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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Class I Drugs Event

Event ID64571
StatusCompleted
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Mar-13
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmGreen Planet Inc
CityRiverside
StateCA
CountryUS
Distribution PatternNationwide.
 

Associated Products

Product DescriptionNight Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA
Code InfoLot# B43N032, Exp 10/15
ClassificationClass I
Reason for RecallMarketed Without an Approved NDA/ANDA; product contains analogues of sildenafil and tadalafil which are active pharmaceutical ingredients in FDA-approved drugs used to treat erectile dysfunction (ED) making this product an unapproved new drug.
Product Quantity429,619 capsules
Recall NumberD-828-2013

Class I Food Event

Event ID65465
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Jun-13
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmOskri Corp.
CityLake Mills
StateWI
CountryUS
Distribution PatternCA, CT, FL, ID, IL, IA, ME, MA, MI, MN, MO, MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SD, TN, TX, VT, VA, WA, WV, WI.
 

Associated Products

Product DescriptionOSKRI, Coconut Bar Dark Chocolate, Net Wt. 1.9 oz ( 53g), UPC 6 66016 30070 3. Ingredients: Coconuts 55%, Rice Syrup, Dark Chocolate 20% ( Sugar, Cocoa Butter, Chocolate, Soy Lecithin, Natural Vanilla).
Code InfoP 1/1/13 to 6/6/13. EXP 7/7/14 to 12/12/14. LOT 001 to 154.
ClassificationClass I
Reason for RecallOSKRI Corp is recalling Coconut Bar Dark Chocolate, Coconut Bar Dark Chocolate Minis, Fig Dark Chocolate Bars and Almond Dark Chocolate Bars because of undeclared milk.
Product Quantity2,364 cases
Recall NumberF-1779-2013
Product DescriptionOSKRI, Fig Dark Chocolate Bar, Net Wt 1.9 oz (53g) UPC 6 66016 30030 7. Ingredients: Figs 80%, dark chocolate 20% ( sugar, cocoa butter, pure chocolate, soy lecithin, natural vanilla).
Code InfoP 1/1/13 to 6/6/13. EXP 7/7/14 to 12/12/14. LOT 001 to 164.
ClassificationClass I
Reason for RecallOSKRI Corp is recalling Coconut Bar Dark Chocolate, Coconut Bar Dark Chocolate Minis, Fig Dark Chocolate Bars and Almond Dark Chocolate Bars because of undeclared milk.
Product Quantity2,138 cases
Recall NumberF-1780-2013
Product DescriptionOSKRI, Almond Dark Chocolate Bars, Net Wt 1.9 oz (53g), UPC 6 66016 30042 0. Ingredients: Almonds 32%, Rice syrup, Rice Crisp, Dark Chocolate 10% ( sugar, chocolate liquor, coco butter, soy lecithin, natural vanilla).
Code InfoP 1/1/13 to 6/6/13. EXP 7/7/14 to 12/12/14. LOT 001 to 154.
ClassificationClass I
Reason for RecallOSKRI Corp is recalling Coconut Bar Dark Chocolate, Coconut Bar Dark Chocolate Minis, Fig Dark Chocolate Bars and Almond Dark Chocolate Bars because of undeclared milk.
Product Quantity897 cases
Recall NumberF-1781-2013
Product DescriptionOSKRI, Coconut Bar Dark Chocolate Minis, Net Wt .88 oz (25g), UPC 6 66016 40031. Ingredients: Coconuts , Rice Syrup, Dark Chocolate ( Sugar, Cocoa Liquor,Cocoa Butter, Chocolate, Soy Lecithin, Vanilla).
Code InfoP 1/1/13 to 6/6/13. EXP 7/7/14 to 12/12/14. LOT 001 to 154.
ClassificationClass I
Reason for RecallOSKRI Corp is recalling Coconut Bar Dark Chocolate, Coconut Bar Dark Chocolate Minis, Fig Dark Chocolate Bars and Almond Dark Chocolate Bars because of undeclared milk.
Product Quantity578 cases
Recall NumberF-1782-2013

Class I Devices Event

Event ID65591
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jul-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmDePuy Orthopaedics, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternWorldwide Distribution-USA including the states of FL, GA, ID, KS, KY, MI, MO, NV, NY, OH, OK, PA, TN, TX, VA, and WA and the countries of AUSTRALIA, CANADA, ENGLAND, GERMANY, INDIA, COUNTY CORK, IRELAND, and TURKEY.
 

Associated Products

Product DescriptionLPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.
Code InfoCATALOG NO. : Part Number: 1987-19-055 and lot numbers:130896, 132131, 132133, 209461, 209466, 219843, 232972, 295965, 310189, 336843, 349283, 352878, 374125, 379089, A1TAR1, A2AGN1, A2AGS1, A2AGT1, A2AGV1, B2VAL1, B43G11, B43G1A, B43G1B, B43G1C, B43G1D, B69HV1, B69HVA, BK1BB1, BW7DX1, BW7DX1A, E3SJD1, and EN4KJ1. In certain documentation, these alphanumeric lot numbers may appear with three zeros at the end (e.g. A1TAR1 may appear as A1TAR1000).
ClassificationClass I
Reason for RecallThe LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the female component when exposed to certain physiological loads.
Product Quantity57 U.S. / 37 OUS
Recall NumberZ-1820-2013

Class I Food Event

Event ID65736
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jul-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmHagee Foods Inc.
CityAuburn
StateWA
CountryUS
Distribution PatternProducts were directly distributed in Oregon and Washington.
 

Associated Products

Product DescriptionPenny's Garlic Hummus 12 oz has UPC 7 49404 83061 4; Harbor Greens Garlic Hummus 8 oz has UPC 7 49404 802123; Tacoma Boys Garlic Hummus 8 oz has UPC 7 49404 902120; The 1 Gallon hummus does not have any brand name and does not have any UPC.
Code InfoUSE BY dates 7/13/2013 - 8/25/2013.
ClassificationClass I
Reason for RecallGarlic Hummus is recalled due to a potential contamination with Listeria monocytogenes.
Product Quantity486/8 oz packages; 1338/12 oz packages; and 12/1 gallon containers
Recall NumberF-1770-2013
Product DescriptionPENNY'S CREAMY HUMMUS 12 oz has UPC 7 49404 90971 6; PENNY'S SALSA Creamy Original Hummus 25 LB has no UPC.
Code InfoUSE BY dates 7/13/2013 - 8/25/2013.
ClassificationClass I
Reason for RecallCreamy Hummus is recalled due to a potential contamination with Listeria monocytogenes.
Product Quantity864/12 oz packages and 16/25 lb containers
Recall NumberF-1771-2013
Product DescriptionPenny's Hummus De Gallo 12 oz has UPC 7 49404 32368 0; Harbor Greens Hummus De Gallo 8 oz has UPC 7 49404 8061609; Tacoma Boys Hummus De Gallo 8 oz has UPC 7 49404 90676 6.
Code InfoUSE BY dates 7/13/2013 - 8/25/2013.
ClassificationClass I
Reason for RecallHummus De Gallo is recalled due to a potential contamination with Listeria monocytogenes.
Product Quantity1080/12 oz. packages and 324/ 8 oz packages
Recall NumberF-1772-2013
Product DescriptionPenny's Roasted Red Pepper Hummus 12 oz has UPC 7 49404 51848 2; Harbor Greens Roasted Red Pepper Hummus 8 oz has UPC 7 49404 80414 1; Tacoma Boys Roasted Red Pepper Hummus 8 oz has UPC 7 49404 90414 8; Roasted Red Pepper Hummus (no brand name) 1 gallon has No UPC.
Code InfoUSE BY dates 7/13/2013 - 8/25/2013.
ClassificationClass I
Reason for RecallRoasted Red Pepper Hummus is recalled due to a potential contamination with Listeria monocytogenes.
Product Quantity10/1 gallon containers; 396/8 oz packages; 1014/12 oz packages
Recall NumberF-1773-2013
Product DescriptionPenny's Jalapeno Hummus 12 oz UPC 7 49404 91368 3; Harbor Greens Jalapeno Hummus 8 oz UPC 7 49404 80313 7; Tacoma Boys Jalapeno Hummus 8 oz UPC 7 49404 90313 4.
Code InfoUSE BY dates 7/13/2013 - 8/25/2013.
ClassificationClass I
Reason for RecallJalapeno Hummus is recalled due to a potential contamination with Listeria monocytogenes.
Product Quantity444/12 oz packages and 369/8 oz packages
Recall NumberF-1774-2013
Product DescriptionPenny's Black Bean Hummus 12 oz has UPC 7 49404 70200 3; Harbor Greens Black Bean Hummus 8 oz has UPC 7 49404 80515 5; Tacoma Boys Black Bean Hummus 8 oz has UPC 7 49404 90515 2.
Code InfoUSE BY dates 7/13/2013 - 8/25/2013.
ClassificationClass I
Reason for RecallBlack Bean Hummus is recalled due to a potential contamination with Listeria monocytogenes.
Product Quantity138/12 oz packages; 270/8 oz packages
Recall NumberF-1775-2013
Product DescriptionHarbor Greens Sun-Dried Tomato Hummus 8 oz has UPC 7 49404 80717 3; Tacoma Boys Sun-Dried Tomato Hummus 8 oz has UPC 7 49404 90717 0.
Code InfoUSE BY dates 7/13/2013 - 8/25/2013.
ClassificationClass I
Reason for RecallSun-Dried Tomatoes Hummus is recalled due to a potential contamination with Listeria monocytogenes.
Product Quantity162/8 oz packages
Recall NumberF-1776-2013
Product DescriptionVegetable tray 8 oz UPC 7 49404 98020 3; Ingredients: Carrot Sticks, Celery, Grape Tomatoes, Creamy Hummus. Penny's Salsa Inc. Snack Pack 8 oz has UPC 07494041923606. Ingredient: W/Hummus, Celery, Carrots, Tomato. Both of these products contain the same ingredients in the same amount. The hummus is in a 1.5 oz container, labeled Made in the Pacific North West.
Code InfoUSE BY dates 7/13/2013 - 7/24/2013.
ClassificationClass I
Reason for RecallVegetable Trays and Snack Pack, 8 oz, are recalled because they contain 1.5 oz cups of hummus. The hummus is recalled due to a potential contamination with Listeria monocytogenes.
Product Quantity946/ 8 oz packages
Recall NumberF-1777-2013
Product DescriptionVegetable tray 8 oz UPC 7 49404 30002 5; Ingredients: Carrot Sticks, Pretzels, Grapes, Creamy Hummus. Penny's Salsa Inc. Snack Pack w/Hummus Grapes, Carrots and Pretzels 8 oz UPC 07494041923679. Both of these products contain the same ingredients in the same amount. Each contains a 1.5 oz package of hummus labeled Made in the Pacific North West.
Code InfoUSE BY dates 7/13/2013 - 7/24/2013.
ClassificationClass I
Reason for RecallVegetable Trays and Snack Pack, 8 oz, are recalled because they contain 1.5 oz cups of hummus. The hummus is recalled due to a potential contamination with Listeria monocytogenes.
Product Quantity245/8 oz packages
Recall NumberF-1778-2013

Class I Food Event

Event ID65737
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jul-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmWhole Foods Market Mid-Atlantic Kitchen
CityLandover
StateMD
CountryUS
Distribution PatternThe product was distributed to Kentucky, Maryland, Pennsylvania, Ohio, Virginia, Washington D.C. and New Jersey.
 

Associated Products

Product DescriptionPimento Cheese, packaged in 7 oz. plastic containers, and labeled in part ***Made by Whole Foods Market, Landover, MD 20785***UPC: 000000234801
Code InfoUse by 07/29/13
ClassificationClass I
Reason for RecallPimento cheese was mislabeled with an ingredient list, which did not declare the presence of mayonnaise, containing egg sub-ingredient.
Product Quantity624 units
Recall NumberF-1746-2013

Class I Food Event

Event ID65768
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNorthwest Gourmet Food Products, Inc.
CitySeattle
StateWA
CountryUS
Distribution PatternDistributed in Washington
 

Associated Products

Product DescriptionHummus is packed in 1.5 oz plastic portion cups with foil peel lids, 100 cups in a case. The product labeled in parts: "***HUMMUS***1.5 oz*** KEEP REFRIGERATED***
Code InfoBEST BY: 07/20/13
ClassificationClass I
Reason for RecallHummus, 1.5 oz. plastic portion cups with foil peel lids, is recalled due to a potential to be contaminated with Listeria monocytogenes.
Product Quantity40 cases/100 cups/1.5 oz
Recall NumberF-1769-2013

Class I Food Event

Event ID65814
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jul-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmLipari Foods, Inc.
CityWarren
StateMI
CountryUS
Distribution PatternOhio, Michigan, Minnesota, West Virginia, Kentucky, Pennsylvania, Illinois, and Indiana
 

Associated Products

Product DescriptionWHOLEY Shrimp, Farm Raised, Cooked, Peeled Deveined, Tail on, Ingredients: Shrimp, Salt and Sodium Tripolyphosphate..., ,Net Wt 1 LB (16 oz) , 399103 UPC Number: 094776074556; Product of Indonesia
Code Infolot No 30081, 10081, 70081, 70084, 30084, and 00884
ClassificationClass I
Reason for RecallLipari Foods of Warren, MI is recalling Wholey peeled, cooked, tail-on 31/40 count shrimp, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Product Quantity1336 cases
Recall NumberF-1783-2013

Class II Biologics Event

Event ID41951
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Feb-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHoxworth Blood Center University of Cincinnati Medical Center
CityCincinnati
StateOH
CountryUS
Distribution PatternKentucky, Ohio.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info1669388 (Part A)
ClassificationClass II
Reason for RecallBlood products, collected from a donor taking the medication Azathioprine, were distributed.
Product Quantity1 unit
Recall NumberB-1387-13
Product DescriptionFresh Frozen Plasma
Code Info1669388 (Part B)
ClassificationClass II
Reason for RecallBlood products, collected from a donor taking the medication Azathioprine, were distributed.
Product Quantity1 unit
Recall NumberB-1388-13

Class II Biologics Event

Event ID42198
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jun-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmZLB Bioplasma, Inc.
CityBoca Raton
StateFL
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionSource Plasma
Code Info0540484287; 0540483625; 0540483261; 0540482451; 0540482200; 0540481553; 0540481206
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of incarceration, were distributed.
Product Quantity7 units
Recall NumberB-1573-13

Class II Biologics Event

Event ID42446
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Jun-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmDepartment of the Air Force
CityWright Patterson AFB
StateOH
CountryUS
Distribution PatternNew Jersey
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW001606000743; W001606701171
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity2 units
Recall NumberB-1971-13

Class II Biologics Event

Event ID42591
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Jun-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTri-counties Blood Bank
CitySan Luis Obispo
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoGW84439
ClassificationClass II
Reason for RecallBlood product, which did not have the required volume of red blood cells, was distributed.
Product Quantity1 unit
Recall NumberB-1865-13

Class II Biologics Event

Event ID42731
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jul-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCreative Testing Solutions
CityTempe
StateAZ
CountryUS
Distribution PatternAZ
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info106681705
ClassificationClass II
Reason for RecallBlood product, in which routine testing was performed, interpreted and/or documented incorrectly, was distributed.
Product Quantity1 unit
Recall NumberB-1386-13

Class II Biologics Event

Event ID42837
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Jul-06
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmZLB Bioplasma, Inc.
CityBoca Raton
StateFL
CountryUS
Distribution PatternIL, IN
 

Associated Products

Product DescriptionSource Plasma
Code Info4020119034
ClassificationClass II
Reason for RecallBlood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-1981-13

Class II Biologics Event

Event ID43129
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Sep-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTri-counties Blood Bank
CitySan Luis Obispo
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoGW90414
ClassificationClass II
Reason for RecallBlood product, which did not meet the acceptable product specifications, was distributed.
Product Quantity1 unit
Recall NumberB-1866-13

Class II Biologics Event

Event ID43553
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Dec-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCentral Kentucky Blood Center Inc
CityLexington
StateKY
CountryUS
Distribution PatternKentucky
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info2311657 (Part B)
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-1980-13

Class II Biologics Event

Event ID43624
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Nov-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBlood Bank Of San Bernardino And Riverside Counties
CitySan Bernardino
StateCA
CountryUS
Distribution PatternCA, Austria
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoGP20788
ClassificationClass II
Reason for RecallBlood products, collected from a donor who warranted deferral due to travel to a malaria endemic area, were distributed.
Product Quantity1 unit
Recall NumberB-1979-13

Class II Biologics Event

Event ID43768
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jan-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBioLife Plasma Services L.P.
CityVan Nuys
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info05CILB7848
ClassificationClass II
Reason for RecallBlood product, which tested negative for viral markers, but was collected from a donor who subsequently tested positive for hepatitis B surface antigen (HBsAg), was distributed.
Product Quantity1 unit
Recall NumberB-1477-13

Class II Biologics Event

Event ID44407
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jan-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTri-counties Blood Bank
CitySan Luis Obispo
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoFZ83288; FZ83288
ClassificationClass II
Reason for RecallBlood products, released from quarantine prior to post leukoreduction, were distributed.
Product Quantity2 units
Recall NumberB-1874-13

Class II Biologics Event

Event ID47185
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Jan-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTri-counties Blood Bank
CityPhoenix
StateAZ
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoLY26329; LY26329; LT54308; LT54308
ClassificationClass II
Reason for RecallBlood Products, which were contaminated with Corynebacterium species, were distributed.
Product Quantity4 units
Recall NumberB-1875-13

Class II Biologics Event

Event ID47998
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-May-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityTucson
StateAZ
CountryUS
Distribution PatternArizona, California
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info007FJ96470; 007FJ96486; 007FQ47632; 007FY69895; 007GT00703
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate were not adequately determined, were distributed.
Product Quantity5 units
Recall NumberB-1970-13

Class II Biologics Event

Event ID48864
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jun-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTri-counties Blood Bank
CityPhoenix
StateAZ
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW142808202624; W142808202624; W142808202626; W142808202626
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity4 units
Recall NumberB-1877-13

Class II Biologics Event

Event ID49622
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Aug-08
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSouthern California Permanente Medical Group Blood Donor Center
CityIrvine
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoGE40780; GJ43610
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity2 units
Recall NumberB-1677-13

Class II Biologics Event

Event ID50436
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Sep-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTri-counties Blood Bank
CityPhoenix
StateAZ
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW142808302845; W142808302845
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity2 units
Recall NumberB-1878-13

Class II Biologics Event

Event ID50556
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Sep-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHoxworth Blood Center University of Cincinnati Medical Center
CityCincinnati
StateOH
CountryUS
Distribution PatternOhio.
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code Info2995677
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-1976-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info2964991(Part A), 2964991(Part B), 2921257, 2995677(Part A), 2995677(Part B), 3018389(Part A), 3018389(Part B)
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity7 units
Recall NumberB-1977-13
Product DescriptionAS-3 Red Blood Cells
Code Info3018389, 2921257
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity2 units
Recall NumberB-1978-13

Class II Biologics Event

Event ID50557
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Sep-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHoxworth Blood Center University of Cincinnati Medical Center
CityCincinnati
StateOH
CountryUS
Distribution PatternKentucky, Ohio.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info2964223; 2949852
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity2 units
Recall NumberB-1974-13
Product DescriptionPlatelets Leukocytes Reduced
Code Info2949852
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-1975-13

Class II Biologics Event

Event ID50558
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Sep-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHoxworth Blood Center University of Cincinnati Medical Center
CityCincinnati
StateOH
CountryUS
Distribution PatternOH
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info3006921(Part A); 3006921(Part B)
ClassificationClass II
Reason for RecallBlood products, collected from a donor taking the medication Proscar, were distributed.
Product Quantity2 units
Recall NumberB-1973-13

Class II Biologics Event

Event ID52146
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Feb-09
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmZLB Bioplasma, Inc.
CityDayton
StateOH
CountryUS
Distribution PatternIL, Germany.
 

Associated Products

Product DescriptionSource Plasma
Code Info4080319226 4080318753 4080316469 4080313795 4080300331 4080297687 4080258643 4080251284 4080250193 4080249518 4080247964 4080247099 4080245763 4080245107 4080243103 4080242441 4080240908 4080240294 4080238911 4080236960 4080235535 4080234863 4080233687 4080232326 4080231293 4080229645 4080228565 4080226946 4080225852 4080225233 4080223440 4080222876
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose physical was improperly documented, were distributed.
Product Quantity32 units
Recall NumberB-1972-13

Class II Devices Event

Event ID63108
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSt. Jude Medical
CityPlano
StateTX
CountryUS
Distribution PatternWorldwide Distribution--USA (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Belgium, Brazil, canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Saudi, South Africa, Spain, Sweden, Switzerland, Turkey and United Kingdom.
 

Associated Products

Product DescriptionEon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back, surgery syndrome, intractable low back and leg pain.
Code InfoMultiple lots recalled are the ones with supplier's inner battery lots of 326-508
ClassificationClass II
Reason for RecallAs part of St. Jude Medical's routine tracking and product monitoring, they have received a total of 214 reports, out of 34,617 Eon Mini IPGs, that lost the ability to communicate or recharge due to an inner battery weld issue resulting in loss of pain relief and subsequent explant. Explant surgery, as with any surgery, presents a risk to patient health. Adverse events associated with an unplanned surgery may be comparable to adverse events associated with planned operations, and may include pain, scarring, and infection, as well as complications from anesthesia. Product investigation and analysis conducted by St. Jude Medical as a result of reports of the inability to communicate or recharge the Eon Mini IPG has identified weld cracks in the IPG's inner battery as the cause of this issue. Prior analysis had indicated that moisture was the cause of weld cracking. However, with the occurrence of additional weld cracks, the firm's investigation has determined that the current weld cracks are not attributed to moisture within the battery. Thorough analysis of the cracked batteries and review of the battery manufacturing processes has identified a need to more frequently maintain and replace certain tools during the internal battery welding process by a St. Jude Medical supplier in order to assure complete alignment between the welding apparatus and the battery. It is important to note that the battery is contained within the hermetically-sealed IPG case and cannot leak electrolyte outside the IPG casing.
Product Quantity34,617
Recall NumberZ-1836-2013

Class II Devices Event

Event ID63935
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLeica Microsystems, Inc.
CityBuffalo Grove
StateIL
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and internationally to Australia, Belgium, Brazil, Chile, France, Germany, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands, Philipines, Singapore, South Africa, Spain, Switzerland, Thailand, Turkey, and United Kingdom.
 

Associated Products

Product DescriptionLeica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens.
Code Info1) Model ASP6025 120V/50-60 Hz; Serial Numbers: 171, 200, 202, 204, 206, 208, 210, 212, 214, 216, 218, 220, 222, 224, 226, 228, 230, 232, 234, 236, 238, 240, 242, 244, 246, 248, 250, 252, 254, 256, 258, 260, 262, 264, 266, 268, 270, 272, 274, 276, 278, 280, 282, 284, 286, 288, 290, 292, 294; 2) Model ASP6025 230V/50-60 Hz; Serial Numbers: 162, 163, 168, 169, 170, 183, 184, 201, 203, 205, 207, 209, 211, 213, 215, 217, 219, 221, 223, 225, 227, 229, 231, 233, 235, 237, 239, 241, 243, 245, 247, 249, 251, 253, 255, 257, 259, 261, 263, 265, 267, 269, 271, 273, 275, 277, 279, 281, 283, 285, 287, 289, 291, 293, 295, 297, 299, 301, 303, 305, 307, 309, 311, 313, 315, 317, 319, 320, 321, 323, 325, 327, 328, 329, 331, 333, 335, 337, 339
ClassificationClass II
Reason for RecallThe Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the Ready To Use (RTU) bottles from other suppliers than Leica. In case of a pressure failure of the device in combination with a bottle with incorrect dimensions, overflow can cause contamination of reagents. Additionally, the current instructions for use does not highlight the importance to check the filling levels of all reagent bottles (RTU and system bottles) prior to every process run. Without this important information, risk of tissue damage or loss is possible. Therefore the missing information will be distributed to all customers by a Field Service Notice.
Product Quantity128 machines
Recall NumberZ-1815-2013

Class II Devices Event

Event ID64625
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAcclarent, Inc.
CityMenlo Park
StateCA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
 

Associated Products

Product DescriptionInspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
Code InfoProduct code: BC0524A; All lots manufactured after March 1, 2011
ClassificationClass II
Reason for RecallLabeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Product Quantity1920
Recall NumberZ-1860-2013
Product DescriptionInspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
Code InfoProduct code: BC0724A; All lots manufactured after March 1, 2011
ClassificationClass II
Reason for RecallLabeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Product Quantity2366
Recall NumberZ-1861-2013
Product DescriptionInspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
Code InfoProduct code: BC8524A; All lots manufactured after March 1, 2011
ClassificationClass II
Reason for RecallLabeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Product Quantity625
Recall NumberZ-1862-2013
Product DescriptionInspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Code InfoProduct code: BC1040A; All lots manufactured after March 1, 2011
ClassificationClass II
Reason for RecallLabeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Product Quantity2703
Recall NumberZ-1863-2013
Product DescriptionInspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Code InfoProduct code: BC1240A; All lots manufactured after March 1, 2011
ClassificationClass II
Reason for RecallLabeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Product Quantity1217
Recall NumberZ-1864-2013
Product DescriptionInspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Code InfoProduct code: BC1440A; All lots manufactured after March 1, 2011
ClassificationClass II
Reason for RecallLabeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Product Quantity3324
Recall NumberZ-1865-2013
Product DescriptionInspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Code InfoProduct code: BC1640A; All lots manufactured after March 1, 2011
ClassificationClass II
Reason for RecallLabeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Product Quantity2175
Recall NumberZ-1866-2013

Class II Biologics Event

Event ID64915
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Dec-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmOneBlood, Inc.
CityLakeland
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW03551095306800;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was not deferred after testing reactive for HTLV-I/II, were distributed.
Product Quantity1
Recall NumberB-1779-13

Class II Biologics Event

Event ID64979
StatusCompleted
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternMichigan, Florida
 

Associated Products

Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036810828093
ClassificationClass II
Reason for RecallBlood products, collected from a donor who lived in an area considered endemic for malaria and had a piercing within 12 months of donation, were distributed.
Product Quantity1 unit
Recall NumberB-1862-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036811053144
ClassificationClass II
Reason for RecallBlood products, collected from a donor who lived in an area considered endemic for malaria and had a piercing within 12 months of donation, were distributed.
Product Quantity1 unit
Recall NumberB-1863-13
Product DescriptionFresh Frozen Plasma
Code InfoW036811053144
ClassificationClass II
Reason for RecallBlood products, collected from a donor who lived in an area considered endemic for malaria and had a piercing within 12 months of donation, were distributed.
Product Quantity1 unit
Recall NumberB-1864-13

Class II Devices Event

Event ID64987
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Oct-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmSpineFrontier, Inc.
CityBeverly
StateMA
CountryUS
Distribution PatternUS distribution in states of: CO, DC, MA and TX.
 

Associated Products

Product DescriptionCaddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients
Code Info31176, 018652, 018645R, 42011
ClassificationClass II
Reason for RecallTwo sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm screws.
Product Quantity11 caddies
Recall NumberZ-1869-2013

Class II Biologics Event

Event ID65011
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifeShare Blood Centers
CityShreveport
StateLA
CountryUS
Distribution PatternLouisiana
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW036512129561; W036512129561
ClassificationClass II
Reason for RecallBlood products, collected from a donor who had recently visited a malarial endemic region, were distributed.
Product Quantity2 units
Recall NumberB-2005-13

Class II Biologics Event

Event ID65012
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifeShare Blood Centers
CityShreveport
StateLA
CountryUS
Distribution PatternLouisiana
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036512158305
ClassificationClass II
Reason for RecallBlood product, collected from a donor who had recently visited a malarial endemic region, was distributed.
Product Quantity1 unit
Recall NumberB-1835-13

Class II Devices Event

Event ID65033
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Apr-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmSpineFrontier, Inc.
CityBeverly
StateMA
CountryUS
Distribution PatternUS distributions to states of: KS and TX.
 

Associated Products

Product DescriptionS-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial instruments that are used to estimate sizes of intervertebral body fusion devices intended to promote fusion. These devices were used in conjunction with lumbar intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients.
Code InfoLot: 56H26
ClassificationClass II
Reason for RecallMalfunction of slap hammer.
Product Quantity3
Recall NumberZ-1870-2013

Class II Devices Event

Event ID65068
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Mar-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCustom Spine, Inc.
CityParsippany
StateNJ
CountryUS
Distribution PatternNationwide Distribution including Nebraska and Virginia.
 

Associated Products

Product DescriptionCustom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ 07054 USA. TEL: 973-808-0019 The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine for pedicular and non-pedicular fixation.
Code InfoCatalog Number 048545; Lot Number L363
ClassificationClass II
Reason for RecallOn March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were found to be out of specification. The screw length was 5 mm shorter in length than the required specification for the screw size. The product is laser marked 8.5mm X 45mm, but its length measured 40mm.
Product Quantity18 units
Recall NumberZ-1819-2013

Class II Devices Event

Event ID65084
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmWako Life Sciences, Inc.
CityMountain View
StateCA
CountryUS
Distribution PatternDistribution to CA, GA, MN, NC, UT and the District of Columbia.
 

Associated Products

Product DescriptionuTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 Terra Bella Ave., Suto A. Mountain View, CA 94043 USA. The product is a single reagent cartridge run on an automated system and each assay performed on a single disposable chip using microfluidic electrophoretic separation. The reagent cartridge contains various buffers and antibodies.
Code InfoTG340, Exp. 11/30/13
ClassificationClass II
Reason for RecallProduct fails to meet the accuracy at the low end of the measuring range.
Product Quantity36 cartridges -100 tests per cartridge
Recall NumberZ-1831-2013

Class II Devices Event

Event ID65328
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHeartWare Inc
CityMiami Lakes
StateFL
CountryUS
Distribution PatternWorldwide Distribution - USA including AL, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI. Internationally to: Australia, Austria, Belguim, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zeland,Norway, Poland Singapore, South Africa, Switzerland, Turkey, and United Kingdom.
 

Associated Products

Product DescriptionHeartWare Ventricular Assist System For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.
Code InfoUS product: Model 1400, 1401US, 1403US, 1404 International: Model 1400, 1401XX, 1407XX, 1408 ALL HEARTWARE CONTROLLER SERIAL NUMBERS
ClassificationClass II
Reason for RecallPotential to electrostatic discharged (ESD)
Product Quantity76 (US) and 82 (International)
Recall NumberZ-1813-2013

Class II Drugs Event

Event ID65338
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmActavis South Atlantic LLC
CitySunrise
StateFL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionRanitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by VistaPharm, Inc., Birmingham, AL 35242. Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28092 USA
Code InfoLot Numbers: 247900, 251000, 256000, 261200, 263600, 266700, 277100, 280300 and 284300.
ClassificationClass II
Reason for RecallFailed Impurity/Degradation Specification; "Related Compound C"
Product QuantityA total of 133,968 bottles (units)
Recall NumberD-829-2013

Class II Biologics Event

Event ID65358
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOne Lambda Inc
CityCanoga Park
StateCA
CountryUS
Distribution PatternUSA, Canada, Germany, Israel, Poland, Spain, Brazil, Japan, Singapore, Thailand, and Vietnam.
 

Associated Products

Product DescriptionMicro SSP" Allele Specific HLA Class I DNA Typing Tray B*38/39, Catalog Identification: SSPR1-16 Micro SSP" Allele Specific HLA Class I DNA Typing Tray B*38/39 Catalog Identification: SSPR1-16 Article Number: SSP_DNAT_PI Rev 18 Lot number: 002, batches 001-003 510(K) Number : BK960062
Code InfoMicro SSP" Allele Specific HLA Class I DNA Typing Tray B*38/39 Catalog Identification: SSPR1-16 Article Number: SSP_DNAT_PI Rev 18 Lot number: 002, batches 001-003
ClassificationClass II
Reason for RecallMicro SSP Allele Specific HLA Class I DNA Typing Trays (B*38/39), manufactured with an incorrect primer, were distributed.
Product Quantity1 device distributed
Recall NumberB-2026-13

Class II Devices Event

Event ID65440
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBeckman Coulter Inc.
CityBrea
StateCA
CountryUS
Distribution PatternWorldwide Distribution, including Nationwide (US) and the countries of China, Italy, Japan, Canada, Turkey, United Kingdom, Singapore, Israel, and the Netherlands.
 

Associated Products

Product DescriptionAU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is for in vitro diagnostic use only.
Code InfoModel Numbers: AU5811-01, AU5821-01, AU5831-01, AU5841-01, AU5811-02, AU5821-02, AU5831-02, AU5841-02, AU5811-03, AU5821-03, AU5831-03, AU5841-03, AU5811-04, AU5821-04, AU5831-04, AU5841-04, AU5811-06, AU5821-06, AU5831-06, AU5841-06 Part Numbers: A94906, A94911, A94916, A91921 A94907, A94912, A94917, A94922 A94908, A94913, A94918, A94923 A94909, A94914, A91949, A94924 A94910, A94915, A94920, A94925 Serial Numbers: All
ClassificationClass II
Reason for RecallThe recall was initiated because Beckman Coulter has identified a software error on AU5800 analyzers with the Automation Ready (AR) Sampler Kit. This software error results in the failure of the concentrated wash solution pump to stop, creating an overflow or leak on each analyzer unit.
Product Quantity76 units
Recall NumberZ-1834-2013

Class II Drugs Event

Event ID65461
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmWarner Chilcott US LLC
CityRockaway
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionEnablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only, Mfd by: Novartis Pharma Stein AG, Stein, Switzerland, NDC 0078-9420-07
Code InfoLot F1002 - Exp.12/13
ClassificationClass II
Reason for RecallFailed Impurities/Degradation Specifications: unspecified degradation product
Product Quantity188,600 bottles
Recall NumberD-822-2013

Class II Devices Event

Event ID65473
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSteritec Products Mfc. Co., Inc.
CityEnglewood
StateCO
CountryUS
Distribution PatternWorldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.
 

Associated Products

Product DescriptionMedline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121°C, 132°C, 134°C and 135°C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.
Code InfoAffected Biological Indicator Lot No.: S-444
ClassificationClass II
Reason for RecallMesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
Product Quantity8200 units
Recall NumberZ-1822-2013
Product DescriptionCardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Code T40360EZ EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121°C, 132°C, 134°C and 135°C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.
Code InfoAffected Biological Indicator Lot No.: S-444
ClassificationClass II
Reason for RecallMesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
Product Quantity200
Recall NumberZ-1823-2013
Product DescriptionEZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121°C, 132°C, 134°C and 135°C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.
Code InfoAffected Biological Indicator Lot No.: S-444
ClassificationClass II
Reason for RecallMesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
Product Quantity14,900 units
Recall NumberZ-1824-2013
Product DescriptionGetinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code 61301606638 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers.
Code InfoAffected Biological Indicator Lot No.:121101-447 and 121101-444
ClassificationClass II
Reason for RecallMesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
Product Quantity10,170 units
Recall NumberZ-1825-2013
Product DescriptionGetinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Product Code 61301606639 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers.
Code InfoAffected Biological Indicator Lot No.:121101-447 and 121101-444
ClassificationClass II
Reason for RecallMesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
Product Quantity15,300 units
Recall NumberZ-1826-2013
Product DescriptionMesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, Distributor Product Code SRSP/25 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 1132 (27270 and 3 minutes at 11357275re-vacuum steam sterilizers.
Code InfoAffected Biological Indicator Lot No.:130301
ClassificationClass II
Reason for RecallMesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
Product Quantity5000 units
Recall NumberZ-1827-2013
Product DescriptionMedline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132°C (270°F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome
Code InfoAffected Biological Indicator Lot No.:130401
ClassificationClass II
Reason for RecallMesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
Product Quantity3535 units
Recall NumberZ-1828-2013
Product DescriptionCardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132°C (270°F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome.
Code InfoAffected Biological Indicator Lot No.:130401
ClassificationClass II
Reason for RecallMesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
Product Quantity360 units
Recall NumberZ-1829-2013

Class II Devices Event

Event ID65491
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions USA, Inc
CityMalvern
StatePA
CountryUS
Distribution PatternUS Distribution including the states of CA, IN, NJ and OK.
 

Associated Products

Product DescriptionSiemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
Code InfoModel number 10094200, serial numbers 4024, 4077, 4043 and 4051
ClassificationClass II
Reason for RecallSiemens became aware of an unintended behavior when using the Luminos dRF with software version VD10A. The possibility exists that a software error may occur causing the table to tilt into an upright position and may collide with the floor. Four consignees were notified of this recall by Update Instruction XP067/12/S -- all four units have been corrected.
Product Quantity4
Recall NumberZ-1848-2013

Class II Devices Event

Event ID65498
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAccelerated Care Plus Corporation
CityReno
StateNV
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionOmnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV. Manufactured by Medica Medizintechnik GmbH, Hochdorf, Germany. The product is indicated for powered exercise equipment intended for medical purposes.
Code InfoModel number A000-533: Serial numbers: 1034-000-00-09033104 1034-000-00-09033107 1034-000-00-09033108 1034-000-00-09033119 1034-000-00-09033120 1034-000-00-09033121 1034-000-00-09033122 1034-000-00-09033132 1034-000-01-09073002 1034-000-01-09073005 1034-000-01-09073018 1034-000-01-09073021 1034-000-01-09073030 1034-000-01-09073123 1034-000-01-09073129 1034-000-01-09073130 1034-000-01-09073134 1034-000-01-09073136 1034-000-01-09073142 1034-000-01-09073146 1034-000-01-09073147 1034-000-01-09090034 1034-000-01-09101119 1034-000-01-09101126 1034-000-01-09101127 1034-000-01-09102107 1034-000-01-09104132 1034-000-01-09105032 1034-000-01-09105039 1034-000-01-09152114 1034-000-01-09152117 1034-000-01-09152120 1034-000-01-09152131 1034-000-01-09162027 1034-000-01-09162034 1034-000-01-09163094 1034-000-01-09163101 1034-000-01-09164098 1034-000-01-09164101 1034-000-01-09164114 1034-000-01-09171128 1034-000-01-09172011 1034-000-01-09172020 1034-000-01-09172021 1034-000-01-09172026 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A000-533-06-13035141 A000-533-06-13035142 A000-533-06-13035144 A000-533-06-13035145 A000-533-06-13035146 A000-533-06-13035147 A000-533-06-13035148 TT006331046 TT007142002 TT007142004 TT007142081 TT007142090 TT007142091 TT007142093 TT007162097 TT007192023 TT007192035 TT007222001 TT007222098 TT007222100 TT007301006 TT007301009 TT007301010 TT007301019 TT007301021 TT007301028 TT007301031 TT007374042 TT007374043 TT007374048 TT007374070 TT007374080 TT007374081 TT007374085 TT007374090 TT007501002 TT007501009 TT007501087 TT007501092 TT007512079 TT007512081 TT007512089 TT007512090 TT007512099 TT008035017 TT008055038 TT008055042 TT008055043 TT008055046 TT008055053 TT008055060 TT008055063 TT008055069 TT008055074 TT008055075 TT008055078 TT008055079 TT008081006 TT008081007 TT008081008 TT008081082 TT008101006 TT008101010 TT008101100 TT008105006 TT008105008 TT008105014 TT008112063 TT008112067 TT008112068 TT008112069 TT008112080 TT008114091 TT008114093 TT008114096 TT008121074 TT008122097 TT008153003 TT008153008 TT008153010 TT008153024 TT008153027 TT008202012 TT008202013 TT008202015 TT008202020 TT008202026 TT008202027 TT008202030 TT008202042 TT008202046 TT008202053 TT008202060 TT008252039 TT008252050 TT008252052 TT008252057 TT008291015 TT008291017 TT008291021 TT008291023 TT008291025 TT008291026 TT008291034 TT008291037 TT008291038 TT008291043 TT008291047 TT008291052 TT008291055 TT008291056 TT008324100 TT008324119 TT008324120 TT008324123 TT008324134 TT008324142 TT008324146 TT008361104 TT008361113 TT008364005 TT008365029 TT008365033 TT008365038 TT008365041 TT008371047 TT008371048 TT008371051 TT008371067 TT008393111 TT008393113 TT008393119 TT008393124 TT008393125 TT008393128 TT008393132 TT008393133 TT008403043 TT008461061 TT008461067 TT008461075 TT008461077 TT008461088 TT008461107 TT008461109 TT008461115 TT008483066 TT008483073 TT008483077 TT008483078 TT008483087 TT008483094 TT008483099 TT008483106 TT008483108 TT008483117 TT008483121.
ClassificationClass II
Reason for RecallAn anomaly in the firmware that may cause Omnicycle Elite to operate at a speed other than what was previously set when in reverse mode.
Product Quantity1001 units
Recall NumberZ-1837-2013

Class II Devices Event

Event ID65544
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jun-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmMesa Laboratories, Inc., Bozeman Manufacturing Facility
CityBozeman
StateMT
CountryUS
Distribution PatternWorldwide Distribution: US (nationwide) and countries of: Australia, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Egypt, Greece, India,Israel, Japan, Jordan, Malaysia, Mexico, Milanese, Netherlands, Peru, Portugal, Pozan, Romania, Spain, Sweden, Taiwan, Thailand, United Kingdom, and Uruguay.
 

Associated Products

Product DescriptionMesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
Code InfoLot No S-444 Manufacture Date 2013 January 21 Expiration Date 2015 January 21; Lot No S-445 Manufacture Date 2013 February 15 Expiration Date 2015 February 15 ; Lot No S-447 Manufacture Date 2013 March 18 Expiration Date 2015 March 18.
ClassificationClass II
Reason for RecallMesa EZTest , Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.
Product Quantity865/25 ct boxes, 414/100 ct boxes, 307/500 ct boxes
Recall NumberZ-1867-2013
Product DescriptionMesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
Code InfoLot No SR-444 Manufacture Date 2013 January 21 Expiration Date 2015 January 21; Lot No SR-445 Manufacture Date 2013 February 15 Expiration Date 2015 February 15. Lot No SR-447 Manufacture Date 2013 March 18 Expiration Date 2015 March 18.
ClassificationClass II
Reason for RecallSelf-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.
Product Quantity2447/100 count boxes
Recall NumberZ-1868-2013

Class II Devices Event

Event ID65568
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-May-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmExactech, Inc.
CityGainesville
StateFL
CountryUS
Distribution PatternUS Distribution including the states of AR, CA, FL, NJ, NY, OK, and TX
 

Associated Products

Product DescriptionExactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
Code InfoLot #: 52667001 Catalog #: 181-00-04
ClassificationClass II
Reason for RecallWhen torque is applied to the Articulated Driver at the maximum angle, the cross pin may shift out of position, potentially leading to disassembly of the instrument.
Product Quantity57
Recall NumberZ-1832-2013

Class II Devices Event

Event ID65576
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTosoh Smd Inc
CityGrove City
StateOH
CountryUS
Distribution PatternWorldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. Internationally to Canada, Japan, Mexico, Chile, and Uruguay.
 

Associated Products

Product DescriptionAIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag AIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Bioscience AIA Analyzers for lab analysis of various immunoassays.
Code InfoThe following lots numbers are affected by this recall: 060811, 070111, B11, B11-12/23/2011, B12-02/07/2012, B12-04/30/2012, B12-06/01/2012, B12-08/06/2012, B12-09/05/2012, B12-10/26/2012, and B12-11/27/2012.
ClassificationClass II
Reason for RecallVisual inspection of the pipette tips indicated that some of the tips were not uniform in size/length which was causing error messages on the analyzers.
Product Quantity11,309 bags
Recall NumberZ-1830-2013

Class II Food Event

Event ID65587
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jun-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmChurch & Dwight Inc
CityPrinceton
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionArm & Hammer Baking Soda a) Net Wt. 1 LB. (454 g) UPC 3320001130 b) Net Wt. 8 oz. (277 g) UPC 3320001110 Church & Dwight, Co. Inc. 469 N. Harrison Street Princeton, NJ 08543-5297 USA
Code InfoLot FF3153 Lot FF3154
ClassificationClass II
Reason for RecallChurch and Dwight Co., Inc. has initiated a recall for Sodium Bicarbonate, USP produced by the Old Fort, OH Sodium Bicarbonate Production facility due to metal and other contamination.
Product Quantity8 oz. - 332 cases; 1lb. - 729 cases
Recall NumberF-1754-2013

Class II Drugs Event

Event ID65601
StatusCompleted
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jun-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmPhysicians Total Care, Inc.
CityTulsa
StateOK
CountryUS
Distribution PatternGA
 

Associated Products

Product DescriptionBelladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP 16.2 mg, Hyoscyamine Sulfate 0.1037 mg, Atropine Sulfate 0.0194 mg, Scopolamine Hydrobromide 0.0065 mg 30-count bottle (NDC 54868-0031-04), Rx only, Repackaged and distributed by Physicians Total Care, Inc. Tulsa, OK 74146.
Code InfoLot# 6GP2; Exp 10/14 West-Ward Lot /WWCN 67331A
ClassificationClass II
Reason for RecallPresence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.
Product Quantity270 tablets
Recall NumberD-826-2013

Class II Devices Event

Event ID65603
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions USA, Inc
CityMalvern
StatePA
CountryUS
Distribution PatternUS Distribution only including the states of PA, OH, UT, CA, NY, MO, and TX.
 

Associated Products

Product Descriptionsyngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo® Dynamics system is intended for the acceptance, transfer, display, storage, archive, and manipulation of digital medical images, including quantification and reportgeneration. syngo® Dynamics is not intended to be used for reading mammography images.
Code InfoModel Number: 10091637, 10091805, with serial numbers 85164, 85289, 85296, 85297, 85149, 85116, 85177, 85051, and 85278.
ClassificationClass II
Reason for RecallSiemens initiate this recall due to a potential issue when using the sDIS matching rules of the syngo Dynamics Information System version 9.5 or VA10A with modality device configured to end study at association close. Images or DICOM SR objects sent from a modality device to syngo Dynamics may not be saved when the modality is configured at syngo Dynamics to end study at association close, and when sDIS matching rules are in effect. The risk is that a study may be missing some of its images and/or DICOM SR objects and there is no indication to the user that images and/or SR objects are missing from the study.
Product Quantity9
Recall NumberZ-1859-2013

Class II Devices Event

Event ID65610
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternUS Distribution including the states of AL, CA, CT, DE, FL, HI, IA, IL, IN, LA, MA, MD, ME, MI, MN, NC, NJ, NY, PA, SD, TX and WA.
 

Associated Products

Product DescriptionThe Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.
Code Info*** 1) List Number 16206, Serial Numbers: 0017234975 , 0017234978 , 0017234979 , 0017234980 , 0017234981 , 0017234982 , 0017234983 , 0017234984 , 0017234985 , 0017234986 , 0017234988 , 0017234991 , 0017234992 , 0017234993 , 0017234994 , 0017234995 , 0017234996 , 0017234997 , 0017234998 , 0017234999 , 0017235001 , 0017235002 , 0017235003 , 0017235004 , 0017235005 , 0017235006 , 0017235007 , 0017235008 , 0017235009 , 0017235010 , 0017235011 , 0017235014 , 0017235015 , 0017235016 , 0017235017 , 0017235018 , 0017235019 , 0017235020 , 0017235021 , 0017235022 , 0017235023 , 0017235024 , 0017235025 , 0017235026 , 0017235028 , 0017235029 , 0017235030 , 0017235031 , 0017235032 , 0017235033 , 0017235034 , 0017235035 , 0017235036 , 0017235037 , 0017235038 , 0017235039 , 0017235041 , 0017235042 , 0017235043 , 0017235044 , 0017235045 , 0017235046 , 0017235048 , 0017235049 , 0017235050 , 0017235051 , 0017235052 , 0017235053 , 0017235054 , 0017235056 , 0017235057 , 0017235058 , 0017235060 , 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ClassificationClass II
Reason for RecallThe devices secondary audio signal fails to activate.
Product Quantity2,791 units
Recall NumberZ-1847-2013

Class II Devices Event

Event ID65619
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBecton Dickinson & Co.
CitySparks
StateMD
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionBD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252; kits are labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle Sparks, MD 21152 USA, 800-638-8663, www.bd.com/ds*** The Affirm VPIII Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Candida species,
Code InfoCat #446257: Lot 3035126 Exp 12/04/13 Cat #446252: Lot 3065261 Exp 08/31/13
ClassificationClass II
Reason for RecallIn vitro diagnostic test kit may exhibit invalid internal negative control results.
Product Quantity177 kits
Recall NumberZ-1812-2013

Class II Devices Event

Event ID65646
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Howmedica Osteonics Corp.
CityMahwah
StateNJ
CountryUS
Distribution PatternUS Distribution including the states of IL, KY and TN.
 

Associated Products

Product DescriptionGAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A single use device intended for the temporary fixation, correction of stabilization of the right femur. The kit consists of intramedullary nail and set screw. The kit is used in combination with lag screw and (distal) locking screws and end cap as well.
Code InfoCatalog Number- 33250400S Catalog Number 33250360S
ClassificationClass II
Reason for RecallStryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails.
Product Quantity5 units
Recall NumberZ-1846-2013

Class II Drugs Event

Event ID65650
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmProcter & Gamble Co
CityMason
StateOH
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionDayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg and phenylephrine HCl 5 mg) liquicaps and NyQuil Sinex NightTime Sinus Relief (acetaminophen 325 mg, doxylamine succinate 6.25 mg, and phenylephrine HCl 5 mg) liquicaps Combopack, each 48-count liquicaps per carton contains 32 DayQuil Sinex DayTime Liquicaps and 16 NyQuil Sinex NightTime Liquicaps per carton, Made In Canada, Dist. by Procter & Gamble, Cincinnati, OH 45202, UPC 3 23900 01454 1.
Code InfoLot # 3051171961, Exp 09/14; Brand Code 84855363
ClassificationClass II
Reason for RecallUnit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomplete blister card cuts, and missing or incorrectly placed liquicaps within the blisters.
Product Quantity35,568 cartons
Recall NumberD-827-2013

Class II Devices Event

Event ID65666
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPicis Inc.
CityWakefield
StateMA
CountryUS
Distribution PatternNationwide Distribution, including the states of: AK, AR, AZ, CA, CO, DC, DE, FL, GA, ID, IN, MA, MD, MO, NH, NJ, OH, OR, SC, TN, WA, and WV.
 

Associated Products

Product DescriptionPicis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in different formats for evaluation by healthcare professionals for informational purposes.
Code InfoSoftware Versions 5.2 and 5.3
ClassificationClass II
Reason for RecallNotes associated with prescription are not printed to the prescription or to the patient chart.
Product Quantity35
Recall NumberZ-1814-2013

Class II Devices Event

Event ID65668
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSynthes USA HQ, Inc.
CityWest Chester
StatePA
CountryUS
Distribution PatternUS distribution: PA only. .
 

Associated Products

Product DescriptionSynthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix; Axon and Synapse Systems are indicated for the following: -Degenerative Disk Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); -Spondylolisthesis; -Spinal Stenosis; -Fracture/dislocation; -Atlantoaxial fracture with instability; -Occipitocervical dislocation; -Revision of previous cervical spine surgery; and -Tumo
Code InfoPart Number SD389.477, Lot Number 6913900
ClassificationClass II
Reason for RecallA complaint was received from the field, that the drill guide was etched incorrectly, 12mm etch instead of 18mm drill guide. The firm identified that this constituted a field action and retrospectively reported this action.
Product Quantity2
Recall NumberZ-1821-2013

Class II Devices Event

Event ID65669
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSynthes USA HQ, Inc.
CityWest Chester
StatePA
CountryUS
Distribution PatternUS Distribution including the states of CA, MN, NC and TN.
 

Associated Products

Product DescriptionSynthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
Code Info Part Number 390.007, Lot Number 6800599
ClassificationClass II
Reason for RecallIt was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Clamp and what was called for in the Bill of Materials. Following a detailed investigation, it was determined that the incorrect insert was used which indicates that the device is MR Safe, when it is actually MR Conditional.
Product Quantity8
Recall NumberZ-1816-2013

Class II Cosmetics Event

Event ID65717
StatusOngoing
Product TypeCosmetics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jul-13
Initial Firm Notification of Consignee or Public Other
Recalling FirmSunflower Hill
CityHollis Center
StateME
CountryUS
Distribution PatternME, VA. Product sold only in two LL Bean stores. No online sales.
 

Associated Products

Product DescriptionLL Bean Balsam Pine Moisturizing Lotion, 16 oz plastic bottle with pump. UPC 5DC6550000
Code InfoLot Number: 132
ClassificationClass II
Reason for RecallMold present in lotion.
Product Quantity39 bottles
Recall NumberF-1751-2013
Product DescriptionLL Bean Sea Spray Moisturizing Lotion, 16 oz plastic bottle with pump. UPC 5DC6520000
Code InfoLot Number: 130
ClassificationClass II
Reason for RecallMold present in lotion.
Product Quantity26 bottles
Recall NumberF-1752-2013
Product DescriptionLL Bean Lemon Verbena Hand and Body Lotion, 16 oz plastic bottle with pump. UPC 5DC6560000, Item Number: 5DC6560
Code InfoN/A
ClassificationClass II
Reason for RecallMold present in lotion.
Product Quantity78 Bottles
Recall NumberF-1753-2013

Class II Devices Event

Event ID65718
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSotera Wireless, Inc.
CitySan Diego
StateCA
CountryUS
Distribution PatternUS distribution including CA and UT.
 

Associated Products

Product DescriptionViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
Code InfoSerial No. AAAA20120800519 AAAA20120800520 AAAA20120800526 AAAA20120800527 AAAA20120800533 AAAA20120800537 AAAA20120800538 AAAA20120800539 AAAA20120900544 AAAA20120900548 AAAA20120900557 AAAA20120900562 AAAA20120900564 AAAA20120900577 AAAA20120900578 AAAA20120900580 AAAA20120900584 AAAA20120900587 AAAA20120900591 AAAA20130400890 AAAA20130400896 AAAA20130400902 AAAA20130400909 AAAA20120800501 AAAA20121200604 AAAA20121200606 AAAA20121200609 AAAA20121200610 AAAA20121200611 AAAA20121200615 AAAA20121200617 AAAA20121200618 AAAA20121200620 AAAA20121200621 AAAA20121200624 AAAA20121200626 AAAA20121200628 AAAA20121200629 AAAA20121200630 AAAA20121200632 AAAA20121200636 AAAA20121200639 AAAA20121200640 AAAA20121200645 AAAA20121200647 AAAA20130100680 AAAA20130100684 AAAA20130100688 AAAA20130100689 AAAA20130100691 AAAA20130100692 AAAA20130100693 AAAA20130100694 AAAA20130100698 AAAA20130100699 AAAA20130100700 AAAA20130100701 AAAA20130100703 AAAA20121200605 AAAA20121200612 AAAA20121200613 AAAA20121200622 AAAA20121200625 AAAA20121200627 AAAA20121200633 AAAA20121200642 AAAA20121200643 AAAA20121200646 AAAA20121200648 AAAA20121200649 AAAA20121200650 AAAA20121200651 AAAA20121200652 AAAA20121200653 AAAA20130100654 AAAA20130100655 AAAA20130100656 AAAA20130100657 AAAA20130100658 AAAA20130100660 AAAA20130100661 AAAA20130100662 AAAA20130100664 AAAA20130100665 AAAA20130100666 AAAA20130100669 AAAA20130100670 AAAA20130100671 AAAA20130100672 AAAA20130100678
ClassificationClass II
Reason for RecallSotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound.
Product Quantity90 units
Recall NumberZ-1817-2013
Product DescriptionViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
Code InfoSerial No. ACBE20120900183 ACBE20120900189 ACBE20120900205 ACBE20120900206 ACBE20121000217 ACBE20121000224 ACBE20121000225 ACBE20121000226 ACBE20121000231 ACBE20121000232 ACBE20121000236 ACBE20121000240 ACBE20121000245 ACBE20121000250 ACBE20121000252 ACBE20121000259 ACBE20121000260 ACBE20121000261 ACBE20121000262 ACBE20121000271 ACBE20121100292 ACBE20121100296 ACBE20121100300 ACBE20130200445 ACBE20120900211 ACBE20121000222 ACBE20121000237 ACBE20121000246 ACBE20121000263 ACBE20121100277 ACBE20121100280 ACBE20121100283 ACBE20121100287 ACBE20121100291 ACBE20121100356 ACBE20121100360 ACBE20121100364 ACBE20130100394 ACBE20130100395 ACBE20130100397 ACBE20130100398 ACBE20130100399 ACBE20130100401 ACBE20130100402 ACBE20130100404 ACBE20130100405 ACBE20130100410 ACBE20130100411 ACBE20130100412 ACBE20130100415 ACBE20130100417 ACBE20121000218 ACBE20121000227 ACBE20121000270 ACBE20121100282 ACBE20121100286 ACBE20121100288 ACBE20121100301 ACBE20121100350 ACBE20121100352 ACBE20121100355 ACBE20130100369 ACBE20130100370 ACBE20130100374 ACBE20130100375 ACBE20130100376 ACBE20130100378 ACBE20130100379 ACBE20130100380 ACBE20130100384 ACBE20130100385 ACBE20130100388 ACBE20130100390 ACBE20130100392 ACBE20130100393
ClassificationClass II
Reason for RecallSotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound.
Product Quantity75 units
Recall NumberZ-1818-2013

Class II Devices Event

Event ID65755
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jul-12
Initial Firm Notification of Consignee or Public Visit
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternWorldwide Distribution - US Distribution including the states AK, AZ, AR, CA, CO, CT, DE, FL, GA, IL, LA, MD, MI, MN, MO, NE, NV, NM, NY, NC, OH, OR, PA, SC, SD, TN,TX, VA, WA and WI., and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRIL, CANADA, CHINA, COLOMBIA, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, INDIA, IRAQ, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF MOLDOVA, NETHERLANDS, NORWAY, POLAND, ROMANIA, RUSSIAN FEDERATION, KINGDOM OF SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA.
 

Associated Products

Product DescriptionGE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal; and Intraoperative (abdominal, PV and neurological).
Code InfoMfg Lot or Serial # D16290 D16293 D16294 D16295 D16296 D16297 D16299 D16300 D16301 D16302 D16303 D16304 D16305 D16306 D16309 D16310 D16311 D16312 D16313 D16314 D16315 D16316 D16318 D16319 D16326 D16335 D16336 D16337 D16338 D16339 D16340 D16341 D16342 D16343 D16345 D16346 D16362 D16366 D16367 D16368 D16370 D16371 D16372 D16373 D16374 D16375 D16377 D16378 D16396 D16398 D16399 D16400 D16401 D16402 D16403 D16404 D16405 D16406 D16432 D16433 D16434 D16435 D16436 D16437 D16438 D16439 D16440 D16441 D16453 D16458 D16460 D16461 D16462 D16466 D16467 D16468 D55513 D55514 D55515 D55519 D55520 D55521 D55522 D55538 D55539 D55540 D55541 D55543 D55549 D55550 D55551 D55565 D55566 D55568 D55578 D55579 D55580 D55581 D55582 D55598 D55603 D55605 D55606 D55615 D55616 D55617 D16407 D55524 D04446 D16477 D55516 D55534 D55557 D55588 D16239 D55576 D55623 D55625 D16348 D16349 D16350 D55552 D55553 D55554 D55555 D55560 D16254 D16257 D16257 D55336 D55337 D55338 D55348 D55595 D13829 D15232 D15425 D15973 D16193 D16245 D16248 D16255 D16260 D16262 D16317 D16324 D16334 D16344 D16352 D16358 D16369 D16380 D16384 D16385 D16390 D16393 D16424 D16445 D16448 D16454 D16455 D16464 D16480 D16481 D16482 D16483 D16484 D16486 D16487 D55437 D55517 D55548 D55575 D55593 D55607 D55608 D55611 D55612 D55621 D55624 D55627 D16240 D55518 D55572 D55573 D55574 D55610 D16442 D55510 D55599 D55622 D03382 D16256 D55544 D55629 D05257 D10516 D13472 D15189 D15444 D15454 D16235 D16242 D16244 D16246 D16251 D16264 D16265 D16277 D16279 D16280 D16281 D16284 D16331 D16333 D16347 D16353 D16382 D16387 D16388 D16389 D16409 D16410 D16411 D16412 D16413 D16414 D16415 D16427 D16428 D16429 D16443 D16444 D16449 D16478 D55532 D55556 D55585 D55586 D55587 D00716 D04334 D11004 D15447 D16241 D16258 D16263 D16276 D16286 D16287 D16289 D16291 D16292 D16307 D16327 D16379 D16391 D16408 D16416 D16423 D16425 D16426 D16430 D16488 D55015 D55472 D55525 D55526 D55527 D55528 D55530 D55535 D55542 D55545 D55567 D55589 D55590 D55591 D55592 D55596 D55597 D55632 D55633 D11463 D16250 D16355 D16363 D16364 D16479 D03377 D16288 D16325 D55563 D55601 D00688 D03104 D04391 D05445 D11398 D11419 D13350 D16267 D16269 D16271 D16272 D16273 D16274 D16321 D16322 D16323 D16419 D16420 D16422 D55546 D16236 D16259 D16351 D55561 D16446 D55531 D55630 D16397 D55594 D16332 D16465 D16392 D16261 D16330 D16473 D16475 D55558 D55583 D55584 D16320 D55577 D55602 D55631 D00101 D00853 D16328 D16329 D16470 D03958 D16252 D16361 D55562 D16395 D16472 D55626 D55628 D55414 D55533 D01077 D16243 D16253 D16268 D16308 D16381 D16451 D16463 D55570 D55600 D55634 D16418 D16270 D16282 D16283 D16285 D55559 D16237 D16359 D16365 D16452 D16476 D55571
ClassificationClass II
Reason for RecallGE Healthcare has recently become aware that during use of the Voluson E6 or E8 systems, that an error message Out of Memory can be displayed which could cause the system to freeze. This is an intermittent behavior that also requires a certain workflow. This issue can be resolved by rebooting the system.
Product Quantity375
Recall NumberZ-1833-2013

Class II Devices Event

Event ID65759
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Nov-12
Initial Firm Notification of Consignee or Public Visit
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, DE, FL, GA, ID, IL , IA, MD, MA, MI, MS, MO, NJ, NM, NY, NC, OH, PA, RI, SC, TN,TX, UT,VT, VA and WI., and the countries of ARAB EMIRATES, AUSTRALIA, AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, HONG KONG, INDIA, ITALY, JAPAN, NETHERLANDS,NEW ZEALAND, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SINGAPORE,SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND and UNITED EMIRATES.
 

Associated Products

Product DescriptionGE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.
Code InfoMfg Lot or Serial # 223133WX0 223134WX8 223135WX5 223136WX3 223137WX1 224634WX6 224635WX3 224636WX1 224637WX9 224638WX7 224639WX5 224640WX3 224641WX1 224642WX9 224643WX7 224644WX5 224645WX2 224786WX4 224787WX2 224788WX0 224789WX8 224790WX6 224791WX4 224792WX2 224793WX0 224794WX8 224795WX5 224796WX3 224797WX1 224798WX9 224799WX7 224800WX3 224801WX1 224802WX9 224803WX7 224804WX5 224805WX2 224806WX0 224807WX8 224808WX6 224951WX4 225010WX8 225011WX6 225012WX4 225013WX2 225014WX0 225015WX7 225143WX7 225144WX5 225145WX2 225146WX0 226933WX0 226934WX8 226935WX5 226936WX3 226937WX1 227218WX5 227219WX3 227221WX9 227222WX7 227223WX5 227224WX3 227225WX0 227226WX8 227227WX6 227228WX4 227229WX2 227230WX0 227231WX8 227232WX6 227233WX4 227279WX7 227280WX5 227281WX3 227282WX1 227283WX9 227284WX7 227285WX4 227286WX2 227287WX0 227288WX8 227574WX1 227575WX8 227576WX6 227577WX4 227578WX2 228256WX4 228257WX2 228258WX0 228259WX8 228260WX6 228772WX0 228773WX8 228774WX6 228775WX3 228776WX1 228777WX9 228778WX7 228779WX5 228780WX3 229786WX9 229787WX7 229790WX1 229791WX9 229792WX7 229793WX5 231677WX6 231678WX4 231679WX2 231680WX0 231681WX8 231682WX6 231683WX4 231684WX2 231685WX9 231686WX7 231687WX5 231688WX3 231689WX1 231690WX9 232467WX1 232468WX9 232470WX5 232471WX3 232472WX1 232473WX9 232474WX7 232500WX9 232501WX7 232502WX5 232503WX3 232504WX1 232505WX8 232506WX6 233383WX9 233384WX7 233385WX4 233386WX2 233387WX0 233388WX8 233389WX6 233390WX4 233391WX2 233392WX0 233393WX8 233394WX6 233395WX3 233396WX1 234475WX2 235601WX2 235602WX0 235603WX8 235604WX6 235605WX3 236395WX0 236396WX8 236397WX6 236398WX4 236399WX2 237120WX1 237121WX9 237122WX7 237123WX5 237124WX3 237617WX6 237618WX4 237619WX2 237620WX0 237621WX8 238640WX7 238641WX5 238642WX3 238643WX1 238644WX9 240405WX1 240406WX9 240407WX7 240408WX5 240409WX3 240410WX1 240411WX9 240412WX7 240413WX5 240414WX3 240415WX0 240416WX8 242064WX4 242065WX1 242070WX1 242071WX9 242073WX5 242074WX3 242075WX0 242076WX8 242077WX6 242078WX4 242499WX2 242500WX7 242501WX5 242502WX3 242503WX1 242504WX9 242505WX6 242506WX4 242507WX2 242508WX0 242509WX8 242510WX6 242511WX4 242512WX2 242513WX0 242514WX8 242515WX5 242516WX3 242517WX1 242518WX9 237748WX9 237749WX7 225460WX5 225461WX3 225462WX1 225463WX9 225464WX7 227289WX6 227290WX4 228781WX1 229268WX8 229269WX6 229272WX0 229938WX6 229939WX4 229940WX2 229941WX0 229988WX1 234511WX4 234512WX2 234513WX0 237717WX4 237718WX2 237719WX0 237720WX8 237721WX6 237722WX4 237723WX2 241117WX1 235655WX8 237114WX4 237116WX9 224959WX7 233265WX8 237747WX1 231964WX8 237119WX3 224958WX9 227137WX7 227855WX4 228803WX3 228804WX1 228805WX8 229156WX5 229157WX3 231967WX1 233263WX3 233316WX9 234462WX0 234463WX8 234464WX6 234465WX3 234617WX9 234925WX6 234927WX2 234928WX0 234930WX6 234931WX4 235656WX6 235665WX7 235666WX5 235667WX3 237102WX9 237112WX8 237113WX6 237742WX2 237752WX1 238517WX7 216340WX0 223130WX6 223131WX4 223132WX2 224955WX5 224956WX3 224960WX5 224989WX4 224990WX2 224991WX0 227856WX2 227857WX0 227859WX6 228807WX4 228811WX6 228812WX4 228879WX3 228880WX1 228881WX9 228883WX5 229152WX4 229153WX2 229154WX0 229155WX7 229159WX9 229160WX7 229161WX5 231962WX2 231966WX3 231969WX7 231970WX5 231973WX9 231974WX7 231975WX4 231976WX2 231977WX0 231978WX8 233261WX7 233314WX4 233320WX1 233322WX7 234468WX7 234469WX5 234471WX1 234472WX9 234613WX8 234614WX6 234615WX3 234616WX1 234618WX7 234921WX5 234926WX4 235600WX4 235658WX2 235660WX8 235661WX6 235662WX4 235663WX2 235668WX1 235891WX9 235892WX7 235893WX5 235894WX3 235895WX0 237096WX3 237097WX1 237099WX7 237110WX2 237115WX1 237118WX5 237739WX8 237743WX0 237744WX8 237745WX5 237746WX3 238519WX3 238520WX1 238521WX9 224954WX8 226012WX3 226013WX1 226014WX9 226015WX6 226016WX4 226017WX2 226018WX0 226019WX8 226020WX6 226021WX4 226217WX8 226218WX6 226219WX4 226220WX2 226221WX0 226222WX8 226223WX6 226224WX4 226225WX1 226226WX9 227118WX7 227119WX5 227120WX3 227121WX1 227122WX9 227123WX7 227124WX5 227125WX2 227126WX0 227127WX8 227128WX6 227129WX4 227130WX2 227131WX0 227132WX8 227133WX6 227134WX4 227135WX1 227136WX9 227858WX8 231972WX1 233262WX5 233317WX7 233318WX5 237117WX7 237738WX0 237750WX5 237751WX3 237570WX7 241229WX4 241230WX2 226296WX2 226297WX0 226298WX8 226299WX6 226300WX2 228242WX4 228243WX2 228244WX0 228245WX7 228246WX5 232582WX7 234619WX5 235642WX6 237106WX0 237125WX0 238639WX9 239507WX7 239525WX9 239559WX8 239560WX6 240337WX6 240338WX4 240339WX2 240340WX0 240362WX4 240437WX4 240438WX2 241113WX0 241114WX8 241115WX5 241116WX3 241188WX2 227860WX4 227861WX2 227862WX0 228806WX6 231965WX5 231971WX3 233321WX9 234466WX1 234470WX3 234473WX7 234922WX3 234923WX1 234924WX9 235599WX8 237101WX1 227677WX2 227678WX0 227683WX0 227684WX8 227687WX1 227688WX9 228884WX3 228885WX0 228886WX8 229944WX4 229945WX1 229946WX9 229947WX7 229948WX5 232446WX5 232447WX3 232448WX1 232449WX9 232450WX7 232451WX5 232452WX3 233397WX9 233398WX7 233399WX5 233657WX6 233658WX4 233659WX2 233660WX0 234932WX2 234933WX0 235596WX4 235643WX4 235644WX2 235645WX9 236233WX3 236234WX1 236235WX8 236236WX6 236237WX4 236238WX2 236239WX0 237544WX2 237545WX9 237546WX7 237547WX5 237548WX3 238645WX6 238646WX4 238647WX2 238648WX0 238649WX8 238650WX6 238651WX4 239526WX7 239527WX5 239528WX3 239529WX1 239571WX3 239572WX1 239573WX9 239574WX7 240363WX2 241178WX3 241179WX1 241180WX9 241181WX7 241182WX5 241183WX3 241184WX1 241185WX8 241232WX8 241249WX2 241250WX0 241251WX8 241252WX6 241613WX9 241614WX7 241615WX4 241616WX2 241617WX0 242355WX6 242356WX4 227863WX8 227864WX6 231961WX4 229270WX4 229271WX2 229942WX8 229943WX6 232570WX2 232571WX0 232572WX8 234514WX8 228810WX8 231968WX9 237103WX7 237108WX6 237109WX4 234467WX9 237111WX0 233319WX3 235664WX0 229608WX5 229609WX3 238638WX1 228808WX2 231959WX8 231960WX6 233264WX1 233313WX6 224957WX1 228882WX7 235659WX0 238518WX5 216341WX8 235654WX1 235657WX4 229158WX1 233315WX1 235598WX0 237740WX6 237741WX4 228809WX0 231963WX0 234929WX8 237098WX9 237100WX3
ClassificationClass II
Reason for RecallGE Healthcare became aware of a potential issue associated with the LOGIQ e system. Image data from one patient has the potential to be linked to the patient ID of another patient.
Product Quantity588
Recall NumberZ-1849-2013

Class II Food Event

Event ID65763
StatusCompleted
Product TypeFood
Voluntary/Mandated FDA Mandated
Recall Initiation Date09-Apr-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmKabco Pharmaceuticals, Inc.
CityAmityville
StateNY
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionPERFECT 3000 CHOCOLATE POWDER, FORMULA # 3098. The product is loose powder packaged in bulk drum.
Code InfoLot BA13032003
ClassificationClass II
Reason for RecallFirm had distributed the bulk product in violation of the Consent Decree for Permanent Injunction (12-CV-3468).
Product Quantity681.60 Kilograms
Recall NumberF-1766-2013
Product DescriptionPERFECT 3000 VANILLA POWDER, FORMULA # 3101. The product is loose powder packaged in bulk drum.
Code InfoLot BA13032004A and 13032004B
ClassificationClass II
Reason for RecallFirm had distributed the bulk product in violation of the Consent Decree for Permanent Injunction (12-CV-3468).
Product Quantity1813.60 Kilograms
Recall NumberF-1767-2013

Class II Food Event

Event ID65766
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jul-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCSM Bakery Products North America
CityDallas
StateTX
CountryUS
Distribution PatternCA, FL, GA, IL, IN, MO, NC, NY, OH, OK, PA, TX, UT, WI, and WY
 

Associated Products

Product Description10-inch Supreme Chocolate Layered Cake; 12 units per shipping case
Code InfoCMS Item Code: 18238200; Lot Code: 6DA 1316100598
ClassificationClass II
Reason for RecallForeign Material Contamination - Ball point pen
Product Quantity6,400 cases; 96,000 pounds
Recall NumberF-1768-2013

Class II Drugs Event

Event ID65780
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTorrent Pharma Inc
CityKalamazoo
StateMI
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionOlanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Prasco Laboratories, Mason OH, 45040, USA, Mfd by: Torrent Pharmaceuticals Ltd., Indrad-382 721, Dist. Mehsana India, NDC 66993-463-30
Code InfoLot #: BS392004A, Exp: 09/2014
ClassificationClass II
Reason for RecallDefective Container; This action is being taken as a precautionary measure due to the product being re-packaged in the U.S. using a filler material that (removes or blocks) less moisture than what is approved in the application.
Product Quantity18,721 bottles
Recall NumberD-830-2013

Class II Drugs Event

Event ID65784
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBaxter Healthcare Corp.
CityDeerfield
StateIL
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionDIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product L5B4826, NDC 0941-0409-07
Code InfoProduct Code: L5B4826, Lot #: C886820, Exp 11/14
ClassificationClass II
Reason for RecallDefective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.
Product Quantity39,486 containers
Recall NumberD-831-2013

Class III Biologics Event

Event ID39995
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Feb-05
Initial Firm Notification of Consignee or Public FAX
Recalling FirmZLB Bioplasma, Inc.
CityColumbus
StateOH
CountryUS
Distribution PatternIL, CA
 

Associated Products

Product DescriptionSource Plasma
Code InfoGFKWMV;GFKXMW; GFLCNS; GFLDJG; GFLFPV; GFLGJT; GFLHQF; GFLJHW; GFLKKC; GFMDZG; GFMGBS; GFMGTN; GFMHXS; GFMJMT; GFMKHX; GFMMBQ; GFMMWS; GFMPJS; GFMQFC; GFMRMP; GFMSVC; GFMVBP; GFMPDV; GFYBVS; GFYCYF; GFYFDR; GFYGLW; GFYGYN; GFYJFM; GFYJTT; GFYKZL; GFYLYK; GFYNZL; GFZHLG; GFZJGY; GFZKMW; GFZLNH; GFZMJH; GFZNFN; GFZPFH; GFZPVM; GFZQPL; GFZRGV; JBBRWK; JBBZYZ
ClassificationClass III
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity46 units
Recall NumberB-1982-13

Class III Biologics Event

Event ID41587
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Feb-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCSL Plasma Inc
CityTempe
StateAZ
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info65630051; 65624203; 65634226,
ClassificationClass III
Reason for RecallBlood products collected from a donor who was previously permanently, were distributed.
Product Quantity3
Recall NumberB-1799-13

Class III Biologics Event

Event ID43506
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Oct-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTri-counties Blood Bank
CityPhoenix
StateAZ
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoLT22661
ClassificationClass III
Reason for RecallBlood product, which was outside the acceptable quality control ranges, was distributed.
Product Quantity1 unit
Recall NumberB-1867-13

Class III Biologics Event

Event ID47629
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Jan-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTri-counties Blood Bank
CitySan Luis Obispo
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoLT53144; LT53148; LT53135
ClassificationClass III
Reason for RecallBlood products, without any coolant in the shipping container, were distributed.
Product Quantity3 units
Recall NumberB-1876-13

Class III Biologics Event

Event ID57800
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Sep-10
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSt. Thomas More Hospital Blood Bank
CityCanon City
StateCO
CountryUS
Distribution PatternCO
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW337609001399, W337610001701
ClassificationClass III
Reason for RecallBlood products, collected from a donor with polycythemia, were distributed.
Product Quantity2 units
Recall NumberB-1860-13
Product DescriptionFresh Frozen Plasma
Code InfoW337610001737, W337609001008, W337609001246, W337609001399, W337610001701, W337610001801
ClassificationClass III
Reason for RecallBlood products, collected from a donor with polycythemia, were distributed.
Product Quantity6 units
Recall NumberB-1861-13

Class III Biologics Event

Event ID65039
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Mar-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross (The)
CityMadison
StateWI
CountryUS
Distribution PatternWisconsin
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Washed
Code Info032LM04000;
ClassificationClass III
Reason for RecallBlood product, with a volume significantly higher than the usual and expected amount, was distributed.
Product Quantity1
Recall NumberB-1991-13

Class III Biologics Event

Event ID65282
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Apr-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAlba Bioscience Limited
CityEdinburgh
State
CountryGB
Distribution PatternMultiple U.S. States
 

Associated Products

Product DescriptionReagent Red Blood Cells
Code InfoV133096
ClassificationClass III
Reason for RecallAntibody Screening Cells, misbranded with incorrect Antigen Profile, were distributed.
Product Quantity1 unit
Recall NumberB-2024-13

Class III Biologics Event

Event ID65386
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jun-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmInternational Sight Restoration, Inc.
CityTampa
StateFL
CountryUS
Distribution PatternIsrael and Florida
 

Associated Products

Product DescriptionCornea
Code Info20110009OD, 20110009OS
ClassificationClass III
Reason for RecallHuman corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Product Quantity2 corneas
Recall NumberB-2023-13

Class III Food Event

Event ID65665
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jul-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmOzark Bottling, LLC
CityLake Ozark
StateMO
CountryUS
Distribution PatternDistribution was made to OH.
 

Associated Products

Product DescriptionLehman's Hot Veggie Mix, packaged in 12/16-oz jars per case, distributed by Lehman's, Kidron, OH 44636
Code InfoLot 050815
ClassificationClass III
Reason for RecallThe pH levels of these products are not accurately measured due to the use of outdated buffers and pH levels do not meet process specifications.
Product Quantity2/12/16-oz jar/cases
Recall NumberF-1745-2013

Mixed Classification Food Event

Event ID65643
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jun-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmFisher's Homestyle Salads
CityLancaster
StatePA
CountryUS
Distribution Pattern1. Esh Foods, L.L.C., located at 58 Hatville Rd; Gordonville, PA 17529 tel # 717-768-8542 Contact: David Esh 2. Landis Foods, located at 679 Hartman Station Road, Lancaster, PA 17602 Tel 717-397-5382 Contact: Lloyd Miller 3. Soup R Salads, located at 2268 Old Philadelphia Pike, Lancaster, PA 17602 Tel # 717-295-3105 Contact: Steve Shenk. Additional quantities (approximately 140 lbs) were sold to customers from the on-site retail counter at Fisher's Homestyle Salads, LLC.
 

Associated Products

Product DescriptionFisher's Homestyle Salads LLC***New England Clam Chowder*** packaged in 5 lb and 10 lb plastic containers.
Code InfoNo sell-by or expiration date code information was included on the package. A 7-day sell-by date was estimated as 7/4/13.
ClassificationClass II
Reason for Recall1) Milk not listed in ingredient statement, but listed in allergen warning statement and as a subingredient of sodium caseinate. 2) Undeclared corn 3) Undeclared crab, lobster and shrimp; allergen statement lists "crustacean shellfish products"
Product Quantity
Recall NumberF-1755-2013
Product DescriptionFisher's Homestyle Salads LLC***Cheddar Potato Soup w/Bacon*** packaged in 5 lb and 10 lb plastic containers.
Code InfoNo sell-by or expiration date code information was included on the package. A 10-day sell-by date was estimated as 7/8/13.
ClassificationClass II
Reason for Recall1) Milk not listed as source of cream, cheese, or butter 2) Undeclared corn
Product Quantity
Recall NumberF-1756-2013
Product DescriptionFisher's Homestyle Salads LLC***Broccoli Cheese Soup*** packaged in 5 lb and 10 lb plastic containers.
Code InfoNo sell-by or expiration date code information was included on the package. A 10-day sell-by date was estimated as 7/8/13.
ClassificationClass II
Reason for Recall1) milk not lsited as source of cream, cheese, or butter
Product Quantity
Recall NumberF-1757-2013
Product DescriptionFisher's Homestyle Salads LLC***Crab & Shrimp Salad*** packaged in 5 lb and 10 lb plastic containers.
Code InfoNo sell-by or expiration date code information was included on the package. A 7-day sell-by date was estimated as 7/4/13.
ClassificationClass II
Reason for Recall1) Undeclared corn 2) undeclared whiting, cod, and/or bream; pollock and whitefish listed in ingredient statement 3) undeclared wheat 4) undeclared Red 40 5) undeclared crab - crab in name of product
Product Quantity
Recall NumberF-1758-2013
Product DescriptionFisher's Homestyle Salads LLC***Gourmet Crab Cakes*** packaged in 6-piece (36 oz) and 12-piece (72 oz) styrofoam trays.
Code InfoNo sell-by or expiration date code information was included on the package. A 7-day sell-by date was estimated as 7/1/13.
ClassificationClass I
Reason for Recall1) undeclared fish 2) undeclared soy lecithin - soy flour listed in ingredient statement 3) undeclared wheat
Product Quantity
Recall NumberF-1759-2013

Mixed Classification Biologics Event

Event ID41487
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Dec-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBlood Bank Of San Bernardino and Riverside Counties
CitySan Bernardino
StateCA
CountryUS
Distribution PatternCA, Switzerland
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoGN97147
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-1984-13
Product DescriptionBlood and Blood Products for Reprocessing.
Code InfoGN97147
ClassificationClass III
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-1985-13

Mixed Classification Biologics Event

Event ID44355
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Feb-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBlood Bank of San Bernardino and Riverside Counties
CitySan Bernardino
StateCA
CountryUS
Distribution PatternCalifornia, Florida, Washington, D.C., Austria
 

Associated Products

Product DescriptionCryoprecipitated AHF
Code InfoGX66980
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-1868-13
Product DescriptionFresh Frozen Plasma
Code InfoGZ12807; GZ07733; GZ01265
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity3 units
Recall NumberB-1869-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoGZ12807; GZ07733; GZ03746; GZ01265; GX91592; GX73202; GX66980
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity7 units
Recall NumberB-1870-13
Product DescriptionCryoprecipitated AHF, Pooled
Code InfoG06089
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-1871-13
Product DescriptionPlasma Frozen Cryoprecipitated Reduced
Code InfoGX73202
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1unit
Recall NumberB-1872-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoGZ03746; GX91592; GX66980
ClassificationClass III
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity3 units
Recall NumberB-1873-13

Mixed Classification Biologics Event

Event ID65026
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036812837810;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1764-13
Product DescriptionFresh Frozen Plasma (Apheresis)
Code Info2452490;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1765-13
Product DescriptionCryoprecipitated AHF
Code Info2055025;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1766-13
Product DescriptionRed Blood Cells
Code InfoW036812491773; W036810005930; 2452490; 2055025; 2009327;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity5
Recall NumberB-1767-13
Product DescriptionPlatelets
Code Info2009327;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1768-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036812491773; W036810005930; 2055025; 2009327;
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity4
Recall NumberB-1769-13

Mixed Classification Food Event

Event ID65499
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jun-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmEl Campestre
CityCompton
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionEl Campestre Brand Ceviche Mixto, 2/5 lbs bulk containers into 1/10lbs carton. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:"CEVICHE MIXTO***NET WT..10 LBS***DIST.BY EL CAMPESTRE DIST TEL (562) 505-7247***".
Code InfoProduct is not coded with lot numbers. Expiration date 06/01/13
ClassificationClass I
Reason for RecallEl Campestre initiated this recall due to the following reason: undeclared allergens: eggs, soy, wheat, and crab extract.
Product Quantity35
Recall NumberF-1760-2013
Product DescriptionEl Campestre Brand Seafood Ranchero. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:"SEA FOOD RANCHERO***NET WT..10 LBS***DIST.BY EL CAMPESTRE DIST TEL (562) 505-7247***".
Code InfoProduct is not coded with lot numbers. Expiration date 06/01/13
ClassificationClass I
Reason for RecallEl Campestre initiated this recall due to the following reason: undeclared allergens: eggs, soy, wheat, and crab extract.
Product Quantity45
Recall NumberF-1761-2013
Product DescriptionEl Campestre Brand Ceviche De Basa. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:"EL CAMPESTRE CEVICHE DE BASA***NET WT.10 LBS***Manufactured by: El Campestre Compton, CA 90221 (310) 764-2461***".
Code InfoProduct is not coded with lot numbers. Expiration date 06/01/13
ClassificationClass III
Reason for RecallEl Campestre initiated this recall due to the following reason: mislabeling: does not contain Basa fish, it contains Swai fish.
Product Quantity259
Recall NumberF-1762-2013
Product DescriptionEl Campestre Brand Ceviche Mixto De Basa. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:"EL CAMPESTRE CEVICHE MIXTO DE BASA***NET WT.10 LBS***Manufactured by: El Campestre Compton, CA 90221 (310) 764-2461***".
Code InfoProduct is not coded with lot numbers. Expiration date 06/01/13
ClassificationClass I
Reason for RecallEl Campestre initiated this recall due to the following reason: undeclared allergens: eggs, soy, wheat, and crab extract.
Product Quantity117
Recall NumberF-1763-2013
Product DescriptionEl Campestre Brand Ceviche De Camaron. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:"EL CAMPESTRE CEVICHE DE CAMARON***NET WT.10 LBS***Manufactured by: El Campestre Compton, CA 90221 (310) 764-2461***".
Code InfoProduct is not coded with lot numbers. Expiration date 06/01/13
ClassificationClass II
Reason for RecallEl Campestre initiated this recall due to the following reason: mislabeling: Shrimp not listed in English, but the whole shrimp are visible.
Product Quantity
Recall NumberF-1764-2013
Product DescriptionEl Campestre Brand Camaron Aquachile. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:"EL CAMPESTRE CAMARON AGUACHILE***NET WT.10 LBS***Manufactured by: El Campestre Compton, CA 90221 (310) 764-2461***".
Code InfoProduct is not coded with lot numbers. Expiration date 06/01/13
ClassificationClass II
Reason for RecallEl Campestre initiated this recall due to the following reason: shrimp are not listed in English, but the whole shrimp are visible.
Product Quantity37
Recall NumberF-1765-2013
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