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U.S. Department of Health and Human Services

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Enforcement Report for May 11, 2005

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.

May 11, 2005
05-19

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

______________________________
PRODUCT
Atenolol Tablets, USP 25 mg, 1000 count bottles, Rx Only. Recall # D-212-5.
CODE
Lots 408107D, Exp. 07/2006.
RECALLING FIRM
Able Laboratories, Inc., S. Plainfield, NJ, by letter dated April 5, 2005. Firm initiated recall is ongoing.
REASON
Subpotent; 6 month stability.
VOLUME OF PRODUCT IN COMMERCE
3,034 packages.
DISTRIBUTION
FL, and OH.

_______________________________
PRODUCT
a) Armour Thyroid (thyroid tablets, USP), 30 mg.,
Rx only, packaged in 100 tablet bottle containers.
Product label contains NDC 0456-0458-01 (FOREST).
Recall # D-217-5;
b) Armour Thyroid (thyroid tablets, USP), 60 mg.,
Rx only, packaged in 100 tablet bottle containers.
Product label contains NDC 0456-0459-01 (FOREST).
Recall # D-218-5;
c) Armour Thyroid (thyroid tablets, USP), 120 mg.,
Rx only, packaged in 100 tablet bottle containers.
Product label contains NDC 0456-0461-01 (FOREST).
Recall # D-219-5.
CODE
a) Lots 034052, 035064, 035066, 036171, and 036456;
b) Lots 034053, 034488, 035065, 035997, 036500, 040423;
c) Lots 034051, 035067, 035995, 035996, 036499, 042018.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amerisource Health Services, Columbus, OH, by letter on April 12, 2005.
Manufacturer: Forest Pharmaceuticals, Inc., Earth City, MO. Firm initiated recall is ongoing.
REASON
Subpotent: Product may not maintain potency throughout shelf life.
VOLUME OF PRODUCT IN COMMERCE
58,544/100 tablet bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

______________________________
PRODUCT
Amoxil (trade name), Amoxicillin as Trihydrate, powder for oral suspension, 250 mg/5 mL, 150mL, Rx only, NDC No.: 0029-6009-22. Recall # D-190-5.
CODE
Lot T40007, Exp 4/30/2007; Lot No. T40008, Exp 4/30/2007.
RECALLING FIRM
Recalling Firm: GlaxoSmithKline, Inc., Durham, NC, by letter on March 29, 2005.
Manufacturer: SmithKline Beecham Corp./dba GlaxoSmithKline, Bristol, TN. Firm initiated recall is ongoing.
REASON
Mislabeling: 250mg/5mL bottles may be mislabeled as 250mg/5mL, 100mL bottles.
VOLUME OF PRODUCT IN COMMERCE
201,744 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Forest Armour Thyroid (thyroid tablets, USP), 1?4 Grain (15 mg),
each tablet contains levothyroxine (T4) 9.5 mcg and
liothyronine (T3) 2.25 mcg, packaged in 100-tablet bottles,
RX, NDC 0456-0457-01. Recall # D-196-5;
b) Forest Armour Thyroid (thyroid tablets, USP), 1/2 Grain (30 mg),
each tablet contains levothyroxine (T4) 19 mcg and
liothyronine (T3) 4.5 mcg, packaged in 100- and 1,000-tablet
bottles, 10/10-tablet unit dose strips, and in 50,000-tablet
drums for repacking only, RX, NDC 0456-0458-01, -00, -63, and
,69 respectively. Recall # D-197-5;
c) Forest Armour Thyroid (thyroid tablets, USP), 1 Grain (60 mg),
each tablet contains levothyroxine (T4) 38 mcg and
liothyronine (T3) 9 mcg, packaged in 100-, 1,000-, and
5,000-tablet bottles, 10/10-tablet unit dose strips boxes,
and 50,000-tablet drums for repacking only, RX,
NDC 0456-0459-01, -00, -51, -63, and ,69 respectively.
Recall # D-198-5;
d) Forest Armour Thyroid (thyroid tablets, USP), 1 1?2 Grain (90 mg),
each tablet contains levothyroxine (T4) 57 mcg and
liothyronine (T3) 13.5 mcg, packaged in 100-tablet bottles,
RX, NDC 0456-0460-01. Recall # D-199-5;
e) Forest Armour Thyroid (thyroid tablets, USP), 2 Grain (120 mg),
each tablet contains levothyroxine (T4) 76 mcg and
liothyronine (T3) 18 mcg, packaged in 100- and 1,000-tablet
bottles, 10/10-tablet unit dose strip boxes, and 50,000-tablet
drums for repacking only, RX, NDC 0456-0461-01, -00, -63, and
,69 respectively. Recall # D-200-5;
f) Forest Armour Thyroid (thyroid tablets, USP), 3 Grain (180 mg),
each tablet contains levothyroxine (T4) 114 mcg and
liothyronine (T3) 27 mcg, packaged in 100-tablet bottles,
RX, NDC 0456-0462-01. Recall # D-201-5;
g) Forest Armour Thyroid (thyroid tablets, USP), 4 Grain (240 mg),
each tablet contains levothyroxine (T4) 152 mcg and
liothyronine (T3) 36 mcg, packaged in 100-tablet bottles,
RX, NDC 0456-0463-01. Recall # D-202-5;
h) Forest Armour Thyroid (thyroid tablets, USP), 5 Grain (300 mg),
each tablet contains levothyroxine (T4) 190 mcg and
liothyronine (T3) 45 mcg, packaged in 100-tablet bottles,
RX, NDC 0456-0464-01. Recall # D-203-5.
CODE
a) Lot 080301, Exp. May-05; Lot 080302, Exp. May-05, and
Lot 080303, Exp. May-05;
b) Unit dose , Lot 100317, Exp. Aug-05;
100-tablet bottles , Lot 060325, Exp. May-05,
Lot 080304, Exp. Jun-05; Lot 080329, Exp. Jun-05;
Lot 090317, Exp. Aug-05; Lot 100317, Exp. Aug-05;
50,000-tablet drum , Lot 060324, Exp. May-05;
Lot 080304, Exp. Jun-05; Lot 090317, Exp. Aug-05;
1,000-tablet bottle , Lot 060324, Exp. May-05;
Lot 060325, Exp. May-05; Lot 100317, Exp. Aug-05;
c) Unit dose , Lot 070322, Exp. Jun-05;
100-tablet bottles , Lot 070311, Exp. May-05,
Lot 070321, Exp. Jun-05; Lot 070322, Exp. Jun-05;
1,000-tablet bottles - Lot 090308, Exp. Aug-05;
50,000-tablet drums , Lot 070311, Exp. May-05;
Lot 110319, Exp. Aug-05;
d) 100-tablet bottles , Lot 040355, Exp. Mar-05;
Lot 050315, Exp. Mar-05; Lot 080340, Exp. Jul-05;
Lot 100319, Exp. Aug-05;
e) Unit dose , Lot 080330, Exp. Jul-05;
100-tablet bottles , Lot 040334, Exp. Mar-05,
Lot 040335, Exp. May-05; Lot 070306, Exp. May-05;
Lot 080330, Exp. Jul-05; Lot 100318, Exp. Aug-05;
50,000-tablet drum , Lot 040334, Exp. Mar-05,
Lot 070306, Exp. May-05, Lot 080330, Exp. Jul-05;
1,000-tablet bottles - Lot 040334, Exp. Mar-05;
Lot 040335, Exp. May-05.
f) Lot 050350, Exp. Apr-05; and Lot 080339, Exp. Jul-05;
g) Lot 040347, Exp. Mar-05;
h) Lot 040348, Exp. Mar-05.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Forest Pharmaceuticals, Inc, Earth City, MO, by letters dated March 17, 2005 and March 31, 2005.
Manufacturer: Forest Pharmaceuticals, Inc, Cincinnati, OH. Firm initiated recall is ongoing.
REASON
Stability failures.
VOLUME OF PRODUCT IN COMMERCE
6,891/10/10-tab. unit dose strip boxes;
598,552/100-tab. bottles;
10,984/1,000-tab. bottles;
350/5,000-tab. bottles;
441/50,000-tab. drums.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
FLUCONAZOLE TABLETS, 100 mg, 100 count unit dose package, 10 Blister Strips of 10 tablets, Rx only. NDC 49884-939-74. Recall # D-211-5.
CODE
Lot FD971A, expiration date Oct 2006.
RECALLING FIRM/MANUFACTURER
Genpharm, Inc., Ontario, Canada, by letters dated April 1, 2005. Firm initiated recall is ongoing.
REASON
Misbranding; partially illegible print on blister strips.
VOLUME OF PRODUCT IN COMMERCE
3,600 cartons.
DISTRIBUTION
Nationwide.

______________________________
PRODUCT
Prascion (sodium sulfacetamide 10% and sulfur 5%) Cleanser, Rx only, 6 oz (170.3 g). Recall # D-213-5.
CODE
Lot #GB472, GB500 & GB803.
RECALLING FIRM
Kiel Laboratories, Inc., Gainesville, GA, by letter on April 12, 2005. Firm initiated recall is complete.
REASON
Subpotent: The product may become sub-potent prior to reaching the assigned 24 month expiration date.
VOLUME OF PRODUCT IN COMMERCE
11,647 units.
DISTRIBUTION
Nationwide.

______________________________
PRODUCT
a) Armour Thyroid (thyroid tablets, USP), 1/2 Grain (30 mg),
each tablet contains levothyroxine (T4) 19 mcg and
liothyronine (T3) 4.5 mcg, packaged in 100-tablet
bottles, Rx, NDC 0456-0458-01. Recall # D-214-5;
b) Armour Thyroid (thyroid tablets, USP), 1 Grain (60 mg),
each tablet contains levothyroxine (T4) 38 mcg and
liothyronine (T3) 9 mcg, packaged in 100-tablet bottles,
Rx, NDC 0456-0459-01. Recall # D-215-5.
CODE
a) Lot Nos.: 09164, 09330, 09792, 10427, 10918, 11215;
b) Lot Nos.: 09530, 09531, 09787, 10011,10794, 11540, 11541.
RECALLING FIRM
Rx PAK, Memphis, TN, by intranet on March 23, 2005. Firm initiated recall is complete.
REASON
Stability Failure.
VOLUME OF PRODUCT IN COMMERCE
135,500 units.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-0832-5.
CODE
Units: 12KZ16113, 12KZ16893.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on January 9, 2004 and by letter dated January 21, 2004. Firm initiated recall is complete
REASON
Blood products, collected from a donor who had traveled to an area considered to be endemic for malaria, were contributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC.

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0936-5.
CODE
Unit number: 4631971.
RECALLING FIRM
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on December 17, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a hematocrit or hemoglobin test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OK.

_______________________________
PRODUCT
Platelet Pheresis, Leukocyte Reduced. Recall # B-0979-5.
CODE
Unit: 26FQ22720.
RECALLING FIRM/MANUFACTURER
The American Red Cross Blood Services, Gulf Coast Region, Mobile, AL, by letter dated February 14, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.

_______________________________
PRODUCT
Platelet, Leukocyte Reduced. Recall # B-0980-5.
CODE
Unit: 19LG19164.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Tennessee Valley Region, Nashville, TN, by telephone and letter on October 25, 2004. Firm initiated recall is complete.                       
REASON
Blood product, manufactured from an overweight unit of Whole Blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Platelets, Leukocyte Reduced. Recall # B-0981-5.
CODE
Unit: 19GW59852.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Tennessee Valley Region, Nashville, TN, by telephone on June 14, 2004 and letter on June 15, 2004. Firm initiated recall is complete.
REASON
Blood product, manufactured from an overweight unit of Whole Blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Source Plasma. Recall # B-0982-5.
CODE
Units: 0420956032, 0420956329, 0420956963, 0420957236, 0420957860, 0420958156, 0420958541, 0420958925, 0420960188, 0420960469, 0420960984, 0420961353, 0420961833, 0420962277, 0420962725, 0420963631, 0420963955, 0420967478, 0420967943, 0420988995, 0420995104, 04220995734, 0420995941, 0420996972.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Lansing, MI, by fax on or about July 22, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had previously been deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 units.
DISTRIBUTION
FL, and NC.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0989-5;
b) Recovered Plasma. Recall # B-0990-5.
CODE
a) and b) Unit: 26FJ34363.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Gulf Coast Region, Mobile, AL, by fax and letter on January 4, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had engaged in high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AL, and Switzerland.

_______________________________
PRODUCT
Platelets, Leukocytes Removed. Recall # B-0992-5.
CODE
Unit number: 19GW51439.
RECALLING FIRM/MANUFACTURER
American Red Cross, Nashville, TN, by telephone and by letter, dated August 27, 2002. Firm initiated recall is complete.
REASON
Blood product, in which the corresponding red blood cell was possibly contaminated with Enterococcus faecalis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Platelet Pheresis, Leukoreduced. Recall # B-0994-5.
CODE
Unit 12W96709.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on December 17, 2004, and by letter on December 27, 2004. Firm initiated recall is complete.
REASON
Blood product, collected in an apheresis collection kit where the set up time may have exceeded the manufacturer?s acceptable time period for use, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0999-5. 
CODE
Unit number: 12LW96259.
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Region, Charlotte, NC, by telephone and letter, dated December 16, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1001-5.
CODE
Unit number: LN12736.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on January 4, 2005. Firm initiated recall is complete.
REASON
Platelet Pheresis, possibly contaminated with bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1002-5.
CODE
Unit number: 26FQ22938 (Part 1).   
RECALLING FIRM/MANUFACTURER
American Red Cross, Gulf Coast Region, Mobile, AL, by telephone and letter, dated February 7, 2002. Firm initiated recall is complete.
REASON
Platelet Pheresis, in which the corresponding blood component was contaminated with coagulase-negative, Staphylococcus and implicated in a transfusion reaction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1006-5.
CODE
Unit 04C92255.
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA, by facsimile on February 4, 2005 and by letter dated February 4, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had lived in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1007-5.
CODE
Unit 04R19468.
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA, by facsimile on February 22, 2005 and by letter dated February 22, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from donors who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1009-5.
CODE
Unit 04P55891.
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA, by telephone on February 14, 2005 and by letter dated February 16, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to use of the medication Proscar, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1013-5;
b) Recovered Plasma. Recall # B-1014-5.
CODE
a) and b) Units: 26FJ14534, 26FJ21236.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Gulf Coast Region, Mobile, AL, by telephone, follow-up letter and fax on December 12, 2000. Firm initiated recall is complete.
REASON
Blood Products, collected from a donor who had previously tested reactive for hepatitis C (HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
AL, and CA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocyte Reduced. Recall # B-1015-5;
b) Recovered Plasma. Recall # B-1016-5.
CODE
a) and b) Units: 04KJ03969, 04KM53407.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, New England Region, Dedham, MA, by fax and follow-up letter on January 11, 2005. Firm initiated recall is complete.
REASON
Blood Products, collected from a donor with a history of hepatitis C and mononucleosis were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
MA, and CA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1019-5;         
b) Plasma Frozen. Recall # B-1020-5;          
c) Recovered Plasma. Recall # B-1021-5.
CODE
a) Unit numbers: 12FZ13002, 12LE98950, 12LW91617;
b) Unit number: 12LW91617;
c) Unit numbers: 12FZ13002, 12LE98950.
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Region, Charlotte, NC, by telephone and by letter, dated July 30, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
NC, GA, and CA.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1023-5.
CODE
Unit 04FC23433.
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA, by telephone on January 21, 2005 and by letter dated January 21, 2005. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
ME.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1024-5.
CODE
Unit 0112239.
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Lauderhill, FL, by facsimile on February 8, 1999. Firm initiated recall is complete.
REASON
Blood product, mislabeled as a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-1028-5;
b) Recovered Plasma. Recall # B-1029-5.
CODE

a) and b) Unit number: 12FC80938.  
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Region, Charlotte, NC, by letters, dated November 7, 2003, and February 2, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to illegal drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA, and NC.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1033-5.
CODE
Units 19LH02074 (Part 1 & Part 2).
RECALLING FIRM/MANUFACTURER
American National Red Cross, Tennessee Valley Region, Nashville, TN, by telephone and by letter dated May 26, 2004. 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-1034-5.
CODE
Unit number: LS05599.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on January 4, 2005. Firm initiated recall is complete.
REASON
Platelets Pheresis, with a decreased platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1038-5.
CODE
Unit 4206982.
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St. Petersburg, FL, by facsimile on October 20, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was incorrectly tested for the antibody to the hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

RECALLS AND FIELD CORRECTIONS: Biologics - CLASS III

_______________________________
PRODUCT
Red Blood Cells, Irradiated. Recall # B-0995-5.
CODE
Unit numbers: 0198903, 0150196, 0197656.
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Lauderhill, FL, by facsimile, on August 6, 1999.
Firm initiated recall is complete.
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Platelet Pheresis, Leukoreduced, Irradiated. Recall # B-1004-5.
CODE
Unit: S14633.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by letter dated November 1, 2004. 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
PA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1005-5.
CODE
Units 33GR76222, 33GR76195.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Connecticut Region, Farmington, CT, by telephone on January 14, 2005 and by letter dated January 18, 2005.
REASON
Blood products, manufactured from units of whole blood more than eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CT.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-1017-5;
b) Platelets. Recall # B-1018-5.
CODE
a) and b) Unit number: 4223645.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by facsimile and by letter, dated May 10, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to the use of Cipro, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1022-5.
CODE
Unit 307736899.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on March 28, 2003.
Manufacturer: Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had surgery within 12 months of the donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MN.

_______________________________
PRODUCT
Source Plasma. Recall # B-1030-5.
CODE
Unit number: BRG012913.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Baton Rouge, LA, by facsimile on November 11, 2002. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was collected from a donor whose medical history was not adequately determined at the time of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Spain.

_______________________________
PRODUCT
Source Plasma. Recall # B-1031-5.
CODE
Unit 02FNDB1927.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Fargo, ND, by facsimile on April 9, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had a sinus infection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Fresh Frozen Plasma (Apheresis). Recall # B-1032-5.
CODE
Unit numbers: 0009621 (FF2, FF3, FF4).
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Lauderhill, FL, by facsimile on November 17, 1998. Firm initiated recall is complete.
REASON
Unlicensed blood products were distributed in interstate commerce.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NY.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1035-5.
CODE
Unit number: 5009411.
RECALLING FIRM/MANUFACTURER
Altru Health System, Grand Forks, ND, by letter dated May 6, 2001. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who tested negative for the antibody for the human immunodeficiency virus (anti-HIV), but previously tested positive for anti-HIV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
Recall # B-1039-5;
b) Red Blood Cells Leukocytes Reduced Irradiated.
Recall # B-1040-5;
CODE
a) Units 04E72996, 04E72997, 04E72998, 04E72999,
04E73000, 04E73001, 04E73002, 04E73003, 04E73004,
04E73005, 04E73008, 04E73009, 04E73010, 04E73011,
04E73012, 04E73013, 04E73014, 04E73016, 04E73017,
04E73018, 04E73020, 04E73021, 04E73022, 04E73023,
04E73024, 04E73025, 04E73026, 04E73027, 04E73028,
04E73029, 04E73030, 04E73031, 04E73032, 04E73033,
04E73034, 04E73035, 04E73036, 04E73037, 04E73038,
04E73039, 04E73040;
b) Unit 04E73006.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Dedham, MA, by facsimile on October 6, 2004 and by letter dated October 7, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from donors in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
42 units.
DISTRIBUTION
MA, and NY.

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Sunrise Hoyer Advance Hydraulic and battery powered Patient lifts.
a) Model: Hoy-Advance-E;
b) Model: Hoy-Advance-H. Recall # Z-0785-05.
CODE
a) Serial Numbers: 0409L2383, 0409L2384, 0411L001-0411L0023;
b) Serial Numbers: 0409L2341-0409L2380, 0410L0680-0410L0727, 0410L0781-0410L0862.
RECALLING FIRM/MANUFACTURER
Sunrise Medical, Inc., Longmont, CO, by telephone and letters, dated February 3, 2005. Firm initiated recall is ongoing.
REASON
The leg actuation mechanism on certain Hoyer Advance Patient Lifts may not operate properly, which could cause the lift to become unstable.
VOLUME OF PRODUCT IN COMMERCE
27 units.
DISTRIBUTION
WI, FL, GA, TX, OK, and Canada.

_______________________________
PRODUCT
VersaRad Generator. Recall # Z-0787-05.
CODE
Generator S/N?s: 9918-0704-002; 9918-0804-003; 9918-0804-007; 9918-0804-005; 9918-0204-001; 9918-0304-001; 9918-0304-003; 9918-03304-004; 9918-0505-002; 9918-0604-001; 9918-0604-003; 9918-0604-006; 9918-0704-001; 9918-0704-003; 9918-0704-004; 9918-0704-005; 9918-0803-002; 9918-0804-002; 9918-0903-002; 9918-1003-001; 9918-1203-002; 9918-0604-007; 9918-0804-004; 9918-0404-002; 9918-0803-001; 9918-0504-003; 0304-002; 0404-003; 0504-004; 9918-0604-005; 9918-0903-001; 9918-0404-001; 9918-0604-002; 9918-0504-001; 9918-0804-001; 9918-1103-001; 9918-1203-001; 9918-0604-004.
RECALLING FIRM/MANUFACTURER
Fisher Imaging Corporation, Denver, CO, by letters on September 30, 2004. Firm initiated recall is ongoing.
REASON
Some VersaRad Systems have a faulty weld that may result in oil leakage.
VOLUME OF PRODUCT IN COMMERCE
38 units.
DISTRIBUTION
Germany, Greece, Italy, Kuwait, Spain, Sweden, and Switzerland.

_______________________________
PRODUCT
a) Asahi AM-BIO Series Hollow Fiber Dialyzers;
a wet model multiple use dialyzer consisting of
hollow fiber membranes of alkyl ether polymer grafted
cellulose housed within a plastic casing of styrene
butadiene block polymer, filled at the factory with
fluid to facilitate priming by the user, and
sterilized by gamma radiation before shipment;
12 units per case;
Schein product code 629-6426, Model AM-BIO-65 ,
1.3 m2 surface area,
Schein product code 629-3146, Model AM-BIO-75 ,
1.5 m2 surface area,
Schein product code 629-0041, Model AM-BIO-100 ,
2.0 m2 surface area. Recall # Z-0788-05;
b) Asahi AM-BIO-HX Extended Range Series Hollow Fiber
Dialyzers; a wet model single use dialyzer consisting
of hollow fiber membranes of alkyl ether polymer
grafted cellulose housed within a plastic casing of
styrene butadiene block polymer, filled at the factory
with fluid to facilitate priming by the user, and
sterilized by gamma radiation before shipment;
12 units per case;
Schein product code 629-6404,Model AM-BIO-HX-75 ,
1.5 m2 surface area and
Schein product code 629-8540, Model AM-BIO-HX-100 ,
2.0 m2 surface area. Recall # Z-0789-05;
c) Asahi APS Series Hollow Fiber Dialyzers; a wet model
mutiple use dialyzer consisting of hollow fiber
membranes of polysulfone housed within a plastic
casing of styrene butadiene block polymer, filled
at the factory with fluid to facilitate priming by
the user, and sterilized by gamma radiation before
shipment; 12 units per case; Schein product CODE
629-4923, Model APS-21R - 2.1 m2 surface area.
Recall # Z-0790-05;
d) Terumo Clirans Series E Excebrane Hollow Fiber
Dialyzers; a wet model single use dialyzer
consisting of hollow fiber membranes (23 microns
thick) of vitamin E coated copolymer cellulose
housed within a polyurethane casing, filled at the
factory with fluid to facilitate priming by the user,
and sterilized by autoclaving before shipment;
24 units per case; Schein product code 629-9041,
Model CL*E12NLA - 1.2 m2 surface area,
Schein product code 629-5978, Model CL*E15NLA ,
1.5 m2 surface area, Schein product code 629-1824,
Model CL*E18NLA - 1.8 m2 surface area and
Schein product code 629-7278, Model CL*E20NLA ,
2.0 m2 surface area. Recall # Z-0791-05;
e) Terumo Clirans Series EE Excebrane Hollow Fiber
Dialyzers; a wet model single use dialyzer
consisting of hollow fiber membranes (28 microns
thick) of vitamin E coated copolymer cellulose
housed within a polyurethane casing, filled at the
factory with fluid to facilitate priming by the user,
and sterilized by autoclaving before shipment;
24 units per case; Schein product code 629-3169,
Model CL*EE12NLA - 1.2 m2 surface area,
Schein product code 629-8232, Model CL*EE15NLA ,
1.5 m2 surface area and Schein product code 629-5106,
Model CL*EE20NLA - 2.0 m2 surface area.
Recall # Z-0792-05.
CODE
a) Lot numbers 04191H, 044A4T, 0419H4A4T;
Lot numbers 044L54, 046Q73, 044L546Q73;
Lot numbers 044J53, 04616X, 04616X626Y,
04626Y, 04626Y636B, 04636B, 04636B696K,
04696K, 046F6Q, 046F6Q6L6S, 046H6S,
046L6S, 046L6S6M6V, 046M6V, 046M6V6P72,
046P72, 046Q73;
b) Lot number 047F7S; Lot numbers 04454F, 045Z5L,
045Z5L5A5N, 045A5N, 045A5N5B5P, 045B5P, 045B5P5Q5W,
045Q5W, 045S64, 045T69;
c) Lot numbers U4383Y, U4383Y8K8N, X46R6V, W4797A,
W4797A7X7B, X47X7B, X47X7B7Q7U, W47Q7U, W47Q7U7R7U,
W47R7U, W48K8N;
d) Lot numbers 040408, 0404080511, 040511, 0405110610,
040610, 040909;
Lot numbers 040406, 0404060511, 040511;
Lot numbers 031020, 0310201215, 031215;
Lot numbers 020604, 0206040711, 020711;
e) Lot number 040116;
Lot number 031212;
Lot numbers 031128, 0311281223, 031223.
RECALLING FIRM/MANUFACTURER
Asahi Medical Co. Ltd, Chiyoda Ku, Japan, by letters dated March 30 and 31, 2005, April 8, April 13, and 14, 2005 and April 21, 2005. Firm initiated recall is ongoing.
REASON
Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.
VOLUME OF PRODUCT IN COMMERCE
174,587 units.
DISTRIBUTION
Nationwide and Puerto Rico.

_______________________________
PRODUCT
Stryker brand Birthing Bed; Model 4701. Recall # Z-0793-05.
CODE
All units manufactured October 18 through November 5, 2004.
RECALLING FIRM
Stryker Medical, Kalamazoo, MI, by letter dated March 31, 2005. Firm initiated recall is complete.
REASON
Trendelenburg and reverse trendelenburg features may not function.
VOLUME OF PRODUCT IN COMMERCE
31 beds.
DISTRIBUTION
Ca, GA, IN, IA, MI, OH, and PA.

_______________________________
PRODUCT
Axiom Artis X-Ray System using software version VB11D or VB20B. Recall # Z-0796-05.
CODE
Model numbers 5904433, 5904441, 5904466, 7007755, 7008605, 7412807, 7413078, 7555365, 7555373, 7727717, and 7728350.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated March 24, 2005.
Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.
REASON
Live display in exam room may sporadically stop working although the display in the control room remains fully operational.
VOLUME OF PRODUCT IN COMMERCE
295 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Altaire, Magnetic Resonance Imaging Device. Recall # Z-0797-05.
CODE
Serial numbers: L001 to L212.
RECALLING FIRM/MANUFACTURER
Hitachi Medical Systems America, Inc., Twinsburg, OH, by letter, dated April 11, 2005. Firm initiated recall is ongoing.
REASON
The electrical cables that supply gradient power to the magnet can become loose over time and create a potential fire hazard.
VOLUME OF PRODUCT IN COMMERCE
212 devices.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product is packaged in 12 treatment kit box labeled as Buffered Iontophoretic Delivery Electrode System Treatment Kit, 12 treatments. Recall # Z-0799-05.
CODE
Lot #251478-003.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Selectivemed Components, Inc., Mount Vernon, OH, by letter, dated March 15, 2005.
Manufacturer: MRP, Inc., Monticello, IN. Firm initiated recall is ongoing.
REASON
The conductor portion of the electrode is installed backwards, with the plastic and silver portions of the electrode reversed.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2,600 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Baxter Spinal Anesthesia Trays; sterile, single use only procedure trays that contain BD 25 G x 8.9 cm (3-1/2?) Whitacre Spinal Needles. Recall # Z-0800-05.
CODE
Product code 1T2156, lots GD809251, GD809582; product code 1T2352, lot GD810325; product code 1T2356, lots GD809152, GD810333; product code 1T2450, lot GD809590; product code 1T2451, lot GD801282; product code 1T2456, lots GD810564, GD808519, GD800516, GD804492, GD805960, GD812024, GD810861, GD806323, GD810366, GD806620; product code 1T7457, lots GD810911, GD809624; product code 2T0086, lot 809335; product code 2T0188, lot GD812255; product code 2T0298, lot GD809632; product code 2T0310, lot GD809640; product code 2T0329, lot GD809657; product code 2T0341, lot GD808642; product code 2T0378, lot GD809673; product code 2T0455, lots GD810614, GD809699; product code 2T0458, lot GD811448; product code 2T0555, lots GD810622, GD809400; product code 2T0618, lot GD811182; product code 2T0642, lots GD810655, GD808931; product code 2T0643, lot GD811455; product code 2T0661, lots GD808956, GD809434; product code 2T0770, lot GD810275; product code 2T0783, lot GD810101; product code 2T0784, lot GD809830; product code 2T2001, lot GD810788; product code 2T2007, lots GD810416, GD812156; product code 2T2008, lot GD809467; product code 2T2011, lot GD811737; product code 2T2014, lots GD809475, GD811026; product code 2T2022, lot GD808683; product code 2T2023, lot GD808311; product code 2T2025, lots GD811471, GD810127; product code 2T2108,lot GD809004; product code 2T2226, lot GD810721; product code 2T2230, lots GD811059, GD808360; product code 2T2287, lot GD809491; product code 2T2342, lots GD811117, GD808410.
FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters, dated March 28, 2005.
Manufacturer: Baxter Healthcare Corp., Cleveland, MI. Firm initiated recall is ongoing.
REASON
The anesthesia trays contain BD 25G Spinal Needles which have leakage at the plastic hub of the needle.
VOLUME OF PRODUCT IN COMMERCE
127,340 trays.
DISTRIBUTION
Nationwide and Internationally.

______________________________
PRODUCT
a) Sentinel Implantable Cardioverter-DefibrilIator (ICD)
model 2010 is a multi-programmable, two-zone,
tiered-therapy device that incorporates anti-tachycardia
pacing (ATP), cardioversion, and defibrillation (DEF)
tachyarrhythmia therapies. The device also includes a
programmable Hot Can electrode and bradycardia pacing
support. Recall # Z-0801-05;
b) Sentinel Implantable Cardioverter-DefibrilIator (ICD)
model 2012 is a multi-programmable, two-zone,
tiered-therapy device that incorporates anti-tachycardia
pacing (ATP), cardioversion, and defibrillation (DEF)
tachyarrhythmia therapies. The device also includes a
programmable Hot Can electrode and bradycardia pacing
support. Recall # Z-0802-05.
CODE
a) AK630187, AK630131, AK630076, AK630290, AK630173,
AK630115, AK730368, AK630130, AK630167, AK630099,
AK630106, AK730377, AK730393, AK730443, AK730363,
AK630157, AK730442, AK630026, AK630135, AK630102,
AK630226, AK630142., AK730431, AK630185, AK630137,
AK630230, AK630147, AK630015, AK630030, AK630197,
AK630098, AK730448, AK630090, AK630265, AK630160,
AK730455, AK730381, AK630146,
OUS codes: AK630029, AK630043, AK630045, AK630046,
AK630048, AK630055, AK630066, AK630067, AK630069,
AK630072, AK630073, AK630075, AK630078, AK630080,
AK630083, AK630101, AK630104, AK630108, AK630111,
AK630112, AK630121, AK630129, AK630154, AK630155,
AK630172, AK630174, AK630175, AK630178, AK630186,
AK630199, AK630207, AK630216, AK630221, AK630223,
AK630231, AK630247, AK630280, AK630281, AK630283,
AK630284, AK630296, AK630297, AK630298, AK630299,
AK730435, AK730439, AK730441;
b) BE650129, BE650026 and BE650027. OUS: BE650038 and BE650002.
RECALLING FIRM
Ela Medical Llc, Plymouth MN, by letter, on January 25, 2005. Firm initiated recall is ongoing.
REASON
A change in the automatic capacitor reform schedule during the later portion of the device?s useful life can result in excessive 750V charge times and disable the device?s ability to report an End of Life (EOL) indicator due to excessive charge times unless the patient is receiving periodic 750V therapy shocks.
VOLUME OF PRODUCT IN COMMERCE
59 within US and 49 OUS.
DISTRIBUTION
Nationwide, UK, Italy, Germany and Argentina.

_______________________________
PRODUCT
a) e-fix E19 power drive. The product is a wheelchair
component/accessory. Recall # Z-0803-05;
b) e-fix E20 power drive. The product is a wheelchair
component/accessory. Recall # Z-0804-05.
CODE
a) Model number E19;
b) Model number E20.
FIRM/MANUFACTURER
Recalling Firm: Frank Mobility Systems, Inc., Oakdale, PA, by letter on September 1, 2004.
Manufacturer: Ulrich-Alber Gmbh, Albstadt Tailfingen, Germany. Firm initiated recall is ongoing.
REASON
Product may short circuit within the interface due to long term exposure of liquid.
VOLUME OF PRODUCT IN COMMERCE
314 units.
DISTRIBUTION
Nationwide, Mexico and Panama.

RECALLS AND FIELD CORRECTIONS: Devices - CLASS III

_______________________________
PRODUCT
Stryker Brand 5.5mm 6 Flute Barrel Bur, Model Number: 375-951-000. Recall # Z-0786-05.
CODE
The following part numbers and subsequent lot numbers are involved in this recall. Part number 0275-950-000: 04109232, 0419292, 04109312, 04119712, 04119732, 04363AG2, 04364AG2. Part number 0275-951-012: 04098532, 04098752, 04098852, 04098872, 04109172, 04109212, 04109292, 4109312, 04119352, 04119392, 04119432, 04119712, 04129892,04129912, 04355AG2, 04357AG2, 04358AG2, 04363AG2. Part number 0275-951-012S1: 4098812, 04119672. Part number 0275-951-200: 04098492, 04362AG2. Part number 0275-952-000: 04108972, 04113432, 04129812, 05013AG2. Part number 0375-950-000: 0409522, 04112882, 04112962, 04123162. Part Number 0975-950-012: 04102542, 04102662, 04123162, 04123202. Part number 0375-951-012: 04092262, 4092362, 04092402, 04112862, 04112882, 04112902, 04113042, 04113082, 04123142, 04123202. Part Number 0375-951-200: 04113042. Part number 0275-950-012: 04098812, 04108912, 04109152, 04119512, 0411612, 0411712, 04129792, 04357AG2. Part Number 0275-951-000: 04098532, 04098552, 04098752, 04098772, 04098832, 04098852, 04098892, 04108912, 04109152, 04109172, 04109192, 04109232, 04109252, 04109292, 04119412, 04119432, 04119612, 04119632, 04119712, 04119732, 04129792, 04129852, 04129912, 04129972, 04352AG2, 04352AG2. Part Number 0375-951-000: 04092262, 4092362, 04102542, 04102662, 04102682, 04102762, 04112882, 04113002, 04113082, 04123162, 04123202, 04123222. Part number 0375-952-000: 04092522, 04102602, 04113042, 04123222.
RECALLING FIRM/MANUFACTURER
Stryker Endoscopy, San Jose, CA, by telephone and Urgent Product Recall Notice on February 8, 2005. Firm initiated recall is ongoing.
REASON
The device has the potential to overheat and cause patient burns during use.
VOLUME OF PRODUCT IN COMMERCE
28935 units (5 units per box).
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
MedRo Rx , Reverse Osmosis System All Models All Voltages. Models: MRORXO1, MRORXO2, MRORXO3,MRORXO4, MRORXO5, MRORXO6, MRORXO8,MRORXO9, MRORX12. CMRORX01, CMRORX02, CMRORX03, CMRORX04, CMRORX05, CMRORX08. Recall # Z-0798-05.
CODE
Serial Numbers: 53130 through 60754 (not consecutive).
RECALLING FIRM/MANUFACTURER
Recalling Firm: U.S. Filter/Ionpure, Inc., Lowell, MA, by letter between March 17, and March 28, 2005.
Manufacturer: U.S. Filter Water Process Inc, Colorado Springs, CO. Firm initiated recall is ongoing.
REASON
Incorrect type of stainless steel firm used 303 vs 316.
VOLUME OF PRODUCT IN COMMERCE
275 units.
DISTRIBUTION
Nationwide, Canada and Mexico.

END OF ENFORCEMENT REPORT FOR May 11, 2005

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