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Enforcement Report for March 22, 2006

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.

 

March 22, 2006
06-12

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS I

______________________________
PRODUCT
WHOLE FOODS MARKET WHOLE CATCH***SMOKED TROUT***LEMON-PEPPER- GARLIC***HOT SMOKED***8oz. 227g, Bar Code #99482 41183. Product packaged in plastic, Recall # F-096-6
CODE
Batch # 10724701
RECALLING FIRM/MANUFACTURER
Recalling Firm: Whole Foods Market, Austin, TX, by email on January 9, 2006.
Manufacturer: Spence & Co., Ltd., Brockton, MA, firm initiated recall is ongoing.
REASON
Trout is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
64 cases of 8 units each, total 512 units
DISTRIBUTION
CA, CO, MA, FL, PA, NY, NV, NJ, KY, VA, MD, DC, and NC

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS II

______________________________
PRODUCT
a) DON CHEPE brand Queso Amarillo De Freir,
Yellow Cheese, varying weights (1 lb., 5 lbs.
7.5 lbs. 20 lbs.), For Frying & Snacking,
Aged 60 days or more, Ing: Cultured Milk,
Enzymes, Salt. The cheese is packaged in
shrink-wrapped plastic, Recall # F-098-6;
b) DON CHEPE brand Queso Blanco De Freir,
White Cheese, varying weights (1 lb., 5
lbs., 7.5 lbs., 20 lbs.), For Frying &
Snacking, Aged 60 days or more,
Ing: Cultured Milk, Enzymes, Salt,
The cheese is packaged in shrink-wrapped
Plastic, Recall # F-099-6
CODE
All date codes
RECALLING FIRM/MANUFACTURER
New York Dominican Cheese Factory, Bronx, NY, by visit on August 12, 2005 and New York State Department of Agriculture and Markets' issued a Consumer Alert on August 17, 2005, firm initiated recall is complete.
REASON
The cheese was made from unpasteurized milk and not properly aged based on New York State Department of Agriculture and Markets' investigation and analysis.
VOLUME OF PRODUCT IN COMMERCE
7,394.5 lbs.
DISTRIBUTION
NY

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS III

______________________________
PRODUCT
Great Value brand Dark Red Kidney Beans, Net Wt. 15.5 oz, Recall # F-097-6
CODE
Lot DBENF best by 10/20/07
RECALLING FIRM/MANUFACTURER
Morgan Foods, Inc., Austin, IN, by telephone on December 6, 2005, firm initiated recall is complete.
REASON
Cans labeled as Dark Red Kidney Beans actually contain Great Northern Beans.
VOLUME OF PRODUCT IN COMMERCE
2,160 cans
DISTRIBUTION
AZ and OK

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I

______________________________
PRODUCT
GenTeal Lubricant Eye Gel, (Hypromellose 0.3%), supplied in 3.5mL and 10mL tubes and 3.5 mL Physician sample tubes, Recall # D-202-6
CODE
Lot # and Exp. date: 10 ml tubes: Z12468, 01/2006; Z12900, 04/2006; Z13161, 05/2006. 3.5 mL Z12912, 03/2006; Z13314, 06/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Novartis Pharmaceuticals, Corp., East Hanover, NJ, by letter and fax on October 10, 2005 and by press release on November 16, 2005.
Manufacturer: Cardinal Health Manufacturing Services B.V., Humacao, PR, firm initiated recall is ongoing.
REASON
Non-Sterility
VOLUME OF PRODUCT IN COMMERCE
142,399 tubes
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

______________________________
PRODUCT
ENBREL for Injection (etanercept), 25mg/vial, Multiple -use Vial with 1mL Diluent For reconstitution of Enbrel, supplied in a carton containing four dose trays, also as replacement component trays and replacement dose trays, For Subcutaneous Use Only, Rx only, NDC 58406-425-01, Recall # D-200-6
CODE
Lot number's: D042015, D041993, D041996, D046583, D042020, D046582, D046585, D046584, D046591, D046594, & D046595;
Lot number: D045965 (Replacement Component Tray);
Lot number: D045966 (Replacement Dose Tray)
RECALLING FIRM/MANUFACTURER
Amgen, Inc., Thousand Oaks, CA, by letters on December 14, 2005, firm initiated recall is complete.
REASON
Lack of Assurance of Sterility; due to possible missing, detached or loose tip caps for the diluent syringe that accompanies Enbrel (etanercept) 25mg/vial.
VOLUME OF PRODUCT IN COMMERCE
827,529 BWDI syringes
DISTRIBUTION
Nationwide

______________________________
PRODUCT
GenTeal Lubricant Eye Gel, (Hypromellose 0.3%), supplied in 3.5mL and 10mL tubes and 3.5 mL Physician sample tubes, Recall # D-201-6
CODE
GenTeal Gel 3.5 mL tubes: Z12747, 01/2006; Z12748, 01/2006; Z12911, 03/2006; Z13193, 05/2006; Z13260, 06/2006; Z13316, 06/2006; Z13259, 06/2006; Z13368, 06/2006; Z13826, 11/2006; Z13748, 11/2006.
GenTeal Gel 10mL tubes: Z12469, 12/2005; Z12470, 01/2006; Z12896, 03/2006; Z12898, 03/2006; Z12897, 03/2006; Z12895, 03/2006; Z12804, 03/2006; Z12899, 04/2006; Z13163, 05/2006; Z13167, 05/2006; Z13110, 05/2006; Z13165, 05/2006; Z13160, 05/2006; Z13111, 05/2006; Z13164, 05/2006; Z13162, 05/2006; Z13320, 07/2006; Z13301, 07/2006; Z13337, 08/2006; Z13335, 08/2006; Z13328, 08/2006; Z13326, 08/2006; Z13324, 08/2006; Z13322, 08/2006; Z13568, 11/2006; Z13570, 11/2006; Z13571, 12/2006; Z13573, 12/2006; Z13646, 12/2006;
GenTeal Gel, 3.5 mL, Physican Samples: Z12390, 01/2006; Z12391, 01/2006; Z12914, 04/2006; Z13026, 04/2006; Z13179, 06/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Novartis Pharmaceuticals, Corp., East Hanover, NJ, by letter and fax on October 10, 2005.
Manufacturer: Cardinal Health Manufacturing Services B.V., Humacao, PR, firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility
VOLUME OF PRODUCT IN COMMERCE
1,182,179 tubes
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Prednisolone, Oral Solution, USP, 15mg/5mL, 240 mL (0472-0250-08) and 480 mL(0472-0250-16), Rx only, NDC 0472-0250-08, Recall # D-203-6
CODE
Lot Numbers, Expiration Date: 501414, 7/06; 501415, 7/06; 506462, 6/07; 506463, 6/07; 510505, 10/07; 510506, 10/07; 511530, 11/07; 511531, 11/07; 601548, 1/08; 601549, 1/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alpharma, Elizabeth, NJ, by letter on March 7, 2006.
Manufacturer: VistaPharm, Inc., Largo, FL, firm initiated recall is ongoing.
REASON
Impurities/Degradation: total related compounds exceed the regulatory specification of 2.0%.
VOLUME OF PRODUCT IN COMMERCE
23,508 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_______________________________
PRODUCT
Red Blood Cells Deglycerolized, Recall # B-0687-6
CODE
Unit number: 71N112433
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Gainesville, FL, by fax on April 26, 2005, firm initiated recall is complete.
REASON
Blood product, which was not deglycerolized in accordance with specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0694-6
CODE
Unit number: 6908785
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center Inc., Amarillo, TX, by letter dated March 23, 2005, firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

_______________________________
PRODUCT
Red Blood Cells, Apheresis, Leukocytes Reduced, Recall # B-0716-6
CODE
Unit numbers: 12KT28263 (Bag 1 and 2)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on August 19, 2004 and by letter on August 20, 2004, firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor who had traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC

_______________________________
PRODUCT
Source Plasma, Recall # B-0719-6
CODE
Unit number: 04FNCB8494
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Fayetteville, NC, by facsimile on December 9, 2004, firm initiated recall is complete.
REASON
Blood product, not properly quarantined after the receipt of post donation information related to a recent tattoo and piercing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

_______________________________
PRODUCT
Platelet pheresis, Leukocytes Reduced (Part 2), Recall # B-0762-6
CODE
Unit number: 03LY14644
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone on July 29, 2004, and by letter dated July 29, 2004, firm initiated recall is complete.
REASON
Plateletpheresis, with an elevated platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

_______________________________
PRODUCT
Source Plasma, Recall # B-0763-6
CODE
Unit numbers: JK0004400, JK0004648, JK0004935, JK0005720, JK0006527, JK0007402, JK0007703, JK0009410, JK0009579, JK0010225, JK0010491, JK0011168, JK0011415, JK0011958, JK0012154
RECALLING FIRM/MANUFACTURER
DCI Biologicals Orlando LLC, Jacksonville, FL, by fax on May 17, 2004, firm initiated recall is complete.
REASON
Blood products, collected from a donor who had not had an annual physical performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
NC

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0769-6;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-0770-6;
c) Red Blood Cells, Apheresis, Leukocytes
Reduced, Recall # B-0771-6
CODE
a) Unit number: 042GF00934;
b) Unit number: 042FC17808;
c) Unit numbers: 042C18461 and 042C18462 (split unit)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Northern Ohio Region, Cleveland, OH, by facsimile and telephone on April 29, 2005 and by letter on March 5, 2005, firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
OH

_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0781-6
CODE
Unit number: W001605002207
RECALLING FIRM/MANUFACTURER
Department of the Air Force, 88th Medical Group/SGQC, Wright Patterson AFB, OH, by letter dated July 15, 2005, firm initiated recall is complete.
REASON
Blood product, mislabeled as to ABO/Rh, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0783-6;
b) Recovered Plasma, Recall # B-0784-6
CODE
a) and b) Unit number: 7271261
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on November 2, 2004, or by facsimile on October 22, 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
2 units
DISTRIBUTION
CA and IL

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0693-6
CODE
Unit numbers: 55C04664, 55C04757, 55C04758, 55R59723
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Ozarks-Arkansas Region, Little Rock, AK, by telephone on June 15, 2005 and follow-up letter on June 24, 2005, firm initiated recall is complete.
REASON
Blood products, stored at an unacceptable temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
AR

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0772-6;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-0773-6;
c) Red Blood Cells, Leukocytes Reduced
Irradiated, Recall # B-0774-6;
d) Red Blood Cells, Apheresis, Leukocytes
Reduced, Recall # B-0775-6;
e) Platelets, Leukocytes Reduced,
Recall # B-0776-6;
f) Fresh Frozen Plasma, Recall # B-0777-6
CODE
a) Unit numbers: 042GQ03072, 042GW02051, 042GW02055,
042GF00933, 042GQ03068, 042GQ03071, 042GW02056,
042GF00932, 042GQ03070, 042GW02049, 042GQ03067,
042GQ03073, 042GW02053, 042GW02052, 042GW02050,
042GW02054, 042GF00931;
b) Unit numbers 042FF92662, 042FF92675, 042FF92708,
042FF92709, 042FF92710, 042FF92711, 042GC14448,
042L23763, 042L23818, 042L23820, 042L23824,
042L23825, 042L23826, 042L23835, 042M15910,
042FF92666, 042FF92670, 042FF92673, 042FF92705,
042FF92716, 042FF92717, 042FF92720, 042FF92724,
042FG14523, 042FG14537, 042FH37221, 042FH37223,
042FP08123, 042FP08127, 042FQ23477, 042FX41613,
042FX41616, 042GC14449, 042GC14451, 042GC14459,
042GC14475, 042GC14478, 042GC14483, 042GC14484,
042GC14487, 042GS05747, 042GS05748, 042GS05749,
042GS05750, 042GS05751, 042GS05755, 042GS05758,
042GS05759, 042H45085, 042H45088, 042H45097,
042H45102, 042H45104, 042H45105, 042H45106,
042H45107, 042H45116, 042H45118, 042L23749,
042L23792, 042L23794, 042L23798, 042L23805,
042L23806, 042L238070, 42L23808, 042L23810,
042L23811, 042L23819, 042L23821, 042L23822,
042L23827, 042L23828, 042L23829, 042L23830,
042L23833, 042L23837, 042M15914, 042R81015,
042R81017, 042R81022, 042R81023, 042R81027,
042R81032, 042R81035, 042R81036, 042R81037,
042R81040, 042S07657, 042S07661, 042S07662,
042S07663, 042S07668, 042S07670, 042S07674,
042S07681, 042S07682, 042L23746, 042X05722,
042X05725, 042X05726, 042X05729, 042G55415,
042FY62172, 042GS05764, 042X05696, 042F61478,
042FF92683, 042FF92712, 042GS05761, 042R81031,
042R81038, 042X05632, 042X05633, 042X05643,
042FP08142, 042FX41611, 042T35758, 042T35765,
042X05634, 042X05636, 042X05639, 042FH37233,
042GC14469, 042GS05760, 042GS05763, 042GS05765,
042H45103, 042L23836, 042R81029, 042S07730,
042X05721, 042H45100, 042L23785, 042FC17800,
042FC17802, 042FC17807, 042FC17818, 042FG14548,
042FG14550, 042FQ23466, 042FQ23479, 042FX41612,
042FX41614, 042H45092, 042H45101, 042L23751,
042L23831, 042S07689, 042FF92676, 042FG14528,
042FG14531, 042FG14536, 042GC14485, 042GC14486,
042GS05742, 042L23755, 042R81039, 042S07673,
042H45117, 042L23780, 042FY62166, 042FY62173,
042F61476, 042F61477, 042F61482, 042FC17793,
042FC17799, 042FC17816, 042GS05739, 042GS05757,
042H45110, 042H45111, 042L23743, 042L23744,
042L23745, 042L23747, 042L23773, 042L23779,
042L23783, 042L23786, 042R81014, 042R81021,
042FY62170, 042FC17796, 042FC17797, 042FC17803,
042FC17805, 042FC17806, 042FC17809, 042FC17815,
042FC17817, 042FF92672, 042FF92674, 042FF92677,
042FP08145, 042FQ23468, 042FQ23473, 042FQ23475,
042GS05753, 042GS05754, 042H45093, 042H45119,
042L23760, 042L23764, 042L23767, 042S07728,
042S07729, 042S07732, 042T35754, 042T35756,
042T35759, 042T35761, 042T35764, 042X05705,
042X05706, 042X05707, 042X05710, 042X05711,
042X05723, 042X05730, 042FJ31992, 042FJ31998,
042FJ32002, 042FJ32003, 042FJ32006, 042FJ32008,
042FH37219, 042FH37222, 042FH37226, 042FH37234,
042GC14488, 042GS05744, 042H45096, 042H45109,
042L23788, 042L23801, 042L23809, 042L23812,
042S07664, 042FJ32001, 042FY62164, 042FF92682,
042FF92685, 042FF92686, 042FG14520, 042FG14530,
042FH37218, 042FP08119, 042FP08122, 042FP08126,
042FP08129, 042FP08137, 042FQ23488, 042FQ23489,
042FX41606, 042GC14465, 042H45091, 042H45108,
042L23816, 042R81024, 042S07666, 042X05647,
042X05649, 042X05650, 042G55406, 042G55408,
042G55409, 042G55413, 042G55416, 042FF92681,
042FQ23487, 042L23757, 042S07669, 042L23759,
042FH37214, 042FH37229, 042G55426, 042FF92667,
042FF92678, 042FF92680, 042L23775, 042F61481,
042FH37236, 042FQ23471, 042L23776, 042L23778,
042L23790, 042S07686, 042S07687, 042S07688,
042X05642, 042FJ32011, 042G55421, 042T35748,
042FY62167, 042FY62168, 042FC17819, 042GS05740,
042FG14551, 042FG14553, 042FG14554, 042FG14555,
042FQ23470, 042FQ23472, 042FQ23474, 042FQ23478,
042FQ23483, 042FQ23485, 042FQ23486, 042H45112,
042H45120, 042H45121, 042L23748, 042L23761,
042M15919, 042S07676, 042G55405, 042G55410,
042G55414, 042G55418, 042G55422, 042G55423,
042G55425, 042FP08138, 042FP08139, 042FQ23465,
042FQ23481, 042S07721, 042S07731, 042X05704,
042X05709, 042X05712, 042X05717, 042X05718,
042X05621, 042FG14521, 042GC14473, 042GS05756,
042L23834, 042S07672, 042X05600, 042X05605,
042X05610, 042X05617, 042X05618, 042X05620,
042X05626, 042T35729, 042T35738, 042T35745,
042T35750, 042H45114, 042G55407, 042G55420,
042FH37220, 042FP08121, 042FP08125, 042FP08128,
042FP08132, 042GC14466, 042H45086, 042H45090,
042H45095, 042H45099, 042L23777, 042L23787,
042L23815, 042R81026, 042X05604, 042X05606,
042X05614, 042X05627, 042X05637, 042X05644,
042G55419, 042T35752, 042FF92719, 042FG14524,
042FG14525, 042FG14529, 042FH37227, 042FH37231,
042FH37235, 042L23756, 042S07667, 042X05631,
042T35731, 042T35747, 042FF92663, 042FF92664,
and 042FF92722;
c) Unit number: 42F61481;
d) Unit numbers: 042C18457 (split unit), 042C18458
(split unit), 042C18459 (split unit), 042C18463
(split unit), 042C18466 (split unit), 042Y47001,
042C18465, (split unit), 042E52663 (split unit),
042E52667 (split unit), 042C18464 (split unit),
042E52655 (split unit), 042Y47000 (split unit),
042Y47002, 042E52657 (split unit), 042E52661
(split unit), 042C18467 (split unit), 042E52666,
and 042E52662;
e) Unit numbers 042FX41606, 042FX41613, 042FX41614,
042FX41616, 042GS05747, 042GS05748, 042GS05754,
042GS05757, 042GS05764, 042X05607, 042X05609,
042X05611, 042X05615, 042X05617, 042X05618,
042X05619, 042X05620, 042X05623, 042X05625,
042X05628, 042X05629, 042X05630, 042X05631,
042X05632, 042X05633, 042X05634, 042X05636,
042X05637, 042X05638, 042X05639, 042X05641,
042X05644, 042X05645, 042X05648, 042T35729,
042T35738, 042T35745, 042T35750, 042F08143,
042F41609, 042G05762, 042X05709, 042X05717,
042X05719, 042F41612, 042G05763, 042F08139,
042F08141, 042F08145, 042F08147, 042G05765,
042S07721, 042S07728, 042S07731, 042S07732,
042T35753, 042T35754, 042T35756, 042T35759,
042T35764, 042X05603, 042X05608, 042X05613,
042X05614, 042X05624, 042X05626, 042X05700,
042X05705, 042X05707, 042X05711, 042X05718,
042X05725, 042X05726, 042F31992, 042F31993,
042F32001, 042F32002, 042F32005, 042F32006,
042F32009, 042T35744, 042T35749, 042T35752,
042X05704, 042X05712, 042X05721, 042X05723,
042X05730, 042F32011, 042S07722, 042X05706,
042T35731, 042X05650, 042FP08142, 042GS05751,
042GS05755, 042X05697, 042X05713, 042X05635,
042T35755, 042T35757, 042T35760, 042T35763,
042F31995, 042F31996, 042T35748, 042F41607,
042F41608, 042G05750, 042G05752, 042G05758,
042G05759, 042G05761, 042T35758, 042X05600,
042X05604, 042X05605, 042X05606, 042X05610,
042X05696, 042X05710, 042X05722, 042X05728,
042X05729, 042X05642, 042X05647, 042X05649,
042X05640, 042X05643, 042X05646, 042T35730,
042T35732, 042T35742, and 042T35734;
f) Unit numbers 042FP08147, 042FX41609, 042FX41615,
042GS05764, 042X05726, 042FJ31997, 042FJ32007,
042FJ32010, 042FJ32012, 042T35732, 042T35734,
042FJ31995, 042T35735, 042T35736, and 042T35737
RECALLING FIRM/MANUFACTURER
American National Red Cross, Northern Ohio Region, Cleveland, OH, by facsimile and telephone dated April 29, 2005 and by letter dated March 5, 2005, firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
591 units
DISTRIBUTION
OH

_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0778-6
CODE
Unit numbers: 2800037 (distributed as 2 split products), 2800052, 4728036
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by phone on November 22 and November 28, 2005, firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced but with white blood counts that had not been verified, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
IN

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

_______________________________
PRODUCT
a) FreeStyle Connect Point of Care Blood Glucose
Monitoring System, including Control Solutions
and Test Strips; Part Number: 70672-01,
Recall # Z-0604-06;
b) FreeStyle Connect Blood Glucose Test Strips;
Part Number: CAT70676-01, Recall # Z-0605-06
CODE
a) All lots, including: FC0010, FC0012,
FC0013, FC0014, FC0015, FC0016, FC0017,
FC0020, FC0019, FC0018, FC0021, FC0022,
FC0023, FC0026, FC0024, FC0025, FC0027,
FC0028, FC0029, FC0030, FC0031, FC0032,
FC0033, FC0034, FC0036;
b) Lot Numbers: 0522524, 0526329, 0526326,
0529324, 0532203, 0533607, 0533641,
0534362, 0534404, 0534421, 0601135,
0601165, 0601608, 0601661
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Diabetes Care, Inc., Alameda, CA, by visit on February 17, 2006 and by letters on February 22, 2006, firm initiated recall is ongoing.
REASON
The device may give inaccurate elevated blood glucose test results. This may lead to over treatment and hypoglycemic complications may result.
VOLUME OF PRODUCT IN COMMERCE
900 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) Test kit used in the assessment of breast
cancer patients for whom Herceptin therapy
is being considered. BioGenex brand InSite
HER-2/neu IHC Kit, Manual; Model
Numbers: RD134-60K, Recall # Z-0606-06;
b) Test kit used in the assessment of breast
cancer patients for whom Herceptin therapy
is being considered. BioGenex brand InSite
HER-2/neu IHC Kit, Automated; Model Numbers:
RD134-YAX, Recall # Z-0607-06;
c) Test kit used in the assessment of breast
cancer patients for whom Herceptin therapy
is being considered. BioGenex brand InSite
HER-2/neu Monoclonal Antibody, Manual;
Model number: AM134-5MP, Recall # Z-0608-06;
d) Test kit used in the assessment of breast
cancer patients for whom Herceptin therapy
is being considered. BioGenex brand InSite
HER-2/neu Monoclonal Antibody, Automated;
Model number: AM134-10MP, Recall # Z-0609-06
CODE
a) Lot Numbers: RD1340205, RD1340205X,
RD1340205Y;
b) Lot Numbers: RD1340205, RD1340205X,
RD1341105, RD1340206;
c) and d) Lot Number: AM134P1005
RECALLING FIRM/MANUFACTURER
Biogenex Laboratories, San Ramon, CA, by letters on February 9, 2006. Firm initiated recall is ongoing.
REASON
Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result.
VOLUME OF PRODUCT IN COMMERCE
28 units
DISTRIBUTION
Nationwide, Italy and United Kingdom

_______________________________
PRODUCT
BD Xstar Bevel Up Slit Knife 2.8 mm, Sterile Catalog number: 373728, Recall # Z-0613-06
CODE
Lot number: 5335524
RECALLING FIRM/MANUFACTURER
BD Opthalmic Systems, Waltham, MA, by telephone on February 28, 2006, firm initiated recall is ongoing.
REASON
Product labeled as a 2.8 mm may contain a 3.2 mm Xstar.
VOLUME OF PRODUCT IN COMMERCE
3,430 units
DISTRIBUTION
Nationwide and Belgium

_______________________________
PRODUCT
Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS, Recall # Z-0622-06
CODE
Versions 3.1.0 and 3.1.1
RECALLING FIRM/MANUFACTURER
Fujifilm Medical System USA, Inc., Stamford, CT, by letter dated February 3, 2006, firm initiated recall is ongoing.
REASON
Image orientation and orientation markers may not match when an image is rotated or flipped when the CT Image is preset.
VOLUME OF PRODUCT IN COMMERCE
82 units
DISTRIBUTION
Nationwide, Canada, Japan, and Germany

______________________________
PRODUCT
Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic), Recall # Z-0623-06
CODE
Serial numbers 4000002, 4000004, 4000006, 4000007, 4000009, 4000010, 4000011, 4000013, 4000014, 4000016, 4000018, 4000019, 4000021 thru 4000024, 4000030, 4000031, 4000034, 4000040, 4000044, 4000045, 4000047, 4000048, 4000050, 4000051, 4000054, 4000057, 4000060, 4000063, 4000064, 4000065, 4000067, 4000072, 4000075, 4000079, 4000080, 4000082, 4000085, 4000086, 4000089, 4000090, 4000095, 4000097, 4000098, 4000099, 4000136, 4000138, 4000140, 4000145, 4000156, 4000162, 4000164, 4000179, 4000184, 4000186, 4000187, 4000192, 4000209, 4000215, 4000227, 4000229, 4000230, 4000232, 4000247, 4000249, 4000250, 4000255, 4000256, 4000264, 4000271, 4000274, 4000287, 4000288, 4000291, 4000295, 4000305, 4000306, 4000314, 4000322, 4000323, 4000324, 4000326, 4000330 thru 4000335, 4000337, 4000342
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardiac Science, Inc., Bothell, WA, by telephone and letter dated February 2, 2006.
Manufacturer: Quinton Cardiology, Inc., Deerfield, WI, firm initiated recall is ongoing.
REASON
Some Powerheart AEDs Model 9300A may contain a suspect electronic component and there is a remote likelihood that the function of this device may be interrupted during the charge.
VOLUME OF PRODUCT IN COMMERCE
91 units
DISTRIBUTION
Nationwide, Hungary and Singapore

______________________________
PRODUCT
In vitro Test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Reagent Pack 100 test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Calibrators are composed of six vials of calibrators A, B, C, D, E, and F containing cyclosporine prepared in human blood component (non-reactive for HBxAg, anti-HCv, anti-HIV-1/HIV-20. TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Controls are composed of three vials L, M and H containing cyclosporine in human blood componenet (nonreactive for HBsAg, anti-HCV, and anti-HIV-1/HIV-2). Recall # Z-0624-06
CODE
Lot 18229Q100 (exp 8/26/2006) Lot 18230Q100 (exp 10/05/2006)
RECALLING FIRM/MANUFACTURER
Abbott Health Products, Inc., Barceloneta, PR, by letter, dated March 23, 2005, firm initiated recall is ongoing.
REASON
Important Product Information Letter containing technical information regarding the TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Calibrators and Controls, implementing new internal reference standards. Patient results reported using calibrators made from new primary material may be falsely decreased by 5-8% compared to results using calibrators made from the previous primary material.
VOLUME OF PRODUCT IN COMMERCE
Lot 18229Q100 -- 1218 kits;
Lot 18230Q100 -- 3296 kits
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR MARCH 22 2006

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