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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Class I Food Event

Event ID63252
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Sep-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmMR Cuts, L.p.
CityDallas
StateTX
CountryUS
Distribution PatternTX
 

Associated Products

Product DescriptionItem # H996189 Mango Diced 1/2" 5 LB, Ingredients: Mango Packed By: Riley's Dallas, Texas 75226 Product of Mexico
Code InfoAll mango products manufactured from mangos sourced by Agricola Daniella. Lot Numbers 0908 and 0913 located on top film of tray and also on the outer box.
ClassificationClass I
Reason for RecallThe product has the potential to be contaminated with salmonella. The mangos were sourced by Agricola Daniella.
Product Quantity8 cases
Recall NumberF-1721-2013
Product DescriptionItem # H175455 Mango Sliced 2/2.5 LB and 5 LB, Ingredients: Mango Packed By: Riley's Dallas, Texas 75226 Product of Mexico
Code InfoAll mango products manufactured from mangos sourced by Agricola Daniella. Lot Numbers 0909 and 0908 located on top film of the tray and also on the outer box.
ClassificationClass I
Reason for RecallThe product has the potential to be contaminated with salmonella. The mangos were sourced by Agricola Daniella.
Product Quantity40 cases
Recall NumberF-1722-2013
Product DescriptionItem # 2999 Mango Chunks 2/5 LB, Ingredients: Mango Packed By: Riley's Dallas, Texas 75226 Product of Mexico
Code InfoAll mango products manufactured from mangos sourced by Agricola Daniella. Lot Number 0913 located on top film of the tray and also on the outer box.
ClassificationClass I
Reason for RecallThe product has the potential to be contaminated with salmonella. The mangos were sourced by Agricola Daniella.
Product Quantity7 cases
Recall NumberF-1723-2013

Class I Drugs Event

Event ID64657
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmApotex Corp.
CityWeston
StateFL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionPiperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0.
Code InfoLot #: 503B015, 503B016, Exp 04/13; 503B019, 503B020, 503B021, 503B022, Exp 07/13; 503B024, Exp 08/13; 503B025, 503B026, 503B027, Exp 09/13; 503C005, 503C006, Exp 12/13; 503C007, 503C008, Exp 01/14; 503C018, Exp 04/14
ClassificationClass I
Reason for RecallCrystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Product Quantity37,303 vials
Recall NumberD-806-2013

Class I Devices Event

Event ID65420
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCodman & Shurtleff, Inc.
CityRaynham
StateMA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including the states of FL, NC, NJ, and TX, and the countries of Austria, Australia, Belgium, China, Denmark, Spain, Great Britain, Germany, Italy, Ireland, Luxemburg, Russia, Saudi Arabia, and Turkey.
 

Associated Products

Product DescriptionMedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofen or Morphine.
Code InfoAll serial numbers
ClassificationClass I
Reason for RecallMiscalibrated Fill Level Sensor may affect dosing level
Product Quantity2 units US and 735 OUS
Recall NumberZ-1690-2013
Product DescriptionMedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump) 91-4201 (40ml pump) Intended for the intrathecal delivery of Baclofen or Morphine.
Code InfoAll serial numbers
ClassificationClass I
Reason for RecallMiscalibrated Fill Level Sensor may affect dosing level
Product Quantity5 US and and 360 OUS
Recall NumberZ-1691-2013

Class I Food Event

Event ID65489
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jun-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmNassau Candy
CityHicksville
StateNY
CountryUS
Distribution PatternNY, NJ, CT, ME, PA, MD, NC, IN, TX, IL, FL, UT, CO
 

Associated Products

Product DescriptionPISTACHIOS-INSHELL-R/S-21/25-6.25LB, Net Wt. 6.25 LB. Item number: 920. Product is packed in a clear plastic liner then in a white corrugated bag. Distributed by Nassau Candy 530 West John Street Hicksville, NY 11801.
Code InfoLot codes: C1306 through F1306
ClassificationClass I
Reason for RecallPotential Salmonella contamination.
Product Quantity8,000 LB (1,280 packages)
Recall NumberF-1719-2013

Class I Food Event

Event ID65540
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jun-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmWindy Acres Candy & Nut, Outlet Inc.
CityWilmington
StateOH
CountryUS
Distribution PatternThe product was distributed only to two consignees in the state of Ohio.
 

Associated Products

Product DescriptionRAW SUNFLOWER KERNEL, DARK RAISIN 50/50 MIX 24/l0 oz packaged in clear plastic wrap.
Code InfoThe affected product includes finished product lot number 0943, which was made using supplier lot number PRO-1349.
ClassificationClass I
Reason for RecallWindy Acres Candy and Nut recalled the affected product because they were informed by the supplier, Lipari Foods, that the sunflower seeds were potentially contaminated with Listeria monocytogenes.
Product Quantity7,968 units of 10 oz bags, 24 bags/case; 332 cases total
Recall NumberF-1720-2013

Class I Food Event

Event ID65566
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Jun-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmKroger Co
CityCincinnati
StateOH
CountryUS
Distribution PatternThe affected product was only distributed in the states of WA and OR.
 

Associated Products

Product DescriptionQFC Chicken Pesto Panini wrapped in polywrap packaging, 10.32 oz. in size, included with five (5) other types of sandwiches in a 6-count "variety pack" case.
Code InfoThe affected product has a sell by date of 06/22/13 and a UPC code of 1111039114.
ClassificationClass I
Reason for RecallThe paninis may contain soy and egg, which are allergens.
Product Quantity235 sandwiches
Recall NumberF-1718-2013

Class I Food Event

Event ID65578
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jun-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmFresh Unlimited Inc
CitySidney
StateOH
CountryUS
Distribution PatternThe affected product was distributed to the following states: Indiana, Kentucky, Michigan, New York, Ohio, and Pennsylvania.
 

Associated Products

Product DescriptionBroccoli Salad Kit No Dressing, packaged in plastic bags inside paper cartons, 4 bags per case.
Code InfoThe affect product has the following SKU #, Description, Pack Size, and Use by Date, respectively: 74716, Broccoli Salad Kit No Dressing, 3.625lb per case, 6/17/2013.
ClassificationClass I
Reason for RecallThe firm was informed for a supplier that the sunflower raisin mix packets they supplied was a part of the Lipari Foods sunflower seed recalls, which was due to contamination with Listeria monocytogenes.
Product Quantity1207 bags
Recall NumberF-1711-2013
Product DescriptionBroccoli Salad Kit No Dressing, No Bacon; packaged in plastic bags inside paper cartons, 4 bags per case.
Code InfoThe affect product has the following SKU #, Description, Pack Size, and Use by Date, respectively: 74717, Broccoli Salad Kit No Dressing No Bacon, 3.375lb per case, 6/17/2013.
ClassificationClass I
Reason for RecallThe firm was informed for a supplier that the sunflower raisin mix packets they supplied was a part of the Lipari Foods sunflower seed recalls, which was due to contamination with Listeria monocytogenes.
Product Quantity1173 bags
Recall NumberF-1712-2013
Product DescriptionBroccoli Salad Kit with Dressing; packaged in plastic bags inside paper cartons, 5 bags per case.
Code InfoThe affect product has the following SKU #, Description, Pack Size, and Use by Date, respectively: 74807, Broccoli Salad, 4.04lbs per case, 6/17/2013.
ClassificationClass I
Reason for RecallThe firm was informed for a supplier that the sunflower raisin mix packets they supplied was a part of the Lipari Foods sunflower seed recalls, which was due to contamination with Listeria monocytogenes.
Product Quantity2958 bags
Recall NumberF-1713-2013
Product DescriptionSweet & Sassy Apple Salad; packaged in plastic bags inside paper cartons, 5 bags per case.
Code InfoThe affect product has the following SKU #, Description, Pack Size, and Use by Date, respectively: 74891, Sweet & Sassy Apple Salad, 6.125lbs per case, 6/17/2013.
ClassificationClass I
Reason for RecallThe firm was informed for a supplier that the sunflower raisin mix packets they supplied was a part of the Lipari Foods sunflower seed recalls, which was due to contamination with Listeria monocytogenes.
Product Quantity189 bags
Recall NumberF-1714-2013

Class I Food Event

Event ID65581
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Jun-13
Initial Firm Notification of Consignee or Public Visit
Recalling FirmSani Fresh Distribution
CityLong Island City
StateNY
CountryUS
Distribution PatternBorough of Queens, NY
 

Associated Products

Product DescriptionSani Fresh Distribution brand MINI KAISER 10, Net Weight 13 OZ, Product of Canada, UPC 0 56931 51125 2 --- DISTRIBUTED BY SANI BAKERY INC. 28-24 STEINWAY ST., SUITE 108, ASTORIA NY 11103 --- The mini kaisers are packed in clear plastic sealed bags (contain 10 rolls per bag) which are placed in unmarked brown boxes/cartons. The product has a short shelf life.
Code InfoUPC 0 56931 51125 2 and no other coding
ClassificationClass I
Reason for RecallCanadian firm recalled Mini Kaiser 10 due to undeclared soy in the product. The product was also found to contain undeclared wheat, sulfites, soybean oil and gluten (barley and/or rye) all from the Doughmaster 200 raw material.
Product Quantity93 cartons
Recall NumberF-1724-2013

Class I Food Event

Event ID65627
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Jul-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSomersault Snack Co., LLC
CitySausalito
StateCA
CountryUS
Distribution PatternDistribution centers in CA, OH, GA, KS and SC and then on to stores in AZ, FL, HI, MO, NC,NE, NV, NY, OK, PA, TX and WV.
 

Associated Products

Product DescriptionSomersault Pacific Sea Salt flavor, crunchy nuggets baked with sunflower seeds and toasted grains. 1 oz. packages sold in 6-count multi packs. Somersault Snacks co., LLC; Sausalito, Ca 94965
Code InfoBOX UPC: 0 898403 00221 5 (located on the bottom of the box); PACKAGE UPC: 0 898403 00220 8 (located on the rear panel of each package;) SELL BY DATES: FEB061483 and FEB061481.
ClassificationClass I
Reason for RecallA limited number of packages of 1 ounce Somersault Pacific Sea Salt products were inadvertently mispackaged - Somersault Santa Fe Salsa flavored product were inadvertently commingled with Somersault Pacific Sea Salt flavored product in packages labeled as Somersault Pacific Sea Salt.
Product Quantity712 cases. Each case contains 6 boxes of 6-count multi packs.
Recall NumberF-1715-2013

Class II Biologics Event

Event ID39044
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-May-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmFlorida Blood Services, Inc.
CitySt Petersburg
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells.
Code Info5318209
ClassificationClass II
Reason for RecallBlood product, incorrectly labeled as negative for the Jka red cell antigen, was distributed.
Product Quantity1 unit
Recall NumberB-1702-13

Class II Biologics Event

Event ID45177
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Aug-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources Inc Dba International Bioresources
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code Info368066965
ClassificationClass II
Reason for RecallBlood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-1668-13

Class II Biologics Event

Event ID48299
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Mar-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCsl Plasma Inc
CityTempe
StateAZ
CountryUS
Distribution PatternIL, Switzerland
 

Associated Products

Product DescriptionSource Plasma
Code Info4270133819; 4270132571; 4270131033; 4270129823; 4270128160; 4270127401; 4270126368
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose annual physical examination was inadequately documented, were distributed.
Product Quantity7 units
Recall NumberB-1796-13

Class II Biologics Event

Event ID50444
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Oct-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCsl Plasma Inc
CityTempe
StateAZ
CountryUS
Distribution PatternIllinois, Switzerland, Germany
 

Associated Products

Product DescriptionSource Plasma
Code Info4270183014, 4270181851, 4270180003, 4270174788, 4270173161, 4270171887, 4270165471, 4270162492, 4270161125, 4270160357, 4270159126, 4270157892, 4270157329, 4270155736, 4270155211, 4270153782, 4270153425, 4270152091, 4270151567, 4270150167, 4270148507, 4270147032, 4270146491, 4270145367, 4270144221, 4270143653, 4270141052, 4270139728, 4270139214, 4270138216, 4270137713, 4270136676, 4270136156, 4270134929, 4270134542, 4270131147, 4270129852
ClassificationClass II
Reason for RecallBlood products, collected from a donor who did not have a complete physical examination, were distributed.
Product Quantity37 units
Recall NumberB-1629-13

Class II Biologics Event

Event ID50656
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Nov-08
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 Info366027304, 366026831, 366025874, 366025391, 366024924, 366024530, 366024101, 366023644, 366023243, 366022718, 366022200, 366021598, 366021268, 366020655, 366020302, 366019234, 366018953, 366018335, 366017996, 366017369, 366017045, 366015267, 366014368, 366014020, 366013394, 366013081, 366010974, 366010638, 366009925, 366009630, 366005720, 366005669,
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of incarceration, were distributed.
Product Quantity32 units
Recall NumberB-1665-13

Class II Biologics Event

Event ID53621
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Feb-09
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternMO; KS; LA; CA;
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045008125859; W045008120117; W045008117463; W045008111946; W045008110989; W045008125925; W045008108260; W045008120091; W045008108305; W045008125939; W045008120163; W045008117428; W045008111068; W045008105566; W045008125812; W045008120184; W045008115702; W045008120115; W045008129826; W045008125919; W045008125203; W045008115685; W045008119980; W045008913232; W045008129832; W045008125399; W045008108310; W045008125660; W045008125922; W045008119876; W045008115637; W045008108306; W045008108304; W045008108294; W045008097193; W045008125923; W045008119838; W045008117459; W045008111075; W045008108333; W045008108327; W045008108321; W045008115778; W045008110803; W045008108721; W045008125941; W045008125678; W045008120106; W045008120097;W045008125943; W045008125813; W045008120092; W045008119995; W045008117417; W045008117413; W045008125914; W045008108757; W045008913235; W045008125398; W045008111070; W045008120149; W045008105792; W045008129848; W045008117435; W045008115676; W045008108342; W045008108340; W045008120152; W045008115633; W045008913221; W045008125670; W045008125658; W045008120158; W045008119951; W045008108856; W045008108323; W045008108796; W045008125201; W045008119991; W045008110901; W045008108399; W045008119985; W045008120025; W045008119926; W045008111951; W045008108522; W045008108510; W045008117461; W045008119329; W045008110986; W045008120028; W045008120027; W045008119923; W045008117445; W045008117439; W045008108566; W045008108544; W045008108314; W045008095756; W045008129924; W045008111978; W045008913211; W045008129861; W045008129855; W045008129852; W045008125918; W045008125816; W045008125295; W045008119893; W045008117444; W045008117425; W045008110991; W045008110940; W045008110894; W045008108998; W045008108747; W045008108724; W045008108723; W045008108299; W045008125913; W045008125911; W045008125909
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the units, were distributed.
Product Quantity122 Units
Recall NumberB-1824-13
Product DescriptionPlasma Frozen Within 24 Hours After Phlebotomy (FP24)
Code InfoW045008120117; W045008117439; W045008117425; W045008119923; W045008119929; W045008111075; W045008120118; W045008117428; W045008913211; W045008115790; W045008111068; W045008110803; W045008095756; W045008111946; W045008108338; W045008108721; W045008119951; W045008119995; W045008119926; W045008108796; W045008120116; W045008129855; W045008129852; W045008120025; W045008119991; W045008119893; W045008117463; W045008115778; W045008115702; W045008115633; W045008111976
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the units, were distributed.
Product Quantity31 Units
Recall NumberB-1825-13

Class II Biologics Event

Event ID57465
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Oct-10
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross (The)
CityAshley
StatePA
CountryUS
Distribution PatternPA, NY
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info30GV71292, 30GV71597, 30GX30904, 30GX32297, 30FN31824, 30FN31831, 30FN32575, 30FN34189, 30GT60367, 30GT60470, 30GT60478, 30GT60484, 30GV69491, 30GV69638, 30GX32685, 30GX32718, 30GX32738, 30GX32923, 30GX32957, 30GY87076, 30GY87106
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity21 units
Recall NumberB-1748-13
Product DescriptionRed Blood Cells
Code Info30GV71814, 30FN33298, 30FW61951, 30FW62308, 30GZ19273
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity5 units
Recall NumberB-1749-13
Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info30LM02557 (Parts 1 and 2)
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-1750-13

Class II Biologics Event

Event ID58782
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-May-11
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBiotest Pharmaceuticals Corporation
CityDickson City
StatePA
CountryUS
Distribution PatternPA
 

Associated Products

Product DescriptionSource Plasma
Code Info0090991017, 0090990692, 0090990207, 0090989917, 0090989427, 0090989110, 0090988619, 0090986626, 0090986135, 0090985782, 0090984487, 0090983458, 0090982937, 0090982638, 0090982076, 0090981765, 0090981181
ClassificationClass II
Reason for RecallBlood products, collected from a donor who did not have a physical examination, were distributed.
Product Quantity17 units
Recall NumberB-1698-13

Class II Devices Event

Event ID60480
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTerumo Cardiovascular Systems Corporation
CityAnn Arbor
StateMI
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV and the countries of Jordan, CANADA, AUSTRALIA, Japan ,Hong Kong ,UNITED ARAB EMIRATES (UAE), BELGIUM, South Korea, Malaysia, Mexico, Philippines, Singapore, Taiwan, and Thailand.
 

Associated Products

Product DescriptionCDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
Code InfoCatalog number: 500AVHCT* and serial numbers: 0012, 1001-1022, 1024, 1028, 1032, 1033,1036, 1038, 1039, 1041-1044, 1046, 1047,1049-1053,1059,1063,1066-1071,1075,1096,1097,1101-1105, 1111-1304-1309,1312-1315,1321,1332-1334,13401344,1350-1354, 1357, 1358, 1379-1383, 13891393,1399-1408,1414-1418, 1421, 1422, 14241433, 1439-1443, 1449-1453, 1459-1463, 1466,1479, 1480, 1494, 1525, 1554, 1597-1601,1605,1617-1631,1637-1646,1657-1661,16721676,1682-1686,1697-1701,1712-1716, 1733-1737, 1787-1789, 1805-1809, 1815-1819, 1830, 1844-1846, 1857-1860, 1886-1890, 1901-1905,1916-1920, 1926-1930, 1936-1940, 1953-1974,1976-1985, 2029-2034, 2036-2038, 2040, 2045, 2059-2063, 2065-2067, 2070-2077, 2086, 2097-2101, 2109-2111, 2113-2115, 2123-2131, 2138-2142, 2149-2155, 2177-2182, 2185-2187, 2189,2195-2199, 2214, 2216-2219, 2224, 2228-2231, 2243-2245, 2249-2253, 2255-2258, 2260, 2263, 2265-2268, 2275-2277, 2279, 2285-2291, 22952298, 2313-2321, 2323-2329, 2338-2354, 2357, 2366,2368-2375,2377,2392,2403-2408,24172426, 2432-2436, 2439-2444, 2453-2458, 2463-2467, 2470-2472, 2476-2483, 2487-2503, 2514-2517,2521-2525,2541-2556,2565-2582,2587-2603, 2629-2633, 2635-2642, 2646, 2647, 2656, 2661,2662,2664-2680,2689-2691,2695,2696, 2701-2708, 2710-2716, 2722-2727, 2737, 2742-2747, 2757-2773, 2783, 2784, 2788, 2793-2795, 2802,2805-2808,2815-2820,2837-2839,28462849, 2865-2870, 2880-2889, 2892-2895, 2906-2908,2913- 2915,2920,2921,2924-2926, 2937-2940, 2942-2947, 2952, 2958-2975, 2979-2983, 2990-2999, 3008-3010, 3022-3027, 3040, 3041, 3052-3055, 3073-3075, 3083-3087, 3096, 3115, 3116, 3139-3145, 3152, 3153, 3155-3162, 3169-3182, 3190-3196, 3214-3220, 3225-3228, 3232, 3238-3245, 3248, 3249, 3264-3268, 3287, 3288, 3291-3306, 3314-3323, 3329-3334, 3340-3349, 3354-3357, 3369-3373, 3383-3391, 3394-3397, 3402-3406, 3416, 3418-3427, 3434-3437, 34413447, 3449-3456, 3458-3462, 3469-3472, 3481, 3482, 3489, 3490, 3500-3503, 3509, 3510, 3518, 3534, 3535, 3541-3545, 3571-3573, 35903609, 3612-3619, 3624-3628, 3636-3639, 36433645, 3669-3681, 3698-3703, 3715, 3716, 3722-3726, 3738-3744, 3753-3757, 3769-3780, 3784-3787, 3799-3804, 3811-3816, 3827-3830, 3838-3841, 3852-3881, 3892-3899, 3902-3906, 3912-3921, 3924-3931, 3937-3952, 3962-3965, 3971-3974, 3986-3989, 3995-3998, 4006-4029, 4038-1113, 1115, 1130, 1133-1140,1146-1152, 1166-1168, 1181-1185, 1216-1220,1231-1236, 1244-1248,1254,1255,1261-1264, 1270-1274, 1285, 1286-1289, 1295-1299, 4043, 4050-4055, 4070-4075, 4082-4089, 4096-4099,4105-4108,4114-4131,4143-4148,4169-4185, 4203-4212, 4219-4224, 4230-4241, 4260-4280, 4290-4299, 4307-4310, 4318-4323, 4335-4344,4351,4352,5001-5010,5036-5039,5048- 5056, 5065-5077, 5082-5085, 5094-5101, 5118-5125,5142-5149,5158-5169, 5178, 5179, 5190, 5197,5198, 5210-5213,5222-5225,5238-5245, 5250-5253, 5274-5277, 5282-5285, 5290-5293, 5298-5305,5318-5321,5334-5337,5341-5344, 5354-5356, 5370-5374, 5383, 5385, 5386, 5516-5526,5532-5541, 5557-5561, 5584-5592, 5601-5608, and 7992.
ClassificationClass II
Reason for RecallTerumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations.
Product Quantity3972 units since 4/26/12
Recall NumberZ-1730-2013
Product DescriptionCDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
Code InfoCatalog number: 500AHCT* and serial numbers: 1023,1025-1027,1029-1031, 1034,1035,1037,1040, 1045, 1048, 1054-1058, 1060-1062, 1064, 1065, 1072-1074, 1076-1095,1098-1100,1106-1110,1114,1116-1129,1131,1132,1141-1145, 1153-1165,1169-1180,1186-1191,1194-1210, 1212-1215,1221, 1230, 1237-1243,1249-1253,1256-1260,1265-1269,1275-1284,1290-1294,1300-1303, 1310, 1311, 1316-1320, 1322-1331,1335-1339,1345-1349,1359, 1378,1384-1388, 1394-1398,1409-1413,1419,1434-1438,1444-1448, 1454-1458, 1469-1478, 1481, 1482, 1484-1493,1495-1503,1505-1520,1528,1531-1553, 1555-1558,1567-1596,1607-1616,1632-1636,1647-1656,1667-1671,1677-1681,1687-1696, 1702-1711,1717-1721,1728-1732,1738-1753, 1759-1775,1777-1786,1790-1794,1796-1804,1810-1814,1820-1829,1831-1843,1847-1850, 1856, 1861-1885, 1891-1900, 1906-1915,1921-1925,1931-1935,1941-1950,1975,1986-2015, 2017-2022, 2024-2028, 2039, 2041-2044, 2046-2058, 2064, 2068, 2069, 2078-2085, 2087-2096, 2108, 2116, 2118- 2122, 2132-2137, 2143-2148, 2156-2176, 2183, 2184, 2188, 2191-2194, 2200-2213, 2215, 2220-2223, 2225-2227, 2232-2242, 2247, 2248, 2254, 2259,2261, 2262, 2264, 2269-2272, 2278, 2280-2284, 2292-2294, 2299-2312,2330-2337, 2353, 2359-2363, 2376, 2378-2388, 2398-2402, 2409-2416, 2427-2431, 2437, 2438, 2445-2452, 2459-2462, 2468, 2469, 2473-2475, 2484-2486, 2505-2513, 2518-2520, 2526-2540, 2557-2564, 2583-2586, 2604-2628, 2643-2645, 2648-2655, 2657-2660, 2663, 2684-2688,2692-2694,2697-2699, 2709, 2717-2721, 2728-2736, 2738-2741, 2748-2756, 2774-2782, 2785-2787, 2789-2792, 2796-2799, 2803, 2809-2814,2821-2836,2840-2845,2850-2859,2861-2864, 2871-2879, 2896-2900, 2903-2905, 2909-2912, 2916-2919, 2922, 2923, 2927-2936, 2941, 2948-2951, 2953-2957, 2976-2978, 2984-2989, 3000-3007, 3014-3021, 3028-3039, 3042-3051, 3056-3072, 3076-3082, 3088-3095, 3097-3114, 3117-3124,3126-3130,3136-3138,3147-3151, 3154,3163-3168,3183-3189, 3197-3213,3221-3224,3229-3231,3233-3237,3246,3247,3250-3260, 3269-3286,3290,3307-3313,3324-3328, 3335-3339, 3350-3353, 3358-3368, 3374-3382, 3392, 3393, 3398-3401, 3407-3409, 3411-3415, 3428-3433, 3438-3440, 3448, 3457, 3463-3468, 3473-3479,3483-3488,3491-3499,3504-3508, 3511-3517,3519-3533,3536-3540,3546-3570, 3574-3589,3610,3611,3620-3623,3632-3635, 3640-3642,3649-3660, 3662-3668,3682-3697, 3704-3714, 3717-3721,3727-3737,3745-3752, 3758-3768, 3781-3783, 3788-3798, 3805-3810, 3817-3826,3831-3837,3842-3851,3882-3891, 3900,3901,3907-3911,3922,3923,3932-3936, 3953-3961, 3966-3970, 3975-3985, 3990-3994, 3999-4005,4030-4037,4044-4049,4056-4069, 4076-4081, 4090-4095, 4100-4104, 4109-4113, 4133-4142,4149-4168,4186-4202,4213-4218, 4225-4229, 4242-4259,4281-4289,4300-4306, 4311-4317, 4324-4334, 4345-4350, 4353-4371, 5011-5035, 5040-5047, 5057-5064, 5078-5081, 5086-5093, 5102-5117, 5126-5141, 5150-5157, 5170-5177, 5180-5189, 5191-5196, 5199-5209, 5214-5221, 5226-5237, 5246-5249, 5254-5273, 5278-5281, 5286-5289, 5294-5297, 5306-5317, 5322-5329, 5345-5348, 5350-5353,5358-5369, 5375-5382, 5387, 5388, 5500-5515, 5527-5531, 5542-5556,5562-5564,5566-5577,5581-5583, 5593-5600, 5609-5660, 5662-5680, 5682-5688, 5690-5706, 5708-5713, 5715-5722, 5725-5727,and 5731.
ClassificationClass II
Reason for RecallTerumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations.
Product Quantity3972 unit since 4/26/12
Recall NumberZ-1731-2013
Product DescriptionCDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
Code InfoCatalog number: 500AV* and serial numbers: 0024, 0033, 0040, 0051, 1192, 1193, 1355,1356, 1420, 1423, 1464, 1465, 1467, 1468,1483,1504,1521-1524,1526,1527,1529,1530, 1602-1604, 1606, 1662, 2023, 2035, 2102-2107, 2800, 2901,2902, 3131-3135, 3261, 3262, 4132, 5330-5333, 5338-5340, 5578, and 5579.
ClassificationClass II
Reason for RecallTerumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations.
Product Quantity3972 since 4/26/12
Recall NumberZ-1732-2013
Product DescriptionCDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
Code InfoCatalog number: 500A* and serial numbers: 1211,1559-1563,1663-1666,1722-1727,1754-1758, 1776, 1795, 1951, 1952, 2016, 2112, 2117, 2190, 2246, 2273, 2274, 2322, 2355, 2356,2389-2391, 2393, 2394, 2397, 2634, 2700, 2801, 2804, 2860, 2890, 2891, 3011-3013, 3125, 3146, 3263, 3289, 3410, 3417, 3480, 3629-3631, 3646-3648, 3661, and 5349.
ClassificationClass II
Reason for RecallTerumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations.
Product Quantity3972 units since 4/26/12
Recall NumberZ-1733-2013
Product DescriptionCDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
Code InfoCatalog number: 500V* and serial numbers: 1564-1566
ClassificationClass II
Reason for RecallTerumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations.
Product Quantity3972 units since 4/26/12
Recall NumberZ-1734-2013

Class II Devices Event

Event ID63109
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSt. Jude Medical
CityPlano
StateTX
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide Including Puerto Rico and countries of: Argentina, Australia, Belgium, Brazil, Canada, China, Chile, Colombia, Ireland, Israel, India, Malaysia, Mexico, Saudi Arabia, Singapore, South Africa, South Korea, Switzerland and United Kingdom.
 

Associated Products

Product DescriptionEon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain. Eon Mini: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Code InfoAll serial numbers manufactured
ClassificationClass II
Reason for RecallSt. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their spinal cord stimulator. In three cases, patients received a burn to the skin (one second-degree and two first-degree burns) at the implant site. As of June 30, 2012, St. Jude Medical has received 127 total patient complaints of warmth or heating at the IPG implant site during charging for the Eon IPG and 198 reports of similar symptoms for the Eon Mini IPG. These reports resulted in total of 29 explants for Eon IPGs and 43 explants for Eon Mini IPGs. As of June 30, 2012, they have received three reports of skin surface burns (one 2nd degree and two 1st degree burns) believed to be associated with heating during charging. Explant surgery, as with any surgery, presents a risk to patient health. Adverse events associated with an unplanned surgery may be comparable to adverse events associated with planned operations, and may include pain, scarring, and infection, as well as complications from anesthesia.
Product Quantity70,638 (combined total for Eon and Eon mini systems)
Recall NumberZ-1738-2013
Product DescriptionEon Mini - 3721 (Charger). Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Code InfoAll serial numbers manufactured
ClassificationClass II
Reason for RecallSt. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their spinal cord stimulator. In three cases, patients received a burn to the skin (one second-degree and two first-degree burns) at the implant site. As of June 30, 2012, St. Jude Medical has received 127 total patient complaints of warmth or heating at the IPG implant site during charging for the Eon IPG and 198 reports of similar symptoms for the Eon Mini IPG. These reports resulted in total of 29 explants for Eon IPGs and 43 explants for Eon Mini IPGs. As of June 30, 2012, they have received three reports of skin surface burns (one 2nd degree and two 1st degree burns) believed to be associated with heating during charging. Explant surgery, as with any surgery, presents a risk to patient health. Adverse events associated with an unplanned surgery may be comparable to adverse events associated with planned operations, and may include pain, scarring, and infection, as well as complications from anesthesia.
Product Quantity70,638 (combined total of the Eon and the Eon Mini systems)
Recall NumberZ-1739-2013

Class II Biologics Event

Event ID64845
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Mar-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMarquette General Hospital, Inc, UP Reg Bl Ctr Marquette
CityMarquette
StateMI
CountryUS
Distribution PatternMichigan
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW121013003828;
ClassificationClass II
Reason for RecallBlood product, with an unacceptable low volume which was not labeled as a low volume unit, was distributed.
Product Quantity1
Recall NumberB-1758-13

Class II Biologics Event

Event ID64938
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Feb-13
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc.
CityOklahoma City
StateOK
CountryUS
Distribution PatternGermany
 

Associated Products

Product DescriptionSource Plasma
Code Info42203722165;
ClassificationClass II
Reason for RecallBlood product, tested for viral markers using a sample that was diluted with saline, was distributed.
Product Quantity1
Recall NumberB-1797-13

Class II Biologics Event

Event ID64946
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Apr-13
Initial Firm Notification of Consignee or Public Other
Recalling FirmCentral California Blood Center
CityFresno
StateCA
CountryUS
Distribution PatternSwitzerland; California
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW115911282177;
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1
Recall NumberB-1777-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW115911282177;
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1
Recall NumberB-1778-13

Class II Biologics Event

Event ID64977
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Mar-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBlood Systems Inc
CityScottsdale
StateAZ
CountryUS
Distribution PatternArizona
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW0410130318458 (2 units)
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-1755-13

Class II Biologics Event

Event ID64978
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Mar-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Centers of the Pacific - Irwin Center
CitySan Francisco
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW117013227836E (2 units)
ClassificationClass II
Reason for RecallBlood products, for which the quality control testing was not performed, were distributed.
Product Quantity2 units
Recall NumberB-1754-13

Class II Devices Event

Event ID64989
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Dec-11
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSpineFrontier, Inc.
CityBeverly
StateMA
CountryUS
Distribution PatternUSA Nationwide Distribution including the state of TX
 

Associated Products

Product DescriptionKRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into place with a set screw or locking cap. The rod may be placed along several pedicle screws. Component rods are used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients.
Code InfoLot Number: 002876-007R
ClassificationClass II
Reason for RecallOne of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles.
Product Quantity2 rods
Recall NumberZ-1737-2013

Class II Biologics Event

Event ID65037
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Apr-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityOakland
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionPlasma Frozen within 24 hours (FP24)
Code Info084FH15109;
ClassificationClass II
Reason for RecallBlood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-1763-13

Class II Biologics Event

Event ID65052
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Apr-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmMemorial Blood Centers
CitySaint Paul
StateMN
CountryUS
Distribution PatternMinnesota
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW051513048004;
ClassificationClass II
Reason for RecallBlood product, labeled leukoreduced which did not meet the requirements for a leukoreduced product, was distributed.
Product Quantity1
Recall NumberB-1761-13

Class II Biologics Event

Event ID65053
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Feb-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCentral Blood Bank
CityPittsburgh
StatePA
CountryUS
Distribution PatternPennsylvania
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis)
Code InfoW084713000100; W084713000100;
ClassificationClass II
Reason for RecallBlood products, which did not undergo the required quality control testing, were distributed.
Product Quantity2
Recall NumberB-1760-13

Class II Biologics Event

Event ID65054
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Feb-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCentral Blood Bank
CityPittsburgh
StatePA
CountryUS
Distribution PatternPennsylvania
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis)
Code InfoW085912007051; W086112001014;
ClassificationClass II
Reason for RecallBlood products, quarantined pending discard, were distributed
Product Quantity2
Recall NumberB-1759-13

Class II Devices Event

Event ID65088
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPaa Laboratories Inc
CityEtobicoke
StateON
CountryCA
Distribution PatternWorldwide Distribution - USA (nationwide), and countries of: Canada and Novia Scotia.
 

Associated Products

Product DescriptionVarious types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.
Code Info510 k exempt No Medical Device Listing number All batches produced within the last 5 years (143 batches)
ClassificationClass II
Reason for RecallCurrent product labeling band data sheets state that FBS Pharma Grade and FBS/FBS Native are pure Fetal Bovine Serum (FBS). These products may contain added adult Bovine Serum Albumin (BSA)of United States origin, water, and/or cell growth promoting additives. All other FBS products, as listed below, including FBS Gold and FBS Standard, described as specialty sera', may contain adult BSA of United States origin, water, and/or cell growth promoting additives.
Product Quantityapproximately 280,000 liters
Recall NumberZ-1735-2013

Class II Biologics Event

Event ID65122
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Mar-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (the)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternMassachusetts
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code Info001KM82603
ClassificationClass II
Reason for RecallBlood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-1879-13

Class II Biologics Event

Event ID65123
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHoxworth Blood Center UC Medical Center
CityCincinnati
StateOH
CountryUS
Distribution PatternOhio
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW037712052449; W037712052449;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
Product Quantity2
Recall NumberB-1683-13

Class II Biologics Event

Event ID65143
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Mar-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifesouth Community Blood Centers - Montgomery Region
CityMontgomery
StateAL
CountryUS
Distribution PatternAlabama
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW1151130719671; W1151130719671; W1151130719671;
ClassificationClass II
Reason for RecallBlood products, with platelet counts below the specified minimum requirement, were distributed.
Product Quantity3
Recall NumberB-1881-13

Class II Biologics Event

Event ID65144
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Apr-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternSwitzerland
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW037912159715;
ClassificationClass II
Reason for RecallBlood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Product Quantity1
Recall NumberB-1682-13

Class II Biologics Event

Event ID65155
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Apr-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmOklahoma Blood Institute - Sylvan N Goldman Center
CityOklahoma City
StateOK
CountryUS
Distribution PatternOklahoma
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW091013118069; W091013118069; W091013118069;
ClassificationClass II
Reason for RecallBlood products, labeled leukoreduced without the assurance they met the criteria for leukoreduced products, were distributed.
Product Quantity3
Recall NumberB-1883-13

Class II Devices Event

Event ID65163
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRoche Diagnostics Operations, Inc.
CityIndianapolis
StateIN
CountryUS
Distribution PatternNationwide distribution: USA including states of: AL, CA, GA, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NY, OH, PA, TX, VA, VT, and WA.
 

Associated Products

Product DescriptionB-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma as an aid in assessing bone resorption. The test may be used as an aid in monitoring antiresorptive therapies (e.g. bisphosphonates, hormone replacement therapy - HRT) in postmenopausal women and individuals diagnosed with osteopenia. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.
Code InfoAll lot numbers
ClassificationClass II
Reason for RecallRoche Diagnostics internal investigations in R&D have shown that the claims for biotin interference and the sample stability given in the Elecsys ß-CrossLaps (ß-CL) assay package insert version 5, could not be reproduced. The ß-CrossLaps test results contribute to the monitoring of antiresorptive therapy. False low or false normal results may lead to delayed diagnosis and treatment of osteoporosis in the short term. To date, no customer complaints have been reported.
Product Quantity3056 units
Recall NumberZ-1727-2013

Class II Devices Event

Event ID65176
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLeibel-Flarsheim Company LLC
CityCincinnati
StateOH
CountryUS
Distribution PatternNationwide Distribution (US), including the states of TN, KY, CO, KS, CT, HI, and AZ.
 

Associated Products

Product DescriptionHydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.
Code InfoThe following catalog numbers, serial numbers and associated manufacturing dates are affected by this recall: 700539 CI0807H273 August2007; 700539 CI0106H162 January 2006; 700539 CI1010H523 October 2010; 700539 CI0811H567 August 2011; 700539 CI0108H313 January 2008; 700539 CI0309H418 March 2009; 700539 15031229 Apri12003; 700539 14031227 Apri12003; 700539 CI0404H045 January 2005; 700539 CI0504H054 May 2004; 700539 CI1106H208 November 2006; 700539 CI0509H424 May 2009
ClassificationClass II
Reason for RecallA complaint was received in which a hospital physicist indicated the dosage was too high on the HUT system. During the service call the systems Maximum Fluoro Dose was found to be 30 R/min which is three times the Maximum Fluoro Dose limit of 10 R/min.
Product Quantity12 units
Recall NumberZ-1753-2013

Class II Devices Event

Event ID65215
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBaxa Corporation
CityEnglewood
StateCO
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada, Latin America, Europe/Middle East/Africa, and Taiwan.
 

Associated Products

Product DescriptionExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.
Code InfoExactaMix 1200 serial numbers 45004-45481 (sequentially), and ExactaMix 2400 serial numbers 40005-40335.
ClassificationClass II
Reason for RecallBaxter Healthcare is recalling certain ExactaMix automated compounding devices due to the complementary metal oxide semi-conductor battery failure resulting in resetting the internal clock of the device to midnight December 31, 2010.
Product Quantity753 units
Recall NumberZ-1752-2013

Class II Devices Event

Event ID65303
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBoston Scientific Corporation
CityMarlborough
StateMA
CountryUS
Distribution PatternWorldwide distribution: US (nationwide) including states of: CA, FL, IA, ID, MI, OK, TA and WA; and countries of: Canada and Thailand.
 

Associated Products

Product DescriptionAlair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS 2-5. Product is manufactured and distributed by Boston Scientific Corporation (BSC), Sunnyvale, CA The Alair Bronchial Thermoplasty System (including the Alair Bronchial Thermoplasty Catheter) is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists.
Code InfoLot/batch Number: CM040212; Exp. Date: April 2014
ClassificationClass II
Reason for RecallBoston Scientific has discovered an inconsistent "Use By" expiration date on a single lot/batch of Alair Bronchial Thermoplasty Catheters. The expiration date indicated on the inner tray, 2012-04, is incorrect. The correct expiration date is 2014-04 as indicated on the outer box label.
Product Quantity35 units
Recall NumberZ-1748-2013

Class II Veterinary Event

Event ID65316
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-May-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmRI Textile Company
CityPawtucket
StateRI
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionPet Shoppe Chicken Jerky premium chicken dog treats, packaged in 20 ounce bags and 3.5 ounce bags. Distributed by Walgreen Co. Deerfield , IL Product Code: 7NPS420672 (3.5 ounce) and 7NPS420673 (20 ounce) Made in China
Code InfoLot Number/Best By Date: Y101E28B12884 , 3.5 oz (Best By: 06/26/2014) Y101I16B15284 , 20 oz (Best By: 10/03/2014) Y101H29B15029 , 20 oz (Best By: 09/19/2014) Y101H16B12775, 20 oz. (Best By: 08/29/2014)
ClassificationClass II
Reason for RecallPet treats contain trace amount of antibiotics
Product Quantity20 oz -61348 bags and 3.2 oz -16031 bags
Recall NumberV-225-2013

Class II Devices Event

Event ID65355
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-May-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmZeiss, Carl Inc
CityThornwood
StateNY
CountryUS
Distribution PatternDistributed in the states of MI, TX, SD, FL, GA, NY, and NY.
 

Associated Products

Product DescriptionPolarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation.
Code InfoModel # 445226-0000-000
ClassificationClass II
Reason for RecallCarl Zeiss Microscopy, LLC is recalling the Polarizer D component used in All upright ZEISS microscopes (Axio Imager, Axio Scope.A1, Axio Lab.A1) due to Misaligned Full-Wave (Lambda) Plate.
Product Quantity12 (1 in quarantine)
Recall NumberZ-1744-2013

Class II Devices Event

Event ID65406
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmIntegra LifeSciences Corporation
CityPlainsboro
StateNJ
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of Austria, Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Israel, Italy, Netherlands, Portugal, Russia, Saudia Arabia, South Africa, Spain and United Arab Emirates.
 

Associated Products

Product Description Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.
Code InfoAll lot numbers for PANTA Arthrodesis Nail Support Device Catalogue Nos: 519-110 and 519-130 from May 2006 to current.
ClassificationClass II
Reason for RecallAs a result of the investigation into an adverse trend of complaints for reports of misalignment of the calcaneal or tibial screws during use of the Panta Nail Support Device, Integra has decided to issue this voluntary medical device correction. The misalignment can result in the inability to properly insert the screws into the Panta Nail and create the potential need for revision surgery.
Product Quantity692
Recall NumberZ-1736-2013

Class II Devices Event

Event ID65456
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Instruments Div. of Stryker Corporation
CityPortage
StateMI
CountryUS
Distribution PatternWorldwide distribution: US (nationwide) including states of: AZ, FL, GA, NC, NY, SC, TX and VA; and countries of: India, Netherlands and Japan.
 

Associated Products

Product DescriptionStryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.
Code InfoSerial Number 0214200753
ClassificationClass II
Reason for RecallThe safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100% speed at full trigger depression in both forward or reverse, the handpiece may exceed full speed in reverse or may have excessive dead trigger travel before motor rotation in reverse, resulting in user annoyance.
Product Quantity0
Recall NumberZ-1740-2013
Product DescriptionCORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System (TPS").The Stryker Total Performance System (TPS) is intended for usein the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.
Code InfoSerial Number 0326801633, 0330802913, 0406200763, 0410401383, 0410600013, 0534203093,0627600783, 0730101013, 0730101033, 0805000553, 0809829593, 0935603083,1011903103, 1011903493, 1013814003, 1025400463, 1025400643, 1126901343, and 1128022593
ClassificationClass II
Reason for RecallThe safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100% speed at full trigger depression in both forward or reverse, the handpiece may exceed full speed in reverse or may have excessive dead trigger travel before motor rotation in reverse, resulting in user annoyance.
Product Quantity11
Recall NumberZ-1741-2013
Product DescriptionRemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment (CORE TM) System. When used with a variety of accessories, the RemB Electric Universal Driver is intended for surgical procedures involving driving wire or pins into bone and hard tissue. This includes but is not limited to Dental, ENT (Ear, Nose, Throat), Neuro, and Endoscopic applications. This device can also be used with the Total Performance System (TPSTM).
Code Info0910505713, 1029801073, 1225400823, 1314201603, 1314300713, 1314300723, 1314300733, 1314300743, 1314300753, 1314300763, 1314300773, 1314300783, 1314300793, 1314300803, 1314300813, 1314300823, 1314300833, 1314300843, 1314300853, 1314300863, 1314300873, 1314300883, 1314300893, 1314300903, 1314804033, 1314900053, 1314906453, 1314908193
ClassificationClass II
Reason for RecallThe safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100% speed at full trigger depression in both forward or reverse, the handpiece may exceed full speed in reverse or may have excessive dead trigger travel before motor rotation in reverse, resulting in user annoyance.
Product Quantity9
Recall NumberZ-1742-2013

Class II Devices Event

Event ID65492
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmEdwards Lifesciences, LLC
CityDraper
StateUT
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and Canada.
 

Associated Products

Product DescriptionEdwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.
Code InfoModels S099 and S099B
ClassificationClass II
Reason for RecallEdwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particulate inside the sterile pouch and within the internal diam ether of the wand.
Product QuantityS099: 171,587 units and S099B: 505,107 units
Recall NumberZ-1749-2013

Class II Devices Event

Event ID65505
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmKarl Storz Endoscopy America Inc
CitySouthbridge
StateMA
CountryUS
Distribution PatternUS distribution to: AZ, FL, IL, IN and TX.
 

Associated Products

Product Description27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments during treatment. The coaxial catheters will also allow simultaneous drainage of urine or infusion of other solutions.
Code InfoLots: 12471, 12281, 12271, 12171, 12101, 12051, 11501, 11401, 09471, 09431, 09251, 09201, 09161, 09091, 09071, 08451.
ClassificationClass II
Reason for RecallKarl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised, and therefore the sterility of the product could be affected.
Product Quantity40 units
Recall NumberZ-1728-2013

Class II Drugs Event

Event ID65511
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSandoz Incorporated
CityBroomfield
StateCO
CountryUS
Distribution PatternDistributed to one consignee in Indiana. No foreign, government, VA, or military consignees.
 

Associated Products

Product DescriptionEstarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540, NDC 0781-4058-15
Code InfoLot: LF01213A, Exp. 02/14
ClassificationClass II
Reason for RecallContraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
Product Quantity10,848 cartons
Recall NumberD-805-2013

Class II Drugs Event

Event ID65512
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFresenius Kabi USA, LLC
CityLake Zurich
StateIL
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionOxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01.
Code InfoLot #: 6003648, Exp. 6/2013
ClassificationClass II
Reason for RecallSubpotent Drug; 15-month stability test station
Product Quantity221,600 vials
Recall NumberD-804-2013

Class II Devices Event

Event ID65558
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStaar Surgical Co.
CityMonrovia
StateCA
CountryUS
Distribution PatternNationwide distribution: USA including states of: AL,AZ, CA, CO, CT, FL, GA, HI, KY, IA, IL, IN, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV.
 

Associated Products

Product DescriptionnanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The IOL is to be implanted in the posterior chamber and in the capsular bag through a tearfree capsulorhexis.
Code InfoSerial Numbers: B377007 B377125 B377343 B377522 B377622 B377914 B378040 B378215 B377008 B377126 B377347 B377526 B377627 B377915 B378041 B378216 B377009 B377130 B377348 B377531 B377632 B377918 B378042 B378217 B377010 B377131 B377349 B377532 B377635 B377920 B378043 B378218 B377013 B377142 B377350 B377536 B377640 B377921 B378051 B378219 B377016 B377151 B377352 B377538 B377643 B377923 B378053 B378220 B377020 B377153 B377353 B377539 B377650 B377926 B378057 B378222 B377024 B377154 B377354 B377541 B377651 B377936 B378058 B378223 B377025 B377158 B377355 B377542 B377655 B377940 B378059 B378225 B377026 B377161 B377356 B377543 B377660 B377942 B378062 B378227 B377029 B377165 B377357 B377544 B377669 B377943 B378063 B378228 B377030 B377167 B377358 B377548 B377678 B377944 B378065 B378231 B377032 B377168 B377359 B377550 B377681 B377945 B378067 B378234 B377034 B377171 B377360 B377551 B377686 B377946 B378068 B378235 B377035 B377172 B377361 B377552 B377687 B377950 B378070 B378236 B377036 B377255 B377362 B377553 B377689 B377959 B378071 B378239 B377037 B377258 B377363 B377554 B377690 B377960 B378072 B378241 B377038 B377259 B377366 B377555 B377691 B377963 B378075 B378242 B377040 B377262 B377367 B377557 B377692 B377964 B378076 B378248 B377041 B377263 B377368 B377558 B377693 B377971 B378077 B378255 B377042 B377264 B377369 B377559 B377700 B377972 B378081 B378257 B377043 B377267 B377370 B377560 B377706 B377974 B378082 B378258 B377045 B377270 B377371 B377561 B377707 B377975 B378083 B378259 B377049 B377273 B377372 B377562 B377713 B377979 B378086 B378263 B377054 B377276 B377374 B377563 B377718 B377983 B378087 B378264 B377057 B377278 B377376 B377564 B377721 B377988 B378165 B378265 B377061 B377285 B377377 B377567 B377727 B377991 B378171 B378267 B377062 B377288 B377378 B377569 B377730 B377993 B378172 B378268 B377065 B377290 B377383 B377570 B377741 B377998 B378173 B378269 B377068 B377291 B377384 B377571 B377744 B377999 B378175 B378271 B377070 B377297 B377386 B377572 B377745 B378000 B378177 B378274 B377074 B377298 B377388 B377573 B377746 B378002 B378178 B378275 B377081 B377301 B377389 B377575 B377748 B378006 B378179 B378277 B377083 B377305 B377396 B377576 B377756 B378008 B378180 B378282 B377085 B377306 B377397 B377578 B377759 B378019 B378182 B378284 B377087 B377308 B377400 B377579 B377764 B378020 B378186 B378286 B377095 B377314 B377402 B377587 B377765 B378024 B378188 B378291 B377096 B377315 B377409 B377588 B377766 B378027 B378190 B378298 B377099 B377317 B377411 B377594 B377769 B378028 B378192 B378299 B377102 B377319 B377414 B377596 B377774 B378029 B378194 B378302 B377105 B377323 B377415 B377598 B377776 B378030 B378198 B378303 B377106 B377324 B377416 B377599 B377900 B378031 B378199 B378304 B377113 B377332 B377420 B377601 B377901 B378032 B378206 B378306 B377114 B377336 B377421 B377602 B377902 B378034 B378208 B378307 B377118 B377337 B377422 B377603 B377904 B378035 B378209 B378308 B377120 B377338 B377498 B377610 B377906 B378036 B378210 B378311 B377121 B377341 B377511 B377616 B377908 B378038 B378211 B378312 B378314 B378415 B378505 B378597 B378750 B378822 B379221 B379329 B378316 B378416 B378506 B378600 B378755 B378824 B379223 B379331 B378317 B378418 B378507 B378601 B378757 B378825 B379226 B379333 B378319 B378421 B378509 B378605 B378759 B378831 B379228 B379334 B378320 B378425 B378510 B378607 B378760 B378833 B379230 B379335 B378321 B378426 B378511 B378611 B378761 B378834 B379231 B379337 B378322 B378427 B378516 B378612 B378762 B378835 B379232 B379343 B378326 B378428 B378517 B378625 B378763 B378836 B379233 B379345 B378328 B378429 B378518 B378626 B378765 B378838 B379235 B379347 B378331 B378430 B378522 B378628 B378766 B378842 B379236 B379349 B378332 B378431 B378523 B378632 B378767 B378847 B379237 B379354 B378334 B378433 B378526 B378634 B378768 B378848 B379239 B379357 B378337 B378438 B378529 B378639 B378769 B378852 B379240 B379363 B378351 B378441 B378530 B378640 B378770 B378853 B379243 B379365 B378353 B378444 B378531 B378642 B378771 B378854 B379244 B379366 B378365 B378445 B378533 B378646 B378774 B378855 B379245 B379367 B378369 B378446 B378535 B378652 B378776 B378856 B379248 B379368 B378371 B378448 B378537 B378653 B378777 B378857 B379249 B379369 B378372 B378449 B378538 B378655 B378780 B378859 B379253 B379371 B378373 B378452 B378539 B378656 B378781 B378860 B379254 B379372 B378374 B378456 B378540 B378659 B378783 B378861 B379256 B379373 B378375 B378462 B378541 B378660 B378785 B378862 B379258 B379374 B378376 B378466 B378546 B378664 B378786 B378864 B379259 B379375 B378378 B378468 B378547 B378671 B378787 B378865 B379260 B379376 B378380 B378470 B378549 B378674 B378790 B378868 B379261 B379377 B378381 B378472 B378550 B378677 B378791 B378874 B379263 B379378 B378383 B378473 B378553 B378679 B378792 B378875 B379265 B379379 B378384 B378474 B378555 B378680 B378793 B378876 B379266 B379380 B378388 B378480 B378556 B378681 B378794 B378877 B379268 B379381 B378390 B378481 B378557 B378684 B378795 B378884 B379277 B379382 B378391 B378483 B378558 B378690 B378798 B378885 B379279 B379383 B378392 B378485 B378559 B378691 B378799 B378888 B379282 B379384 B378394 B378486 B378560 B378692 B378800 B378894 B379284 B379385 B378395 B378487 B378561 B378701 B378801 B378895 B379288 B379387 B378399 B378488 B378563 B378703 B378802 B378897 B379289 B379388 B378402 B378490 B378565 B378705 B378803 B379197 B379290 B379389 B378403 B378491 B378569 B378712 B378805 B379198 B379291 B379390 B378404 B378492 B378570 B378714 B378808 B379201 B379292 B379391 B378405 B378493 B378571 B378716 B378809 B379202 B379293 B379393 B378406 B378494 B378572 B378727 B378810 B379205 B379296 B379396 B378407 B378496 B378573 B378729 B378811 B379208 B379308 B379397 B378408 B378498 B378574 B378735 B378812 B379211 B379309 B379398 B378410 B378500 B378575 B378737 B378813 B379212 B379311 B379400 B378411 B378501 B378583 B378740 B378814 B379215 B379319 B379404 B378412 B378502 B378586 B378742 B378815 B379216 B379321 B379405 B378413 B378503 B378588 B378746 B378820 B379219 B379324 B379406 B378414 B378504 B378595 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B384646 B384776 B385001 B385344 B385526 B385645 B386438 B384510 B384647 B384816 B385003 B385346 B385527 B385648 B386444 B384511 B384648 B384820 B385004 B385348 B385529 B385754 B386446 B384513 B384649 B384821 B385215 B385350 B385531 B385817 B386449 B384517 B384651 B384822 B385219 B385353 B385532 B385819 B386451 B384520 B384657 B384823 B385232 B385354 B385535 B385823 B386452 B384522 B384709 B384825 B385236 B385355 B385538 B385829 B386454 B384524 B384711 B384827 B385243 B385358 B385540 B385845 B386457 B384526 B384713 B384829 B385246 B385363 B385543 B385848 B386465 B384527 B384715 B384834 B385249 B385364 B385544 B385851 B386467 B384530 B384716 B384835 B385253 B385367 B385546 B385853 B386471 B384532 B384717 B384836 B385255 B385374 B385550 B385862 B386484 B384533 B384719 B384840 B385257 B385377 B385551 B385865 B386545 B384535 B384722 B384843 B385266 B385381 B385556 B385871 B386546 B384540 B384724 B384845 B385267 B385393 B385558 B385878 B386547 B384541 B384727 B384847 B385271 B385407 B385559 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ClassificationClass II
Reason for RecallSTAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial.
Product Quantity3,361 units total
Recall NumberZ-1746-2013
Product DescriptionAfinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction.
Code InfoSerial Numbers: B377178 B377469 B377877 B378928 B379032 B379638 B380197 B380796 B377192 B377473 B377879 B378940 B379048 B379643 B380200 B380800 B377193 B377480 B377880 B378945 B379062 B379645 B380206 B380801 B377194 B377481 B377883 B378946 B379063 B379646 B380208 B380803 B377195 B377482 B377885 B378947 B379066 B379650 B380214 B380807 B377196 B377485 B377887 B378949 B379093 B379652 B380227 B380816 B377197 B377487 B377888 B378951 B379095 B379653 B380230 B381000 B377200 B377488 B377889 B378953 B379096 B379660 B380235 B381001 B377205 B377490 B377890 B378954 B379099 B379661 B380245 B381009 B377208 B377491 B377894 B378955 B379100 B380060 B380246 B381011 B377211 B377493 B378097 B378956 B379101 B380070 B380251 B381012 B377213 B377495 B378099 B378957 B379103 B380071 B380257 B381014 B377214 B377496 B378107 B378958 B379104 B380072 B380261 B381017 B377216 B377497 B378110 B378959 B379106 B380073 B380265 B381019 B377217 B377804 B378111 B378960 B379107 B380078 B380270 B381021 B377232 B377812 B378112 B378961 B379110 B380081 B380271 B381022 B377236 B377816 B378122 B378963 B379111 B380084 B380272 B381024 B377238 B377819 B378123 B378964 B379112 B380085 B380273 B381026 B377239 B377820 B378124 B378965 B379114 B380087 B380274 B381028 B377241 B377821 B378126 B378967 B379115 B380088 B380280 B381029 B377243 B377822 B378130 B378968 B379117 B380091 B380281 B381030 B377245 B377824 B378131 B378969 B379119 B380092 B380283 B381032 B377248 B377825 B378132 B378970 B379121 B380093 B380285 B381034 B377249 B377827 B378135 B378972 B379123 B380094 B380286 B381036 B377253 B377828 B378137 B378973 B379125 B380097 B380287 B381037 B377423 B377829 B378144 B378976 B379129 B380098 B380288 B381038 B377426 B377830 B378145 B378979 B379131 B380102 B380290 B381039 B377428 B377831 B378148 B378981 B379132 B380106 B380291 B381040 B377429 B377834 B378156 B378982 B379133 B380108 B380519 B381041 B377432 B377839 B378160 B378986 B379134 B380118 B380529 B381051 B377435 B377842 B378899 B378990 B379135 B380125 B380548 B381052 B377437 B377843 B378901 B378991 B379141 B380129 B380554 B381054 B377440 B377844 B378902 B378993 B379145 B380135 B380560 B381057 B377441 B377845 B378906 B378994 B379147 B380137 B380561 B381060 B377442 B377847 B378909 B379000 B379148 B380143 B380562 B381071 B377443 B377848 B378911 B379002 B379156 B380152 B380563 B381073 B377444 B377849 B378913 B379003 B379162 B380154 B380564 B381078 B377445 B377852 B378915 B379005 B379165 B380156 B380573 B381079 B377446 B377855 B378917 B379006 B379168 B380159 B380575 B381083 B377447 B377856 B378918 B379010 B379170 B380162 B380580 B381087 B377448 B377857 B378919 B379012 B379171 B380163 B380585 B381089 B377450 B377860 B378920 B379013 B379174 B380178 B380586 B381091 B377455 B377861 B378923 B379017 B379176 B380186 B380588 B381093 B377457 B377862 B378924 B379020 B379183 B380187 B380594 B381094 B377459 B377863 B378925 B379021 B379189 B380190 B380595 B381095 B377460 B377873 B378926 B379022 B379627 B380191 B380597 B381096 B377466 B377875 B378927 B379030 B379637 B380193 B380600 B381099 B381102 B381476 B382514 B383250 B384698 B385137 B381104 B381478 B382544 B383252 B384699 B385143 B381105 B381488 B382546 B383256 B384703 B385144 B381106 B381493 B382547 B383257 B384797 B385147 B381107 B381516 B382548 B383912 B385006 B385158 B381109 B381518 B382554 B383914 B385015 B385171 B381112 B381519 B382555 B383930 B385016 B385650 B381114 B381521 B382557 B383932 B385017 B385651 B381116 B381529 B382558 B383948 B385021 B385652 B381118 B381539 B382636 B384045 B385022 B385655 B381119 B381540 B382637 B384054 B385023 B385656 B381121 B381542 B382645 B384058 B385026 B385658 B381122 B381543 B382647 B384063 B385030 B385659 B381123 B381545 B382648 B384066 B385031 B385965 B381124 B382384 B382652 B384067 B385032 B385967 B381127 B382386 B382658 B384068 B385033 B385968 B381130 B382388 B382660 B384071 B385035 B385987 B381140 B382389 B382661 B384072 B385037 B386070 B381142 B382392 B382662 B384077 B385043 B386081 B381147 B382396 B382669 B384081 B385044 B386131 B381168 B382400 B382672 B384085 B385050 B386179 B381175 B382401 B382679 B384089 B385058 B386228 B381176 B382416 B382683 B384091 B385074 B386250 B381177 B382423 B382686 B384096 B385079 B386258 B381178 B382428 B382687 B384097 B385091 B386259 B381182 B382429 B382688 B384101 B385092 B386260 B381183 B382430 B382692 B384183 B385093 B386263 B381185 B382432 B382693 B384184 B385094 B386265 B381186 B382437 B382702 B384186 B385096 B386266 B381189 B382438 B382709 B384187 B385098 B386930 B381191 B382441 B382710 B384188 B385099 B386932 B381192 B382442 B382711 B384190 B385101 B386943 B381195 B382446 B382719 B384193 B385102 B386953 B381199 B382448 B382722 B384194 B385104 B381201 B382450 B382743 B384202 B385105 B381202 B382453 B382761 B384203 B385108 B381203 B382455 B382776 B384207 B385109 B381204 B382456 B382790 B384208 B385112 B381206 B382457 B382801 B384212 B385116 B381208 B382465 B382807 B384213 B385118 B381211 B382471 B383231 B384215 B385119 B381213 B382472 B383235 B384670 B385120 B381216 B382484 B383237 B384675 B385121 B381220 B382485 B383238 B384677 B385122 B381223 B382505 B383240 B384682 B385125 B381228 B382509 B383246 B384684 B385127 B381466 B382512 B383247 B384686 B385129
ClassificationClass II
Reason for RecallSTAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial.
Product Quantity3,361 units total
Recall NumberZ-1747-2013

Class II Devices Event

Event ID65561
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-May-13
Initial Firm Notification of Consignee or Public Visit
Recalling FirmSynthes USA HQ, Inc.
CityWest Chester
StatePA
CountryUS
Distribution PatternUS Nationwide Distribution including the states of MA, TX, MN, SC, UT, VA, and NY.
 

Associated Products

Product DescriptionMulti Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector Distractor can be utilized to perform bone transport procedures as an alternative to bone grafts and free flaps.
Code Info Titanium Multi Vector Distractor Pin Holding Clamp, body, limited bone stock Part # 487.941 with lot numbers: 3769720, 3779569, 3788731, 3794434, 7806093, 7823463 and Titanium Multi Vector Distractor Pin Holding Clamp, ramus, limited bone stock Part # 487.942 with lot numbers: 3769706, 3779571, 3788741, 7806096, 7823464.
ClassificationClass II
Reason for RecallSynthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited bone stock. The firm received complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. It is not likely that a serious adverse event will result due to a nonconforming clamp, however there is a remote potential that additional intervention would be required due to a non-functioning clamp.
Product Quantity121
Recall NumberZ-1745-2013

Class II Food Event

Event ID65592
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jun-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 PatternAlaska, CT, ID, IL, IN, MD, MA, MT, NH, NJ, NY, NC, OH, PA, TN, VA, WA and WI.
 

Associated Products

Product DescriptionTalenti Gelato, Toasted Almond, One Pint (473ml), Crafted by: Talenti, Marietta, GA 30062
Code InfoLot #: 11/15/2014 M1, UPC #:1 86852 00039 6
ClassificationClass II
Reason for RecallProduct contains undeclared Allergen; Pecans.
Product Quantity420 Cases/3360 units.
Recall NumberF-1717-2013

Class II Devices Event

Event ID65620
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions USA, Inc
CityMalvern
StatePA
CountryUS
Distribution PatternUnited States Nationwide Distribution - including the states of: CA, CO, FL, IA, IL, IN, MA, MD, MI, NC, NY, PA, TX, VA and WA and Puerto Rico.
 

Associated Products

Product DescriptionSiemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system
Code InfoMaterial number 10094137 -- serial numbers 147515, 147500, 147528, 147514, 147516, 147526; material number 10094141 -- serial numbers 154408, 154406, 154453, 154423, 154430, 154425, 154429; material number 10280959 -- serial numbers 160813, 160823, 160812, 160800, 160431, 160814, 160807, 160817, 160816; material number 10094139 -- serial number 157907.
ClassificationClass II
Reason for RecallDuring the course of product monitoring, Siemens became aware of a tolerance problem in the power supply of the generator control above a specific value, thus, the generator may fail.
Product Quantity23
Recall NumberZ-1750-2013

Class II Drugs Event

Event ID65642
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jun-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmChurch & Dwight Inc
CityPrinceton
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionSodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 1 Powdered, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60111.
Code InfoLot #: FF3153, FF3154, FF3155, FF3156, FF3157, and FF3158
ClassificationClass II
Reason for RecallPresence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Product Quantity749 tons total
Recall NumberD-797-2013
Product DescriptionSodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP2 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 2 Fine Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60211.
Code InfoLot #: FF3153, FF3154, FF3155, FF3156, FF3157, and FF3158
ClassificationClass II
Reason for RecallPresence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Product Quantity749 tons total
Recall NumberD-798-2013
Product DescriptionSodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 3 Fine Powdered, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60311.
Code InfoLot #: FF3153, FF3154, FF3155, FF3156, FF3157, and FF3158
ClassificationClass II
Reason for RecallPresence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Product Quantity749 tons total
Recall NumberD-799-2013
Product DescriptionSodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, Sodium Bicarbonate U.S.P. No. 4 Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60411.
Code InfoLot #: FF3153, FF3154, FF3155, FF3156, FF3157, and FF3158
ClassificationClass II
Reason for RecallPresence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Product Quantity749 tons total
Recall NumberD-800-2013
Product DescriptionSodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 5 Coarse Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60511.
Code InfoLot #: FF3153, FF3154, FF3155, FF3156, FF3157, and FF3158
ClassificationClass II
Reason for RecallPresence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Product Quantity749 tons total
Recall NumberD-801-2013

Class II Devices Event

Event ID65647
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternWorldwide Distribution - US (nationwide) including the states of IA, IL, MN, SD and WA., and Costa Rica.
 

Associated Products

Product DescriptionLifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 97 IN (249 CM); PRIMING VOLUME: 14 ML; For the administration of I.V. fluids; Made in Costa Rica; Hospira, Inc., Lake Forest, IL 60045 USA The Hospira Symbiq Infusion System is a general infusion system which provides IV infusion across the general spectrum of clinical care. The Symbiq pumps are standard sized pumps which are typically facility-based infusion pumps which may be used to deliver continuous and/or intermittent infusions to a variety of patient populations.
Code InfoList Number: 19666-04-28; Lot Number: 87-188-5H
ClassificationClass II
Reason for RecallHospira has received reports of customers experiencing air-in-line alarms related to administration sets that have a drip chamber with a ball valve. Preliminary investigation findings found that there is a potential for the ball valve to not seal the drip chamber as intended, leading to air in the line of the administration set.
Product Quantity14,400 units
Recall NumberZ-1751-2013

Class II Devices Event

Event ID65664
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmKooJoo Trading Company
CityGimpo City, Gyeongki-Do
State
CountryKR
Distribution PatternUS Distribution GA only.
 

Associated Products

Product DescriptionSafety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retracts, No lancing device required. 26G - Single Use Only, Made In Korea Distributed by Hummingbird Medical, Savannah, GA 100 count Boxes; 40 boxes per case Blood collection by penetrating skin with needle.
Code InfoLot # HBM1303-4886, Exp 3/6/2016; Lot# HBM1303-4886, Exp 3.6 to 3/21/2016; Lot# HBM1201-02, Exp 1/16/2015; Lot# HBM1203-02, Exp 4/5/2015
ClassificationClass II
Reason for RecallLancets were not sterilized within the dose range established by sterilization validation.
Product Quantity7, 712, 000 pieces (1928 cartons)
Recall NumberZ-1729-2013

Class II Devices Event

Event ID65670
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSynthes USA HQ, Inc.
CityWest Chester
StatePA
CountryUS
Distribution PatternNationwide Distribution including PA, CT, DE, and NY.
 

Associated Products

Product DescriptionSynthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.
Code InfoPart # 04.315.067 with lot #s 6184270 and/or 22612-04.
ClassificationClass II
Reason for RecallThe firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF) Distractor System, due to a mis-alignment issue. There have been instances reported within the impacted lots in which the slot in the barrel of the BC distractor was rotated such that it was not possible to attach the B-type and C-type foot plates.
Product Quantity10
Recall NumberZ-1726-2013

Class II Drugs Event

Event ID65683
StatusCompleted
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Health Packaging
CityColumbus
StateOH
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionQUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01
Code InfoLot 122600 Exp. 03/14
ClassificationClass II
Reason for RecallFailed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Product Quantity19060 blister cards
Recall NumberD-802-2013

Class III Biologics Event

Event ID45167
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jul-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityPomona
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionCryoprecipitated AHF
Code Info084FT06904, 084FT06961, 084FT07108, 084FT07114, 084FT07188, 021LC88992, 084FT07115, 084FT07117, 084FT07155, 084FT07157, 084FT06946, 084FT07211, 021LK33581, 021LC88495, 084FT07300, 084FT07101, 084Q 49296, 084FT07112, 084K 90768, 084K 91006, 084Q 49188, 021LC89396, 021LG50163, 021LH48240,021KS63809, 021KS63820, 021LJ44014, 021LJ44023, 021LK33463, 021LK33471, 084K 91594, 021KS63816, 084FT07855, 084FT07858, 084FT07860, 084FT07895, 084FT02469, 084K 91668, 084FT07872, 084Q 50129, 084W 89449,
ClassificationClass III
Reason for RecallBlood products, lacking assurance of having been maintained at an acceptable temperature during shipping, were distributed.
Product Quantity41
Recall NumberB-1800-13

Class III Biologics Event

Event ID45176
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Aug-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources Inc Dba International Bioresources
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code Info368059868
ClassificationClass III
Reason for RecallBlood product, collected from a donor whose arm inspection was not documented, was distributed.
Product Quantity1
Recall NumberB-1798-13

Class III Biologics Event

Event ID48296
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Apr-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources Inc Dba International Bioresources
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code Info368092877
ClassificationClass III
Reason for RecallBlood product, collected from a donor whose arm inspection was not documented, was distributed.
Product Quantity1 unit
Recall NumberB-1666-13

Class III Biologics Event

Event ID48297
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Apr-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources Inc Dba International Bioresources
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code Info368095570
ClassificationClass III
Reason for RecallBlood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-1700-13

Class III Biologics Event

Event ID48872
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jun-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources Inc Dba International Bioresources
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code Info368078740, 368078739, 368078741, 368078742, 368078743, 368078744, 368078745, 368078746, 368078747, 368078749, 368078750, 368078751
ClassificationClass III
Reason for RecallSource Plasma, which reached unacceptable temperatures during storage and was not relabeled as Source Plasma, Salvaged, was distributed.
Product Quantity12 units
Recall NumberB-1699-13

Class III Biologics Event

Event ID48873
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jun-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources Inc Dba International Bioresources
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code Info368096614
ClassificationClass III
Reason for RecallBlood product, collected from a donor whose arm inspection was not documented, was distributed.
Product Quantity1 unit
Recall NumberB-1667-13

Class III Biologics Event

Event ID52248
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Apr-09
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources Inc Dba International Bioresources
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code Info368113477, 368113196, 368112733, 368112468, 368111928, 368111524, 368110980, 368110672, 368110337, 368109593, 368109176, 368108774, 368108556, 368105673, 368105400, 368105048, 368104748, 368104352, 368104082, 368103299, 368102857, 368102609, 368102190, 368101662, 368101408, 368100001, 368099530, 368099017, 368098657, 368097870, 368097647, 368097193, 368096831, 368095975, 368095635, 368095159, 368095028, 368094533, 368094268, 368093898, 368093518, 368093303, 368092635, 368092317, 368091546, 368091172, 368090881, 368089542, 368089273, 368087926, 368079629, 368079115, 368078896, 368077952, 368077703, 368077147, 368076780, 368075538, 368074011, 368073101, 368100408, 368098257
ClassificationClass III
Reason for RecallBlood products, collected from a donor who was deferred for a history of Hepatitis A, were distributed.
Product Quantity62 units
Recall NumberB-1757-13

Class III Biologics Event

Event ID59509
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Jul-11
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmOctapharma Plasma, Inc.
CityCharlotte
StateNC
CountryUS
Distribution PatternAustria
 

Associated Products

Product DescriptionSource Plasma
Code Info5250051627, 5250051321, 5250050643, 5250050422, 5250049708, 5250049571, 5250048584, 5250047966, 5250047708, 5250046985, 5250046641, 5250046068, 5250045742, 5250045161, 5250044825, 5250044144, 5250043890, 5250042937, 5250041894, 5250041609, 5250040334, 5250040089, 5250038529
ClassificationClass III
Reason for RecallSource Plasma, collected from donors who did not have a complete medical history interview, was distributed.
Product Quantity23 units
Recall NumberB-1701-13

Class III Biologics Event

Event ID64976
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Mar-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Centers of the Pacific - Irwin Center
CitySan Francisco
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells Deglycerolized Leukocytes Reduced
Code InfoW117010183953S, W1170081297363, W117008114557A
ClassificationClass III
Reason for RecallBlood products, which did not meet the minimum requirement for Red Blood Cell recovery, were distributed.
Product Quantity3 units
Recall NumberB-1756-13

Class III Biologics Event

Event ID65038
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Mar-13
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 Info3790257469; 3790257180; 3790256644; 3790256260; 3790255828; 3790255494; 3790255100; 3790254863; 3790254530; 3790254270; 3790253472; 3790252922; 3790252673; 3790251933; 3790251841; 3790251087; 3790250939; 3790250281; 3790250177; 3790249386; 3790249125; 3790248527; 3790248244; 3790247722; 3790247421; 3790246602; 37902246113; 3790245714; 3790245113; 3790244885; 3790244154; 3790244048; 3790243116; 3790242788; 3790242245; 3790241926; 3790241428; 3790241095; 3790240608; 3790240359; 3790239984; 3790239546; 3790239042; 3790238716; 3790238168; 3790237858; 3790237272; 3790236967; 3790236464; 3790236130; 3790235562; 3790235177; 3790234608; 3790234316; 3790233728; 3790233443; 3790232961; 3790232696; 3790231965; 3790231667; 3790231096; 3790230808; 3790230300; 3790229982; 3790229441; 3790229192; 3790228604; 3790228279; 3790227732; 3790227402; 3790261668; 3790261235; 3790261038; 3790260537; 3790260346; 3790259386; 3790259110; 3790258319; 3790258054;
ClassificationClass III
Reason for RecallBlood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Product Quantity79
Recall NumberB-1762-13

Class III Biologics Event

Event ID65114
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternSwitzerland
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036812339618;
ClassificationClass III
Reason for RecallBlood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-1880-13

Class III Biologics Event

Event ID65232
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCryoLife, Inc.
CityKennesaw
StateGA
CountryUS
Distribution PatternPennsylvania; Nebraska; Indiana
 

Associated Products

Product DescriptionVascular Graft
Code Info9863824; 9863853; 9863911
ClassificationClass III
Reason for RecallVascular grafts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Product Quantity3 allografts
Recall NumberB-1983-03

Class III Biologics Event

Event ID65233
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCryoLife, Inc.
CityKennesaw
StateGA
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionCardiac Tissue, Non-valved
Code Info9985176; 9985185
ClassificationClass III
Reason for RecallCardiac grafts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Product Quantity2 allografts
Recall NumberB-1942-13

Class III Biologics Event

Event ID65234
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCryoLife, Inc.
CityKennesaw
StateGA
CountryUS
Distribution PatternNew York; West Virginia; Indiana
 

Associated Products

Product DescriptionVascular Graft
Code Info9962023
ClassificationClass III
Reason for RecallHuman tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.
Product Quantity1 allograft
Recall NumberB-1995-13
Product DescriptionCardiac Tissue, Non-valved
Code Info9962099
ClassificationClass III
Reason for RecallHuman tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.
Product Quantity1 allograft
Recall NumberB-1996-13
Product DescriptionHeart Valve
Code Info9962113
ClassificationClass III
Reason for RecallHuman tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.
Product Quantity1 unit
Recall NumberB-1997-13

Class III Biologics Event

Event ID65235
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCryoLife, Inc.
CityKennesaw
StateGA
CountryUS
Distribution PatternCalifornia; Texas
 

Associated Products

Product DescriptionVascular Graft
Code Info9832390; 9832483; 9840388
ClassificationClass III
Reason for RecallVascular grafts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Product Quantity3 allografts
Recall NumberB-1751-13

Class III Biologics Event

Event ID65236
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCryoLife, Inc.
CityKennesaw
StateGA
CountryUS
Distribution PatternCanada; South Carolina; Florida
 

Associated Products

Product DescriptionHeart Valve
Code Info9860382
ClassificationClass III
Reason for RecallHuman tissue allograft, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.
Product Quantity1 allograft
Recall NumberB-1992-13
Product DescriptionVascular Graft
Code Info9860472
ClassificationClass III
Reason for RecallHuman tissue allograft, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.
Product Quantity1 allograft
Recall NumberB-1993-13
Product DescriptionCardiac Tissue, Non-valved
Code Info9860511
ClassificationClass III
Reason for RecallHuman tissue allograft, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.
Product Quantity1 allograft
Recall NumberB-1994-13

Class III Biologics Event

Event ID65238
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCryoLife, Inc.
CityKennesaw
StateGA
CountryUS
Distribution PatternMichigan; Maryland; Texas; Minnesota
 

Associated Products

Product DescriptionVascular Graft
Code Info10022449; 10022514; 10022551
ClassificationClass III
Reason for RecallHuman tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Product Quantity3 units
Recall NumberB-1988-13
Product DescriptionHeart Valve
Code Info10022483
ClassificationClass III
Reason for RecallHuman tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Product Quantity1 unit
Recall NumberB-1989-13
Product DescriptionCardiac Tissue, Non-valved
Code Info10022525
ClassificationClass III
Reason for RecallHuman tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Product Quantity1 unit
Recall NumberB-1990-13

Class III Biologics Event

Event ID65239
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCryoLife, Inc.
CityKennesaw
StateGA
CountryUS
Distribution PatternCalifornia; Texas
 

Associated Products

Product DescriptionVascular Graft
Code Info9984625; 9984638
ClassificationClass III
Reason for RecallHuman vascular allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Product Quantity2 allografts
Recall NumberB-1938-13

Class III Biologics Event

Event ID65241
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCryoLife, Inc.
CityKennesaw
StateGA
CountryUS
Distribution PatternLouisiana; Georgia
 

Associated Products

Product DescriptionHeart Valve
Code Info9951484; 9951491
ClassificationClass III
Reason for RecallHeart Valves, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Product Quantity2 allografts
Recall NumberB-1937-13

Class III Biologics Event

Event ID65242
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCryoLife, Inc.
CityKennesaw
StateGA
CountryUS
Distribution PatternCanada; New York
 

Associated Products

Product DescriptionCardiac Tissue, Non-valved
Code Info9799209; 9856929
ClassificationClass III
Reason for RecallCardiac tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Product Quantity2 allografts
Recall NumberB-1936-13

Class III Food Event

Event ID65427
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jun-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmKenton Burr
CityTrumansburg
StateNY
CountryUS
Distribution PatternNew York State (Fingerlakes region)
 

Associated Products

Product DescriptionKENTON'S CHEESE CO. Bianco A soft Brie-Style cheese Aged at least 60 days, Net Wt. 8 oz wheel. Distributed by Kenton's Cheese Company 5939 Burr Rd. Trumansburg, NY 14886.
Code InfoBatch: 13064
ClassificationClass III
Reason for RecallKenton's Cheese Co. is recalling Bianco A Soft Brie-Style Cheese due to E.coli contamination. Consumers who have purchased Bianco-Brie from Kenton's Cheese Co. between May 9, 2013 and May 19, 2013 listed with Batch number 13064, are urged to return the product to Kenton's Cheese Co. 5939 Burr Road Trumansburg, NY 14886. Questions may be directed to Kenton Burr (607) 592-0746 or via e-mail kenton@kentonscheeseco.com. A full refund will be provided by Kenton's Cheese Co.
Product Quantity200 wheels
Recall NumberF-1716-2013

Class III Drugs Event

Event ID65516
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTeva Pharmaceuticals USA, Inc.
CitySellersville
StatePA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionAmoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960.
Code InfoLot #s: a) 35426557A, 35426558A, Exp 08/14; b) 35426554A, 35426555A, 35426556A, Exp 08/14
ClassificationClass III
Reason for RecallDiscoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.
Product Quantity109,080 Bottles
Recall NumberD-803-2013

Class III Devices Event

Event ID65652
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTechnidata S.A.
CityMontbonnot St Martin
State
CountryFR
Distribution PatternUS Distribution CA only.
 

Associated Products

Product DescriptionTDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)
Code InfoAll TDHistology/Cytology product versions.
ClassificationClass III
Reason for RecallA recall was initiated by Technidata because use of symbols (less than or equal to or greater than or equal to or any other symbol) in Microsoft Word reports when using electronic transmissions of results by of HPRIM (including HPRIM Medecin via Kermit) or HL7 must be absolutely prohibited. Such symbols are not supported by the Microsoft Word interface used by the Histology/Cytology software and this could potentially lead to the wrong conversion of symbols less than or equal to or greater than or equal to into "=".
Product Quantity1 site
Recall NumberZ-1743-2013

Class III Drugs Event

Event ID65702
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBayer HealthCare Pharmaceuticals Inc.
CityWayne
StateNJ
CountryUS
Distribution PatternNY, CA
 

Associated Products

Product DescriptionMedroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg), Bayer Schering Pharma AG, D-13342 Berlin
Code InfoLot 87100040
ClassificationClass III
Reason for RecallFailed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
Product Quantity194.62 kg
Recall NumberD-807-2013

Mixed Classification Biologics Event

Event ID64955
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Feb-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmSouth Texas Blood & Tissue Center
CitySan Antonio
StateTX
CountryUS
Distribution PatternTexas
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info7188318;
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1
Recall NumberB-1772-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code Info7188318;
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1
Recall NumberB-1773-13
Product DescriptionFresh Frozen Plasma
Code InfoW140912138630; 2488230;
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity2
Recall NumberB-1774-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW140912138630; 2488230;
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity2
Recall NumberB-1775-13
Product DescriptionPlatelets
Code Info2488230;
ClassificationClass III
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1
Recall NumberB-1776-13

Mixed Classification Biologics Event

Event ID65025
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Mar-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLake Worth
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW036810221666;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1770-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036810221666;
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1771-13
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