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U.S. Department of Health and Human Services

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Enforcement Report for July 5, 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.

July 5, 2006
06-27

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

______________________________
PRODUCT
Sesame Seeds, Hulled 50# Bags.  Product of India.  Recall # F-230-6
CODE
Pack for UTI/FL/PO 5174 29411/686 Sesame
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sparrow Enterprises Ltd., East Boston, MA, by e-mail and letter on June 2, 2006.
Manufacturer: Ultra Trading Intl. Ltd., Aventura, FL, firm initiated recall is complete.
REASON
Sesame seeds are contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
817/50# bags
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Bhavani Brand Golden Raisins, 7 oz clear plastic bags, Recall # F-231-6
CODE
No codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Shree Bhavani, Inc., Jersey City, NJ, by telephone on May 16, 2006
Manufacturer: Kalahari Raisins (Pty) Ltd., Friersdales, South Africa.  Firm initiated recall is complete.
REASON
Raisins contain undeclared sulfites based on the New York State Department of Agriculture & Markets' analysis.
VOLUME OF PRODUCT IN COMMERCE
131 x 30 lb bulk cases; 20 x 7 oz packs
DISTRIBUTION
NJ and NY
 

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

______________________________
PRODUCT
BLAINE brand UroMag, Magnesium Oxide 140 mg, Magnesium Dietary Supplement, Capsule form, 100 count bottle, UPC barcode # 3 01650 05401 7,  Recall # F-228-6
CODE
Lot 04M030, Exp. date 12/07
RECALLING FIRM/MANUFACTURER
Ultratab Laboratories Inc., Highland, NY, by telephone on March 20, 2006 and by letter and e-mail on March 22, 2006.  Firm initiated recall is complete.
REASON
The own label distributor received a complaint of 1 foreign capsule found in a bottle of UroMag Magnesium Oxide 140 mg Magnesium Dietary Supplement, lot 04M030. Analysis of the foreign capsule confirmed it to be Selegiline HCl 5 mg, a prescription product intended for the treatment of Parkinson's disease.
VOLUME OF PRODUCT IN COMMERCE
10,044 - 100 count bottles (1,018,368 capsules)
DISTRIBUTION
KY

______________________________
PRODUCT
AVEENO Positively Radiant Triple Boosting Serum. 1.7 fl oz and .25 fl oz. Recall # F-229-6
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Johnson & Johnson Consumer Products Co., Skillman, NJ, by letter on May 17, 2006.
Manufacturer: Vee Pak Inc., Countryside, IL, firm initiated recall is ongoing.
REASON
 Triple Boosting Serum is contaminated with Enterobacter gergoviae.
VOLUME OF PRODUCT IN COMMERCE
242735 1.7 fl oz plastic pump containers/154944 0.25 fl oz plastic tubes
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Prepared Mrs. Gerry's Tuna Salad sold in 14 oz. container (code #60201),
    and 5 lb. container (code # 60205), Recall # F-232-6;
b) Prepared Mrs. Gerry's Ham Salad sold in 14 oz. container (code # 60501), and
    5 lb. container (code # 60505), Recall # F-233-6;
c) Prepared Mrs. Gerry's Gourmet Potato Salad sold in 12 lb. container (code # 10112),
    Recall # F-234-6;
d) Prepared Mrs. Gerry's Macaroni Salad sold in 5 lb. container (code # 10705), and
    12 lb. container (code # 10712), Recall # F-235-6;
e) Prepared Mrs. Gerry's White Macaroni Salad sold in 14 oz. container (code # 14001),
    40 oz. container (code # 14003) and 5 lb. container (code # 14005), Recall # F-236-6;
f) Prepared Mrs. Gerry's Deviled Egg Potato Salad sold in 5 lb. container (code # 09005),
    Recall # F-237-6;
g) Prepared Mrs. Gerry's New York Style Potato Salad sold in 14 oz. container
    (code # 10901), and 5 lb. container (code # 10905), Recall # F-238-6;
h) Prepared Supreme Seafood Salad sold in 4 lb. container (code # 59904), sold under 
    the names: Block & Barrel Classic Supreme Seafood Salad, and Mrs. Gerry's
    Supreme Seafood Salad, Recall # F-239-6;
i) Prepared Mrs. Gerry's Summer Fresh Pasta Salad sold in 14 oz. (code # 81801)
    and 5 lb. container (code # 81805).  Also sold under the name:  Block & Barrel
    Classic Summer Fresh Pasta Salad in 5 lb. container (code # 81801),
    Recall # F-240-6;
j) Prepared Mrs. Gerry's Sour Kream “N” Cheese Macaroni Salad sold in 14 oz.
   container (code # 11001), and 5 lb. container (code # 11005), Recall # F-241-6;
k) Prepared Mrs. Gerry's Deli Fresh Macaroni Salad sold in 14 oz. container
    (code # 12201), 40 oz. container (code # 12203) and 11 lb. container
    (code # 12211).  Also sold as Block & Barrel Classic Deli Fresh Macaroni
    Salad, 11 lb. (code # 12211) Recall # F-242-6;
l) Prepared Mrs. Gerry's Shell Macaroni Salad sold in 14 oz. container
    code (code # 10601), 5 lb. container (code # 10605) and 12 lb.
    container (code # 10612), Recall # F-243-6;
m) Mrs. Gerry's Smoked turkey Jarlsberg Kit (code # 83205), sold in 5 lb. container,
     Recall # F-244-6;
n)  Prepared Mrs. Gerry's Seafood Royale Salad sold in 10 oz. container
     (code # 81162), and 5 lb. container (code # 81105).  Also sold as
    Block & Barrel Classic Seafood Royale Salad in 5 # container (code # 81105),
    Recall # F-245-6;
o) Prepared Spoon River Potato Salad sold in 12 lb. container (code # 98012),
    Recall # F-246-6;
p) Prepared festival foods Knowlan's Homestyle Potato Salad, sold in
    12 lb. container (code # 22913), Recall # F-247-6;
q) Prepared Mrs. Gerry's Associated Rigatoni Pasta Base Kit sold in 5 lb.
    containers (code # 83305), Recall # F-248-6;
r) Mrs. Gerry's King Krab Salad sold in 5 lb. container (code # 13605),
    Recall # F-249-6;
s) Prepared Fareway Old Fashioned Potato Salad sold in 5 lb. container
    (code # 93505) and 35 lb. container, Recall # F-250-6
CODE
a) Use by code date 6-27-06, 7-02-06, 7-07-06, 7-08-06, 7-11-06;
b) Use by code dates: 6-06-06, 6-11-06, 6-12-06, 6-13-06, 6-16-06,
    6-17-06, 6-21-06;
c) Use by code date 06/08/2006;
d), g), h), o) Use by date 6-11-06;
e) and f)  Use by date 6-18-06;
i) Use by date 6-12-06;
j) Use by date 6-9-06;
k) Use by date 6-19-06;
k), l), p), r) Use by date 6-10-06;
m), n), q), s) Use by date 6-13-06
RECALLING FIRM/MANUFACTURER
Mrs. Gerry's Kitchen, Inc., Albert Lea, MN, by telephone, press release, fax and personal visits beginning on May 19, 2006.  Firm initiated recall is ongoing.
REASON
Prepared salads were manufactured using a canned celery ingredient, which was inadequately acidified to prevent the growth of pathogens.
VOLUME OF PRODUCT IN COMMERCE
54,544 lbs
DISTRIBUTION
IA, IL, MI, MN, ND, NE, SD, UT, and WI
 

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

______________________________
PRODUCT
a) Roha FD&C Red # 40 Granular, Pure Dye 90%,
    packaged in a 50 lb. case, Recall # F-225-6;
b) Roha FD&C Yellow # 6 Spheroclean, Pure Dye 92%,
    packaged in a 50 lb. case, Recall # F-226-6
CODE
a) AM7926;
b) AM6366
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Roha U.S.A., L.L.C., Saint Louis, MO, by letter dated February 10, 2006 and by fax on February 13, 2006.
Manufacturer:  ROHA DYECHEM PVT. LTD, DHATAV, India.  Firm initiated recall is complete. 
REASON
Colors do not meet specification for certification.
VOLUME OF PRODUCT IN COMMERCE
12,950 lbs.
DISTRIBUTION
AL, IL, ID, CA, PA, and OH

______________________________
PRODUCT
Liquid potassium supplement under the following brands: a) MRI brand Elemental Potassium, 99mg, Net 2 Fl. Oz., b) Liquimins brand Ionic Potassium, 99mg, Net 2 Fl. Recall # F-227-6
CODE
Lot numbers: 073-502, 073-504, 073-506, and 073-602
RECALLING FIRM/MANUFACTURER
 Mineral Resources International, Ogden, by telephone on March 23, 2006 and by letter on April 12, 20006, firm initiated recall is ongoing.
REASON
Dietary supplement may be contaminated with Aspergillis sydowii and yeast.
VOLUME OF PRODUCT IN COMMERCE
8,469 bottles
DISTRIBUTION
UT, Netherlands, Philippines, and UK
 

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

______________________________
PRODUCT
Amantadine HCI, USP, 100 mg, Soft Gelatin Capsules, shipped in bulk cartons of 20,000 capsules each, CAUTION: For Further Manufacturing, Processing or Repackaging Only, Rx ONLY, Recall # D-274-6
CODE
Lot numbers:  25101150, 25030655 and 25101146
RECALLING FIRM/MANUFACTURER
Banner Pharmacaps, Inc., High Point, NC, by letter on May 17, 2006 and May 18, 2006.  Firm initiated recall is ongoing.
REASON
Failed USP Content Uniformity Requirements.
VOLUME OF PRODUCT IN COMMERCE
20,000 capsules
DISTRIBUTION
CO

______________________________
PRODUCT
Budesonide 2.0 mg, 5 mL unit dose, Black Vials Only  Product Number:  8590, Compute Rx Bronscho Dose, Recall # D-276-6
CODE
All lot numbers
RECALLING FIRM/MANUFACTURER
Computerx Pharmacy, Inc., Stratford, CT, by letter on June 12, 2006.  Firm initiated recall is ongoing.
REASON
Subpotent
VOLUME OF PRODUCT IN COMMERCE
6,800 vials
DISTRIBUTION
CA, PA, PR, and VA

______________________________
PRODUCT
Thiothixene Capsules, 5 mg, 30 Capsule Box, Rx Only, NDC 61392-175-30, Recall # D-280-6
CODE
Lot K39006B30, exp. 09/30/07
RECALLING FIRM/MANUFACTURER
Heartland Repack Services LLC, Toledo, OH, by telephone on June 22, 2006 and by fax on or about June 23, 2006.  Firm initiated recall is ongoing.
REASON
Mislabeled; Outer carton is labeled as Thiothixene 5 mg Capsules but actually contains blister packs of Metformin Hydrochloride ER 500 mg Tablets.
VOLUME OF PRODUCT IN COMMERCE
145/30 count boxes
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Ultram ER Tablets, (Tramadol Hydrochloride) Extended Release Tablets 300mg,
    30 count bottle, Rx Only, NDC 0062-0657-30, Recall # D-281-6;
b) Ultram ER Tablet, (Tramadol Hydrochloride) Extended Release Tablet, 200 mg,
    30 count bottles, Rx Only, NDC 0062-0655-30, Recall # D-282-6
CODE
a) Lot Number/ Expiration Date: Note: All lots Expire November 2007: 
    Lot Numbers: 06A066P; 06A067P; 06A068P; 06A094P; 06A111P; 06A097P;
    06B012P; 06B013P; 06B023P; 06B024P; 06B025P; 06B031P; 06B002P;
    06B056P; 06B059P; 06B067P; 06B072P;
b) Lot Number:  06A081P, Exp Date:  November 2007
RECALLING FIRM/MANUFACTURER
 Recalling Firm:  Ortho-McNeil Pharmaceutical Inc., Raritan, NJ, by letter on June 12, 2006.
Manufacturer:  Biovail Corp., Steinbach, Canada.  Firm initiated recall is ongoing.
REASON
Dissolution failure due to a tablet coating defect caused by the tablet printer.
VOLUME OF PRODUCT IN COMMERCE
89,064 bottles
DISTRIBUTION
Nationwide
 

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

______________________________
PRODUCT
Benzonatate USP Soft Gelatin Capsules, 100 mg, shipped in bulk cartons of 40,000 capsules each, CAUTION:  For Further Manufacturing, Processing or Repackaging Only, Rx ONLY, Recall # D-276-6
CODE
Lot number:  24122208
RECALLING FIRM/MANUFACTURER
Banner Pharmacaps, Inc., High Point, NC, by telephone on May 8, 2006.  Firm initiated recall is ongoing.
REASON
Failed Impurity Specification (6 and 9 month stability)
VOLUME OF PRODUCT IN COMMERCE
1 million capsules
DISTRIBUTION
NJ

______________________________
PRODUCT
a)  Anbesol® Regular Strength Liquid, Oral Anesthetic/10% Benzocaine,
    Cool Mint, 0.41 fl. oz. glass bottle, packaged in blister cards,
    36 bottles/case and may further be packaged for wholesale accounts as
    12 piece display lots. Blister cards are labeled in part  *** Do Not Use if
    plastic blister or backing material is broken or if backing material is
    separated from the plastic*** Bottles are labeled in part ***This bottle
    should be in a sealed outer package. Do Not Use if outer package is missing
    or broken*** Product is sold as ''open stock'', 36 blister carded bottles/case
    and as ''display lots'' with 12 blister carded bottles per clip strip. Recall # D-278-6;
b) Anbesol® Maximum Strength Liquid, Oral Anesthetic/20% Benzocaine,
    0.41 fl. oz. glass bottle, packaged in blister cards, 36 bottles/case and may
    further be packaged for wholesale accounts as 12 piece display lots. Blister
    cards are labeled in part ***Do Not Use if plastic blister or backing material is
    broken or if backing material is separated from the plastic***; Bottles are
    labeled in part ***This bottle should be in a sealed outer package. Do Not Use
    if outer package is missing or broken*** Product is sold as ''open stock'',
    36 blister carded bottles/case and as ''display lots'' with 12 blister carded
    bottles per clip strip, Recall # D-279-6
CODE
a) Lots A47396, A56081, A65472, A76577, A90503, A94016, B09092, B21466,
    with expiration dates December 2006 through July 2008. Lots A47396, A56081,
    A65472, A76577, A90503, A94016, B09092, B21466, with expiration dates
    December 2006 through July 2008;
b) Lots A56114, A68117, A68118, A68120, A68124, A81724, A90505, A94445,
    B05676, B05677, B05679, B13738, B20342, B25020, B39562, with expiration
    dates September 2006 through January 2008
RECALLING FIRM/MANUFACTURER
Richmond Division of Wyeth, Richmond, VA, by letter on May 12, 2006.  Firm initiated recall is ongoing.
REASON
Packaging Defect; tamper-evident blister seal may separate.
VOLUME OF PRODUCT IN COMMERCE
3,360,973 bottles
DISTRIBUTION
Nationwide and US Virgin Island
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1279-6;
b) Cryoprecipitated AHF, Recall # B-1280-6    
CODE
a) and b) Unit number: 003GF10071
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone on August 24, 2004, and by letter dated August 27, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1281-6
CODE
Unit number:  GR35489
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by facsimile dated June 2, 2004.  Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of T-Cell Lymphoma, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI and Switzerland

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1284-6;
b) Recovered Plasma, Recall # B-1285-6
CODE
a) and b) Unit number:  12KQ48283
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Carolinas Region, Charlotte, NC, by letter and electronically, on October 6, 2005.  Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibody to hepatitis C virus (anti-HCV), but were collected from a donor that previously tested repeatedly reactive for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC and CA

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1350-6;
b) Plasma, Cryoprecipitate Reduced, Recall # B-1351-6;
c) Cryoprecipitated AHF, Pooled, Recall # B-1352-6
CODE
a) and b) Unit number:  KC22444;
c) Unit number:  KC22444 (pool # KR 14173)
RECALLING FIRM/MANUFACTURER
Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI,  by facsimile dated May 25, 2004.  Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking Sulfasalazine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
WI

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1353-6
CODE
Unit number:  6655539
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile dated April 8, 2005.  Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1355-6;
b) Recovered Plasma, Recall # B-1356-6
CODE
a) and b) Unit number:  2425117
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June 18, 2003.  Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had sexual contact with an individual who lived in an HIV Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and Austria

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1357-6;
b) Recovered Plasma, Recall # B-1358-6
CODE
a) and b) Unit number:  2360402
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on December 19, 2003.  Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had sexual contact with an individual who lived in an HIV Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and Austria

______________________________
PRODUCT
a) Platelets, Recall # B-1376-6;
b) Fresh Frozen Plasma, Recall # B-1377-6
CODE
a) and b) Unit numbers:  GP80618
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on November 28, 2005.  Firm initiated recall is complete.
REASON
Blood products, which were manufactured from whole blood in which the associated blood components contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1379-6;
b) Platelets, Recall # B-1380-6;
c) Fresh Frozen Plasma, Recall # 1381-6;
d) Recovered Plasma, Recall # B-1382-6
CODE
a) Unit numbers:  2343106, 2377779, and 2403533;
b) and c) Unit numbers:  2377779;
d) Unit numbers:  2343106 and 2403533
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June 12, 2003.  Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
TX and Austria

______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1418-6
CODE
Unit number:  2307258
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone on April 3, 2006 and by letter dated May 12, 2006.  Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which the associated blood product contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1419-6
CODE
Unit numbers:  18FZ42683 and 18GN27218
RECALLING FIRM/MANUFACTURER
 American Red Cross Blood Services, Lansing, MI, by facsimile and letter dated April 6, 2006.  Firm initiated recall is complete.
REASON
Blood products, which were collected from donors who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1420-6
CODE
Unit numbers:  18GK40320 and 18GK41620
RECALLING FIRM/MANUFACTURER
 American Red Cross Blood Services, Lansing, MI, by facsimile on July 16, 2005, and letter dated July 22, 2005.  Firm initiated recall is complete.
REASON
Blood products, which were collected from donors who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1467-6;
b) Recovered Plasma, Recall # B-1468-6
CODE
a) and b) Unit numbers:  2329380
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on May 8, 2003.  Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and Switzerland

______________________________
PRODUCT
Platelets Pheresis, Recall # B-1469-6
CODE
Unit numbers:  7066384 (split unit)
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on December 4, 2003.  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
TX

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1470-6;
b) Platelets, Recall # B-1471-6
CODE
a) and b) Unit numbers:  2438086
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on August 6, 2003.  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
TX

______________________________
PRODUCT
a) Red Blood Cells (Apheresis), Recall # B-1472-6;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-1473-6
CODE
a) Unit numbers:  7068590, 7066312, and 7062161;
b) Unit numbers:  7068590, 7066312, 7062161 and 7061523
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on December 11, 2003.  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
7 units
DISTRIBUTION
TX

______________________________
PRODUCT
a) Red Blood Cells (Apheresis), Recall # B-1474-6;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-1475-6
CODE
a) and b)  Unit numbers:  7070835 and 7068416
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on December 5, 2003.  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
4 units
DISTRIBUTION
TX

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1476-6;
b) Platelets, Recall # B-1477-6
CODE
a) and b)  Unit numbers:  2453956
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on December 4, 2003.  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
TX

______________________________
PRODUCT
Red Blood Cells (Apheresis), Recall # B-1478-6
CODE
Unit number:  2480680
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on December 10, 2003.  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
TX

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1479-6;
b) Cryoprecipitated AHF, Recall # B-1480-6;
c) Recovered Plasma, Recall # B-1481-6
CODE
a), b), and c) Unit numbers:  2383280
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on July 23 and 29, 2004.  Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX and Switzerland

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1482-6;
b) Fresh Frozen Plasma, Recall # B-1483-6
CODE
a) and b) Unit number:  2501452
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on October 5, 2004.  Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and NY

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1484-6;
b) Plasma Cryoprecipitated Reduced, Recall # B-1485-6;
c) Recovered Plasma, Recall # B-1486-6
CODE
a) and c) Unit number:  2554077;
b) Unit number:  2415708
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on August 13, 2004.  Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX and Austria
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

______________________________
PRODUCT
 Platelet Pheresis, Leukoreduced, Recall # B-1119-6   
CODE
Unit number: 6332777
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone on May 26, 2000. 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
CO

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated, Recall # B-1122-6
CODE
Unit numbers:  0595641, 0645925
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone, on November 19, 1999.  Firm initiated recall is complete.
REASON
Blood products, with an unacceptably low percent red cell recovery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO

______________________________
PRODUCT
Red Blood Cells, Leukoreduced, Recall # B-1123-6
CODE
Unit numbers:  0679672, 0705959
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone, on March 20, 2000.  Firm initiated recall is complete.
REASON
Blood products, out of controlled storage for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO

______________________________
PRODUCT
Red Blood Cells, Recall # B-1124-6
CODE
Unit number:  0710566
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone, on July 7, 2000.  Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1125-6
CODE
Unit numbers:  0678391, 0680462, 0705355
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone, on March 10, 2000.  Firm initiated recall is complete.
REASON
Blood products, out of controlled storage for an undocumented length of time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1126-6
CODE
Unit number:  0668489
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone, on January 31, 2000.  Firm initiated recall is complete.
REASON
Blood product, out of controlled storage for an undocumented length of time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1127-6
CODE
Unit number:  0666786
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone, on January 17, 2000.  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
Red Blood Cells, Recall # B-1128-6
CODE
Unit number:  0667679
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone, on February 25, 2000.  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
Red Blood Cells, Recall # B-1130-6
CODE
Unit number:  6034181
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone, on October 16, 2005.  Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
Recovered Plasma, Recall # B-1282-6
CODE
Unit number:  GR35489
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by facsimile dated June 2, 2004.  Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of T-Cell Lymphoma, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI and Switzerland

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1347-6
CODE
Unit numbers:  03GP57953, 03GP57954, 03GP57948, 03GP57928, 03GP57927, 03GP57929, 03GP57951, 03GP57952, 03GP57925, 03GP57926, 03GP57920, 03GP57921, 03GP57922, 03GP57944, 03GP57942, 03GP57938, 03GP57941, 03GP57947, 03GP57946, 03GP57945, 03GP57930, 03GP57931, 03GP57937, 03GP57924
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southern Region, Atlanta, GA, by telephone on March 31, 2004 and by letter on April 5, 2004.  Firm initiated recall is complete.
REASON
Blood products, which did not have the red cell preservative solution added within the specified timeframe, were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
GA

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1359-6
CODE
Unit numbers:  398-9541731, 398-9558152, and 398-9561802
RECALLING FIRM/MANUFACTURER
American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by letter dated May 13, 2005.  Firm initiated recall is complete.
REASON
Blood products, which may have been exposed to unacceptable temperatures during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IN

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1414-6
CODE
Unit numbers:  4804691 and 4805829 (split unit)
RECALLING FIRM/MANUFACTURER
 Central Indiana Regional Blood Center, Indianapolis, IN, by telephone on April 19, 2006 and by letter dated May 5, 2006.  Firm initiated recall is complete.
REASON
Blood products, which were not manufactured in accordance to acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IN

______________________________
PRODUCT
Red Blood Cells, Recall # B-1421-6
CODE
Unit number:  2143666
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter dated December 24, 2004.  Firm initiated recall is complete.
REASON
Blood product, which was not prepared within eight hours of whole blood collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
 

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
a) Weck Hem-o-lok ML Polymer Ligating Clips; Rx, sterile, medium large size,
non-absorbable polymer ligation clips; 6 clips per cartridge, 14 cartridges
per sales unit, 12 sales units per case. Catalog number 544230,
Recall # Z-1096-06;
b) Weck Hem-o-lok L Polymer Ligating Clips; Rx, sterile, large size,
    non-absorbable polymer ligation clips; 6 clips per cartridge, 14 cartridges
    per sales unit, 12 sales units per case. Catalog number 544240,
    Recall # Z-1097-06;
c) Weck Hem-o-lok XL Polymer Ligating Clips; Rx, sterile, extra large size,
    non-absorbable polymer ligation clips; 6 clips per cartridge, 14 cartridges
    per sales unit, 12 sales units per case. Catalog number 544250,
    Recall # Z-1098-06;
d) Weck Hem-o-lok Endo 5 Automatic Clip Applier with Medium Polymer
    Ligating Clips; Rx, sterile, single use, disposable clip applier with medium
    size, non-absorbable polymer ligation clips; 15 clips per applier, 3 appliers
    per sales unit, 6 sales units per case.  Catalog number 543965,
    Recall # Z-1099-06
CODE
All lots
RECALLING FIRM/MANUFACTURER
 Teleflex Medical, Research Triangle Park, NC, by letter dated April 18, 2006, firm initiated recall is ongoing.
REASON
The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephrectomies in living donor patients.
VOLUME OF PRODUCT IN COMMERCE
10,458,708 clips
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Adept-Med brand Glassman Viscera Retainer FISH Sterile, Item Numbers: 3204, 3202, 3203, 3202, 3201, 3200, 3206, Recall # Z-1156-06
CODE
1104, 1204, 11203, 11103, 11503, 11403, 10503
RECALLING FIRM/MANUFACTURER
Adept-Med International Inc., Diamond Springs, CA, by letter on August 13, 2004, firm initiated recall is complete.
REASON
Devices for which sterility may be compromised as evidenced by a loss of package integrity.
VOLUME OF PRODUCT IN COMMERCE
7,600 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09, Recall # Z-1160-06
CODE
Lot numbers 603006, exp. 3/1/2008, and 602013, exp. 2/6/2008.
RECALLING FIRM/MANUFACTURER
Suros Surgical Systems Inc., Indianapolis, IN, by telephone on May 25, 2006 and by letters on May 25, 2006 and June 19, 2006 firm initiated recall is ongoing. 
REASON
Lack of assurance of sterility, as package may have a seal defect (improperly sealed primary packaging).
VOLUME OF PRODUCT IN COMMERCE
939 guides
DISTRIBUTION
Nationwide

______________________________
PRODUCT
OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected to BacT/ALERT 3D. Recall # Z-1161-06
CODE
Software version R.02.00.17
RECALLING FIRM/MANUFACTURER
Recalling Firm:  bioMerieux, Inc., Hazelwood, MO, by telephone and letters on May 22, 2006.
Manufacturer:  bioMerieux, Inc., Durham, NC, firm initiated recall is ongoing. 
REASON
Software problem with scanner inter-character delay which may result in false positive or false negative results after incorrect scanning of bottle IDs.
VOLUME OF PRODUCT IN COMMERCE
51 systems
DISTRIBUTION
Nationwide and Internationally
 

______________________________
PRODUCT
Leica M520 Surgical Microscope; a surgical microscope with a 6:1 motorized zoom magnification, 207-470 mm motorized Multi-Foc variable objective lens with diameter and light intensity of illuminated field continuously adjustable and high power 300W xenon lamp (both main and back-up illimuniation) through fiber optic cable; Leica Microsystems (Schweiz) AG, Business Unit SOM, Max Schmidheiny-Strasse 201, CH-9435 Heerbrugg, Switzerland; Leica Microsystems Inc., 90 Boroline Road, Allendale, NJ 07401; Leica Microsystems Inc., 2345 Waukegan Road, Bannockburn, IL 60015-9792 The M520 microscope was sold with the following floor stands to form Leica Surgical Microscope Systems: a) MS-1 floor stand with manual balancing for the microscope carrier in three axes and three electromagnetic and mechanical brakes; b) MS-2 floor stand with 3 step balancing for the optical head, autobalance for the floor stand and six electromagnetic brakes; c) MS-3 floor stand with semi-automatic balancing system and six electromagnetic permanent magnetic brakes, cantilever range: 1456 mm d) ) OHS1 floor stand with semi-automatic balancing system and six electromagnetic permanent magnetic brakes, e) OH3 floor stand with fully-automatic balancing system and six electromagnetic permanent magnetic brakes, cantilever range: Max. 1520 mm f) F40 floor stand with continuously adjustable balancing system and four electromagnetic permanent magnetic brakes, Maximum reach 1496 mm, Recall # Z-1162-06
CODE
All units shipped prior to December 1, 2005
RECALLING FIRM/MANUFACTURER
Leica Microsystems (Schweiz),  Heerbrugg, Switzerland, by fax on November 15, 2005, firm initiated recall is ongoing.
REASON
Patient Burns-The use of the surgical microscope at high light intensity and short working distances can result in patient burns.
VOLUME OF PRODUCT IN COMMERCE
581 systems
DISTRIBUTION
Nationwide

______________________________
PRODUCT
B Braun 9F (O/S) Locking Tearway Introducers non-sterile. Catalog number 614008. The product is packaged as 50 bulk nonsterile units per pouch, 2 pouches per shipping carton. Recall # Z-1163-06
CODE
Lot number 60745623
RECALLING FIRM/MANUFACTURER
 B. Braun Medical, Inc., Cherry Hill, NJ, by telephone on May 10, 2006, firm initiated recall is complete.
REASON
Mislabeled-9F labeled units actually contain 10F devices
VOLUME OF PRODUCT IN COMMERCE
9300 units
DISTRIBUTION
FL, NY, CT and Germany

______________________________
PRODUCT
a) CPS Slitter, Model 410191, Recall # Z-1164-06;
b) CPS Valve Bypass Tool (VBT), Model 410192, Recall # Z-1165-06;
c) CPS Direct SL, Models 410110, 410111, 410112, 410113, 410114, 410115,
    410116, 410120, 410121, 410122, 410123, 410124, 410125, & 410126,
    Recall # Z-1166-06;
d) CPS Aim, Models 410140, 410141, 410142, 410144, 410145, 410146,
    410147, & 410148, Recall # Z-1167-06;
e) CPS Implant Kit, Model 410190, Recall # Z-1168-06
CODE
All lots with a manufacturing date of May 30, 2006 or earlier
RECALLING FIRM/MANUFACTURER
 Recalling Firm: St Jude Medical CRMD, Sylmar, CA, by letter on June 1, 2006
Manufacturer: Oscor Inc.,Palm Harbor, FL, firm initiated recall is ongoing.
REASON
Sterility - Some of the sterile pouches in which these products are packaged may not have been properly sealed during the packaging process.
VOLUME OF PRODUCT IN COMMERCE
13,655
DISTRIBUTION
AZ, CA, MS, NY and PA

______________________________
PRODUCT
i-STAT EG7+ Cartridge, Blood Gas Panel. pH, PCO2 PO2, Na K iCa, Hct, HCO3 TCO2 BE, sO2 Hb. Manufacturer, i-STAT Corp, 104 Windsor Center Drive, East Windsor, NJ 08520. Made in Canada. i-STAT Catalog Number -- 220300; Abbott List Number (US and Canada)-- 06F01-01; Abbott List Number (Rest of World) -- 06F01-02. Recall # Z-1171-06
CODE
Lot Number -- Expiration Date: U06024B -- exp. date 09/14/06; U06037C -- exp. date 09/28/06; U06062A -- exp. date 10/28/06; U06063 -- exp. date 10/28/06.
RECALLING FIRM/MANUFACTURER
 Recalling Firm: Abbott Laboratories, East Windsor, NJ, by letters on May 8, 2006 through June 7, 2006.
Manufacturer: I Stat, Kanata, Ontario, Canada, firm initiated recall is ongoing.
REASON
Erroneous sodium and/or ionized calcium readings could be obtained with a patient sample.
VOLUME OF PRODUCT IN COMMERCE
59,775 cartridges
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; Cat. No. 04585984160. Recall # Z-1176-06
CODE
Lots A157001 (exp. 7/31/07) and A157002 (exp. 9/30/07).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated June 6, 2006
Manufacturer: Reagents Applications Inc., San Diego, CA, firm initiated recall is ongoing.
REASON
Falsely low patient and control results may be reported when the reagent has been on-board for less than the 8 hour use period specified in the labeling.
VOLUME OF PRODUCT IN COMMERCE
933 kits
DISTRIBUTION
Nationwide
 

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
 

______________________________
PRODUCT
Medtronic Zinetics Manometric Catheter, Model 9012P2271. Water perfused, motility catheter, Recall # Z-1159-06
CODE
Lots 0001391 and 0001464
RECALLING FIRM/MANUFACTURER
 Recalling Firm: Medtronic Gastroenterology / Urology, Shoreview, MN, by letter on April 5, 2005 and April 6, 2006.
Manufacturer: Catheter & Disposable Technology, Inc., Plymouth, MN, firm initiated recall is ongoing.
REASON
Mislabeling - The 8 ports of the manometric catheter were incorrectly labeled 1,3,5,7,8,2,4,6 from the distal to the proximal end of the catheter. The correct port configuration is sequentially 1 through 8, from the distal to the proximal end of the catheter.
VOLUME OF PRODUCT IN COMMERCE
94 catheters
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Syringe, 62RNR 2.5 Microliter Syringe, with needle point style 3 (blunt needle
    point for use with HPLC injection valves and for sample pipetting)
    Part #: 87942. Recall # Z-1169-06;
b) 62 RNR Series 2.5 microliter syringe without needle, Part#: 7632-01.
    Recall # Z-1170-06
CODE
a) Lot 340007 and 342081;
b) Lot 342268 and 345852
RECALLING FIRM/MANUFACTURER
 Hamilton Co., Reno, NV, by letter on March 28, 2006, firm initiated recall is ongoing.
REASON
There is an error in the marking of the graduated divisions on syringes in affected lots that shows an amount that is double the actual volume of the syringe
VOLUME OF PRODUCT IN COMMERCE
99 units
DISTRIBUTION
Nationwide and Canada, Switzerland and Japan

END OF ENFORCEMENT REPORT FOR July 5, 2006

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