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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced 6731694 Class II Blood product, negative for the Fyb-antigen but typed as Fyb-antigen positive, was distributed. Belle Bonfils Memorial Blood Center
Biologics Blood and Blood Products for Reprocessing 2143525 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Belle Bonfils Memorial Blood Center
Biologics Red Blood Cells 2143525 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Belle Bonfils Memorial Blood Center
Biologics Red Blood Cells Leukocytes Reduced W045005005778 Class II Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. Community Blood Center of Greater Kansas City
Biologics Source Plasma 380017145, 380016941, 380016754, 380016610, 380016394, 380016226, 380015934, 380015846, 380015692, 380015570, 380015308, 380015112, 380014344, 380013925, 380013756, 380013475, 380013131, 380012882, 380012613, 380012361, 380012134, 380011958, 380011604, 380011323, 380010943, 380010817, 380010306, 380010299, 380009793, 380009785, 380009266, 380008811, 380008710, 380008281, 380008184, 380007743, 380007677, 380007001, 380006596, 380006435, 380006007, 380005874, 380005430, 380005279, 380004898, 380004255, 380003648, 380003044, 380002818 Class II Blood products, collected from a donor who was previously deferred, were distributed. Biomat USA, Inc.
Biologics Red Blood Cells Leukocytes Reduced 02LH75991 Class II Blood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed. American Red Cross Blood Services
Biologics Blood and Blood Products for Reprocessing 02LH75991 Class II Blood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 006GG69748, 006LM40904, 006LQ64474, 084FT72355, 084FT72408, 084FT73012, 084FT73025, 084FT73593, 084FT73801, 084FT73906, 084FT73920, 084FT73945, 084FT73954, 084FT74138, 084FT74145, 084FT74193, 084FT74371, 084FT74399, 084FT74407, 084FT74422, 084FT74426, 084FT74476, 084FT74486, 084FT74491, 084FT74494, 084FT74505, 084FT74507, 084FT74508, 084FT74512, 084FT74520, 084FT74544, 084FT74574, 084FT74638, 084FT74642, 084FT74650, 084FT74692, 084FT74704, 084FT74780, 084FT74831, 084FT74928, 084FT74935, 084FT74936, 084FT74958, 084FT75074, 084FT75138, 084FT75166, 084FT75212, 084FT75218, 084FT75241, 084FT75248,  ...
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Class II Blood products, lacking proper documentation of antigen phenotyping, were distributed. American National Red Cross (The)
Biologics Red Blood Cells 084LT31329, P-2; 084LT31329, P-I; 084LT31600, P-1; 084LT31600, P-2 Class II Blood products, lacking proper documentation of antigen phenotyping, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Deglycerolized Leukocytes Reduced 021KC66135, 084FT77211, 084FT78046, 084FT81909, 084J90862, 084J93534, 084KM43545, 084LP37814, 084Q20379 084T15992 084T18414 084T21858 084Z84403 084Z88455 Class II Blood products, lacking proper documentation of antigen phenotyping, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Deglycerolized Leukocytes Reduced 084FT82947, 084FT83618, 084J96023, 084J96301, 084J97023, 084J98141, 084K55016, 084K58706, 084K60043, 084K60194, 084K62037, 084K62556, 084KM48320, 084Q13262, 084Q13611, 084Q13772, 084Q15707, 084Q17490, 084Q20457, 084Q22541, 084T21666, 084T21812, 084T21893, 084T22978, 084W62556, 084W62563, 084W66330, 084W69575, 084Z84745, 084Z86429, 084Z88735, 084Z90229 Class II Blood products, lacking proper documentation of antigen phenotyping, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Deglycerolized Leukocytes Reduced 084FT72445, 084FT74945, 084FT75422, 084FT76207, 084FT76466, 084FT76787, 084FT79582, 084J88571, 084K56474, 084K57952, 084KM45730, 084KM47908, 084KM47958, 084LP37808, 084LP39576, 084LP39785, 084LP40062, 084Q13430, 084Q14912, 084Q18636, 084Q18827, 084T16406, 084T16514, 084T17835, 084T18403, 084T22494, 084T23219, 084W62702, 084W62726, 084W64387, 084W65869 Class II Blood products, lacking proper documentation of antigen phenotyping, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced Frozen 084FT80048, 084FT80056, 084K59787, 084Q14901, 084T20919 Class II Blood products, lacking proper documentation of antigen phenotyping, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced W045005057009 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Community Blood Center of Greater Kansas City
Biologics Red Blood Cells W045005063760 Class II Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. Community Blood Center of Greater Kansas City
Biologics Red Blood Cells Leukocytes Reduced W045005101342 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Community Blood Center of Greater Kansas City
Biologics Fresh Frozen Plasma 24FC35223- part 1; 24FC35223- part 2; 24FC35223- part 3 Class III Blood components, processed more than 8 hours after collection, were distributed. American National Red Cross (The)
Biologics Red Blood Cells C79023 Class III Blood product, manufactured without the entire quantity of additive solution, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced GK12345 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells 6921760, 6417894, 6613297 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Belle Bonfils Memorial Blood Center
Biologics Fresh Frozen Plasma 6419927, 6417894 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Belle Bonfils Memorial Blood Center
Biologics Red Blood Cells Leukocytes Reduced 6731967, 6920467, 6915184, 6419927, 6910371, 6179510. Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Belle Bonfils Memorial Blood Center
Biologics Blood and Blood Products for Reprocessing 6731967, 6921760, 6920467, 6915184, 6910371, 6613297, 6179510. Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Belle Bonfils Memorial Blood Center
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 6040735(Part A): 6040735(Part B) Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Source Plasma 06BOHA4075 Class III Blood product, which tested initially reactive for the hepatitis C virus, was distributed. Bio-Blood Components, Inc.
Biologics Red Blood Cells Leukocytes Reduced W045006104362 Part A, W045006104362 Part B Class III Blood products, which did not meet acceptable product specifications, were distributed. Community Blood Center Of Gtr KC
Biologics Red Blood Cells Y53727 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Mississippi Valley Regional Blood Center
Biologics Platelets Pheresis Leukocytes Reduced Irradiated K41143(Part A); K41143(Part B) Class II Blood products, which did not meet the acceptable product specifications, were distributed. Mississippi Valley Regional Blood Center
Biologics Platelets Pheresis Leukocytes Reduced KW07812 Class II Blood product, which did not meet acceptable product specifications, was distributed. Mississippi Valley Regional Blood Center
Biologics Red Blood Cells Leukocytes Reduced 3732972 Class II Blood product, which was collected from a donor who lived in a malarial endemic area, was distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Platelets Pheresis Leukocytes Reduced E26323 Class II Blood product, which did not meet acceptable product specifications, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 6074434(Part A); 6074434(Part B) Class II Blood products, collection bag with pin size hole under the label were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Red Blood Cells 3713775 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Belle Bonfils Memorial Blood Center
Biologics Recovered Plasma 3713775 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Belle Bonfils Memorial Blood Center
Biologics Platelets GP02952 Class II Blood product, which was collected in a collection system that had product integrity compromised during component preparation, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced 09FF23771; 09FF25553 Class II Blood products, in which testing for Jka antigen was interpreted, or incorrectly documented were distributed American Red Cross Blood Services
Biologics Platelets Pheresis Leukocytes Reduced Irradiated KW09237 Class II Blood products, which did not meet acceptable product specifications, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Platelets Pheresis Leukocytes Reduced KW09237 Class II Blood products, which did not meet acceptable product specifications, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced V80168 Class II Blood product, collected from a donor who traveled to a malaria endemic area, was distributed. Delta Blood Bank
Biologics Blood and Blood Products for Reprocessing 6559105 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Belle Bonfils Memorial Blood Center
Biologics Red Blood Cells Leukocytes Reduced 6559105 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Belle Bonfils Memorial Blood Center
Biologics Red Blood Cells H24693 Class II Blood products, collected from a donor taking the drug methotrexate, were distributed. Delta Blood Bank
Biologics Red Blood Cells Leukocytes Reduced H24295 Class II Blood products, collected from a donor taking the drug methotrexate, were distributed. Delta Blood Bank
Biologics Blood and Blood Products for Reprocessing H24693, H24295 Class II Blood products, collected from a donor taking the drug methotrexate, were distributed. Delta Blood Bank
Biologics Platelets Pheresis Leukocytes Reduced Irradiated K47326; K47326; K47326 Class II Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed. Mississippi Valley Regional Blood Center
Biologics Platelets Apheresis Leukoreduced 7354767, 9348475,7354764,7354767, 9348475 Class III Blood products, which were exposed to unacceptable temperature during transport, were distributed. Blood Centers of the Pacific
Biologics Platelets Apheresis Leukoreduced (Irradiated) 7354764, 9348470, 9348470 Class III Blood products, which were exposed to unacceptable temperature during transport, were distributed. Blood Centers of the Pacific
Biologics Red Blood Cells Leukocytes Reduced 02GC00390 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Recovered Plasma 02GC00390 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Source Plasma 07DIAF9913 Class II Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. BioLife Plasma Services L.P.
Biologics Source Plasma. 2010162630 , 2010162088. Class II Blood products, which were not quarantined subsequent to receiving disqualifying post donation information, were distributed. Plasma Care, Inc. dba Marion Blood Plasma, Inc.
Biologics Blood and Blood Products for Reprocessing W036208303073 Class II Blood products, collected from a donor with a history of Hepatitis A, were distributed. Belle Bonfils Memorial Blood Center
Biologics Red Blood Cells, Leukocytes Reduced. W036208303073 Class II Blood products, collected from a donor with a history of Hepatitis A, were distributed. Belle Bonfils Memorial Blood Center
Biologics Red Blood Cells Leukocytes Reduced 24KS91773 Class II Blood products, manufactured from overweight whole blood unit, were distributed. American National Red Cross (The)
Biologics Cryoprecipitated AHF 24KS91773 Class II Blood products, manufactured from overweight whole blood unit, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced F01615 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Center of Northcentral Wisconsin, Inc.
Biologics Plasma Frozen F01615 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Center of Northcentral Wisconsin, Inc.
Biologics Source Plasma 6160249894; 6160249295; 6160247737; 6160246995; 01266146; 01222340; 01101348; 85399372; 85308510; 85296886 85284470 80754343 80750888 0540414653 0540414348 Class II Blood products, collected from a donor regarding multiple high-risk behaviors, were distributed. CSL Plasma, Inc.
Biologics Source Plasma 15 BKNGFX;15 BKNDPJ;15 BKMCMC;15 BKMBTN 15 BKLZNS;15 BKLZFX;15 BKLYQT;15 BKLXRS 15 BKLXFQ;15 BKLCPJ;15 BKLBMV;15 BKKZPJ 15 BKKXZM;15 BKKRWP Class II Blood products, collected from a donor who was permanently deferred, were distributed. Csl Plasma Inc
Biologics Red Blood Cells Leukocytes Reduced W128710220363 Class II Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. Delta Blood Bank
Biologics Human Skin for Transplant NLGIL100017002, NLGIL100017003, NLGIL100017004, NLGIL100017005, NLGIL100017008, NLGIL100017012, NLGIL100017013, NLGIL100017014, NLGIL100017015, NLGIL100017017, NLGIL100017018, NLGIL100017019, NLGIL100017020, NLGIN100004001, NLGIN100004002, NLGIN100004003, NLGIN100004004, NLGIN100004005, NLGIN100004006, NLGIN100004007, NLGIN100004008, NLGIN100004009, NLGIN100004011, NLGIN100004012, NLGIN100004013, NLGIN100004014, NLGIN100004015, NLGIN100004016, NLGIN100004018, NLGIN100004019, NLGIN100004020, NLGIN100005001, NLGIN100005003, NLGIN100005004, NLGIN100005006, NLGIN100005007, NLGIN100005008, NLGIN100005009, NLGIN100005010, NLGIN100005011, NLGIN100005012, NLGIN100005013, NLGIN100005014, NLGIN100005015, NLGIN100005016, NLGIN100005017, NLGIN100005018, NLGIN100005019, NLGIN100006001, NLGIN100006002,  ...
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Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. New Life Generation, INC.
Biologics Human Skin for Transplant NLGIN100003001, NLGIN100003002, NLGIN100003003, NLGIN100003004, NLGIN100003005, NLGIN100003006, NLGIN100003007, NLGIN100003008, NLGIN100003009, NLGIN100003010, NLGIN100003011, NLGIN100003012, NLGIN100003013, NLGIN100003014, NLGIN100003015, NLGIN100003016, NLGIN100003017, NLGIN100003018, NLGIN100003019, NLGIN100003020, NLGIN100003021 Class II Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. New Life Generation, INC.
Biologics Products: .5-1mm 2cc Cancellous Chips; .5-1mm 15cc Cancellous Chips; .5-1mm 30cc Cancellous Chips. Cancellous Chips. Product s are labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID: NLGIN09-0024C NLGIN10-0004 NLGIN10-0005 NLGIN10-0009 NLGIN10-0012 NLGIN10-0016 NLGIN10-0018 NLGIN10-0020 NLGIN10-0024 NLGIN10-0033 Tissue ID #: AI090024C2013, AI090024C2014, AI090024C2015, AI090024C2016, AI090024C2017, AI090024C2018, AI1000042016, AI1000052013, AI1000052014, AI1000052015, AI1000052016, AI1000052017, AI1000092019, AI1000092020, AI1000122013, AI1000122014, AI1000122015, AI1000122016, AI1000122017, AI1000122018, AI1000122019, AI1000122020, AI1000122021, AI1000122022, AI1000162019, AI1000182005, AI1000202018, AI1000202019, AI1000202020, AI1000202021, AI1000242009, AI1000242010, AI1000242011, AI10110402005, AI10110402006, AI10110402007, AI10110402008 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Product: .25-.5mm 15cc Cancellous Chips. Cancellous Chips Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" . Donor ID # - NLGIN10-0016. Tissue ID #: AI1000162018 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: 1-4mm 5cc Cancellous Chips; 1-4mm 10cc Cancellous Chips; 1-4mm 15cc Cancellous Chips; 1-4mm 30cc Cancellous Chips; 1-4mm 40cc Cancellous Chips; 1-4mm 60cc Cancellous Chips. Cancellous Chips Products are labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID#: NLGIN09-0024C NLGIN10-0001 NLGIN10-0004 NLGIN10-0005 NLGIN10-0007 NLGIN10-0009 NLGIN10-0012 NLGIN10-0013 NLGIN10-0016 NLGIN10-0018 NLGIN10-0020 NLGIN10-0021 NLGIN10-0024 NLGIN10-0025 NLGIN10-0031 NLGIN10-0033 NLGIN10-0038 NLGIN10-0040 NLGIN10-0047 NLGIN10-0052 NLGIN10-0066 NLGIN10-0069 NLGIN10-0076 NLGIN11-0014 NLGIN11-0051 Tissue ID: AI090024C2009, AI090024C2010, AI090024C2011, AI090024C2012, AI1000012005, AI1000012006, AI1000012007, AI1000012010, AI1000012011, AI1000042011, AI1000042012, AI1000042013, AI1000042014, AI1000042015, AI1000052010, AI1000052011, AI1000052012, AI1000072006, AI1000072007, AI1000072008, AI1000072009, AI1000072010, AI1000072011, AI1000092014, AI1000092015, AI1000092016, AI1000092017, AI1000092018, AI1000122010, AI1000122011, AI1000122012, AI1000132005, AI1000132006, AI1000132007, AI1000162020, AI1000162021, AI1000162022, AI1000162023, AI1000162024, AI1000182006, AI1000202005, AI1000202006, AI1000202007, AI1000202008, AI1000202009, AI1000202010, AI1000202022, AI1000202023, AI1000212014,  ...
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Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: 4-10mm 15cc Cancellous Chips; 4-10mm 30cc Cancellous Chips, 4-10mm 40cc Cancellous Chips, 4-10mm 60cc Cancellous Chips. Products are labeled in part: Cancellous Chips. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN09-0024C NLGIN10-0001 NLGIN10-0004 NLGIN10-0005 NLGIN10-0007 NLGIN10-0009 NLGIN10-0012 NLGIN10-0013 NLGIN10-0016 NLGIN10-0020 NLGIN10-0021 NLGIN10-0024 NLGIN10-0025 NLGIN10-0033 NLGIN10-0047 NLGIN10-0052 NLGIN10-0066 Tissue ID #: AI090024C2005, AI090024C2006, AI090024C2007, AI090024C2008, AI1000012008, AI1000012009, AI1000042005, AI1000042006, AI1000042007, AI1000042008, AI1000042009, AI1000042010, AI1000052005, AI1000052006, AI1000052007, AI1000052008, AI1000052009, AI1000072005, AI1000092005, AI1000092006, AI1000092007, AI1000092008, AI1000092009, AI1000092010, AI1000092011, AI1000092012, AI1000092013, AI1000122005, AI1000122006, AI1000122007, AI1000122008, AI1000122009, AI1000132008, AI1000132009, AI1000162005, AI1000162006, AI1000162007, AI1000162008, AI1000162009, AI1000162010, AI1000162011, AI1000162012, AI1000162013, AI1000162014, AI1000162015, AI1000162016, AI1000162017, AI1000202011,  ...
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Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: .5-1mm 1cc Cortical Cancellous Chips, .5-1mm 2cc Cortical Cancellous Chips. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0013 NLGIN10-0024 NLGIN10-0025 NLGIN10-0035 NLGIN10-0038 NLGIN10-0066 Tissue ID#: AI1000130505, AI1000130506, AI1000130507, AI1000130508, AI1000130516, AI1000130517, AI1000130518, AI1000130519, AI1000240509, AI1000240510, AI1000240511, AI1000240512, AI1000240513, AI1000240514, AI1000240515, AI1000240516, AI1000240517, AI1000240518, AI1000240519, AI1000240521, AI1000240522, AI1000240523, AI1000240524, AI1000240525, AI1000240526, AI1000240528, AI1000240529, AI1000240530, AI1000240531, AI1000240532, AI1000240533, AI1000240534, AI1000240535, AI1000240536, AI1000240537, AI1000240539, AI1000240540, AI1000240544, AI1000240545, AI1000250524, AI1000250525, AI1000250526, AI1000250527, AI1000250528, AI1000250529, AI1000350535, AI1000350536, AI1000350537, AI1000350538,  ...
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Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: 1-2mm 1cc Cortical Cancellous Chips, 1-2mm 2cc Cortical Cancellous Chips,1-2mm 5cc Cortical Cancellous Chips. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0020 NLGIN10-0031 NLGIN10-0035 NLGIN10-0038 NLGIN10-0047 Tissue ID #: AI1000200536, AI1000200537, AI1000200538, AI1000200539, AI1000200540, AI1000310510, AI1000350505, AI1000350506, AI1000350507, AI1000350508, AI1000350509, AI1000350510, AI1000350511, AI1000350512, AI1000350513, AI1000350514, AI1000350515, AI1000350516, AI1000350517, AI1000350518, AI1000350519, AI1000350520, AI1000350521, AI1000350522, AI1000350523, AI1000350524, AI1000350525, AI1000350526, AI1000380518, AI1000380519, AI1000380520, AI1000380521, AI1000380522, AI1000380523, AI1000380525, AI1000380526, AI1000380527, AI1000380528, AI1000380529, AI1000380530, AI1000380531, AI1000380532, AI1000380533, AI1000380534, AI1000380535, AI1000380536, AI1000380537, AI1000380538,  ...
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Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: 100mm Femur Shaft Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0038 NLGIN10-0047 Tissue ID #: AI1000380105, AI1000380106, AI1000470105, AI1000470106 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: 150mm Femur Shaft. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0047 Tissue ID #: AI1000470107 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: 10x10x18 Ilium Tricortical Block. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0004 NLGIN10-0038 Tissue ID #: AI1000045005, AI1000045008, AI1000045011, AI1000385007 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: 11-13x10x18 Ilium Tricortical Block Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0004 NLGIN10-0038 Tissue ID #: AI1000045006, AI1000045009, AI1000385009, AI1000385012, AI1000385015, AI1000385017, AI1000385018 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: 14-17x11x25 Ilium Tricortical Block. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0004 NLGIN10-0038 Tissue ID #: AI1000045007, AI1000045010, AI1000385005, AI1000385006, AI1000385008, AI1000385010, AI1000385011, AI1000385013, AI1000385014 AI1000385016 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: 150mm x 20mm Cortical Plate. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0047 Tissue ID #: AI1000470205, AI1000470206, AI1000470207 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: 200mm Tibia Shaft Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0033 Tissue ID #: AI10110400105 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: 5mm 30cc Cancellous Cubes. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0025 Tissue ID #: AI1000252019, AI1000252020, AI1000252021 AI1000252023, AI1000252024, AI1000252025 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: 8mm Cancellous Block. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0004 Tissue ID #: AI1000040753, AI1000040754, AI1000040755, AI1000040756, AI1000040757, AI1000040758, AI1000040759, AI1000040760, AI1000040761, AI1000040762, AI1000040763, AI1000040771 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: 9mm Cancellous Block. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0004 Tissue ID #: AI1000040776, AI1000040777, AI1000040778, AI1000040779 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: 5mm Lordotic Cervical Cancellous Spacer Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0016 Tissue ID #: AI1000163005 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: 6mm Lordotic Cervical Cancellous Spacer. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0001 NLGIN10-0007 NLGIN10-0013 NLGIN10-0016 Tissue ID #: AI1000013007, AI1000073006, AI1000073007, AI1000073010, AI1000073011, AI1000073013, AI1000073014, AI1000073016, AI1000073018, AI1000133008, AI1000133009, AI1000133010, AI1000163006, AI1000163007 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: 7mm Lordotic Cervical Cancellous Spacer. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0007 NLGIN10-0013 NLGIN10-0016 Tissue ID #: AI1000073024, AI1000073026, AI1000073028, AI1000133011, AI1000163008, AI1000163009, AI1000163010, AI1000163011, AI1000163012 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: 5mm Lordotic Cervical Spacer. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0024 Tissue ID #: AI1000244006, AI1000244015, AI1000244016, AI1000244017, AI1000244018 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: 6mm Lordotic Cervical Spacer. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0012 NLGIN10-0024 NLGIN10-0069 Tissue ID #: AI1000124005, AI1000124006, AI1000124007, AI1000124008, AI1000244022, AI1000244023, AI1000244024, AI1000244025, AI1000244026, AI1000244027, AI10110034011, AI10110034012, AI10110034013, AI10110034014, AI10110034015, AI10110034016, AI10110034017, AI10110034018, AI10110034019, AI10110034020, AI10110034021, AI10110034022, AI10110034023, AI10110034024, AI10110034025, AI10110034026, AI10110034028 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: 7mm Lordotic Cervical Spacer. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0012 NLGIN10-0069 Tissue ID #: AI1000124009, AI1000124010, AI1000124011, AI1000124012, AI1000124013, AI1000124014, AI1000124015, AI10110034029, AI10110034030, AI10110034031, AI10110034032 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: Achilles with Bone Block. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0021 Tissue ID #: AI1000210005, AI1000210006 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: Achilles with Bone Block Pre-sized. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0004 NLGIN10-0009 NLGIN10-0012 NLGIN10-0016 NLGIN10-0033 NLGIN10-0038 NLGIN10-0047 NLGIN10-0069 Tissue ID #: AI1000040006, AI1000090005, AI1000090006, AI1000120005, AI1000160005, AI1000160006, AI1000380015, AI1000380016, AI10110030006, AI10110400005, AI10110400006 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: Achilles without Bone Block.. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0005 Tissue ID #: AI1000050005, AI1000050006 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: Medial Femur Hemi-Condyle. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0038 Tissue ID #: AI1000380030 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: Patella Tendon - Hemi Presized. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0016 NLGIN10-0016 NLGIN10-0016 NLGIN10-0016 NLGIN10-0021 NLGIN10-0021 NLGIN10-0021 NLGIN10-0024 NLGIN10-0024 NLGIN10-0025 NLGIN10-0025 NLGIN10-0033 NLGIN10-0038 NLGIN10-0038 NLGIN10-0066 NLGIN10-0066 NLGIN10-0069 NLGIN10-0069 NLGIN10-0069 Tissue ID #: AI1000160007, AI1000160008, AI1000160009, AI1000160010, AI1000210007, AI1000210008, AI1000210009, AI1000240007, AI1000240008, AI1000250007, AI1000250008, AI1000380017, AI1000380018, AI1000660002, AI1000660003, AI10110030007, AI10110030008, AI10110030009, AI10110400007 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: Patella Whole. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0004 NLGIN10-0009 NLGIN10-0012 Tissue ID #: AI1000040007, AI1000040008, AI1000090007, AI1000090008 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: Peroneus Longus Tendon. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0004 NLGIN10-0005 NLGIN10-0009 NLGIN10-0012 NLGIN10-0016 NLGIN10-0024 NLGIN10-0038 NLGIN10-0047 NLGIN10-0069 NLGIN11-0051 Tissue ID #: AI1000040013, AI1000040014, AI1000050012, AI1000090013, AI1000090014, AI1000120013, AI1000120014, AI1000160015, AI1000160016, AI1000240012, AI1000380010, AI1000470013, AI10110030014, AI10110030015, AI11060010013 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: Semitendinosus/Gracilis Tendon . Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0033 NLGIN10-0047 Tissue ID #: AI10110400014, AI1000470014 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: Semitendinosus Tendon . Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN09-0024C NLGIN10-0033 NLGIN10-0047 NLGIN10-0066 Tissue ID #: AI090024C0011, AI1000470015, AI1000660009, AI1000660010, AI10110400015 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: Tibialis Tendon - Anterior. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN09-0024C NLGIN10-0004 NLGIN10-0005 NLGIN10-0009 NLGIN10-0012 NLGIN10-0013 NLGIN10-0016 NLGIN10-0021 NLGIN10-0024 NLGIN10-0025 NLGIN10-0033 NLGIN10-0038 NLGIN10-0047 NLGIN10-0066 NLGIN10-0069 NLGIN11-0051 Tissue ID #: AI090024C0007, AI090024C0008, AI1000040010, AI1000050007, AI1000050008, AI1000090009, AI1000090010, AI1000120009, AI1000120010, AI1000130008, AI1000130009, AI1000160011, AI1000160012, AI1000210010, AI1000210011, AI1000240009, AI1000240010, AI1000250009, AI1000250010, AI1000380005, AI1000380006, AI1000470008, AI1000660004, AI1000660005, AI10110030010, AI10110030011, AI10110400008, AI10110400009 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: Tibialis Tendon - Posterior. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN09-0024C NLGIN10-0004 NLGIN10-0005 NLGIN10-0009 NLGIN10-0012 NLGIN10-0013 NLGIN10-0016 NLGIN10-0021 NLGIN10-0024 NLGIN10-0025 NLGIN10-0033 NLGIN10-0038 NLGIN10-0066 NLGIN10-0069 Tissue ID #: AI090024C0009, AI090024C0010, AI1000040011, AI1000040012, AI1000050009, AI1000050010, AI1000090011, AI1000090012, AI1000120011, AI1000120012, AI1000130010, AI1000160013, AI1000160014, AI1000210012, AI1000210013, AI1000240011, AI1000250011, AI1000250012, AI1000380007, AI1000380008, AI1000660006, AI10110030012, AI10110030013, AI10110400010, AI10110400011 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: 5mm Cancellous Block Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Block***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0004 NLGIN10-0021 NLGIN10-0024 Tissue ID #: AI1000040705, AI1000040706, AI1000210705, AI1000210706, AI1000210707, AI1000210708, AI1000210709, AI1000210710, AI1000210711, AI1000210712, AI1000240705, AI1000240706, AI1000240707, AI1000240708, AI1000240709, AI1000240710 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: 6mm Cancellous Block Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Block***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0004 Tissue ID #: AI1000040707, AI1000040708, AI1000040709, AI1000040710, AI1000040711, AI1000040712, AI1000040713, AI1000040714, AI1000040715, AI1000040716, AI1000040717, AI1000040718, AI1000040719, AI1000040720, AI1000040721, AI1000040722, AI1000040723, AI1000040724, AI1000040725, AI1000040726, AI1000040727, AI1000040728, AI1000040729, AI1000040730, AI1000040731 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Products: 7mm Cancellous Block Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Block***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0004 Tissue ID #: AI1000040732, AI1000040733, AI1000040734, AI1000040735, AI1000040736, AI1000040737, AI1000040738, AI1000040739, AI1000040740, AI1000040741, AI1000040742, AI1000040743, AI1000040744, AI1000040750, AI1000040751, AI1000040752 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Blood and Blood Products for Reprocessing W128711161270 Class III Blood products, collected from a donor for whom there was no documentation on the donor record of an arm inspection, were distributed. Delta Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W128711161270 Class III Blood products, collected from a donor for whom there was no documentation on the donor record of an arm inspection, were distributed. Delta Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W128711016818 Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Delta Blood Bank
Biologics Cornea SA20120362, SA201203451, SA20120361 Class III Human Corneas, processed in a manner that may cause the introduction, transmission, or spread of communicable disease, were distributed. San Antonio Eye Bank
Devices Powered Mobility Offers Versatility (MÖV)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs. Model number: EMS with serial codes: 100393, 100395, 100400, 100402, 100410, 100451, 100460, 100499, 100500, 100502, 100503, 100504, 100506, 100507, 100508, 100509, 100510, 100511, 100512, 100513, 100514, 100515, 100516, 100517, 100518, 100519, 100522, 100523, 100524, 100525, 100533, 100537, 100538, 100541, 100542, 100544, 100545, 100548, 100549, 100553, 100554, 100555, 100556, 100557,  ...
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Class II Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Paramed's powered Mobility Offers Versatility (MÖV) chair was reviewed to identify potential compliance issues in relation to product documentation and classification. Stryker Medical Division of Stryker Corporation
Devices Powered Mobility Offers Versatility (MÖV)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs. Model: EMS24 with serial codes: 100346, 100348, 100355, 100356, 100357, 100358, 100359, 100360, 100362, 100363, and 100364. Class II Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Paramed's powered Mobility Offers Versatility (MÖV) chair was reviewed to identify potential compliance issues in relation to product documentation and classification. Stryker Medical Division of Stryker Corporation
Devices Powered Mobility Offers Versatility (MÖV)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs Model: HHC with serial codes: 100391, 100394, 100397, 100401, 100403, 100404, 100405, 100407, 100408, 100409, 100411, 100413, 100414, 100416, 100417, 100418, 100419, 100420, 100421, 100422, 100423, 100424, 100425, 100426, 100427, 100428, 100430, 100430, 100431, 100433, 100434, 100435, 100436, 100437, 100438, 100439, 100440, 100441, 100442, 100443, 100444, 100445, 100446, 100447, 100448,  ...
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Class II Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Paramed's powered Mobility Offers Versatility (MÖV) chair was reviewed to identify potential compliance issues in relation to product documentation and classification. Stryker Medical Division of Stryker Corporation
Devices Powered Mobility Offers Versatility (MÖV)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs. Model: IND with serial codes: 100546, 100547, 100558, 100560, 100561, 100562, 100563, 100564, 100565, 100567, 100568, 100569, 100570, 100571, 100572, 100573, 100574, 100575, 100576, 100577, 100585, 100589, 100592, 100594, 100596, 100620, and 100638. Class II Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Paramed's powered Mobility Offers Versatility (MÖV) chair was reviewed to identify potential compliance issues in relation to product documentation and classification. Stryker Medical Division of Stryker Corporation
Drugs Morton, Sodium Chloride, USP, Granular, packaged in kraft paper bags, fiber drums, and semi-bulk bags. Product is shipped in 80 lb bags, 350 lb drums & 2000 lb semi-bulk sacks. Manufactured by Morton Salt, Inc., Chicago, Illinois 60606-1743. Lot #: OCT251BC01, NOV041BA01 & NOV071BA01. Class III Impurities/Degradation Products: The product was found to contain a slightly out of specification level of bromides, exceeding the bromides limit for USP Sodium Chloride. Morton Salt Co.
Biologics Siemens brand Trugene HIV-1, Genotyping Kit, Box 1 and Box 2, Catalog Numbers: 10336823 10336826; Product is manufactured and distributed by Siemens Healthcare Diagnostics Inc., Berkeley, CA Lot Numbers: U080A1, U080A2 Class II Trugene HIV-1 Genotype kits, not meeting current performance claims due to variation during manufacture, were distributed. Siemens Healthcare Diagnostics Inc.
Veterinary Diamond Pet Foods Naturals Small Breed Adult Dog Lamb & Rice Formula, packaged in 6-lb. (6/case) and 18-lb. bags, and 6-oz. sample-size bags (30/case). The firm name on the label is Diamond Pet Foods, Meta, MO. Best Before 26Aug2012, 27-Sept 2012, 18-Oct-2012 and 20-Oct-2012 Class I Contaminated with Salmonella Diamond Pet Foods
Drugs V Maxx Rx, All Natural Male Enhancement, a) 1-count blister pack UPC Code 2802803561; b) 5-count blister pack UPC Code 0972859402; c) 10-count bottle UPC code 0913251017 bottles, Manufactured by The Menz Club, LLC, 103 W. Washington Street, Suite B5, Ridgeland, MS 39157, Phone: 601-866-6746 Lot #s: a) 101108, 101009, 101010, 101011; b) 101108, 101109, 101110; c) 301000, 301001 Class I Marketed Without An Approved NDA/ANDA: Samples tested by FDA were found to contain sulfoaildenafil, an analogue of sildenafil, an FDA approved drug used in the treatment of male erectile dysfunction, making these products unapproved new drugs. The Menz Club, LLC
Devices OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color. Use with LOGIC Tibial Components. REF 02--012-42-2508. The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. The Optetrak Comprehensive Knee Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, patients without sufficient soft tissue integrity to provide adequate stability, patients with either mental or neuromuscular disorders that do not allow control of the knee joint, and patients whose weight, age, or activity level might cause extreme loads and early failure of the system. Catalog Number: 02-012-42-2508. Class II Exactech, Inc. of Gainesville, FL recalled their Optetrak Proximal Tibial Spacer after the devices were determined to be dimensionally incompatible to mate as intended with the Logic Tibial Tray. Exactech, Inc.
Biologics Corneas AAG744ODCN; AAG744OSCN Class II Human Corneas, recovered from a donor with evidence of infection due to a communicable disease agent, were distributed. SightLife
Devices i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac I troponin measurement cane be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. 510(K)K031739 List Number 06F15-03, 06F15-04, 03P90-25, 600-9009-25 All lots Class II Abbott Point of Care has determined that i-Stat CTNL cartridges have the potential to exhibit incorrectly elevated cardiac troponin I results. This recall was expanded on July 19 2012 to include additional information regarding user documentation. Abbott Point Of Care Inc.
Devices Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use Version 6.4.2 Class III In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number associated to the CID is no longer inactive. Sunquest Information Systems, Inc.
Devices EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended tot duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. The EasyLink Informatics System is classified as a data calculator and processing module for use with in vitro diagnostic devices. The EasyLink is included with the Dimension Vista System and may be used with other Siemens analyzers as a communications and connectivity workstation for integration with laboratory information system (LIS) networks. Part Number: 1000034805, Version 5.0 and Version 5.0 Service Pack 1 through 4 Class II When using the EasyLink Quality Control Package the system may not perform as intended for Multi-Rule QC violations [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions send with the Urgent Field Safety Notice. When this situation occurs, QC status may not be flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out, the patient results will not be held as expected. Siemens Healthcare Diagnostics, Inc.
Veterinary PEDIGREE+® Healthy Weight Premium Ground Entrée in Meaty Juices, 375 g (13.2 oz) cans, FOOD FOR DOGS, Ingredients: Sufficient Water For Processing: Chicken, Meat By-Products, Liver, Chicken By-Products, chicken Breast, Carrots, Spinach, Brewers Rice***1-800-525-5273 Distributed by Mars Petcare US, Inc., P. O. Box 683006, Franklin, TN 37068-3006***, UPC 0 23100 34974 9 UPC 0 23100 34974 9, Each product will have a lot code printed on the end of the can that begins with 209, 210, 211 or 212 and a Best Before date that falls between 2/24/2014 and 3/23/2014. Class I Product is being recalled because it may contain small pieces (2/3 x 2/3 x 2/5) of blue plastic. These pieces may represent a choking hazard to dogs. Mars Petcare USA
Veterinary PEDIGREE® Weight Management Meaty Ground Dinner Beef & Liver Dinner in Meaty Juices, 375 g (13.2 oz) cans, Ingredients: Sufficient Water for Processing, Meat By-Products, Chicken, Beef, Liver, Brewers Rice***1-800-525-5273 Distributed by Mars Petcare US PO Box 683006, Franklin, TN 37068-3006***, UPC 0 23100 01913 0 UPC 0 23100 01913 0, Each product will have a lot code printed on the end of the can that begins with 209, 210, 211 or 212 and a Best Before date that falls between 2/24/2014 and 3/23/2014. Class I Product is being recalled because it may contain small pieces (2/3 x 2/3 x 2/5) of blue plastic. These pieces may represent a choking hazard to dogs. Mars Petcare USA
Veterinary PEDIGREE® Weight Management Meaty Ground Dinner Chicken & Rice Dinner in Meaty Juices, 375 g (13.2 oz) cans, Ingredients: Sufficient Water for Processing, Chicken, Meat By-Products, Chicken By-Products (Source of Linoleic Acid), Liver, Brewers Rice***1-800-525-5273 Distributed by Mars Petcare US P. O. Box 683006, Franklin, TN 37068-3006***, UPC 0 23100 23045 9 UPC UPC 0 23100 23045 9, Each product will have a lot code printed on the end of the can that begins with 209, 210, 211 or 212 and a Best Before date that falls between 2/24/2014 and 3/23/2014. Class I Product is being recalled because it may contain small pieces (2/3 x 2/3 x 2/5) of blue plastic. These pieces may represent a choking hazard to dogs. Mars Petcare USA
Food Whiskey Pecan Cookies, packaged in cellophane sleeve wrap, 9.6 oz each. Sold in individual sleeves or in a case of 6 packages (cello sleeves). "135", "141", "146", "148", "154", "155", "157", "160", "163", "166", and "173". These are the julian dates that the dough was baked and packaged. The dough was made on 4/29/12 and 5/28/12 and frozen. Class II The wheat germ used by the firm to make their products was recalled by the wheat germ manufacturer because it was potentially contaminated with metal fragments approximately 05.mm in diameter and 3-15 mm in length. The contamination occurred at the raw ingredient manufacturer. Breadfarm
Food Wheat Crackers, packaged in cellophane sleeve wrap, 6.4 oz each. Sold in individual sleeves or in a case of 12 packages (cello sleeves). "122", "130", "137", "148", "165". These are the julian dates that the dough was made,baked and packaged. Class II The wheat germ used by the firm to make their products was recalled by the wheat germ manufacturer because it was potentially contaminated with metal fragments approximately 05.mm in diameter and 3-15 mm in length. The contamination occurred at the raw ingredient manufacturer. Breadfarm
Food Fig Bars (Fig Newton style), bulk packed and refrigerated for individual sales. "128" and "149". These are the julian dates that the dough was baked and packaged. The dough was produced on 5/5/12 and 5/26/12. Class II The wheat germ used by the firm to make their products was recalled by the wheat germ manufacturer because it was potentially contaminated with metal fragments approximately 05.mm in diameter and 3-15 mm in length. The contamination occurred at the raw ingredient manufacturer. Breadfarm
Drugs Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3. Lot # 55302, Exp 12/12 Class II Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration. Noven Pharmaceuticals, Inc.
Drugs Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5555-3. Lot # 56506, Exp 12/12 Class II Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration. Noven Pharmaceuticals, Inc.
Drugs Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3. Lot #53823, Exp 08/12 Class II Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration. Noven Pharmaceuticals, Inc.
Food Cheese Pizza. Label is not provided. Product is packaged and delivered in bulk. None Class II Cheese Pizza is recalled due to the lack of temperature control to prevent pathogens growth. KT Specialty Foods Inc.
Food Pizza Bagel. Label is not provided. Product is packaged and delivered in bulk. None Class II Pizza Bagel is recalled due to the lack of temperature control to prevent pathogens growth. KT Specialty Foods Inc.
Food Veggie Pizza. Label is not provided. Product is packaged and delivered in bulk. None Class II Veggie Pizza is recalled due to the lack of temperature control to prevent pathogens growth. KT Specialty Foods Inc.
Drugs Hipoglos Ointment (zinc oxide and lanolin), Helps prevent and treat diaper rash, skin irritation, Manufactured by Laboratorios Andromaco S.A. Av. Quilin 5273, Penalolen, Santiago. www.hipoglos.cl, www.laboratoriosandromaco.cl, Made in Chile, Net wt. per Tube: a) 0.18 oz (5 g), NDC: 50145-111-05; b) 2.2 oz (60 g), NDC: 50145-111-04; c) 2.5 oz (72 g), NDC: 50145-111-03; d) 3.5 oz (100 g), NDC: 50145-111-02; e) 4.2 oz (120 g), NDC: 50145-111-01. Lot #/Product #: a) C1557B/MM26306, Exp 03/31/2014; b) C1387B/PV16856, Exp 03/31/2014, G0288C/PV16856, Exp 07/31/2013; c) G0288A/PV16855, Exp 07/31/2013; d) G0289B/PV16854, Exp 07/31/2013; e) C1387A/PV16853, Exp 03/31/2014, G0288B/PV16853, Exp 07/31/2013 Class II Misbranded Victus, Inc.
Food Dinner Rolls, 12 oz. net weight,, manufactured by Italian Peoples Bakery, 61-63 Butler Street, Trenton, NJ 08611; UPC 53277101246 Class I Product has an error on the ingredient listing of the packaging for product produced by Italian Peoples Bakery. The listing should include whey, but it is not included. Peoples Bakery Inc
Food Kaiser Roll, 12 oz. net weight,, manufactured by Italian Peoples Bakery, 61-63 Butler Street, Trenton, NJ 08611; UPC 53277101253 Class I Product has an error on the ingredient listing of the packaging for product produced by Italian Peoples Bakery. The listing should include whey, but it is not included. Peoples Bakery Inc
Food Torps Rolls 12 oz. net weight,, manufactured by Italian Peoples Bakery, 61-63 Butler Street, Trenton, NJ 08611; UPC 5327710125 Class I Product has an error on the ingredient listing of the packaging for product produced by Italian Peoples Bakery. The listing should include whey, but it is not included. Peoples Bakery Inc
Devices Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medial technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medial images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images). Horizon Medial Imaging (HMI) versions 11.5, 11.5.1, 11.5.2, 11.6 and 11.7. Class II There is a potential to save reports in RadReport with an Incorrect Final Status. Mckesson Medical Imaging Group
Devices Medtronic O-arm® Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R. Serial Numbers: 109R, 118R, 124, 136, 159 ,170, 218, 222, 223, 236, 239 , 299, 309R, 402, 410, 412, 414. Class II A fault in a high voltage relay in the 0-arm® Imaging System might cause the relay to overheat and burn. Medtronic Navigation, Inc.
Devices Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Right Knee Product Usage : Usage: The iTotal CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patello-femoral or bi-compartmental prosthesis. All serial numbers Class II Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique Conformis Inc
Devices syngo Dynamics Version 9.5 10091862 and 10091863 Class II If multiple uncompressed images/clips are sent to the syngo Dynamics server, around the same time, it is possible for an image from a patient to be placed in another patient's study. Siemens Medical Solutions, USA, Inc
Food Oysters, Frozen IQF, packaged in 5 lb bags, 6x5 lb/cartons, labeled in part ***Product of Korea*** All codes Class II Molluscan shellfish may have been exposed to human fecal waste and are potentially contaminated with norovirus. LD Amory & Company
Devices Siemens ADVIA Centaur® Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (SYPH) assay is an in vitro diagnostic immunoassay for the qualitative determination of antibodies to Treponema pallidum in human serum or plasma (EDTA, lithium or sodium heparinized, citrate) using the ADVIA Centaur and ADVIA Centaur XP systems as an aid in the diagnosis of syphilis US Lot Number/Exp. Date 85456003 2012-10-13; 86036003 2012-10-13; 87129003 2012-10-13; 88440003 2012-10-13; 90054004 2013-04-09; 90422004 2013-04-09. Outside the US: Kit lots, 77749002, 80615003, 82640003, 84120003, 85456003, 86036003, 87129003,88440003,90054004,90422004. Class II Syphilis Assay Interference with HBsAg Assay Siemens Healthcare Diagnostics, Inc
Devices Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates. Model 8100; Lot/Serial numbers-various Class I The recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump module model 8100. The pump module door keypad overlay may separate from the keypad assembly CareFusion 303, Inc.
Devices Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the damaged hip joint to help increase patient mobility and to reduce pain. Packaging: Product is placed into a PETG tray, sealed with a Tyvek lid. This is placed into a second PETG tray and sealed with a Tyvek lid. This package is placed into a paperboard carton, labeled, and shrink-wrapped. Intended Use: An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Catalog number: 1221-36-054 and Lot Number: 231859 Class II In the recalled lot, the products were not machined according to the production router, a size 52 cup (122136052) was machined instead. This resulted in a size 52 liner being etched and labeled as a size 54 liner. DePuy Orthopaedics, Inc.
Devices Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 55 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 60 mm STANDARD POST SCREW Manufactured by: STRYKER Spine SAS, Z.I. Marticot - 33610 - Cestas-France +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct., Allendale, NJ 07401-1677 USA +1-201-750-8000. The Stryker Spine Trio/Trio+ Spinal Fixation Systems are comprised of spinal screws, rods, and connectors. The components are available in a variety of lengths in order to accommodate patient anatomy. The system is intended for posterior, non-cervical pedicle and non-pedicle pedicle fixation of the spine. It is indicated for: degenerative disc disease (DDD), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis kyphosis, lordosis, spinal tumor, pseudarthrosis, and failed previous fusion. Code information listed in the following format: Manufacturer Part Number/Prodcut Description/Corresponding IFU Part Number/Affected Lot #s are as follows: 48900445/Trio Standard Post Screw 5.5x55mm/#NOLI135B03Rev02/57281 and 57201 48900450/Trio Standard Post Screw 5.5x60mm/#NOLI135B03Rev02/57197 48900455/Trio Standard Post Screw 4.5x45mm/#NOLI135B03Rev02/57198 48900555/Trio Standard Post Screw 4.5x50mm/#NOLI135B03Rev02/56599 48900560/Trio Standard Post Screw 4.5x55mm/#NOLI135B03Rev02/57192 Class II The front cover of Instructions For Use (IFU) #NOLI135B03Rev02 was improperly marked with a "Sterile" logo in the lower right corner. The products these IFUs were packed with are sold as "Non-Sterile" and require sterilization before use in surgery. Stryker Spine
Food Yellow onions Diced 3/8", packaged in 25-lb. plastic bags, 1 per case (item 19551); Diced 1/4", packaged in 5-lb. bags, 2 per case (item #19516), 4 per case (item 19510), and 1 per case (item 19515). Diced yellow onion packaged in 5-oz. plastic containers, 4 per case, UPC 815970010153, and 10-oz. plastic containers, 4 per case, UPC 815970011082, for retail sale. The firm name on the label is Cool Creations, LLC, North Kansas City, MO. Lot numbers 12201 thru 12207 (last use by date affected is 8/30/2012) Class I Products may be contaminated with Listeria monocytogenes Cool Creations, LLC
Food Yellow onions: Julienne 1/4", packaged in 5-lb. plastic bags, 4 per case (item 19540) The firm name on the label is Cool Creations, LLC, North Kansas City, MO. Lot numbers 12201 thru 12207 (last use by date affected is 8/30/2012) Class I Products may be contaminated with Listeria monocytogenes Cool Creations, LLC
Food Yellow onions: Sliced 1/4", packaged in 5-lb. plastic bags, 4 per case (item 19500) and 1 per case (item 19505) The firm name on the label is Cool Creations, LLC, North Kansas City, MO. Lot numbers 12201 thru 12207 (last use by date affected is 8/30/2012) Class I Products may be contaminated with Listeria monocytogenes Cool Creations, LLC
Food Yellow onions: Whole peeled, packaged in 10-lb. plastic bags, 1 per case (item 19530). The firm name on the label is Cool Creations, LLC, North Kansas City, MO. Lot numbers 12201 thru 12207 (last use by date affected is 8/5/2012) Class I Products may be contaminated with Listeria monocytogenes Cool Creations, LLC
Food Cool Creations Pico de Gallo packaged for food service in 5-lb. trays, 2 per case (item 17502), and Pico de Gallo packaged for retail sale in 16-oz plastic containers, 4 per case, UPC 815970011013; and 8-oz. plastic containers, 4 per case, UPC 815970010252. The firm name on the label is Cool Creations, LLC, North Kansas City, MO. Lot numbers 12201 thru 12207 (last use by date affected is 8/5/12) Class I Products may be contaminated with Listeria monocytogenes Cool Creations, LLC
Food Cool Creations Fajita Mix Deluxe packaged for food service in 5-lb. plastic trays, 4 per case (item #15741). Lot numbers 12201 thru 12207 (last affected use by date 8/4/12) Class I Products may be contaminated with Listeria monocytogenes Cool Creations, LLC
Food Grillers Fajita Mix, packaged in 10-oz. foil trays, 4 trays per case, UPC 815970011341. The firm name on the label is Cool Creations, LLC, North Kansas City, MO. Lot numbers 12201 thru 12207 (last use by date affected is 8/6/2012) Class I Products may be contaminated with Listeria monocytogenes Cool Creations, LLC
Food Grillers Potato & Mushroom, packaged in 12-oz. foil trays, 4 trays per case, UPC 815970011334. The firm name on the label is Cool Creations, LLC, North Kansas City, MO. Lot numbers 12201 thru 12207 (last use by date affected is 8/6/2012) Class I Products may be contaminated with Listeria monocytogenes Cool Creations, LLC
Food Grillers Asparagus Medley, packaged in 10-oz. foil trays, 4 trays per case, UPC 815970011440. The firm name on the label is Cool Creations, LLC, North Kansas City, MO. Lot numbers 12201 thru 12207 (last use by date affected is 8/6/2012) Class I Products may be contaminated with Listeria monocytogenes Cool Creations, LLC
Food Grillers Squash Medley, packaged in 12-oz. foil trays, 4 trays per case, UPC 815970011389. The firm name on the label is Cool Creations, LLC, North Kansas City, MO. Lot numbers 12201 thru 12207 (last use by date affected is 8/6/2012) Class I Products may be contaminated with Listeria monocytogenes Cool Creations, LLC
Food Kabob Kit, packaged in 24-oz. plastic containers, 2 containers per case, UPC 815970011792. The firm name on the label is Cool Creations, LLC, North Kansas City, MO. Lot numbers 12201 thru 12207 (last use by date affected is 8/5/2012) Class I Products may be contaminated with Listeria monocytogenes Cool Creations, LLC
Food Beef Stew Kit, packaged in 32-oz. plastic containers, 2 containers per case, UPC 815970011150. The firm name on the label is Cool Creations, LLC, North Kansas City, MO. Lot numbers 12201 thru 12207 (last use by date affected is 8/5/2012) Class I Products may be contaminated with Listeria monocytogenes Cool Creations, LLC
Food Vegetable Medley, packaged in 20-oz. plastic containers, 2 containers per case, UPC 815970011259. The firm name on the label is Cool Creations, LLC, North Kansas City, MO. Lot numbers 12201 thru 12207 (last use by date affected is 8/5/2012) Class I Products may be contaminated with Listeria monocytogenes Cool Creations, LLC
Food Bean dip packaged in the following configurations: 1. Bean Dip Bowl, packaged in 10-oz. plastic bowls, 4 bowls per case, UPC 815970011198; 2. Bean Dip Bowl, packaged in 20-oz. plastic bowls, 4 bowls per case, UPC 815970010368; 3. Bean Dip Tray, packaged in 20-oz. foil pans, 4 per case, UPC 815970011648; and 4. Bean Dip Platter, packaged in 45-oz. trays, 2 per case, UPC 815970010375. The firm name on the label is Cool Creations, LLC, North Kansas City, MO. Lot numbers 12201 thru 12207 (last use by date affected is 8/5/2012) Class I Products may be contaminated with Listeria monocytogenes Cool Creations, LLC
Food Fiesta garden Fresh Salsa, Black Beans & Corn, packaged in 16-oz. plastic containers, 6 per case, UPC 829595000055. Distributed by Vanscoy Industries, Cedar Rapids, IA. Lot numbers 12201 thru 12207 (last use by date affected is 8/30/2012) Class I Products may be contaminated with Listeria monocytogenes Cool Creations, LLC
Food Fiesta garden Fresh Salsa, Garlic, packaged in 16-oz. plastic containers, 6 per case, UPC 829595000062. Distributed by Vanscoy Industries, Cedar Rapids, IA. Lot numbers 12201 thru 12207 (last use by date affected is 8/30/2012) Class I Products may be contaminated with Listeria monocytogenes Cool Creations, LLC
Food Fiesta garden Fresh Salsa, Hot, packaged in 16-oz. plastic containers, 12 per case, UPC 829595000048. Distributed by Vanscoy Industries, Cedar Rapids, IA. Lot numbers 12201 thru 12207 (last use by date affected is 8/30/2012) Class I Products may be contaminated with Listeria monocytogenes Cool Creations, LLC
Food Fiesta garden Fresh Salsa, Mild, packaged in 16-oz. plastic containers, 12 per case, UPC 829595000017. Distributed by Vanscoy Industries, Cedar Rapids, IA. Lot numbers 12201 thru 12207 (last use by date affected is 8/30/2012) Class I Products may be contaminated with Listeria monocytogenes Cool Creations, LLC
Food Fiesta garden Fresh Salsa, Pineapple, packaged in 16-oz. plastic containers, 6 per case, UPC 829595000079. Distributed by Vanscoy Industries, Cedar Rapids, IA. Lot numbers 12201 thru 12207 (last use by date affected is 8/30/2012) Class I Products may be contaminated with Listeria monocytogenes Cool Creations, LLC
Food Kaiser Rolls, Seeded Rolls, Brat Buns, French Bread, Pretzel Rolls, Pretzels, Pizza Dough, Hoagie Rolls and French Baguettes each packaged in identical semi-transparent plastic bags identified as fresh from the OVEN SOUR DOUGH 12 KAISER ROLLS, NET WT 20 OZ, WIMBERGER'S OLD WORLD BAKERY 2321 Bott St., Colorado Springs, Colo 80904. The labeling is yellow, white, and brown, with black print writing bearing the UPC 7960540012. These items are also distributed in 10 oz. UPC 7960540012. Class I Wimberger's Old World Bakery is recalling various baked bread products due to the omission of major allergens milk, soy, and wheat from their finished product labeling. Wimberger's Old World Bakery, Inc.
Devices Serial interface module RS-232 Product Usage: The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is the interface between the TLink Data Management ystem or Sarns CCPro Data Perfusion oftware and the system. The data collected and exported by the data transfer module includes physiological data and device events to record the progress and events during a procedure. catalog number: 802113 and serial numbers: 00007-00036, 00038-00045, 00047-00064, 00066-00077, 00080-00121, 00123-00214,00216-00283, 00285-00363, 00366-00498, 00500-00548, and 00550-00597. Class II Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the odor of smoke was as associated with the failures. The malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the module. Terumo CVS's investigation has determined that the the malfunctions are caused by a circuit board that failed. There have been no reports of patient injury as a result of this issue. Terumo Cardiovascular Systems Corporation
Devices Serial interface module RS-485 Product Usage: The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is the interface between the TLink Data Management ystem or Sarns CCPro Data Perfusion oftware and the system. The data collected and exported by the data transfer module includes physiological data and device events to record the progress and events during a procedure. catalog number: 803518 and serial numbers:00007-00038, 00041, and 00043. Class II Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the odor of smoke was as associated with the failures. The malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the module. Terumo CVS's investigation has determined that the the malfunctions are caused by a circuit board that failed. There have been no reports of patient injury as a result of this issue. Terumo Cardiovascular Systems Corporation
Devices Interface module for CDl System 100/101 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data from the CDl 500 catalog number: 802558 and serial numbers:00008-00013, and 00015-00241. Class II Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the odor of smoke was as associated with the failures. The malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the module. Terumo CVS's investigation has determined that the the malfunctions are caused by a circuit board that failed. There have been no reports of patient injury as a result of this issue. Terumo Cardiovascular Systems Corporation
Devices Interface module for CDl System 500 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data from the CDl 500 catalog number: 803479 and serial numbers:00009-00122, 00124-00210, 00213-00365, 00367-00458, and 00461-00596. Class II Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the odor of smoke was as associated with the failures. The malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the module. Terumo CVS's investigation has determined that the the malfunctions are caused by a circuit board that failed. There have been no reports of patient injury as a result of this issue. Terumo Cardiovascular Systems Corporation
Food Processed Yellow Onions - Yellow Sliced 1/8", 1/4" and 3/16" Julian Date 12188 through Julian Date 12206 - Item No. 900258, 801459, 900253, 801103, 501083, 501459, 500258, 900569, Class I Product may be contaminated with Listeria monocytogenes. Freshpoint Atlanta, Inc.
Food Processed Yellow Onions - Yellow Julienne 1/8", 1/4", 3/4" and 3/8" Julian Date 12188 through Julian Date 12206 - Item No. 900540, 500245, 901329, 900215, 901081, 501081, 801329, 700245, 500206, 900245, 501329, 501699, 901699 Class I Product may be contaminated with Listeria monocytogenes. Freshpoint Atlanta, Inc.
Food Processed Yellow Onions -Yellow Diced 1/4", 1/2" 3/4", 3/8", and 1/8" Julian Date 12188 through Julian Date 12206 - Item No. 500200, 500656, 900262, 500262, 900200, 901597, 901957, 901926, 900201, 901059, 901076, 501059, 700656, 900656, 501076, 501622, 500448, 500209, 500569, 900264, 500201, 501461, 500264 Class I Product may be contaminated with Listeria monocytogenes. Freshpoint Atlanta, Inc.
Food Processed Yellow Onions Veg. Ratatouille Mix Julian Date 12188 through Julian Date 12206 - Item No. 900776, 500776 Class I Product may be contaminated with Listeria monocytogenes. Freshpoint Atlanta, Inc.
Food Processed Yellow Onions Cubed 1" Julian Date 12188 through Julian Date 12206 - Item No. 500236, 800236 Class I Product may be contaminated with Listeria monocytogenes. Freshpoint Atlanta, Inc.
Food Processed Yellow Onions - Veg. Harvest Hash Mix Julian Date 12188 through Julian Date 12206 - Item No. 901786, 501786 Class I Product may be contaminated with Listeria monocytogenes. Freshpoint Atlanta, Inc.
Food Processed Yellow Onions - Veg. Mirepoix Julian Date 12188 through Julian Date 12206 - Item No. 901041, 501205 Class I Product may be contaminated with Listeria monocytogenes. Freshpoint Atlanta, Inc.
Food Processed Yellow Onions - Veg. Mix Asp/On/Ryg Pep Jul Julian Date 12188 through Julian Date 12206 - Item No. 501441 Class I Product may be contaminated with Listeria monocytogenes. Freshpoint Atlanta, Inc.
Food Processed Yellow Onions - Whole Peeled Julian Date 12188 through Julian Date 12206 - Item No. 500557, 500267, 501884, 800267, 900267 Class I Product may be contaminated with Listeria monocytogenes. Freshpoint Atlanta, Inc.
Food Processed Yellow Onions - Veg. Fajita Mix II & III Julienne Julian Date 12188 through Julian Date 12206 - Item No. 500619, 900619, 901393 Class I Product may be contaminated with Listeria monocytogenes. Freshpoint Atlanta, Inc.
Food Processed Yellow Onions - Yellow Slivered Julian Date 12188 through Julian Date 12206 - Item No. 501200 Class I Product may be contaminated with Listeria monocytogenes. Freshpoint Atlanta, Inc.
Food Processed Yellow Onions - Veg. Asian Bias Mix Julian Date 12188 through Julian Date 12206 - Item No. 501204 Class I Product may be contaminated with Listeria monocytogenes. Freshpoint Atlanta, Inc.
Food Processed Yellow Onions - Yellow Colossal Ring Julian Date 12188 through Julian Date 12206 - Item No. 901375 Class I Product may be contaminated with Listeria monocytogenes. Freshpoint Atlanta, Inc.
Food Trader Joe's Roasted Butternut Squash, Red Quinoa and Wheatberr Salad, 9.5 oz. Product packaged in plastic tray with plastic lid. 18 units/basket. Use by date 7/28/12 and 7/30/12 Class I Recall initiated by firm because the onions uses as an ingredient have the potential to be contaminated by Listeria monocytogenes. Huxtable's Kitchen Inc
Devices 892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide fluoroscopic and spot film imaging of the patient during diagnostic surgical and interventional procedures. The systems include features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and are also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures. The systems may be used for other imaging applications at the physician's discretion. Model Number HDS721616PLAT80; GE Healthcare part number 5304649. Class II GE OEC is recalling certain 9800 Image Intensified Flouroscopic x-ray systems due to customer complaint analysis showing that a replacement Hitachi 160 GB Hard Drive, when installed on certain models is susceptible of causing unanticipated system shut downs, no boots, data loss or data mix, or unexpected hard drive corruption. GE OEC Medical Systems, Inc
Food Crispy Just Baked Punjabi Cookies, packaged in clear clam shell container and sealed in clear plastic wrap. Net weight is 800 gram (1.76 lb). The UPC is 6 27265 00152 0. The product is labeled in parts: "***CRISPY PUNJABI COOKIES Just Baked!***By TWI Foods***Ingredients: Wheat Flour, soybean oil, margarine, sugar, semolina, baking powder, ammonium carbonate***". USE BYE DATE JULY 31ST 2012. Class I Crispy Just Baked Punjabi Cookies contain milk but the label does not declare milk. Reshmi's Group Inc.
Food Strawberry Filled Cake, 21.9 oz (1lb 6oz) (620g), UPC 3 760147 195867 Lot # FR110803DD Class II The recall was initiated because Authentic Gourmet was alerted by FDA sample analysis that the Strawberry Cake and the Raspberry Cake has non-permitted color additive and allergen, cochineal red A (also known as ponceau 4R). Authentic Gourmet
Food Raspberry Filled Cake, 21.9 oz (1lb 6oz) (620g), UPC 3 760147 195881 Lot # FR110801BB Class II The recall was initiated because Authentic Gourmet was alerted by FDA sample analysis that the Strawberry Cake and the Raspberry Cake has non-permitted color additive and allergen, cochineal red A (also known as ponceau 4R). Authentic Gourmet
Food Crispy Just Baked Punjabi Cookies, packaged in clear clam shell container and sealed in clear plastic wrap. Net weight is 800 gram (1.76 lb). The UPC is 6 27265 00152 0. The product is labeled in parts: "***CRISPY PUNJABI COOKIES Just Baked!***By TWI Foods***Net Wt. 800 g/1.76 lbs***Ingredients: Wheat Flour, soybean oil, margarine, sugar, semolina, baking powder, ammonium carbonate***". All lots and all codes Class I Crispy Just Baked Punjabi Cookies contain milk but the label does not declare milk. Mother India foods LLC
Devices UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. Class II The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results. Beckman Coulter Inc.
Devices UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460. Class II The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results. Beckman Coulter Inc.
Devices UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Numbers: DxC 660i: A64871; DxC 680i: A64903; DxC 860i: A64935; DxC 880i: A59102. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Part Numbers: DxC 660i: A64871; DxC 680i: A64903; DxC 860i: A64935; DxC 880i: A59102 Class II The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results. Beckman Coulter Inc.
Food Tomales Bay Foods brand Artisan Cheese in PARTIAL WHEELS of Cheese, from cheese makers in US (VA, VT, Ca, WI, OR, WA and UT) and Ireland, Italy, Switzerland, France, Holland and Greece. Varieties include Appalachian, Coolea, Cabot clothbound Cheddar, Big Rock Blue, Goat Gouda, Holey Cow, Big Woods Blue, Fiore Sardo,, Valdeon, Pecorino Romano, Sottocenere, Capriago, Capricious, Cave Aged Gruyere, Cave Aged Marisa, Fenacho, Pondhopper, Comte, L'Amuse Signature Gouda, Dante Waxed Rind, Dry Jack Special Reserve, Mezzo Secco, Extra Mature Bandage Cheddar, San Joaquin Gold, Flagship Reserve Truckle, Fontina Vallet Pietro, Grana Padano, Parmigiano Reggiano Organic, Taleggio Organic, Comte Reserve Ete, Loma Alta, Mt. Viko Barrel Aged Feta, Pepato, San Andreas Bellwether Farms, Reading, Tarentaise, Seahive, St. George, Toma and Wagon Wheel. Cheese is cut per order and wrapped in cheese paper and marked with a magic marker indicating the type of cheese, poundage and pack date as well as a Tomales Bay Foods label. There are no code numbers or expiration dates marked on the product. After positive findings of listeria in finished product of Pondhopper and Big Woods Blue, Tomales Bay recalled additional partial wheels of these cheeses cut between June 25 and July 27, 2012. Product is cut and packaged by Tomales Bay Foods, Petaluma, CA All product cut and wrapped on July 24 and 25, 2012. Class II Firm received a positive environmental for Listeria Monocytogenes from their internal testing samples. Tomales Bay Foods, Inc.
Devices GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures. Serial numbers: 69-0128, 82-0157, 82-0158, 82-0185, 82-0191, 82-0210, 82-0215, 82-0223, 82-0229, 82-0266, 82-0324, 82-0328, 82-0464, 82-0477, 82-0484, 82-0505-RC, 82-0507, 82-0542, 82-0544, 82-0546, 82-0551, 82-0604, 82-0648, 82-0673, 82-0680, 82-0714, 82-0733, 82-0779, 82-0858, 82-0869, 82-0884, 82-0906, 82-0918, 82-0965, 82-1004, 82-1009, 82-1057-RC, 82-1070, 82-1139, 82-1191, 82-1194, 82-1225, 82-1247, 82-1303, 82-1405, 82-1434, 82-1458, 82-1480,  ...
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Class II GE OEC recalled certain 9800 Fluoroscope & 9900 Elite Models because the Snubber Board did not conform to the IEC 60601-1 standard for clearance and creepage of voltage isolation. GE OEC Medical Systems, Inc
Devices OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray. Model number A857680 with various serial numbers (refer to consignee list). Class II GE Healthcare had recalled certain OEC InstaTrak 3500 Carts due to the potential for the cart to tip over when the arm of the imaging device is extended during use. GE OEC Medical Systems, Inc
Devices Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension gaps when preparing the femur to accept the femoral component. Catalog Number: 32-422801 and Lot Number Identification: ZB111101, ZBll1201, ZB120101, ZB120501, ZB111102, and ZB120201. Class II A drafting error during an unrelated design change has led to 4 misleading dimensions on the drawing. The CAD model remained the same thickness but the problem dimensions were accidentally struck from an incorrect point result in an increase of 1.0mm in the value of each dimension Biomet U.K., Ltd.
Devices GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provides a signal to the auto-injector to trigger a contrast injection. Part numbers include 00-902260-01 and 00-883654-01. Serial Numbers: 82-1138, 82-1586, 82-2089, 82-2117, 82-2182, 82-2214, 82-2226, 82-2262, 82-2264, 82-2308, 82-2312, 82-2314, 82-2321, 82-2328, 82-2380, 82-2391, 82-2438, 82-2483, 82-2512, 82-2516, 82-2535, 82-2722, 82-2796, 82-2821, 82-2846, 82-2848, 82-3052, 82-3055, 82-3129, 82-3144, 82-3170, 82-3171, 82-3201, 82-3256, 82-3267, 82-3314, 82-3350, 82-3361, 82-3377, 82-3467, 82-3468, 82-3659, 82-3709, 82-3722, 82-3859, 82-7016-MH, 82-7022-MH, 82-7037-MH, 82-7055-MH,  ...
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Class II GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye. GE OEC Medical Systems, Inc
Devices Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting. versions 2.4 and later Class III Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect time is displaying and printing one hour later than the actual collect time only when Daylight Saving Time is active. Sunquest Information Systems, Inc.
Devices UniCel DxH Slidemaker Stainer Instrument System, PN 775222. The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole blood-sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: " Allows for the differentiation of white blood cells " Facilitates the characterization of red blood cells and platelets " Aids in the identification of blood components and cellular abnormalities The optional floor stand has four drawers for storing the reagent and waste containers currently in use in the DxH Slidemaker Stainer. Part Number(s) 775222 and A96152; Serial #s-MP010, MP023, MP026, AS23001, AS23002, AS25003, AS25004, AS25005, AS33008, AS33009, AS33010, AS33011, AS37013, AS38014, AS38015, AS39016, AS39017, AS40018, AS44012, AT04001, AT04002, AT04003, AT04004, AT04005, AT22010, AT22011, AT22012, AT35013, AT35014, AT35015, AT35016, AT35017, AT35018, AT40019, AT40020, AT40021, AT40022, AT40023, AT40024, AT40025, AT40026, AT40027, AT40028, AT40029,  ...
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Class II The recall was initiated because Beckman Coulter has confirmed that the DxH Slidemaker Stainer Floor Stand shipped with Slidemaker Stainer instruments were missing vinyl caps, exposing sharpt edges on the DxH Slidemaker Stainer Reagent Cabinet (Floor Stand) drawer slides. The sharp edges on the drawer slides may expose operators to physical injury when replacing reagents and waste containers which potentially poses a risk to operator safety. Beckman Coulter Inc.
Devices UniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152. The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole blood-sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: " Allows for the differentiation of white blood cells " Facilitates the characterization of red blood cells and platelets " Aids in the identification of blood components and cellular abnormalities The optional floor stand has four drawers for storing the reagent and waste containers currently in use in the DxH Slidemaker Stainer. Part Number(s) 775222 and A96152; Serial #s-MP010, MP023, MP026, AS23001, AS23002, AS25003, AS25004, AS25005, AS33008, AS33009, AS33010, AS33011, AS37013, AS38014, AS38015, AS39016, AS39017, AS40018, AS44012, AT04001, AT04002, AT04003, AT04004, AT04005, AT22010, AT22011, AT22012, AT35013, AT35014, AT35015, AT35016, AT35017, AT35018, AT40019, AT40020, AT40021, AT40022, AT40023, AT40024, AT40025, AT40026, AT40027, AT40028, AT40029,  ...
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Class II The recall was initiated because Beckman Coulter has confirmed that the DxH Slidemaker Stainer Floor Stand shipped with Slidemaker Stainer instruments were missing vinyl caps, exposing sharpt edges on the DxH Slidemaker Stainer Reagent Cabinet (Floor Stand) drawer slides. The sharp edges on the drawer slides may expose operators to physical injury when replacing reagents and waste containers which potentially poses a risk to operator safety. Beckman Coulter Inc.
Drugs Mercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottle (NDC 49884-922-02) and b) 250-count tablets per bottle (NDC 49884-922-04), Rx only, Distributed by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Lot #s: a) 11A003, 11A004, 11A005, Exp 01/13; 11L071, 11L072, Exp 10/13; b) 11B009, Exp 01/13; 11L073, Exp 10/13 Class II Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution. Prometheus Laboratories Inc.
Drugs Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CMS-1667-R2(94-2478), Manufactured for KM Medical, Inc., 124 Jewett Street, Georgetown, MA 01833, the tray also contains other components not listed in this product description. Lot #: 25744-1111, Exp 09/2012 Class II Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags Custom Medical Specialties, Inc.
Drugs CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMS, Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine level, NC 27568, the tray also contains other components not listed in this product description. Lot #: 25915-1111, Exp 12/2012 Class II Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags. Custom Medical Specialties, Inc.
Drugs CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Manufactured by: CMS Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine Level, NC 27568, the tray also contains other components not listed in this product description. Lot #: 26124-1112, Exp 12/2012 Class II Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags. Custom Medical Specialties, Inc.
Food Two Moms in the Raw, Gluten-Free Pesto Sea Cracker enclosed in brown semi-synthetic packaging with a transparent section displaying the contents. Labeling on the product is green, white, and blue with blue, green, and red print writing. Lot numbers: 1008, 1016, 1027, 1055, 1067. Class I Two Moms in the Raw is issuing a voluntary recall for Pesto Sea Cracker, 4 oz, because they were notified by their raw material supplier that the pine nuts used in the product may contain peanuts. 2 Moms in the Raw, LLC
Food Crispy Punjabi Cookies, By TWI Foods, Net Wt. 800g/1.76 lb, Manufactured by TWI Foods, Inc. 1-866-9-CRISPY, www.crispyjustbaked.com, UPC 627265001520, Product of Canada. All lots shipped to customers between August 1, 2011 to current date (8/2/2012). Class I This recall has been initiated due to Non-Declared Milk. This product may have traces that can cause an allergic reaction and is not declared on certain labels. Deep Foods Inc
Food Organic Pinenut, 25 kg, Product of China Mfg Lot No: 97638 Class I A customer of Specialty Commodities reported that they found peanuts in a container of pine nuts. Specialty Commodities, Inc.
Food Apple Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES, PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt. Pie Label: Apple All product on market. Class II Undeclared soy lecithin, partially hydrogenated soybean oil and wheat. Flywheel's Pies
Food Peach Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt Pie Label: Peach All product on market. Class II Undeclared soy lecithin, partially hydrogenated soybean oil and wheat. Flywheel's Pies
Food Cherry Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE, FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt Pie Label: Cherry All product on market. Class II Undeclared soy lecithin, partially hydrogenated soybean oil and wheat. Flywheel's Pies
Food Blueberry Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE, FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt Pie Label: Blueberry All product on market. Class II Undeclared partially hydrogenated soybean oil and wheat. Flywheel's Pies
Food Raisin Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almon, Salt Pie Label: Raisin All product on market. Class II Undeclared partially hydrogenated soybean oil and wheat. Flywheel's Pies
Food Strawberry Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Egg Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt Pie Label: Strawberry All product on market. Class II Undeclared partially hydrogenated soybean oil and wheat. Flywheel's Pies
Food Sweet Potato Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Nigeriense: Fruit, Sugar, Butter, Almond, Salt Pie Label: Sweet Potato All product on market. Class II Undeclared partially hydrogenated soybean oil and wheat. Flywheel's Pies
Food Apricot Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt Pie Label: Apricot All product on market. Class II Undeclared soy lecithin, partially hydrogenated soybean oil and wheat. Flywheel's Pies
Food Chocolate Pies: Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt. Pie Label: Chocolate All product on market. Class II Undeclared soy lecithin, partially hydrogenated soybean oil and wheat. Flywheel's Pies
Food Coconut Pies: Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt. Pie Label: Coconut All product on market. Class II Undeclared soy lecithin, partially hydrogenated soybean oil and wheat. Flywheel's Pies
Food Lemon Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt Pie Label: Lemon All product on market. Class II Undeclared partially hydrogenated soybean oil and wheat. Flywheel's Pies
Food Pineapple Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt Pie Label: Pineapple All product on market. Class II Undeclared partially hydrogenated soybean oil and wheat. Flywheel's Pies
Food Blackberry Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt All product on market. Class II Undeclared partially hydrogenated soybean oil and wheat. Flywheel's Pies
Food Sugar Free Apple Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt All product on market. Class II Undeclared soy lecithin, partially hydrogenated soybean oil and wheat. Flywheel's Pies
Devices The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Product Usage: The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories System Code # 728243, Serial #s: 7392, 7394, 7399, 7405, 7406, 7429, 7433, 7440, 7457, 7465, 7469, 7479, 7481, 7487, 7488, 7491, 7502, 7506, 7507, 7517, 7518, 7520, 7521, 7532, 7539, 7545, 7547, and 7556. System Code # 728244, Serial #s: 7190, 7195, 7318, 7383, 7427, 7430, 7510, and 7533. System Code  ...
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Class II The patient support may move in an unintended manner if the foot switch cover becomes damaged and impinges on the foot switch. Philips Medical Systems (Cleveland) Inc
Devices Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma in the assessment of thyroid function and diagnosis of thyroid disorders when T3 levels are between 0.1 and 8.0 ng/mL. All Lots Class III A recall was initiated because Beckman Coulter has identified a negative bias in test results when comparing elevated Total T3 patient samples diluted with Sample Diluent A to samples diluted with Access Total T3 Calibrator S0. Beckman Coulter Inc.
Food Menno Beachy, Cresco, IA Certified Organic Grape Tomato packaged in 1-pint square-shaped clear plastic clamshell containers, UPC 044419310176, 12/1-pint. containers per case. Lot numbers MB725GT0, MB725GT3, and MB725GT8. These lot numbers only appear on the case label, not on the clamshell label. Class I Salmonella Montevideo was isolated in one lot of the grape tomatoes Menno Beachy
Devices AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device All software versions of DICOMstore in combination with Media Purge Daemon (MPD) or Cardiovascular Purge Services (CPS). Class II Loss of patient data can occur under certain circumstances due to misconfiguration of DICOMstore configured with Agfa's Medical Image Storage Devices - Media Purge Daemon (MPD) and Cardiovascular Purge Service (CPS). AGFA Corp.
Devices GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy. Serial numbers: 2791PU2, 2797PU9, 2817PU5, 2824PU1, 2827PU4, 2899PU3, 2900PU9, 2901PU7, 2918PU1, 2919PU9, 2922PU3, 2939PU7, 3095PU7, 3103PU9, 3107PU0, 3219PU3, 3223PU5, 3224PU3, 3230PU0, 3233PU4, 3236PU7, 3358PU9, 3368PU8, 3500PU6, 3513PU9, 3514PU6, 3516PU2, 3523PU8, 3562PU6, 3580PU8, 3957PU8, 3973PU5, 3978PU4, 3994PU1, 4012PU1, 4018PU8, 4025PU3, 4029PU5, 4041PU0, 4043PU6, 4378PU6, 4394PU3, 4397PU6, 4446PU1, 4458PU6, 4767PU0, 4777PU9, 4782PU9,  ...
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Class II X-ray units did not meet manufacturer's specification for linearity. GE OEC Medical Systems, Inc
Food Pine Nuts, 5lbs, Item 40476-214, UPC 8 12986 01288. Lot #21712 Class I Essential Living is recalling Pine Nuts because it has undeclared peanuts. Essential Living Foods, Inc
Food Cilantro, 2.5 dozens, 30 bunches/case Produt is not coded. Class I Fresco Green Farms Inc. is recalling cilantro because it has the potential to be contaminated with Salmonella. Fresco Green Farms, Inc.
Devices Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with physiological and clinical information that can be useful in diagnosis determination. Echelon, V001 through V061, inclusive. Oasis, M001 through M105, inclusive, M951 Class II Hitachi discovered a software error with a feature called Multi-Planar Reconstruction (MPR). MPR takes an original volume dataset reconstructed in any plane view and creates a new image set from another view (i.e. axial to coronal, coronal to sagittal, etc.). The error causes the first image in the dataset to have a right/left reversed orientation. The software error can occur randomly when executing the MPR task. Hitachi Medical Systems America Inc
Devices Visual-ICE® Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these procedures. The Visual-ICE System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts) by the application of extremely cold temperatures. VL0004 VL0014 VL0015 VL0016 Class II Galil Medical is recalling a number of Visual Ice Cryoablation Systems because the gas regulators may fail to regulate the gas pressure, rendering the devices inoperable. Galil Medical, Inc.
Devices Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16 PET/CT, GEMINI TF Big Bore PET/CT, Philips Medical Systems, Cleveland, OH. The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: " The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders. " The detection, localization, and staging of tumors and diagnosing cancer patients. " Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of with regional cerebral activity from PET images. GEMINI TF 16 System serial numbers: 7194, 7186, 7235, 7233 GEMINI GXL 16 System serial number: 4201 GEMINI TF Big Bore System serial numbers: 9022, 9201 Class II Philips became aware of an issue relating to a UPS battery cabinet that appeared to have burned a hole through the casing on one of the batteries. Supplier of the UPS, Chloride/Emerson, determined the batteries, housed within the UPS battery cabinet, entered thermal runaway causing the battery to overheat. Philips Medical Systems (Cleveland) Inc
Drugs Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC 66689-035-50 Lot 202800, NDC 66689-035-50 Class II Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume VistaPharm, Inc.
Food Southern Home Cranberry Nut Antioxidant Blend, Trail Mix, Net Wt. 16oz. (1 LB) 454g, Distributed by Southern Home, P.O. Box 99, Mauldin, SC 29662. Item Code: 627888, UPC 6-07880-03039. Class II Undeclared allergen, soy lecithin. Winn Dixie Stores, Inc.
Food Frozen Oysters (IQF), Net Weight: 30 lbs (6/5lbs). none Class II J&S Group is recalling Frozen Oysters because the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. J&S Group
Food Spartan/Fresh Selections Wedge Sandwich W/Sandwich Spread 4oz LOT NUMBER: All dates up to and including 8/12/12 UPC: 011213-900001 SPARTAN CODE: 744 Class II During an FDA inspection, the investigation found the 4oz sandwich spread label did not declare Yellow # 5 as an ingredient. Spartan Central Kitchen
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