ-0901-2013

Class II Drugs Event

Event ID64105
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmWest-ward Pharmaceutical Corp.
CityEatontown
StateNJ
CountryUS
Distribution PatternGA
 

Associated Products

Product Descriptiona)60 tablets NDC 61748-014-06, b)90 tablets, NDC 61748-014-09, c)100 tablets, NDC 61748-014-01, d)1000 tablets, NDC 61748-014-10, e) blister pack (10s) 61748-014-11
Code Info69877A; 68977B; 68978B; 6978C; 68979A - exp JUL 2015 68977C; 68978A exp JUL 2013
ClassificationClass II
Reason for RecallDiscoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.
Product Quantity18,825 bottles
Recall NumberD-189-2013

Class II Devices Event

Event ID64195
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSynthes USA HQ, Inc.
CityWest Chester
StatePA
CountryUS
Distribution PatternNationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT.
 

Associated Products

Product DescriptionSynthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
Code InfoPart number 487.831 - Lot numbers 7826459,7750064, 7667285, and 7806090.
ClassificationClass II
Reason for RecallIt was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
Product Quantity2
Recall NumberZ-0903-2013
Product DescriptionSynthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengthening.
Code InfoPart number 487.966 - Lot numbers 7823465, 3817114, 7806086, 3824427, 3808871, 3794465, and 7793336.
ClassificationClass II
Reason for RecallIt was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
Product Quantity24
Recall NumberZ-0904-2013
Product DescriptionSynthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.
Code InfoPart number 487.967 - Lot numbers 7883454, 3808876, 7824423, 3800758, 3817116, 3794466
ClassificationClass II
Reason for RecallIt was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
Product Quantity18
Recall NumberZ-0905-2013

Class II Devices Event

Event ID64214
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions USA, Inc
CityConcord
StateCA
CountryUS
Distribution Pattern5 devices, all located outside of the United States in Germany.
 

Associated Products

Product DescriptionSIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY.
Code InfoAll codes/units of ARTISTE model.
ClassificationClass II
Reason for RecallSiemens became aware of a potential safety issue when using the "In-session resumption" feature of the syngo RT Therapist (RTT) 4.3 software. The RTT will send again the previously completed beam or segment for delivery to the control console, thus repeating the already delivered Monitor Units of the same beam or segment.
Product Quantity5 units
Recall NumberZ-0907-2013

Class II Food Event

Event ID64257
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmR-Kane Products Inc.
CityPennsauken
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionZ Pro 25 High Protein Supplement Net. Wt. 1.3 oz. - Vanilla Flavor Formulated and Distributed by: R-Kane Products, Inc. 8351 National Highway, Pennsauken, NJ 08110
Code InfoAll codes distributed between 1/1/2011 and 1/24/2013
ClassificationClass II
Reason for RecallZ Pro High Protein Vanilla Flavor Supplement is under recall because it contains the allergens milk and coconut, a tree nut, which are not declared on the label of the individual packets of the product.
Product Quantityunavailable
Recall NumberF-1056-2013
Product DescriptionZ Pro 25 High Protein Supplement Net. Wt. 1.5 oz. - Chocolate Flavor Formulated and Distributed by: R-Kane Products, Inc. 8351 National Highway, Pennsauken, NJ 08110
Code InfoAll codes distributed between 1/1/2011 and 1/24/2013
ClassificationClass II
Reason for RecallZ Pro High Protein Chocolate Flavor Supplement is under recall since it contains milk and soy, allergens, which are not declared on the label of the individual packets of the product.
Product Quantity
Recall NumberF-1057-2013

Class II Devices Event

Event ID64259
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Medical Systems (Cleveland) Inc
CityCleveland
StateOH
CountryUS
Distribution PatternWorldwide Distribution - USA including the states of AL, AT, AZ, BAH, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NJ, NV, NY, OH, OR, PA, PR, PR, SC, TN, TX, VA, VT, WA, WI & WV. and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican, Republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Gabon, Georgia, Germany, Greece, Guadeloupe, Guinea, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, LAO People's Dem, Rep., Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Malta, Martinique, Mexico, Netherlands, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela & Viet Nam.
 

Associated Products

Product Description Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Code InfoModel 728260, Serial #, 3467,5610,6151,6204,6209,6221,6437,6483,6543,6636,6658,6717,6788,6865,7154,7186,7253,7470, 7507,7576,7579,7639,7690,7692,7708,7835,7977,8099,8255,8332,8443,8756,8757,8890,8922,9079, 9201,9395,9422,10085,10086,10090,10102,10138,10155,10180,10197,10216,10240,10261,10264,10271, 10312, 10324,10328,10346,10355,10359,10378,10383,10389,10422,10427,10431,10435,10437,10442, 10455,10456,10470,10476,10492,10537,10547,10561,10584,10598,10604,10606,10622,10630,10646, 10672,10686,10699,10722,10727,10738,10745,10747,10770,10776,10778,10796,10798,10817,10821, 10822,10823,10838,10841,10874,10889,10890,10897,10952,10953,10965,10980,10985,10988,10998, 11007,11010,11025,11036,11037,11043,11051,11054,11058,11062,11065,11080,11083,11085,11086, 11088,11089,11105,11107,11113,11121,11127,11128,11140,11141,11147,11148,11149,11151,11152, 11153,11166,11169,11173,11174,11208,11221,11230,11232,11241,11243,11260,11262,11267,11274, 11278,11280,11282,11291,11314,11317,11324,11334,11339,11341,11557,11561,11564,11567,11572, 11577,11581,11585,11603,11610,11612,11620,11622,11630,11631,11633,11644,11649,11650,11656, 11657,11659,11660,11662,11663,11667,11668,11670,11673,11674,11684,11685,11692,11694,11696, 11699,11700,11703,11706,11708,11711,11714,11717,11718,11720,11729,11739,11740,11742,11743, 11744,11745,11747,11748,11749,11750,11751,11753,11754,11755,11756,11758,11760,11762,11765, 11766,11768,11769,11770,11772,11773,11774,11776,11779,11780,11781,11782,11784,11785,11788, 11790,11791,11793,11794,11795,11796,11797,11798,11800,11801,11802,11803,11804,11805,11806, 11807,11808,11809,11810,11812,11813,11814,11816,11817,11818,11819,11822,11823,11830,11831, 11832,11833,11834,11838,11839,11840,11841,11842,11843,11844,11845,11846,11847,11848,11850, 11851,11852,11854,11856,11858,11859,11862,11863,11864,11865,11866,11868,11869,11870,11873, 11874,11877,11878,11879,11880,11881,11882,11883,11884,11885,11886,11888,11889,11890,11891, 11892,11893,11896,11897,11898,11899,11900,11901,11902,11903,11904,11905,11906,11907,11911, 11912,11913,11916,11917,11918,11920,11923,11925,11927,11928,11929,11930,11932,11933,11934, 11935,11936,11937,11938,11939,11942,11943,11944,11947,11976,11977,11978,11979,11980,12049, 12051,12100,12100,12102,12103,12104,12105,12106,12107,12108,12109,12110,12111,12112,12115, 12117,12118,12119,12120,12121,12122,12123,12124,12125,12126,12128,12129,12130,12132,12133, 12136,12138,12139,12140,12141,12142,12144,12145,12146,12147,12152,12154,12155,12157,12158, 12159,12160,12162,12163,12164,12167,12170,12171,12172,12173,12174,12175,12176,12178,12179, 12180,12181,12182,12183,12200,12201,12202,12203,12204,12205,12206,12207,12208,12209,12210, 12211,12215,12216,12217,12218,12219,12220,12222,12223,12224,12225,12226,12227,12228,12229, 12230,12231,12236,12237,12239,12240,12241,12242,12243,12244,12248,12249,12250,12271,12273, 12274,12302,12303,12304,12305,12306,12309,12310,12311,12312,12314,12315,12316,12317,12318, 12321,12322,12323,12324,12325,12326,12327,12328,12329,12330,12331,12332,12333,12336,12337, 12338,12339,12341,12342,12343,12345,12346,12347,12348,12349,12350,12351,12352,12353,12354, 12355,12356,12357,12359,12360,12362,12363,12364,12366,12369,12370,12373,12376,12377,12379, 12380,12382,12383,12386,12388,12389,12391,12392,12394,12396,12397,12398,12399,12400,12403, 12405,12406,12407,12408,12409,12410,12411,12412,12413,12414,12415,12416,12417,12418,12419, 12420,12421,12422,12423,12424,12425,12428,12429,12430,12431,12432,12434,12435,12436,12438, 12439,12440,12441,12443,12444,12445,12446,12447,12471,12472,12473,12474,12475,12476,12477, 12492,12493,12494,12495,12496,12497,12498,12500,12501,12503,12504,12505,12508,12510,12513, 12514,12516,12517,12521,12522,12526,12527,12528,12530,12531,12538,12539,12541,12542,12543, 12544,12545,12546,12547,12548,12549,12550,12551,12552,12553,12554,12555,12556,12557,12558, 12559,12561,12562,12563,12565,12567,12568,12569,12570,12573,12574,12575,12577,12579,12580, 12581,12583,12584,12586,12587,12588,12589,12591,12592,12594,12595,12596,12597,12598,12601, 12602,12603,12604,12605,12606,12611,12612,12614,12617,12618,12619,12620,12621,12622,12623, 12625,12626,12627,12628,12629,12631,12632,12633,12634,12636,12638,12640,12641,12643,12645, 12646,12647,12648,12649,12650,12651,12652,12653,12654,12656,12657,12658,12662,12663,12664, 12665,12669,12670,12671,12672,12673,12674,12675,12676,12677,12678,12679,12680,12681,12700, 12701,12702,12703,12704,12705,12706,12707,12708,12709,12710,12711,12712,12713,12716,12719, 12720,12722,12723,12724,12725,12726,12727,12730,12731,12732,12733,12734,12735,12740,12741, 12742,12743,12744,12745,12747,12748,12752,12753,12756,12757,12761,12763,12765,12767,12768, 12769,12770,12771,12772,12773,12774,12776,12777,12778,12780,12783,12784,12786,12791,12792, 12797,12800,12801,12802,12803,12805,12806,12807,12808,12809,12814,12817,12818,12819,12820, 12821,12822,12823,12826,12827,12828,12829,12830,12831,12832,12833,12834,12835,12836,12837, 12838,12839,12840,12844,12845,12846,12847,12848,12849,12850,12851,12861,12865,12874,12875, 12877,12878,12879,12900,12901,12902,12904,12905,12907,12908,12909,12911,12913,12917,12919, 12920,12922,12923,12925,12926,12927,12928,12929,12930,12931,12932,12935,12937,12938,12939, 12940,12941,12942,12944,12947,12949,12953,12956,12957,12958,12960,12961,12962,12963,12964, 12965,12966,12967,12968,12969,12970,12971,12972,12973,12974,12976,12978,12979,12980,12983, 12985,12986,12987,12988,12992,12994,12996,12997,12999,13000,13002,13003,13004,13005,13007, 13008,13009,13010,13013,13014,13015,13016,13017,13018,13019,13020,13022,13023,13024,13025, 13026,13027,13028,13029,13031,13034,13035,13036,13039,13041,13042,13043,13044,13046,13047, 13060,13061,13062,13063,13064,13065,13066,13067,13068,13069,13070,13071,13072,13073,13074, 13075,13076,13077,13078,13079,13080,13081,13082,13083,13084,13086,13088,13089,13101,13102, 13103,13104,13105,13109,13110,13113,13114,13115,13116,13117,13118,13119,13120,13121,13122, 13123,13125,13128,13129,13131,13132,13133,13134,13135,13136,13137,13138,13139,13142,13148, 13149,13150,13151,13152,13153,13154,13155,13156,13157,13158,13159,13160,13163,13164,13165, 13166,13167,13168,13169,13170,13171,13173,13177,13178,13179,13180,13181,13182,13183,13184, 13185,13186,13188,13189,13190,13191,13192,13194,13195,13196,13197,13198,13199,13201,13202, 13203,13204,13206,13207,13208,13213,13214,13215,13217,13218,13219,13220,13221,13223,13224, 13225,13226,13227,13228,13229,13230,13231,13232,13233,13234,13238,13239,13240,13241,13242, 13244,13245,13246,13249,13263,13264,13265,13266,13272,13273,13274,13277,13278,13279,13298, 13299,13301,13302,13303,13304,13305,13306,13307,13308,13309,13310,13312,13313,13314,13315, 13316,13317,13318,13320,13321,13322,13323,13324,13325,13326,13327,13328,13329,13330,13331, 13332,13333,13334,13336,13337,13341,13342,13343,13344,13348,13351,13353,13355,13359,13362, 13363,13365,13366,13367,13368,13370,13371,13373,13374,13375,13376,13377,13378,13379,13381, 13382,13385,13386,13389,13391,13393,13397,13399,13400,13401,13402,13403,13404,13406,13407, 13408,13410,13411,13412,13415,13416,13417,13420,13421,13423,13425,13427,13428,13429,13430, 13431,13438,13439,13440,13443,13444,13445,13447,13448,13450,13451,13453,13454,13455,13456, 13458,13459,13463,13465,13466,13467,13471,13472,13473,13474,13475,13476,13477,13478,13500, 13501,13502,13508,13509,13510,13511,13512,13513,13514,13515,13516,13517,13518,13519,13520, 13521,13522,13523,13524,13525,13526,13527,13528,13529,13530,13531,13532,13533,13534,13535, 13536,13537,13538,13539,13540,13541,13542,13543,13544,13545,13546,13547,13548,13549,13550, 13552,13553,13556,13557,13558,13560,13561,13562,13563,13564,13566,13567,13568,13569,13570, 13571,13572,13574,13575,13578,13579,13580,13581,13582,13584,13585,13586,13587,13588,13589, 13590,13591,13592,13593,13594,13595,13596,13598,13599,13600,13602,13603,13604,13605,13606, 13607,13608,13609,13610,13611,13612,13613,13614,13616,13617,13619,13622,13624,13625,13626, 13627,13628,13629,13634,13637,13638,13639,13640,13641,13642,13643,13644,13645,13648,13649, 13651,13652,13653,13654,13655,13656,13657,13658,13659,13661,13664,13666,13667,13672,13675, 13679,13680,13681,13684,13686,13690,13693,13694,13696,13697,13698,13715,13716,13718,13727, 13739,13750,13751,13752,13753,13754,13755,13756,13757,13758,13759,13760,13761,13762,13763, 13764,13765,13766,13767,13768,13769,13770,13771,13772,13773,13774,13775,13776,13777,13779, 13784,13785,13786,13787,13788,13789,13790,13791,13792,13793,13794,13796,13797,13798,13799, 13803,13804,13805,13806,13808,13809,13810,13811,13814,13816,13817,13823,13824,13825,13846, 13847,13848,13849,13850,13851,13852,13853,13856,13857,13859,13862,13863,13864,13867,13868, 13869,13870,13871,13872,13875,13876,13877,13878,13880,13883,13884,13886,13887,13892,13893, 13894,13895,13896,13897,13899,13900,13901,13902,13903,13904,13905,13906,13907,13908,13909, 13910,13911,13912,13913,13914,13915,13916,13917,13918,13919,13920,13921,13923,13925,13926,13927,13928, 13930,13931,13950,13951,13952,13953,13954,13955,13957,13959,13962,13963,13966,13967,13968,13969,13970, 13971,13972,13974,13976,13977,13978,13980,13982,13983,13984,13986,13987,13988,13989,13990,13992,13993,13995,13997,13998,13998,13999,14000,14005,14006,14007,14008,14009,14010,14011,14012,14013,14014,14015,14016,14017,14018,14019,14020,14021,14022,14023,14024,14025,14026,14027,14028,14029,14030,14031,14032,14033,14034,14035,14036,14037,14038,14039,14040,14050,14054,14055,14058,14059,14061,14062,14063,14064,14065,14068,14069,14070,14071,14072,14073,14074,14075,14076,14077,14078,14079,14080,14081,14082,14083,14084,14085,14086,14087,14088,14089,14090,14091,14095,14096,14097,14098,14100,14101,14102,14103,14105,14106,14107,14108,14109,14110,14111,14113,14114,14115,14117,14118,14119,14120,14121,14122,14123,14125,14126,14129,14130,14131,14132,14133,14135,14136,14137,14138,14139,14140,14141,14142,14147,14148,14149,14152,14157,14158,14159,14162,14163,14164,14165,14167,14170,14174,14219,14221,14223,14224,14248,14250,14254,14255,14256,14257,14258,14259,14260,14261,14262,14263,14264,14265,14266,14267,14268,14269,14269,14270,14271,14274,14275,14276,14277,14278,14279,14282,14284,14285,14286,14287,14288,14289,14290,14291,14293,14295,14296,14297,14298,14299,14300,14301,14302,14303,14304,14305,14306,14307,14309,14311,14313,14314,14315,14316,14317,14318,14319,14320,14321,14322,14323,14324,14325,14327,14328,14329,14330,14331,14332,14333,14334,14335,14336,14337,14338,14339,14340,14341,14342,14343,14344,14345,14346,14347,14348,14349,14350,14351,14352,14353,14354,14355,14356,14357,14358,14359,14360,14361,14362,14363,14365,14366,14367,14368,14369,14370,14373,14374,14375,14376,14377,14378,14379,14380,14381,14382,14383,14384,14385,14386,14388,14389,14390,14391,14393,14394,14395,14396,14398,14399,14400,14402,14403,14450,14451,14452,14453,14454,14455,14456,14457,14458,14459,14460,14461,14462,14463,14464,14465,14466,14467,14468,14469,14470,14471,14472,14473,14474,14475,14476,14477,14478,14479,14481,14482,14483,14486,14489,14490,14491,14492,14493,14494,14495,14496,14497,14498,14499,14500,14504,14534,14535,14536,14537,14538,14539,14540,14541,14558,14559,14560,14561,14562,14563,14564,14566,14567,14568,14569,14570,14571,14572,14586,14587,14588,14595,14596,14597,14598,14599,14600,14603,14604,14605,14606,14607,14609,14610,14611,14613,14614,14617,14619,14620,14621,14622,14625,14627,14628,14629,14630,14631,14632,14633,14634,14635,14637,14638,14639,14640,14642,14644,14645,14647,14648,14649,14650,14651,14652,14653,14654,14655,14656,14657,14658,14659,14661,14662,14663,14664,14665,14667,14668,14669,14670,14671,14673,14674,14675,14676,14678,14679,14680,14683,14685,14686,14687,14688,14690,14691,14693,14696,14697,14698,14699,14701,14704,14706,14708,14709,14711,14712,14714,14715,14717,14719,14720,14721,14722,14723,14724,14725,14729,14731,14732,14733,14736,14737,14739,14740,14742,14743,14744,14745,14746,14747,14748,14749,14750,14753,14754,14756,14757,14759,14760,14761,14762,14763,14764,14765,14766,14767,14768,14770,14771,14773,14774,14775,14776,14777,14778,14779,14780,14782,14783,14785,14786,14787,14788,14789,14790,14791,14792,14793,14794,14795,14796,14797,14798,14799,14800,14801,14802,14803,14804,14806,14807,14808,14809,14810,14811,14812,14813,14815,14816,14819,14820,14821,14823,14826,14828,14829,14831,14832,14833,14834,14835,14837,14838,14839,14842,14843,14844,14845,14846,14847,14848,14849,14850,14851,14852,14853,14854,14855,14856,14857,14859,14860,14863,14864,14865,14867,14868,14869,14870,14871,14872,14873,14874,14875,14876,14878,14880,14881,14882,14883,14884,14885,14886,14888,14889,14890,14891,14892,14893,14894,14895,14896,14897,14898,14899,14900,14901,14902,14903,14904,14905,14906,14907,14908,14909,14910,14911,14912,14913,14914,14915,14916,14918,14919,14920,14922,14923,14924,14925,14927,14928,14931,14933,14934,14935,14937,14938,14941,14943,14944,14945,14946,14948,14949,14950,14951,14952,14953,14954,14955,14956,14957,14958,14959,14960,14961,14965,14966,14971,14972,14973,14974,14975,14976,14977,14979,14981,14982,14983,14984,14985,14986,14987,14988,14989,14990,14991,14992,14993,14994,14995,14996,14997,14999,15000,15001,15003,15004,15005,15007,15009,15010,15011,15013,15016,15018,15019,15023,15025,15026,15027,15028,15029,15030,15031,15032,15033,15035,15036,15040,15043,15044,15153,15154,15155,15156,15157,15158,15159,15160,15161,15162,15163,15164,15165,15166,15167,15168,15169,15170,15171,15172,15173,15174,15175,15176,15177,15178,15179,15180,15181,15182,15183,15185,15186,15188,15189,15196,15198,15199,15201,15203,15204,15207,15208,15209,15210,15211,15212,15213,15214,15215,15216,15222,15223,15224,15226,15228,15229,15230,15231,15254,15255,15256,15259,15260,15261,15263,15273,15274,15275,15276,15278,15279,15280,15283,15284,15288,15289,15290,15291,15292,15293,15294,15315,15316,15317,15320,15321,15322,15325,15326,15328,15330,15331,15332,15333,15334,15335, 15336,15338,15339,15340,15341,15343,15344,15347,15348,15349,15350,55525,55529,55533,10032,10175, 10192,10361,10372,10449, 10192, 10266,10356, 10372, 10449, 10690, 11016, 11167, 11229, 11320, 11611, 11618,11682,11683,11688,11698,11712,11763,11783,11792,11811,11815,11820,11825,11849,11853,11855,11860,11871,11872,11894,11895,11908,11909,11910,11914,11915,11921,11922,12062,12063,12064,12065,12113,12116,12134,12143,12148,12149,12150,12151,12161,12165,12166,12168,12214,12221,12238,12245,12246,12247,12267,12300,12301,12307,12308,12319,12320,12358,12365,12367,12374,12381,12385,12390,12427,12448,12449,12506,12507,12509,12515,12519,12525,12529,12560,12564,12566,12571,12572,12576,12585,12590,12593,12608,12609,12616,12637,12659,12660,12661,12666,12714,12739,12749,12750,12751,12754,12755,12758,12759,12760,12764,12787,12799,12804,12811,12812,12824,12841,12842,12876,12912,12914,12915,12921,12924,12933,12934,12936,12946,12951,12952,12954,12955,12959,12981,12989,12990,12991,12995,12998,13001,13006,13012,13021,13030,13032,13033,13038,13048,13049,13100,13106,13108,13111,13112,13124,13140,13141,13143,13145,13146,13147,13161,13162,13172,13187,13222,13235,13236,13237,13243,13247,13248,13276,13300,13311,13335,13352,13357,13358,13361,13372,13380,13383,13384,13388,13390,13398,13414,13419,13422,13424,13432,13433,13434,13446,13457,13468,13503,13504,13505,13506,13551,13559,13565,13583,13615,13620,13623,13630,13631,13632,13635,13646,13647,13650,13660,13662,13663,13665,13683,13699,13719,13720,13738,13740,13795,13807,13813,13815,13839,13854,13855,13860,13861,13865,13866,13873,13882,13885,13889,13890,13891,13898,13922,13924,13956,13960,13961,13973,13975,13979,13981,13985,13994,13996,14001,14002,14003,14051,14052,14053,14057,14060,14066,14067,140802,14092,14093,14094,14099,14104,14112,14116,14124,14143,14145,14155,14156,14160, 14161,14169,14171,14172,14173,14199,14200,14220,14222,14251,14252,14253,14273,14280,14281,14283, 14292,14294,14308,14310,14371,14372,14387,14397,14480,14624,14666,14677,14682,14694,14695,14702,14707,14710,14726,14727,14728,14730,14741,14769,14781,14784,14805,14814,14817,14818,14824,14827,14840,14926,14930,14932,14940,14967,14970,15002,15008,15015,15017,15020,15038,15039,15184,15187,15193,15194,15195,15197,15205,15206,15218,15219,15220,15221,15227,15281,15287,15295,15296,15297,15298,15299,15345,41968,41980,55553 & 72762.
ClassificationClass II
Reason for RecallIncorrect values may be displayed. Philips is issuing a software update (version 4.5.5) to the Extended Brilliance Workspace (EBW) systems currently running software version(s) 4.0.2, V4.5.2 or V4.5.3, addressing a number of non-conformances.
Product Quantity2,580 units
Recall NumberZ-0906-2013

Class II Food Event

Event ID64284
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Dec-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmDeep Foods Inc
CityUnion
StateNJ
CountryUS
Distribution Pattern27 states (Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Louisiana, Massachusetts, Maryland, Maine, Mississippi, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia and West Virginia.
 

Associated Products

Product DescriptionDeep Best Quality Dry Garlic Chutney (Thechaa); Net Wt. 4 OZ.; UPC 011433111201; Deep Foods, Inc. Union, NJ 07083
Code InfoUPC 011433111201
ClassificationClass II
Reason for RecallUnapproved dye in product (Rhodamine B - Basic Violet 10).
Product Quantity7000 units per month
Recall NumberF-1051-2013

Class II Devices Event

Event ID64343
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmEthicon Endo-Surgery Inc
CityCincinnati
StateOH
CountryUS
Distribution PatternWorldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY; and, the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, GERMANY, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KUWAIT, LIBYAN ARAB JAMAHIRIYA, MALAYSIA, MEXICO, NETHERLANDS ANTILLES, NICARAGUA, NICOSIA, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PROVINCE OF CHINA, PUERTO RICO, REPUBLIC OF KOREA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA &, YEMEN.
 

Associated Products

Product DescriptionPROXIMATE® Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC Guaynabo, Puerto Rico 00969 USA Assembled in Mexico. For routine skin closure in a wide variety of surgical procedures.
Code InfoExpiration dates: September 2012 - August 2017
ClassificationClass II
Reason for RecallEthicon Endo-Surgery initiated a voluntary recall for all PSX Proximate® Skin Staple Extractors because the possibility exists that damage to the packaging may have compromised the sterility of the device.
Product Quantity5,894,975 pieces
Recall NumberZ-0918-2013

Class II Devices Event

Event ID64383
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSalyer Prn Biomedical
CityMesa
StateAZ
CountryUS
Distribution PatternDistributed in the states of MA,CA, and WI.
 

Associated Products

Product DescriptionCentury Console Base, Model #043625051b Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.
Code InfoSerial Numbers: CCB40120, CCB40121, CCB40122, CCB40123, CCB40124, CCB40139, CCB40140, CCB40143, and CCB40144.
ClassificationClass II
Reason for RecallConcerns that the addition of the UPS Battery Backup to the Century Console Base Shelf did not comply with the FDA premarket notification regulations.
Product Quantity9 units
Recall NumberZ-0902-2013

Class II Food Event

Event ID64396
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRich Products Corp
CityBuffalo
StateNY
CountryUS
Distribution PatternNY, PA, VA, TN, IN, MI, WI, MN, SD, ND, IL, MO, NE, KS, OK, TX, CA, WA
 

Associated Products

Product DescriptionALL NATURAL ANCIENT GRAIN BREAD, NET WT. 13.8 OZ. (393 g), PRODUCT OF CANADA, UPC 0 49800 08712 5 (appears on bag), Product Code 08712 --- RICH PRODUCTS CORP., BUFFALO, NY 14213 --- The product is a frozen bread dough packaged in a plastic bag with 24 plastic bags per case. The frozen dough is sold to in-store bakeries and food service customers.
Code InfoProduct produced from July 27, 2012 through February 1, 2013 (Julian Dates 77002209 - 77003302)
ClassificationClass II
Reason for RecallProduct was manufactured with bulk flour supplied by Dakota Specialty Milling which is being recalled due to reports of metal fragments..
Product QuantityApproximately 6,000 cases
Recall NumberF-1052-2013

Class II Food Event

Event ID64397
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRich Products Corp
CityBuffalo
StateNY
CountryUS
Distribution PatternCA, CO, TX, UT, SC, NC, WA, NM
 

Associated Products

Product DescriptionSara Lee Thin Style Buns, 100% Multi-Grain, 1.5 oz., Goglanian Bakeries Product Code 77474, UPC 072945611788 --- The product is packaged in a plastic bag with a green bag clip. There are 8 buns per retail package (plastic bag) and there are 18 bags per tray.
Code InfoProduction Date Green Bag Clip Code 7/24/12 G01206Gxx* 8/1/12 G01214Gxx* 8/6/12 G01219Gxx* 8/30/12 G01243Gxx* 9/26/12 G01270Gxx* 10/17/12 G01291Gxx* 11/28/12 G01333Gxx* 12/16/12 G01351Gxx* 12/31/12 G01366Gxx* 1/18/13 G01018Gxx* (*xx denotes the hour of production and will be represented by two numeric digits (e.g. 09 would mean 9:00 a.m. production hour).
ClassificationClass II
Reason for RecallThe product was manufactured with bulk flour supplied by Dakota Specialty Milling. Dakota Specialty Milling is recalling the bulk flour because of reports of metal fragments (stainless steel) caused by a faulty mesh screen.
Product QuantitySara Lee Buns: 17,238 cases
Recall NumberF-1053-2013
Product DescriptionDaphne's California 6 inch Multigrain Flatbread, 2.1 oz., Product Code 77468, Net Wt. 13.50 lbs. (case) --- There are 12 - 10 count bags per case
Code InfoProduction Date Bag Clip Code Case Jet Code 09/06/2012 09/06/12 09/06/12 L1 HH:MM 11/13/2012 11/13/12 11/13/12 L1 HH:MM 01/20/2013 01/20/13 01/20/13 L1 HH:MM *HH:MM denotes the hour and minute of production and will be represented by four numeric digits (e.g. 09:20 would mean 9:20 a.m. time of production)
ClassificationClass II
Reason for RecallThe product was manufactured with bulk flour supplied by Dakota Specialty Milling. Dakota Specialty Milling is recalling the bulk flour because of reports of metal fragments (stainless steel) caused by a faulty mesh screen.
Product QuantityDaphne's Flatbread: 1,254 cases
Recall NumberF-1054-2013

Class II Devices Event

Event ID64404
StatusOngoing
Product TypeDevices
Voluntary/Mandated
Recall Initiation Date14-Jan-13
Initial Firm Notification of Consignee or Public
Recalling FirmAtricure Inc
CityWest Chester
StateOH
CountryUS
Distribution PatternNationwide Distribution including the states of MD, PA and TX.
 

Associated Products

Product DescriptionAtricure Inc. The Isolator Transpolar Pen is intended to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.
Code InfoModel Number(s): MAX1 A000163, Lot Number 41865
ClassificationClass II
Reason for RecallAtriCure has identified that products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
Product Quantity5 devices
Recall NumberZ-0912-2013

Class II Devices Event

Event ID64417
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMedtronic Inc. Cardiac Rhythm Disease Management
CitySaint Paul
StateMN
CountryUS
Distribution PatternWorldwide distribution, including USA nationwide, Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Viet Nam.
 

Associated Products

Product DescriptionMedtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318; 69320; 69322; 69324; 69328; 69331.
Code InfoModel Catalog# Lot 67312 6731210NO 2012090293 67312 6731210NO 2012090294 67312 6731210NO 2012090337 67312 6731210NO 2012100039 67312 6731210NO 2012100086 67312 6731210NO 2012100087 67312 6731210NO 2012100161 67312 6731210NO 2012110326 67312 6731210NO 2012110767 67312 6731210NO 2012110899 67312 6731210NO 2012111721 67314 6731410NO 2012090416 67314 6731410NO 2012090435 67314 6731410NO 2012090571 67314 6731410NO 2012090572 67314 6731410NO 2012100040 67314 6731410NO 2012100041 67314 6731410NO 2012100107 67314 6731410NO 2012101346 67314 6731410NO 2012110007 67314 6731410NO 2012110008 67314 6731410NO 2012110327 67314 6731410NO 2012111419 67314 6731410NO 2012111420 67314 6731410NO 2012120019 67316 6731610NO 2012090239 67316 6731610NO 2012090389 67316 6731610NO 2012090854 67316 6731610NO 2012091024 67316 6731610NO 2012110030 67316 6731610NO 2012110144 67316 6731610NO 2012110394 67316 6731610NO 2012110395 67316 6731610NO 2012110396 67318 67318 2012110850 67318 67318 2012110851 67318 67318 2012111013 67318 67318 2012111789 67318 67318 2012120328 67318 67318 2012120330 67318 67318 2013010932 67318 67318 2013010933 67318 67318 2013011226 67320 67320 2012121379 67320 67320 2012121629 67320 67320 2013010002 67320 67320 2013010105 69312 6931210NO 2012090236 69312 6931210NO 2012110010 69312 69312INK 2012090296 69312 69312INK 2012100905 69312 69312INK 2012110251 69312 69312INK 2012110252 69314 6931410NO 2012090855 69314 6931410NO 2012091222 69316 6931610NO 2012090240 69318 69318 2012111225 69318 69318 2013010966 69320 69320 2012121408 69320 69320 2013010003 69322 69322 2012111723 69322 69322 2012120118 69322 69322 2012120513 69322 69322 2013010812 69322 69322 2013010935 69324 69324 2012121060 69324 69324 2012121061 69324 69324 2012121062 69324 69324 2012121148 69324 69324 2012121149 69324 69324 2012121362 69328 69328 2012110184 69328 69328 2012120660 69328 69328 2012120661 69328 69328 2012120992 69328 69328 2012121004 69328 69328 2012121005 69328 69328 2012121006 69328 69328 2012121150 69328 69328 2012121192 69328 69328 2012121193 69328 69328 2012121364 69328 69328 201301C189 69331 69331 2012121063 69331 69331 2012121064 69331 69331 2012121151 69331 69331 2012121382 69331 69331 2013010224 69331 69331 2013010437 69331 69331 2013010438 69331 69331 2013010510 69331 69331 2013010511 CB67314 CB67314 206409412 CB67318 CB67318 206513557 CB67318 CB67318 206642303
ClassificationClass II
Reason for RecallPotential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula.
Product Quantity13,691 (6711 USA; 6980 OUS)
Recall NumberZ-0908-2013

Class II Devices Event

Event ID64425
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBard Access Systems
CitySalt Lake City
StateUT
CountryUS
Distribution PatternUSA Nationwide Distribution and the countries Europe, Belgium, Australia, and Latin America.
 

Associated Products

Product DescriptionHickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (pediatric product code 0600580; adult product code 0600600). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequate peripheral venous access.
Code InfoLot numbers: HUWI1379 and HUWI1380.
ClassificationClass II
Reason for RecallBard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer being included with the kit.
Product Quantity195 units.
Recall NumberZ-0909-2013
Product DescriptionLeonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 0600630). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequate peripheral venous access.
Code InfoLot numbers: HUWI1379 and HUWI1380.
ClassificationClass II
Reason for RecallBard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer being included with the kit.
Product Quantity73 units
Recall NumberZ-0910-2013

Class II Devices Event

Event ID64440
StatusOngoing
Product TypeDevices
Voluntary/Mandated
Recall Initiation Date12-Feb-13
Initial Firm Notification of Consignee or Public Visit
Recalling FirmSteris Corporation
CityMentor
StateOH
CountryUS
Distribution PatternWorldwide Distribution - USA including Canada and the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, SK, TN, TX, UT, VA, VT, WA, WI, and WV.
 

Associated Products

Product DescriptionAMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
Code InfoAMSCO C: Serial Numbers: 021911201  023461202 AMSCO 400: Serial Numbers: 030181215-030291310
ClassificationClass II
Reason for RecallThe control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (analog/digital) alarm as temperature fluctuated during operation. When this alarm occurs, the sterilizer locks up and cannot be used until serviced, causing Customer nuisance.
Product Quantity395 Units
Recall NumberZ-0915-2013

Class II Devices Event

Event ID64464
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmChurchill Medical Systems, Inc.
CityDover
StateNH
CountryUS
Distribution PatternNationwide Distribution including MO, IL, FL, PA, VA, MO, NY, NE, NH, and OH.
 

Associated Products

Product DescriptionLifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
Code InfoLot #1210099
ClassificationClass II
Reason for RecallThe label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the pouch contains a 22Ga set.
Product Quantity2340
Recall NumberZ-0914-2013

Class II Drugs Event

Event ID64541
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRX South LLC DBA RX3 Pharmacy
CityChester
StateVA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionMedi-bolic Booster Injectable (methionine 8.3 mg/mL, choline chloride 16.6 mg/mL, inositol 16.6 mg/mL, cyanocobalamin USP [Vit B12] 0.33 mg/mL, chromium chloride 2.6 mg/mL), 30 mL multi-dose vials, Rx3 Compounding Pharmacy, 12230 Ironbridge Rd., Suite C, Chester, VA 23831.
Code InfoLot #: 10292012:56, Exp 01/27/13 and 10302012:77, Exp 01/28/13
ClassificationClass II
Reason for RecallCGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.
Product Quantity126 vials
Recall NumberD-191-2013

Class III Biologics Event

Event ID47152
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jan-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNew York Blood Center, Inc.
CityNew York
StateNY
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info7764846;7764844
ClassificationClass III
Reason for RecallBlood products, which were exposed to unacceptable temperature during storage, were distributed.
Product Quantity2 units
Recall NumberB-0724-13

Class III Biologics Event

Event ID48953
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Mar-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomat USA, Inc.
CityPortland
StateOR
CountryUS
Distribution PatternSpain and California
 

Associated Products

Product DescriptionSource Plasma
Code Info0530052514, 0530052215, 0530050895, 0530050580, 0530047198, 0530046819, 0530046556, 0530046177, 0530045908, 0530045575, 0530045209, 0530044864, 0530044645, 0530044165, 0530043843, 0530043544, 0530043221, 0530042952, 0530042614, 0530042283, 0530041970, 0530041692, 0530041301, 0530040953, 0530040591, 0530040201, 0530040019, 0530039491, 0530039298, 0530038835, 0530038580, 0530038196, 0530037947, 0530037640, 0530037395, 0530037079, 0530036854, 0530036272, 0530035763, 0530035112, 0530034619, 0530034010, 0530033447, 0530031462, 0530031138, 0530030785, 0530030640, 0530030316, 0530029897, 0530029726, 0530029139, 0530028900, 0530028569, 0530028132, 0530024940, 0530024718, 0530024335, 0530024098, 0530023670, 0530023432, 0530023031.
ClassificationClass III
Reason for RecallBlood products, collected from a donor who was previously deferred, were distributed.
Product Quantity61 units
Recall NumberB-0220-13

Class III Biologics Event

Event ID57168
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Jul-10
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc.
CityPortland
StateOR
CountryUS
Distribution PatternIllinois, Germany, and Switzerland.
 

Associated Products

Product DescriptionSource Plasma
Code Info05500078721, 0550884624, 0550880694, 0550878282, 0550877802, 0550876130, 0550874472, 0550872589, 0550869379, 0550866855, 0550866106, 0550865200, 0550864090, 0550862725, 0550862005, 0550860313, 0550859462, 0550857143, 0550856245, 0550855001, 0550854403, 0550852476, 0550850598, 0550850013, 0550848572, 0550848061, 0550846449, 0550844814, 0550843807, 0550842770, 0550840117, 0550838522, 0550837750, 0550836435, 0550834107, 0550832459, 0550829940, 0550828624, 0550827749, 0550826098, 0550825574, 0550823940, 0550823081, 0550821608, 0550819697, 0550819061.
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
Product Quantity46 components
Recall NumberB-0747-13

Class III Biologics Event

Event ID63282
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmEthicon, Inc.
CitySomerville
StateNJ
CountryUS
Distribution PatternNationwide and Foreign (Canada, Israel, Singapore, and Switzerland)
 

Associated Products

Product Description Fibrin Sealant (Human) Evicel Rx Only Sterile Disposable Single Use Distributed by: Johnson and Johnson Wound Management A division of Ethicon Inc. Johnson & Johnson Wound Management A division of ETHICON, INC. P.O. Box 151, Somerville, NJ 08876-0151 USA Manufacturer: omrix Omrix biopharmaceuticals, Ltd. MDA blood bank, Sheba Hospital Ramat-Gan POB 888, Kiryat Ono 55000 ISRAEL NDC 63713-390-55 for EVICEL Fibrin Sealant (Human) 5 mL NDC 63713-390-11 for EVICEL Fibrin Sealant (Human) 1 mL NDC 63713-390-22 for EVICEL Fibrin Sealant (Human) 2 mL
Code Info5 mL sample PRODUCT CODE S3905 LOT NUMBERS Q02F010, Q05F120, Q19F420, Q35F780, Q33F700 1 mL PRODUCT CODE 3901 LOT NUMBERS Q44F97K, Q53F350 2 mL PRODUCT CODE 3902 LOT NUMBERS Q03F030, Q09F310, Q29F610, Q44F980, Q31F640, Q35F750, Q36F820, Q46F040, Q47F050 5 mL PRODUCT CODE 3905 LOT NUMBERS P44F050 P45F100 P45F090 P46F120 P48F180 R06F130 R07F180 R07F190 R07F250 R07F260 R10F310 P50F330 R10F320 R10F330 R12F380 P48F190 P53F390 Q03F040 P50F310 Q02F010 P52F370 Q11F320 P52F360 Q02F020 Q04F090 Q04F100 Q04F110 Q05F120 Q32F660 Q05F130 Q05F140 Q06F160 Q06F170 Q07F210 Q08F280 Q08F290 Q16F400 Q08F300 Q13F340 Q33F710 Q13F350 Q14F360 Q14F370 Q15F380 Q15F390 Q19F410 Q28F560 Q19F420 Q21F470 Q21F480 Q32F670 Q31F620 Q31F630 Q22F490 R03F090 Q28F570 Q35F760 Q29F580 Q29F590 Q33F720 Q34F730 Q34F740 Q32F680 Q33F690 Q50F210 Q33F700 Q35F770 Q35F790 Q36F810 Q41F900 R01F010 R010F020 R01F030 Q41F920 Q40F880 Q41F910 Q48F090 R06F140 Q42F940 Q43F950 Q48F100 Q43F960 Q45F990 Q47F070 Q49F140 Q49F150 Q50F220 Q52F300 R03F080 Q51F280 Q52F290 R07F200 Q50F230 Q50F240 Q51F260 Q51F270 Q52F310 Q53F330 R02F060 R09F270 R10F300 R10F340 R11F350 R12F370
ClassificationClass III
Reason for RecallEvicel and Evithrom, manufactured with a processing deviation that potentially led to decreased potency, were distributed.
Product Quantity120
Recall NumberB-1048-13
Product DescriptionThrombin, Topical (Human) Evithrom Rx only Distributor: Johnson & Johnson Wound Management A division of Ethicon, Inc. Manufacturer: Omrix Biopharmaceuticals Ltd. 2 mL - NDC 63713-460-02 5 mL- NDC 63713-460-05
Code InfoEvithrom 2mL Product Code S4602, Lot Number Q36T62K; Product Code 4602, Lot Numbers P49T05K, Q11T44J, Q2T46K, Q45T77J; Evithrom 5 mL Product Code 4605 Lot Numbers P46T84J, P50T150, Q07T23J, Q08T28K, Q23T88K, Q25T93J, Q25T94J, Q27T08J, Q30T31J, Q31T34J, Q31T360, Q32T41K, Q33T48J
ClassificationClass III
Reason for RecallEvicel and Evithrom, manufactured with a processing deviation that potentially led to decreased potency, were distributed.
Product Quantity18
Recall NumberB-1049-13

Class III Devices Event

Event ID64013
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Mar-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBecton Dickinson & Company
CityFranklin Lakes
StateNJ
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionBD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA. Used in hospitals, outpatient clinics and physicians' offices to collect blood from patients for specialized chemistry testing.
Code InfoReference No.: 367960; Tube Size: 13 X 75. Reference Nos. 367961-367963, and 368035; Tube Size: 13 X 100; all lots
ClassificationClass III
Reason for RecallBD is conducting a recall of the BD Vacutainer Plus Plastic Plasma Separator Tube (PST) with Light Green/BD Homogard Closure due to a deformed top of the tube reservoir reported in two customer complaints.
Product Quantity225 million units
Recall NumberZ-0911-2013

Class III Biologics Event

Event ID64206
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFlorida Lions Eye Bank, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternNationwide; Jamica; Costa Rica; Egypt, El Salvador, St. Thomas, Venezuela, Ecuador, China and Guatemala
 

Associated Products

Product DescriptionCornea
Code Info0801006COS, 0801006COD, 0801016COD, 0801016COS, 0801020COD, 0801022COS, 0801022COD, 0802009COSG2, 0802009COD, 0802009COSG1, 0802015COD, 0802015COSGPC, 0802015COS, 0802023COD, 0802023COS, 0802060COS, 0802060COD, 0802076COD, 0802076COS, 0802080CODG2, 0802080CODG1, 0802080COSG1, 0802080COSG2, 0802084COSG1, 0802084COSG2, 0802084CODG1, 0802084CODG2, 0803007COS, 0803007COD, 0803011COD, 0803011COS, 0803025COS, 0803025COD, 0803025COSGPC, 0803058COD, 0803076CODG1, 0803076CODG2, 0803076COSG2, 0803076COSG1, 0804015COD, 0804015COS, 0804042COD, 0805019COSG2, 0805019COSG1, 0805019COD, 0805056COS, 0805056COD, 0805056COSGPC, 0805064COD, 0805064COS, 0806007COD, 0806007COS, 0806014CODG2, 0806014COS, 0806014CODG1, 0806018COD, 0806018COS, 0806022COS, 0806022COD, 0806024COD, 0806024COSG2, 0806024COSG1, 0806032CODGPC, 0806032COSG1, 0806032COD, 0806032COSG2, 0806040CODG1, 0806040CODG2, 0806040COSG2, 0806040COSG1, 0806046COSG2, 0806046COSG1, 0806046CODG2, 0806046CODG1, 0806058COS, 0806058COD, 0807006COS, 0807006COD, 0807037COS, 0807037COD, 0807041COS, 0807041COD, 0807049COD, 0807049COS, 0808009COD, 0808009COS, 0808009COSGPC, 0808009CODGPC, 0808012COD, 0808041COD, 0808041COS, 0808046COS, 0808046COD, 0808046COSGPC, 0808046CODGPC, 0809002COD, 0809002COS, 0809028COD, 0809028COS, 0809075COSGPC, 0809075COS, 0809075COD, 0810002COD, 0810002COS, 0810012CODG2, 0810012COS, 0810012CODG1, 0810041COS, 0810041COD, 0811008CODG1, 0811008CODG2, 0811008COSG2, 0811008COSG1, 0811057COS, 0811057CODGPC, 0811057COD, 0811069COD, 0811069COS, 0811080CODG1, 0811080COSG1, 0811080CODG2, 0811080COSG2, 0811084COSG1, 0811084CODG2, 0811084CODG1, 0811084COSG2, 0812015COD, 0812015COS, 0812045CODG2, 0812045CODG1, 0812045COSG2, 0812045COSG1, 0812045COD, 0812059COSG2, 0812059COSG1, 0812059CODG2, 0812059CODG1, 0812060COD, 0812060COS, 0901001COS, 0901001COD, 0901016COD, 0901016COS, 0901021COS, 0901021COD, 0901055COS, 0901055COD, 0901059COS, 0901059COD, 0901066CODGPC, 0901066COS, 0901066COD, 0902020COS, 0902020COD, 0902028COD, 0902028COS, 0902032COS, 0902032COD, 0902043CODG1, 0902043CODG2, 0902043COSG1, 0902043COSG2, 0902061COSG1, 0902061COSG2, 0902061COD, 0903004WEOS, 0903004CODG1, 0903004SOD2, 0903004SOD3, 0903004SOD5, 0903004CODG2, 0903004SOD1, 0903004SOD4, 0903004SOD6, 0903004SOD7, 0903004SOD8, 0903027COD, 0903050COSG1, 0903050COD, 0903050COSG2, 0904012COS, 0904012COD, 0904039COSG1, 0904039COD, 0904039COSG2, 0904041COD, 0904041COS, 0904047COS, 0904047COD, 0904065COD, 0904065COS, 0904095COSG2, 0905006COSG1, 0905006COD, 0905006COSG2, 0905012COS, 0905012COD, 0905067COSG2, 0905067CODG1, 0905067CODG2, 0905067SOSW, 0905067SODW, 0905067COSG1, 0906011COS, 0906011COD, 0907015CODG1, 0907015COS, 0907015CODG2, 0907016SOD1, 0907016SOD2, 0907016SOD3, 0907016SOD4, 0907016CODG1, 0907016SOD7, 0907016SOD8, 0907016SOS1, 0907016SOS3, 0907016SOS4, 0907016COSG2, 0907016SOS7, 0907016COSG1, 0907016SOD5, 0907016SOD6, 0907016SOS2, 0907016SOS5, 0907016SOS6, 0907016CODG2, 0907025COSG1, 0907025COSG2, 0907025SOSW, 0907025SODW, 0907025CODG1, 0907025CODG2, 0907045COS, 0907045COD, 0908048COS, 0908048CODG2, 0908048CODG1, 0909009COD, 0909009COS, 0909022WEOD, 0909059CODG1, 0909059CODG2, 0909059COSG1, 0909059COSG2, 0909059SOSW, 0909059SODW, 0909073COS, 0909073COD, 0909078COSG2PC, 0909078COSG1PC, 0909078CODG1PC, 0909078CODG2PC, 0909089COD, 0909089COS, 0910002COS, 0910003COSG1, 0910003SOSW, 0910003SODW, 0910003COSG2, 0910003CODG1, 0910003CODG2, 0911007COS, 0911007COSGPC, 0911007COD, 0911008COD, 0911008CODGPC, 0911008COS, 0911021COS, 0911021COD, 0911033COSGPC, 0911033COD, 0911033COS, 0911040CODG2, 0911040COSG2, 0911040COSG1, 0911040CODG1, 0911065COD, 0911065COS, 0912002CODG2, 0912002SOS2, 0912002SOS7, 0912002SODW, 0912002SOS1, 0912002SOS3, 0912002SOS4, 0912002SOS5, 0912002SOS6, 0912002SOS8, 0912002COSG1, 0912002COSG2, 0912002CODG1, 0912013COS, 0912013COD, 0912022COS, 0912022COD, 0912052CODG1, 0912052CODG2, 0912062COS, 0912062COD, 1001004COD, 1001004COS, 1001008SOSW, 1001008CODG1, 1001008SODW, 1001008CODG2, 1001008COSG1, 1001008COSG2, 1001009COD, 1001009COS, 1001010COD, 1001010COS, 1001011CODG2, 1001011CODG1, 1001011COSG1, 1001011COSG2, 1001016COSG1, 1001016COSG2, 1001016WEOD, 1001016SOSW, 1001017COD, 1001017CODGPC, 1001017COSGPC, 1001017COS, 1001052COD, 1001052COS, 1001090COD, 1001096COS, 1001096COD, 1002008SOD2, 1002008SOS4, 1002008SOD1, 1002008SOD8, 1002008SOD7, 1002008SOS6, 1002008CODG2, 1002008COSG2, 1002008SOD3, 1002008SOD4, 1002008SOD5, 1002008SOD6, 1002008SOS1, 1002008SOS2, 1002008SOS7, 1002008SOS8, 1002008CODG1, 1002008COSG1, 1002008SOS3, 1002008SOS5, 1002009COD, 1002009COS, 1002009CODGPC, 1002009COSGPC, 1002035COS, 1002035COD, 1002066COD, 1002066COS, 1003002COD, 1003002COS, 1003010COD, 1003010COS, 1003016COS, 1003016COD, 1004031COD, 1004031COS, 1004037COS, 1004037COD, 1004045CODG2, 1004045COSG1, 1004045CODG1, 1004045COSG2, 1004049COS, 1004049CODG1, 1004049CODG2, 1004050COD, 1004050COS, 1004051CODG2, 1004051CODG1, 1004051COSG1, 1004051SODW, 1004051SOSW, 1004051COSG2, 1004054COD, 1004054COS, 1004054COD, 1004054COS, 1004077COS, 1004077CODG2, 1004077CODG1, 1004079COD, 1004079COS, 1005004COSG1, 1005004COD, 1005004COSG2, 1005009COD, 1005009COSG1, 1005009COSG2, 1005011COD, 1005011COS, 1005013CODG2, 1005013CODG1, 1005013COSG2, 1005019COS, 1005019COD, 1005021COD, 1005021COS, 1005023CODG2, 1005023COS, 1005023CODG1, 1005024COD, 1005024COS, 1005037COD, 1005037COSG1PC, 1005037COSG2PC, 1005037COSGPC, 1005060CODG1, 1005060CODG2, 1005060COS, 1005063COSGW, 1005067COD, 1005067COS, 1005077COD, 1005077COS, 1005078COD, 1005078COS, 1005079COS, 1005079COD, 1006002COD, 1006002COS, 1006005COS, 1006005COD, 1006013COD, 1006013COS, 1006014COSG1, 1006014CODG1, 1006014CODG2, 1006014COSG2, 1006021COD, 1006021COS, 1006027COD, 1006027COS, 1006033COD, 1006033COS, 1006049COD, 1006049COS, 1006053COS, 1006053COD, 1006055COD, 1006055COS, 1006059COD, 1006059COS, 1006067CODG1, 1006067COS, 1006067CODG2, 1007001CODG2, 1007001CODG1, 1007001COS, 1007007COD, 1007007COS, 1007008COS, 1007008COD, 1007010COD, 1007010COS, 1007014COD, 1007014COS, 1007019COS, 1007019COD, 1007024COD, 1007024COS, 1007041COS, 1007041COD, 1007043COD, 1007043COS, 1007052COSG1, 1007052COSG2, 1007052CODG1, 1007052SODW, 1007052SOSW, 1007052CODG2, 1007055COD, 1007055COS, 1007062COS, 1007062CODG1, 1007062CODG2, 1007064CODG1, 1007064COSG1, 1007064SODW, 1007064SOSW, 1007064CODG2, 1007064COSG2, 1007072COD, 1007072COS, 1008004CODG1PC, 1008004CODG2PC, 1008004CODGPC, 1008004COS, 1008005COD, 1008005COS, 1008008COS, 1008008COD, 1008009COD, 1008009COS, 1008019COS, 1008019COD, 1008022COD, 1008022COS, 1008036COD, 1008036COS, 1008042CODG1, 1008042COSG1, 1008042COSG2, 1008042CODG2, 1008077COD, 1008077COSG1PC, 1008077COSG2PC, 1008079COD, 1008079COS, 1009001CODG1, 1009001CODG2, 1009001COSG1, 1009001COSG2, 1009046COS, 1009046COD, 1009057SODW, 1009057COSG2, 1009057SOSW, 1009057CODG1, 1009057CODG2, 1009057COSG1, 1009061COS, 1009061COD, 1010006CODG1, 1010006CODG2, 1010006COSG1, 1010006COSG2, 1010012COS, 1010012COD, 1010035SOS1, 1010035SOS2, 1010035SOS3, 1010035COSG2, 1010035COD, 1010035SOD1, 1010035SOD2, 1010035SOD4, 1010035SOS4, 1010035SOD3, 1010037COS, 1010037SODW, 1010037SOSW, 1010037COD, 1010044CODG1, 1010044CODG2, 1010044COS, 1010044SOD1, 1010044SOD2, 1010044SOD3, 1010044SOD4, 1010044SOS1, 1010044SOS2, 1010044SOS3, 1010044SOS4, 1010051COD, 1010051COS, 1010066COD, 1010066COS, 1011006SOS6, 1011006COS, 1011006SOS5, 1011006SOD5, 1011006SOD6, 1011006SOD8, 1011006SOS3, 1011006SOS4, 1011006SOS7, 1011006SOS8, 1011006SOD3, 1011006SOD1, 1011006SOD2, 1011006SOD4, 1011006SOS1, 1011006SOS2, 1011006COD, 1011028CODG2, 1011028COSG1, 1011028COSG2, 1011028SOS2, 1011028SOS3, 1011028SOS1, 1011028CODG1, 1011028SODW, 1011034COSG1, 1011034CODG2, 1011034CODG1, 1011034COSG2, 1011040COD, 1011040SOD1, 1011040SOD2, 1011040COS, 1011045COD, 1011045COS, 1012021CODG2, 1012021CODG1, 1012044COD, 1012044COS, 1101042CODG1, 1101042CODG2, 1101042COSG1, 1101042COSG2, 1101061COD, 1101061COS, 1101064COS, 1101064COD, 1101070CODG1PCBED, 1101070CODG2PCBED, 1101070COS, 1101074CODG1, 1101074CODG2, 1101074COS, 1101084CODG1, 1101084CODG2, 1101084COSG1, 1101084COSG2, 1102007COD, 1102007COS, 1102030COD, 1102030COS, 110232CODG1PCBED, 110232CODG2PCBED, 102032COSG1PCBED, 1102032COSG2PCBED, 1102033COD, 1102033COSG1, 1102033COSG2, 1102044COD, 1102044COSG1, 1102044COSG2, 1103024COD, 1103024COS, 1103028COD, 1103028COSG1, 1103028COSG2, 1103057COD, 1103057COS, 1103063COD, 1103063COS, 1105017COD, 1105017COSG1, 1105017COSG2, 1105026COD, 1105026COS, 1105039COD, 1105039COS, 1105053COD, 1105053COS, 1106002CODG1, 1106002CODG2, 1106002COSG1, 1106002COSG2, 1106056COSGW, 1107036COD, 1107036COS, 1107045CODG1, 1107045CODG2, 1107045COS, 1107047COS, 1108027CODG2PCBED, 1108027CODG1PCBED, 1108027CODG2PCBED, 1108027COS, 1108027CODG1PCBED, 1108027CODGPCCAP, 1108031COD, 1108031COS, 1108045CODG1, 1108045CODG2, 1108045COSG1, 1108045COSG2, 1108050COD, 1108050COSG1, 1108050COSG2, 1108075COD, 1108075COS, 1108076CODG2, 1108076CODG1, 1108076COSG1, 1108076COSG2, 1108079COD, 1108079COS, 1202048SOSW, 1202048COS, 1202048SODW, 1202048COD
ClassificationClass III
Reason for RecallHuman Corneas, recovered from donors whose donor eligibility was not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed.
Product Quantity693
Recall NumberB-0971-13

Class III Drugs Event

Event ID64298
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jan-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAaron Industries Inc
CityLynwood
StateCA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionWell at Walgreens Wal-Tussin CF Max, MAXIMUM STRENGTH ADULT NON-DROWSY, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (237 mL) bottles, Distributed by: Walgreen Co, Deerfield, IL 60015 ---- NDC 0363-0229-08
Code InfoLot# 80798; FP-49-081-14870
ClassificationClass III
Reason for RecallPresence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Product Quantity6,108 bottles (509 cases)
Recall NumberD-185-2013
Product DescriptionRite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg, 4 FL. OZ./12 PK (UPC Code: 0-11822-57307-8) and 8 FL.OZ./12 PK (UPC Code: 0-11822-57313-9), Distributed by: Rite Aid, Camp Hill, PA, 17011
Code InfoLot# 68089, 68415, 70046, 700516, 70665, 71157, 71704, 80795; FP-38-081-57313; FP-38-041-57307
ClassificationClass III
Reason for RecallPresence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Product Quantity35,652 bottles (2,971 cases)
Recall NumberD-186-2013
Product DescriptionSelect Brand Cough Control CF Max, Maximum Strength for MUCUS RELIEF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 4 fl.oz 12pk (NDC 15127-025-04; UPC Code: 0-15127-02535-5), Distributed by: Select Brand Distributors, Pine Bluff, AR 71603 USA.
Code InfoLot# 71648, 68088; FP-47-041-02535
ClassificationClass III
Reason for RecallPresence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Product Quantity5,676 bottles (473 cases)
Recall NumberD-187-2013
Product DescriptionWal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (235 mL) (NDC 49035-229-08; UPC Code: 6-81131-03884-30), Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72712.
Code InfoLot# 81198, 82183, 80797; FP-44-081-03884
ClassificationClass III
Reason for RecallPresence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Product Quantity43,464 bottles (3,622 cases)
Recall NumberD-188-2013

Class III Drugs Event

Event ID64338
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGlenmark Generics Inc., USA
CityMahwah
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionMontelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per bottle (NDC 68462-392-30) and b) 90-count tablets per bottle (NDC 68462-392-90), Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430.
Code Info02122956, 02123226, 02123269, 02123480, 02123481, 02122933, 02122955, 02123062, 02123075, 02123085, 02123114, 02123115, 02123124, 02123125, 02123189, 02123199, 02123205, 02123219, 02123253, 02123270, 02123289, 02123295, 02123320, 02123333, 02123343, 02123349, 02123411, 02123421, 02123431, Exp 09/14 and 10/14
ClassificationClass III
Reason for RecallChemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an off-odor, described as moldy, musty or fishy in nature which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA).
Product Quantity591,972 bottles
Recall NumberD-182-2013

Class III Devices Event

Event ID64367
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jan-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmLinvatec Corp. dba ConMed Linvatec
CityLargo
StateFL
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) including the states of: CA, FL, GA, IL, KS, MA, MD, MO, NE, NY, and TX and the countries of: Canada, Germany, Romania, Spain, Palestine, South Africa, France, Sweden and Singapore
 

Associated Products

Product DescriptionD3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone
Code InfoModel #D3000
ClassificationClass III
Reason for RecallThe Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207 is used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third edition IEC60606-01 Medical Electrical Equipment: General requirements for basic safety and essential performance.
Product Quantity31 units
Recall NumberZ-0916-2013
Product DescriptionD3000I Advantage Drive System, 230v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone
Code InfoModel #D3000I
ClassificationClass III
Reason for RecallThe Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207 is used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third edition IEC60606-01 Medical Electrical Equipment: General requirements for basic safety and essential performance.
Product Quantity23 units
Recall NumberZ-0917-2013

Class III Drugs Event

Event ID64506
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmActavis Elizabeth LLC
CityElizabeth
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx Only, C II, 100 capsules per bottle, MFG. By Actavis Elizabeth LLC. 200 Elmora Ave, Elizabeth, NJ, 07207, USA, NDC 0228-3063-11.
Code InfoLot #: 50077231
ClassificationClass III
Reason for RecallFailed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.
Product Quantity9,264 Bottles
Recall NumberD-190-2013

Mixed Classification Biologics Event

Event ID63590
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Oct-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternSwitzerland; FL
 

Associated Products

Product DescriptionRed Blood Cells
Code Info2533388
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-0269-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info2533388
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0270-13

Mixed Classification Biologics Event

Event ID63592
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Sep-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternSwitzerland and FL
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036811258578
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-0474-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036811258578; W036810173369
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-0475-13
Product DescriptionRed Blood Cells
Code InfoW036810173369
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-0476-13
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