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U.S. Department of Health and Human Services

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Enforcement Report for December 6, 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.

December 6, 2006
06-49

RECALLS AND FIELD CORRECTIONS: FOOD and COSMETICS -- CLASS I

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PRODUCT
a) Dragonfly Brand Mango Pudding, UPC code: 721557357408,
Net Wt.: 2.82oz packed in 6 clear plastic cups, Recall # F-060-7;
b) Dragonfly Brand Banana Pudding, UPC code: 721557357415,
Net Wt.: 2.82oz packed in 6 clear plastic cups, Recall # F-061-7;
c) Dragonfly Brand Jackfruit Pudding, UPC code: 721557357422,
Net Wt.: 2.82oz packed in 6 clear plastic cups, Recall # F-062-7;
d) Dragonfly Brand Pink Guava Pudding, UPC code: 721557357446,
Net Wt.: 2.82oz packed in 6 clear plastic cups, Recall # F-063-7;
e) Dragonfly Brand COCONUT Pudding, UPC code: 721557357460,
Net Wt.: 2.82oz packed in 6 clear plastic cups, Recall # F-064-7;
f) Dragonfly Brand Pandan Pudding, UPC code: 721557357484,
Net Wt.: 2.82oz packed in 6 clear plastic cups, Recall # F-065-7;
g) Dragonfly Brand Papaya Pudding, UPC code: 721557357491,
Net Wt.: 2.82oz packed in 6 clear plastic cups, Recall # F-066-7;
h) Dragonfly Brand Taro Pudding, UPC code: 721557357507,
Net Wt.: 2.82oz packed in 6 clear plastic cups, Recall # F-067-7;
i) Dragonfly Brand Assorted Pudding, UPC code: 721557357552,
Net Wt.: 50.76oz packed in clear plastic container, Recall # F-068-7;
j) Dragonfly Brand Mini Lychee Pudding, UPC code: 21557357606,
Net Wt.: 14oz packed in clear plastic bag, Recall # F-069-7;
k) Dragonfly Brand Mini Mango Pudding, UPC code: 721557357613,
Net Wt.: 14oz packed in clear plastic bag, Recall # F-070-7;
l) Dragonfly Brand Mini Tropical Pudding, UPC code: 721557357620,
Net Wt.: 14oz packed in clear plastic bag, Recall # F-071-7;
m) Dragonfly Brand Mini Tropical Pudding, UPC code: 721557357637,
Net Wt.: 33.6oz packed in clear plastic container, Recall: # F-072-7
CODE
All Codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ustov, dba U.S. Trading Company, Hayward, CA, by letters on September 13, 2006 and by press release on September 20, 2006.
Manufacturer: Thomyam Food Industries, dba Wonder Food Enterprise, Kantan, Malaysia. Firm initiated recall is ongoing.
REASON
The products contain milk product (Sodium Caseinate) which is not declared in the ingredients statement on the label.
VOLUME OF PRODUCT IN COMMERCE
975 cases
DISTRIBUTION
Nationwide

______________________________
PRODUCT
General Mills Golden Grahams, Honey Graham, Ridged Cereal, Net Wt. 13 oz (368g). UPC 1600069320, Recall # F-075-7
CODE
"Better if Used By" codes: 20JUL07WC, 21JUL07WC, 22JUL07WC, 23JUL07WC, 24JUL07WC, 25JUL07WC and 26JUL07WC.
RECALLING FIRM/MANUFACTURER
Recalling Firm: General Mills, Inc., Minneapolis, MN., by press release and letter dated October 13, 2006 and e-mail on October 16, 2006.
Manufacturer: General Mills, West Chicago, IL. Firm initiated recall is ongoing.
REASON
Product may contain undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
30,606 cases (each case contains 12 retail packages, 13 oz)
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I

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PRODUCT
Ultravist (brand of iopromide) Injection, 370mg I/mL, 50, 75, 100, 125, 150, 200, 250, and 500 mL Sterile Solution Vials, Rx only, Not for Intrathecal Use, NDC 50419-346-58, Recall # D-404-7
CODE
All unexpired lots, all presentations. Item #, Size (mL), Lot, Exp: 34605, 50, 121082T, 12/2006; 34605, 50, 142682T, 02/2007; 34605, 50, 162002T, 04/2007; 34605, 50, 172692T, 05/2007; 34605, 50, 182012T, 06/2007; 34605, 50, 53511B, 07/2008. 34607, 75, 151532T, 03/2007; 34607, 75, 172242T, 05/2007. 34610, 100, 080282T, 08/2006; 34610, 100, 100612T, 10/2006; 34610, 100, 141322T, 02/2007; 34610, 100, 141332T, 02/2007; 34610, 100, 181882T, 06/2007; 34610, 100, 232652T, 11/2007; 34610, 100, 232662T, 11/2007; 34610, 100, 52508A, 04/2008; 34610, 100, 53513D, 08/2008; 34610, 100, 53514A, 08/2008; 34610, 100, 61526B, 01/2009; 34610, 100, 61531E, 03/2009; 34610, 100, 61533A, 03/2009. 34612, 125, 101762T, 10/2006; 34612, 125, 202222T, 08/2007; 34612, 125, 41500A, 01/2007; 34612, 125, 61501A, 03/2009. 34615, 150, 100602T, 10/2006; 34615, 150, 121202T, 12/2006; 34615, 150, 172462T, 05/2007; 34615, 150, 202412T, 08/2007; 34615, 150, 222472T, 10/2007; 34615, 150, 44501E, 10/2007; 34615, 150, 52502A, 04/2008; 34615, 150, 53504B, 09/2008; 34615, 150, 61506A, 03/2009. 34620, 200, 110912T, 11/2006; 34620, 200, 120922T, 12/2006; 34620, 200, 171832T, 05/2007; 34620, 200, 242852T, 12/2007; 34620, 200, 53512C, 09/2008; 34620, 200, 61520B, 03/2009. 34625, 250, 101542T, 10/2006; 34625, 250, 133092T, 01/2007; 34625, 250, 143102T, 02/2007; 34625, 250, 61504A, 01/2009, (Release date 4/11/2006); 34625, 250, 61504A, 01/2009, (Release date 4/28/2006). 34650, 500, 111092T, 11/2006. 34658, 500, 142642T, 02/2007; 34658, 500, 182282T, 06/2007; 34658, 500, 192062T, 07/2007; 34658, 500, 212442T, 09/2007; 34658, 500, 262832T, 02/2008; 34658, 500, 263062T, 02/2008,(Release date 4/20/2006); 34658, 500, 263062T, 02/2008, (Release date 5/17/2006); 34658, 500, 263072T, 02/2008; 34658, 500, 263072T, 02/2008; 34658, 500, 52504F, 04/2008; 34658, 500, 53508A, 03/2008; 34658, 500, 61516B, 03/2009. The following are SAMPLE Lots: 34691, 100, 141322T, 02/2007; 34691, 100, 181882T, 06/2007; 34691, 100, 232662T, 11/2007; 34691, 100, 53513D, 08/2008, (Release date 3/20/2006); 34691, 100, 53513D, 08/2008, (Release date 5/31/2006); 34691, 100, 53514A, 08/2008. 34695, 150, 100602T, 10/2006; 34695, 150, 222472T, 10/2007; 34695, 150, 52502A, 04/2008; 34695, 150, 53504B, 09/2008, (Release date 1/31/2006); 34695, 150, 53504B, 09/2008, (Release date 4/19/2006). 34697, 500, 111092T, 11/2006; 34697, 500, 262832T, 02/2008; 34697, 500, 52504F, 04/2008; 34697, 500, 53508A, 09/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Berlex, Inc., Wayne, NJ, by press release on July 31, 2006 and by letter o n August 3, 2006.
Manufacturer: Schering Ag (Wedding Plant), Berlin, Germany. Firm initiated recall is ongoing.
REASON
Presence of precipitate
VOLUME OF PRODUCT IN COMMERCE
854,629 vials
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

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PRODUCT
Megatope (Iodinated I 131 Albumin Injection USP), 4mL vials; each mL contains 10mg protein (human albumin), 16mg dibasic sodium phosphate, 1.6mg monobasic sodium phosphate, not more than 0.4mg guanidine HCl, sodium chloride and 9mg benzyl alcohol; NDA #17-837; manufactured by Iso-Tex Diagnostics, Inc., Friendswood, TX 77546, Recall # D-405-7
CODE
Lot #: M62010-115
RECALLING FIRM/MANUFACTURER
Iso-Tex Diagnostics, Inc., Friendswood, TX, by telephone and letter on October 31, 2006. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE
1/4mL vials
DISTRIBUTION
TN

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PRODUCT
Citalopram HBr Tablets, 20 mg, 100 Tablet bottles, Rx only, NDC 0258-3696-01, Recall # D-411-7
CODE
Lot #: P12047, Exp. Date: 6/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Inwood Laboratories, Inc., Commack, NY, by telephone on October 2, 2002 and by letter dated November 27, 2006.
Manufacturer: Forest Laboratories Ireland, Ltd., Dublin, Ireland. Firm initiated recall is ongoing.
REASON
Presence of foreign substance -- potential metal contamination.
VOLUME OF PRODUCT IN COMMERCE
11,276 bottles of 100 Tablets
DISTRIBUTION
Nationwide and PR

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

______________________________
PRODUCT
Source Plasma, Recall # B-0274-7
CODE
Units: 05FIND3352, 05FIND3662, 05FIND4719, 05FIND5250
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Fort Wayne, IN, by fax on June 8, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who acquired body piercings within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0283-7;
b) Recovered Plasma, Recall # B-0284-7
CODE
a) and b) Unit: 4037982
RECALLING FIRM/MANUFACTURER
Lifeshare Blood Centers, Beaumont, TX, by fax on November 10, 2005. 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 and Switzerland

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PRODUCT
Platelet Pheresis, Leukocytes Reduced, Recall # B-0289-7
CODE
Unit: 5711514
RECALLING FIRM/MANUFACTURER
Lifeshare Blood Centers, Beaumont, TX, by telephone on September 13, 2005. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect product code, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

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PRODUCT
Source Plasma, Recall # B-0294-7
CODE
Units: BY0137688, BY0138347
RECALLING FIRM/MANUFACTURER
DCI Biologicals Bryan LLC, Bryan, TX, by fax and follow-up letter on June 24, 2004. 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
2 units
DISTRIBUTION
NC

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PRODUCT
a) Fresh Frozen Plasma (Apheresis), Recall # B-0295-7;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-0296-7
CODE
a) Unit: R61749;
b) Units: R61749 (distributed as split product)
RECALLING FIRM/MANUFACTURER
Coastal Bend Blood Center, Corpus Christi, TX, by fax and telephone between September 19, 2005 and March 6, 2006.
REASON
Blood products, collected from a donor whose health history screening was not adequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX

______________________________
PRODUCT
Red Blood Cells, Recall # B-0299-7
CODE
Unit: 7389553
RECALLING FIRM/MANUFACTURER
Marquette General Hospital Inc., Marquette, MI, by letter dated July 10, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had previously tested reactive for hepatitis C (HCV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0300-7;
b) Fresh Frozen Plasma, Recall # B0301-7
CODE
a) and b) Unit: 7400061
RECALLING FIRM/MANUFACTURER
Marquette General Hospital, Inc., Marquette, MI, by letter dated July 10, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI

______________________________
PRODUCT
Source Plasma, Recall # B-0302-7
CODE
Units: 05FINC0735, 05FINC2158, 05FINC3109, 05FINC4494, 05FINC4876, 05FINC9417, 05FIND0383, 05FIND1013, 05FINE3104, 05FINE3414, 05FINE4088, 05FINE4559, 05FINC8351, 05FIND3928, 05FIND4258, 05FIND5784, 05FIND6840
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Fort Wayne, IN, by fax on May 10, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from donors who had body piercings within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
CA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0304-7
CODE
Unit: 268347415
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on August 9, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
Platelet Pheresis, Leukocytes Reduced, Recall # B-0305-7
CODE
Units: 04P60766 (distributed as split product)
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone on July 10, 2006 and by fax on July 11, 2006. Firm initiated recall is complete.
REASON
Blood products, possible contaminated with coagulase negative staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0330-7;
b) Cryoprecipitated AHF, Recall # B-0331-7;
c) Recovered Plasma, Recall # B-0332-7
CODE
a), b), and c) Unit: 5575374
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource, Glenview, IL., by telephone or facsimile on June 14, 2006 and June 16, 2006.
Manufacturer: LifeSource Oak Lawn, Oak Lawn, IL. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt - Jakob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IL and Switzerland

______________________________
PRODUCT
Platelets, Recall # B-0362-7
CODE
Units: 6217779
RECALLING FIRM/MANUFACTURER
Florida’s Blood Center, Inc., Orlando, FL, by telephone on April 22, 2002. Firm initiated recall is ongoing.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

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PRODUCT
Recovered Plasma, Recall # B-0366-7
CODE
Unit: 6972331
RECALLING FIRM/MANUFACTURER
Florida’s Blood Center, Inc., Orlando, FL, by facsimile on September 3, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0367-7;
b) Recovered Plasma, Recall # B-0368-7
CODE
a) and b) Unit: 3243882
RECALLING FIRM/MANUFACTURER
Florida’s Blood Center, Inc., Orlando, FL, by telephone on July 22, 2002 or by facsimile on September 4, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL and Austria

______________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0369-7
CODE
Units: 12631-8827 (Split unit)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated September 25, 2006.
Manufacturer: Blood Systems, Inc, Albuquerque, NM. Firm initiated recall is ongoing.
REASON
Blood products, collected from an ineligible donor due to use of the medication Avodart, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC and TX

______________________________
PRODUCT
Source Plasma, Recall # B-0375-7
CODE
Unit: 05HMSA9164
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Hattiesburg, MS, by facsimile on July 28, 2005. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0391-7
CODE
Unit: 5758049
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center Oklahoma, Oklahoma City, OK, by facsimile on May 15, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to use of Antibiotic medication, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0393-7
CODE
Unit: 12KJ21108 (part 1 and 2)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolina Region, Charlotte, NC, by facsimile on October 5, 2005. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Staphylococcus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC

______________________________
PRODUCT
Recovered Plasma, Recall # B-0403-7
CODE
Unit: 03KP25041
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by facsimile dated July 23, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt - Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

______________________________
PRODUCT
Source Plasma, Recall # B-0404-7
CODE
Units: 372002294, 372001398, 372000776, I65091427, I65084568, I65084057, I65082855, I65078367, I65077953, I65063100, I65062271, I65061851, I65061036 , I65050804, I65049273, I65048306, I65047223, I65046689, I65045133, I65044631, I65045517, I65043902, I65043283, I65042672, I65042154, I65041743, I65040747, I65040363, I65038830, I65038313, and I65030232
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, El Paso, TX, by facsimile on March 31, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had engaged in multiple high risk behavior activities, were distributed.
VOLUME OF PRODUCT IN COMMERCE
31 units
DISTRIBUTION
NC

______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0405-7
CODE
Unit: 16459-9747
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on April 1, 2005.
Manufacturer: Blood Systems, Inc., dba United Blood Services, Meridian, MS. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0406-7
CODE
Unit: 2063531
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on July 15, 2005. Firm initiated recall is complete.
REASON
Blood product, which was not properly quarantined after being confidentially identified by the donor to be excluded for donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0409-7
CODE
Unit: 2066386
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone and facsimile on September 13, 2005. Firm initiated recall is complete.
REASON
Blood product, which was possibly contaminated with Corynebacterium species, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0410-7
CODE
Unit: 2066003
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone and facsimile on September 5, 2005. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Micrococcus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced, Recall # B-0414-7;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0415-7
CODE
a) Unit: 2064961 (Part B);
b) Unit: 2064961
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone and facsimile on August 10, 2005. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0417-7
CODE
Units: 9039563 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 2, 2006. Firm initiated recall is complete.
REASON
Platelets, which were contaminated with Propionibacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0418-7
CODE
Unit: 49GP22247 (Part 2)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southwest Region, Tulsa, OK, by telephone on December 27, 2004. Firm initiated recall is complete.
REASON
Platelets, which were contaminated with Lactobacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0419-7
CODE
Unit: KC04519
RECALLING FIRM/MANUFACTURER
Blood Center of Southeastern Wisconsin, Milwaukee, WI, by facsimile transmission dated June 25, 2004. Firm initiated recall is complete.
REASON
Red Cells. collected from a donor who relayed a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0422-7;
b) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0423-7;
c) Platelets Pheresis Leukocytes Reduced, Recall # B-0424-7;
d) Fresh Frozen Plasma (Apheresis), Recall # B-0425-7
CODE
a) Unit: 4547142;
b) Unit: 4786424, 4757201, 4650003 and 4658564;
c) Unit: 4947135 (parts 1 and 2);
d) Unit: 4786424, 4757201, 4650003, 4663954, 4652404, 4658564 and 4547142
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on September 19, 2005. 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
14 units
DISTRIBUTION
OK and NY

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0426-7;
b) Recovered Plasma, Recall # B-0427-6
CODE
a) and b) Unit: 4957648
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on April 26, 2005. 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
CA and Switzerland

______________________________
PRODUCT
Source Plasma, Recall # B-0428-7
CODE
Unit numbers: CZ002370, CZ002228, CZ002075, CZ001939, CZ001815, CZ001606, CZ001446, CZ001321, CZ001174, CZ001023, CZ000429, 05BOH8576, 05BOHB8345, 05BOHB7973, 05BOHB7506, 05BOHB7237, 05BOHB6811, 05BOHB6587, 05BOHB2953, 05BOHA9332, 05BOHA8899, 05BOHA8411, 05BOHA7656, 05BOHA7425, 05BOHA6814, 05BOHA6254, 05BOHA5564, 05BOHA4492, 05BOHA4107, 05BOHA3933, 05BOHA3374, 05BOHA2517, 05BOHA1831, 05BOHA1470, 05BOHA1244, 05BOHA0819, and 05BOHA0324
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Mankato, MN, by facsimile on February 6, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
37 units
DISTRIBUTION
CA and Austria

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0170-7
CODE
Unit: 17FP06364
RECALLING FIRM/MANUFACTURER
American National Red Cross, North Central Region, St. Paul, MN, by telephone on March 2, 2004. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may compromise the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0298-7
CODE
Units: 22GM05973, 22GM05976, 22GM05980, 22GM05983, 22GM06991, 22GM06978, 22GM06969, 22GM06985, 22GM06977, 22GM06993, 22GM06981 22GM06990
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Philadelphia, PA, by telephone on July 19, 2006 and follow-up letter dated July 28, 2006. Firm initiated recall is complete.
REASON
Blood products, collected on a trip scale for which there was no documented daily QC, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
PA and NJ

______________________________
PRODUCT
Red Blood Cells, Frozen, Irradiated, Recall # B-0361-7
CODE
Units: 3764382 (Parts 1, 2, and 3), 3860440 (Parts 1, 2, and 3), 3764381 (Parts 1, 2, and 3), 3860487 (Parts 1, 2, and 3)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on July 30, 2002. Firm initiated recall is complete.
REASON
Blood products, which were not treated with rejuvenating solution prior to freezing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
FL

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PRODUCT
Source Plasma, Recall # B-0363-7
CODE
Unit: HP142301
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc., Chicago, IL, by facsimile on July 13, 2006. Firm initiated recall is complete.
REASON
Blood product, which was not properly quarantined after receiving post donation information concerning high-risk behavior, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0364-7
CODE
Unit: 9317166
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on August 28, 2002 and by letter dated August 29, 2002. Firm initiated recall is complete.
REASON
Blood product, which was labeled leukoreduced, but had an unacceptable white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

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PRODUCT
Red Blood Cells, Recall # B-0370-7
CODE
Unit: FJ14121
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by letter dated August 25, 2006.
Manufacturer: Heartland Blood Centers, Naperville, IL. Firm initiated recall is complete.
REASON
Blood product, collected in an expired collection bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0376-7
CODE
Unit: 12W05886
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by facsimile on July 8, 2005. Firm initiated recall is complete.
REASON
Platelets, which was possibly contaminated with coagulase negative Staphylococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0392-7
CODE
Unit: 4140793
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on July 17, 2006 and by letter July 27, 2006. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Propionibacterium acnes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0407-7
CODE
Units: 71X136302 (3 splits)
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on December 5, 2004.
Manufacturer: LifeSouth Community Blood Centers, Inc., Birmingham, AL. Firm initiated recall is complete.
REASON
Blood products, which were not processed according to specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AL

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0408-7
CODE
Unit: 71X13829X
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on March 1, 2005.
Manufacturer: LifeSouth Community Blood Centers, Inc., Birmingham, AL. Firm initiated recall is complete.
REASON
Blood product, which were not processed according to specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0411-7;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0412-7;
c) Platelets Pheresis, Leukocytes Reduced, Recall # B-0413-7
CODE
a) and b) Unit: 163821175;
c) Unit: 163821175 (split unit)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on March 29, 2005.
Manufacturer: Blood Systems, Inc., dba United Blood Services, Meridian, MS. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Penicillium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MS

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PRODUCT
Cryoprecipitated AHF, Recall # B-0416-7
CODE
Units: FH21897, FH21898, FH23288, FH23307
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by telephone on May 26, 2006 and by letter dated July 5, 2006. Firm initiated recall is complete.
REASON
Blood products, which were not manufactured according to specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
IL

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

_____________________________
PRODUCT
a) Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings,
Model #1104; Recall # Z-0212-2007;
b) Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings,
Model #1107, Recall # Z-0213-2007;
c) Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings,
Model #1110, Recall # Z-0214-2007
CODE
a) Lot #6000 (Serial numbers: 1480 thru 1489);
Lot #6058 (Serial numbers: 1490 thru 1493 and 1534 thru 1539); &
Lot #6155 (Serial numbers: 1540 thru 1559);
b) Lot #5869 (Serial numbers: 5193 thru 5200, 5207 thru 5211
and 5213 thru 5229);
Lot #5924 (Serial numbers: 5244, 5245, 5254, 5256 thru 5260, 5169,
5172, 5181, 5152, and 5185 thru 5187); &
Lot #5982 (Serial numbers: 5148, 5176, 5183, 5184, 5188, 5192, 5204,
5206, 5253 and 5255):
c) Lot #5868 (Serial numbers: 7558 thru 7565);
Lot #5890 (Serial numbers: 5230 thru 5243 and 7548) &
Lot #5923 (Serial numbers: 7533, 7536, 7539, 7543 thru 7545, 7548 and 7549)
RECALLING FIRM/MANUFACTURER
Lone Star Medical Products, Inc, StaffordTX., by letters on October 6, and November 8, 2004, and by telephone November 9 through November 12, 2004. Firm initiated recall is ongoing.
REASON
Ni-Cr Plated 1100 Series Retractors with a chromium finish were replaced by Retractors with a hard-anodized finish after complaints of peeling were received.
VOLUME OF PRODUCT IN COMMERCE
126 units
DISTRIBUTION
Nationwide and Internationally
_____________________________
PRODUCT
Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of MEB-2200A -Neuropack Evoked Potential and EMG Measuring System), Recall # Z-0218-2007
CODE
Any serial numbers up to 02160
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nihon Kohden America Inc, Foothill Ranch,CA, by telephone and fax starting September 1, 2006.
Manufacturer: Nihon Kohden Corp., Shinjuku-ku, Tokyo, Japan. Firm initiated recall is ongoing.
REASON
When the device is subject to physical shock, such as a drop to the floor, it may output a different value from the preset value. This may result in a superficial burn on the patient if the stimulation is done for a long time.
VOLUME OF PRODUCT IN COMMERCE
59 units
DISTRIBUTION
Nationwide

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PRODUCT
AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system, Model #DS300, Recall # Z-0221-2007
CODE
All Model #DS300 steppers
RECALLING FIRM/MANUFACTURER
Computerized Medical Systems, Inc., Saint Louis, MO, by letters dated November 9, 2006. Firm initiated recall is ongoing.
REASON
The In/Out adjustment knob can be over-turned, ultimately causing the incorrect placement of radioactive seeds in the patient.
VOLUME OF PRODUCT IN COMMERCE
62 steppers
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use Product Code: 852-00, Recall # Z-0222-2007.
CODE
Lot Number: 024448, Exp. Date: March 14, 2008
RECALLING FIRM/MANUFACTURER
Inverness Medical Professional Diagnostics, Scarborough, ME, by letter on September 29, 2006. Firm initiated recall is ongoing.
REASON
Mislabeled product: Outer kit label reads NOW Legionella Urinary Antigen Test, inside contains S.pneumonia test pouches.
VOLUME OF PRODUCT IN COMMERCE
533 kits x 22 tests (11,726 tests)
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
a) Roche Modular Drive (rchmdlri), analytical laboratory data interface,
Recall # Z-0223-2007;
b) Roche Cobas driver (rchcob6i), analytical laboratory data interface,
Recall # Z-0224-2007
CODE
a) Software Version: v8.00.0016, v8.00.0017, v7.00.0023 and v7.00.0024;
b) Software version: v8.00.0001 and v7.00.0001
RECALLING FIRM/MANUFACTURER
Data Innovations, Inc., South Burlington,VT., by letter dated October 25, 2006. Firm initiated recall is ongoing.
REASON
Software of modular driver may incorrectly report patient results as Quality Control Results.
VOLUME OF PRODUCT IN COMMERCE
56 units
DISTRIBUTION
Nationwide and Canada

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PRODUCT
a) Magnetom Trio magnetic resonance imaging, Model number 7387074,
Recall # Z-0225-2007;
b) Magnetom Trio TIM, magnetic resonance imaging, Model number 10018221,
Model number 10018222, Recall # Z-0226-2007
CODE
a) Serial numbers 20596, 20602, 20613, 20601, 20567, 20557, 20507,
20554, 20559, 20523, 20577, and 20565;
b) Serial numbers 35114, 35115, and 35177;
Serial numbers 35025, 35006, 35022, 35008, 35014, and 35019
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by Customer Safety Advisory on October 12, 2006.
Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.
REASON
Possible excessive RF exposure/may burn.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use), 3116239 (12 strip pack-patient self test), Non-U.S. Catalog Numbers 11937642190 [packaged 48 strips per box] and 11937634190 (packaged 12 strips per box), Recall # Z-0227-2007
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by press release and letters dated October 19, 2006. Firm initiated recall is ongoing.
REASON
Erroneous Test Results: Monitor may display "error" message or report falsely elevated patient results caused by insufficient amounts of active ingredient (thromboplastin) in the test strips.
VOLUME OF PRODUCT IN COMMERCE
Approx. 57,000,000 test strips
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) XiVE S plus Screw Implant D3.0/L11, Model Number 26-0122,
Friadent GmbH. (dental implant), Recall # Z-0230-2007;
b) XiVE S plus Screw Implant D3.0/L13, Model Number 26-0123,
Friadent GmbH. (dental implant), Recall # Z-0231-2007;
c) XiVE S plus Screw Implant D3.0/L15, Model Number 26-0125,
Friadent GmbH. (dental implant), Recall # Z-0232-2007
CODE
a) Model # 26-0122;
b) Model # 26-0123;
c) Model # 26-0125
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dentsply Friadent Ceramed, Lakewood, CO., by letter on November 17, 2006.
Manufacturer: Dentsply Friadent GmbH, Mannheim, Germany. Firm initiated recall is ongoing.
REASON
Sterility of dental implants may be compromised due to cracks in packaging/caps on vials.
VOLUME OF PRODUCT IN COMMERCE
5,050 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
Laborie Transducer Cartridge with Luer Lock Reference: DIS130, Recall # Z-0229-2007
CODE
Lot Numbers: 36G20M41 and 36H03M005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Laborie Medical Technologies, Williston,VT, by telephone on October 4-5, 2006.
Manufacturer: Smiths Medical, DublinOH. Firm initiated recall is ongoing.
REASON
Mislabeling: Product labeled with incorrect "Use Before" date and pouch labels missing lot number. (Incorrect dates-2006/07 or 2006/08; correct Use by dates-2009/08 for Lot 36H03M005 and 2009/07 for Lot 36G20M041
VOLUME OF PRODUCT IN COMMERCE
2,625 units
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR December 6, 2006

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