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U.S. Department of Health and Human Services

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Enforcement Report for September 20, 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.

September 20, 2006
06-38

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

______________________________
PRODUCT
Roasted barley and peanuts snack food sold in 3 oz, 1/2 lb, 5 lb, and 10 lb sizes, packaged in clear plastic bags with or without labels. Labeled product is identified as Elsa Kolo Roasted Barley. The product is also sold in 88 pound bulk white bags, Recall # F-315-6.
CODE
None
RECALLING FIRM/MANUFACTURER
Maru Bakery/Wholesale, Dallas TX, by press release on August 10, 2006 and by letter on August 11, 2006. Firm initiated recall is ongoing.
REASON
Snack food may contain undeclared peanuts.
VOLUME OF PRODUCT IN COMMERCE
384 pounds plus an unknown amount distributed to the wholesale firm's own retail outlet.
DISTRIBUTION
TX, GA, and OH

______________________________
PRODUCT
a) H-E-B Baby Peas (Chicharo) Phase 1; Net Wt. 2.5 oz. (71g);
UPC #41220 90575 (US distribution) and #41220 90862
(Mexico distribution), Recall # F-317-6;
b) H-E-B Baby Carrots (Zanahoria) Phase 1; Net Wt. 2.5 oz. (71g);
UPC #41220 90570 (US distribution) and #41220 90866
(Mexico distribution), Recall # F-318-6;
c) H-E-B Baby Peaches (Durazno) Phase 2; Net Wt. 4.0 oz. (113g);
UPC #41220 67381 (US distribution) and #41220 67742
(Mexico distribution), Recall # F-319-6
CODE
a) C0256X6614;
b) C0256X58;
c) C3283X62
RECALLING FIRM/MANUFACTURER
Recalling Firm: HE Butt Corporate Headquarters, San Antonio, TX, by e-mail on March 15, 2006, press release and telephone on March 16, 2006.
Manufacturer: Initiative Foods, Sanger, CA. Firm initiated recall is ongoing.
REASON
Glass pieces found in baby food jars.
VOLUME OF PRODUCT IN COMMERCE
a) 1,560 cases (US); 24 jars/case;
b) 1,820 cases (US); 24 jars/case;
c) 195 cases (US) and 585 cases (Mexico); 24 jars/case
DISTRIBUTION
TX and Mexico

______________________________
PRODUCT
Ethos WATER, NATURAL SPRING WATER. Bottled Exclusively For: Ethos Water. Water is packaged in clear plastic bottles in 440 mL (14.9 FL OZ), 700 mL (1.48PT), 1250 mL (2.64 PT) sizes. 440 mL size bottles are packaged with 24 bottles per carton with shrink wrap. 700 mL size bottles are packaged 24 bottles per carton with shrink wrap. 1250 mL size bottles are packaged with 12 bottles per carton with shrink wrap, Recall # F-320-6
CODE
CBC 05 020 xxxx EXP JAN 20 07, CBC 05 035 xxxx EXP FEB 04 07, CBC 05 108 xxxx EXP APR 18 07, CBC 05 115 xxxx EXP APR 25 07, CBC 05 123 xxxx EXP MAY 03 07, CBC 05 127 xxxx EXP MAY 07 07, CBC 05 128 xxxx EXP MAY 08 07, CBC 05 129 xxxx EXP MAY 09 07, CBC 05 133 xxxx EXP MAY 13 07, CBC 05 142 xxxx EXP MAY 22 07, CBC 05 143 xxxx EXP MAY 23 07, CBC 05 150 xxxx EXP MAY 30 07, CBC 05 170 xxxx EXP JUN 19 07, CBC 05 171 xxxx EXP JUN 20 07, CBC 05 187 xxxx EXP JUL 06 07, CBC 05 188 xxxx EXP JUL 07 07, CBC 05 189 xxxx EXP JUL 08 07, CBC 05 190 xxxx EXP JUL 09 07, CBC 05 191 xxxx EXP JUL 10 07, CBC 05 192 xxxx EXP JUL 11 07, CBC 05 203 xxxx EXP JUL 22 07, CBC 05 204 xxxx EXP JUL 23 07, CBC 05 205 xxxx EXP JUL 24 07, CBC 05 225 xxxx EXP AUG 13 07, CBC 05 226 xxxx EXP AUG 14 07, CBC 05 227 xxxx EXP AUG 15 07, CBC 05 267 xxxx EXP SEP 24 07, CBC 05 268 xxxx EXP SEP 25 07, CBC 05 267 xxxx EXP SEP 26 07, CBC 05 273 xxxx EXP SEP 30 07, CBC 05 275 xxxx EXP OCT 02 07, CBC 05 278 xxxx EXP OCT 05 07, CBC 05 279 xxxx EXP OCT 06 07, CBC 05 282 xxxx EXP OCT 09 07, CBC 05 283 xxxx EXP OCT 10 07, CBC 05 284 xxxx EXP OCT 11 07, CBC 05 293 xxxx EXP OCT 20 07, CBC 05 294 xxxx EXP OCT 21 07, CBC 05 296 xxxx EXP OCT 23 07, CBC 05 304 xxxx EXP OCT 31 07, CBC 05 305 xxxx EXP NOV 01 07, CBC 05 312 xxxx EXP NOV 08 07, CBC 05 313 xxxx EXP NOV 09 07, CBC 05 322 xxxx EXP NOV 18 07, CBC 05 323 xxxx EXP NOV 19 07, CBC 05 324 xxxx EXP NOV 20 07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Starbucks Coffee Co., SeattleWA, by email, telephone and/or visits on December 8, 2005.
Manufacturer: Chameleon Beverage Co Inc., Los Angeles,CA. Firm initiated recall is complete.
REASON
Laboratory analysis indicate bromate levels in excess of Federal limit of 10 ppb.
VOLUME OF PRODUCT IN COMMERCE
176634 cases (4154580 bottles)
DISTRIBUTION
OR, WA, CO, AZ, CA, NV, TX, ID, NM, UT, AK, OK, MT, and WY
 

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

______________________________
PRODUCT
a) Dr. Praegar's California Veggie Burgers (11 oz and 60 oz). Made with Oat Bran,
0g trans fat, saturated fat & cholesterol GMO free. Ingredients: carrots, onions, string
beans, soy beans, zucchini, peas, textured soy flour, spinach broccoli, oat bran,
expeller pressed canola oil, corn, red pepper, arrowroot, corn starch, garlic, corn
meal, salt, parsley, black pepper, Recall # F-313-6;
b) Dr. Praeger's Tex Mex veggie burgers (11oz). Ingredients: carrots, black beans,
onion, string beans, corn, oat bran, zucchini, soy beans, edamame, red pepper,
peas, soy flake, spinach, broccoli, cilantro, expeller pressed canola oil, arrowroot,
corn starch, garlic, jalapeno peppers, salt, chili powder, corn meal, parsley, black
pepper, Recall # F-314-6
CODE
a) Codes: H06AB; H06AC; H06AJ; H06BD; H06CH; N06BB; N06BI; N06BJ; N06DA;
N06DB; T06AH; T06AI; T06AJ; T06BA; T06BG; T06CA; T06CD; T06CE; T06CH;
T06CI; W05CC; W05CH;
b) Codes: H06AJ; H06BA; H06BD; L05CC; N06DB; R05BC; R05CB; T06CI
RECALLING FIRM/MANUFACTURER
Ungar"s Food Products, Inc., Elmwood Park, NJ, by telephone and e-mail on May 10, 2006 and by letter on May 11, 2006. Firm initiated recall is ongoing.
REASON
Veggie Burgers contain mislabeled fat content on the nutritional label.
VOLUME OF PRODUCT IN COMMERCE
22,744 packages
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Wel-Pac brand Frozen Broad Band Beans in 16 oz. package, plastic carton, Product of China, UPC 11152-01442, Recall # F-316-6
CODE
All products received between June 1 and June 13, 2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: JFC International, Inc., South San Francisco, CA, by letter on June 13, 2006.
Manufacturer: Asia Foods (Nanjing) Co. Ltd., Zhangzhou Fujian, China. Firm initiated recall is ongoing.
REASON
Broad beans are labeled with incorrect sodium content.
VOLUME OF PRODUCT IN COMMERCE
864 cases
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

_____________________________
PRODUCT
Amantadine Hydrochloride Capsules, USP, 100 mg; an Rx oral antiviral and antiparkinson agent; single soft gelatin capsule unit dose blister packs, 10 sheets of 10 unit dose capsules per carton; NDC # 51079-481-20, Recall # D-364-6
CODE
Lot: 6B943, Expiration Date 08/07
RECALLING FIRM/MANUFACTURER
UDL Laboratories, Inc., Rockford, IL, by letters dated August 14, 2006. Firm initiated recall is ongoing.
REASON
Failed USP Content Uniformity Requirements.
VOLUME OF PRODUCT IN COMMERCE
3,587 unit cartons
DISTRIBUTION
Nationwide including PR
 

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

______________________________
PRODUCT
a) Uritact-EC Tablets, each enteric coated tablet contains Methenamine 81.6 mg,
Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Benzoic Acid 9.0 mg,
Atropine Sulfate 0.06 mg, Hyoscyamine Sulfate 0.06 mg; 90 tablets,
Rx Only, NDC 60258-517-09, Recall # D-359-6;
b) Prosed/DS Tablets, each tablet contains Methenamine 81.6 mg,
Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Benzoic Acid
9.0 mg, Atropine Sulfate 0.06 mg, Hyoscyamine Sulfate 0.06 mg;
Rx Only. 100 tablet bottles, NDC 0076-0108-03; 4 tablet Physician
Samples, NDC 0076-0108-02, Recall # D-360-6;
c) Prosed EC tablets, each enteric coated tablet contains Methenamine
81.6 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg,
Benzoic Acid 9.0 mg, Atropine Sulfate 0.06 mg, Hyoscyamine Sulfate
0.06 mg; Rx Only, 90 tablet bottles, NDC 15456-0909-90, Recall # D-361-6;
d) Prosed EC tablets, each enteric coated tablet contains Methenamine
81.6 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg,
Benzoic Acid 9.0 mg, Atropine Sulfate 0.06 mg, Hyoscyamine
Sulfate 0.06 mg; Rx Only, pouch containing 2 tablets, NDC 0076-0909-02,
Recall # D-362-6
CODE
a) Lot 053104 (exp. 7/08);
b) Lots: 043151, 043617, 044513;
c) Lots: 042253, 043616, 044512, 053615;
d) Lots: 042253, 043616, 044512, 053615
RECALLING FIRM/MANUFACTURER
Contract Pharmacal Corporation, HauppaugeNY, by letters dated July 18, 2006. Firm initiated recall is ongoing.
REASON
No testing was performed for hyoscyamine sulfate and atropine sulfate ingredients in these products to determine satisfactory conformance to specifications and to verify stability of these products over labeled shelf life.
VOLUME OF PRODUCT IN COMMERCE
Uritact-EC: 5,874 bottles; Prosed/DS: 9,598 bottles; Prosed-EC: 27,709 bottles & 20,016 displays (12 x 2 tabs)
DISTRIBUTION
Nationwide

______________________________
PRODUCT
PREMARIN® (conjugated estrogens tablets, USP) 0.9 mg, bottles of 100 tablets, Rx only, NDC 0046-0864-81 (old NDC # - old formulation), Recall # D-363-6
CODE
Lot: B17989, Exp. Date 6/2007
RECALLING FIRM/MANUFACTURER
Wyeth Pharmaceuticals, Inc., Rouses Point, NY, by letters dated August 28, 2006. Firm initiated recall is ongoing.
REASON
Dissolution Failure: Failed USP dissolution test requirement.
VOLUME OF PRODUCT IN COMMERCE
97,301 units
DISTRIBUTION
Nationwide
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1745-6;
b) Fresh Frozen Plasma, Recall # B-1746-6;
c) Recovered Plasma, Recall # B-1747-6
CODE
a) Units: 9093003, 9092974, 9092979, 9092981, 9092983, 9092984,
9092987, 9094581, 9094588, 9094590, 9094597, 9094605, 9094607,
9094613, 9094614, 9094615, 9094619, 9094621, 9094623, 9094627,
9094633, 9093813, 9093830, 9093835, 9093841;
b) Units: 9092984, 9092987, 9094595, 9094605, 9094607, 9094622;
c) Units: 9092974, 9092979, and 9092983
RECALLING FIRM/MANUFACTURER
W.E. & Lela I Stewart Blood Center, Inc., Tyler, TX, by telephone and letters beginning January 12, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from donors with incomplete donor screening performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
34 units
DISTRIBUTION
TX and Switzerland

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1752-6
CODE
Unit: 4700430
RECALLING FIRM/MANUFACTURER
W.E. & Lela I Stewart Blood Center, Inc., Tyler, TX, by letter dated April 5, 2005. Firm initiated recall is complete.
REASON
Blood product, which tested negative for hepatitis, but was collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
Platelet Pheresis Leukocytes Reduced Irradiated, Recall # B-1757-6
CODE
Unit: 4720370
RECALLING FIRM/MANUFACTURER
W.E. & Lela I Stewart Blood Center, Inc., Tyler, TX, by telephone on November 13, 2003 and follow-up letter dated January 8, 2004. Firm initiated recall is complete.
REASON
Blood product, labeled as leukoreduced, but which did not meet the requirements for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
Source Plasma, Recall # B-1764-6
CODE
Units: 420000167, 420000350
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomat USA, Inc, City of Industry, CA, by facsimile on February 17, 2005.
Manufacturer: Biomat USA, Inc., Yakima, WA. Firm initiated recall is complete.
REASON
Blood products, which were untested for viral markers, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Spain

______________________________
PRODUCT
Red Blood Cells, Recall # B-1766-6
CODE
Unit: 0976636
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ, by letter dated April 19, 2005. Firm initiated recall is complete.
REASON
Blood product, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but was collected from a donor who was subsequently determined to have previously tested positive for HIV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced, Recall # B-1767-6;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-1768-6
CODE
a) Units: 0949368, 0952100;
b) Units: 0949034, 0949484
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ, by letter dated September 30, 2004. Firm initiated recall is complete.
REASON
Blood products, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NJ

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1769-6;
b) Fresh Frozen Plasma, Recall # B-1770-6
CODE
a) and b) Unit: 4713104
RECALLING FIRM/MANUFACTURER
W.E. & Lela I Stewart Blood Center, Inc., Tyler, TX, by telephone on October 10, 2003 and follow-up letter on October 23, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

______________________________
PRODUCT
Source Plasma, Recall # B-1773-6
CODE
Units: CD0160327, CD0161211, CD0161447, CD0161751, CD0162484, CD0163053, CD0163865, CD0164076, CD0164361, CD0164443, CD0164798, CD0165275, CD0165374, CD0165639, CD0165699, CD0165983, CD0166085, CD0166372, CD0166468, CD0166890, CD0167097, CD0167265, CD0167473, CD0167674, CD0167892, CD0168025, CD0168253, CD0168410, CD0168607, CD0168730, CD0168975, CD0169167, CD0169349, CD0169583, CD0169749, CD0177650, CD0177821, CD0177930, CD0178112, CD0178359, CD0178740, CD0178933, CD0179230, CD0179423, CD0179908, CD0180118, CD0180673, CD0180922, CD0181142, CD0181440
RECALLING FIRM/MANUFACTURER
DCI Biologicals Carbondale LLC, Carbondale, IL, by fax on March 30, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
50 units
DISTRIBUTION
NC

______________________________
PRODUCT
Source Plasma, Recall # B-1776-6
CODE
Units: CD0178850, CD0179055, CD0179321, CD0179543, CD0179810, CD0180025, CD0180283, CD0180610, CD0180814, CD0181137, CD0181337, CD0181719, CD0182060
RECALLING FIRM/MANUFACTURER
DCI Biologicals Carbondale LLC, Carbondale, IL, by fax on May 4, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had a tattoo applied within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
NC

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1779-6
CODE
Units: 6591640, 6595397, 6597893
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on February 5, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO and TN

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1780-6;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-1781-6
CODE
a) Unit: 9074056;
b) Unit: 9702683
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on March 31, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA and CO

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1782-6
CODE
Units: 6848672, 9016232, 9049882
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on August 4, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1783-6;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-1784-6
CODE
a) Units: 9014127, 6848674;
b) Unit: 9016231
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on August 4, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1786-6
CODE
Unit: 4997334
RECALLING FIRM/MANUFACTURER
Coral Blood Services, Scarborough, ME, by letter dated March 29, 2006 and follow-up letter faxed on July 21, 2006. Firm initiated recall is complete.
REASON
Blood product, leukoreduced after the allowable time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
ME

______________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1787-6
CODE
Unit: 027GH30254
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone on April 12, 2006 and follow-up letter dated April 13, 2006. Firm initiated recall is complete.
REASON
Blood product, collected in a collection system that was possibly contaminated, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

______________________________
PRODUCT
Platelets Apheresis Leukocytes Reduced, Recall # B-1788-6
CODE
Units: 0941964, 0943532, 0950634
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ, by letter dated October 10, 2004. Firm initiated recall is complete.
REASON
Platelets, with a low pH, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NJ

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1795-6
CODE
Unit: 003LX34324
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone and letter dated December 19, 2005. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood that was collected in the incorrect size collection bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

______________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-1796-6
CODE
Unit: 1961537
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on April 24, 2006 and by letter dated June 27, 2006. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that was hemolyzed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1798-6;
b) Recovered Plasma, Recall # B-1799-6
CODE
a) and b) Units: 6841806, 4695368
RECALLING FIRM/MANUFACTURER
W. E. and Lela I Stewart Blood Center, Inc., Tyler, TX, by facsimile on May 2, 2003 and May 5, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of a liver infection and jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX and Switzerland

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1801-6
CODE
Unit: 04KC35390
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA, by letter dated June 13, 2006. Firm initiated recall is complete.
REASON
Blood product, which was inappropriately distributed in a single storage bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VT

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1802-6;
b) Source Leukocytes, Recall # B-1803-6
CODE
a) and b) Unit: 5729726
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on January 17, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ and TX

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1812-6
CODE
Unit: 5562587
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by fax on May 19, 2005. Firm initiated recall is complete.
REASON
Blood product, collected in a collection system that was possibly contaminated, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1818-6;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-1819-6;
c) Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1820-6;
d) Cryoprecipitate, AHF, Recall # B- 1821-6;
e) Fresh Frozen Plasma, Recall # B-1822-6
CODE
a) Units: 18GQ14005, 18GQ14017, 18GQ14029 and 18GQ14031;
b) Units: 18GG77457, 18GK46232, 18GK46270, 18GK46271, 18FS96302,
18GK45767, 18GF54712, 18GF56644, 18GG74359, 18GK46197,
18GQ11885, 18GQ12119, 18GQ13048, 18GQ14075, 18GQ14072,
18GQ14048, 18GQ14040, 18GK46220, 18GK46203, 18GG77317,
18FS96301, 18GG74458, 18GG77356, 18GG77353, 18GK42381,
18GQ14090, 18GF56636, 18GF56635, 18GK45670, 18GK45673,
18GK45690, 18GK45688, 18GK45694, 18GK45692, 18GF56598,
18GF56615, 18GK45862, 18GK46479, 18GQ14758, 18GQ14755,
18GK46534, 18GF54181, 18FS96317, 18FS96318, 18GG77334,
18GG77336, 18GG77338, 18GK45625, 18GQ14141, 18GG77596,
18GK46359, 18GK46246, 18GQ14052, 18GK45992, 18GK45995,
18GK46003, 18GQ13995, 18GK45836, 18GK45638, 18GF54338,
18GF55275, 18GK46467, 18GK46463, 18GF56979, 18GK46382,
18GK46023, 18GK45746, 18GQ09052, 18GG73473, 18GK44032,
18GG76291, 18GK46362, 18FS96304, 18GK46462, 18GK45848,
18GK45845, 18GG77601, 18GG77428, 18GG77332, 18GQ12883,
18GK43841, 18GF56626, 18GG77619, 18GK46202, 18GK46378,
18GG77461, 18GG77458, 18GF56634, 18GK46594, 18GF56608,
18GQ13876, 18GQ14772, 18GQ14145, 18GK46269, 18GK46256,
18GK46251, 18GQ14123, 18GQ14663, 18GK46009, 18GK46005,
18GG77320, 18GG77346, 18GK45997, 18GQ14744, 18GK46591,
18GF56597, 18GQ13870, 18GK46383, 18GK46386, 18GQ14096,
18GG74660, 18GQ10959, 18GF55706, 18GK46200, 18GQ14748,
18GK45839, 18GQ10832, 18GQ14067, 18GK46215, 18GF56960,
18GQ14099, 18GK46399, 18GF56958, 18GK46364, 18GG73927,
18GQ14640, 18GQ14633, 18GF56624, 18GK45743, 18GK45776,
18GQ14742, 18GK46519, 18GK45859, 18GQ14150, 18FS96327,
18GK45852, 18GK45855, 18GQ14731, 18GK46025, 18GG77590,
18GG77618, 18GQ14102, 18GK46244, 18GK46243, 18GK46180,
18GQ14095, 18GF56625, 18GF56614, 18GK45769, 18GK45609,
18GQ13828, 18GK42685, 18GF54597, 18GG73788, 18GQ14667,
18GQ14033, 18GG74511, 18GK46402, 18GK46406, 18GK46407,
18GQ14139, 18GG77593, 18GF56962, 18GK46614, 18GK46608,
18GK46611, 18GK46184, 18GF56974, 18GF56977, 18GG77581,
18FS96316, 18GQ14092, 18GQ13847, 18GQ13852, 18GQ13833,
18GK45621, 18GQ13879, 18GF55131, 18GK45672, 18GK45636,
18GQ14014, 18GQ14711, 18GG77359, 18GK45759, 18GK45761,
18GK45779, 18GK46574, 18GR05927, 18GF56955, 18GQ14760,
18GK46661, 18GK46658, 18GK45623, 18GK45635, 18GQ10944,
18GK46275, 18GK45657, 18GK45835, 18GK45612, 18GQ14645,
18GK46678, 18GK45643, 18FS96325, 18GF55724, 18GG75614,
18GK45748, 18GQ11654, 18GQ11862, 18GQ09937, 18GG77455,
18GG77318, 18GG77445, 18GG77424, 18GK46011, 18GK46226,
18GQ14117, 18GQ14060, 18GK46012, 18GQ13845, 18GK45860,
18GK45774, 18GK45770, 18GF56621, 18GG77600, 18GK45849,
18GQ14726, 18GG77603, 18GG77615, 18GG77598, 18GG77443,
18GG77426, 18GK45656 and 18GQ14660;
c) Units: 18GK44672, 18GK45653, 18GF56976, 18GF56971,
18GK46179, 18GG77622, and 18GK45650;
d) Units: 18FS96302 and 18FS96317;
e) Units: 18GK46533, 18GK46246, 18GG77603, 18GK46464,
18GG77615, 18GQ14760, 18GK46462, 18GG77424, 18GK46243,
18GQ14660, 18GQ14645, 18GG77323, 18GG77320, 18GG77428,
18GQ14758, 18GQ14755, 18GQ14731, 18GQ14640, 18GG77619,
18GR05927, 18GF55275, 18GQ14637, 18GG77443, 18GG77601,
18GQ14633, 18GK46467, 18GF56962, 18GK46463, 18GQ14763,
18GG77426, 18GQ14125, 18GG74660, and 18GG77618
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by telephone, letter, facsimile and/or electronic mail beginning January 23, 2006 thru January 25, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
259 units
DISTRIBUTION
OH, ME, MI, MA, CA, and Switzerland

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B- 1825-6;
b) Red Blood Cells, Leukocytes Reduced, Washed Unit,
Recall # B-1826-6;
c) Red Blood Cells, Leukocytes Reduced, Irradiated Units,
Recall # B-1827-6;
d) Cryoprecipitate, AHF, Recall # B-1828-6;
e) Fresh Frozen Plasma, Recall # B-1829-6
CODE
a) Units: 18GF53515, 18GF53517, 18GF53525, 18GF53527,
18GF53533, 18GF53554, 18GF53555, 18GF53557, 18GF53558, 18GF53560, 18GF53573, 18GF53576, 18GF53578, 18GF53580, 18GF53581, 18GF53582, 18GF53593, 18GF53606, 18GF53608, 18GF53620, 18GF53621, 18GF53622, 18GF53632, 18GF53633, 18GF53634, 18GF53635, 18GF53640, 18GF53645, 18GF53650, 18GF53652, 18GF53685, 18GF53686, 18GF53693, 18GF53695, 18GF53703, 18GF53705, 18GF53800, 18GF53801, 18GF53806, 18GF53810, 18GF53812, 18GF53816, 18GF53817, 18GF53820, 18GF53821, 18GF53822, 18GF53825, 18GF53830, 18GF53832, 18GF53833, 18GF53905, 18GF53906, 18GF53907, 18GF53916, 18GF53917, 18GF53920, 18GF53925, 18GF53927, 18GF53928, 18GF54342, 18GF54344, 18GF54346, 18GF54347, 18GF54357, 18GF54361, 18GF54362, 18GF54368, 18GF54369, 18GF54370, 18GF54371, 18GF54373, 18GF54376, 18GF54377, 18GF54379, 18GF54380, 18GF54381, 18GF54386, 18GF54387, 18GF54420, 18GF54422, 18GF54426, 18GF54428, 18GF54441, 18GF54443, 18GF54509, 18GF54521, 18GF54522, 18GF54525, 18GF54965, 18GF54966, 18GF54970, 18GF54973, 18GG73386, 18GG73387, 18GG73396, 18GG73431, 18GG73432, 18GG73438, 18GG73443, 18GG73446, 18GG73514, 18GG73515, 18GG73518, 18GG73526, 18GG73601, 18GG73629, 18GG73648, 18GG73655, 18GG73775, 18GG73780, 18GG73781, 18GG73797, 18GG73798, 18GG73804, 18GG73876, 18GG73879, 18GG73885, 18GG73886, 18GG73887, 18GG73890, 18GG73899, 18GG73902, 18GG73909, 18GG73911, 18GG73912, 18GG73926, 18GG73928, 18GG73949, 18GG73953, 18GG73957, 18GG73959, 18GG74022, 18GG74031, 18GG74035, 18GG74043, 18GG74048, 18GG74049, 18GG74072, 18GG74073, 18GG74075, 18GG74083, 18GG74089, 18GG74090, 18GG74091, 18GG74092, 18GG74096, 18GG74097, 18GG74098, 18GG74100, 18GG74190, 18GG74192, 18GG74193, 18GG74199, 18GG74201, 18GG74204, 18GG74244, 18GG74246, 18GG74256, 18GG74257, 18GG74262, 18GG74264, 18GG74266, 18GG74497, 18GG74499, 18GG74502, 18GG74505, 18GG74516, 18GG74518, 18GG74521, 18GG74524, 18GG74525, 18GG74807, 18GG74823, 18GG74830, 18GG74831, 18GG74834, 18GG74844, 18GG74858, 18GG74875, 18GG74877, 18GG74880, 18GG74893, 18GG75018, 18GG75033, 18GK41582, 18GK41584, 18GK41587, 18GK41588, 18GK41594, 18GK41599, 18GK41604, 18GK41606, 18GK41784, 18GK41787, 18GK41788, 18GK41799, 18GK41800, 18GK41801, 18GK41803, 18GK41808, 18GK41852, 18GK41855, 18GK41865, 18GK41868, 18GK41870, 18GK41872, 18GK41883, 18GK41886, 18GK41890, 18GK42067, 18GK42068, 18GK42081, 18GK42083, 18GK42095, 18GK42098, 18GK42099, 18GK42100, 18GK42108, 18GK42109, 18GK42112, 18GK42130, 18GK42132, 18GK42133, 18GK42136, 18GK42143, 18GK42145, 18GK42279, 18GK42282, 18GK42287, 18GK42303, 18GK42518, 18GK42521, 18GK42522, 18GK42535, 18GK42565, 18GK42587, 18GK42589, 18GK42591, 18GK42598, 18GK42603, 18GK42605, 18GK42607, 18GK42615, 18GK42617, 18GK42620, 18GK42622, 18GK42627, 18GK42630, 18GK42631, 18GK42645, 18GK42649, 18GK42661, 18GK42662, 18GK42667, 18GK42678, 18GK42680, 18GK42684, 18GK42727, 18GK42728, 18GK42732, 18GK42739, 18GK42740, 18GK42748, 18GK42835, 18GK42836, 18GK42838, 18GK42841, 18GK42848, 18GK42852, 18GK42853, 18GK42855, 18GK42856, 18GK42857, 18GK42858, 18GK42859, 18GK42871, 18GK42875, 18GK42877, 18GK42879, 18GK42881, 18GK42888, 18GK42890, 18GK42894, 18GK42895, 18GK42907, 18GK42912, 18GK42923, 18GK42924, 18GK42928, 18GK42929, 18GK42934, 18GK42946, 18GK42947, 18GK42949, 18GK42952, 18GK43089, 18GK43091, 18GK43093, 18GK43108, 18GK43109, 18GK43115, 18GK43130, 18GK43144, 18GQ09107, 18GQ09110, 18GQ09127, 18GQ09128, 18GQ09133, 18GQ09134, 18GQ09151, 18GQ09152, 18GQ09174, 18GQ09533, 18GQ09536, 18GQ09542, 18GQ09547, 18GQ09570, 18GQ09572, 18GQ09591, 18GQ09594, 18GQ09599, 18GQ09604, 18GQ09606, 18GQ09700, 18GQ09707, 18GQ09723, 18GQ09737, 18GQ09740, 18GQ09759, 18GQ09760, 18GQ09771, 18GQ09775, 18GQ09811, 18GQ09814, 18GQ09822, 18GQ09823, 18GQ09830, 18GQ09833, 18GQ09854, 18GQ09857, 18GQ09870, 18GQ09873, 18GQ09875, 18GQ09886, 18GQ09889, 18GQ09892, 18GQ09907, 18GQ09912, 18GQ09914, 18GQ09988, 18GQ09989, 18GQ09991, 18GQ09994, 18GQ10004, 18GQ10007, 18GQ10009, 18GQ10019, 18GQ10021, 18GQ10025, 18GQ10039, 18GQ10043, 18GQ10045, 18GQ10051, 18GQ10068, 18GQ10070, 18GQ10081, 18GQ10111, 18GQ10116, 18GQ10131, 18GQ10132, 18GQ10133, 18GQ10135, 18GQ10137, 18GQ10154, 18GQ10156, 18GQ10160, 18GQ10162, 18GQ10185, 18GQ10186, 18GQ10194, 18GQ10199, 18GQ10203, 18GQ10216, 18GQ10220, 18GQ10223, 18GQ10238, 18GQ10242, 18GQ10318, 18GQ10324, 18GQ10325, 18GQ10336, 18GQ10339, 18GQ10343, 18GQ10345, 18GQ10358, 18GQ10361, 18GQ10365, 18GQ10499, 18GQ10511, 18GQ10517, 18GQ10519, 18GQ10523, 18GQ10531, 18GQ10535, 18GQ10536, 18GQ10541, 18GQ10542, 18GQ10849, 18GQ10850, 18GQ10851, 18GQ10859, 18GQ10861, 18GQ10865, 18GQ10866, 18GQ11060, 18GQ11061, 18GQ11064, 18GQ11065, 18GQ11105, 18GQ11128, 18GQ11131, 18GQ11148, 18GQ11151, 18GQ11163, 18GQ11165, 18GQ11172, 18GQ11173, 18GT02154, 18GT02165, 18GT02167, 18GT02168, 18GT02175, 18GT02176, 18GT02611, 18GT02613, 18GT02615, 18GT02633, 18GT02635, 18GT02638, 18GT02645, 18GT02648, 18GT02653, 18GT02656, 18GT02666, 18GT02667, 18GT02674, 18GT02678 and 18GT02695;
b) Unit: 18GG73952;
c) Units: 18GG73625, 18GG73630, 18GG74017, 18GG74018,
18GG74019, 18GG74030, 18GG74033, 18GG74081, 18GK41591,
18GK42533, 18GQ09150, 18GQ09834 and 18GQ09908;
d) Units: 18GK42133, 18GK42145, 18GT02165, 18GT02167 and 18GT02168;
e) Units: 18GF53580, 18GF53581, 18GF53593, 18GF53645, 18GF53650,
18GF54370, 18GF54376, 18GF54377, 18GF54386, 18GF54387,
18GF54522, 18GF54525, 18GG73655, 18GG73876, 18GG73879,
18GG73899, 18GG73902, 18GK41582, 18GK41584, 18GK42645,
18GK42835, 18GK42838, 18GK42848, 18GK42849, 18GK42853,
18GK43109, 18GQ09870, 18GQ09875, 18GQ09889, 18GQ09892,
18GQ10039, 18GQ10043, 18GQ10045, 18GQ10051, 18GQ10216,
18GT02628, 18GT02631, 18GT02642, 18GT02645, 18GT02666,
and 18GT02695.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, 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
508 units
DISTRIBUTION
CA, GA, IN, MD, MI, MA, MN, NH, OH, and PA

______________________________
PRODUCT
Source Plasma, Recall # B-1830-6
CODE
Units: 0141201631, 0141201260 and 0141200307
RECALLING FIRM/MANUFACTURER
ZIB Bioplasma, Inc., Tulsa, OK, by facsimile on May 7, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC

______________________________
PRODUCT
Source Plasma, Recall # B-1831-6
CODE
Units: WN0056842, WN0057139 and WN0057220
RECALLING FIRM/MANUFACTURER
DCI Biologicals Wilmington LLC, Wilmington, NC, by telephone on September 9, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1832-6;
b) Fresh Frozen Plasma, Recall # B-1833-6
CODE
a), and b) Unit: 4280731
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone on April 11, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1840-6
CODE
Unit: 3835695
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone on March 9, 2006. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

______________________________
PRODUCT
Platelet Pheresis Leukocytes Reduced, Recall # B-1755-6
CODE
Unit: 4615816
RECALLING FIRM/MANUFACTURER
Life Source, Glenview, IL, by telephone on May 8, 2006. Firm initiated recall is complete.
REASON
Blood product, labeled as leukoreduced but not tested for white blood cell (WBC) count as required, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

______________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1756-6
CODE
Units: 4729523, 4730768, 4730771 (1), 4730771 (2), 4730775
RECALLING FIRM/MANUFACTURER
W. E. & Lela I. Stewart Blood Center, Tyler, TX, by telephone on March 9, 2004. Firm initiated recall is complete.
REASON
Blood products, tested using samples that exceeded the required time frame for analysis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
TX

______________________________
PRODUCT
Platelet Pheresis Leukocytes Reduced, Recall # B-1758-6
CODE
Unit 2800198
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone on July 12, 2006 and follow-up letter dated July 13, 2006. Firm initiated recall is complete.
REASON
Blood product, labeled "Leukocyte Reduced" without verification of the white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN

______________________________
PRODUCT
Red Blood Cells, Recall # B-1765-6
CODE
Unit: K41599
RECALLING FIRM/MANUFACTURER
Carlisle Regional Medical Center, Carlisle, PA, by facsimile on July 13, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for Leishmaniasis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Irradiated, Recall # B-1772-6
CODE
Unit: 040KC13049
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Heart of American Region, Peoria, IL, by telephone on May 17, 2006. Firm initiated recall is complete.
REASON
Blood product, that was out of controlled storage for an undocumented length of time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1777-6
CODE
Unit: 4709569
RECALLING FIRM/MANUFACTURER
W. E. & Lela I. Stewart Blood Center, Tyler, TX, by telephone on January 23, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had taken the antibiotic Keflex within two days of donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Irradiated, Recall # B-1778-6
CODE
Unit: FH77105
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by telephone on April 20, 2006. Firm initiated recall is complete.
REASON
Blood product, that was out of controlled storage for an undocumented length of time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1785-6
CODE
Unit: 7787284
RECALLING FIRM/MANUFACTURER
Coral Blood Services, Scarborough, ME, by letter dated April 5, 2006. Firm initiated recall is complete.
REASON
Blood product, with an unacceptably low red cell recovery rate, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
ME

______________________________
PRODUCT
a) Platelets Pheresis Leukocytes Reduced, Recall # B-1789-6;
b) Whole Blood CPDA-1, Recall # B-1790-6
CODE
a) Units: 2090368 -1, 2090368 -2, 2090370-1, 2090370-2, 2090372
b) Unit: 9539332
RECALLING FIRM/MANUFACTURER
New York Blood Center Inc., New York, NY, by telephone and letter on October 21, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from donors who were qualified with expired thermometers, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
NY

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1791-6
CODE
Unit: 6694465
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on April 15, 2005. Firm initiated recall is complete.
REASON
Blood product, that was not prepared in accordance with specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
Red Blood Cells Leukoreduced, Recall # B-1792-6
CODE
Unit: 6904483
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on April 5, 2005. Firm initiated recall is complete.
REASON
Blood product, out of controlled storage for more than 30 minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
Platelets Pheresis Leukocyte Reduced, Recall # B-1793-6
CODE
Units: E56152 (parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank, Inc., Rockford, IL, by telephone on May 24, 2006. Firm initiated recall is complete.
REASON
Blood products, possible contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL

______________________________
PRODUCT
Red Blood Cells, Washed, Recall # B-1804-6
CODE
Units: C35887, C38306
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by telephone on May 8, 2006, and by letter dated June 22, 2006. Firm initiated recall is complete.
REASON
Blood products, which failed to meet the minimum specification for red blood cell recovery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1810-6;
b) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1811-6
CODE
a) Units: 6223161, 6221875, 6191227, 6223127, 6220185,
6218862, 6192443, 8930283, 8930276, 6220173, 6220180,
6191219, 6220203, 6191244, 6220188, 6191220;
b) Units: 9541610, 9544393, 9541619
RECALLING FIRM/MANUFACTURER
New York Blood Center Inc., New York, NY, by telephone on March 10, 2004 and follow-up letter dated January 6, 2005. Firm initiated recall is complete.
REASON
Blood products, exposed to unacceptable shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
NY

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, (for further manufacture),
Recall # B-1823-6;
b) Recovered Plasma, Recall # B-1824-6
CODE
a) Unit: 18GG73801;
b) Units: 18GG77457, 18GG77318, 18GG77356, 18GG77353,
18GG77338, 18GG77336, 18GG77334, 18GG77332, 18GQ13847,
18GQ14095, 18GQ14092, 18GQ14090, 18GQ14031, 18GQ14029,
18GQ14014, 18GQ14017, 18GQ14005, 18GQ13998, 18GQ13995,
18GK45860, 18GK45638, 18GK45636, 18GG77455, 18GG77317,
18GG77461, 18GG77346, 18GG77458, 18GG77445, 18GQ13845,
18GQ13833, 18GQ13830, 18GK45643, 18GK45635, 18GK45625,
18GQ14150, 18GQ14145, 18GQ14141, 18GQ14139, 18GK46011,
18GK46009, 18GK46005, 18GQ13850, 18GK46003, 18GK45997,
18GK45995, 18GK45992, 18GG77359, 18GK46028, 18GK46025,
18GK46023, 18GK46012, 18GQ14123, 18GQ14120, 18GQ14117,
18GQ14102, 18GQ14099, 18GQ14096, 18GQ14052, 18GQ14048,
18GQ14040, 18GQ14033, 18GK45612, 18GK45862, 18GK45859,
18GK45855, 18GK45852, 18GK45849, 18GK45848, 18GK45845,
18GK45836, 18GK45835, 18GK45779, 18GK45776, 18GK45774,
18GK45770, 18GK45769, 18GK45767, 18GK45761, 18GK45759,
18GK45748, 18GK45746, 18GK45743, 18GK45623, 18GK45621,
18GK45839, 18GQ14075, 18GQ14072, 18GQ14067, 18GQ14060,
18GK45609, 18GF56615, 18GF56614, 18GF56608, 18GF56598,
18GF56597, 18GG73473, 18GK44672, 18GQ12883, 18GQ13048,
18GQ09052, 18GG73788, 18GG73801, 18GG73927, 18GQ09937,
18GF54181, 18GG74359, 18GK42381, 18GF54338, 18GG74458,
18GG74511, 18GK42685, 18GF54597, 18GQ10832, 18GF54712,
18GQ10959, 18GQ10944, 18GF55131, 18GQ11654, 18GG75614,
18GK43841, 18GQ11862, 18GQ11885, 18GK44032, 18GQ12119,
18GF55706, 18GF55724, 18GK44070,18GG76291, and 18GQ13520
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by telephone, letter, facsimile and/or electronic mail beginning January 23, 2006 thru January 25, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
130 units
DISTRIBUTION
OH, ME, MI, MA, CA, and Switzerland

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1839-6
CODE
Units: 3835123 (split)
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone on May 18, 2006 and follow-up letter on May 22, 2006. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Propionibacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN
 

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

______________________________
PRODUCT
Disetronic D-TRONplus Insulin Pump Battery Pack; Ref/Catalog no. 04697014001, Recall # Z-1413-06
CODE
Lots 06010107, 06030242, 06040085, 06050110 and 06060126
RECALLING FIRM/MANUFACTURER
Recalling Firm: Disetronic Medical System, Fishers, IN, by press release and letter dated July 13, 2006.
Manufacturer: Disetronic Medical Systems AG, Burgdorf, Switzerland. Firm initiated recall is ongoing.
REASON
The battery may turn the pump off without warning due to a design change in the battery.
VOLUME OF PRODUCT IN COMMERCE
6,604 packs
DISTRIBUTION
Nationwide and Canada

______________________________
PRODUCT
a) Medtronic Intrathecal Catheter, Model 8731, (part of infusion systems
using Medtronic implantable pumps) The catheter is designed for
use in the intrathecal space, Recall # Z-1414-06;
b) Medtronic Intrathecal Catheter Distal Revision Kit, Model 8598,
(provides replacement parts for the distal section of the 8731
Intrathecal Catheter), Recall # Z-1415-06
CODE
a) Model 8731 Base Lot Numbers: B011311N, B011421N, B011422N,
B011500N, B011721N, B011737N, B011738N, B011786N,
N0012097, N0012140, N0012141, N0012521, N0012692,
N0012814, N0012815, N0012816, N0013149, N0013150,
N0013352, N0013353, N0013354, N0013355, N0013707,
N0013710, N0013936, N0014007, N0014236, N0014237,
N0014330, N0014331, N0014332, N0014722, N0015050.
*Model 8731 Catheters and model 8598 Distal Revision kits
have a Base Lot number of eight (8) characters plus a two
(2) digit suffix that represents serialization within these
recalled lots. This list provides just the Base lot Number
(the first eight characters of the product Lot No. found on
the product labeling);
b) Model 8598 Base Lot Numbers: B011468N, B011893N,
B011894N, N0012129, N0012612, N0012969, N0012970,
N0012971, N0014057, N0014058, N0014179, N0014180,
N0016472. *Model 8731 Catheters and model 8598 Distal
Revision kits have a Base Lot number of eight (8) characters
plus a two (2) digit suffix that represents serialization within
these recalled lots. This list provides just the Base lot Number
(the first eight characters of the product Lot No. found on the
product labeling)
RECALLING FIRM/MANUFACTURER
Medtronic Neurological, Minneapolis,MN, by letter on July 20, 2006. Firm initiated recall is ongoing.
REASON
Tip dislodgement during implantation-Medtronic is recalling Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit because the platinum-iridium tip may be dislodged by the guide wire during implantation.
VOLUME OF PRODUCT IN COMMERCE
934 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Alaris® SE Pump (formerly Signature Edition® Infusion Pump); Model Numbers: 7000, 7100, 7101, 7130, 7131, 7132, 7200, 7201, 7230, 7231, and 7232, Recall # Z-1484-06.
CODE
All Lots. The serial numbers are not sequential.
RECALLING FIRM/MANUFACTURER
Cardinal Health 303 Inc DBA Alaris Products, San Diego, CA, by letters dated August 15, 2006. Firm initiated recall is ongoing.
REASON
This recall was initiated because of a potential for over infusion with all models of the Alaris® SE Pumps (formerly the Signature Edition® Infusion Pumps) caused by key bounce.
VOLUME OF PRODUCT IN COMMERCE
147,461
DISTRIBUTION
Nationwide and Internationally
 

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
a) BD Vacutainer Blood Collection Assembly with BD Blunt
Plastic Cannula; Catalog #303380, Recall # Z-1461-06;
b) BD Vacutainer Luer Adapter; Catalog #367290 and #367300,
Recall # Z-1462-06;.
c) BD Direct Draw Adapters, Catalog Number 364896,
Recall # Z-1463-06
CODE
a) Lot numbers: 5326641; 5336280; 5340618; 5341943; 5342548;
5342549; 5348212; 5348215; 5355629; 5357860; 5357891;
6009122; 6020878; 6024334; 6031704; 6040224;
b) Lot Number 5305585; Lot Numbers 5307894; 5307896;
5307900;
c) Lot Numbers 5311376, 5312193, 5312201
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes,NJ, by letters on June 21, 2006.
Manufacturer: BD Preanalytical Solutions, Sumter,SC. Firm initiated recall is ongoing.
REASON
Firm received complaints indicating failure of the Non-Patient (NP) sleeve to function properly. This sleeve covers the cannula and prevents leakage during blood collection.
VOLUME OF PRODUCT IN COMMERCE
4,786,350 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient monitoring system. Model: M3001A, Recall # Z-1487-06
CODE
M3001A options A01, A01C06, A01C12, and A01C18 with serial number prefix DE512 and MMS software revision C.0 or B.1 M3001A options A02, A02C06, and A02C18 with serial number prefix DE441 and DE512 and MMS software revision C.0 or B.1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems, AndoverMA, by letter dated July 21, 2006.
Manufacturer: Philips Medizin Systeme Boblingen Gmbh, Boblingen, Federal Republic of Germany. Firm initiated recall is ongoing.
REASON
Patient monitor may display inaccurate reading when the Disposable Sp02 Sensor is not attached
VOLUME OF PRODUCT IN COMMERCE
55,901 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) dideco Preassembled Surgical Wash Set, Compact , Cobe
part numbers WS55C, WS125C, WS225C, Recall # Z-1488-06;
b) dideco Preassembled Surgical Wash Set, Electa Essential ,
Cobe part numbers WS55E, WS125E, WS175E, WS225E,
Recall # Z-1489-06;
c) Cobe STAT PAC, Autotransfusion Set (Made with Compact
Wash Sets), Cobe Product Codes: AS4C12, AS4C22,
ASCBC12C, ASCBC22C, ASCBFC22C, Recall # Z-1490-06;
d) Cobe STAT PAC Autotransfusion Set (made with Electa Wash Set),
Cobe Product Codes: ASCBFE22, ASCBE22, AS9E55, AS9E22,
AS9E12, AS4E55, AS4E22, AS4E17, Recall # Z-1491-06
CODE
a) Lot numbers: 0604030062, 0605310137,
Lot Numbers: 0602170043, 0603030050, 0603170057,
0603270019, 0604210104, 0605310135, 0606200074, 0606280029,
Lot Numbers: 0602100031, 0602170037, 0602240025, 0603030052,
0603100018, 0603270020, 0604070034, 0604130049, 0605030155,
0606200075, 0607200058;
b) Lot numbers: 0603030047, 0604030059, 0605170017,
Lot Numbers: 0602170041, 0603030051, 0604210103,
Lot Numbers: 0601180099, 0604030060,
Lot Numbers: 0601180100, 0602170042, 0603030049, 0603170058,
0604030061, 0604070035, 0604130050, 0605230075, 0607200059;
c) Lot numbers: 0611600045, 0615000020, 0616400010, 0617800124,
0618600111, 0619200113, 0620600004,
Lot Numbers: 0611600044, 0615000019, 0616400009,
0619200112, 0620600003, 0621300089,
Lot Numbers: 0615700004, 0618600106, 0621300091,
Lot Numbers: 0614300112, 0617100072, 0617800125,
0619200114, 0620600005,
Lot Numbers: 0611600046, 0613000074, 0613600144,
0615000021, 0615700003, 0617100073, 0617800126,
0619200115, 0619900050, 0620600006;
d) Lot numbers: 0610100225, 0613000077, 0615700007, 0618600109,
0621300094, Lot Numbers: 0608000247, 0610800007, 0612300036,
0613000076, 0613600146, 0615700006, 0617200003, 0617800128,
0619200116, 0619900053, 0621300093, Lot Numbers: 0617200004,
0619900054, 0621300095, Lot Numbers: 0611600047, 0612300034,
0613000075, 0614300116, 0617200002, 0617800127, 0618600107,
0621300092, Lot Numbers: 0612300035, 0615000022, 0616400011,
0618600108, 0619900052, Lot Numbers: 0616400012, 0618600110,
Lot Numbers: 0609400006, 0610100223, 0615700005, 0619900051,
Lot Numbers: 0613600145, 0616400013, 0617200005, 0619900055
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cobe Cardiovascular, Inc, Arvada, CO, by telephone and e-mail on August 4, 2006.
Manufacturer: Sorin Group Italia Srl, Mirandola Modena, Italy. Firm initiated recall is ongoing.
REASON
Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.
VOLUME OF PRODUCT IN COMMERCE
8,964 wash sets, 1,518 Stat pacs
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) CORDIS SV-5 Steerable Guidewire, 180 cm., 5 Steerable Guidewires,
ENDOVASCULAR, Catalog # 503558, Recall # Z-1492-06;
b) CORDIS-SV-5 Steerable Guidewire, 300 cm.,5 Steerable Guidewires,
Cordis a Johnson Johnson Company ,ENDOVASCULAR,
Catalog # 503558X, Recall # Z-1493-06;
c) CORDIS SV-8 Steerable Guidewire, 180 cm, 5 Steerable Guidewires,
ENDOVASCULAR, Catalog # 503658, Recall # Z-1494-06;
d) CORDIS SV-8 Steerable Guidewire, 300 cm., 5 Steerable Guidewires,
ENDOVASCULAR, Catalog # 503658X, Recall # Z-1495-06
CODE
a) Lots: 70206754 70206755 70206760 70306717 70306718 70306754 70306771
70306791 70306821 70306848 70406714 70406739 70406767 70506775;
b) 70905743 70905744 70905745 70206756 70206758 70206759 70306719
70306720 70306792 70306822 70306849 70406715 70406768 70406796
70506745 70506753 70506754 70506755;
c) 70306850 70406741 70406797 70506746;
d) 70306851 70406742 70406769 70506720 70506777
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cordis Corporation, Miami Lakes, FL, by letter on July 21, 2006.
Manufacturer: Lake Region Mfg Co, Inc, ChaskaMN. Firm initiated recall is ongoing.
REASON
Tip separation-Cordis SV-5 and SV-8 Steerable Guidewires may have a potential for guidewire fracture resulting in tip separation.
VOLUME OF PRODUCT IN COMMERCE
14,788 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Skytron General Purpose Surgical Table; Model 6600, Recall # Z-1496-06;
b) Skytron General Purpose Surgical Table, battery model;
Model 6600B, Recall # Z-1497-06
CODE
a) All units. Serial numbers 6600-2D-001 through 6600-2L-102;
b) All units. Serial numbers 6600B-2D-002 through 6600B-2L-060
RECALLING FIRM/MANUFACTURER
Recalling Firm: Skytron, Div. The KMW Group, Inc, Grand Rapids, MI, by a service bulletin on August 12, 2005.
Manufacturer: Mizuho Medical Co, Ltd., Tokyo, Japan. Firm initiated recall is ongoing.
REASON
The release levers can inadvertently release under load while the leg section is positioned at a ninety degree angle causing the leg section to drop.
VOLUME OF PRODUCT IN COMMERCE
160 tables
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Greiner bio-one, Vacuette® Tube * 9C Coagulation Sodium, Citrate 3.2%, * 3.5mL * blue cap-black ring * 24 racks of 50, 1200 pcs in total * non-ridged * Sandwich Tube * 454332 * B050609 * 2007-05 * Sterile *, Recall # Z-1498-06
CODE
Item #454332, Lot #B050609
RECALLING FIRM/MANUFACTURER
Greiner Bio-One North America, Inc., Monroe, NC, by fax on August 2, 2006. Firm initiated recall is ongoing.
REASON
Coagulation tubes found with no additive.
VOLUME OF PRODUCT IN COMMERCE
160 cases (192,000 pieces)
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Boston Scientific vanSonnenberg Sump with 'J' Tip, 30 cm, 14Fr (4.7 mm), for percutaneous abscess and fluid drainage, single use only, sterile; UPN M001202010, REF/Catalog No. 20-201, Recall # Z-1499-06
CODE
Lot 8606405; exp. March 31, 2009
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp, Spencer,IN, by letter on August 10, 2006. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility, as the sterile barrier is weak and may be damaged on one edge.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX

______________________________
PRODUCT
a) Neoligaments Staple Impactor, 6 mm Staple Impactor: 202-3001,
Recall # Z-1500-06;
b) Neoligaments Staple Impactor, 8 mm Staple Impactor: 202-3010,
Recall # Z-1501-06
CODE
N/A
RECALLING FIRM/MANUFACTURER
Xiros Plc, Leeds, United Kingdom, by telephone and letters on June 1, 2006. Firm initiated recall is ongoing.
REASON
The impactors are being recalled for modification so that they can be disassembled fully for cleaning and sterilization, on suspicion that the assembled items retain contamination after cleaning and may not be effectively sterilized by the recommended hospital sterilization cycles.
VOLUME OF PRODUCT IN COMMERCE
99
DISTRIBUTION
Nationwide and Internationally
___________________________
PRODUCT
LIFEPAK 20 external defibrillator/monitor, Recall # Z-1502-06
CODE
LP 20 domestic serial numbers 34107307, 33911492, 33946302, 33894355, 33933894, 33951494, 33980272, 33986554, 33924702, 33881437, 33905482, 33894423, 33951266, 33905466, 33955767, 33971830, 34022189, 34071195, 34107256, 33900980, 33971829, 33980275, 33980280, 33980281, 33980287, 34017814, 34107419, 34071134, 33986933, 33947927, 34071165, 33967385, 34066585, 34071189, 34011819, 34011822, 33894426, 33894572, 33900981, 33936889, 34054495, 34060183, 33938363, 33959538, 33981789, 33981792, 33981793, 33981794, 33981795, 33981796, 33981797, 33981799, 33981805, 34071237, 34011821, 33894425, 33922299, 33938921, 33938924, 33959550, 33930122, 33933904, 34107178, 33955760, 33897337, 33955747, 33894255, 33951295, 33951456, 33976455, 33951447, 33894406, 33951275, 33933878, 33946268, 33946277, 33976406, 33976407, 33976408, 33976410, 33976411, 33976412, 33976413, 33976414, 33976415, 33976416, 33976417, 33976418, 33976419, 33976420, 33976424, 33976426, 33976427, 33976428, 33976429, 33976430, 33976431, 33979469, 33979470, 33979471, 33979472, 33979473, 33979474, 33905581, 33905585, 33905590, 33905609, 33905621, 33905622, 33911446, 33911449, 33911450, 33911470, 33911477, 33911528, 33911571, 33897320, 33897322, 33897329, 33897342, 33905514, 33905518, 33911627, 33955832, 33951484, 33951605, 33955759, 33955765, 34017742, 34107418, 33951059, 33951467, 34017810, 34022168, 34022175, 34022176, 33951473, 33951487, 34017813, 33955761, 33894580, 33992539, 33905444, 33971948, 33950588, 33951128, 33951273, 33951287, 33951434, 33951551, 33915884, 33915964, 33922357, 34066561, 33911587, 33971953, 33986931, 33997554, 33955806, 33955833, 34003587, 34003615, 34011698, 34011712, 34022213, 33947935, 33967345, 33967356, 33967367, 33967382, 33967402, 33967413, 33971817, 33971825, 33971832, 33971853, 33971860, 33971898, 33980313, 33981782, 33981787, 33986322, 30568540, 33951292, 33951293, 33951403, 33951409, 33951462, 33951468, 33951497, 33951518, 33951535, 33951552, 33951553, 33951560, 33951569, 33951576, 33951580, 33951582, 33951583, 33951585, 33951586, 33951588, 33951589, 33951592, 33951593, 33951595, 33951597, 33951598, 33951599, 33951600, 33951601, 33951604, 33955748, 33955751, 33955752, 33959570, 33992551, 33992569, 34022195, 34052650, 34052661, 34052662, 34052673, 34052685, 34052686, 34054508, 34060208, 34060827, 34060849, 34063588, 34063590, 34063596, 34063600, 34063602, 34063603, 34063604, 34063605, 34063606, 34063607, 34063608, 34063615, 34063619, 34066562, 34066573, 34066574, 34066576, 34066581, 34066584, 34066587, 34107052, 34107058, 34107059, 34107118, 34107165, 34107170, 34107171, 32601734, 33894320, 33946296, 34011706, 33997567, 33901753, 33901761, 33901762, 33901770, 33901771, 33901773, 33901777, 33901782, 33901787, 33904876, 33904910, 33904913, 33904914, 33904917, 33904921, 33904922, 33904923, 33904926, 33904928, 33904929, 33904931, 33904932, 33904933, 33904936, 33904937, 33904938, 33905427, 33905430, 33905432, 33905434, 33905440, 33905441, 33905443, 33905451, 33905470, 33905473, 33905474, 33905488, 33967403, 33981780, 33911601, 33915910, 33915916, 33915917, 33915961, 33959578, 33894289, 33897319, 33905507, 33905516, 33905520, 33905521, 33911611, 33911614, 33911624, 33911631, 33911632, 33911634, 33911635, 33917440, 33917443, 33917444, 33917447, 33917448, 33917452, 33917453, 33917454, 33917455, 33917456, 33917457, 33917461, 33917463, 33917464, 33917465, 33917466, 33917467, 33917468, 33917470, 33921045, 33921046, 33921047, 33921049, 33921050, 33921052, 33921053, 33921055, 33922294, 33959606, 33951603, 33955750, 33955762, 33955771, 34107379, 34071180, 34071197, 34107378, 34107380, 34107411, 34107426,34107438, 33986324, 33986555, 33979488, 33980264, 33981778, 33986878, 33986897, 33904924, 33905459, 33905495, 33905496, 33905497, 33905587, 33911468, 33933906, 33901735, 31491390, 33894413, 33938926, 33951405, 33951426, 33951596, 33955802, 33955803, 33955827, 33955829, 33955831, 33955839, 33924675, 33924679, 33947909, 33986550, 33986566, 33986915, 33986917, 33986920, 33986921, 33986922, 33986923, 33986924, 33986925, 33990262, 33990270, 34015700, 33997552, 33901737, 33904878, 33905438, 33986873, 33986877, 34071213, 33924704, 33950587, 33951283, 33951298, 34107265, 34017808, 33976463, 33980266, 33980278, 33980279, 33980285, 33980290, 33980291, 33980294, 33980301, 33980304, 33911597, 33911602, 33911603, 33915887, 33915888, 33915889, 33915890, 33915892, 33915893, 33915894, 33915895, 33915897, 33915898, 33915899, 33915908, 33915911, 33915912, 33915914, 33915919, 33915922, 33915925, 33915928, 33915929, 33915930, 33915931, 33936874, 33936877, 33947249, 33947264, 33947931, 33976446, 33976447, 33976456, 33976468, 33976470, 33976471, 33976477, 33976478, 33976479, 34011825, 34017783, 33971838, 33971901, 33971905, 33971910, 33980268, 33980300, 33986330, 33986338, 33986342, 33986344, 33986345, 33986348, 33986349, 33986351, 33986543, 33986561, 33986562, 33986563, 33986564, 33986565, 34017806, 33897344, 33897350, 34063598, 34063616, 33990265, 34015699, 34071185, 34071171, 34054499, 33986913, 34071193, 33911532, 33911535, 33936914, 33980311, 33981772, 33990276, 33971950, 33894290, 33911625, 34071214, 33986323, 33986549, 33986551, 33986559, 34071202, 34071190, 34022185, 34066483, 34107401, 34071233, 33911554, 33911595, 33915885, 33933909, 33951449, 33951602, 33986840, 34107157, 34066570, 33986325, 33986339, 33986553, 33986556, 33986558, 33951439, 33951556, 33951568, 33951572, 33980297, 33897327, 33980274, 33915956, 33951476, 34071212, 33905589, 33905592, 31388033, 34071209, 32659831, 33933911, 33990271, 34011832, 33905582, 33894597, 33955840, 33915926, 33915939, 34071178, 33933931, 33924682, 33924699, 33924703, 33924706, 33930102, 33997573, 33924684, 33924692, 33924695, 33924696, 33924697, 33924701, 33924705, 33930103, 33930105, 33930107, 33946303, 33946314, 33980308, 33981781, 33997566, 33897353, 33936850, 33947897, 33947915, 33947942, 33971845, 33955755, 33986911, 34011824, 34017741, 34017744, 33915896, 33980296, 33986334, 33986335, 33986337, 33986343, 33986546, 33898437, 33898439, 33951475, 33951517, 33980298, 33915962, 33901774, 33971913, 33971926, 33986879, 33986880, 33986894, 33911512, 33986871, 33936879, 33951430, 34052669, 33955775, 34063572, 34066583, 33894316, 33894323, 33894329, 33894332, 33894334, 33894335, 33894337, 33894339, 33894342, 33894344, 33894351, 33894354, 33971867, 33971918, 34107103, 33894315, 33894331, 33894346, 33894348, 33894350, 33894352, 33898455, 33900759, 33900761, 33900762, 33900763, 33900858, 33900859, 33900862, 33900864, 33900983, 33900985, 33900986, 33900987, 33901091, 33971921, 33986898, 34017749, 33900765, 33900856, 33900979, 33900982, 33901098, 33901099, 33901100, 33901116, 33901117, 33901120, 33901122, 33901127, 33901128, 33901717, 33901720, 33901722, 33901725, 33901726, 33901729, 33901731, 33901732, 33901733, 33901768, 33901769, 33986886, 33986901, 33901785, 33905598, 33905600, 33905603, 33905616, 33911445, 33911516, 33911538, 33911539, 33911545, 31532377, 33980309, 34015702, 33976453, 33986567, 33986896, 33986881, 33922356, 33922369, 33922377, 33936899, 33936906, 33946315, 33947259, 33967350, 33967359, 33967360, 33967379, 33976458, 33976464, 33981768, 33900984, 33955816, 34060830, 34063624, 34063632, 34063635, 34063640, 34066577, 34107131, 34107154, 33901092, 33936893, 34022181, 33951280, 33951457, 33951297, 33951543, 33955757, 33955758, 33955763, 33955764, 33955766, 33955768, 33955769, 33955772, 33955774, 33901115, 33955838, 33980283, 33986853, 33951472, 33951288, 34107168, 33967362, 33924661, 33933925, 33947910, 33930113, 33947939, 33967390, 34011820, 34071173, 34063637, 34066566, 34107128, 34107135, 34107167, 33897340, 33911638, 33897331, 33951285, 33915921, 33915953, 33915958, 33922383, 33917442, 33922372, 33897321, 33897325, 33897328, 33897343, 33905501, 33905503, 33905509, 33905511, 33905513, 33905517, 33905519, 33905522, 33905525, 33905526, 33911604, 33911610, 33911628, 33911633, 33911641, 33917441, 33917450, 34063614, 34063617, 34107397, 34054493, 33986874, 33901096, 33901106, 33951118, 33917459, 33933915, 33933916, 33933917, 33933920, 33933922, 33946307, 33946319, 33946322, 33947256, 33976487, 33947904, 34017792, 33947936, 33979475, 33979479, 33955818, 31689589, 34022188, 34066507, 34066526, 34071159, 33955813, 34017820, 33900855, 33905428, 33971835, 34060835, 33933905, 33936878, 33946305, 33946311, 33946317, 33947900, 33967377, 33967383, 33967384, 33967387, 33967388, 33967396, 33967398, 33967406, 33967409, 33967410, 33967411, 33971813, 33971814, 33971822, 33971823, 33971826, 33971833, 34017807, 34017809, 34017815, 34017817, 34017819, 34017821, 34022169, 34022174, 34022177, 34022183, 34022184, 34022187, 34071181, 34071216, 34071217, 34107247, 34107268, 34107404, 33897318, 33897323, 33897336, 33905506, 33905512, 33905515, 33905523, 33905524, 33911605, 33911612, 33911615, 33911616, 33911623, 33911626, 33986340, 34017731, 33980293, 33992544, 33933907, 33933932, 33936849, 33947899, 33951474, 34017816, 33905611, 33894392, 33894410, 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34107415, 34107420 Military serial numbers: 33894425, 33894255, 33997567, 33959578, 33894287, 33938356, 33938357, 33938359, 33938928, 33951441, 33951459, 33955756, 33955770, 33955778, 33955779, 33955780, 33955781, 33955782, 33955784, 33955785, 33955787, 33955788, 33955789, 33955790, 33955791, 33955793, 33955795, 33955796, 33955798, 33955800, 33955801, 33955805, 33955830, 33955846, 33955847, 33955853, 33959560, 33959561, 33959562, 33959568, 33959572, 33959573, 33959574, 33959602, 33959603, 33959609, 33981808, 33981809, 33986865, 33992540, 33992542, 33992545, 33992547, 33992549, 33992550, 33992552, 33992553, 33992554, 33992555, 33992556, 33992557, 33992558, 33992559, 33992560, 33992561, 33992562, 33992563, 33992564, 33992565, 33992566, 33992567, 33992568, 33992571, 33992572, 34022190, 34022191, 34022193, 34022194, 34022196, 34022197, 34022199, 34022200, 34052635, 34052637, 34052638, 34052641, 34052642, 34052643, 34052645, 34052646, 34052647, 34052652, 34052656, 34052657, 34052665, 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International serial numbers: 33947246, 33947247, 33892605, 33893092,
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33991485, 33991486, 33991487, 33991492, 33991493, 33991495, 33991496, 33991497, 33991498, 34003562, 34003563, 34003566, 34003575, 34003580, 34003586, 34003595, 34003602, 34003603, 34003607, 34003609, 34003612, 34003626, 34003630, 34011714, 33904919, 33905433, 33905442, 33905446, 33905447, 33905449, 33905463, 33905467, 33905468, 33905577, 33905591, 33905618, 33905619, 33911511, 33915883, 33915886, 33930109, 33930110, 33930114, 33930116, 33933929, 33936911, 34017745, 34017791, 33819592, 33881450, 33893078, 33893083, 33893101, 33894367, 33894375, 33894381, 33894383, 33894384, 33894385, 33894386, 33894388, 33894389, 33894390, 33932679, 33933858, 33933870, 33933872, 33933944, 33933886, 33936902, 33947930, 34003598, 34022201, 33976480, 33976481, 33976482, 33976483, 33917460, 33921054, 33921056, 33951594, 34060847, 33894291, 33894571, 33921048, 33950446, 33950449, 33950574, 33950583, 33955834, 34060203, 34060207, 34060212, 34060817, 34060821, 34060825, 34060828, 34060832, 34060836, 34060852, 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34054517, 33938925, 33950586, 33951074, 33951115, 33951116, 34022198, 33959600, 34054528, 34054531, 33894387, 34003571, 34003574, 34003576, 34003596, 34003599, 34011715, 34011717, 34011722, 33905620, 34015714, 34017733, 34017798, 34017805, 34071191, 34060841, 34066568, 33915902
RECALLING FIRM/MANUFACTURER
Medtronic Emergency Response Systems, Inc., Redmond, WA, by letter on August 30, 2006. Firm initiated recall is ongoing.
REASON
Devices with v38 system software do not display a "LOW BATTERY: CONNECT TO AC POWER" message when the monitor is on backup (DC) battery power and may shut down without warning.
VOLUME OF PRODUCT IN COMMERCE
2,831 devices
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR SEPTEMBER 20, 2006

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