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U.S. Department of Health and Human Services

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Enforcement Report for March 14, 2007

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 14, 2007
07-11

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

___________________________________
PRODUCT
Gingerbread cookies under two separate labels: Elegant Sweets and Sweet Williams Hand Decorated Gingerbread Boy, Elegant Gourmet. Gingerbread Boy Cookies, 3 oz. cookies, packaged in clear shrink-wrap then packed in a clear cello bag and closed by a twist tie; 12 cookies/case, Recall # F-131-7
CODE
Individual cookies are not coded. Code on master carton only - 126048, QCCBOY3, ECBOY
RECALLING FIRM/MANUFACTURER
Elegant Gourmet, Inc, Woodinville, WA, by press release on January 12, 2007, by telephone on January 13, 2007 and by letters on January 17-18 and February 2, 2007. Firm initiated recall is complete.
REASON
Cookies contain eggs as an ingredient, but the labeling on the product did not reveal the presence of eggs.
VOLUME OF PRODUCT IN COMMERCE
51,857/3 oz. cookies
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

___________________________________
PRODUCT
Organic amaranth, Grain, 100% Organic, Triple Washed/Cleaned, Net Weight 25 lb (11.35 kg), Recall # F-132-7
CODE
Lot Number: BN-16
RECALLING FIRM/MANUFACTURER
Recalling Firm: United Natural Foods, Inc., Chesterfield, NH, by telephone and email on November 20, 2006.
Manufacturer: Quinoa Foods Company, La Paz, Bolivia. Firm initiated recall is complete.
REASON
Product may contain corroded ferrous materials.
VOLUME OF PRODUCT IN COMMERCE
421 bags (25 lbs)
DISTRIBUTION
Nationwide

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

___________________________________
PRODUCT
Care340B Glyburide Tablets, 5 mg, 30 tablet bottles, Rx only, Product # CC528, NDC 66336-938, Recall # D-467-2007
CODE
Lots: A00330, exp. 8/07 and A00458, exp. 8/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dispensing Solutions, Inc, Santa Ana, CA, by telephone on December 22, 2006.
Manufacturer: Novopharm Ltd, Scarborough, Ontario Canada. Firm initiated recall is ongoing.
REASON
Ingredient statement incorrectly reports that each tablet contains 5 mg Glipizide instead of 5 mg Glyburide.
VOLUME OF PRODUCT IN COMMERCE
150/30-tablet bottles
DISTRIBUTION
CA, and AK

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

___________________________________
PRODUCT
a) Platelets Pheresis Leukocytes Reduced, Recall # B-0386-07;
b) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0387-07
CODE
a) Units: 4053617, 3798340, 5606869, 7685507-1, 7685507-2,
7677707, 7676672, and 7674878;
b) Unit: 4053617
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by facsimile on September 12, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
TX and NY

___________________________________
PRODUCT
FETALSCREEN, Product Code 780540, Recall # B-0448-07
CODE
Lot Number: FS472 Exp. Date Jan 16, 2007;
Lot Number: FS473 Exp. Date Feb 13, 2007
RECALLING FIRM/MANUFACTURER
Ortho Clinical Diagnostics, Inc., Raritan, NJ, by letter dated January 9, 2007. Firm initiated recall is complete.
REASON
FETALSCREEN test kits, demonstrating weak or negative reactivity with the positive control, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0775-07;
b) Recovered Plasma, Recall # B-0776-07
CODE
a) and b) Unit: 0750553
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by letter and facsimile dated August 31, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA and Switzerland

___________________________________
PRODUCT
Platelets, Recall # B-0777-07
CODE
Units: L57625, L62332, L56534, L62333, L62331, L58708, L58711, L58709, L60377
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by fax on January 21, 2005. Firm initiated recall is complete.
REASON
Platelets, processed in a manner that may have caused the yield to be below the firm’s specified minimum, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
GA and TN

___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0780-07;
b) Platelets, Recall # B-0781-07
CODE
a) and b) Unit: 6816046
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by letter dated November 25, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH

___________________________________
PRODUCT
Red Blood Cells Leukocyte Reduced, Recall # B-0782-07
CODE
Unit: 8865355
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on July 8, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

___________________________________
PRODUCT
Platelets Pheresis, Leukocyte Reduced, Recall # B-0783-07
CODE
Units: 9931218 (distributed as split product)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on October 6, 2005. Firm initiated recall is complete.
REASON
Blood products, labeled as leukoreduced, but which did not meet the requirements for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL

___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0785-07
CODE
Unit: 113483855
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., El Paso, TX, by telephone on August 13, 2006. Firm initiated recall is complete.
REASON
Blood product, collected without quality control testing during apheresis machine validation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

___________________________________
PRODUCT
a) Platelets Pheresis Leukocytes Reduced, Recall # B-0786-07;
b) Platelets Pheresis Leukocytes Reduced, Irradiated, Recall # B-0787-07
CODE
a) Unit: 04GP64828, Part 2 ;
b) Unit: 04GP64828, Part 1
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by fax and follow-up letter on October 26, 2006. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NH and NY

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0789-07
CODE
Units: 1674391, 9594017
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by letters dated September 8, 2006 and November 3, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the drug Aricept, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN and Austria

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0791-07
CODE
Units: Y28792, Y33329
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by telephone on November 21, 2005. Firm initiated recall is complete.
REASON
Blood products, incorrectly labeled as irradiated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA

___________________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-0803-07
CODE
Unit: LG46100
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by telephone on October 5, 2006. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Red Blood Cells that was implicated in a transfusion reaction and possibly contaminated with Staphylococcus aureus, was distributed,
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

___________________________________
PRODUCT
Platelets, Recall # B-0804-07
CODE
Unit: N88070
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on November 30, 2006. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI

___________________________________
PRODUCT
a) Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0813-07;
b) Fresh Frozen Plasma Pheresis, Recall # B-0814-07
CODE
a) and b) Unit: 5272834
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by telephone and facsimile on March 29, 2005. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may compromise the sterility of the products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK

___________________________________
PRODUCT
Red Blood Cells, Leukocytes, Reduced, Recall # B-0816-07
CODE
Unit: H79738
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter dated June 1, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of melanoma, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA

___________________________________
PRODUCT
Red Blood Cells, Recall # B-0818-07
CODE
Unit: 5541829
RECALLING FIRM/MANUFACTURER
New York Blood Center, New Brunswick, NJ, by letter dated February 8, 2006. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving post-donation information regarding a history of pneumonia, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

___________________________________
PRODUCT
a) Red Blood Cells Pheresis, Leukoctyes Reduced, Recall # B-0821-07
b) Red Blood Cells, Recall # B-0822-07;
c) Fresh Frozen Plasma Pheresis, Recall # B-0823-07;
d) Recovered Plasma, Recall # B-0824-07
CODE
a) and c) Units: 4961587;
b) and d) Units: 4923250
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on November 16, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of a hepatitis and jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OK and Switzerland

___________________________________
PRODUCT
Source Plasma, Recall # B-0825-07
CODE
Unit: F-50100-072
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Long Beach, CA, by facsimile on April 4, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1unit
DISTRIBUTION
Sweden

___________________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced, Recall # B-0845-07;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0846-07
CODE
a) Units: GS39540, GS39580 (2 units), GS39606, GS40880, GS39784 (3 units), GS40930, GS40925, GS40978, GS40960, GS39806 (2 units), GS41033 (3 units), GS42764 (3 units), GS42833, GS42512 (3 units), GS42599 (3 units), GS42573 (3 units), GS39913 (3 units), GS42990 (2 units), GS42773 (3 units), GS42596, GS42678 (2 units), GS42915 (2 units), GS42919 (3 units), GS39890 (3 units), GS41192 (3 units), GS42699, GS42592, GS42550, GS39967 (3 units), GS41183 (3 units), GS42718 (2 units), GS39972, GS42796 (3 units), GS39911 (2 units), GS42571 (2 units), GS42475 (3 units), GS40000 (2 units), GS40037 (2 units), GS41136 (3 units), GS42935 (3 units), GS40009, GS40017 (2 units), GS42835 (2 units), GS42768, GS42828, GS40008 (2 units), GS39825 (3 units), GS41041 (2 units), GS42395 (2 units), GS39929 (2 units), GS42460, GS42441 (2 units), GS42707, GS40938, GS40028 (2 units) , GS40012 (3 units), GS39824, GS42603, GS42872 (2 units), GS42663, GS40080, GS42623 (2 units), GS42821 (3 units), GS42963, GS41168, GS41087, GS41082 (2 units), GS42704, GS42611, GS39998 (2 units), GS42856, GS42408, GS42425, GS42784, GS41106, GS42482;

b) Units: GS40908 (2 units), GS42957 (3 units), GS40008, GS42395, GS42460, GS39929, GS39957, GS42571, GS39973 (2 units), GS40009, GS40080 (2 units), GS42623, GS39912 (2 units), GS42835
RECALLING FIRM/MANUFACTURER
Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA, by letter dated December 17, 2003. Firm initiated recall is complete.
REASON
Platelets Pheresis, with an elevated platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
158 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0847-07
CODE
Units: G-97942-077, G-97665-077, N-65454-077, N-65425-077
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Riverside, CA, by facsimile on October 8, 2002. Firm initiated recall is complete.
REASON
Blood products, which were not properly quarantined after receiving post donation information concerning high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Spain

___________________________________
PRODUCT
Recovered Plasma, Recall # B-0854-07
CODE
Unit: V10665
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by email on August 25, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0855-07;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-0856-07;
c) Platelets, Recall # B-0857-07;
d) Fresh Frozen Plasma, Recall # B-0858-07
CODE
a) Units: H44634, H38812 and H52963;
b) Unit: H23237;
c) Unit: H52963;
d) Units: H44634, H38812 and H52963
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter and e-notification on August 4, 2005, August 10, 2005, August 24, 2005 and September 14, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
VA, WI and Switzerland

___________________________________
PRODUCT
Source Plasma, Recall # B-0867-07
CODE
Unit: 377023103
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., dba International BioResources, LLC, Anderson, IN, by facsimile on October 24, 2006. Firm initiated recall is complete.
REASON
Blood product, which was untested for viral markers, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0868-07
CODE
Units 172054103 (split unit parts 1, 2, and 3)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., McAllen, TX, by letter dated March 9, 2006. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX

___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0870-07;
b) Platelets Leukocytes Reduced, Recall # B-0871-07;
c) Fresh Frozen Plasma, Recall # B-0872-07;
d) Recovered Plasma, Recall # B-0873-07
CODE
a) Units 32KY21202 and 32KY20652;
b) and d) Unit: 32KY20652;
c) Unit 32KY21202
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Madison, WI, by facsimile on February 21, 2003 and by letter dated March 3, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus encoded antigen (anti-HCV), but were collected from an ineligible donor based on the subsequent disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
IL, OH, and FL

___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0874-07;
b) Recovered Plasma, Recall # B-0875-07
CODE
a) and b) Unit: 7679080
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by facsimile on December 30, 2004, January 28, 2005, April 20, 2006, July 31, 2006, and August 2, 2006. Firm initiated recall is ongoing.
REASON
Blood products, which were collected from a donor who had previously tested repeatedly reactive for the antibody to the human immunodeficiency virus (anti-HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA and Switzerland

___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0876-07;
b) Red Blood Cells, Apheresis, Recall # B-0877-07;
c) Red Blood Cells, Leukocytes Reduced, Recall # B-0878-07;
d) Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0879-07;
e) Platelets, Leukocytes Reduced, Recall # B-0880-07;
f) Platelets Pheresis, Leukocytes Reduced, Recall # B-0881-07;
g) Fresh Frozen Plasma, Recall # B-0882-07;
h) Cryoprecipitate, AHF, Recall # B-0883-07;
i) Plasma Frozen, Recall # B-0884-07;
j) Plasma Frozen, Cryoprecipitate, Reduced, Recall # B-0885-07
CODE
a) Units: 022FN80287, 022FN80300, 022FN80387, 022FN80466,
022FN80475, 022FN80625, 022FN80628, 022FN80629, 022FN80634,
022FN80822, 022FN80824, 022FN80827, 022FN80843, 022FN80844,
022FN80845, 022FE98354, 022FE98570, 022FJ97459, 022FJ99446,
022FS35042, 022FS41308, 022FX19089, 022FZ13240, 022GE84970,
022KF56805, 022KF56806, 022KF56811, 022KF56899, 022KF60302,
022KF60303, 022KF60304, 022KF60305, 022KH10289, 022KK72529,
022KT72123, 022KW66117, 022LP09374, 022LW81415, and 022LZ09069;
b) Unit: 022LE14716;
c) Units: 022FN80757, 022FN80821, 022FN80330, 022FN80429,
022FN80453, 022FN80458, 022FN80542, 022FN80579, 022FN80582,
022FN80623, 022FN80644, 022FN80648, 022FN80669, 022FN80670,
022FN80671, 022FN80672, 022FN80750, 022FN80754, 022FN80783,
022FN80784, 022FN80792, 022FN80793, 022FN80796, 022FN80797,
022FN80798, 022FN80874, 022FN80875, 022FN81012, 022GL34871, and
022GL34873;
d) Unit: 022FN80837;
e) Units: 022FR01073 and 022LP17414;
f) Units: 022LE16844, 022LE16848, 022LE16849, 022LE16858, 022LE16862,
022LE16848, 022LE16858, and 022LE16858;
g) Units: 022FC30434, 022FC30437, 022FC30441, 022FC31017, 022FC31018,
022FC33170, 022FC34170, 022FC34516, 022FC34521, 022FC34526,
022FE99486, 022FE99682, 022FE99683, 022FE99685, 022FE99769,
022FE99770, 022FE99874, 022FN74787, 022FN75898, 022FN75905,
022FN75908, 022FN76431, 022FN76435, 022FN76436, 022FN76443,
022FN76450, 022FN76453, 022FN76456, 022FN76459, 022FN76610,
022FN76613, 022FN76687, 022FN76689, 022FN76705, 022FN76709,
022FN76710, 022FN76791, 022FN76807, 022FN77332, 022FN77334,
022FN77335, 022FN77336, 022FN77337, 022FN77368, 022FN77376,
022FN77378, 022FN77392, 022FN77457, 022FN77466, 022FN77470,
022FN77474, 022FN77856, 022FN77861, 022FN78425, 022FN78426,
022FN78430, 022FN79118, 022FN79127, 022FN80475, 022FN80783,
022FQ29133, 022FQ29138, 022FQ29143, 022FQ29144, 022FQ29145,
022FQ29146, 022FQ29792, 022FQ29803, 022FQ29827, 022FQ29951,
022FQ33507, 022FQ33509, 022FQ33510, 022FQ33512, 022FQ33514,
022FQ33515, 022FQ33516, 022FQ33526, 022FR01073, 022FS40156,
022FS40158, 022FS40161, 022FS40254, 022FS40255, 022FS40256,
022FS40257, 022FS40259, 022FS40260, 022FS40271, 022FS40272,
022FS40273, 022FS40275, 022FS40276, 022FS40277, 022FS40278,
022FS41308, 022FS41310, 022FS41313, 022FS41314, 022FS41317,
022FS41318, 022FX19090, 022FX19095, 022FX20683, 022FX20729,
022FX20730, 022FZ18364, 022FZ20163, 022FZ20164, 022FZ20165,
022FZ20166, 022FZ20168, 022GE88407, 022GE88414, 022GE88416,
022GE88425, 022GE88428, 022GE89025, 022GE89026, 022GE89028,
022GE89030, 022GE89031, 022GE89033, 022GE90295, 022GE90296,
022GE90303, 022GE90310, 022GE91551, 022GE92131, 022GE92132,
022GE92136, 022GE92137, 022GE92143, 022GE92152, 022GE92153,
022GE92154, 022GG00273, 022GG00286, 022GG02289, 022GH20751,
022GL28174, 022GL28440, 022GL28442, 022GL28462, 022GM01134,
022GM01136, 022GM01140, 022GM01147, 022GM04577, 022GM04633,
022GM05342, 022GM05353, 022GM05357, 022GM05360, 022GQ10059,
022GQ10060, 022GQ10063, 022GQ10066, 022GS15861, 022GS15863,
022GS15871, 022GS15872, 022GS15875, 022GS16471, 022GS17587,
022GS18004, 022GS18080, 022GS18085, 022GS18088, 022GS18089,
022GS18090, 022GS18093, 022GS18094, 022GS18099, 022GS18100,
022KC78883, 022KC78884, 022KC78887, 022KC78888, 022KC79971,
022KC79980, 022KC80832, 022KC80836, 022KC80839, 022KC80841,
022KC81561, 022KC81567, 022KC81569, 022KC81571, 022KC81572,
022KC81573, 022KC81578, 022KC81579, 022KC81580, 022KC81582,
022KC82886, 022KC82889, 022KC82898, 022KC82901, 022KC82909,
022KC82975, 022KC83429, 022KC83434, 022KC83437, 022KC83438,
022KC83440, 022KF59563, 022KF59564, 022KF59566, 022KF59577,
022KF59923, 022KF60721, 022KF60722, 022KF61014, 022KF61299,
022KF61300, 022KF61308, 022KF61528, 022KF61546, 022KF61547,
022KF61549, 022KF61553, 022KF61554, 022KF61555, 022KF61868,
022KF61869, 022KK74167, 022KK74168, 022KK74173, 022KK74175,
022KK74176, 022KK74184, 022KK74185, 022KK74186, 022KK74187,
022KK74188, 022KK74192, 022KK74194, 022KK77686, 022KK77687,
022KK77698, 022KK77700, 022KK77703, 022KL26157, 022KL26160,
022KL26162, 022KL26694, 022KL26695, 022KL26709, 022KT74888,
022KT74892, 022KT74893, 022KV80323, 022KV80328, 022KV80334,
022KV80339, 022KV80349, 022KV80354, 022KV80355, 022KV80359,
022KV80370, 022KV80374, 022KV80415, 022KV80417, 022KV80418,
022KV80419, 022KV80422, 022KV80440, 022KV80471, 022KW68282,
022KW68288, 022KW68292, 022KW68296, 022KW68298, 022KW68300,
022KW68303, 022KW68305, 022KW69831, 022KW69837, 022KW69902,
022KW69903, 022KW69909, 022KW69910, 022KW70272, 022KW70273,
022KW70279, 022KW70286, 022KW70290, 022KW70292, 022KX78215,
022KX78577, 022KX80640, 022KX80641, 022KX80643, 022KX80646,
022KX80647, 022KX80651, 022KX80656, 022KX80670, 022KY97511,
022KY97512, 022KY97519, 022KY97549, 022KY99847, 022KY99867,
022KY99870, 022KY99877, 022KY99932, 022KY99942, 022KZ78282,
022KZ78284, 022KZ78286, 022KZ78287, 022KZ78301, 022KZ78306,
022KZ79455, 022KZ79864, 022KZ79875, 022KZ80478, 022KZ84986,
022KZ84993, 022KZ84995, 022KZ85003, 022KZ85010, 022KZ85064,
022KZ86479, 022KZ86480, 022KZ86481, 022KZ86669, 022LC26832,
022LC26833, 022LC26835, 022LC26836, 022LC26840, 022LC26843,
022LC26848, 022LC26854, 022LC26864, 022LJ94373, 022LJ94374,
022LJ94375, 022LJ94377, 022LJ94378, 022LJ94804, 022LJ94805,
022LJ94807, 022LJ94808, 022LJ94809, 022LJ94810, 022LJ94812,
022LJ94814, 022LJ94815, 022LJ95328, 022LJ95330, 022LJ98143,
022LJ98144, 022LJ98147, 022LJ98148, 022LJ98150, 022LJ98152,
022LJ98154, 022LJ98156, 022LP09360, 022LP09361, 022LP09369,
022LP09370, 022LP09374, 022LP10215, 022LP11298, 022LP11304,
022LP11305, 022LP11309, 022LW84869, 022LW84876, 022LW84890,
022LW84897, 022LW84902, 022LZ07966, 022LZ07975, 022LZ07986,
022LZ07988, 022LZ07989, 022LZ07990, 022LZ07991, 022LZ07992,
022LZ07998, 022LZ09049, 022LZ09062, 022LZ09063, 022LZ09064,
022LZ09065, 022LZ09066, 022LZ09067, 022LZ09069, 022LZ09073,
022LZ09077, 022LZ09528, 022LZ09530, 022LZ09532, 022LZ09533,
022KG92746, 022KG92749, 022KG93303, 022KG93330, 022KG93340,
022KG93429, 022KG93447, 022KG93451, 022KG93464, 022KG93468,
022KG93510, 022KG93515, 022KG93519, 022KG93530, 022KG94403,
022KG94565, 022KG94572, 022KG94662, 022KG95205, 022KG95258,
022KG95313, 022KG95358, 022KG95379, 022KG95383, 022KG95389,
022KG95541, 022KG96012, 022KG96016, 022KG96042, 022KG96047,
022KG96063, 022KG96312, 022KG96373, and 022KG97093;
h) Units: 022FC34522, 022FN74059, 022FN74062, 022FN74063,
022FN78969, 022FN78970, 022FN78973, 022FN78981, 022FN79384,
022FN79456, 022FN79526, 022FN80111, 022FN80162, 022FN80164,
022FN80230, 022FN80300, 022FN80330, 022FN80453, 022FN80458,
022FQ29837, 022FX20782, 022FX22200, 022FX23222, 022FX23225,
022FX23226, 022FX23228, 022FX23230, 022FX23231, 022FZ20172,
022FZ20173, 022FZ20174, 022FZ20175, 022FZ20178, 022GG02221,
022GG02227, 022GG02230, 022GG02237, 022GH18474, 022GH18480,
022GH18481, 022GH18500, 022GH18539, 022GH18545, 022GH18573,
022GH18598, 022GH20732, 022GL34873, 022GQ09770, 022GQ09777,
022GQ09941, 022GQ11495, 022GQ11497, 022GQ11503, 022GS16466,
022GS16519, 022KC82906, 022KF61042, 022KK74174, 022KK74191,
022KL24301, 022KL24303, 022KL24304, 022KL24305, 022KL24306,
022KT74881, 022KT74890, 022KW68307, 022KY97552, 022KY97557,
022KY97558, 022KY97571, 022KZ79849, 022LJ95337, 022LJ95342,
022LJ95478, 022LJ95479, 022LJ95481, 022LJ95482, 022LJ98178,
022LJ98182, 022LJ98184, 022LJ98186, 022LW84175, 022LW84190,
and 022LW84903;
i) Units: 022FC31021, 022FE99742, 022FE99879, 022FN76713, 022FN76716,
022FN77395, 022FN78419, 022FN78801, 022FN79528, 022FN80466,
022FZ18310, 022GG00275, 022GG00276, 022GG00277, 022GG00278,
022GG01458, 022GL28433, 022GM01142, 022GM01144, 022GQ09915,
022GQ09917, 022GS16478, 022KK77679, 022KK77681, 022KL26687,
022KL26688, 022KL26690, 022KV80424, 022KZ86425, 022KZ86450,
022KZ86670, 022LJ94368, 022LJ94439, 022LJ94442, 022LJ94444,
022LJ94456, 022LJ94462, 022LJ94465, 022LJ94806, 022LJ96794, 022LJ96795,
and 022LJ96796;
j) Units: 022FQ29837, 022FX22200, 022FX23222, 022FX23226, 022FX23228,
022FX23230, 022FZ20173, 022FZ20175, 022FZ20178, 022GH18474,
022GH18480, 022GH18481, 022GH18598, 022GH20732, 022GQ09770,
022GQ11495, 022GQ11497, 022GQ11503, 022KC82906, 022KL24303,
022LJ98178, 022LJ98184, 022LJ98186, 022LW84190, and 022LW84903
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by facsimile, letter or telephone on August 19, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose arm scrubs may have been incorrectly performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
670 units
DISTRIBUTION
PA, NJ, AZ, IL, CA, MD, MI, MA, MN, TN, TX and WI

___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0895-07;
b) Platelets, Recall # B-0896-07
CODE
a) and b) Unit: L164243
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by letter on August 4, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

___________________________________
PRODUCT
Red Blood Cells (Apheresis) Deglycerolized, Recall # B-0784-07
CODE
Units: 6970928 (Parts 1 and 2)
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO., by telephone on June 15, 2004. Firm initiated recall is complete.
REASON
Blood products, labeled with extended expiration dates, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO

___________________________________
PRODUCT
Red Blood Cells, Recall # B-0788-07
CODE
Unit: 5768891
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., New York, NY, by telephone, fax and follow-up letter on January 12, 2004. Firm initiated recall is complete.
REASON
Blood product, labeled with extended expiration date, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

___________________________________
PRODUCT
Recovered Plasma, Recall # B-0790-07
CODE
Units: 1674391, 9594017
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by letters dated September 8, 2006 and November 3, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the drug Aricept, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN and Austria

___________________________________
PRODUCT
Platelets Pheresis, Recall # B-0796-07
CODE
Unit: Y02049
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by telephone on June 27, 2006. Firm initiated recall is complete.
REASON
Blood product, lacking a verified platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

___________________________________
PRODUCT
Red Blood Cells, Recall # B-0853-07
CODE
Unit: 4447265
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on October 28, 2006. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Diphtheroids, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

___________________________________
PRODUCT
a) Platelets (for further manufacturing), Recall # B-0859-07;
b) Recovered Plasma, Recall # B-0860-07
CODE
a) Unit: H44634;
b) Unit: H23237
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter and e-notification on August 4, 2005, August 10, 2005, August 24, 2005 and September 14, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA, WI and Switzerland

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

___________________________________
PRODUCT
a) Defibtech Sentry Semi-Automatic External Defibrilator (AED)
sold as "Lifeline AED" brand -Model DDU-100A
(version 2.002 and earlier), Recall # Z-0580-2007;
b) Defibtech Sentry Semi-Automatic External Defibrilator (AED)
sold as "ReviveR AED" brand -Model DDU-100B (version 2.002
and earlier), Recall # Z-0581-2007
CODE
Software versions earlier than version 2.002
RECALLING FIRM/MANUFACTURER
Defibtech, LLC, Guilford, CT, by email on February 17, 2007 and by letters on February 22, 2007. Firm initiated recall is ongoing.
REASON
Device Malfunction-The self-test software may allow a self-test to clear a previously detected low battery condition. If this occurs, the operator may be unaware of the low battery and the device may be "unable" to deliver a defibrillation shock, which could result in failure to resuscitate a patient.
VOLUME OF PRODUCT IN COMMERCE
42,650 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

___________________________________
PRODUCT
Sample Management System software for in vitro diagnostic testing Product # 030102-03, Recall # Z-0545-2007
CODE
Serial #’s D0314, D0280, E0545, C0081, C0026, D0384, D0244, E0515, E0511, E0550, C0222, C0223, C0207, D0355, E0517, C0219R,C0221, B0021, B0022, D0353, E0503, E0446, C0193, E0471, E0566, D0299, E0513, D0281, D0356, C0101, C0203, C0205, B0027, E0426, E0440, C0176, C0182, E0504, C0220, E0495, D0272, E0490, E0534, C0208, C0218, C0191, E0473, D0296, C0168, E0470, C0199, D0330, C0206, D0313, C0192, E0509, D0369, E0492, E0493, D0304, D0310, D0311, E0563, D0331, C0204, E0589, D0327, D0275, E0514, E0443, E0444, D0243, C0216, C0217, E0546, E0548, C0209, E0450, D0291, D0276, D0273, D0332, E0508, B0033, E0449, E0516, D0357
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions Diagnostics, Flanders, NJ, by fax on January 15, 2007. Firm initiated recall is ongoing.
REASON
Under limited circumstances, an incorrect patient result could be printed on the optional chartable patient report.
VOLUME OF PRODUCT IN COMMERCE
558 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
a) Alcon Custom-Pak®, part #10975-02, containing BD Beaver™ Mini-Blade
(part #BD6400 or part #BD6900); individual blades repackaged into custom
ophthalmic surgical packs and resterilized, Recall # Z-0560-2007;
b) Alcon Custom-Pak®, part #2638-17, containing BD Beaver™ Mini-Blade
(part #BD6400 or part #BD6900); individual blades repackaged into custom
ophthalmic surgical packs and resterilized, Recall # Z-0561-2007;
c) Alcon Custom-Pak®, part #4917-54, containing BD Beaver™ Mini-Blade
(part #BD6400 or part #BD6900); individual blades repackaged into custom
ophthalmic surgical packs and resterilized, Recall # Z-0562-2007;
d) Alcon Custom-Pak®, part #6515-51, containing BD Beaver™ Mini-Blade
(part #BD6400 or part #BD6900); individual blades repackaged into custom
ophthalmic surgical packs and resterilized, Recall # Z-0563-2007;
e) Alcon Custom-Pak®, part #11148-02, containing BD Beaver™ Mini-Blade
(part #BD6400 or part #BD6900); individual blades repackaged into custom
ophthalmic surgical packs and resterilized, Recall # Z-0564-2007
CODE
a) Lot #649244H;
b) Lot #627618H and 636380H;
c) Lot #629460H, 631237H, 632356H and 642330H;
d) Lot #633317H, 645074H, and 629784H;
e) Lot #632178H, 634400H and 642229H
RECALLING FIRM/MANUFACTURER
Alcon Laboratories, Inc., Houston, TX, by telephone, fax and letter on December 22, 2006 and December 26, 2006. Firm initiated recall is ongoing.
REASON
Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.
VOLUME OF PRODUCT IN COMMERCE
206 custom surgical packs
DISTRIBUTION
Nationwide
______________________________
PRODUCT
Coulter LH700 Series Hematology Analyzers, Part Number 6605632 with 2B Software (2B3, 2B4 and 2B5), Recall # Z-0566-2007
CODE
2B Software (2B3, 2B4 and 2B5)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA., by letter on September 12, 2006.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON
There is a potential for erroneous yet credible results for Body Fluids on the LH700 series hematology analyzers when a cassette label fails to read and the subsequent sample is cycled in Body Fluid mode.
VOLUME OF PRODUCT IN COMMERCE
1,987 units
DISTRIBUTION
Nationwide and Canada
______________________________
PRODUCT
a) Wright Medical Technology, Gladiator™ Bipolar Hip Prosthesis,
REF: GLBP-2241, Size 41mm O.D., use with 22 mm Head,
Recall # Z-0567-2007;
b) Wright Medical Technology, Gladiator™ Bipolar Hip Prosthesis,
REF: GLBP-3650, Size 50mm O.D., use with 36 mm Head,
Recall # Z-0568-2007;
c) Wright Medical Technology, Gladiator™ Bipolar Hip Prosthesis,
REF: GLBP-3651, Size 51mm O.D., use with 36 mm Head,
Recall # Z-0569-2007;
d) Wright Medical Technology, Gladiator™ Bipolar Hip Prosthesis,
REF: GLBP-3652, Size 52mm O.D., use with 36 mm Head,
Recall # Z-0570-2007;
e) Wright Medical Technology, Gladiator™ Bipolar Hip Prosthesis,
REF: GLBP-3653, Size 53mm O.D., use with 36 mm Head,
Recall # Z-0571-2007;
f) Wright Medical Technology, Gladiator™ Bipolar Hip Prosthesis,
REF: GLBP-3654, Size 54mm O.D., use with 36 mm Head,
Recall # Z-0572-2007;
g) Wright Medical Technology, Gladiator™ Bipolar Hip Prosthesis,
REF: GLBP-3655, Size 55mm O.D., use with 36 mm Head,
Recall # Z-0573-2007
CODE
a) Lot Nos.: 106379171, 106380364, 106382079;
b) Lot Nos.: 106381250, 106382088, 116389380 (3 were implanted);
c) Lot Nos.: 106381252, 106382089, 116389381;
d) Lot Nos.: 106381253, 106382090
e) Lot Nos.: 106381255, 106382091;
f) Lot Nos.: 106381256, 106382092;
g) Lot Nos.: 106379830, 106382095, 116389421
RECALLING FIRM/MANUFACTURER
Wright Medical Technology Inc., Arlington, TN, by telephone on January 3, 2007 and letters on January 15, 2007. Firm initiated recall is ongoing.
REASON
Product specification failure which could result in improper locking of the cup onto the femoral head.
VOLUME OF PRODUCT IN COMMERCE
84 units
DISTRIBUTION
Nationwide and Japan

___________________________________
PRODUCT
AB5000 Console Circulatory Support System, Catalog number: 0015-000, Recall # Z-0574-2007
CODE
Serial Numbers: 5261-5317
RECALLING FIRM/MANUFACTURER
Abiomed, Inc., Danvers, MA, by letter dated January 8, 2007. Firm initiated recall is ongoing.
REASON
Unit may alarm “Low Pressure” due to manufacturing material in the pressure source.
VOLUME OF PRODUCT IN COMMERCE
55 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
StarClose Vascular Closure System (Clip Applier & Exchange System), Catalog Number: 14677, Recall # Z-0575-2007
CODE
Lot Numbers starting from 43034-6H to 47139-6H
RECALLING FIRM/MANUFACTURER
Abbott Vascular Inc., Redwood City, CA, by letters on January 31, 2007. Firm initiated recall is ongoing.
REASON
Premature release of the vessel locator wings, which stabilize the device prior to clip deployment, will result in no hemostasis.
VOLUME OF PRODUCT IN COMMERCE
97,952 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
EKOS EndoWave Infusion System and EKOS Lysus Infusion Systems - drug delivery catheters. EKOS Corporation Bothell, WA Packaging: *EndoWave(TM) Ultrasound Accelerated Thrombolysis (USAT) EKOS EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core. and ''Lysus Infusion System''. EndoWave Infusion Systems 06, 2.7W, part #4599-001, catalog #500-52106; Systems 12, 2.7W, part #4599-002, catalog 500-52112; Systems 18, 2.7W, part #4599-003, catalog #500-52118; Systems 24, 2.7W, part #4599-004, catalog #500-52124; Systems 30, 2.7W, part #4599-005, catalog #500-52130; Systems 40, 2.7W, part 4599-006, catalog #500-52140; Systems 50, 2.7W, part #4599-007, catalog #500-52150; Systems 06, 3.5W, part #5199-001, catalog #500-54106; Systems 12, 3.5W, part #5199-002, catalog #500-54112; Systems 18, 3.5W, part #5199-003, catalog #500-54118; Systems 24, 3.5W, part #5199-004, catalog #500-54124; Systems 30, 3.5W, part #5199-005, catalog #500-54130, Systems 40, 3.5W, part #5199-006, catalog #500-54140; Systems 50, 3.5W, part #5199-007, catalog #500-54150; Lysus Infusion Systems 06, 2.7W, part #4599-001, catalog 500-52106; Systems 12, 2.7W, part #4599-002, catalog 500-52112; Systems 18, 2.7W, part #4599-003, catalog #50-52118; Systems 24, 2.7W, part #4599-004, catalog #500-52124; Systems 30, 2.7W, part #4599-005, catalog #500-52130; Systems 40, 2.7W, part #4599-006, catalog #500-52140; Systems 50, 2.7W, part #4599-007, catalog #500-52150; Systems 06, 3.5W, part #5199-001, catalog 500-54106; Systems 12, 3.5W, part #5199-002, catalog #500-54112; Systems 18, 3.5W, part #5199-003, 500-54118; Systems 24, 3.5W, part #5199-004, catalog #500-54124; Systems 30, 3.5W, part #5199-005, catalog #500-54130; Systems 40, 3.5W, part #5199-005, catalog #500-54140; Systems 50, 3.5W, part #5199-007, catalog #500-54150, Recall # Z-0577-2007
CODE
All Models with Serial Number greater than and equal to 0610XXXX-XXX
RECALLING FIRM/MANUFACTURER
Ekos Corp, Bothell, WA, by letter on February 9, 2007. Firm initiated recall is ongoing.
REASON
Ekos Corporation received three reports that distal radiopaque marker bands on the EndoWave Drug Delivery Catheter became detached from the catheter during use and remained in the patient.
VOLUME OF PRODUCT IN COMMERCE
446 devices
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
a) AXIOM Artis MP, Angiographic x-ray system, model number 5904466,
Recall # Z-0578-2007;
b) AXIOM Artis MP, Angiographic x-ray system, model number 7555365,
Recall # Z-0579-2007
CODE
a) Serial numbers: 20281, 20294, 20264, 20295, 20265, 20303, and 20282;
b) Serial numbers 57012, 57045, 57016, 57024 and 57041
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by visit beginning February 1, 2007.
Manufacturer: Siemens Medical Solutions, Forchheim, Germany. Firm initiated recall is ongoing.
REASON
C-arm gantry could rapidly descend without command during use.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
Nationwide
______________________________
PRODUCT
ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01. It is a single-use, disposable device that is used to perform percutaneous maceration and removal of thrombus and restoration of blood flow, Recall # Z-0597-2007
CODE
Lot number 54877 exp December 2007, Lot number 55318 exp January 2008, Lot number 55218 exp January 2008, and Lot number 54821 exp December 2007
RECALLING FIRM/MANUFACTURER
Kensey Nash Corp, Exton, PA, by email on February 7, 2007 and fax on February 9, 2007. Firm initiated recall is ongoing.
REASON
Face seal may wear excessively and cause particulate matter.
VOLUME OF PRODUCT IN COMMERCE
165 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
Architect i System Assay CD-ROM, U.S. Version 21.0, for use on the Architect i System, list number 06E58-21, in vitro diagnostic, Recall # Z-0413-2007
CODE
Lot: 45572P100
RECALLING FIRM/MANUFACTURER
Abbott Laboratories MPG, Abbott Park, IL, by letters dated December 29, 2006. Firm initiated recall is ongoing.
REASON
The Architect Ausab and Architect Anti-HCV assay parameter default interpretation screens when using Architect Assay CD-ROM US Version 06E58-21 does not align with the result interpretation options in the Architect Ausab Reagent Package Insert (PI) 34-4162/R1 and ARCHITECT Anti-HCV PI 34-4152/R1.
VOLUME OF PRODUCT IN COMMERCE
51 CD-ROMs
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
AccuGuide Injection Needles (Surface electrodes) The AccuGuide EMG Injection Needle, product 8263210, contains 5 individually packaged and sterilized injection needles and 10 nonsterile surface electrodes that are packaged 2 per non-breathable pouch, but are not sterilized, Recall # Z-0576-2007
CODE
Lot Numbers: 45648300, 46526000, 46709500, 48166300
RECALLING FIRM/MANUFACTURER
Medtronic Xomed, Inc., Jacksonville, FL, by telephone on January 22, 2007, and then a follow-up fax letter on February 2, 2007. Firm initiated recall is ongoing.
REASON
A labeling discrepancy was internally identified for the surface electrode component of REF 8263210 AccuGuide EMG Injection Needle, 30G X 25MM. The outside box label correctly indicates 'Content: 5 sterile Injection Needles and 10 non-sterile Surface electrodes'; however, the pouches for the 10 surface electrodes inside the box are incorrectly labeled as “sterile”.
VOLUME OF PRODUCT IN COMMERCE
48 boxes
DISTRIBUTION
Nationwide
______________________________
PRODUCT
Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack 2T10R1 consists of two PVC lines; one of them is 132 inch in length and is capped. The second line is 102 inch in length and has a one way vacuum relief valve assembled in one end. Tubing is used in the vent roller heads of the heart lung machine. This tubing is connected to the cannula in the patient in order to divert blood to the circuit when the patient is on bypass, Recall # Z-0583-2007
CODE
Lot 5666215
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Perfusion Systems, Brooklyn Park, MN, by letter on December 29, 2006.
Manufacturer: Medtronic Mexico, S. De R. L. De C.V. Tijuana, Baja California, Mexico. Firm initiated recall is ongoing.
REASON
One lot of Custom Perfusion Sets, Catalog 2T10R1 was incorrectly assembled. The one way vacuum relief valve on the 102 inch line is attached backwards, thus preventing flow.
VOLUME OF PRODUCT IN COMMERCE
17 packs
DISTRIBUTION
IL

___________________________________
PRODUCT
JariTrak™ Table Clamp, 1 inch diameter, vertical post, Catalog Number 206-160. The JariTrak™ Table Clamp with vertical post (206-160) is part of the Table Mounted Hardware that is used with the JariTrak™ Retractor System. The JariTrak™ self-retaining retractor system consists of the Table Clamp with Vertical Post, Flexible or Horizontal Bar with Universal Joint, Oval or Segment Rings, Tilting Blade Clamps and various blades. The product is supplied non-sterile and may be packaged individually or as part of the JariTrak™ retractor set, Recall # Z-0596-2007
CODE
Manufacturer lot numbers 55L and 125L
RECALLING FIRM/MANUFACTURER
Recalling Firm: J. Jamner Surgical Instruments, Inc. Hawthorne, NY, by letter dated November 14, 2006.
Manufacturer: Koros USA Inc., Moorpark, CA. Firm initiated recall is ongoing.
REASON
The JariTrak™ Table Clamp may not securely fasten to the bed rail of the OR table during set up of the retractor system. In the event that the clamp is not securely fastened to the bed rail, the system may move during surgery. The firm received several complaints from hospitals.
VOLUME OF PRODUCT IN COMMERCE
41 units
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR MARCH 14, 2007

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