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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Class I Food Event

Event ID61696
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Apr-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmHong Lee Trading Inc
CityBrooklyn
StateNY
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionPreserved Apricots -- NET WEIGHT 300gr (10.6oz) -- Ingredient: Salt, apricot, refined sugar. Firm on label: packed for Hong Lee Trading Inc., 225 Johnson Ave., Brooklyn, NY 11203. Product of Vietnam.
Code InfoNo codes
ClassificationClass I
Reason for RecallThe product contained undeclared sulfites (108.8 ppm) and undeclared Yellow #5 based on sampling and analysis by New York State Department of Agriculture and Markets.
Product Quantity30 cases
Recall NumberF-1457-2013

Class I Food Event

Event ID63268
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Sep-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmThe Sourdough: A European Bakery Inc.
CityHouston
StateTX
CountryUS
Distribution PatternAR, LA, OK, and TX
 

Associated Products

Product DescriptionWhole Foods Mini Peanut Butter Cookies 12 pack sold in small, plain brown bags featuring a cellophane window on the front with an oval Whole Foods Market sticker that reads "mini peanut butter cookies - OLD-FASHIONED TREATS FROM WHOLE FOOD MARKET-" PLU 22096100000
Code InfoAll cookies sold before September 29, 2012, manufactured from May 1, 2012 to September 24, 2012
ClassificationClass I
Reason for RecallThe cookies were manufactured using peanut butter recalled by Sunland, Inc. for salmonella
Product Quantity
Recall NumberF-1460-2013
Product DescriptionWhole Foods 3 oz Peanut Butter Cookies sold under PLU 47963 from the retail store self-serve pastry case.
Code InfoAll cookies sold before September 29, 2012, manufactured from May 1, 2012 to September 24, 2012,
ClassificationClass I
Reason for RecallThe cookies were manufactured using peanut butter recalled by Sunland, Inc. for salmonella.
Product Quantity
Recall NumberF-1461-2013
Product DescriptionWhole Foods 3 oz Peanut Butter Chocolate Chunk Cookies sold under PLU 47963 from the retail store self-serve pastry case.
Code InfoAll cookies sold before September 29, 2012, manufactured from May 1, 2012 to September 24, 2012.
ClassificationClass I
Reason for RecallThe cookies were manufactured using peanut butter recalled by Sunland, Inc. for salmonella.
Product Quantity
Recall NumberF-1462-2013

Class I Food Event

Event ID63277
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmPecan Deluxe Candy Company
CityDallas
StateTX
CountryUS
Distribution PatternCA, IA, MI, MO, NC, NV, NY, OH, PA, TX, UT, WI and Canada
 

Associated Products

Product DescriptionPeanut Butter Ribbon, 40 lb Pail, Item Numbers 07-012-40, 07-212-40, and 49-00100-40, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212
Code InfoItem 07-012-40, Lots 100992, 10209241, 103361, 110381, 11117241, 11117141, 11222231, 11222241, 12030241, 10244241, 10049241, 10099231, and 10244241. Lots of 07-212-40: 102882, 120462, 10162241, 11133231, 120462, 101621, 101622, 10209141, 10209131, 10288131, 10288141, 10288231, 10349241, 10349231, 11133241, 11133231, 11176231, 11176241, 11194231, 11251231, 11251241, 12034231, 120951, 121322, 12182241, 12182132, 12182142, 12182141, 12182131, 12182231, and 12208233. Lots of 49-00100-40: 10133241, 1014715, 10133241, 1023225, 110612, 10133241, 1019625, 103072, and 1116015.
ClassificationClass I
Reason for RecallThe Peanut Butter products were manufactured using peanut butter recalled by Sunland, Inc. for salmonella.
Product Quantity262,410 lbs
Recall NumberF-1448-2013
Product DescriptionPeanut Butter Crunch, 45 lb Case, Item Number 01-326-45, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212
Code InfoLot #s: 111752, 100781, 101562, 102312, 102662, 103432, 110402, 110401, 113191, and 120971.
ClassificationClass I
Reason for RecallThe Peanut Butter products were manufactured using peanut butter recalled by Sunland, Inc. for salmonella.
Product Quantity76,550 lbs
Recall NumberF-1449-2013
Product DescriptionPeanut Butter Fudge Ribbon, 50 lb Pail, Item Number 07-094-50, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212
Code InfoLot #s: 112142
ClassificationClass I
Reason for RecallThe Peanut Butter Ribbon and Chunky Peanut Butter Ribbon were manufactured using peanut butter recalled by Sunland, Inc. for salmonella.
Product Quantity3600 lbs
Recall NumberF-1450-2013
Product DescriptionChunky Peanut Butter Ribbon, 40 lb Pail, Item Number 07-712-40, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212
Code InfoLot Numbers: 10077242, 10077231, 10077241, 101562, 101561, 10196141, 101961, 10196141, 10267231, 10267241, 11089211, 11089221, 11140241, 11140231, 11111231, 11285242, 11285141, 12030241, 12030231, 120871, 121252, 122131, 10085231, 100862, 1005623, 10133242, 10267242, 10267241, 10267231, 10343231, 10343241, 11089221, 11089212, 11089211, 11089221, 11111241, 11111231, 11089212, 111762, 11237231, 11243242, 11243241, 11285242, 11285241, 11237231, 11243242, 12074231, 12073231, 120931, and 121441.
ClassificationClass I
Reason for RecallThe Peanut Butter products were manufactured using peanut butter recalled by Sunland, Inc. for salmonella.
Product Quantity100,030 lbs
Recall NumberF-1451-2013
Product DescriptionPeanut Butter Base, 30 lb Pail, Item Numbers 08-010-30, 08-310-30, and 08-810-30, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212
Code InfoLot #s: 120462, 11021231, 100122, 10118241, 10118231, 1105412, 110541, 102211, 1032215, 110212, 110542, 10118231, 10118241, 102581, 11140231, 11140242, 11140241, 120462, 10118231, 12034241, 100842, 10111231, 1015515, 110742, 1115425, 112861, 112862, 1103115, 11140242, 11318142, 10111231, 100851, 110212, 11291231, 11291241, 1012525, 103332, and 103471.
ClassificationClass I
Reason for RecallThe Peanut Butter products were manufactured using peanut butter recalled by Sunland, Inc. for salmonella.
Product Quantity76,170 lbs
Recall NumberF-1452-2013

Class I Food Event

Event ID63366
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Sep-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmNature's Candy, Inc.
CityFredericksburg
StateTX
CountryUS
Distribution PatternCA and CO
 

Associated Products

Product DescriptionMaple Macadamia Nuts, 25 lb bulk boxes
Code InfoLot #s 7241, 7242, and 7243
ClassificationClass I
Reason for RecallThe macadamia nuts have the potential to be contaminated with Salmonella.
Product Quantity20 boxes
Recall NumberF-1459-2013

Class I Food Event

Event ID65003
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Apr-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling Firm7-Eleven Stores of Oklahoma
CityOklahoma City
StateOK
CountryUS
Distribution PatternOklahoma
 

Associated Products

Product Description7th Heaven Bakeries Oatmeal Raisin Cookie, 7th Heaven Bakeries, Oklahoma City, OK
Code InfoBest By Dates prior to 05/07/13.
ClassificationClass I
Reason for RecallUndeclared egg, soy and milk.
Product Quantity1,873 cookies
Recall NumberF-1453-2013

Class I Devices Event

Event ID65070
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNephron Pharmaceuticals Corp.
CityOrlando
StateFL
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AZ, CA, CO, CT, FL, IL, IN, IO, GA, KS, KY, LA, MD, MN, MS, MO, NK, NV, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN , TX, VT, VA, WA, and WV, and the countries of Guatemala, Poland, Panama, and United Kingdom.
 

Associated Products

Product DescriptionEZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.
Code InfoModel # EZ-100 Lots # R2029A, R2029B, R2039A, R2042A, R2045A, and R2047A. Atomizer Serial Number Ranges: 1206034476-1206069065 1207003710-1237038299 1207046505-1207081124 1208027421-1208062155 1209000001-1209069179 1209069180-1209069202 1209069203-1209069460 1210000001-1210103680 1210104001-1210104044
ClassificationClass I
Reason for RecallPossible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
Product Quantity604 each
Recall NumberZ-1371-2013
Product DescriptionAsthmanefrin Starter Kit contains ten (10) Asthmanefrin vials and one (1) EZ Breathe Atomizer. For the delivery of liquid medications for respiratory usage.
Code InfoLots # R2029A, R2029B, R2039A, R2042A, R2045A, and R2047A. Atomizer Serial Number Ranges: 1206034476-1206069065 1207003710-1237038299 1207046505-1207081124 1208027421-1208062155 1209000001-1209069179 1209069180-1209069202 1209069203-1209069460 1210000001-1210103680 1210104001-1210104044
ClassificationClass I
Reason for RecallPossible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
Product Quantity241,538 kits
Recall NumberZ-1372-2013
Product DescriptionEZ Breathe Medication Cup. For the delivery of liquid medications for respiratory usage.
Code InfoLots #120902, Lot # 120903 and Lot # 120904
ClassificationClass I
Reason for RecallPossible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
Product Quantity750 Medications Cups
Recall NumberZ-1373-2013

Class I Food Event

Event ID65203
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Apr-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmTropical Valley Foods, Inc.
CityPlattsburgh
StateNY
CountryUS
Distribution PatternMichigan, Oregon, Colorado, and New Jersey
 

Associated Products

Product Descriptionnext by Nature brand DARK CHOCOLATE BANANAS, NET WT. 3 Oz. (85g), UPC 8 17582 25600 4, Produced by Tropical Valley Foods
Code Info"Best by Date" of 12/18/2013 and 12/19/2013
ClassificationClass I
Reason for RecallThe product contains the undeclared allergens walnuts and milk.
Product Quantity
Recall NumberF-1458-2013

Class I Food Event

Event ID65211
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-May-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmArthur Schuman Midwest LLC
CityElgin
StateIL
CountryUS
Distribution PatternNationwide (MA and VA)
 

Associated Products

Product DescriptionGRATED 2/25 GRANA PADANO; Lot Code: 313701A01; Pack Size: 2/25#; Net Pounds: 50; PACK DATE: 05/18/13; ITEM#DGP03; arthur schuman inc, 40 new dutch lane fairfield nj 07004 U.S.A.; 937-227-0030 www.arthurschuman.com;
Code InfoProduct Code: ARG07146JP; Lot No.: 311501A01
ClassificationClass I
Reason for RecallGrated Grana Padano Hard Italian Cheese was tested and found to be positive for Listeria monocytogenes.
Product Quantity2,500 lbs.
Recall NumberF-1465-2013

Class II Biologics Event

Event ID38597
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jun-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross (The)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info01LJ41562
ClassificationClass II
Reason for RecallBlood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Product Quantity1 component
Recall NumberB-1337-13

Class II Biologics Event

Event ID39075
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jun-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info2432047
ClassificationClass II
Reason for RecallBlood products, labeled leukoreduced which did not meet the requirements for leukoreduced products, were distributed.
Product Quantity2
Recall NumberB-1321-13

Class II Biologics Event

Event ID39077
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Jun-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionPlatelets Leukocytes Reduced
Code Info2432106 (split product)
ClassificationClass II
Reason for RecallBlood products, which did not meet the specified pH for platelets, were distributed.
Product Quantity3
Recall NumberB-1327-13

Class II Biologics Event

Event ID39567
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jan-05
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNorthwest Florida Blood Center, Inc.
CityPensacola
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionPlatelets Leukocytes Reduced
Code Info 4727989; 4727982A; 4727982B.
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity3 units
Recall NumberB-1252-13

Class II Biologics Event

Event ID39591
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Oct-04
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNorthwest Florida Blood Center, Inc.
CityPensacola
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info4072021A; 4072021B.
ClassificationClass II
Reason for RecallBlood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed.
Product Quantity2 units
Recall NumberB-1253-13

Class II Biologics Event

Event ID39660
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Dec-04
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBioLife Plasma Services L.P.
CityLakeland
StateFL
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code InfoLF240346; LF240044; LF239620; LF239240; LF238990; LF238603; LF238237; LF237823; LF237303; LF237056.
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was permanently deferred after testing reactive for Hepatitis B surface antigen (HbSAg), were distributed.
Product Quantity10
Recall NumberB-1328-13

Class II Biologics Event

Event ID41692
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Mar-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center of the Ozarks
CitySpringfield
StateMO
CountryUS
Distribution PatternMO; AL; NJ; TX; OH; AR; FL; TN; MD
 

Associated Products

Product DescriptionCryoprecipitated AHF
Code Info6649425; 6649457; 6659087; 6659089; 6659092; 6659103; 6659109; 6659113; 6664719; 6665319; 6667046
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity11 Units
Recall NumberB-1242-13
Product DescriptionPlasma Cryoprecipitate Reduced
Code Info6659087; 6659089; 6659092; 6659109; 6659132; 6665305
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity6 Units
Recall NumberB-1243-13
Product DescriptionRed Blood Cells Irradiated
Code Info6653749; 6675572; 6677598
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity3 Units
Recall NumberB-1244-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info6657393; 6658379; 6662239; 6665764; 6666351; 6666704; 6672394; 6683753
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity8 Units
Recall NumberB-1245-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info6631297; 6631298; 6631306; 6642075; 6644449; 6644454; 6644472; 6644477; 6644485; 6644490; 6645308; 6645310; 6645311; 6645336; 6648163; 6648184; 6648191; 6648194; 6648486; 6648493; 6648509; 6648643; 6648659; 6648664; 6650172; 6650426; 6653060; 6654801; 6654804; 6654813; 6654838; 6654841; 6654920; 6655131; 6655133; 6655145; 6655534; 6655715; 6655718; 6655719; 6656667; 6656682; 6656696; 6656713; 6656714; 6656747; 6656751; 6656769; 6656785; 6656828; 6657630; 6657643; 6657651; 6657678; 6657680; 6657772; 6657783; 6658045; 6659437; 6659448; 6659537; 6659564; 6661572; 6664688; 6664712; 6664719; 6664721; 6664727; 6664936; 6665732; 6665743; 6665760; 6665792; 6666390; 6668800; 6668802; 6669194; 6669397; 6669408; 6669450; 6669460; 6669489; 6670615; 6672311; 6672399; 6672406; 6672812; 6674206; 6674953; 6674978; 6674984; 6675016; 6675455; 6675571; 6675903; 6676347; 6676349; 6676355; 6676369; 6676371; 6676382; 6676391; 6676759; 6676768; 6677968; 6677971; 6677976; 6677979; 6677988; 6678025; 6678032; 6678045; 6678053; 6678058; 6678065; 6678089; 6682015; 6682088; 6682089; 6682229; 6682247; 6682248; 6682370; 6682374; 6682383; 6683403; 6683420; 6683422; 6683746; 6688102
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity129 Units
Recall NumberB-1246-13
Product DescriptionPlatelets
Code Info6631299; 6642184; 6648158; 6648165; 6648509; 6650155; 6650188; 6650472; 6650508; 6654804; 6654841; 6654846; 6654920; 6654940; 6655058; 6655074; 6655083; 6655089; 6655094; 6655096; 6655145; 6656667; 6656682; 6656696; 6656792; 6656804; 6656824; 6656842; 6657703; 6657772; 6657802; 6657804; 6657806; 6657809; 6658068; 6661565; 6661592; 6661601; 6661604; 6661612; 6661627; 6663323; 6664339; 6664390; 6664398; 6664409; 6664938; 6664946; 6665740; 6665743; 6665756; 6665764; 6665765; 6666373; 6666390; 6666401; 6666734; 6666759; 6666906; 6666909; 6666919; 6668800; 6668802; 6668807; 6669182; 6669397; 6669450; 6672678; 6672682; 6672683; 6672690; 6672697; 6672715; 6674946; 6674970; 6674972; 6675016; 6675560; 6675563; 6675888; 6675931; 6675973; 6676497; 6677563; 6677588; 6677597; 6677598; 6677979; 6678053; 6678065; 6678089; 6681181; 6681192; 6681204; 6681954; 6682248; 6682356; 6682365; 6682380; 6682387; 6682396; 6682399; 6682403; 6682406; 6682473; 6682478; 6682502; 6683014; 6683015; 6683018; 6683019; 6683173; 6683208; 6683212; 6683222; 6683386; 6683387; 6683400; 6683403; 6683746; 6683752; 6683753; 6685148; 6685153; 6685157; 6685181; 6685187; 6685190; 6688178; 6688196; 6688202; 6688768; 6688816; 6675013
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity132 Units
Recall NumberB-1247-13
Product DescriptionFresh Frozen Plasma
Code Info6659164; 6631297; 6642184; 6642186; 6642196; 6644449; 6644451; 6644472; 6644477; 6644483; 6644485; 6645305; 6645308; 6645310; 6645336; 6648165; 6648167; 6648685; 6648706; 6648710; 6648722; 6648725; 6650191; 6650472; 6650475; 6650496; 6650508; 6650509; 6653060; 6654920; 6654940; 6654957; 6655053; 6655058; 6655074; 6655083; 6655089; 6655094; 6655096; 6655525; 6656682; 6656710; 6656713; 6656731; 6656747; 6656751; 6656753; 6656768; 6656769; 6656785; 6656804; 6656806; 6657703; 6657705; 6657708; 6657711; 6657772; 6657783; 6657787; 6657802; 6657804; 6657806; 6657809; 6657812; 6658050; 6658068; 6658071; 6659158; 6661592; 6661604; 6661631; 6663341; 6664501; 6664938; 6664942; 6664946; 6665740; 6665743; 6665756; 6665766; 6666734; 6666759; 6666762; 6666906; 6666919; 6666938; 6666945; 6666973; 6667206; 6667215; 6667225; 6667265; 6668802; 6669182; 6669184; 6669397; 6669408; 6669450; 6669460; 6669489; 6672673; 6672678; 6672690; 6672697; 6672718; 6672727; 6672988; 6673598; 6674941; 6674946; 6674959; 6674970; 6674972; 6674977; 6674978; 6674980; 6674984; 6674996; 6675563; 6676483; 6676497; 6676499; 6676810; 6676811; 6677563; 6677567; 6677571; 6677588; 6677602; 6677979; 6678089; 6681181; 6681192; 6681204; 6681206; 6681604; 6681609; 6681612; 6681616; 6682224; 6682248; 6682383; 6682399; 6682473; 6682478; 6682502; 6683587; 6683592; 6683594; 6683615
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity149 Units
Recall NumberB-1248-13
Product DescriptionRed Blood Cells
Code Info6631299; 6631302; 6642054; 6642061; 6642072; 6642077; 6642184; 6642186; 6642196; 6644447; 6644451; 6644483; 6645305; 6645315; 6645332; 6645343; 6647910; 6647911; 6647912; 6648158; 6648165; 6648167; 6648196; 6648206; 6648215; 6648216; 6648220; 6648457; 6648463; 6648481; 6648645; 6648681; 6648682; 6648685; 6648706; 6648710; 6648722; 6648725; 6648756; 6648759; 6648762; 6648832; 6649339; 6649344; 6649347; 6649352; 6649378; 6649405; 6649417; 6649421; 6649425; 6649457; 6650165; 6650169; 6650188; 6650191; 6650209; 6650404; 6650406; 6650408; 6650414; 6650422; 6650472; 6650473; 6650475; 6650486; 6650491; 6650496; 6650501; 6650508; 6650509; 6652910; 6652911; 6652912; 6652914; 6652915; 6653500; 6653503; 6653513; 6653746; 6654846; 6654940; 6654957; 6655053; 6655058; 6655062; 6655074; 6655081; 6655083; 6655089; 6655094; 6655096; 6655104; 6655122; 6655130; 6655520; 6655524; 6655525; 6655528; 6655531; 6656680; 6656681; 6656689; 6656707; 6656708; 6656710; 6656731; 6656753; 6656768; 6656790; 6656792; 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ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity599 Units
Recall NumberB-1249-13

Class II Biologics Event

Event ID42043
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Apr-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNew York Blood Center, Inc.
CityNew York
StateNY
CountryUS
Distribution PatternNew York, California
 

Associated Products

Product DescriptionRed Blood Cells
Code Info5353013
ClassificationClass II
Reason for RecallBlood products, with unacceptable, undocumented, or incomplete product QC, were distributed.
Product Quantity1 unit
Recall NumberB-1315-13
Product DescriptionFresh Frozen Plasma
Code Info5353013
ClassificationClass II
Reason for RecallBlood products, with unacceptable, undocumented, or incomplete product QC, were distributed.
Product Quantity1 unit
Recall NumberB-1316-13

Class II Biologics Event

Event ID42352
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Mar-06
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 DescriptionRed Blood Cells, Leukocyte Reduced
Code Info1159239
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-1317-13
Product DescriptionFresh Frozen Plasma
Code Info1159239
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-1318-13

Class II Biologics Event

Event ID43691
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Nov-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Red Cross Blood Services
CityOmaha
StateNE
CountryUS
Distribution PatternCO; NE; PA; IA; MA; TX; NY; IL; ME; MI
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info009FK67524;009GH72357;009GX55678;009FK67528; 009GH72361;009GX56251;009FK67530;009GH72370; 009GX56253;009FK67532;009GH72371;009GX56256; 009FK67534;009GH72378;009GX56261;009FK67536; 009GH72383;009GX56262;009FK67541;009GJ72636; 009GX56265;009FK67544;009GJ72641;009GX56270; 009FK67548;009GJ72645;009GX56272;009FK67551; 009GJ72648;009GX56275;009FK67555;009GJ72650; 009KG34257;009FK67557;009GJ72652;009KG34261; 009FK67559;009GJ72657;009KG34265;009FK67562; 009GJ73151;009KG34850;009FK67565;009GJ73154; 009KG34855;009FK68014;009GJ73161;009KG34856; 009FK68021;009GJ73179;009KG34862;009FV21440; 009GJ73189;009KG34878;009FV21442;009GJ73195; 009KG34883;009FV21445;009GJ73196;009KG34890; 009FV21498;009GJ73204;009KG34894;009FV21660; 009GJ73444;009KG34897;009FV21661;009GJ73447; 009KG35556;009FV21663;009GJ73453;009KG35561; 009FV21664;009GJ73458;009KG35570;009FV21666; 009GJ73465;009KG35574;009FV21667;009GJ74325; 009KG35577;009FV21671;009GJ74331;009KG35592; 009FV21674;009GJ74337;009KG35596;009FV21675; 009GJ74342;009KG35601;009FV21679;009GJ74408; 009KG35605;009FV21682;009GJ74533;009KG35610; 009FV22236;009GJ74538;009KG35614;009FV22237; 009GJ74547;009KG35615;009FV22239;009GJ74552; 009KG35724;009FV22242;009GJ74556;009KG35726; 009FV22243;009GJ74570;009KG35728;009FV22246; 009GJ74577;009KG35731;009FV22248;009GJ74589; 009KG35734;009FV22253;009GJ74580;009KG35735; 009FV22254;009GJ74583;009KG35738;009FV22255; 009GJ74592;009KG35740;009FV22257;009GJ74598; 009KG35742;009FV22258;009GJ74600;009KG35753; 009FV22261;009GJ74635;009KG35754;009FV22262; 009GJ74641;009KG35758;009FV22265;009GJ74645; 009KG35761;009FV22266;009GJ74647;009KG35763; 009FV22268;009GJ74650;009KG35767;009FV22270; 009GJ74652;009KG35892;009FV23223;009GJ74655; 009KG35905;009FV23234;009GJ74676;009KG35912; 009FV23244;009GJ74680;009KG35949;009FV23247; 009GJ74681;009KG35951;009FV23614;009GJ74683; 009KG35956;009FV23615;009GJ74687;009KG35961; 009FV23622;009GJ74688;009KG35962;009FV23623; 009GJ74691;009KG36778;009FV23624;009GJ74692; 009KG36779;009FV23626;009GJ74697;009KG36783; 009FV23630;009GJ74702;009KG36784;009FZ57832; 009GJ74704;009KG36788;009FZ57834;009GJ74706; 009KG36790;009FZ57840;009GR04276;009KG36792; 009FZ57842;009GR04279;009KG36793;009FZ57845; 009GR04282;009KG36796;009FZ57852;009GR04285; 009KG36798;009FZ57855;009GR04287;009KG36813; 009FZ57861;009GR04291;009KG36815;009FZ57865; 009GR04299;009KG36817;009GH70743;009GR04302; 009KG36832;009GH70746;009GR04305;009KG36845; 009GH70765;009GR04306;009KG36856;009GH70772; 009GR04637;009KG36859;009GH70778;009GR04646; 009KG36866;009GH70889;009GR04648;009KG36934; 009GH70892;009GR04650;009KG36941;009GH70896; 009GR04654;009KG36962;009GH71375;009GR04679; 009KG36965;009GH71379;009GR04682;009Q87153; 009GH71380;009GR04884;009Q87157;009GH71386; 009GR04887;009Q87169;009GH71397;009GR04888; 009Q87172;009GH71400;009GR04891;009Q87175; 009GH71409;009GR04892;009Q87177;009GH71418; 009GR04984;009Q87178;009GH71419;009GX55455; 009Q87182;009GH72002;009GX55457;009Q87186; 009GH72014;009GX55462;009Q87188;009GH72017; 009GX55466;009Q87189;009GH72026;009GX55469; 009Q88335;009GH72079;009GX55473;009Q88365; 009GH72083;009GX55475;009Q88367;009GH72233; 009GX55477;009Q88372;009GH72236;009GX55653; 009Q88375;009GH72240;009GX55658;009Q88375; 009GH72244;009GX55665;009Q88378;009GH72256; 009GX55668;009Q88381;009GH72261;009GX55670; 009Q88383;009GH72349;009GX55673;009Q88385 009Q88388 009Q88390 009Q88395 009Q88398 009Q88399 009Q88405
ClassificationClass II
Reason for RecallBlood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity306 Units
Recall NumberB-1262-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info009FK68018;009FZ57830;009FZ57863;009GH71412; 009GH72251;009GR04642;009GR04883;009GR04885; 009KG34879;009KG35535;009KG35620;009KG35621; 009KG35897;009KG35920;009Q87158;009Q88411
ClassificationClass II
Reason for RecallBlood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity16 Units
Recall NumberB-1263-13
Product DescriptionFresh Frozen Plasma
Code Info009GJ74600;009GJ74577;009GJ74645;009GJ74647; 009GJ74650
ClassificationClass II
Reason for RecallBlood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity5 Units
Recall NumberB-1264-13

Class II Biologics Event

Event ID44013
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Dec-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLane Memorial Blood Bank
CityEugene
StateOR
CountryUS
Distribution PatternSwitzerland, ID, Alaska, HI, CA, FL, TN, OR, NY
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info7128661, 7125441, 7125468, 7227594, 7229093, 7229269, 7229699, 7229772, 7231367, 7234488.
ClassificationClass II
Reason for RecallBlood products, collected from a donor who emigrated from an area considered at risk for human immunodeficiency virus (HIV) Group O, were distributed.
Product Quantity10 units
Recall NumberB-1266-13
Product DescriptionCryoprecipitated AHF, Pooled
Code Info8000554, 8000567, 8000570, 8000572, 8000574, 8000575, 8000576, 8000581, 8000583, 8000589, 8000603, 8000611, 8000613, 8000624, 8000646, 8000648, 8000652, 8000658, 8000672, 8000678.
ClassificationClass II
Reason for RecallBlood products, collected from a donor who emigrated from an area considered at risk for human immunodeficiency virus (HIV) Group O, were distributed.
Product Quantity20 units
Recall NumberB-1267-13
Product DescriptionRed Blood Cells, Leukocytes Reduced
Code Info7126037, 7126851, 7231541, 7233722, 7427262, 7428103, 7428115, 7428185, 7428187, 7428237, 7428238, 7428253, 7428259, 7428600, 7428672, 7429322, 7429567, 7432600, 7126394, 7428520, 7429211, 7126153, 7430972, 7430291, 7433622, 7130041, 7230313, 7231344, 7231852, 7429968, 7431818, 7432498, 7433768, 7433777, 7434213, 7434544, 7434564, 7436396, 7436397, 7125583, 7125987, 7126505, 7126628, 7126785, 7127086, 7127154, 7127314, 7127414, 7127430, 7127442, 7127600, 7127854, 7128317, 7129588, 7130255, 7130711, 7131415, 7131976, 7227278, 7228058, 7228132, 7228479, 7228512, 7228520, 7228571, 7228682, 7229235, 7229305, 7229507, 7229775, 7229793, 7230034, 7230109, 7230326, 7230801, 7231028, 7231162, 7231714, 7232224, 7232363, 7232640, 7232746, 7232986, 7233600, 7233993, 7235656, 7427539, 7427541, 7427770, 7427776, 7427801, 7428067, 7428135, 7428155, 7428399, 7428410, 7428574, 7428619, 7428642, 7428665, 7428718, 7428841, 7428843, 7428845, 7428850, 7428871, 7428876, 7428907, 7428922, 7428944, 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7429187, 7429191, 7429205, 7429210, 7429441, 7429465, 7125279, 7125367, 7125400, 7125457, 7125625, 7125651, 7125672, 7125817, 7125976, 7126000, 7126056, 7126133, 7126262, 7126301, 7126308, 7126344, 7126349, 7126364, 7126481, 7126488, 7126541, 7126598, 7126627, 7126783, 7126818, 7126819, 7126878, 7127099, 7127119, 7127131, 7127170, 7127310, 7127370, 7127406, 7127408, 7127488, 7127489, 7127535, 7127576, 7127615, 7127802, 7127809, 7127915, 7127929, 7128582, 7128635, 7128651, 7128849, 7129022, 7129026, 7129028, 7129034, 7129128, 7129449, 7129843, 7129884, 7129900, 7129911, 7130005, 7130065, 7130195, 7130253, 7130467, 7130473, 7130558, 7130624, 7130646, 7130708, 7130772, 7130884, 7130983, 7131235, 7131346, 7131712, 7131966, 7226975, 7227201, 7227471, 7227619, 7227648, 7227729, 7227770, 7227813, 7227821, 7228037, 7228042, 7228061, 7228063, 7228089, 7228092, 7228122, 7228191, 7228198, 7228311, 7228351, 7228392, 7228482, 7228526, 7228642, 7228648, 7228722, 7228771, 7228818, 7228824, 7228868, 7228948, 7228953, 7228962, 7229231, 7229272, 7229323, 7229349, 7229396, 7229427, 7229488, 7229723, 7229799, 7229972, 7229990, 7230103, 7230229, 7230420, 7230487, 7230524, 7230649, 7230650, 7230671, 7231059, 7231096, 7231102, 7231126, 7231145, 7231153, 7231224, 7231300, 7231303, 7231820, 7231892, 7232595, 7232619, 7232641, 7232757, 7232827, 7232832, 7232910, 7232915, 7232987, 7233084, 7233125, 7233133, 7233145, 7233207, 7233330, 7233347, 7233452, 7233461, 7233571, 7233599, 7233686, 7233707, 7233887, 7234194, 7234350, 7234358, 7234700, 7234870, 7234877, 7234893, 7235188, 7235321, 7235381, 7235414, 7235732, 7236361, 7236733, 7427149, 7427170, 7427229, 7427327, 7427339, 7427361, 7427390, 7427406, 7427441, 7427442, 7427468, 7427529, 7427530, 7427531, 7427584, 7427637, 7427649, 7427673, 7427727, 7427736, 7427743, 7427752, 7427756, 7427764, 7427767, 7427772, 7427894, 7427895, 7427896, 7427899, 7427901, 7427903, 7427946, 7427986, 7428000, 7428009, 7428049, 7428063, 7428068, 7428089, 7428113, 7428142, 7428216, 7428232, 7428236, 7428247, 7428252, 7428260, 7428272, 7428277, 7428287, 7428300, 7428318, 7428346, 7428347, 7428396, 7428466, 7428500, 7428501, 7428509, 7428522, 7428531, 7428533, 7428534, 7428538, 7428552, 7428554, 7428560, 7428562, 7428570, 7428571, 7428590, 7428591, 7428596, 7428606, 7428607, 7428610, 7428612, 7428616, 7428626, 7428658, 7428659, 7428664, 7428666, 7428673, 7428680, 7428706, 7428707, 7428713, 7428728, 7428730, 7428731, 7428740, 7428751, 7428759, 7428792, 7428800, 7428808, 7428812, 7428817, 7428890, 7428910, 7428918, 7428923, 7428928, 7428933, 7428937, 7428938, 7428939, 7428945, 7428948, 7428953, 7428956, 7428969, 7428972, 7428985, 7428990, 7428991, 7428996, 7429011, 7429022, 7429051, 7429087, 7429092, 7429094, 7429095, 7429096, 7429099, 7429111, 7429117, 7429118, 7429119, 7429127, 7429145, 7429150, 7429160, 7429206, 7429208, 7429212, 7429215, 7429216, 7429245, 7429253, 7429254, 7429288, 7429307, 7429417, 7429423, 7429429, 7429439, 7429457, 7429464, 7429471, 7429477, 7429491, 7429585, 7429587, 7429657, 7429663, 7429674, 7429725, 7429853, 7429861, 7429874, 7429875, 7429899, 7429900, 7429907, 7429909, 7430032, 7430035, 7430088, 7430098, 7430107, 7430123, 7430144, 7430159, 7430170, 7430175, 7430176, 7430187, 7430198, 7430237, 7430238, 7430248, 7430318, 7430321, 7430343, 7430347, 7430352, 7430353, 7430414, 7430487, 7430554, 7430558, 7430660, 7430748, 7430796, 7430813, 7430828, 7430834, 7430840, 7430878, 7430911, 7430935, 7430955, 7430965, 7430998, 7431009, 7431014, 7431031, 7431033, 7431049, 7431050, 7431052, 7431054, 7431058, 7431059, 7431062, 7431065, 7431069, 7431093, 7431117, 7431191, 7431197, 7431209, 7431265, 7431318, 7431478, 7431501, 7431517, 7431569, 7431584, 7431645, 7431677, 7431696, 7431718, 7431727, 7431751, 7431754, 7431760, 7431762, 7431770, 7431773, 7431794, 7431817, 7431895, 7431907, 7431910, 7431935, 7431936, 7431944, 7432012, 7432032, 7432088, 7432089, 7432142, 7432168, 7432172, 7432182, 7432187, 7432274, 7432317, 7432324, 7432413, 7432499, 7432508, 7432526, 7432539, 7432563, 7432662, 7432690, 7432691, 7432692, 7432696, 7432699, 7432719, 7432725, 7432762, 7432773, 7432778, 7432927, 7432937, 7432966, 7432983, 7432993, 7433003, 7433013, 7433075, 7433112, 7433114, 7433127, 7433368, 7433458, 7433495, 7433507, 7433508, 7433596, 7433616, 7433617, 7433647, 7433760, 7434079, 7434098, 7434099, 7434155, 7434346, 7434377, 7434545, 7434550, 7434683, 7434688, 7434761, 7434932, 7434946, 7435012, 7435021, 7435070, 7435096, 7435320, 7435423, 7435439, 7435512, 7435618, 7435637, 7435661, 7435997, 7436081, 7436197, 7436260, 7436261, 7436367, 7436401, 7436413, 7436472, 7436499, 7436543, 7436706, 7436861, 7436994, 7437188, 7600012, 7600055, 7600059, 7600121, 7600125, 7600127, 7600130, 7600147, 7126350, 7126375, 7126900, 7127274, 7127299, 7128407, 7227227, 7227672, 7228301, 7228374, 7228606, 7230906, 7234715, 7236689, 7427094, 7427928, 7427929, 7428445, 7428456, 7428459, 7428461, 7428463, 7428469, 7428481, 7428489, 7428676, 7428747, 7428758, 7428902, 7428940, 7429048, 7430211, 7430219, 7432253, 7432828, 7433837, 7436480, 7129886, 7430684, 7233549, 7235338, 7433149.
ClassificationClass II
Reason for RecallBlood products, collected from a donor who emigrated from an area considered at risk for human immunodeficiency virus (HIV) Group O, were distributed.
Product Quantity909 units
Recall NumberB-1268-13
Product DescriptionFresh Frozen Plasma
Code Info7433003, 7427598, 7126000, 7129884, 7129900, 7129911, 7227001, 7229972, 7230034, 7230618, 7231303, 7231892, 7232394, 7232746, 7427094, 7429022, 7429417, 7431031, 7431970, 7435205, 7125625, 7125928, 7126034, 7126056, 7126364, 7126375, 7126398, 7127086, 7127170, 7127274, 7127310, 7127370, 7127600, 7127773, 7127854, 7129022, 7129026, 7129034, 7129449, 7129588, 7129843, 7129886, 7130195, 7130253, 7131235, 7227171, 7227201, 7227507, 7228351, 7228392, 7228859, 7229272, 7229323, 7229349, 7229364, 7229488, 7229723, 7229799, 7230109, 7230650, 7231162, 7231300, 7231344, 7231415, 7232619, 7232986, 7233571, 7233686, 7233707, 7235321, 7235381, 7235414, 7427055, 7427113, 7427170, 7427293, 7427482, 7427600, 7427601, 7427612, 7427929, 7428062, 7428065, 7428075, 7428103, 7428229, 7428231, 7428232, 7428388, 7428410, 7428459, 7428846, 7428851, 7428902, 7428918, 7428956, 7428963, 7428969, 7428991, 7429206, 7429208, 7429288, 7429423, 7429657, 7429875, 7429900, 7429911, 7430051, 7430123, 7430955, 7430963, 7431033, 7431078, 7431478, 7431569, 7431785, 7432089, 7432142, 7432144, 7432242, 7432253, 7432344, 7432662, 7432692, 7432699, 7432719, 7432773, 7432778, 7432828, 7433050, 7433075, 7433112, 7433114, 7433118, 7433127, 7433144, 7433176, 7433495, 7433507, 7433508, 7433516, 7433596, 7433617, 7433647, 7433677, 7433945, 7434078, 7434098, 7434099, 7434137, 7434139, 7434155, 7434469, 7434761, 7435005, 7435210, 7435661, 7435997, 7436543, 7600127, 7600130, 7233549, 7235338, 7126505, 7130473, 7131976, 7229363, 7230671, 7428552.
ClassificationClass II
Reason for RecallBlood products, collected from a donor who emigrated from an area considered at risk for human immunodeficiency virus (HIV) Group O, were distributed.
Product Quantity169 units
Recall NumberB-1269-13
Product DescriptionRed Blood Cells
Code Info7125234, 7125397, 7125784, 7227088, 7227333, 7427134, 7427141, 7427411, 7427566, 7427775, 7427808, 7427841, 7428040, 7428099, 7428112, 7125231, 7125263, 7125557, 7125692, 7125759, 7125928, 7126034, 7226962, 7227039, 7227305, 7227399, 7227534, 7427067, 7427113, 7427591, 7427598, 7427617, 7427624, 7427738, 7427755, 7427867, 7427889, 7427904, 7427945, 7428030, 7428056, 7428064, 7428139, 7428160, 7125556, 7227359, 7228335, 7427216, 7427554, 7427563, 7427784, 7427866, 7427888, 7427890, 7427891, 7427897, 7427907, 7428017, 7428058, 7125243, 7125274, 7125290, 7125447, 7125517, 7125632, 7125834, 7226952, 7226982, 7227001, 7227012, 7227024, 7227087, 7227156, 7227166, 7227171, 7227252, 7227413, 7227527, 7227631, 7227831, 7227832, 7227917, 7228007, 7427055, 7427073, 7427083, 7427099, 7427102, 7427142, 7427143, 7427151, 7427155, 7427173, 7427200, 7427215, 7427220, 7427231, 7427252, 7427253, 7427278, 7427283, 7427293, 7427306, 7427412, 7427419, 7427420, 7427425, 7427482, 7427502, 7427546, 7427548, 7427551, 7427569, 7427576, 7427589, 7427590, 7427592, 7427593, 7427600, 7427612, 7427721, 7427722, 7427740, 7427741, 7427760, 7427778, 7427780, 7427792, 7427794, 7427847, 7427871, 7427887, 7427898, 7427905, 7427947, 7427951, 7427959, 7427994, 7428001, 7428065, 7428075, 7428087, 7428102, 7428150, 7600026, 7427280, 7227235.
ClassificationClass II
Reason for RecallBlood products, collected from a donor who emigrated from an area considered at risk for human immunodeficiency virus (HIV) Group O, were distributed.
Product Quantity147 units
Recall NumberB-1270-13
Product DescriptionPlatelets Pheresis
Code Info7230082, 7230082.
ClassificationClass II
Reason for RecallBlood products, collected from a donor who emigrated from an area considered at risk for human immunodeficiency virus (HIV) Group O, were distributed.
Product Quantity2 units
Recall NumberB-1271-13

Class II Biologics Event

Event ID44633
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Feb-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityCleveland
StateOH
CountryUS
Distribution PatternOhio
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info42FG97856; 42FX18928; 42FS77056; 42FW04560; 42FS77179; 42T14091; 42FW07587; 42FE77508; 42X69153; 42FT30987; 42FT32094; 42FT33242; 42Q80247; 42FX23314; 42FW14032; 42Y40592; 42K62728; 42FW15079; 42FP95695; 42T21726; 42FY46506; 42GC04041; 42FP95993; 42FW16055; 42FW16474; 42FJ17909; 42FY47360; 42E44031; 42GC04913; 42K65715; 42GC05249; 42K67824; 42GE10615; 42J50877; 42GE13124; 42K72330; 42FE88710; 42FX31697; 42FY54263; 42L17022; 42FE89129; 42FR09116; 42L17139; 42FY54595; 42FP01778; 42FC14745; 42FR09262; 42S01248; 42FP01855; 42FS86720; 42FT48521; 42T29128; 42GC09331; 42T29166; 42FE89487; 42FY54962; 42FJ25411; 42R75970; 42FJ25415; 42FJ25426; 42FP02096; 42FR09541; 42S01299; 42FP02164; 42FS87036; 42FE89738; 42X93965; 42R76080; 42K73873; 42FY55530; 42FW24320; 42FT49145; 42FH30943; 42G51800; 42H42656; 42L18182; 42X95754; 42L18885; 42FW25808; 42J54932; 42T31952; 42GS00091; 42FY58222; 42X97267; 42FX37195; 42T33419; 42FT51218; 42FR13746; 42J56320; 42X99784; 42J56672; 42GS02007; 42FX38429; 42K77697; 42FJ29389; 42GS02147; 42FT52111; 42GS02320; 42T34299; 42R79190; 42GC12641; 42FH35085; 42GS02509; 42J57025; 42T34535; 42FR14728; 42FX39460; 42FH35912; 42FR16537; 42K79507; 42FP07542; 42GS05379; 42FP08044; 42FG15013; 42FH38035; 42H45608; 42S09475; 42FR19529; 42T38927; 42J60615; 42R82601; 42FH38847; 42FX44325; 42FR20428; 42G57322; 42GE20896; 42FC20185; 42J62490; 42G57855; 42FY65616; 42GT06076; 42X11341; 42S13088; 42FR23408; 42X12294; 42G58827; 42J65036; 42J65656; 42GC19207; 42GC19403; 42J66118; 42FY68678; 42R87050; 42S16700; 42GE23950; 42S15779; 42FQ30098; 42S15858; 42W46282; 42J67374; 42FR27493; 42GE24867; 42J67510; 42FX51450; 42GT09019; 42FW28723; 42FW28741; 42FG21636; 42FX51795; 42GS14057; 42FP17550; 42FK72737; 42S17380; 42K86097; 42L33714; 42GS14524; 42FY70348; 42W46697; 42W46920; 42FR28885; 42FF00777; 42FY70871; 42FS94875; 42K88149; 42FT66986; 42GC22493; 42FK73459; 42GS16278; 42FH46147; 42FS95385; 42FJ41705; 42GT11407; 42T47055; 42FG24377; 42FP21685; 42GE28365; 42GS18470; 42K90300; 42R91583; 42G63752; 42FH48245; 42FY73968; 42GC24357; 42FP22670; 42FK74477; 42FW34872; 42FW34918; 42FH48985; 42FW34999
ClassificationClass II
Reason for RecallBlood products, which were not screened for antibodies according to the reagent manufacturer's instructions, were distributed.
Product Quantity199 components
Recall NumberB-1296-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info42KP12009; 42KW21131; 42KW23881; 42KW32826; 042KW33193
ClassificationClass II
Reason for RecallBlood products, which were not screened for antibodies according to the reagent manufacturer's instructions, were distributed.
Product Quantity4 components
Recall NumberB-1297-13
Product DescriptionRed Blood Cells
Code Info42FZ04668; 42FQ07085; 42G40637; 42Q78142; 42K57455; 42X70520; 42GC01832; 42FY42018; 42S96094; 42G43536; 42FE80206; 42GC03025; 42FP94339; 42FC12027; 42H38306; 42G45141; 42R70525; 42K63770; 42GF00087; 42GC04186; 42X79525; 42FX25436; 42F57319; 42FE85263; 42H42171; 42GC07199; 42K69861; 42GQ00947; 42GE12459;42R75067; 42FR08846; 42K72538; 42FF87015; 42GW00822; 42H41922; 42H42001; 42FT47934; 42G50965; 42FX32315; 42FY54715; 42FH29950; 42FH29952; 42FE89385; 42FG08750; 42FZ04668; 42FX32821; 42W37413; 42FE89690; 42FK67898; 42FF87745; 42FQ18227; 42FE89800; 42R76089; 42FX33179; 42FF87875; 42FR10445; 42FC15239; 42FZ05440; 42L18360; 42H42959; 42GW01149; 42FW25652; 42GW01166; 42G52689; 42R77333; 42W39053; 42FP04088; 42FE92188; 42GQ02161; 42F59943; 42FP04467; 42FF89640; 42FQ20201; 42FX37359; 42FY58678; 42FG12022; 42J56537; 42S04645; 42FX38323; 42FG12246; 42X00136; 42F60609; 42W40533; 42FP05906; 42FC16758; 42GE17473; 42W40923; 42R80473; 42FR17226; 42L24243; 42FG14862; 42H45314; 42S08856; 42FC18434; 42R81577; 42GS06844; 42FK70290; 42GK01123; 42L25375; 42FP09719; 42L26574; 42J61392; 42GW02619; 42GT05538; 42GS08851; 42FX45740; 42T41101; 42FX47488; 42FK71589; 42FG19047; 42GW03072; 42GS11320; 42FC21422; 42GW03167; 42FK72004; 42T43436; 42FQ29372; 42M21467; 42L31825; 42R87247; 42FR26882; 42GQ01660; 42GW03782; 42GW03913; 42FF02862; 42GK01702
ClassificationClass II
Reason for RecallBlood products, which were not screened for antibodies according to the reagent manufacturer's instructions, were distributed.
Product Quantity126 components
Recall NumberB-1298-13
Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info42C18441; 42E48391; 42E48501; 42GX00897; 42N21930; 42Y48405; 42FN17577
ClassificationClass II
Reason for RecallBlood products, which were not screened for antibodies according to the reagent manufacturer's instructions, were distributed.
Product Quantity7 components
Recall NumberB-1299-13
Product DescriptionRed Blood Cells Leukocytes Removed Washed
Code Info42FG09596
ClassificationClass II
Reason for RecallBlood products, which were not screened for antibodies according to the reagent manufacturer's instructions, were distributed.
Product Quantity1 component
Recall NumberB-1300-13
Product DescriptionRed Blood Cells Deglycerolized
Code Info42GQ00737
ClassificationClass II
Reason for RecallBlood products, which were not screened for antibodies according to the reagent manufacturer's instructions, were distributed.
Product Quantity1 component
Recall NumberB-1301-13

Class II Biologics Event

Event ID44651
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Feb-07
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNorthwest Florida Blood Center, Inc.
CityPensacola
StateFL
CountryUS
Distribution PatternFlorida, Alabama.
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info4737455A; 4737455B; 4737432A; 4737432B; 4737442A; 4737442B; 4737442C.
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity7 units
Recall NumberB-1319-13

Class II Biologics Event

Event ID44985
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jul-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmFlorida Georgia Blood Alliance, Inc.
CityJacksonville
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells
Code Info4825254
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose close contact with partner who emigrated from an area at risk for HIV-Group O, were distributed.
Product Quantity1 unit
Recall NumberB-1255-13
Product DescriptionPlatelets
Code Info4825254
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose close contact with partner who emigrated from an area at risk for HIV-Group O, were distributed.
Product Quantity1 unit
Recall NumberB-1256-13
Product DescriptionFresh Frozen Plasma
Code Info4825254
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose close contact with partner who emigrated from an area at risk for HIV-Group O, were distributed.
Product Quantity1 unit
Recall NumberB-1257-13

Class II Biologics Event

Event ID48059
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Feb-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternNY
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info01GE68894; 01GE67226; 01GE68077; 01GE63062
ClassificationClass II
Reason for RecallBlood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
Product Quantity4
Recall NumberB-1326-13

Class II Devices Event

Event ID49033
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFisher & Paykel Healthcare, Ltd.
CityNorth Shore City
State
CountryNZ
Distribution PatternWorldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.
 

Associated Products

Product DescriptionFisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. ICON Novo: ICONNAN, ICONNAN-HT, ICONNAJ. ICON Premo: ICONPBN, ICONPBN-HT, ICONPBN-HTC. The ICON CPAP unit is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory. The device is not intended to be used as a life supporting device.
Code InfoLot 121210: December 10th, 2012. Lot 121221: December 21st, 2012.
ClassificationClass II
Reason for RecallFisher and Paykel Healthcare is recalling the ICON CPAP units because there is a potential power issue on certain ICON CPAP. These ICON CPAP units could potentially become inoperable, which would result in a lack of treatment to the patient's obstructive sleep apnea symptoms until a replacement unit is obtained.
Product Quantity1,407 units
Recall NumberZ-1437-2013

Class II Biologics Event

Event ID49838
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Aug-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info01KL11353
ClassificationClass II
Reason for RecallBlood product, which may have been contaminated during collection, was distributed.
Product Quantity1
Recall NumberB-1325-13

Class II Biologics Event

Event ID49941
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Aug-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info01KM46955
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 component
Recall NumberB-1322-13
Product DescriptionPlatelets Leukocytes Reduced
Code Info01KM46955
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 component
Recall NumberB-1323-13
Product DescriptionPlasma Frozen
Code Info01KM46955
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 component
Recall NumberB-1324-13

Class II Biologics Event

Event ID52246
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Feb-09
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican Red Cross Blood Services
CityOmaha
StateNE
CountryUS
Distribution PatternNE; CO; PA; NJ; AL; OK
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info009FC30192; 009GP38408; 009FC30192; 009GP38408; 009FC30202; 009GP38509; 009FC30205; 009GP38509; 009FC30205; 009GP38510; 009FC30548; 009GP38513; 009FC30548; 009GP38513; 009FC30559; 009GP38514; 009FC30559; 009GP38514; 009FC30562; 009GP38529; 009FC30562; 009GP38536; 009FC30567;009GP38536; 009FC30567; 009GP38537; 009FC30585; 009GP38537; 009FC30585; 009GP38713; 009FC30608; 009GP38713; 009FC30608; 009GP38722; 009FC30611; 009GP38722; 009FC30613; 009GP38765; 009FC30614; 009GP38765; 009FC30617; 009GP38778; 009FC30617; 009GP38778; 009FC30686; 009GP38790; 009FC30686; 009GP38790; 009FC30702; 009GP38791; 009FC30702; 009GP38791; 009FC30704; 009GP38845; 009FC30704; 009GP38848; 009FC30707; 009GP38848; 009FC30707; 009GP38858; 009GP38367; 009GP38858; 009GP38367; 009KE16379; 009GP38376; 009GP38376; 009GP38384; 009GP38384; 009GP38394; 009GP38394
ClassificationClass II
Reason for RecallBlood products, labeled 'leukocytes reduced' which did not meet the QC requirements for leukoreduced products, were distributed.
Product Quantity70 Units
Recall NumberB-1320-13

Class II Biologics Event

Event ID52257
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Mar-09
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNorth Carolina.
 

Associated Products

Product DescriptionSource Plasma
Code Info367034032, 367034336,
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
Product Quantity2
Recall NumberB-1107-13

Class II Biologics Event

Event ID57156
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Aug-10
Initial Firm Notification of Consignee or Public FAX
Recalling FirmPlasma Biological Services Inc
CitySaint Joseph
StateMO
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code InfoPQ071610; PQ071249; PQ070893; PQ070094; PQ069852; PQ069370; PQ069143; PQ068762; PQ068560; PQ068072; PQ067943; PQ066719; PQ066061; PQ065980; PQ065418; PQ065379; PQ064784; PQ064274; PQ063587; PQ061774; PQ060955; PQ060615; PQ060331; PQ059896; PQ059735; PQ057946; PQ057755; PQ057245; PQ057087; PQ056562; PQ056469
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred for possibly exposure to vCJD, were distributed.
Product Quantity31 Units
Recall NumberB-1260-13

Class II Biologics Event

Event ID57227
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Sep-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternMissouri; Texas; Kentucky
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code Info011LS57296;011LS57296;011LS57303;011LS57311; 011LS57324;011LS57324;011LS57311;011LS57296; 011LS57354;011LS57354
ClassificationClass II
Reason for RecallBlood products, collected using equipment that had not been validated, were distributed.
Product Quantity10 Units
Recall NumberB-1293-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info011LS57298; 011LS57298; 011LS57298; 011LS57301; 011LS57301; 011LS57301; 011LS57303; 011LS57308; 011LS57311; 011LS57315; 011LS57315; 011LS57319; 011LS57324; 011LS57330; 011LS57349; 011LS57358; 011LS57358; 011LS57330; 011LS57324; 011LS57319; 011LS57354; 011LS57308; 011LS57349; 011LS57338; 011LS57363; 011LS57361; 011LS57330
ClassificationClass II
Reason for RecallBlood products, collected using equipment that had not been validated, were distributed.
Product Quantity27 Units
Recall NumberB-1294-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info011LS57368; 011LS57364; 011LS57327; 011LS57338
ClassificationClass II
Reason for RecallBlood products, collected using equipment that had not been validated, were distributed.
Product Quantity4 Units
Recall NumberB-1295-13

Class II Biologics Event

Event ID57229
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Oct-10
Initial Firm Notification of Consignee or Public FAX
Recalling FirmPlasma Biological Services Inc
CityColumbia
StateMO
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code InfoMQ086809; MQ086137; MQ085668; MQ084840; MQ084732; MQ083488; MQ082531; MQ081187; MQ080888; MQ079861; MQ079318; MQ077682; MQ076813; MQ075820; MQ075570; MQ074794; MQ074060; MQ073403; MQ073078; MQ072489; MQ072067; MQ071694; MQ071390; MQ071115; MQ070687; MQ070398; MQ070025; MQ069544; MQ069344
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred after receiving a tattoo within a year of donating, were distributed.
Product Quantity29 Units
Recall NumberB-1258-13

Class II Devices Event

Event ID63204
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOrthovita, Inc., dBA Stryker Orthobiologics.
CityMalvern
StatePA
CountryUS
Distribution PatternUSA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
 

Associated Products

Product DescriptionStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Code InfoManufacturer Part Number 2090-0502, Lot Number Q1006003
ClassificationClass II
Reason for RecallThere have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
Product Quantity78
Recall NumberZ-1387-2013
Product DescriptionStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 6", Part Number 2090-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Code InfoManufacturer Part Number 2090-0505, Lot Number A1006027
ClassificationClass II
Reason for RecallThere have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
Product Quantity164
Recall NumberZ-1388-2013
Product DescriptionStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Code InfoManufacturer Part Number 2090-0501, Lot Numbers A1109035 and Q1006002
ClassificationClass II
Reason for RecallThere have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
Product Quantity411
Recall NumberZ-1389-2013
Product DescriptionStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6", Part Number 2090-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Code InfoManufacturer Part Number 2090-0504, Lot Numbers A1006026 and A1111020
ClassificationClass II
Reason for RecallThere have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
Product Quantity155
Recall NumberZ-1390-2013
Product DescriptionStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4", Part Number 2110-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Code InfoManufacturer Part Number 2110-0505, Lot Numbers E909002 and E909002R
ClassificationClass II
Reason for RecallThere have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
Product Quantity35
Recall NumberZ-1391-2013
Product DescriptionStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Code InfoManufacturer Part Number 2110-0526, Lot Numbers E908004R and E908004
ClassificationClass II
Reason for RecallThere have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
Product Quantity27
Recall NumberZ-1392-2013
Product DescriptionStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6", Part Number 2110-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Code InfoManufacturer Part Number 2110-0501, Lot Numbers E909004R and E909004
ClassificationClass II
Reason for RecallThere have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
Product Quantity414
Recall NumberZ-1393-2013
Product DescriptionStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamond Needle, 4", Part Number 2110-0506 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Code InfoManufacturer Part Number 2110-0506, Lot Number E909005R
ClassificationClass II
Reason for RecallThere have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
Product Quantity19
Recall NumberZ-1394-2013
Product DescriptionStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Code InfoManufacturer Part Number 2110-0525, Lot Numbers E909006R
ClassificationClass II
Reason for RecallThere have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
Product Quantity5
Recall NumberZ-1395-2013
Product DescriptionStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number 2110-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Code InfoManufacturer Part Number 2110-0504, Lot Number E909007R
ClassificationClass II
Reason for RecallThere have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
Product Quantity7
Recall NumberZ-1396-2013
Product DescriptionStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 8", Part Number 2110-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Code InfoManufacturer Part Number 2110-0502, Lot Number E909008R
ClassificationClass II
Reason for RecallThere have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
Product Quantity17
Recall NumberZ-1397-2013
Product DescriptionStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 6", Part Number 2110-0524 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Code InfoManufacturer Part Number 2110-0524, Lot Number E909009R and E909009R
ClassificationClass II
Reason for RecallThere have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
Product Quantity12
Recall NumberZ-1398-2013
Product DescriptionStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6", Part Number 2110-0503 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Code InfoManufacturer Part Number 2110-0503, Lot Numbers E908003R and E908002
ClassificationClass II
Reason for RecallThere have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
Product Quantity69
Recall NumberZ-1399-2013

Class II Devices Event

Event ID63367
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBeckman Coulter Inc.
CityBrea
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide and the countries of Canada, Australia, Belgium, Czech Republic, France, French Polynesia, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Jordon, Kuwait, Lebanon, Malawi, Morocco, Namibia, Netherlands, oman, Panama, Paraguay, Qatar, Reunion, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom
 

Associated Products

Product DescriptionSynchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF).
Code InfoLot Number: M206209
ClassificationClass II
Reason for RecallBeckman Coulter initiated the recall for the Lactate Assay (LACT) Lot M206209 as they received a customer complaint of error message (RXN RATE HI), i.e. no numerical values reported for samples containing Lactate concentration greater than 6.5 mmol/L.
Product Quantity8,774 units
Recall NumberZ-1400-2013

Class II Devices Event

Event ID64586
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSpinal Solutions, LLC
CityMurrieta
StateCA
CountryUS
Distribution PatternUSA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.
 

Associated Products

Product Description45 mm Screw, Item #BG7045 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Code InfoItem #BG7045
ClassificationClass II
Reason for RecallThe recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Product Quantity24 units
Recall NumberZ-1409-2013
Product Description50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Code InfoItem #BG7050
ClassificationClass II
Reason for RecallThe recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Product Quantity52 units
Recall NumberZ-1410-2013
Product DescriptionSet Screw, Item #BG3010 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Code InfoItem #BG3010
ClassificationClass II
Reason for RecallThe recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Product Quantity106 units
Recall NumberZ-1411-2013
Product Description40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Code InfoItem #BG1640
ClassificationClass II
Reason for RecallThe recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Product Quantity63 units
Recall NumberZ-1412-2013
Product Description50 mm Rod, Item #BG1650 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Code InfoItem #BG1650
ClassificationClass II
Reason for RecallThe recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Product Quantity55 units
Recall NumberZ-1413-2013
Product Description60 mm Rod, Item #BG1660 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Code InfoItem #BG1660
ClassificationClass II
Reason for RecallThe recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Product Quantity72 units
Recall NumberZ-1414-2013
Product Description12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11mm 12mm x 27mm x 12mm 12mm x 27mm x 13mm 12mm x 27mm x 14mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Code InfoItem # 10227-008 10227-009 10227-010 10227-011 10227-012 10227-013 10227-014
ClassificationClass II
Reason for RecallThe recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Product Quantity56 units
Recall NumberZ-1415-2013
Product Description14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9mm 7 deg 14 x 11 x 10mm 7 deg 14 x 11 x 11mm 7 deg 14 x 11 x 12mm 7 deg Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Code InfoItem # 21411-706 21411-707 21411-708 21411-709 21411-710 21411-711 21411-712
ClassificationClass II
Reason for RecallThe recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Product Quantity35 units
Recall NumberZ-1416-2013
Product DescriptionCopperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copperhead IBFD, Large Neutral, 8mm Copperhead IBFD, Large Neutral, 9mm Copperhead IBFD, Large Neutral, 10mm Copperhead IBFD, Large Neutral, 11mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Code InfoItem # C5006 C5007 C5008 C5009 C5010 C5011
ClassificationClass II
Reason for RecallThe recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Product Quantity24 units
Recall NumberZ-1417-2013
Product DescriptionFang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Code InfoItem # FP1220 FP1221
ClassificationClass II
Reason for RecallThe recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Product Quantity16 units
Recall NumberZ-1418-2013

Class II Devices Event

Event ID64588
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOrthopedic Alliance LLC
CityMurrieta
StateCA
CountryUS
Distribution PatternNationwide Distribution including the states of CA, MD, TX, NV, and WI.
 

Associated Products

Product DescriptionFemoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, cemented, #2, left 2103-1320 Femoral component, CR, cemented, #3, left 2103-1330 Femoral component, CR, cemented, #4, left 2103-1340 Femoral component, CR, cemented, #5, left 2103-1350 Femoral component, CR, cemented, #6, left 2103-1360 Femoral component, CR, cemented, #1, right 2103-1410 Femoral component, CR, cemented, #2, right 2103-1420 Femoral component, CR, cemented, #3, right 2103-1430 Femoral component, CR, cemented, #4, right 2103-1440 Femoral component, CR, cemented, #5, right 2103-1450 Femoral component, CR, cemented, #6, right 2103-1460 Femoral component, PS, #1, left 2103-3110 Femoral component, PS, #2, left 2103-3120 Femoral component, PS, #3, left 2103-3130 Femoral component, PS, #4, left 2103-3140 Femoral component, PS, #5, left 2103-3150 Femoral component, PS, #6, left 2103-3160 Femoral component,PS, #1, right 2103-3210 Femoral component,PS, #2, right 2103-3220 Femoral component,PS, #3, right 2103-3230 Femoral component,PS, #4, right 2103-3240 Femoral component,PS, #5, right 2103-3250 Femoral component,PS, #6, right 2103-3260 Variety of hip and knee implants and instruments, multiple uses.
Code InfoCatalog No. 2103-1310 2103-1320 2103-1330 2103-1340 2103-1350 2103-1360 2103-1410 2103-1420 2103-1430 2103-1440 2103-1450 2103-1460 2103-3110 2103-3120 2103-3130 2103-3140 2103-3150 2103-3160 2103-3210 2103-3220 2103-3230 2103-3240 2103-3250 2103-3260
ClassificationClass II
Reason for RecallThe recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Product Quantity136 units
Recall NumberZ-1378-2013
Product DescriptionTibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cemented,#3 2203-3030 Tibial baseplate,cemented,#4 2203-3040 Tibial baseplate, cemented, #5 2203-3050 Tibial baseplate, cemented, #6 2203-3060 Tibial insert,CR,plained,#1,9mm 2303-1211 Tibial insert,CR,plained,#1,11mm 2303-1212 Tibial insert,CR,plained,#1,13mm 2303-1213 Tibial insert,CR,plained,#1,15mm 2303-1214 Tibial insert,CR,plained,#1,18mm 2303-1215 Tibial insert,CR,plained,#2,9mm 2303-1221 Tibial insert,CR,plained,#2,11mm 2303-1222 Tibial insert,CR,plained,#2,13mm 2303-1223 Tibial insert,CR,plained,#2,15mm 2303-1224 Tibial insert,CR,plained,#2,18mm 2303-1225 Tibial insert,CR,plained,#3,9mm 2303-1231 Tibial insert,CR,plained,#3,11mm 2303-1232 Tibial insert,CR,plained,#3,13mm 2303-1233 Tibial insert,CR,plained,#3,15mm 2303-1234 Tibial insert,CR,plained,#3,18mm 2303-1235 Tibial insert,CR,plained,#4,9mm 2303-1241 Tibial insert,CR,plained,#4,11mm 2303-1242 Tibial insert,CR,plained,#4,13mm 2303-1243 Tibial insert,CR,plained,#4,15mm 2303-1244 Tibial insert,CR,plained,#4,18mm 2303-1245 Tibial insert,CR,plained,#5,9mm 2303-1251 Tibial insert,CR,plained,#5,11mm 2303-1252 Tibial insert,CR,plained,#5,13mm 2303-1253 Tibial insert,CR,plained,#5,15mm 2303-1254 Tibial insert,CR,plained,#5,18mm 2303-1255 Tibial insert,CR,plained,#6,9mm 2303-1261 Tibial insert,CR,plained,#6,11mm 2303-1262 Tibial insert,CR,plained,#6,13mm 2303-1263 Tibial insert,CR,plained,#6,15mm 2303-1264 Tibial insert,CR,plained,#6,18mm 2303-1265 Tibial insert, PS , #1, 9mm 2303-3011 Tibial insert, PS , #1, 11mm 2303-3012 Tibial insert, PS , #1, 13mm 2303-3013 Tibial insert, PS , #1, 15mm 2303-3014 Tibial insert, PS , #1, 18mm 2303-3015 Tibial insert, PS , #2, 9mm 2303-3021 Tibial insert, PS , #2, 11mm 2303-3022 Tibial insert, PS , #2, 13mm 2303-3023 Tibial insert, PS , #2, 15mm 2303-3024 Tibial insert, PS , #2, 18mm 2303-3025 Tibial insert, PS , #3, 9mm 2303-3031 Tibial insert, PS , #3, 11mm 2303-3032 Tibial insert, PS , #3, 13mm 2303-3033 Tibial insert, PS , #3, 15mm 2303-3034 Tibial insert, PS , #3, 18mm 2303-3035 Tibial insert, PS , #4, 9mm 2303-3041 Tibial insert, PS , #4, 11mm 2303-3042 Tibial insert, PS , #4, 13mm 2303-3043 Tibial insert, PS , #4, 15mm 2303-3044 Tibial insert, PS , #4, 18mm 2303-3045 Tibial insert, PS , #5, 9mm 2303-3051 Tibial insert, PS , #5, 11mm 2303-3052 Tibial insert, PS , #5, 13mm 2303-3053 Tibial insert, PS , #5, 15mm 2303-3054 Tibial insert, PS , #5, 18mm 2303-3055 Tibial insert, PS , #6, 9mm 2303-3061 Tibial insert, PS , #6, 11mm 2303-3062 Tibial insert, PS , #6, 13mm 2303-3063 Tibial insert, PS , #6, 15mm 2303-3064 Tibial insert, PS , #6, 18mm 2303-3065 Variety of hip and knee implants and instruments, multiple uses.
Code InfoCatalog No. 2203-3010 2203-3020 2203-3030 2203-3040 2203-3050 2203-3060 2303-1211 2303-1212 2303-1213 2303-1214 2303-1215 2303-1221 2303-1222 2303-1223 2303-1224 2303-1225 2303-1231 2303-1232 2303-1233 2303-1234 2303-1235 2303-1241 2303-1242 2303-1243 2303-1244 2303-1245 2303-1251 2303-1252 2303-1253 2303-1254 2303-1255 2303-1261 2303-1262 2303-1263 2303-1264 2303-1265 2303-3011 2303-3012 2303-3013 2303-3014 2303-3015 2303-3021 2303-3022 2303-3023 2303-3024 2303-3025 2303-3031 2303-3032 2303-3033 2303-3034 2303-3035 2303-3041 2303-3042 2303-3043 2303-3044 2303-3045 2303-3051 2303-3052 2303-3053 2303-3054 2303-3055 2303-3061 2303-3062 2303-3063 2303-3064 2303-3065
ClassificationClass II
Reason for RecallThe recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Product Quantity459 units
Recall NumberZ-1379-2013
Product DescriptionUKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE Patella,X-large 2401-1040 UKNEE Onset Patella, 3 pegs, x-small 2403-1010 UKNEE Onset Patella, 3 pegs, small 2403-1020 UKNEE Onset Patella, 3 pegs, medium 2403-1030 UKNEE Onset Patella, 3 pegs, large 2403-1040 UKNEE Onset Patella, 3 pegs,X-large 2403-1050 Variety of hip and knee implants and instruments, multiple uses.
Code InfoCatalog No. 2401-1010 2401-1020 2401-1030 2401-1040 2403-1010 2403-1020 2403-1030 2403-1040 2403-1050
ClassificationClass II
Reason for RecallThe recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Product Quantity57 units
Recall NumberZ-1380-2013
Product DescriptionU2 Acetabular cup, Ti beads porous coated, È44mm U2 Acetabular cup, Ti beads porous coated, È46mm U2 Acetabular cup, Ti beads porous coated, È48mm U2 Acetabular cup, Ti beads porous coated, È50mm U2 Acetabular cup, Ti beads porous coated, È52mm U2 Acetabular cup, Ti beads porous coated, È54mm U2 Acetabular cup, Ti beads porous coated, È56mm U2 Acetabular cup, Ti beads porous coated, È58mm U2 Acetabular cup, Ti beads porous coated, È60mm U2 Acetabular cup, Ti beads porous coated, È62mm U2 Acetabular cup liner assembly, 10°hooded,44mm U2 Acetabular cup liner assembly, 10°hooded,46mm U2 Acetabular cup liner assembly, 10°hooded,48mm U2 Acetabular cup liner assembly, 10°hooded,50mm U2 Acetabular cup liner assembly, 10°hooded,52mm U2 Acetabular cup liner assembly, 10°hooded,54mm U2 Acetabular cup liner assembly, 10°hooded,56mm U2 Acetabular cup liner assembly, 10°hooded,58mm U2 Acetabular cup liner assembly, 10°hooded,60mm U2 Acetabular cup liner assembly, 10°hooded,62mm Variety of hip and knee implants and instruments, multiple uses.
Code InfoItem No. 1303-5444 1303-5446 1303-5448 1303-5450 1303-5452 1303-5454 1303-5456 1303-5458 1303-5460 1303-5462 1403-1044 1403-1046 1403-1048 1403-1250 1403-1252 1403-1654 1403-1656 1403-1658 1403-1660 1403-1662
ClassificationClass II
Reason for RecallThe recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Product Quantity30 units
Recall NumberZ-1381-2013
Product DescriptionFemoral head, standard, Æ26mm, +0mm Femoral head,medium, Æ26mm,+3mm Femoral head, long, Æ26mm, +6mm Femoral head, X-long, Æ26mm, +9mm Femoral head, Æ28mm, -3mm Femoral head, Æ28mm, +0mm Femoral head, Æ28mm, +5mm Femoral head, Æ28mm, +10mm Femoral head, Æ32mm, -3mm Femoral head, Æ32mm, +0mm Femoral head, Æ32mm, +5mm Femoral head, Æ32mm, +10mm Femoral head, Æ36mm, -3mm Femoral head, Æ36mm, +0mm Femoral head, Æ36mm, +5mm Femoral head, Æ36mm, +10mm Variety of hip and knee implants and instruments, multiple uses.
Code InfoItem No. 1201-1126 1201-1326 1201-1526 1201-1726 1201-1028 1201-1128 1201-1428 1201-1828 1201-1032 1201-1132 1201-1432 1201-1832 1201-1036 1201-1136 1201-1436 1201-1836
ClassificationClass II
Reason for RecallThe recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Product Quantity21 units
Recall NumberZ-1382-2013
Product DescriptionBipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, OD46mm Bipolar Cap, ID28mm, OD48mm Bipolar Cap, ID28mm, OD50mm Bipolar Cap, ID28mm, OD52mm Bipolar Cap, ID28mm, OD54mm Bipolar Cap, ID28mm, OD56mm
Code InfoItem No. 1503-3042 1503-3144 1503-3146 1503-3148 1503-3150 1503-3152 1503-3154 1503-3156
ClassificationClass II
Reason for RecallThe recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Product Quantity37 units
Recall NumberZ-1383-2013
Product DescriptionCo-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone screw,25mm Co-Cr cancellous bone screw,30mm Co-Cr cancellous bone screw,35mm Co-Cr cancellous bone screw,40mm Variety of hip and knee implants and instruments, multiple uses.
Code InfoItem No. 5201-6715 5201-6720 5201-6725 5201-6730 5201-6735 5201-6740
ClassificationClass II
Reason for RecallThe recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Product Quantity5 units
Recall NumberZ-1384-2013
Product DescriptionZweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard Sz 00 Zweimueller Type Stem SCS-Standard Sz 1 Zweimueller Type Stem SCS-Standard Sz 2 Zweimueller Type Stem SCS-Standard Sz 3 Zweimueller Type Stem SCS-Standard Sz 4 Zweimueller Type Stem SCS-Standard Sz 5 Zweimueller Type Stem SCS-Standard Sz 6 Zweimueller Type Stem SCS-Standard Sz 7 Zweimueller Type Stem SCS-Standard Sz 8 Zweimueller Type Stem SCS-Standard Sz 9 Zweimueller Type Stem SCS-Standard Sz 10 Zweimueller Type Stem SCL-Lateralized Sz 3 Zweimueller Type Stem SCL-Lateralized Sz 4 Zweimueller Type Stem SCL-Lateralized Sz 5 Zweimueller Type Stem SCL-Lateralized Sz 6 Zweimueller Type Stem SCL-Lateralized Sz 7 Zweimueller Type Stem SCL-Lateralized Sz 8 Zweimueller Type Stem SCL-Lateralized Sz 9 Zweimueller Type Stem SCR-Revision Sz 3 Zweimueller Type Stem SCR-Revision Sz 4 Zweimueller Type Stem SCR-Revision Sz 5 Zweimueller Type Stem SCR-Revision Sz 6 Zweimueller Type Stem SCR-Revision Sz 7 Zweimueller Type Stem SCR-Revision Sz 8 Zweimueller Type Stem SCR-Revision Sz 9 Zweimueller Type Stem SCR-Revision Sz 10 Zweimueller Type Stem SCR-Revision Sz 11 Variety of hip and knee implants and instruments, multiple uses.
Code InfoPart No. 120.00.15 120.00.00 120.00.01 120.00.02 120.00.03 120.00.04 120.00.05 120.00.06 120.00.07 120.00.08 120.00.09 120.00.10 123.00.03 123.00.04 123.00.05 123.00.06 123.00.07 123.00.08 123.00.09 126.00.03 126.00.04 126.00.05 126.00.06 126.00.07 126.00.08 126.00.09 126.00.10 126.00.11
ClassificationClass II
Reason for RecallThe recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Product Quantity50 units
Recall NumberZ-1385-2013
Product DescriptionBall Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 Short CERAMIC Ball Head, 32 Medium CERAMIC Ball Head, 32 Long CERAMIC Ball Head, 28 Short CoCr Ball Head, 28 Medium CoCr Ball Head, 28 Long CoCr Ball Head, 28 X-Long CoCr Ball Head, 28 XX-Long CoCr Ball Head, 32 Short Ball Head, 32 Medium Ball Head, 32 Long
Code InfoPart No. 194.01.28 194.02.28 194.03.28 195.01.32 195.02.32 195.03.32 188.01.28 188.02.28 188.03.28 188.04.28 188.05.28 189.01.32 189.02.32 189.03.32
ClassificationClass II
Reason for RecallThe recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Product Quantity26 units
Recall NumberZ-1386-2013

Class II Biologics Event

Event ID64628
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Jan-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW036809153837;
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-1434-13

Class II Biologics Event

Event ID64629
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jan-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Bank of Lancaster County Medical Society
CityLincoln
StateNE
CountryUS
Distribution PatternNebraska
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW087909308200;
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to malarial endemic areas, was distributed.
Product Quantity1 unit
Recall NumberB-1435-13

Class II Biologics Event

Event ID64630
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFlorida's Blood Centers, Inc.
CityOrlando
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW038112323158; W038112238855; W038112187650
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to malarial endemic areas, were distributed.
Product Quantity3 units
Recall NumberB-1436-13

Class II Biologics Event

Event ID64639
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBlood Bank Of San Bernardino And Riverside Counties
CitySan Bernardino
StateCA
CountryUS
Distribution PatternCalifornia; Georgia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW125612431026
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of Hepatitis A, were distributed.
Product Quantity1 unit
Recall NumberB-1437-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW125612431026
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of Hepatitis A, were distributed.
Product Quantity1 unit
Recall NumberB-1438-13

Class II Biologics Event

Event ID64658
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Feb-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center of Carolinas
CityCharlotte
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW227013005262;
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity1 unit
Recall NumberB-1439-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW227013005262; W227013005262;
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity2 units
Recall NumberB-1440-13

Class II Devices Event

Event ID64886
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Mar-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmThe Anspach Effort, Inc.
CityPalm Beach Gardens
StateFL
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including DC and the states of OH, TX, IL, CA, GA, KY, FL, WI, NC, VA, WI, MN, MD, KS, OK, PA, OR ,HI, AZ, WA, TN, AR, IA, MI, CO, LA, NJ, IN, WV, MO, AL, NY, VT, and SC and the countries of France, Canada, Great Britain, Mexico, Australia, Sweden and Netherlands.
 

Associated Products

Product Description***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
Code InfoLots numbers: D433040800, D403040236, D383039472.
ClassificationClass II
Reason for RecallDue to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.
Product Quantity1,827 burrs
Recall NumberZ-1377-2013

Class II Drugs Event

Event ID65008
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMylan Pharmaceuticals Inc.
CityMorgantown
StateWV
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionRopinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Made in India
Code InfoLot # ZRMB11004, Exp 09/13
ClassificationClass II
Reason for RecallLabeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..
Product Quantity3,048 bottles
Recall NumberD-500-2013

Class II Drugs Event

Event ID65019
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Apr-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNora Apothecary and Alternative Therapies, Inc.
CityIndianapolis
StateIN
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionBimix Inj 30 :1 Syr, 12x1.5 ml syr, 10x1.2 ml syr, 2x2 ml syr, 2x1 ml syr, 12x.05 ml syr Penile Injection,30 and 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity5
Recall NumberD-453-2013
Product DescriptionBimix Inj 30:0.5 MDV, 5 ml syr Penile Injection, 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity5
Recall NumberD-454-2013
Product DescriptionBimix Inj 30:1 MDV: 5ml, 10 ml, 3x10ml, 2x10ml Penile Injection, 30 and 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity128
Recall NumberD-455-2013
Product DescriptionPapaverine Inj 30mg/ml Syr, 5mlsyr, 10mlsyr,10x0.95mlsyr Penile Injection, 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity8
Recall NumberD-456-2013
Product DescriptionPGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection, 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity
Recall NumberD-457-2013
Product DescriptionPGE-1 Inj 20mcg/ml MDV: 5ml, 7ml, 10ml, 20ml Penile Injection, 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity37
Recall NumberD-458-2013
Product DescriptionPGE-1 Inj 30mcg/ml MDV, 7 ml Penile Injection, 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity
Recall NumberD-459-2013
Product DescriptionPGE-1 Inj 40mcg/ml MDV, 5 ml Penile Injection, 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity2
Recall NumberD-460-2013
Product DescriptionTrimix Inj 30:1:10 MDV, 5 ml Penile Injection, 30 and 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity2
Recall NumberD-461-2013
Product DescriptionTrimix Inj 30:1:20 MDV: 5 ml, 10 ml, 2x5 ml Penile Injection, 30 and 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity72
Recall NumberD-462-2013
Product DescriptionTrimix Inj 30:1:40 MDV, 5 ml Penile Injection, 30 and 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity
Recall NumberD-463-2013
Product DescriptionTrimix Inj 30:3:5 MDV, 10ml Penile Injection, 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity1
Recall NumberD-464-2013
Product DescriptionTrimix Inj 4.25ml Form MDV Penile Injection, 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity
Recall NumberD-465-2013
Product DescriptionSuper Trimix #1 Inj MDV, 12 ml Penile Injection, 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity1
Recall NumberD-466-2013
Product DescriptionVancomycin Opth Soln 25mg/ml PF, 10ml Opthalmic Soln, 10 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity2
Recall NumberD-467-2013
Product DescriptionVancomycin Opth Soln 30mg/ml PRES, 10ml Opthalmic Soln, 30 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity
Recall NumberD-468-2013
Product DescriptionVancomycin Opth Soln14mg/ml PF, 10ml Opthalmic Soln, 30 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity1
Recall NumberD-469-2013
Product DescriptionTobramycin Opth Soln 14mg/ml, 7ml Opthalmic Soln, 10 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity
Recall NumberD-470-2013
Product DescriptionTobramycin Opth Soln 13mg/ml, 7ml Opthalmic Soln, 10 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity
Recall NumberD-471-2013
Product DescriptionChlorhexidine Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity1
Recall NumberD-472-2013
Product DescriptionDexamethasone Opth Soln 0.1% PF, 10 ml Opthalmic Soln, 30 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity7
Recall NumberD-473-2013
Product DescriptionPHMB Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity2
Recall NumberD-474-2013
Product DescriptionFolic Acid Inj 5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity
Recall NumberD-475-2013
Product DescriptionHCG Inj 1000un/ml MDV: 4ml, 8 ml Subcutaneous, 30 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity3
Recall NumberD-476-2013
Product DescriptionHCG Inj 1200un/ml MDV, 10 ml Subcutaneous, 30 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity3
Recall NumberD-477-2013
Product DescriptionHCG Inj 1250 un/ml MDV, 4 ml Subcutaneous, 30 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity
Recall NumberD-478-2013
Product DescriptionHCG Inj 500un/ml MDV, 5 ml Subcutaneous, 30 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity
Recall NumberD-479-2013
Product DescriptionHydroxycobalamin Inj 1000mcg/ml MDV: 10 ml, 15 ml, 20 ml, 30 ml Subcutaneous, 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity7
Recall NumberD-480-2013
Product DescriptionHydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity
Recall NumberD-481-2013
Product DescriptionHydroxycobalamin Inj 2500 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity
Recall NumberD-482-2013
Product DescriptionMethylcobalamin Inj 1mg/ml MDV, 10 ml, 15 ml, 20 ml, 30 ml, 4x30 ml Subcutaneous, 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity14
Recall NumberD-483-2013
Product DescriptionMethylcobalamin Inj 5mg/ml MDV: 5 ml, 10 ml, 12 ml, 20 ml Subcutaneous, 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity11
Recall NumberD-484-2013
Product DescriptionMethylcobalamin 5mg/ml Inj Syr, 10x0.4syr Subcutaneous, 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity2
Recall NumberD-485-2013
Product DescriptionMethylcobalamin Inj 2.5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity3
Recall NumberD-486-2013
Product DescriptionMethylcobalamin Inj 25mg/ml Syr: 8x0.06mlsyr, 10x0.06 ml syr, 12x0.06 ml syr Subcutaneous, 30 and 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity5
Recall NumberD-487-2013
Product DescriptionHydroxyprogesterone Inj 250mg/ml MDV, 5 ml Intramuscular, 30 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity5
Recall NumberD-488-2013
Product DescriptionRenacidin Irrigation: 1000 ml,1120ml Bladder Irrigation, 30 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity2
Recall NumberD-489-2013
Product DescriptionGentamicin 24mg/60ml Irrigation, 15x60ml Syr Irrigation, 14 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity
Recall NumberD-490-2013
Product DescriptionGlutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expiration
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity2
Recall NumberD-491-2013
Product DescriptionM.I.C.+B12 Inj MDV: 3x50ml, 4x50 ml 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity2
Recall NumberD-492-2013
Product DescriptionLidocaine 2% Inj MDV, 20 ml 30 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity
Recall NumberD-493-2013
Product DescriptionMeperidine 100mg/ml MDV, 5ml 90 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity
Recall NumberD-494-2013
Product DescriptionPyridoxine 100mg/ml Inj MDV, 1X30 ml 30 day expiration,
Code InfoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Quantity
Recall NumberD-495-2013

Class II Devices Event

Event ID65031
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Apr-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmIntel-GE Care Innovations LLC
CityRoseville
StateCA
CountryUS
Distribution PatternUS and Great Britain
 

Associated Products

Product DescriptionQuietCare-Networked. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
Code InfoQuietCare-Networked: Facility Server QC101601
ClassificationClass II
Reason for RecallCustomers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.
Product Quantity46
Recall NumberZ-1374-2013
Product DescriptionQuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
Code InfoUS  QuietCare: QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 UK  QuietCare: QCE200403, v.02; QCE200403, v.03
ClassificationClass II
Reason for RecallCustomers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.
Product Quantity1722S; 99 Out of US
Recall NumberZ-1375-2013

Class II Devices Event

Event ID65042
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Mar-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmZimmer, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionNEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia.
Code InfoPart No. 00-5887-052-00; lots 62181290 and 62183430
ClassificationClass II
Reason for RecallZimmer is initiating a lot specific recall of the Trabecular Metal" Tibia Stop Drill due to the potential of the outside diameter being oversized. As a result, there is a potential for the drill to not pass through the applicable drill guide.
Product Quantity69 units
Recall NumberZ-1376-2013

Class II Devices Event

Event ID65048
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAlere San Diego, Inc.
CitySan Diego
StateCA
CountryUS
Distribution PatternUnited States Nationwide Distribution
 

Associated Products

Product DescriptionAlere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine, as an aid in the early detection of pregnancy. It is for healthcare professionals only.
Code InfoLot/Unit Codes: hCG1110133 & hCG1110135 Part Number: 92215 Expiration date, or Expected shelf life: 9/30/13 & 10/31/13
ClassificationClass II
Reason for RecallThe firm initiated recall of Alere" hCG Combo Cassette (20/10 mIU/mL) kit PN 92215, lots hCG1110133 and hCG1110135, because an investigation has indicated a portion of these Alere" hCG Combo Cassette (20/10 mIU/mL) PN 92215 kit lots were incorrectly packaged with the Alere" hCG Cassette (20 mIU/mL) PN 92210 Product Insert. The Alere" hCG Cassette (20 mIU/mL) Product Insert contains information for hCG urine testing but lacks information for performing the hCG serum testing using the Alere" hCG Combo Cassette product.
Product Quantity3975 kits
Recall NumberZ-1401-2013

Class II Devices Event

Event ID65060
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmElekta, Inc.
CityAtlanta
StateGA
CountryUS
Distribution PatternUSA Nationwide including the states of CA, FL, IL, MD, MA, NJ, NY, NC, ND, OH, OR, PA, TN, TX, VA, WA, DC and Puerto Rico
 

Associated Products

Product DescriptionIntegrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.
Code Info325134, 325254, 325082, 325159, 325268, 325237, 325331, 325267, 325236, 325314, 325127, 325261, 325286, 325077, 325269, 325129, 325296, 325273, 325139, 325201, 325137, 325184, 325161, 325076, 325086, 325112, 325081, 325083, 325099, 325110, 325271
ClassificationClass II
Reason for RecallUnexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0.
Product Quantity31
Recall NumberZ-1402-2013

Class II Devices Event

Event ID65067
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPolymer Technology Systems, Inc.
CityIndianapolis
StateIN
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide including Puerto Rico and countries of: UK, CHL, ENG, BEL, ITA, TKY, BEL, LIT, LTV, EGY, SPG, HOK, SWE, MEX, UAE, COR, ISR, MAL, AUS, POR, POL, SLN and STQ.
 

Associated Products

Product DescriptionPTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals with diabetes to measure glucose in whole blood
Code InfoU1117
ClassificationClass II
Reason for RecallInternal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk.
Product Quantity7048 total, 3499 in USA
Recall NumberZ-1403-2013

Class II Devices Event

Event ID65072
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Oct-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmIntuitive Surgical, Inc.
CitySunnyvale
StateCA
CountryUS
Distribution PatternUSA Nationwide distribution
 

Associated Products

Product DescriptionThyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional (open) procedures that utilize a cervical incision because they leave no visible neck scar.
Code InfoNA - marketing and promotional only.
ClassificationClass II
Reason for RecallPromotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).
Product Quantity2,423 consignee
Recall NumberZ-1426-2013

Class II Devices Event

Event ID65073
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Sep-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmIntuitive Surgical, Inc.
CitySunnyvale
StateCA
CountryUS
Distribution PatternWorldwide distribution - USA Nationwide and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom.
 

Associated Products

Product DescriptionTip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the Monopolar Curved Scissors instrument so that FR energy is only available at the scissors blades.
Code InfoModel numbers: 400180-10 and prior versions 400180-01, 400180-02, 400180-03, 400180-04, 400180-05, 400180-05, 400180-06. 400180-07, 400180-08 and 400180-09.
ClassificationClass II
Reason for RecallClarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System.
Product Quantity50,000 boxes of 10 tip covers
Recall NumberZ-1425-2013

Class II Devices Event

Event ID65082
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCanon Inc.
CityTokyo
State
CountryJP
Distribution PatternWorldwide Distribution - USA Nationwide and countries of: Australia, Japan, Korea, Singapore and United Kingdom.
 

Associated Products

Product DescriptionCanon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
Code InfoCatalog Number 6937B002AA. All serial numbers from the first unit onward.
ClassificationClass II
Reason for RecallCanon Inc. had received 17 claims from our foreign sales companies between October to November 2012 that measurement value of RK-F2s refractive power (SPH value) sometimes indicated abnormal value which occurs approximately 5% in probability.
Product Quantity384 units
Recall NumberZ-1404-2013

Class II Devices Event

Event ID65083
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Sep-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmIntuitive Surgical, Inc.
CitySunnyvale
StateCA
CountryUS
Distribution PatternWorldwide Distribution- USA Nationwide and countries of: Argentina, Australia,Canada, Chile, China, Czech Republic, Egypt, India, Israel, Italy,Korea-Republic of, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Thailand, Turkey, and Venezuela.
 

Associated Products

Product DescriptionCannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body.
Code InfoModel number 420002-07
ClassificationClass II
Reason for RecallClarification of existing labeling information and operating procedures.
Product QuantityNA
Recall NumberZ-1427-2013
Product DescriptionFlush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.
Code InfoModel numbers: 340066-07 - straight; 340234-02 - extended taper; 340241-03 - 5mm; 340584-01 - Gemini 8mm straight; 340586-02 - Gemini 5mm; 340725-01 - Vespa straight; 340800-01 - Gemini ext taper; 340971-01 - IS1200 Grasping 340972-01 IS2000 Grasping.
ClassificationClass II
Reason for RecallClarification of existing labeling information and operating procedures.
Product QuantityNA
Recall NumberZ-1428-2013
Product Descriptionda Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.
Code InfoModel number: 314850, versions 1-6
ClassificationClass II
Reason for RecallClarification of existing labeling information and operating procedures.
Product QuantityNA
Recall NumberZ-1429-2013

Class II Devices Event

Event ID65085
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Apr-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmHeart Sync, Inc
CityAnn Arbor
StateMI
CountryUS
Distribution PatternWorldwide Distribution - USA including AL, GA, MI, MN, NC, ND, OH, PA, SD, VA, VT, OH, TX, MA, and Internationally to Korea.
 

Associated Products

Product DescriptionHeart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /ECG Monitoring electrodes Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies.
Code InfoPart number : C100-Physio and Lot numbers: Y100112-02, Y102212-03, Y121312-18, Y012413-02, Y022013-01, Y032113-01
ClassificationClass II
Reason for RecallOn 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installed in August 2012. The result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient.
Product Quantity17180 units for all part numbers
Recall NumberZ-1434-2013
Product DescriptionVermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes. Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies.
Code InfoPart Number: D304 and lot numbers:Y100112-02, Y102212-03, Y121312-18, Y012413-02, Y022013-01, Y032113-01
ClassificationClass II
Reason for RecallOn 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installed in August 2012. The result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient.
Product Quantity17180 units for all part numbers
Recall NumberZ-1435-2013

Class II Devices Event

Event ID65089
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Apr-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmBecton Dickinson & Co.
CitySparks
StateMD
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide and tthe countries of Australia, Canada, Europe, Hong Kong, Mexico, New Zealand, Singapore, and Taiwan.
 

Associated Products

Product DescriptionBBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria.
Code InfoPYR kit - lot 2276481 with expiration date 09/30/13
ClassificationClass II
Reason for RecallIn-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.
Product Quantity610 total test kits (PYR and Oxidase)
Recall NumberZ-1422-2013
Product Description BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic aid for gram-negative bacteria.
Code InfoOxidase kit - lot 2222008 with expiration date 08/31/13
ClassificationClass II
Reason for RecallIn-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.
Product Quantity610 total test kits (PYR and Oxidase)
Recall NumberZ-1423-2013

Class II Devices Event

Event ID65094
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmIntuitive Surgical, Inc.
CitySunnyvale
StateCA
CountryUS
Distribution PatternUS Distribution Only
 

Associated Products

Product DescriptionUser Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral Otolaryngology Surgery.
Code InfoModel number 552002-01
ClassificationClass II
Reason for RecallChange to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
Product Quantity1,374
Recall NumberZ-1424-2013

Class II Devices Event

Event ID65118
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBeckman Coulter Inc.
CityBrea
StateCA
CountryUS
Distribution PatternWorldwide Distribution-USA Nationwide and countries of: AU, CA, DE, ES, GB, IT, PT, and JP.
 

Associated Products

Product DescriptionAU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood.
Code InfoAll Serial Numbers Model Numbers: AU2700, AU27000ISE, AU5421, AU5421ISE, AU5431. Part Numbers: E0750053 N3663400 N3663700 N3664000 N3664200 N3664400 N3664600 N3664800 N3878500 1465600 64270G E61DAU2700 N3663500 N3663600 N3663800 N3663900 N3664100 N3664300 N3664500 N3664700 N3664900 N3878600 O9102700 N3665000 N3665100 N3665200 N3665300 N3665400 N3878300 64542 A94504 N1683100 AU5431-U1 N3665500 N3665600 N3665700 N3665800 N3665900 N3878400
ClassificationClass II
Reason for RecallBeckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it was determined that the tubing/joint connections associated with these MODs may leak concentrated detergent. Beckman Coulter has received complaints that the joint connecting the tubing appears to disintegrate over time, causing a leak.
Product Quantity108 units
Recall NumberZ-1430-2013

Class II Devices Event

Event ID65119
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAngiodynamics, Inc.
CityQueensbury
StateNY
CountryUS
Distribution PatternUSA Nationwide Distribution including the states of: IL, GA, CA, NY OH, AZ, TX, NE, FL, PA, NC, WI, AL, IN, CO, MO, MT, NE, MA, VA, AK, IN, MI, NJ, MD, TN, CT, WA, MN
 

Associated Products

Product DescriptionAngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597005, 2) AngioDynamics 5F Standard Micro-Introducer Kit, Sterile, Catalog number: 06597012; 3) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597013; 4) AngioDynamics 5F Standard Micro- Introducer Kit, Sterile, Catalog Number: 06597018; and 5) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597019. Product kits are individually wrapped in plastic, 10 units included per box. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
Code InfoCorresponding Lot numbers: 1) 588918 (Expiration date 01/2016), 2) 588927 (Expiration date 12/2015), 3) 588915 (Expiration date 01/2016), 4) 588913 (Expiration date 12/2015) and 5) 588930 (Expiration date 01/2016).
ClassificationClass II
Reason for RecallAngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit could be the incorrect French size.
Product QuantityDomestic(1,760 units): 1)260 units/26 boxes, 2)310 units/31 boxes,3)260 units/26 boxes,4)880 units/88 boxes,5)60 units/6 boxes,Foreign:10 units/1 box
Recall NumberZ-1405-2013
Product DescriptionAngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling: 1) Gold-Tipped Fiber 45cm Kit, Catalog Number: 11403301; 2) Gold-Tipped Fiber 65cm Kit, Catalog Number: 11403302; 3) Gold-Tipped Fiber 90cm Kit, Catalog Number: 11403304. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
Code InfoCorresponding Lot numbers: 1) 588948, 2) 588495 and 3)588480. Expiration date for these lot numbers: 12/2013.
ClassificationClass II
Reason for RecallAngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit could be the wrong French size.
Product QuantityDomestic Only: 1) 300 units, 2) 300 units, 3) 151 units.
Recall NumberZ-1406-2013

Class II Devices Event

Event ID65120
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Apr-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTZ Medical Inc.
CityPortland
StateOR
CountryUS
Distribution PatternWorldwide distribution - USA (nationwide) and Chile.
 

Associated Products

Product Descriptionadult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usage: Used by trained professionals in hospitals, doctors offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring.
Code InfoModel P-211-M1 Lot numbers: Y081712-17; Y081712-18; Y081712-19; Y081712-20; Y112612-08; Y112612-09; Y112612-10; Y112612-11; Y112612-12; Y112612-13; and Y020113-07. Model P-214-M1 Lot numbers: Y081712-04; Y112612-24; Y112612-23; and Y031913-10.
ClassificationClass II
Reason for RecallTZ Medical Inc is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible transparent defibrillation electrodes because it may contain a defective white wire on the connector assembly. If a failure were to occur, the end user would be able to identify the failure by inspecting the white wire 1/4 inch from the Gray Medtronic / Physio adapter. The consignees will notice discoloration in the protective plastic jacket.
Product QuantityUS: 10,410 pieces; Outside US: 100 pieces
Recall NumberZ-1438-2013

Class II Food Event

Event ID65134
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-May-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmTalenti Gelato
CityMarietta
StateGA
CountryUS
Distribution PatternIN
 

Associated Products

Product DescriptionTalenti Roman Raspberry Sorbetto, 16fl oz, Crafted by Talenti, Marietta, GA 30062
Code InfoUPC 1 86852 00082 2, Lot #10/19/2014 M2
ClassificationClass II
Reason for RecallUndeclared Allergen, Pecans
Product Quantity420 cases (2260/16 fl oz units)
Recall NumberF-1464-2013

Class II Devices Event

Event ID65136
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Feb-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmRAYSEARCH LABORATORIES AB
CityStockholm
State
CountrySE
Distribution PatternWorldwide Distribution - USA including Connecticut, Florida, Massachusetts, Missouri, New York, Ohio, and foreign distribution to(Canada, Italy, Australia, Germany, Netherlands, and Switzerland.
 

Associated Products

Product DescriptionRayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Code InfoSoftware version and build numbers 2.0.0.15, 2.5.1.89, and 3.0.0.251 (to determine if the version used is affected, bring up the About box in the RayStation application and check the build number reported0.
ClassificationClass II
Reason for RecallUnder some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avoid incorrect dose calculations during treatment planning.
Product QuantityDomestic: 70 units; Foreign: 27 units
Recall NumberZ-1419-2013

Class II Devices Event

Event ID65150
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMerit Medical Systems, Inc.
CitySouth Jordan
StateUT
CountryUS
Distribution PatternUSA Nationwide Distribution.
 

Associated Products

Product DescriptionMerit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
Code InfoLot Numbers: 1662386, 1662390, 1662385, 1662387, 1662391
ClassificationClass II
Reason for RecallMerit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape.
Product Quantity1,465
Recall NumberZ-1408-2013

Class II Devices Event

Event ID65165
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-May-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAlphatec Spine, Inc.
CityCarlsbad
StateCA
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionLeucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.
Code Info83010 85001 85002 83005-30 83005-35 83005-40 83005-45 83005-50 83006-30 83006-35 83006-40 83006-45 83006-50 83006-55 83006-60 83007-30 83007-35 83007-40 83007-45 83007-50 83007-55 83008-30 83008-35 83008-40 83008-45 83008-50 83008-55 83008-80 82001-1 Catalog Numbers: LA-HSS0010 LA-HDOO01 LA-CTOO02 LA-PS0530 LA-PS0535 LA-PS0540 LA-PS0545 LA-PS0550 LA-PS0630 LA-PS0635 LA-PS0640 LA-PS0645 LA-PS0650 LA-PS0655 LA-PS0660 LA-PS0730 LA-PS0735 LA-PS0740 LA-PS0745 LA-PS0750 LA-PS0755 LA-PS0830 LA-PS0835 LA-PS0840 LA-PS0845 LA-PS0850 LA-PS0855 LA-PS0880 LA-SOO01 Lots Affected: All
ClassificationClass II
Reason for RecallAlphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia" Autolok set screw may interfere with the top of the screw head prior to fully locking the rod. If this condition occurs, the polyaxial screw head and rod may fail to provide a rigid construct under loading. To date there have been no reports of patient injury, adverse events or complaints received for this issue.
Product Quantity1,814
Recall NumberZ-1421-2013

Class II Devices Event

Event ID65171
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Apr-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmAlpine Biomed Aps
CitySkovlunde
State
CountryDK
Distribution PatternWorldwide Distribution - US Nationwide and the countries of: Germany, France, Bulgaria, India, Colombia, Tunisia, Saudi Arabia, Finland, Denmark, Brasil, Italy, Estonia, South Korea, Russia, Greece, Thailand, Israel, Poland, Turkey, Slovakia, Portugal, Switzerland, Hungary, Great Britain, Netherlands, China, Indonesia, Australia, Sweden, Spain, Iran, Singapore, Norway, Austria and Czech Republic.
 

Associated Products

Product DescriptionNatus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103, 9031A006502, 9033A071103, 9033A072102, 9031A070102, 9033A007402, 9033A071102, 9033A072103, 9033A0701, 9033A0711HA, 9033A071101, 9031A070101, 9031A006401, 9031A006501, 9033A004701, 9031A0032, 9033A0517, 9033A072101, 9031A0031, 9031A0701BV, 9033A0044, 9033A0073AA, 9031A0063, 9033A0523, 9033A071143, 9033A072143, 9031A006406, 9031A006506, 9031A070106, 9033A004606 9033A004706, 9033A007406, 9033A0537, 9033A0544, 9033A071106, 9033A072106, 9033A0524, 9033A0711BV, 9033A007401, 9033A0516, 9031A006403, 9031A006503, 9033A056403, 9033A0721BV, 9031A006402, 9031A006405, 9031A051306, 9031A070105, 9033A0072, 9033A007301, 9033A0711AA, 9033A0721AA Product Usage: Dantec KEYPOINT.NET Software 2.20 is installed on the Keypoint EMG System which is intended as an electro-physiological aid to assess diagnosis and prognosis and to monitor diseases of the central and peripheral nervous system. It can also be used to study functional aspects of nerves and muscles.
Code InfoSERIAL NUMBERS: 30317 22029 36079 36063 35182 36070 21963 21964 30068 30240 30170 22083 22085 30285 30286 30288 30323 30192 30214 30207 30325 30106 30168 21971 21972 30075 30212 21760 2717 30293 30365 36002 30193 36121 21962 36124 30364 35089 30045 35101 36090 21677 30362 35244 35209 36091 35297 36089 35032 35304 30167 30290 30110 30111 36012 30382 30410 30411 30412 30419 36107 36113 30407 35245 35293 35312 35181 35254 30315 30318 30384 35178 35173 35144 36186 36178 36199 2730 36125 36123 36132 30380 30428 20945 21249 21398 21580 21892 22120 30149 4268 20661 20704 20646 4140 4035 35190 30314 30328 30313 30327 30348 30401 30400 20322 21278 21272 21273 21678 21898 21747 21750 21823 21983 21741 21662 21989 22185 21821 22018 22017 22027 21826 21656 30124 30128 30130 30122 30032 30267 30268 30084 30022 30257 3637 4012 1956 20742 20737 20878 21581 21586 21587 20876 21110 21111 21156 21275 21281 21282 21283 21401 2363 35162 35163 35168 35170 35151 35024 35183 30349 36167 36168 36170 36171 36067 36111 36181 36183 20909 20952 20998 21634 21522 21614 21655 21673 21713 21718 21719 21720 21723 21724 21977 21978 21979 21980 22077 21981 22050 22051 22049 22052 22074 22076 30078 30079 30080 30082 30083 30102 30133 30134 30135 30208 30210 30209 30121 30132 30188 30187 30190 30189 30191 30220 30221 30223 30222 30304 30279 30057 3926 4099 4100 5248 5264 5288 20178 20746 4223 5152 35233 35102 35290 35120 35154 35225 35226 35227 35229 35230 35231 35232 35155 30330 30390 30391 30311 30347 36054 36056 36068 36119 36037 36069 36118 36108 36109 36106 30395 30406 36155 36164 36165 36196 36152 21471 20875 21863 21864 21862 21855 21928 21929 22209 22010 21919 30225 30227 30228 30211 30028 30141 30142 30027 20410 20794 20860 20870 2561 2856 2857 5369 5387 5094 5095 5273 5274 35052 35076 35077 35096 35100 30346 30358 30359 35305 35316 35309 30429 30123 30150 30259 30278 21540 4055 4320 5479 35200 35201 35115 30388 30393 36041 35318 36047 36100 36101 36103 36127 36131 35126 35234 35280 35285 36046 36099 35259 35287 36049 36102 30392 36145 36190 21668 21680 21900 21984 21661 21867 22067 22068 22024 22098 22128 22129 22173 22184 22055 30119 30269 30273 30271 30275 2705 5137 5142 5309 5311 5380 5411 5451 5135 2954 20807 20820 21373 21394 5370 5418 5108 35106 35160 35267 35093 35185 30310 30350 30351 30378 36021 36042 36074 36143 36142 30272 35263 36110 36188 30439 36117 21173 21705 21704 21751 21866 30151 30118 30234 3932 5224 35060 35103 36018 36053 30404 30430 21479 21875 21876 30036 30064 30063 30152 36078 36036 36016 36153 36179 36180 36200 21162 21268 21228 22103 22044 22045 30072 30113 30144 30238 30295 30296 30019 30029 5308 5429 20673 5301 5122 5419 35167 35110 35153 35069 35237 35248 35236 30354 35288 36154 36038 35314 35255 36104 30396 30432 30379 21745 21830 21908 21907 21943 21944 21942 21945 21947 22175 22236 22237 30180 30179 30181 30177 30215 30127 30250 30251 30255 30258 2648 2707 2935 2712 5315 20955 21092 21142 21333 21328 21330 21331 21443 21445 21509 21563 21577 35157 35215 35216 35217 35223 35224 30301 30283 30335 36051 36052 35310 36135 35317 36031 35274 30413 36112 36115 36141 36146 30247 36160 20902 20922 21348 21392 21388 21389 21551 7487 30366 30367 30368 22021 22061 4169 5105 5106 30136 30137 30139 30140 5367 5530 5529 30387 30386 35306 36203 20982 20984 20985 22181 22177 22195 22196 22197 22199 22198 22211 22212 22222 22220 22227 22229 22241 21858 21860 21903 21906 22125 22123 22130 22133 22135 22138 22140 22141 22146 22148 22149 22176 22189 22188 22192 22231 22242 22092 22131 22218 22248 22244 22249 22252 22253 22255 22254 22256 22259 22261 22262 30185 30186 2006 2242 2205 2086 3990 3998 3999 4000 3750 3882 3881 3884 3888 3889 3901 3902 3909 3936 3944 3975 4272 4274 20799 21632 21622 21595 21596 21608 21602 21085 21180 21242 21244 21245 21300 21309 21316 21308 21310 21317 21315 21319 21424 21425 21395 21396 21459 21470 21484 21485 21499 21525 21523 21532 21557 21559 21560 21561 21542 21502 4288 4291 4295 4297 4299 4300 4307 4308 4309 4310 4313 4314 4318 4322 4325 4334 4335 4336 4338 4339 4198 4201 4194 4206 4215 4222 4237 4257 4255 4261 4262 4241 4245 4220 4343 4344 4351 4349 4353 4356 4357 4358 4359 4361 4365 4367 4368 4370 4373 4240 2323 2409 2461 2462 2463 2464 2465 5446 5298 5303 5344 5351 5352 5358 5361 5405 5406 5407 5409 5416 5388 5389 5390 5415 5491 5526 5527 5532 5506 35063 22264 22265 22263 30312 4378 30398 30399 30403 30416 30418 4375 4380 4381 4383 4385 5534 30031 30047 30056 30129 30148 30147 30253 30248 30277 35186 35038 35188 35146 36050 36133 35291 36144 30394 36040 30397 21299 21321 21442 22054 30074 30262 30263 30264 30274 2078 36129 36128 36187 35127 35139 30086 30131 35243 35257 36163 30055 30219 30229 30276 30020 36137 35315 30414 30353 30381 21585 21488 21489 21623 21593 21594 21609 21612 21897 21909 21953 21982 22014 22066 22065 22070 22091 22090 22178 22059 30041 3778 3976 3978 3864 3986 3987 4045 4052 4132 4136 4138 4141 4184 4187 4197 4287 4311 5055 5061 35286 30402 30405 30417 30024 35141 35166 35092 35191 35192 36011 36007 36094 36138
ClassificationClass II
Reason for RecallAlpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the presence of a software bug.
Product Quantity871 licenses installed
Recall NumberZ-1407-2013

Class II Devices Event

Event ID65194
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-May-13
Initial Firm Notification of Consignee or Public
Recalling FirmIntuitive Surgical, Inc.
CitySunnyvale
StateCA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including the states of AL, CA, CO, FL, IL, KY, MI, MS, NJ, NY, PA, TX, UT, VA, WA, and WI, and the countries of Austria, Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Norway, Qatar, Romania, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Saudi Arabia, Singapore, and Venezuela.
 

Associated Products

Product Description8mm Precise Bipolar Forceps used in conjunction with the da Vinci S Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
Code InfoModel number: 400110-10; Lot numbers: M10120807 M10120817 M10120831 M10120910 M10121008 M10121012 M10121024 M10121115 M10121123 M10121130 M10121206 M10121210 M10130124 M10130131 M10130205 M10130304 M10130319 M10130321
ClassificationClass II
Reason for RecallReports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments.
Product Quantity697 units - all products
Recall NumberZ-1431-2013
Product Description8mm Maryland Bipolar Forceps used in conjunction with the da Vinci S Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
Code InfoModel number: 400172-08; Lot numbers: M10120815 M10120817 M10120831 M10120913 M10120918 M10121008 M10121024 M10121120 M10121123 M10121203 M10121210 M10121215 M10130220 M10130222 M10130311 M10130315 M10130327 M10130411.
ClassificationClass II
Reason for RecallReports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments.
Product Quantity697 - all products
Recall NumberZ-1432-2013
Product Description8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci S Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
Code InfoModel number: 400205-04; Lot numbers: M10120816 M10120820 M10120903 M10120910 M10120912 M10120921 M10121008 M10121024 M10121120 M10121130 M10121206 M10121213 M10121215 M10130124 M10130131 M10130213 M10130218 M10130222 M10130313 M10130319 M10130402.
ClassificationClass II
Reason for RecallReports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments.
Product Quantity697 - all products
Recall NumberZ-1433-2013

Class III Biologics Event

Event ID40349
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jun-04
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNorthwest Florida Blood Center, Inc.
CityPensacola
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info4952908
ClassificationClass III
Reason for RecallBlood product, manufactured from Whole Blood units that may have had an extended collection time, was distributed.
Product Quantity1 unit
Recall NumberB-1313-13

Class III Biologics Event

Event ID40755
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Jan-05
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNorthwest Florida Blood Center, Inc.
CityPensacola
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info4074426
ClassificationClass III
Reason for RecallBlood product, which was not manufactured in accordance to acceptable product specifications, was distributed.
Product Quantity1 unit
Recall NumberB-1314-13

Class III Biologics Event

Event ID41001
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Oct-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAtlanta Blood Services
CityAtlanta
StateGA
CountryUS
Distribution PatternGA
 

Associated Products

Product DescriptionPlatelets Leukocytes Reduced
Code Info8464482- A, 8464482- B
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose temperature was not documented, were distributed.
Product Quantity2
Recall NumberB-1336-13

Class III Biologics Event

Event ID44981
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jun-07
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNorthwest Florida Blood Center, Inc.
CityPensacola
StateFL
CountryUS
Distribution PatternFlorida.
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info Unit numbers 5213976A; 5213976B.
ClassificationClass III
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity2 units
Recall NumberB-1254-13

Class III Biologics Event

Event ID47005
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Nov-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info01GH09575; 01KS81880
ClassificationClass III
Reason for RecallBlood products, which may have been exposed to unacceptable temperature during storage, were distributed.
Product Quantity2 units
Recall NumberB-1259-13

Class III Biologics Event

Event ID50416
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Sep-08
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmTacoma Pierce County Blood Bank
CityTacoma
StateWA
CountryUS
Distribution PatternWashington and Utah
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW127808500548, W127808500549, W127808500555, W127808500568, W127808500584, W127808500589, N 22878, N 22883, V 72291.
ClassificationClass III
Reason for RecallBlood products, collected using a copper sulfate solution which had unacceptable specific gravity QC results were distributed.
Product Quantity9
Recall NumberB-0908-13
Product DescriptionRed Blood Cells
Code InfoW127808500544, W127808500546, W127808500550, W127808500551, W127808500556, W127808500558, W127808500562, W127808500565, W127808500567, W127808500569, W127808500572, W127808500573, W127808500575, W127808500577, W127808500579, W127808500580, W127808500582, W127808500583, W127808500587, W127808500588, N 22876, N 22880, N 22881, V 72286, V 72287, V 72288, V 72292, V 72293, V 72294.
ClassificationClass III
Reason for RecallBlood products, collected using a copper sulfate solution which had unacceptable specific gravity QC results, were distributed.
Product Quantity29
Recall NumberB-0909-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW127808500543, W127808500547, W127808500570, W127808500574, W127808500578, W127808500581, W127808500585, N 22879
ClassificationClass III
Reason for RecallBlood products, collected using a copper sulfate solution which had unacceptable specific gravity QC results, were distributed.
Product Quantity8
Recall NumberB-0910-13

Class III Drugs Event

Event ID64608
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTeva Pharmaceuticals USA, Inc.
CitySellersville
StatePA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionSeasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets each, Rx only, TEVA Women Health, Inc., Subsidiary of TEVA Pharmaceuticals USA, Inc., Sellersville, PA NDC 51285-058-66
Code InfoNDC 51285-058-66 -- lot numbers 33802330A, exp 6/2013; and 33802464A, exp 6/2013.
ClassificationClass III
Reason for RecallFailed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Product Quantity17,108 blister packs
Recall NumberD-496-2013
Product DescriptionCamrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and Ethinyl Estradiol 0.01 Tablets, 2 Extended-Cycle Tablet Dispensers (NDC 0093-3134-82) and 1 Extended-Cycle Tablet Dispenser NDC 0093-3134-91), 91 Tablets Each, Rx only, TEVA Womens Health Inc., Subsidiary of TEVA Pharmaceuticals, Inc., Sellersville, PA
Code InfoNDC 0555-3134-82 and 0093-3134-91 -- lot numbers 33802566A, exp 3/2013; 33802967A, exp 8/2013; 33803529A, exp 10/2013; and 33803609A, exp 11/2013.
ClassificationClass III
Reason for RecallFailed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Product Quantity120,049 blister packs
Recall NumberD-497-2013

Class III Drugs Event

Event ID64996
StatusCompleted
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Mar-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmPhysicians Total Care, Inc.
CityTulsa
StateOK
CountryUS
Distribution PatternMO
 

Associated Products

Product DescriptionCamila 0.35 mg Tablets, 6 cards of 28 pills, Dist. By: Physicians Total Care, Tulsa, OK --- NDC 54868-4814-0, MFG By TEVA Pharmaceuticals USA, Sellersville, PA
Code InfoPhysicians Total Care Lots: 6Z4C Exp. 10/31/2013
ClassificationClass III
Reason for RecallFailed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Product Quantity6 cards of 28 tablets
Recall NumberD-499-2013

Class III Drugs Event

Event ID65071
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAurobindo Pharma USA Inc
CityPlainsboro
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionLisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad- 500 072 India
Code InfoLot KP3012001-A Exp.12/13 Lot KP3012002-A Exp.12/13
ClassificationClass III
Reason for RecallLabeling: Label Error on Declared Strength: Incorrect strength on side display panel of label
Product Quantity1776 bottles
Recall NumberD-498-2013

Class III Food Event

Event ID65079
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Apr-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmMeijer Distribution, Inc
CityGrand Rapids
StateMI
CountryUS
Distribution PatternMeijer stores (201) located in Illinois, Indiana, Kentucky, Michigan, and Ohio may have received product from Meijer distribution centers.
 

Associated Products

Product DescriptionMeijer Diced Pears in Fruit Juice 8oz cup
Code InfoUPC: 71373337044 and All lots produced from November 29, 2012 through January 2, 2013.
ClassificationClass III
Reason for RecallMeijer Diced Pears in Fruit Juice, Meijer Diced Peaches in Fruit Juice, and Meijer Mandarin Oranges in Fruit Juice 8 oz (226g) labels were developed, the Serving Size was updated to 1 cup (226g) but the nutrition facts still reflect the 4 oz (113g) information.
Product Quantity26,931
Recall NumberF-1454-2013
Product DescriptionMeijer Diced Peaches in Fruit Juice 8oz cup
Code InfoUPC: 71373337017 and All lots produced from November 29, 2012 through January 2, 2013.
ClassificationClass III
Reason for RecallMeijer Diced Pears in Fruit Juice, Meijer Diced Peaches in Fruit Juice, and Meijer Mandarin Oranges in Fruit Juice 8 oz (226g) labels were developed, the Serving Size was updated to 1 cup (226g) but the nutrition facts still reflect the 4 oz (113g) information.
Product Quantity35,721
Recall NumberF-1455-2013
Product DescriptionMeijer Mandarin Oranges in Fruit Juice 8oz cup
Code InfoUPC: 88692601216 and All lots produced from November 29, 2012 through January 2, 2013.
ClassificationClass III
Reason for RecallMeijer Diced Pears in Fruit Juice, Meijer Diced Peaches in Fruit Juice, and Meijer Mandarin Oranges in Fruit Juice 8 oz (226g) labels were developed, the Serving Size was updated to 1 cup (226g) but the nutrition facts still reflect the 4 oz (113g) information.
Product Quantity65,718
Recall NumberF-1456-2013

Class III Food Event

Event ID65117
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNational Food & Beverage, Inc
CityDallas
StateTX
CountryUS
Distribution PatternFL, GA, and SC
 

Associated Products

Product DescriptionRed Bone Alley Restaurant Wasabi All Natural Sauce for all Seafood & Chicken, Net Wt. 12 fl oz. Distributed by: Red Bone Alley Foods, LLC, 1903 W. Palmetto Street, Florence, SC 29501. Clear Plastic (Pet) Ring Neck Round bottle with neck band with white screw top cap. 6/12oz bottles= 1 case.
Code InfoLot Codes 060213, 0611130003, 072713007, 122713006, 012114001, and 040514003
ClassificationClass III
Reason for RecallUndeclared metabisulfite
Product Quantity3388 cases
Recall NumberF-1463-2013

Mixed Classification Biologics Event

Event ID39140
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Apr-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center of the Ozarks
CitySpringfield
StateMO
CountryUS
Distribution PatternMO; CO; FL; Austria
 

Associated Products

Product DescriptionRed Blood Cells
Code Info6772914; 6772936; 6772968; 6772994; 6777568; 6782640; 6782660; 6787452; 6787455; 6787484; 6787677; 6787684; 6787704; 6787750; 6792487; 6792517; 6792529; 6792541; 6792543; 6792566; 6792572; 6792580; 6792596; 6792616
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the units, were distributed.
Product Quantity24 Units
Recall NumberB-1329-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info6771844; 6772928; 6772953; 6772954; 6772957; 6772969; 6772984; 6772988; 6772993; 6785513; 6785518; 6785525; 6787661
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the units, were distributed.
Product Quantity13 Units
Recall NumberB-1330-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info3772819; 3778044; 6713590; 6713593; 6713595; 6713597; 6714962; 6725151; 6725153; 6725156; 6725168; 6725170; 6725171; 6725190; 6725192; 6725194; 6725197; 6725200; 6725203; 6725204; 6725206; 6725207; 6725208; 6725209; 6725210; 6725211; 6725218; 6725220; 6725222; 6725225; 6725615; 6725768; 6726419; 6730260; 6731455; 6731539; 6731635; 6737411; 6737416; 6737417; 6737418; 6737419; 6737430; 6737432;6737438; 6737442; 6737445; 6737446; 6737449; 6737451; 6737453; 6737454; 6737455; 6737456; 6737460; 737461; 6737465; 6737470; 6737477; 6737478; 6737479; 6737480; 737481; 6737484; 6737484; 6737485; 6737486; 6737499; 6737500; 6737501; 6737503; 6737504; 6737507; 6737508; 6737509; 6737512; 6737516; 6737518; 6737519; 6737520; 6737525; 6737530; 6737531; 6737533; 6737534; 6737535; 6737537; 6737541; 6737542; 6737545; 6737547; 6737550; 6737555; 6737556; 6737558; 6737559; 6737561; 6737563; 6737572; 6737573; 6737575; 6737577; 6737578; 6737581; 6737585; 6737586; 6737591; 6737592; 6737607; 6737609; 6737610; 6737613; 6737615; 6737626; 6737636; 6737641; 6737644; 6737647; 6737649; 6737652; 6737653; 6737657; 6737661; 6737663; 6737670; 6737674; 6737678; 6737680; 6737693; 6737709; 6737713; 6737727; 6737733; 6737734; 6738931; 6738974; 6738981; 6738983; 6739032; 6742616; 6742633; 6744553; 6745834; 6745895; 6746018; 6746021; 6746028; 6746069; 6746070; 6746119; 6746123; 6746475; 6746482; 6746498; 6747375; 6747376; 6747377; 6747378; 6747384; 6750700; 6750702; 6751276; 6751294; 6751305; 6751315; 6751329; 6751331; 6753648; 6753654; 6753671; 6753681; 6755189; 6755196; 6757571; 6757619; 6757626; 6757631; 6757650; 6757683; 6758562; 6758566; 6758567; 6758570; 6758574; 6760288; 6760292; 6760300; 6760310; 6760318; 6760322; 6760332; 6761069; 6761082; 6761086; 6761089; 6761097; 6761120; 6761121; 6761124; 6761133; 6761146; 6761148; 6771148; 6771178;6771179; 6771186; 6771191; 6771205; 6771225; 6771285; 6771303; 6771310; 6771852; 6772750; 6772751; 6772755; 6772756; 6772759; 6772759; 6772762; 6772768; 6772771; 6772774; 6772776; 6772779; 6772782; 6772782; 6772783; 6772784; 6772787; 6772791; 6772792; 6772793; 6772795; 6772800; 6772802; 6772804; 6772805; 6772811; 6772822; 6772828; 6772831; 6772833; 6772836; 6772837; 6772840; 6772842; 6772844; 6772848; 6772850; 6772855; 6772861; 6772868; 6772868; 6772882; 6772884; 6772886; 6772888; 6772890; 6772892; 6772893; 6772894; 6772898; 6772905; 6772907; 6772912; 6772913; 6772914; 6772915; 6772918; 6772920; 6772922; 6772923; 6772924; 6772936; 6772941; 6772942; 6772948; 6772953; 6772954; 6772957; 6772958; 6772964; 6772966; 6772969; 6772984; 6772988; 6772990; 6772992; 6772993; 6772994; 6777568; 6777570; 6777576; 6777579; 6777582;6778033;6778037;6778051;6782905;6782913;6782914
ClassificationClass III
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the units, were distributed.
Product Quantity301 Units
Recall NumberB-1331-13
Product DescriptionCryoprecipitated AHF
Code Info6713590; 6721055; 6725204; 6725206;6725207; 6725208; 6725209; 6725210; 6725211; 6725218; 6725220; 6725222; 6725225; 6725768; 6737670; 6737689; 6737732
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the units, were distributed.
Product Quantity17 Units
Recall NumberB-1332-13
Product DescriptionPlasma Cryoprecipitate Reduced
Code Info6737687; 6737690
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the units, were distributed.
Product Quantity2 Units
Recall NumberB-1333-13
Product DescriptionPlatelets
Code Info6787684; 6787747; 6787750
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the units, were distributed.
Product Quantity3 Units
Recall NumberB-1334-13
Product DescriptionFresh Frozen Plasma
Code Info6731455; 6771161; 6772928; 6772931
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the units, were distributed.
Product Quantity4 Units
Recall NumberB-1335-13
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