Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

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August 16, 2006
06-33

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

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PRODUCT
FDG F-18 Fluorodeoxyglucose Injection, 20 mCi/mL as of 7/18/06 7:00; 5 mL and 10 mL vials, Recall # D-323-6
CODE
Lot 140718061, exp. 7/18/06 15:28
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health Inc., Dublin, OH, by telephone and letter dated July 18, 2006.
Manufacturer: Cardinal Health 420 LLC, Beltsville, MD. Firm initiated recall is ongoing.
REASON
Pharmaceutical for injection was out of specification for endotoxin levels.
VOLUME OF PRODUCT IN COMMERCE
3 vials
DISTRIBUTION
MD

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PRODUCT
Extra Strength Super Troche DM, each troche contains 15 mg Benzocaine and 10 mg Dextromethorphan HBr, 10 troches per bottle, Recall # D-324-6
CODE
06039A1, Exp. 7/08
RECALLING FIRM/MANUFACTURER
Weeks & Leo Co., Inc., Des Moines, IA, by letters on July 10, 2006. Firm initiated recall is ongoing.
REASON
Drug Facts label on back of the bottle does not list Dextromethorphan HBr as an active ingredient and lacks the warning not to use the product if taking a monoamine oxidase inhibitor.
VOLUME OF PRODUCT IN COMMERCE
509/10-troche bottles
DISTRIBUTION
Nationwide

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PRODUCT
Comfort Shield Personal Cleansing Perineal Care Washcloths, Dimethicone 3%, supplied in 3, 8 and 24 count packages, Recall # D-325-6
CODE
Reorder #7503 - lot 1999; reorder #7503-M - lots 1702 and 1995; reorder #7403 - lots 1301, 1312, 1457, 1651 and 1677; reorder #7408 - lot 1848; reorder #7905 - lot 1766; reorder #7524 - lots 2070 and 2086
RECALLING FIRM/MANUFACTURER
Sage Products, Inc., Cary, IL, by letters dated June 21, 2006. Firm initiated recall is ongoing.
REASON
Microbial contamination; Burkholderia cepacia
VOLUME OF PRODUCT IN COMMERCE
4,180 cases -- US, 7,468 cases - Canada
DISTRIBUTION
Nationwide and Canada

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PRODUCT
Flumazenil Injection, 1 mg/10 mL (0.1 mg/mL), Sterile, Rx drug for I.V. use only; 10 mL multiple dose vial; product code 402410, NDC #63323-424-10, Recall # D-329-6
CODE
Lot number 200324, expiration date 4/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abraxis Pharmaceutical Products, Rosemont, IL, by letters dated July 27, 2006.
Manufacturer: Abraxis Pharmaceutical Products, Melrose Park,IL. Firm initiated recall is ongoing.
REASON
Mispackaging: Some of the boxes of Flumazenil Injection may contain vials of Levothyroxine Sodium for Injection.
VOLUME OF PRODUCT IN COMMERCE
14,691 vials
DISTRIBUTION
Nationwide and PR

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

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PRODUCT
Source Plasma, Recall # B-1540-6
CODE
Units: 0421074947, 0421074114, 0421073373, 0421071954 and 0421068618.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Lansing, MI, by email on March 6, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
IL

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PRODUCT
Red Blood Cells, Recall # B-1634-6
CODE
Unit: KJ68156
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by fax on January 24, 2006. Firm initiated recall is complete.
REASON
Blood product, mislabeled as to CMV status, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

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PRODUCT
a) Red Blood Cells, Recall # B-1635-6;
b) Cryoprecipitated AHF, Recall # B-1636-6
CODE
a) and b) Unit: KC92360
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by fax on February 1, 2006. Firm initiated recall is complete.
REASON
Blood product, mislabeled as to CMV status, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA

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PRODUCT
Recovered Plasma, Recall # B-1666-6
CODE
Unit: 2505256
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on April 16, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

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PRODUCT
Galileo Automated Blood Bank Analyzer, Recall # B-1667-6
CODE
Galileo CMV Assay 1.02 (20MAY04)
RECALLING FIRM/MANUFACTURER
Immucor, Inc., Norcross, GA, by telephone beginning June 5, 2006. Firm initiated recall is complete.
REASON
Galileo Blood Bank Analyzer, loaded with the wrong version of CMV Assay, was distributed.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
Nationwide

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1668-6;
b) Platelets, Leukocytes, Reduced, Recall # B-1669-6
CODE
a) Units: LH39588, LH34329;
b) Unit: LH39588
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., Dba Rhode Blood Center, Providence, RI, by letter dated May 15, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
RI and MA

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1670-6;
b) Platelets, Leukocytes, Reduced, Recall # B-1671-6
CODE
a) and b) Unit: 1006206
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, Cincinnati, OH, by letter dated September 27, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL and OH

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1672-6
CODE
Unit: 28LT5494
RECALLING FIRM/MANUFACTURER
American National Red Cross, South Carolina Region, Columbia, SC, by letter dated August 7, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC

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PRODUCT
a) Red Blood Cells, Recall # B-1674-6;
b) Recovered Plasma, Recall # B-1675-6
CODE
a) and b) Unit: 12GE40856
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by letter dated June 5, 2000. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided post donation information regarding multiple high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC and Switzerland

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1676
CODE
Unit: 22FZ20136
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by facsimile on January 27, 2006 and by letter dated January 27, 2006. Firm initiated recall is complete.
REASON
Blood product, which a platelet yield that may have been below the acceptable limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

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PRODUCT
Source Plasma, Recall # B-1678-6
CODE
Units: 0040133218, 0041033488, 0041034165, 0041034500, 0041035451, 0041035739, 0041036480, 0041036905, 0041037382, 0041037818, 0041038386, 0041038975, 0041039435, 0041040092, 0041040409, 0041041157, 0041041681, 0041042188, 0041042671, 0041043279, 0041050545, 0041044310, 0041044763, 0041045352, 0041045769, 0041046323, 0041046781, 0041047381, 0041047845, 0041048475, 0041048895, 0041049865, 0041049943, 0041050854, 0041051274, 0041051821, 0041052296, 0041052813, 0041053336, 0041053873, 0041054464, 0041055416, 0041055948, 0041056329, 0041056906, 0041057494
RECALLING FIRM/MANUFACTURER
Nabi Biopharmaceuticals, Gainesville, FL, by facsimile on April 12, 2005. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who had received a piercing within 12 months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
46 units
DISTRIBUTION
NC and Korea

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PRODUCT
Source Plasma, Recall # B-1680-6
CODE
Units: 0440483542, 0440482567, 0440477493, 0440476789, 0440476223, 0440475800, 0440475308, 0440474504, 0440474280, 0440473571, 0440472434
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Charleston, SC, by facsimile on December 28, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided post donation information regarding multiple high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
NC

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1681-6
CODE
Unit: 003E59603
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by facsimile and by letter dated November 18, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose documentation of a hematocrit test during the donor screening process was discrepant, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1682-6
CODE
Unit: 003LJ38321
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone on November 3, 2005 and by letter dated November 5, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a hematocrit test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1683-6
CODE
Unit: 71X348833
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by letter dated March 4, 2006. Firm initiated recall is complete.
REASON
Blood product, which yielded a platelet count that was below the acceptable limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

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PRODUCT
Galileo Automated Blood Bank Analyzer, Immediate Spin Crossmatch (IS_XM) Assay, Recall # B-1684-6
CODE
Units: 00064999, 00064997
RECALLING FIRM/MANUFACTURER
Immucor, Inc, Norcross, GA, by letter and facsimile dated June 30, 2005. Firm initiated recall is complete.
REASON
Blood Bank Analyzers, which may not give expected compatibility results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
75 units
DISTRIBUTION
Nationwide, Canada and Japan

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PRODUCT
Becton Dickinson CMV scan Card Test Kit, Recall # B-1685-6,
Catalog No. 255205, Catalog No. 255001, and Catalog No. 255126
CODE
Lot No. 6095886; Exp. 8/31/2006;
Lot No. 6095884; Exp. 8/31/2006;
Lot No. 6114596; Exp. 10/31/2006;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co., Sparks, MD, by email and letter dated June 22, 2006.
Manufacturer: Becton Dickinson Caribe LTD, Cayey, PR. Firm initiated recall is complete.
REASON
CMV Test Kits, which may produce false positive test results when testing some plasma specimens, were distributed.
VOLUME OF PRODUCT IN COMMERCE
393 test kits
DISTRIBUTION
Nationwide, Canada, Australia, and Bermuda

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PRODUCT
Fresh Frozen Plasma, Recall # B-1687-6
CODE
Unit: KJ84399
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on May 2, 2006. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving information regarding a post-donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1688-6
CODE
Unit: 36M69917
RECALLING FIRM/MANUFACTURER
American National Red Cross, South Carolina Region, Columbia, SC, by letter dated April 21, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC

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PRODUCT
a) Red Blood Cells, Recall # B-1689-6;
b) Fresh Frozen Plasma, Recall # B-1690-6
CODE
a) and b) Unit: 28LJ10623
RECALLING FIRM/MANUFACTURER
American National Red Cross, South Carolina Region, Columbia, SC, by letter dated August 11, 1999. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from a donor with a history of Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
SC

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1691-6
CODE
Unit: 7036900
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by letter dated November 18, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to use of the medication Finasteride (Proscar), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1692-6;
b) Platelets, Leukocytes Reduced, Recall # B-1693-6;
CODE
a) and b) Unit: 16KJ11127
RECALLING FIRM/MANUFACTURER
American National Red Cross, Central Ohio Region, Columbus, OH, by telephone on January 20, 2006 and by letter dated January 23, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH

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PRODUCT
a) Red Blood Cells, Recall # B-1697-6;
b) Platelets, Recall # B-1698-6;
c) Fresh Frozen Plasma, Recall # B-1699-6
CODE
a), b) and c) Unit: 4173807
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by letter dated December 21, 2005. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from a donor who had a history of non-sexual exposure to Hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OH

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1702-6
CODE
Units: 1611885 (split unit)
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, Cincinnati, OH, by letter dated October 29, 2005. Firm initiated recall is complete.
REASON
Blood products, which were inappropriately distributed in single storage bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

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PRODUCT
Source Plasma, Recall # B-1673-6
CODE
Units: 4120006824, 4120006814, 4120006834, 4120006815, 4120006823, 4120006833, 4120006838, 4120006846, 4120006835, 4120006844, 4120006841, 4120006840, 4120006839, 4120006837, 4120006830, 4120006832, 4120006829, 4120006825, 4120006826, 4120006827, 4120006828, 4120006842, 4120006843, 4120006847, 4120050462, 4120050466, 4120050463, 4120050460, 4120050454, 4120050469, 4120050468, 4120050449, 4120050455, 4120050467, 4120050459, 4120050236, 4120050237, 4120050240, 4120050239, 4120050229, 4120050213, 4120050223, 4120050227, 4120050225, 4120050224, 4120050220, 4120050226, 4120050211, 4120050214, 4120050218, 4120050221, 4120050228, 4120050233, 4120050241, 4120050238, 4120050464, 4120050452, 4120050232, 4120050230, 4120050216, 4120050217, 4120050235, 4120050422, 4120050457
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Indianapolis, IN, by email or facsimile on March 23, 2006. Firm initiated recall is complete.
REASON
Blood products, which were possibly exposed to unacceptable storage temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
64 units
DISTRIBUTION
IL and Switzerland

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PRODUCT
Fresh Frozen Plasma, Recall # B-1677-6
CODE
Units: 22LW81325 (4 units), 22GS16769 (2 units)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on December 15, 2005 and by letter dated February 1, 2006. Firm initiated recall is complete.
REASON
Blood products, which were not frozen within the appropriate time frame following collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
PA

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PRODUCT
Source Plasma, Recall # B-1679-6
CODE
Units: 0041063949, 0041063461, 0041063061, 0041062209, 0041061707, 0041061226, 0041060760, 0041059964, 0041059467, 0041058867, 0041057900, 0041057600, 0041056282, 0041055560, 0041054928, 0041054453, 0041053415, 0041052782, 0041052384, 0041051569, 0041051030, 0041050545, 0041049884, 0041049550, 0041048850, 0041048267, 0041047778, 0041046765, 0041046359, 0041045363, 0041044788, 0041043710, 0041042672, 0041042564, 0041041647, 0041041564, 0041040416, 0041039497, 0041038730, 0041037590, 0041037231, 0041036356, 0041035323, 0041034698, 0041033507, 0041032992, 0041032476, 0041031772, 0041031512, 0041030760, 0041029381, 0041023311, 0041022528, 0041022137, 0041021357
RECALLING FIRM/MANUFACTURER
Nabi Biopharmaceuticals, Gainesville, FL, by facsimile on January 20, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom post-donation information was received regarding a previous deferral for unacceptable viral marker test results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
55 units
DISTRIBUTION
NC and Korea

______________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-1686-6
CODE
Unit: 18427-1807
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on April 18, 2006.
Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to a history of receiving a tissue transplant, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS

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PRODUCT
Recovered Plasma, Recall # B-1694-6
CODE
Unit: 16KJ11127
RECALLING FIRM/MANUFACTURER
American National Red Cross, Central Ohio Region, Columbus, OH, by electronic notification on January 20, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

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PRODUCT
Fugo Blade Incising Tip Assembly. Incising tips to be used with the Fugo Blade M1000 Anterior Capsulotomy Unit. For Ophthalmic Use Only. The product is shipped 12 units per carton. Recall # Z-1224-06
CODE
Lot numbers 01013786, 01017917, 01017918, 01017684 and 01017442
RECALLING FIRM/MANUFACTURER
Medisurg Research & Management Corp, NorristownPA, by fax on April 28, 2006. Firm initiated recall is ongoing.
REASON
No documentation to support shelf life/sterility
VOLUME OF PRODUCT IN COMMERCE
155 bags
DISTRIBUTION
Nationwide and Canada

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PRODUCT
a) Abbott brand FreeStyle Blood Glucose Meter, Recall # Z-1306-06
b) Abbott brand FreeStyle Flash Blood Glucose Meter, Recall # Z-1307-06
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Diabetes Care, Inc. AlamedaCA, by letters on May 22, 2006. Manufacturer: Flextronics International, Shenzhen, China, Firm initiated recall is ongoing.
REASON
The products may encounter display problem, 'Er 4' message, during prolonged use when the low battery symbol is displayed. The situation can render the meter either inoperable or operable with invalid user configuration data including selectable unit of measure, and strip calibration code.
VOLUME OF PRODUCT IN COMMERCE
Approx. 2,365,000 meters
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
TEKLENS II (TEKIA label) and Polylens A60 (Polytech label) Model 614, intraocular lens (IOL) :
1a) Products labeled with TEKIA as manufacturer: IOLs with power of 17.0 D;
1b) IOLs with power of 22.5 D;
2a) Products labeled with Polytech as manufacturer: IOLs with power of 17.0 D:
2b)IOLs with power of 22.5 D, Recall # Z-1311-06
CODE
1a) 616170E031002180207, 616170E031002190207, 616170E031002200207, 616170E031002210207;
1b) 616225E031001460207, 616225E031001470207, 616225E031001480207, 616225E031001490207, 616225E031001500207, 616225E031001510207; 616225E031001520207, 616225E031001530207.
2a) 613170E031000640207, 613170E031000650207, 613170E031000660207, 613170E031000670207, 613170E031000680207, 613170E031000690207, 613170E031000700207, 613170E031000710207,613170E031000720207, 613170E031000730207, 613170E031000740207, 613170E031000750207, 613170E031000760207, 613170E031000770207, 613170E031000780207, 613170E031000790207, 613170E031000800207, 613170E031000810207, 613170E031000820207, 613170E031000830207, 613170E031000840207, 613170E031000851207, 613170E031000860207, 613170E031000870207, 613170E031000880207, 613170E031000890207;
2b)613225E031000990207, 613225E031001000207, 613225E031001010207, 613225E031001020207, 613225E031001030207, 613225E031001040207, 613225E031001050207, 613225E031001060207, 613225E031001070207, 613225E031001080207, 613225E031001090207, 613225E031001100207, 613225E031001110207, 613225E031001120207, 613225E031001130207, 613225E031001140207, 613225E031001150207, 613225E031001160207, 613225E031001170207, 613225E031001180207, 613225E031001190207, 613225E031001200207
RECALLING FIRM/MANUFACTURER
Tekia, Inc., Irvine, CA, by telephone, on July 2, 2004 and July 8, 2004. Firm initiated recall is ongoing.
REASON
Intraocular lenses (IOLs) with power of 17.0 D and 22.5 D are mislabeled with each other's labels.
VOLUME OF PRODUCT IN COMMERCE
60 IOLs
DISTRIBUTION
Germany

______________________________
PRODUCT
OPUS SpeedStitch Suture Cartridge with Magnumwire, a component of the OPUS MiniPlus Implant Set, for use in placement of sutures through soft tissue in endoscopic and other limited access procedures., Catalog number OM-6006. This catalog number is referred to as the OPUS MiniPlus Implant Set, Recall # Z-1312-06
CODE
Lot number: 110399
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arthrocare, Corp., Sunnyvale, CA, by letters on June 29, 2006.
Manufacturer: Arthrocare, Corp., Aurora de Heredia, Costa Rica. Firm initiated recall is ongoing.
REASON
The product may lose sterility due to omission of the final pouch seal.
VOLUME OF PRODUCT IN COMMERCE
170 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer,
ABL-700 series, Recall # Z-1317-06;
b) Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer,
ABL-800 series, Recall # Z-1318-06
CODE
a) All analyzers manufactured from 1/1999-12/2005. The devices
contain serial numbers 902-441RxxxNxxx. The Rxxx number
denotes manufacturing run, and the Nxxx number denotes the
individual instrument within the run;
b) All analyzers manufactured from 1/2005-10/31/2005. The devices
contain serial numbers 902-441RxxxNxxx. The Rxxx number
denotes manufacturing run, and the Nxxx number denotes the
individual instrument within the run.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc, WestlakeOH, by letter on June 17, 2005
Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is complete.
REASON
Software defect. pO2 and pCO2 sample test results run on the firm's ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the sample calibration phase.
VOLUME OF PRODUCT IN COMMERCE
Series 700 -- 1,635 Analyzers;
Series 800 -- 108 Analyzers
DISTRIBUTION
Nationwide

______________________________
PRODUCT
ABL 5 Capillary Adaptor (a connection that fits the capillary tube on to the aspirator on the ABL 5 & BPH 5 Analyzers), in vitro diagnostic accessory, Recall # Z-1320-06
CODE
Part #906-018
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc, WestlakeOH, by letter on June 9, 2005
Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is complete.
REASON
The dimensions and shape of the analyzer adaptor do not fit the analyzer tubes or probe, causing air to be aspirated with the blood sample and causing a deviation in the p02 sample results.
VOLUME OF PRODUCT IN COMMERCE
155 bags
DISTRIBUTION
Nationwide and Canada

______________________________
PRODUCT
a) Capillary (end) caps, accessory for use with blood gas analyzers included in
Radiometer's CLINITUBES kits. The end caps are packaged in bags.
These bags are placed in the capillary tube kit which also contains: capillary tubes,
end caps, mixing wires, and a magnet. Each kit may contain 1 or 5 bags depending
on the kit model. Each bag contains: 110 Green caps per bag and 160 Red caps per bag,
Recall # Z-1321-06;
b) Capillary (end) caps, accessory for use with blood gas analyzers included in
Radiometer's CLINITUBES kits. The end caps are packaged in bags.
These bags are placed in the capillary tube kit which also contains: capillary tubes,
end caps, mixing wires, and a magnet. Each kit may contain 1 or 5 bags depending on
the kit model. Each bag contains: 110, Recall # Z-1322-06
CODE
a) Model # 904-439;
b) Model # 904-453
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc, WestlakeOH, by letter on March 22, 2006
Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.
REASON
Capillary end caps, an accessory for ABL blood gas analyzers, leak blood from capillary tubes during transport.
VOLUME OF PRODUCT IN COMMERCE
386 kits
DISTRIBUTION
Nationwide, Canada and Istanbul

______________________________
PRODUCT
a) Pointe Scientific Liquid Glucose HEX (R1) Reagent Set, for the quantitative
determination of glucose in serum, 5 x 600 ml R1 glucose HEX, for use with Hitachi
analyzer; in vitro diagnostic, Catalog number HG420-R1, Recall # Z-1326-06;
b) Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, for the quantitative
determination of glucose in serum, 5 x 600 ml R2 glucose HEX, for use with Hitachi
analyzer; in vitro diagnostic, Catalog number HG420-R2, Recall # Z-1327-06;
c) Pointe Scientific Liquid Glucose (HEX) Reagent Set, for the quantitative determination
of glucose in serum, 10 x 5 ml R1 and 5 x 20 ml R2, or 9 x 67 ml R1and 9 x 17 ml R2
glucose reagent, for use with Hitachi analyzer; in vitro diagnostic, Catalog numbers
HG720-600 and HG920-756, Recall # Z-1328-06;
d) Pointe Scientific Liquid Glucose (HEXO) Reagent Set, for the quantitative
determination of glucose in serum, 10 x 100 ml R1, 10 x 20 ml R2 glucose reagent,
or 1 x 2 L R1 x 500 ml R2, for use with Hitachi analyzer; in vitro diagnostic, Catalog
numbers HG920-1200 and HG920-2500, Recall # Z-1329-6;
e) Glucose Hex reagent sold by Pointe Scientific; in vitro diagnostic, Catalog no.
3-HG920-L, Recall # Z-1330-06;
f) Glucose HEX reagent sold by Pointe Scientific; in vitro diagnostic, Catalog no.
3-HG920-L, Recall # Z-1331-06;
g) Glucose HEX R1 reagent sold by Pointe Scientific; in vitro diagnostic, Catalog no’s
3-HG920-R1, 7-HG920-R1-67, 7-HG920-R1-600 and 7-HG920-R1-800,
Recall # Z-1332-06;
h) Glucose HEX R2 reagent sold by Pointe Scientific; in vitro diagnostic,
Catalog no’s 3-HG920-R2, 7-HG920-R2-17, 7-HG920-R2-200 and 7-HG920-R2-300,
Recall # Z-1333-06
CODE
a) and b) Lots 511901, exp. 4/07 and 525101, exp. 9/07;
c), d), e) and f) Lots 431704, exp. 11/06 and 511901, exp. 4/07;
g) and h) Lots 431704, exp. 11/06, 511901, exp. 4/07 and 525101, exp. 9/07
RECALLING FIRM/MANUFACTURER
Pointe Scientific, Inc., Lincoln Park, MI, by letter dated June 7, 2006. FDA initiated recall is ongoing.
REASON
Product does not meet performance specification through its labeled expiration period.
VOLUME OF PRODUCT IN COMMERCE
13 boxes
DISTRIBUTION
Nationwide and Canada

______________________________
PRODUCT
a) Zimmer M/DN Intramedullary Fixation 4.5 dia. cortical screw, 3.5 mm hex head,
52.5 mm length, 22-13-5 stainless steel, sterile bone screw;
Cat. no. 2253-52-45 (00225305545), Recall # Z-1335-06;
b) Zimmer M/DN Intramedullary Fixation 4.5 dia. cortical screw, 3.5 mm
hex head, 55 mm length, 22-13-5 stainless steel, sterile bone screw;
Cat. no. 2253-55-45 (00225305545), Recall # Z-1336-06;
c) Zimmer M/DN Intramedullary Fixation 4.5 dia. cortical screw, 3.5 mm hex head,
65 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-65-45
(00225306545), Recall # Z-1337-06;
d) Zimmer M/DN Intramedullary Fixation 4.2 dia. cortical screw, 3.5 mm hex head,
70 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-70-42
(00225307042), Recall # Z-1338-06;
e) Zimmer M/DN Intramedullary Fixation 5.5 dia. cortical screw, 3.5 mm hex head,
70 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-70-55
(00225307055), Recall # Z-1339-06;
f) Zimmer M/DN Intramedullary Fixation 4.2 dia. cortical screw, 3.5 mm hex head,
75 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-75-42
(00225307542), Recall # Z-1340-05;
g) Zimmer M/DN Intramedullary Fixation 4.2 dia. cortical screw, 3.5 mm hex head,
85 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-85-42
(00225308542). Recall # Z-1341-06;
h) Zimmer M/DN Intramedullary Fixation 5.5 dia. cortical screw, 3.5 mm hex head,
95 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-95-55
(00225309555), Recall # Z-1342-06;
i) Zimmer M/DN Intramedullary Fixation 5.5 dia. cortical screw, 3.5 mm hex head,
100 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-100-55
(00225310055), Recall # Z-1343-06;
j) Zimmer Bone Screw, self tapping, 6.5 mm dia., 20 mm length, tivanium TI-6AL-4V
alloy, sterile, Catalog no. 6250-65-20 (00625006520), Recall # Z-1344-06;
k) Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia.,
30 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 6624-65-30
(00662406530), Recall # Z-1345-06;
l) Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia.,
35 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 6624-65-35
(00662406535); Recall # Z-1346-06;
m) Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia.,
40 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 6624-65-40
(00662406540); Recall # Z-1347-06;
n) Zimmer Herbert Cannulated Bone Screw System Bone Screw, 4.5 mm dia.,
25 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 47-1155-25-05
(47115502505), Recall # Z-1348-06;
o) Zimmer Herbert Cannulated Bone Screw System Bone Screw, 6.5 mm dia.,
35 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 47-1155-35-07
(47115503507), Recall # Z-1349-06;
p) Zimmer Herbert Cannulated Bone Screw System Bone Screw, 4.5 mm dia.,
45 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 47-1155-45-05
(47115504505); Recall # Z-1350-06;
q) Zimmer Herbert Cannulated Bone Screw System Bone Screw, 4.5 mm dia.,
50 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 47-1155-50-05
(47115505005), Recall # Z-1351-06
CODE
a) Lots 24122200, 24730600, 25342400, 25765300, 60025157 and 60034732;
b) Lots 24122600, 24122700, 24123000, 24667300, 24730700, 24730800,
25769900, 26003200, 26113700, 26435200, 60005229, 60019022,
60034734, 60034735, 60043306, 60043307 and 60043308;
c) Lots 24667700, 24732400, 24732500, 24732600, 24732700, 25770200,
26003400, 26435500, 60005230, 60019029, 60030638, 60034743,
60034748, 60043067 and 60043311;
d) Lots 17035000, 17308200, 17600700, 17733300, 18277400, 19001000,
19148900 and 19149000;
e) Lot 60310724;
f) Lots 14865700, 17308800, 17733600, 17733700, 19001400, 24543400
and 25105000;
g) Lots 15887800, 16568000, 17310000, 17310100, 17657500, 17734300
and 23083300;
h) Lots 17036400, 17658000, 17734800, 17887700, 18279700, 21846200,
22983000 and 23083900;
i) Lots 16568200, 16706800, 16706900, 17036500, 17658100, 17887900,
18129600, 18448200, 19501900, 19682100, 19805800, 22708900
and 23843500;
j) Lot 60330168;
k) Lots 12921700, 14414400, 14915600, 15878600, 70234200;
l) Lots 12662700, 12718800, 12718900, 12757600, 12808600, 13331900,
13776600, 13776700, 13935600, 14196100, 14238900, 15590000, 15590100,
15610700, 16419200, 16579200, 16718400, 16718500, 16718600, 43764000,
48387800, 49078400, 49539800, 51295600, 52044900, 57690600, 57690800,
58905500, 59114400, 59476000, 66527800, 66527900, 66816800, 68890400,
68890500, 68890600 and 69606300;
m) Lots 42330300, 56131900, 71517900, 73057500 and 77838200;
n) Lots 15550200 and 19495400;
o) Lot 15751900:
p) Lot 14878500;
q) Lot 19908900
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer Caribe, Inc., Warsaw, IN, by letters letter dated June 26, 2006 and June 28, 2006. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
VOLUME OF PRODUCT IN COMMERCE
43
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers, Recall # Z-1319-06
CODE
Lot Code: R0308, Expiration Date: 4/07; Lot Code: R0309, Expiration Date: 5/07; and Lot Code: R0310, Expiration Date: 5/07.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc, WestlakeOH, by telephone on June 17, 2005.
Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is complete.
REASON
The recalled membranes cause the status value of the pH and electrolyte electrodes to be offset causing readings outside of the acceptable range.
VOLUME OF PRODUCT IN COMMERCE
13 boxes
DISTRIBUTION
Nationwide and Canada

______________________________
PRODUCT
ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21, Recall # Z-1325-06
CODE
Software Versions 5.21 i.e. ABL8xx 754R00xx N0xx
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America, Inc., Westlake, OH, by memo and visits beginning on October 31, 2005.
Manufacturer: Radiometer Medical Aps, Bronshoj, Denmark. Firm initiated recall is complete.
REASON
ABL800 Series Blood Gas Analyzer became inoperable when the restore default setup button was touched.
VOLUME OF PRODUCT IN COMMERCE
36 analyzers
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR AUGUST 16, 2006

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