• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

  • Print
  • Share
  • E-mail
-
Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Blood and Blood Products for Reprocessing LT94863 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Center of Central Iowa (The)
Biologics Red Blood Cells KX15411 Class III Blood product, collected from a donor with a history of surgery within 12 months, was distributed. Blood Center of Central Iowa (The)
Biologics Red Blood Cells Leukocytes Reduced FC11222; LF14391 Class II Blood products, collected from a donor who was taking Prednisone, were distributed. Blood Center of Central Iowa (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 003GJ84411 (part 1); 003GJ84411 (part 2) Class III Blood products, collected under conditions where the sterility of the products may have been compromised, were distributed. The American National Red Cross - Southern Region
Biologics Blood and Blood Products for Reprocessing 112538839;119944156;119936451 Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Blood Systems, Inc.
Biologics Red Blood Cells FM50697 Class II Blood products, collected from a donor taking the Prednisone, were distributed. Blood Center of Central Iowa (The)
Biologics Blood and Blood Products for Reprocessing KW65638 Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Blood Center of Central Iowa (The)
Biologics Platelets Pheresis Leukocytes Reduced 09FC14644; 09FC14644 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced H15057 Class III Blood product, which failed to meet the minimum specification for 85% red blood cell recovery, was distributed. LifeServe Blood Center
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced H15054 Class III Blood product, which failed to meet the minimum specification for 85% red blood cell recovery, was distributed. LifeServe Blood Center
Biologics Red Blood Cells Leukocytes Reduced 020LE04030, 020LE04031, 020LE04032, 020LE04033, 020LE04034, 020LE04035, 020LE04036, 020LE04037, 020LE04038, 020LE04039, 020LE04040, 020LE04041, 020LE04042, 020LE04043, 020LE04044. Class III Blood products, in which instrument QC or validation was unacceptable were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 20LF61216 Class II Blood product, collected from a donor whose health history screening was inadequately performed, was distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 020LY57772 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. American National Red Cross (The)
Biologics Source Plasma FD0404494; FD0405248 Class II Blood products, which tested reactive to HIV 1/2 and staff failed to quarantine units due to medical history, were distributed. DCI Biologicals LLC
Biologics Platelets Pheresis Leukocytes Reduced 21KP50423 Class III Blood product, which shipment exceeded time allowed for shipping, was distributed. American Red Cross Blood Services
Biologics Red Blood Cells FW11611 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. LifeServe Blood Center
Biologics Blood and Blood Products for Reprocessing FW11611 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. LifeServe Blood Center
Biologics Red Blood Cells Leukocytes Reduced 020Q30582. Class III Blood product, leukoreduced after five day timing requirement, was distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced 02GG06978 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 02GG11896 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 020X 25176. Class II Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced 020KK40568 Class II Blood products, collected from a donor for whom donor suitability were not adequately determined, was distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 020KK40568 Class III Blood products, collected from a donor for whom donor suitability were not adequately determined, was distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced LH85065 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. American National Red Cross (The)
Biologics Cryoprecipitated AHF LH85065 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing LQ10869 Class III Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. LifeServe Blood Center
Biologics Red Blood Cells LQ10869 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. LifeServe Blood Center
Biologics Cryoprecipitated AHF LF32631 Class II Blood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed. LifeServe Blood Center
Biologics Blood and Blood Products for Reprocessing 21LV32945. Class III Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced 21LV32945 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced Irradiated 03KH34072 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. The American National Red Cross - Southern Region
Biologics Plasma Cryoprecipitated Reduced 03KH34072 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. The American National Red Cross - Southern Region
Biologics Blood and Blood Products for Reprocessing 003LH13062 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells Leukocytes Reduced 003LH13062 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells 21GV49837 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. American National Red Cross
Food Banana Nut Bread packed in carton, placed in polypropelin Bag 1 lb each Bar Code 0 36746 03961 5 Class II The firm had pecans and not walnuts listed in their ingredient statement. Servatii Inc
Biologics Cryoprecipitated AHF 21LZ10857, 21LZ10863, 21LZ10864, 21GE85270, 21KS75301, 21LG68117, 21LJ62045, 21LK47755, 21LZ11063, 21KW65496, 21KW65814, 21LG67732, 21LV34200, 21LZ09910, 21KS75960, 21LG68533, 21LG68547, 21LG68583, 21LH64005, 21LJ62119, 21LJ62128, 21LK47589, 21LZ09070, 21LZ10746, 21KW65944, 21KW65964, 21LG67958, 21LG68114, 21LG68131, 21LZ11061. Class III Blood products, which may have reached an unacceptable temperature during shipment, were distributed.. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced Irradiated W037908143525; W037908141792; W037908141784; W037908141565; W037908139613 Class III Blood products, which were labeled with an incorrect expiration date, were distributed.. LifeServe Blood Center
Biologics Red Blood Cells Leukocytes Reduced W037908133161;LF42976 Class III Blood products, collected from a donor taking the medication Enbrel, were distributed. LifeServe Blood Center
Biologics Red Blood Cells LX68719 Class III Blood products, collected from a donor taking the medication Enbrel, were distributed. LifeServe Blood Center
Biologics Plasma Frozen W037908133161;LX68719 Class III Blood products, collected from a donor taking the medication Enbrel, were distributed. LifeServe Blood Center
Biologics Blood and Blood Products for Reprocessing LF42976 Class III Blood products, collected from a donor taking the medication Enbrel, were distributed. LifeServe Blood Center
Biologics Red Blood Cells (Apheresis) Irradiated W047008155090B; W047008155091A; W047008155089B Class II Blood products, which did not meet the acceptable product specifications, were distributed. New York Blood Center, Inc.
Biologics Red Blood Cells (Apheresis) W047008155090A; 047008155046A; W047008155046B; W047008155053A; W047008155053B; W047008155085A; W047008155085B; W047008155087A; W047008155087B; W047008155088A; W047008155089A; W047008155091B; W047008155093A; W047008155093B; W047008155094A; W047008155094B; W047008155118B; W047008155120B; W047008155121B; W047008155122B; W047008155118A; W047008155120A; W047008155121A; W047008155122A; W047008155123A; W047008155123B; W047008155124B; W047008155125B; W047008161334B; W047008161341B; W047008184441B; W047008184422B; W047008184435B; W047008184441B; W047008155124A; W047008155125A; W047008161334A; W047008161341A; W047008184441A; W047008184422A; W047008184435A; W047008184441A Class II Blood products, which did not meet the acceptable product specifications, were distributed. New York Blood Center, Inc.
Biologics Source Plasma 383033676;383033437;383033025;383032539;383032332;383030509; 383030274;383030058;383034026;383037227;383036451;383036067; 383035886;383035593;383035197;383034952;3830334655;383034255 383029803 ,383029600 ,383029286 ,383029044 ,383028734 ,383028522 , 383028239,383027475 ,383027303 ,383026281 ,383020830 ,383020596 , 383020280 ,383020007 ,383019791 ,383019360 ,383018812 ,383023458 , 383023441 Class III Blood products, which were collected from a donor with a history of high risk behaviors, were distributed. Talecris Plasma Resources, Inc.
Food Miravalle brand "Pan Rallado Sazonado", 8 oz. Seasoned bread crumbs. Also packaged in 12 pack. Product labeling reads in part:"Miravalle PAN RALLADO SAZONADO SEASONED BREAD CRUMBS Net Wt. 8 Oz.***Packed and Distributed by: Miravalle El Monte, CA 91733***". UPC: 7 12810-00812 Lot numbers: 0010 Expiration date: 08/2013 Class II In response to a FDA inspection, the firm initiated this recall due to undeclared wheat and no nutritional facts listed, for the product "Pan Rallado Sazonado". Miravalle Food, Inc
Biologics Source Plasma 0130049526, 0130050511. Class II Blood products, collected from a donor who had been incarcerated, were distributed. Biomat USA, Inc.
Devices Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist at the point of care within the operating room. All Pyxis Anesthesia System Model 2000 Class II The recall was initiated because Carefusion has confirmed that when the PAS 2000 drawers due to inaccessability of drawers caused by system down time or lock-up. CareFusion Corporation
Biologics Plasma Frozen Cryoprecipitate Reduced W04230905631400S Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Systems, Inc
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W042309037311008 , W042309037311008 , W04230903736500H , W04230903736500H , W042309060749001 , W042309063237001 , W042309060749001 , W042309061224006 , W042309061224006 , W04230906193800C , W04230906193800C , W04230906239600O , W04230906280300Q , W042309063237001 , W04230906345900A , W04230906357100A. Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Systems, Inc
Biologics Red Blood Cells Leukocytes Reduced W04230903733800N, W04230903734700L, W04230903735000V, W042309037369009, W04230903738000J, W04230903794300I, W04230903795000K, W042309037956008, W042309037967002, W04230903797000C, W042309037975002, W04230903797800X, W042309037980008, W04230903803600Z, W04230906124500X, W04230906125600R, W04230906126600N, W04230906139800*, W04230906339100I, W04230906347200G, W042309063476008, W04230906377900F, W042309037231008, W04230903730800Z, W042309037315000, W042309037331000, W04230903803000A, W04230905301900G, W04230906074300D, W042309060747005, W04230906075200B, W042309061231008, W04230906133400V, W04230906133700P, W042309061386007, W042309061393009, W04230906191700M, W04230906195000K, W042309061967002, W04230906197900V, W04230906239800K, W04230906281100Q, W04230906281400K, W04230906320100P, W04230906320500H, W042309063228003, W04230906365900V. Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.. Blood Systems, Inc
Biologics Cryoprecipitated AHF W04230903945900A, W042309041794002, W04230904353400A, W042309048028003, W042309048037001, W04230905009000D, W04230905054000U, W04230905457700E, W04230905753400P, W042309057809003, W042309057833003, W042309062051000, W04230906206400R, W04230906215500L, W04230900651700I, W04230900652100Q, W042309006538008, W042309006562008, W042309006570008, W04230900658300Z, W04230900658400X, W04230900740100Q, W042309011086006, W042309011087004, W04230901109800Z, W042309012535009, W042309012538003, W042309012545005, W04230901256800S, W04230901348500I, W04230901349200K, W042309013498008, W042309013505005, W04230901351600*, W04230903946300I, W04230903947000K, W04230903948200C, W042309039484008, W042309039486004, W04230903987000P, W04230903987500F, W04230903989200D, W04230904070400H, W04230904171600U, W04230904175300K, W042309041769004, W042309041779000, W042309041785004 , W042309041800001,  ...
More
Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.. Blood Systems, Inc
Biologics Blood and Blood Products for Reprocessing W04230804145700G , W04230804146600E , W042308041469008 , W04230804264200Z , W04230804265700L , W04230804270900T , W04230804271400Z , W042308042794003 , W04230804287800W , W042308042880007 , W042308042890003 , W04230804289800O , W04230900651700I , W04230900652100Q , W042309006538008 , W042309006562008 , W042309006570008 , W04230900658300Z , W04230900658400X , W04230900659300V , W04230900735000G , W04230900739700N , W04230900740100Q , W04230900762700R , W04230900771200X ,  ...
More
Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Systems, Inc
Biologics Fresh Frozen Plasma W04230900860500N , W042309010963001 , W04230901112000Y , W04230901181100H , W04230901351700Y , W042309041019006 , W04230904319800A , W04230904454800J , W04230904455800F , W04230904456700D , W04230904800700D , W04230905001700V , W04230905059700X , W04230905198500U , W04230905314800Z , W042309054782004 , W04230905502400R , W04230905944900O , W04230905956800A , W04230906003700S , W04230906191700M , W04230906195000K , W04230906212400Z , W04230906239800K , W04230906281100Q ,  ...
More
Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Systems, Inc
Biologics Red Blood Cells Leukocytes Reduced Irradiated W042309061251000, W04230906126200V, W04230906324900U. Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Systems, Inc
Biologics Red Blood Cells (Apheresis) W042309063726004 , W042309063726004 , W04230906376600P , W04230906376600P , W04230906379500F , W04230906379500F. Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Systems, Inc
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated W04230906345300M , W04230906239600O , W04230906345600G. Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Systems, Inc
Biologics Fresh Frozen Plasma (Apheresis) W042309011078006 , W04230904071300F , W04230904071300F , W042309041704001 , W04230904174600I , W04230904174600I , W04230904800400J , W04230905584300V , W04230905585900F , W042309062042002 , W042309062042002 , W04230906210100C , W04230906210100C , W04230906212900P , W04230800018300W, W04230800331700P, W04230803557400B, W04230803557400B, W04230803982000P, W042308042036005, W04230804206600U, , W04230804291100P , W04230804291100P , W04230900650400S , W04230901022300* , W04230901022300* , W04230901022300* ,  ...
More
Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Systems, Inc
Biologics Source Plasma 6210346135, 6210344265, 6210335862, 6210335217, 6210333853, 6210333251, 6210329053, 6210327943, 6210326613, 6210325739, 6210324574, 6210321258, 6210310643, 6210306788, 6210305188, 6210301617, 6210299079, 6210298069, 6210294949, 6210293682, 6210287516, 6210284758, 6210283498, 6210282474, 6210278432, 6210276911, 6210275811, 6210274810, 6210273435, 6210347674, 6210347091, 6210346214, 6210345705, 6210344604, 6210343974, 6210335603, 6210334978, 6210333632, 6210333059, 6210331571, 6210328848, 6210327413, 6210326812, 6210325490, 6210324983, 6210323469, 6210322922, 6210321366, 6210320715, 6210319299,  ...
More
Class II Blood products, collected from a donor who was permanently deferred, were distributed. CSL Plasma, Inc.
Biologics Source Plasma 0440733325, 0440732998, 0440693444, 0440693223, 0440692465, 0440692173, 0440691045, 0440690318, 0440689983, 8800005470, 8800005133, 8800004264, 8800002762, 8800002466, 8800001697, 8800001179, 8800000460, 0440719469. 0440712328, 0440711835, 0440711180, 0440710859, 0440708974, 0440708243, 0440704527, 0440704223, 0440700965, 0440700666, 0440699862, 0440699651, 0440697278, 0440697057, 0440696346, 0440696117, 0440694297, 0440694063 Class III Blood products, collected from a donor with a permanent deferral history, were distributed CSL Plasma, Inc
Biologics Source Plasma 3670025086, 3670025298, 3670025347, 3670025312, 3670025264, 3670025276, 3670025542, 3670025538, 3670025517, 3670025487, 3670025775, 3670025771, 3670025765, 3670026255, 3670026342, 3670026244, 3670026344, 3670026371, 3670026248, 3670026392, 3670026324, 3670026291, 3670027721, 3670028627, 3670028631, 3670028742, 3670028749, 3670028666, 3670028762, 3670028753, 3670029111, 3670029920, 3670033662, 3670034865, 3670037689, 3670037788, 3670037858, 3670037809, 3670037813, 3670038433, 3670038437, 3670038452, 3670039310, 3670039444, 3670039291, 3670039316, 3670039315, 3670039401, 3670039400, 3670039750,  ...
More
Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 3340071032; 3340070642; 3340044324; 3340081726; 3340081366; 3340080719; 3340080104; 3340086530; 3340086069; 3340084877; 3340083843; 3340092284; 3340090982; 3340090228; 3340088666; 3340088012; 3340087273; 3340082485; 3340070129, 3340069731, 3340067853, 3340067544 , 3340066891, 3340066603, 3340065983, 3340065723, 3340065086 , 3340064810, 3340064234, 3340063955, 3340063394, 3340063120, 3340062623 , 3340062177 , 3340061767, 3340061288, 3340060867, 3340058732 , 3340057797, 3340056897, 3340056423, 3340055934, 3340055465, 3340054968, 3340054612,  ...
More
Class III Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 3520106217, 3520105237, 3520104785, 3520104321, 3520103389, 3520103092, 3520102516, 3520102151, 3520101469, 3520101137, 3520100521, 3520100182, 3520099763, 3520099375, 3520098791, 3520098484, 3520097883, 3520097506, 3520096995, 3520096625, 3520096034, 3520095797, 3520095227, 3520094909, 3520094387, 3520094077, 3520093473, 3520093337, 3520092658, 3520092507, 3520091974, 3520091846, 3520091273, 3520091159 Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. Talecris Plasma Resources, Inc
Biologics Source Plasma LU0379044; LU0379710; LU0380678; LU0381529; LU0382702; LU0383550; LU0384610; LU0385521; LU0386735; LU0387674; LU0388895; LU0389714; LU0390974; LU0391873; LU0392808; LU0393902; LU0394735; LU0395923; LU0418962; LU0419548; LU0420344; LU0421067; LU0421920; LU0422596; LU0423523; LU0424104; LU0424957; LU0425579; LU0426965; LU0427689; LU0428136; LU0428868; LU0429392; LU0429948; LU0430416; LU0431140; LU0431634; LU0397683; LU0398242; LU0398772; LU0399475; LU0400792; LU0401796; LU0402477; LU0403532; LU0404243; LU0406646; LU0407300; LU0408032; LU0408728;  ...
More
Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. DCI Biologicals LLC
Drugs Lactated Ringer's Injection, USP, 1000 mL, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09 Lot 16-836-FW, Exp 04/14 Class III CGMP Deviations: Shipment of product not approved for release. Hospira, Inc.
Devices Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System. Lot 2AD052 Catolog KC330 Class III Correlation slope bias and accuracy shift Siemens Healthcare Diagnostics, Inc.
Devices Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates. Lot/Serial Numbers: M76369, M76370, M76373, M76374, M76375, and M76377. Class II An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions. Smiths Medical ASD, Inc.
Drugs PHYSICIANS TOTAL CARE, TETRACYCLINE, 250 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0024-08 69MO EXP 05/13, 69SH EXP 05/13, 5KXZ EXP 05/12, 5RE1 EXP 05/12 Class II Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API. Physicians Total Care, Inc.
Drugs PHYSICIANS TOTAL CARE, TETRACYCLINE, 500 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0025-09 5YLZ EXP 04/13, 5ZCE EXP 04/13, 61TX EXP 04/13, 65YD EXP 07/13, 6COJ EXP 09/13, 4ZT6 EXP 02/12, 58HD EXP 02/12, 5G4L EXP 08/12, 5KBU EXP 10/12, 5M3W EXP 10/12, 5OHI EXP 10/12, 6JHL EXP 01/14, 6HJQ EXP 01/14 Class II Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API. Physicians Total Care, Inc.
Devices ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum. All shipped out to this date Class II Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assays (LNs 4P53 and 4P54) on the ARCHITECT i1000SR System were mistakenly made available on abbottdiagnostics.com in October 2012. Additionally, some i1000SR customers received notification through AbbottLink in November 2012 that assay files for LNs 4P53 and 4P54 were available. The ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assays (LNs 4P53 and 4P54) are not yet approved by the FDA for use on the ARCHITECT i1000SR, but they are under active review for approval. Abbott will notify you when FDA approval is obtained. This is a voluntary device recall. Abbott Laboratories, Inc
Devices Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA) Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 3FM40SSA) Product Usage: Disposal system for counting of used surgical blades and needles. Catalog Number: 3FA40SSA Lot Numbers: all lot numbers less than or equal to 928782 Catalog Number: 3FM40SSA Lot Numbers: all lot numbers less than or equal to 911379 Class II Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Cardinal Health
Devices Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA40SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FM40SSA) Product Usage: Disposal system for counting of used surgical blades and needles. Catalog Number: FA40SSA Lot Numbers: lot number 763998 Catalog Number: 4FM40SSA Lot Numbers: all lot numbers less than or equal to 933099 Class II Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Cardinal Health
Devices Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FS30SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Double Foam Strips (Cat. No. 4FS31SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Double Numbered Magnets (Cat. No. 4MM30SSA) Product Usage: Disposal system for counting of used surgical blades and needles. Catalog Number: 4FS30SSA Lot Numbers: all lot numbers less than or equal to 848031 Catalog Number: 4FS31SSA Lot Numbers: lot number 739269 Catalog Number: 4MM30SSA Lot Numbers: all lot numbers less than or equal to 858154 Class II Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Cardinal Health
Devices Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 3FS60SSA) Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips; (Cat. No. 3FS61SSA) Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Numbered Magnets (Cat. No. 3MM60SSA) Product Usage: Disposal system for counting of used surgical blades and needles. Catalog Number: 3FS60SSA Lot Numbers: all lot numbers less than or equal to 898712 Catalog Number: 3FS61SSA Lot Numbers: all lot numbers less than or equal to 898714 Catalog Number: 3MM60SSA Lot Numbers: all lot numbers less than or equal to 931754 Class II Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Cardinal Health
Devices Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 4FS60SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips (Cat. No. 4FS61SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Numbered Magnets (Cat. No. 4MM60SSA) Product Usage: Disposal system for counting of used surgical blades and needles. Catalog Number: 4FS60SSA Lot Numbers: all lot numbers less than or equal to 752068 Catalog Number: 4FS61SSA Lot Numbers: all lot numbers less than or equal to 802581 Catalog Number: 4MM60SSA Lot Numbers: all lot numbers less than or equal to 898715 Class II Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Cardinal Health
Devices Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA70SSA) Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area; (Cat. No. 3FM70SSA) Product Usage: Disposal system for counting of used surgical blades and needles. Catalog Number: 3FA70SSA Lot Numbers: all lot numbers less than or equal to 843761 Catalog Number: 3FM70SSA Lot Numbers: all lot numbers less than or equal to 933614 Class II Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Cardinal Health
Devices Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double Removable Numbered Foam Blocks (Cat. No. 3FF80SSA) Product Usage: Disposal system for counting of used surgical blades and needles. Catalog Number: 3FF80SSA Lot Numbers: all lot numbers less than or equal to 912899 Class II Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Cardinal Health
Devices Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA70SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FM70SSA) Product Usage: Disposal system for counting of used surgical blades and needles. Catalog Number: 4FA70SSA Lot Numbers: all lot numbers less than or equal to 931750 Catalog Number: 4FM70SSA Lot Numbers: all lot numbers less than or equal to 912173 Class II Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Cardinal Health
Devices Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capacity; Sterile; Removable Numbered Foam Block; Double Numbered Magnets (Cat. No. 4FM100SSA) Product Usage: Disposal system for counting of used surgical blades and needles. Catalog Number: 4FM100SSA Lot Numbers: all lot numbers less than or equal to 847028 Class II Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. Cardinal Health
Biologics Insects (Whole Body), Mite Dermatophagoides farinae E1203031; E1201566; E1201592; E1201780; E1202429; E1202633; E1204095; E1202443; E1202442; E1202056; E1203032; E1202002; E1202615; E1203147; E1201608; E1202612; E1202737; E1203047; E1202193; E1202045; E1201457; E1201884; E1201270; E1202518; E1202021; E1201356; E1202349; E1202240; E1202059; E1202444; E1201567; E1201774; E1202634; E1202060; E1202445; E1201713; E1201714; E1201775; E1202062; E1201711; E1201779; E1201676; E1201677; E1201726; E1202063; E1201702; E1201727; E1202061; E1202057; E1202094;  ...
More
Class III Allergenic Extracts, with confirmed OOS potency results at 15 month stability time point, were distributed. Jubilant HollisterStier, LLC
Biologics Custom Patient Prescriptions T12003022, T12003259, T12003260, T12003261, T12005541, T12003052, T12003212, T12007935, T12003055, T12007934, T12005543, T12003309, T12003290, T12005559, T12005560, T12005561, T12005824, T12005832, T12005833, T12005836, T12006132, T12006134, T12006136, T12006140, T12006142, T12006148, T12007600, T12007603, T12007604, T12007605, T12007610, T12005860, T12007138, T12007142, T12007146, T12002944, T12006685, T12002947, T12005534, T12005536, T12005539, T12007657, T12007926, T12007929, T12003220, T12007562, T12002866, T12003053, T12002871, T12002872,  ...
More
Class III Allergenic Extracts, with confirmed OOS potency results at 15 month stability time point, were distributed. Jubilant HollisterStier, LLC
Drugs Ciprofloxacin Tablets USP, 500 mg, 100-count bottle, Rx only, Manufactured for West-ward Pharmaceutical Corp., Eatowntown, NJ 07724 by Hikma Pharmaceuticals, Amman, Jordan, NDC 0143-9928-01 Lot #: CB222A, Exp 06/16 Class II Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet. West-ward Pharmaceutical Corp.
Devices BS-200 Chemistry Analyzer Designed for clinical laboratory use. Part number BA20E-PA00003; Serial Numbers: WN-28103978F, WN-28103976F, and WN-28103977F. Class II An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate. Mindray DS USA, Inc. d.b.a. Mindray North America
Devices Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) The Synthes Dens instrument Set has been designed to facilitate internal fixation of the odontoid process for the reduction of Type II and shallow Type III fractures, as proposed by Anderson and d'Alonzo. Part number 687.030, All Lots Class II The Dens Instrument Set has been designed to facilitate the anterior internal fixation of the Dens (odontoid process). There are currently no screws specifically indicated to treat Dens fractures via anterior screw fixation therefore the affected product will be removed. Synthes USA HQ, Inc.
Food Norwegian Smoked Salmon Sides (2-3 lbs.) Lot 1768 Class I Private lab result was positive for Listeria Monocytogenes Mkg Provisions Inc
Food Scottish Style Smoked Salmon Pre-sliced Sides (2-3 lbs) Lot 1768 Class I Private lab result was positive for Listeria Monocytogenes Mkg Provisions Inc
Food Pastrami Style Smoked Salmon Pre-sliced Sides (2.5-3.5 lbs. and 2-3 lbs.) Lot 1768 Class I Private lab result was positive for Listeria Monocytogenes Mkg Provisions Inc
Food Cold Smoked Salmon Trimmings (5 lbs.) Lot 1768 Class I Private lab result was positive for Listeria Monocytogenes Mkg Provisions Inc
Food Prestige Smoked Scottish 2.5-3.5 Smoked Salmon Sides (2-3 lbs.) Lot 1768 Class I Private lab result was positive for Listeria Monocytogenes Mkg Provisions Inc
Food UpRiver Tri-Peppered Vodka Smoked Salmon (2-3 lbs) Lot 1768 Class I Private lab result was positive for Listeria Monocytogenes Mkg Provisions Inc
Food UpRiver Tequila/Cilantro Smoked Salmon Sides( 2-3 lbs.) Lot 1768 Class I Private lab result was positive for Listeria Monocytogenes Mkg Provisions Inc
Food Prestige Scottish Smoked Salmon 16 oz. Lot 1768 Class I Private lab result was positive for Listeria Monocytogenes Mkg Provisions Inc
Food Norwegian Smoked Salmon (4 oz..) Lot 1768 Class I Private lab result was positive for Listeria Monocytogenes Mkg Provisions Inc
Food Prestige Irish Style Smoked Salmon (4 oz..) Lot 1768 Class I Private lab result was positive for Listeria Monocytogenes Mkg Provisions Inc
Food Prestige Nova Smoked Salmon retail packs (4 oz.) Lot 1768 Class I Private lab result was positive for Listeria Monocytogenes Mkg Provisions Inc
Food UpRiver Norwegian Smoked Salmon Peppered (2-3 lbs.) Lot 1768 Class I Private lab result was positive for Listeria Monocytogenes Mkg Provisions Inc
Devices BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5***BD Max Group B Streptococcus (GBS) Assay is an in vitro diagnostic (IVD) test for detection of GBS DNA in Lim Broth cultures. The BD MAX" PCR Cartridge is a consumable required for the BD MAX" System. Lot/Exp. date: 2235001 2014-08-22 Class II Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs. Becton Dickinson & Co.
Devices bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents. lot number: 540274420 Class II The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements. Biomerieux Inc
Biologics Bone UBO009160011810 Class III HCT/P allografts, mislabeled with an incorrect expiration date, were distributed. University Of Miami Miller School of Medicine Tissue Bank
Biologics Bone UBO008704012410; UBO008704012510; UBO008704012610; UBO008704012710; UBO008704012810; UBO008704012910; UBO008704013010; UBO008704013110; UBO008704013210; UBO008704013310; UBO008704013510; UBO008704013610; UBO008704013710; UBO008704013810; UBO008704013910; UBO008704014110; UBO008704014210; UBO008704014310; UBO008704014410; UBO008704014510; UBO008704014710; UBO008704014810; UBO008704014910; Class III HCT/P allografts, mislabeled with an incorrect expiration date, were distributed. University Of Miami Miller School of Medicine Tissue Bank
Biologics Tendon UBI009136012610; UBI009136012710; UBI009136012810; UBI009136012910; UBI009136013110; UBI009136013210; UBI009136013310; UBI009136013410 Class III HCT/P allografts, mislabeled with an incorrect expiration date, were distributed. University Of Miami Miller School of Medicine Tissue Bank
Biologics Bone UBO005935003010; UBO005935003110; UBO005935003210; UBO005935003310; UBO005935003410; UBO005935003510 Class III HCT/P allografts, mislabeled with an incorrect expiration date, were distributed. University Of Miami Miller School of Medicine Tissue Bank
Drugs PE Daytime Cold/Flu LiqGel, Multi Symptom Relief, Acetaminophen/Dextromethorphan HBr/Phenylephrine HCL 325/10/5 mg gel caps 20 count blister pack, Distributed By: Wal-Mat Stores Inc., Bentonville, AR, 72716 2 AE1549 Exp. 02/13 Class III Failed Stability Specifications: The product had a stability failure at the 12 month time point for the active ingredient Phenylephrine HCL. L. Perrigo Co.
Devices VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441; (6) dc7100 8-port (refurbished), Cat. #W0441R; (7) dc7700 8-port, Cat. #W0447; (8) dc7700 8-port (refurbished), Cat. #W0447R; (9) dc7800, Cat. #W0449; and (10) dc7800 (refurbished), Cat. #W0449R. VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Manufactured from September, 2004, to present. Class II There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS. Biomerieux Inc
Devices VITEK 2 XL computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441; (6) dc7100 8-port (refurbished), Cat. #W0441R; (7) dc7700 8-port, Cat. #W0447; (8) dc7700 8-port (refurbished), Cat. #W0447R; (9) dc7800, Cat. #W0449; and (10) dc7800 (refurbished), Cat. #W0449R. VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Manufactured from September, 2004, to present. Class II There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS. Biomerieux Inc
Devices VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models: (1) dc7100 8-port, Cat. #W0441; (2) dc7100 8-port (refurbished), Cat. #W0441R; (3) dc7700 8-port, Cat. #W0447; (4) dc7700 8-port (refurbished), Cat. #W0447R; (5) dc7800, Cat. #W0449; (6) dc7800 (refurbished), Cat. #W0449R (7) rp5700, Cat. #W0452; (8) rp5700 (refurbished), Cat. #W0452R; (9) rp5800 XPE, Cat. 413642; (10) rp5800WES7, Cat. #413862; (11) d530 6-port, Cat. #W0438; (12) d530 6-port (refurbished), Cat. #W0438R; and (13) d530 4-port, Cat. #W0437. VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Manufactured from September, 2004, to present. Class II There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS. Biomerieux Inc
Food Item #1815, Kettle brand Natural Chocolate Lovers Trail Mix UPC 8411401910 Label reads in part "8411401910 Honey Roast Harvest Mix Net Weight 24 Lbs. ***" 03JUL12 through 15JUN13 Class III Dried pineapple which contains sulfur dioxide was accidently used to manufacturer the trail mix. The formula calls for untreated dried pineapple. Kettle Foods, Inc.
Food Item #1900 Kettle Brand Honey Roast Nuts and Fruit Trail Mix UPC 8411401900 Label reads in part "8411401900 Honey Roast Nuts & Fruit Mix Net Weight 24 Lbs. ***" 26 MAY12 through 02APR13 Class III Dried pineapple which contains sulfur dioxide was accidently used to manufacturer the trail mix. The formula calls for untreated dried pineapple. Kettle Foods, Inc.
Food Item #1910 Kettle brand Honey Roast Harvest trail mix UPC 8411401910 Label reads in part "8411401910 Honey Roast Harvest Mix Net Weight 24 Lbs.***" Best Before 27JUN12 through 09JUN13 Class III Dried pineapple which contains sulfur dioxide was accidently used to manufacturer the trail mix. The formula calls for untreated dried pineapple. Kettle Foods, Inc.
Food Ruthies Cranberry Orange Breakfast Cookie, individually wrapped in plastic, net wt. 4.9 oz. The product is labeled in parts: "***Ruthies Cranberry Orange Breakfast COOKIE***INGREDIENTS***Butter (pasteurized cream, salt)***Contains the following allergens: Wheat, Eggs***NET WT. 4.9 Oz***Manufactured for Ruthie's, LLC***www.ruthiescookies.com******(888) 7-RUTHIE***". no codes Class II Ruthies Cranberry Orange Breakfast Cookie is recalled because butter (cream) is declared but milk is NOT declared on label. Wholesale Baking, Inc.
Food Ruthies Cashew Raisin Breakfast Cookie, individually wrapped in plastic, net wt. 4.9 oz. The product is labeled in parts: "***Ruthies Cashew Raisin Breakfast COOKIE***INGREDIENTS***Butter***Half & Half***NET WT. 4.9 Oz***Manufactured for Ruthie's, LLC***www.ruthiescookies.com***(888) 7-RUTHIE***". no codes Class II Ruthies Cashew Raisin Breakfast Cookie is recalled because butter and half & half are declared but milk is NOT declared on label. Wholesale Baking, Inc.
Veterinary Hy-Vee Complete Dog, Complete Nutrition, 34-lb bag. UPC code: 07545005647 Lot # ending with 29812KC, Best by date: 11/24/13 Class II The recalled products may contain elevated levels of Aflatoxin. Hy-Vee Stores Inc
Veterinary Hy-Vee Complete Dog, Complete Nutrition, 8-lb bag. UPC code: 07545005667 Lot # ending with 29812KC, Best by date: 11/24/13 Class II The recalled products may contain elevated levels of Aflatoxin. Hy-Vee Stores Inc
Veterinary Hy-Vee Complete Dog, Complete Nutrition, 4.4-lb bag. UPC code: 07545005665 Lot # ending with 29812KC, Best by date: 11/24/13 and Lot # ending with 29912KC, Best by date: 11/25/13 Class II The recalled products may contain elevated levels of Aflatoxin. Hy-Vee Stores Inc
Veterinary Hy-Vee Complete Dog, Bones & Squares, 20-lb bag. UPC code: 07545005680 Lot # ending with 29312KC, Best by date: 11/19/13 Class II The recalled products may contain elevated levels of Aflatoxin. Hy-Vee Stores Inc
Veterinary Hy-Vee Complete Dog, Bones & Squares, 4.4-lb bag. UPC code: 07545005660 Lot # ending with 29312KC, Best by date: 11/19/13 Class II The recalled products may contain elevated levels of Aflatoxin. Hy-Vee Stores Inc
Drugs Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford, Florida 32773 --- NDC 28105-150-04 Lot J111040, Exp. (09/13) Class III Subpotent; 12 month stability timepoint Hill Dermaceuticals, Inc.
Drugs Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE, Net Contents 118.28 mL (4 fl. oz.), Hill Dermaceuticals, Inc., Sanford, Florida --- NDC 28105-149-04 Lot # D110550, Exp. 04/2013. Class III Subpotent; 22 month stability timepoint Hill Dermaceuticals, Inc.
Devices Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multidimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities, including CT, MR, D, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography. Serial Number 5080109343 5080109769 5080109726 5080123222 5080108401 5080107812 5080107804 5080107790 5080108428 5070933221 5070933248 5070933264 5070933272 5070933256 5080123109 5050411467 5080103442 5080103418 5090110913 5070934023 5080103434 5070931695 5080110775 5080113081 5080102977 5080103272 5080113340 5080121009 5080121122 5080121092 5080121106 5080121114 5080120827 5080111631 5080111755 5080116595 5080116609 5080116617 5080112883 5080122439 5080117214 5080119764 5080119772 5080119780 5080123095 5080121769 5080121750 5090102805  ...
More
Class II Vital Images has found a potential error in measurement generated through the software which affects all versions of Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3. This error occurs when images are rotated at the time of reconstruction by the scanner in non-90 degree increments of the transverse/axial plane (rotation around the z-axis), while not being simultaneously rotated around the x-axis and y-axis. We have found this orientation adjustment to occur on rare occasions, such as to straighten tilts in head or neck scans, usually with minimal effect on measurements, but sometimes resulting in differences in length measurements of up to twenty-nine percent and in volume measurements of up to fifty percent, so please use caution when reviewing measurements of images reconstructed with orientations that are adjusted in such a manner. This issue was found through internal testing. No customer reports of the issue have been received. Vital Images, Inc.
Devices Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium Slides). Slide preparations serving as quality control challenges to demonstrate satisfactory performance of staining reagents. SL42-10 Lots 4239 to 4243 SL43-10 Lots 4333 to 4337 Class II Microbiologics Inc is initiating a voluntary recall on products KWIK-QC Acid Fast Stain Slide, SL42-10 and KWIK-QC Mycobacterium, SL43-10. These products are being recalled because the control organisms are not properly fixated on the slide, which may cause the user to unintentionally contaminate the patient area of the slide by flooding the control well with stain. This contamination could potentially lead to misdiagnosis and improper treatment of a patient. There have been no complaints or reports of death or injury due to this issue. Microbiologics Inc
Devices Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures. Part #: IFS-072-17-C, Lot #: 2399041; Part #: IFS-72-20-C, Lot #: 2399051 & Lot #: 2399051R and Part #: IFS-072-25-C, Lot #: 2399061. Class II The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire. Orthohelix Surgical Designs Inc
Devices Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA). Kit Lot Number 3000389 Class II Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate values when testing the kit Positive Control and patient samples. The variation in reactivity can lead to invalid assays. If an invalid assay is obtained, those results should not be reported and the test should be re-run. An invalid assay would not result in significant harm to a patient. However, some kits from this lot may produce false negative results. A false negative result could contribute to a delay in diagnosis and initiation of alternative therapies, and may increase the risk of complications. Genetic Testing Institute,inc
Devices Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception. Lot 113367 Class II Incorrect size was printed on the outer product packaging. Cooper Surgical, Inc.
Devices Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex Part Number: MXPCON04 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum. Lot Number:117301 Class III Pessary mislabeled outer package may not reflect the size of the product contained in the package Cooper Surgical, Inc.
Devices Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex :Part Number: MXPCONDS05 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum. Lot Number:117443 Class III Pessary mislabeled outer package may not reflect the size of the product contained in the package Cooper Surgical, Inc.
Devices Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Number: MXKPCONDS00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum. Lot Number:111732 Class III Pessary mislabeled outer package may not reflect the size of the product contained in the package Cooper Surgical, Inc.
Devices Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXKPCOND00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum. Lot Number:114288 Class III Pessary mislabeled outer package may not reflect the size of the product contained in the package Cooper Surgical, Inc.
Devices Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXPCOND00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum. Lot Number:114287 Class III Pessary mislabeled outer package may not reflect the size of the product contained in the package Cooper Surgical, Inc.
Devices Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: MXPGE2-3/4 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum. Lot Number:117560 Class III Pessary mislabeled outer package may not reflect the size of the product contained in the package Cooper Surgical, Inc.
Devices Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE3- A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum. Lot Number:117568 Class III Pessary mislabeled outer package may not reflect the size of the product contained in the package Cooper Surgical, Inc.
Devices Cooper Surgical Cube Pessary 1 5/8"", 41mm. Milex Part Number: MXKPEC04 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum. Lot Number:117376 Class III Pessary mislabeled outer package may not reflect the size of the product contained in the package Cooper Surgical, Inc.
Devices Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number: MXKPECH00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum. Lot Number:121784 Class III Pessary mislabeled outer package may not reflect the size of the product contained in the package Cooper Surgical, Inc.
Food Opalescence treswhite Supreme Peach Patient Kit Lot B6LZS, Part number 5705 Class III Product was packaged into kits labeled as having a shelf life of 2103-05. The correct shelf life is 2013-05. Ultradent Products, Inc.
Devices 20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System. Impacted serial Numbers: 120, 132, 134,136, 151, 342, 350, 354, 356, 363, 368, 373, 379, 380, 384, 385, 402, 405, 424, 919, 953, 954, 960, 963, 968, 970, 977, 980, 993, 998, 1001, 1123, 1148, 1378, 1596, 1729, 1745, 1747, 1749, 1750, 1751, 1753, 1754, 1758, 1759, 1760, 1761, 1797,  ...
More
Class II Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. When a catheter is connected to an affected to an affected 20-Pole Eco Cable, the catheter will not be recognized by the impacted 54 cable serial numbers within the field. Biosense Webster, Inc.
Drugs SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators (net 0.67 mL each) per carton, Cat. No 260201, NDC 54365-170-01, CareFusion, Leawood, KS 66211. All lots distributed between 01/10 to 02/13 Class II Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. CareFusion 213, LLC
Drugs SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodium Iodide USP, & Purified Water USP), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, Cat. No 260261, NDC 54365-161-01, CareFusion, Leawood, KS 66211; b) 3000-count applicators (Net 0.67 mL each) per case, Cat. No 260431, NDC 54365-151-01, CareFusion, Leawood, KS 66211; and c) 3000-count applicators (Net 0.67 mL each) per case, Reorder TA6200, Manufactured for: Tri-State Hospital Supply Corporation, Howell, MI 48843. a) All lots with expiry between 02/12 to 10/15; b) All lots with expiry between 09/11 to 12/13; and c) All lots with expiry between 12/11 to 12/11. Class II Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. CareFusion 213, LLC
Drugs SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified Water), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, CareFusion, Leawood, KS 66211, Cat. No 260286, NDC 54365-145-01; and b) 3000-count applicators per case, Cat. No 260681, CareFusion, Leawood, KS 66211. a) All lots with expiry between 09/12 to 10/15 and b) All lots with expiry between 10/11 to 07/14. Class II Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. CareFusion 213, LLC
Drugs Blood Culture Prep Kit II containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260307, NDC 54365-200-99, CareFusion, Leawood, KS 66211. All lots with expiry between 12/11 to 10/15. Class II Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. CareFusion 213, LLC
Drugs Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260311, NDC 54365-201-99, CareFusion, Leawood, KS 66211. All lots with expiry between 09/11 to 09/13. Class II Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. CareFusion 213, LLC
Drugs FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net 1.1 mL and 1 SEPP (povidone iodine 10% USP), Net 0.67 mL per kit, packaged in 20 kits per carton, Cat. No 260288, NDC 54365-202-99, CareFusion, Leawood, KS 66211. All lots with expiry between 07/11 to 08/14. Class II Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. CareFusion 213, LLC
Devices Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product Tincture Packaged: Product Number 260619 and Product ID D086353; Tincture 3,000 Bulk: Product Number 260520 and Product ID D086353. Class III An internal review of CareFusion's labeling for preoperative skin prep product codes was recently conducted. The labeling of the product codes identified above state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized. Some product labeling states "Sterility guaranteed unless seal broken" or "Contents sterile if package is intact." These claims were intended to indicate surface sterilization only but could mistakenly lead to the conclusion that the drug product solution is sterile. It was determined that labeling on certain products could be misleading in relation to sterility claims. There is no patient safety risk associated with these products. CareFusion 213, LLC
Food Sonoma Mock Chix Salad Ingredients: Dist. by Whole Foods Market 525 N. Lamar Blvd, Austin, TX 78703. Product is made in store and sold under the name of Sonma Mock Chix Salad. It comes in 6oz, 8oz, 16oz, and 24oz clear plastic hinged containers. There are no lot numbers for the product, it is produced and packaged at the store level. The product was produced on 02/27/13, packaged on 02/28/13 with a best-by date of 03/06/13. It was then removed from the store's shelves on 3/02/13. Class I The product is being recalled due to undeclared pecans. Whole Foods Market
Drugs Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-021-01. Lot #: MM8490, Exp 09/14 Class II Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle. Zydus Pharmaceuticals USA Inc
Food ProtiDiet High Protein Chocolate Dream Bar UPC 6 21498 42238 1, lot code CR 18 13B, and Best Before: 2015-08. Class I Recall was initiated after CFIA notified FDA of implicated products sold to the firm. During a FDA visit, the firm discovered that they were selling product that were recalled in Canada by the manufacturer, "Pro-Amino International Inc." because it may be contaminated with Salmonella. Upon further FDA investigation at the firm product was further distributed to a consignee in Canada. Doctors Best Weight Loss
Devices STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer. N/A Class II Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is applied. Advanced Sterilization Products
Devices Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta. Lot number GFWA0387 Class II Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire, model ARCSJ200W, where the PTFE (Teflon) coating has the potential to separate from the wire during in-vivo use. Medtronic Inc. Cardiac Rhythm Disease Management
Food LiveSmart Bruschetta Pizza #661, Contains 2 - 6.30 OZ PIZZAS, net WT 12.60 oz (357 G), UPC 631488, Distributed by Schwan's Home Service, Marshall, MN 56258, Date codes: 312244xxxx, 312286xxxx & 312349XXXX. Class II Schwan's is conducting a recall because they were informed by one of their flour suppliers, Dakota Specialty Milling, Inc., that a limited number of its flours and grains blends are being recalled due to the possible presence of fragments of thin metal wire from a defective screen on one of its manufacturing lines. As a precautionary measure, Schwan's has chosen to voluntarily recall Schwan's® LiveSmart" Bruschetta Pizza #661 after being notified by Dakota Specialty Milling of their recall. Schwan's Corporate One Building HS/FS
Devices Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide. Product Usage: The Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta, where increased support, distal flexibility, and low surface friction of the guidewire is needed. Model ARCSJ200W Lot Numbers: GFWC1124, GFWC1506, GFWC2138, GFWC2652, GFWC2653, GFWD0353, GFWD0881, GFWD0882, GFWD2048, GFWD2049, GFWD2050, GFWD2051, GFWD2052, GFWE0743, GFWE0744, GFWE0745, GFWE0746, GFWE0747, GFWE3710, GFWE4272, GFWE4273, GFWE4274, GFWE4275, GFWF0143, GFWF0144, GFWF0147, GFWF0148, GFWF0149, GFWG0428, GFWG0429, GFWG0430, GFWG0431, GFWG0432, GFWG0433, GFWG0434, GFWH0333, GFWH0334, GFWH0335, GFWH0336, GFWH0337, GFWH0338, GFWI0190, GFWI0191, GFWI0192, GFWI0193, GFWI0194,  ...
More
Class II Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W, where a change in the manufacturing process has been identified as the cause for potential kinking and breaking at the proximal weld end of the outer spring coil during in-vivo use. Medtronic Inc. Cardiac Rhythm Disease Management
Food Kameda Brand Rice Cracker Kotsubukko, 12/4.37 oz, Item #63018. UPC Code 0-74410-63018-8. Expiration Dates: 2013/03/15 2013/03/27 2013/03/28 2013/03/31 2013/04/05 2013/04/17 2013/04/19 2013/04/21 2013/04/23 2013/04/24 2013/04/28 2013/05/26 2013/05/27 2013/06/03 2013/06/13 2013/06/22 2013/06/23 2013/07/03 2013/07/17 2013/07/18 2013/07/21 Class I Nishimoto Trading Co. is recalling Kameda Brand Rice Cracker Kotsubukko because it contains undeclared milk. Nishimoto Trading Co Ltd
Devices Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system Model numbers 10094135, 10094137, 10094139, 10094141 and 10280959. Class II The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Under certain preconditions, executing roadmap OGP (organ program) in the DSA overlay mode may lead to imprecise registration of the DSA mask image with the roadmap image displayed on the live monitor. Siemens Medical Solutions USA, Inc
Devices Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures. NO. SERIAL NO. LASTFOUR MANUFACTURE DATE 1 A3SS2014 2014 MAY 2003 2 UVBlOS2001 2001 MAY  ...
More
Class II Lost and incorrect images. When using the "F-Rec" fluoroscopy image acquisition recording option in the "manual mode" an infrequent software error may cause images from another study to be displayed on the monitor. The acquired images may be lost requiring additional image acquisitions to be performed. Toshiba American Medical Systems Inc
Devices KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider. Product Code 68507 (Round) Case Lot Numbers MF1284XXX, MF1287XXX, MF1294XXX, MF1316XXX, MF2012XXX, MF2055XXX, MF2086XXX, MF2098XXX, MF2115XXX, MF2146XXX, MF2178XXX, MF2188XXX, MF2196XXX, MF2210XXX, MF2228XXX, MF2243XXX, MF2264XXX, MF2271XXX, MF2285XXX, MF2328XXX, and MF2338XXX. Product Code 68509 (Square) Case Lot Numbers MF1279XXX, MF1287XXX, and MF1288XXX. Class II Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier. Kimberly-Clark Corporation
Drugs TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only, Packaged in a carton containing 1 vial TORISEL injection and 1 vial DILUENT for TORISEL, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA --- NDC 0008-1179-01 Lots P00025A; P00027B Class III Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials. Pfizer Inc.
Food Meijer, Spiced Jelly Beans, 32 oz, Product of Mexico, UPC 8-86926-50931-1. all lots Class II 32 oz bags of Meijer Spiced Jelly Beans contain undeclared Yellow # 6. Meijer Distribution, Inc
Drugs Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials per carton, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 10 x 100 mL Single patient infusion vials per carton, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA. a) Lot #: 06-804-DJ*, Exp 1JUN2013; and b) Lot #: 05-736-DJ*, Exp 1MAY2013; 09-066-DJ*, Exp 1SEP2013. *Note: the lot number may be followed by 01 or 02. Class II Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection. Hospira Inc.
Food Taco Seasoning, Net Wt. 1.25 lb and 5.75 lb. Distributed by Decoty Coffee Company, San Angelo, TX 76903, 800-588-8001. The products come in 1.25lb and 5.75lb sizes and are distributed in plastic spice containers with resealable lids. The item code numbers are 71400 (1.25 lb) and 71410 (5.75 lb) with lot numbers from 010111 through 021313. Class II Recently, DeCoty Taco Seasoning, 1.25 lb (Lot numbers 010111-021313) and 5.75 lb (Lot numbers 010111-021313), were recalled for the undeclared ingredient Soy. Tests show that these lot numbers of this product also contain the undeclared ingredient Wheat Gluten, therefore represents a potential health hazard. Decoty Coffee Company, Inc
Show all Code Info
-
-