Enforcement Report

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.

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April 6, 2005
05-14

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Yilin brand Dried Bamboo Shoot, Net Wt. 350g (12.3 oz). Ingredients: Bamboo Shoot. Product is packaged in a clear plastic pouch. --- Serving Size: 70 g (2.4 oz.), Serving Per Container: 5. --- Product is labeled in Chinese & some English, with no firm information listed. Recall # F-239-5.
CODE
Q/SMWL4-2002, Barcode # 6 925020 001117.
RECALLING FIRM/MANUFACTURER
J. V. Trading (Glendale) Ltd., Hicksville, NY, by press release on December 30, 2003. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites based on sampling & analysis by the New York State Department of Agriculture & Markets (NYSDAM).
VOLUME OF PRODUCT IN COMMERCE
50 cases (24 packages per case).
DISTRIBUTION
NY, NJ, OH, GA, and MI.

_______________________________
PRODUCT
Judy's brand Handmade The Old-Fashioned Way Assorted Caramels Candy in Jars, 50 pieces/Jar; The label reads in part: "Item #0517, Assorted Caramels - 50 Ct. Jar". Recall # F-240-5.
CODE
Lot numbers 0045, 0185, 3574, 3054, 2874, 2654, 2564.
RECALLING FIRM/MANUFACTURER
Judy's Candy Co., Berkeley, CA, by press release, letters and telephone on January 20, 2005. Firm initiated recall is complete.
REASON
The product contained undeclared almonds.
VOLUME OF PRODUCT IN COMMERCE
28 tubs, 50 pcs/tub.
DISTRIBUTION
CA, ID, WA, and FL.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
a) Intron A Powder for Injection, (Interferon alfa-2b,
recombinant), 10 million IU per vial, For
Intramuscular/Subcutaneous/Intralesional Use, Rx only,
Refrigerate, NDC 0085-0571-02. Recall # D-156-5;
b) Intron A Powder for Injection, (Interferon alfa-2b,
recombinant) 18 million IU per vial, For
Intramuscular/Subcutaneous/Intravenous Use, Not for
Intralesional Use, Rx only, Refrigerate, NDC 0085-
Recall # D-157-5;
c) Intron A Powder for Injection, (Interferon alfa-2b,
recombinant) 50 million IU, For
Intramuscular/Subcutaneous/Intravenous Use,
Not for Intralesional Use, Rx only, Refrigerate,
NDC 0085-0539-01. Recalling # D-158-5.
CODE
a) Lot Numbers, exp.: 10 MIU-- 4-CO-200, June, 2006;
b) 18 MIU--4-CO-303, January, 2006; 18 MIU--4-CO-304,
January, 2006; 18 MIU--4-CO-305, June, 2006.
c) 50 MIU--4-CO-400, June, 2006; 50 MIU--4-CO-401,
June, 2006; 50 MIU--4-CO-402, June, 2006;
50 MIU--4-CO-403, June, 2006.
RECALLING FIRM/MANUFACTURER
Schering Corporation, Kenilworth, NJ, by letters on February 7, 2005. Firm initiated recall is ongoing.
REASON
Label on powder vial incorrectly states Use reconstituted solution within one month. Label should correctly state Use reconstituted solution within 24 hours.
VOLUME OF PRODUCT IN COMMERCE
90,545 vials.
DISTRIBUTION
Nationwide.

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PRODUCT
Antacid, Mint Flavor, Regular Strength, 150 count bottles packaged under the Bartell Drugs label, Distributed by: The Bartell Drug Company, Seattle, WA. Recall # D-159-5.
CODE
Lot #330660, Exp. 11/06.
RECALLING FIRM/MANUFACTURER
Magno Humphries, Inc., Tigard, OR, by telephone and letter on March 4, 2005. Firm initiated recall is ongoing.
REASON
Presence of foreign material: Bottles contain white powder, broken tablets and dark foreign material.
VOLUME OF PRODUCT IN COMMERCE
24 bottles.
DISTRIBUTION
WA.

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PRODUCT
Faslodex (fulvestrant) Injection. Each carton contains 2 pre-filled syringes, 125 mg/2.5 ml(50 mg/ml), Rx only, Recall # D-162-5.
CODE
Lot number BX373 Exp 6/30/06,
Lot number CC148 Exp 6/30/06, and
Lot number BX829 Exp 6/30/06.
RECALLING FIRM/MANUFACTURER
Astra Zeneca, Wilmington, DE, by letter dated March 2, 2005. Firm initiated recall is ongoing.
REASON
Defective syringe delivery system.
VOLUME OF PRODUCT IN COMMERCE
7,716 units.
DISTRIBUTION
Nationwide.

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PRODUCT
Sulfazineô EC 500 mg, Sulfasalazine Delayed Release Tablets, USP 500 mg, Rx only, 300 Tablets, NDC 0603-5803-25. Recall # D-164-5.
CODE
Lot #C0900703A (100 counts), C0900703B (300 counts).
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals, Inc., Charlotte, NC, by letter on/about March 4, 2005 and March 8, 2005. Firm initiated recall is ongoing.
REASON
Dissolution Failure: Out of Specification Results for Dissolution at 6 month room temperature stability.
VOLUME OF PRODUCT IN COMMERCE
7,123 bottles.
DISTRIBUTION
Nationwide.
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PRODUCT
a) Antacids, chewable, assorted flavors in plastic
bottles distributed under 5 brands: BI-MART brand
150 tablet and 500 tablet bottles Distributed by:
BI-MART; MEDICAP PHARMACY brand 150 tablets,
Distributed by: Medicap Pharmacies, Inc.
BARTELL DRUGS brand 150 tablets Distributed by:
The Bartell Drug Company; Pharmacist's Choice brand
175 tablets DISTRIBUTED BY: PHARMACIST'S CHOICE;
Superior brand 150 tablets Distributed by: WinCo Foods,
Inc. Recall # D-165-5.
b) Acetaminophen/non-aspirin pain reliever, 325 mg,
100 tablet plastic bottles distributed under 5 brands:
Kinney brand Distributed by: Kinney Drugs, Inc.;
BI-MART brand Distributed by: BI-MART; HEALTH CARE
AMERICA brand Distributed by: AFW Alliance;
MEDICAP PHARMACY brand Distributed by: Medicap
Pharmacies, Inc.; Superior brand Distributed by:
WinCo Foods, Inc. Recall # D-166-5;
c) Aspirin, 81 mg tablets, in plastic bottles,
distributed under 7 brands: BARTELL DRUGS brand
250 tablet and 350 tablet bottles Distributed by:
The Bartell Drug Company; MHL brand, 100 tablet
bottles and 250 tablet bottles, Manufactured &
Distributed by: Magno-Humphries Labs;
Superior brand 100 tablet bottles Distributed by:
WinCo Foods, Inc; Pharmacist's Choice, 150 tablet
bottles, Distributed by Pharmacist's Choice;
MEDICAP PHARMACY brand, 100 tablet and 250 tablet
bottles Distributed by: Medicap Pharmacies, Inc;
BI-MART brand 100 tablet and 250 tablet bottles
Distributed by: BI-MART; HealthPrin 500 coated
aspirin tablets Distributed by: SMART
PHARMACEUTICALS. Recall # D-167-5;
d) Extra strength non-aspirin pain reliever/sleep
aid, acetaminophen 500mg & diphenhydramine
hydrochloride 25mg, in plastic bottles,
distributed under 5 brands: BI-MART brand
100 tablet and 250 tablet bottles Distributed by:
BI-MART; MEDICAP PHARMACY brand, 50 tablet
bottles Distributed by: Medicap Pharmacies, Inc.;
Superior brand, 50 tablets, Distributed by: WinCo
Foods, Inc.; MHL brand 100 tablets Manufactured &
Distributed by: Magno-Humphries Labs; BARTELL
DRUGS brand 100 tablets, Distributed by:
The Bartell Drug Company. Recall # D-168-5;
e) Children's non-aspirin pain reliever, acetaminophen
80 mg, fruit flavored tablets, 30 tablet plastic
bottles, distributed under two brands: Suprior
brand distributed by: WinCo Foods, Inc;
BI-MART brand Distributed by: BI-MART.
Recall # D-169-5;
f) Diphenhydramine hydrochloride 25 mg labeled
as an allergy medication or sleep aid. Allergy
labeling - BI-MART brand COMPLETE ALLERGY
MEDICINE 100 tablet bottle Distributed by:
BI-MART; Hi-SCHOOL pharmacy brand ALER-TABS
100 tablet bottles Distributed by: Hi-School
Pharmacy, Inc.; Sleep aid labeling ‚
Pharmacist's Choice brand SLEEP-TABS 100 tablet
bottle Distributed by Pharmacist's Choice; MHL
Sleep-Tabs 36 tablet and 100 tablet bottle
Manufactured & Distributed by: Magno-Humphries
Labs; BI-MART brand SLEEP TABLETS 36 tablets
Distributed by: BI-MART; Superior brand
Sleep-Tabs 36 tablet bottle Distributed by:
WinCo Foods, Inc; BARTELL DRUGS brand Sleep-
Tabs 36 tablet bottle Distributed by:
The Bartell Drug Company. Recall # D-170-5.
CODE
a) Lot #s 329765, 329897, 329968, 329994, 330032,
330145, 330636; all with expiration 10/06;
b) Lot #s 329858, 330036, 330037, 330412, 330866;
all with expiration 12/06;
c) Lot #s 328905, 329016, 329045, 329046, 328647,
327907, 329001, 328329, 329373, 329372, 329371,
329370, 329190, 329861, 330239, 330107, 330290,
330429, 330558, 330559, 330560, 330561, 330598,
330769, 330873, 330874, 331135, 331136; all with
expiration 10/06;
d) Lot #s 330116, 330484, 330672, 330772, 330512,
330871, 330870, 330941, 330936; all with
expiration date 12/07;
e) Lot #s 330242, 330431, 330901, 331000;
all with expiration date 10/07;
f) Lot # 328988; expiration 10/06. Lot #s 325624,
325651, 325774, 326039, 325875, 326273, 326296,
326247, 326504, 326559, 326480, 326592; expiration
date 3/07.
RECALLING FIRM
Magno Humphries, Inc., Tigard, OR, by telephone on March 8, 2005, and by letter on March 9, 2005. Firm initiated recall is ongoing.
REASON
Potential for products to be contaminated with metal particles.
VOLUME OF PRODUCT IN COMMERCE
38,824 bottles.
DISTRIBUTION
Nationwide.

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PRODUCT
a) Paxil CR Tablets (paroxetine HCl) 12.5 mg
Controlled-Released Tablets, 30 count bottles
and 7 count sample packs, Rx only, GlaxoSmithKline,
Research Triangle Park, NC **** NDC 0029-3206-13.
Recall # D-171-5
b) Paxil CR Tablets (paroxetine hydrochloride)
25 mg Controlled-Release Tablets, 30 count
bottles and 7 count sample packs, Rx only,
NDC 0029-3207-13. Recall # D-172-5;
c) Paxil CR (paroxetine hydrochloride) 37.5 mg
Controlled-Release Tablets, 30 count bottles,
Rx only, NDC 0029-3208-29. Recall # D-173-5;
d) Avandametô Tablets (rosiglitazone maleate/
metformin HCl), 1mg/500mg, 60 and 100 count
bottles, Rx only, 60's tablets -NDC-0007-3166-18
and 100 tablets -NDC-0007-3166-20. Recall # D-174-5.
CODE
a), b), c) All Codes;
d) Lot/Exp. 1284A66/Jun-06; 1344A66/Sep-06;
1354A66/Sep-06; 1364A66/Sep-06;
F1394A66/Sep-06; 1294A66/Jun-06;
1304A66/Jun-06; 1314A66/Jun-06.
RECALLING FIRM/MANUFACTURER
Glaxosmithkline, Cidra, PR, by letter dated February 14, 2005. Firm initiated recall is ongoing.
REASON
Low-level manufacturing defect that may result in the tablets splitting apart and patients not receiving the proper amount of medication;
VOLUME OF PRODUCT IN COMMERCE
a) 5,690,165 bottles, 30's count;
b) 11,803,780 bottles, 30's counts;
c) 2,103,976 bottles, 30's count;
d) 71,048 bottles, 60's count; 43,309 bottles,
100's count.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

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PRODUCT
Aplicare Povidone-Iodine USP 7.5%, 4 Fl. Oz. (118 mL) bottle, OTC. Recall # D-160-5.
CODE
Lot Numbers: 92763 Exp 12/06 92767 Exp 01/07 92768 Exp 01/07 93725 Exp 02/07 93730 Exp 02/07
RECALLING FIRM
Aplicare, Inc., Branford, CT, by letter on March 11, 2004. Firm initiated recall is ongoing.
REASON
Mislabeled: The front panel incorrectly states Povidone Iodine Concentration as 7.5% instead of the actual concentration of 10.0%.
VOLUME OF PRODUCT IN COMMERCE
3,938 cases.
DISTRIBUTION
Nationwide.

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PRODUCT
Synthroid (levothyroxine sodium tablets, USP) 50 mcg, Rx only, Hospital Unit Dose Blister Packaging 10 tablets per Blister Card, 100 tablets per Carton. Recall # D-163-5.
CODE
Lot Numbers: 0000347787 - Expiration Mar 1, 2005 and 0000349661 - Expiration Aug 1, 2005.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories MPG, Abbott Park, IL, by letter dated December 9, 2004. Firm initiated recall is ongoing.
REASON
Lack of assurance of meeting stability potency through expiry.
VOLUME OF PRODUCT IN COMMERCE
4,191 units.
DISTRIBUTION
Nationwide.

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PRODUCT
a) Metronidazole Capsules, 375mg, Rx only,
NDC 53265-353-05 (50 count). Recall # D-175-5;
b) Metronidazole Tablets, 250mg, Rx only,
NDC 53265-374-10 (100 count);
NDC 53265-374-50 (500 count);
NDC 53265-374-70 (250 count). Recall # D-176-5;
c) Metronidazole Tablets USP, 500mg, Rx only,
NDC 53265-375-10 (100 count); NDC 53265-375-50
(500 count); 53265-375-60 (60 count).
Recall # D-177-5;
d) Metronidazole Extended-Release Tablets, 750mg,
Rx only, NDC 53265-352-03 (30 count).
Recall # D-178-5.
CODE
a) Lot Number, Exp. Date: 307256B, 07/05;
307257B, 07/05; 411107B, 11/06;
b) Lot Number, Exp. Date: 307078B, 06/05;
307080B, 06/05; 312124A, 02/06; 402077A, 03/06;
408155B, 09/06; 411036A, 10/06; 307079F, 06/05;
307080F, 06/05; 312122B, 01/06; 312123A, 01/06;
312124B, 02/06; 402078A, 03/06; 402077C, 03/06;
408155D, 09/06; 411035A, 10/06; 411036C, 10/06;
312122A, 01/06; 402077B, 03/06; 408155C, 09/06;
c) Lot Number, Exp. Date: 308158C, 08/05;
401162A, 02/06; 401163A, 02/06; 409101A, 09/06;
410108B, 10/06; 401161D, 01/06; 401163B, 02/06;
401162B, 02/06; 402080B, 03/06; 402081A, 08/06;
409100A, 09/06; 409102B, 09/06; 410107A, 10/06;
410108C, 10/06; 401161B; 01/06; 402080A, 03/06;
409102A, 09/06;
d) Lot Number, Exp Date: 310104A, 09/05;
310105A, 09/05; 310106A, 10/05; 402079A, 03/06;
405002A, 05/06; 405001A, 05/06.
RECALLING FIRM/MANUFACTURER
Able Laboratories Inc., South Plainfield, NJ, by letter on January 31, 2005. Firm initiated recall is ongoing.
REASON
Mislabeled due to non compliance with 21CFR201.24.
VOLUME OF PRODUCT IN COMMERCE
75,468 bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

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PRODUCT
Human Tissue for Transplantation, Corneas. Recall # B-0721-5.
CODE
04121203R and 04121203L.
RECALLING FIRM/MANUFACTURER
Center for Organ Recovery & Education, Pittsburgh, PA, by telephone and letter dated January 10, 2005. Firm initiated recall is complete.
REASON
Human tissue for transplantation, collected from a donor whose sexual partner tested positive for the hepatitis C virus (HCV) by NAT, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
CA and PA.

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PRODUCT
Red Blood Cells for further manufacture into non-injectable products. Recall # B-0846-5.
CODE
Unit: UM007279.
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank Inc., Memphis, TN, by letter on October 11, 2004. Firm initiated recall is complete.
REASON
Blood product, processed from a unit of whole blood that had not been tested for viral markers, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

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PRODUCT
a) Red Blood Cells. Recall # B-0847-5;
b) Platelets. Recall # B-0848-5;
c) Fresh Frozen Plasma. Recall # B-0849-5.
CODE
a), b), and c) Unit: KS72484.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by fax on June 9, 2004. Firm initiated recall is complete.
REASON
Blood products, processed from a unit of whole blood that tested negative for CMV but was collected from a donor who previously tested CMV positive, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
PA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0851-5;
b) Platelets. Recall # B-0852-5;
c) Fresh Frozen Plasma. Recall # B-0853-5.
CODE
a) Units: 53GE69468, 53L60812, 53L51874;
b) and c) Units: 53L60812, 53L51874.
RECALLING FIRM/MANUFACTURER
American Red Cross, Chesapeake Region, Baltimore, MD, by telephone on August 16, 2004, and by letters dated August 16, 17, and September 30, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the medical Amiodarone, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
MD, and DC.

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PRODUCT
Source Plasma. Recall # B-0863-5.
CODE
Units 0490339933, 0490339693, 0490339050, 0490337817, 0490337351, 0490336375, 0490335521, 0490335373, 0490334545.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Grand Prairie, TX, by facsimile on April 24, 2003. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Source Plasma. Recall # B-0864-5.
CODE
Units 12279012, 12276721.
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc. of Wisconsin, Madison, WI, by letter dated April 3, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had received a piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0892-5.
CODE
Units 14F75, 14G37, 41H73, 21I70, 47I19, 65J08, 78K84, 73P26, 77P34, 00Q51, 77W78, 01X12, 12B82, 91U42, 01W21, and 71U91.
RECALLING FIRM/MANUFACTURER
Mayo Clinic Rochester, Division of Transfusion Medicine,
Rochester, MN, by letters dated September 12, 2000. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV), but were collected from donors who previously tested repeatedly reactive for anti-HIV and negative by Western Blot test, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
FL, PA, CA, and MN.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0893-5;
b) Recovered Plasma. Recall # B-0894-5.
CODE
a) Units 18R33721 and 18W56823;
b) Unit 18W56823.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Lansing, MI, by facsimile on September 20, 2004, by electronic mail on January 12, 2005, and/or by letter dated September 20, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV), but were collected from a donor who had previous tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MI and CA.

_______________________________
PRODUCT
Platelets. Recall # B-0895-5.
CODE
Unit K89107.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Rapids, MI, by telephone on January 14, 2005. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which the associated red blood cells contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0896-5.
CODE
Unit 17FH87764.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Shoreview, MN, by letter dated December 17, 1999. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WI.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
Recall # B-0897-5;
b) Recovered Plasma. Recall # B-0898-5.
CODE
a) and b) unit 11FT02739.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, St. Louis, MO, by telephone on April 28, 2004, and by letter dated May 5, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV), but were collected from a donor who had previously tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL, and CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0899-5.
CODE
Unit 19GR48444.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Tennessee Valley Region,
Nashville, TN, by letter dated May 16, 2003. Firm initiated recall is complete.
REASON
Problem: Blood product, corresponding to Fresh Frozen Plasma that was possibly contaminated with Staphylococcus and implicated in an adverse transfusion reaction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
a) Platelets. Recall # B-0901-5;
b) Platelets Leukocytes Reduced.
Recall # B-0902-5;
c) Fresh Frozen Plasma. Recall # B-0903-5.
CODE
a) Units 19GF48042, 19GH26355, 19GF59069, 19GK30014,
19GZ43875, 19GF63720, 19GF58503, 19GW31786,
19LF09902, 19LF09915, 19GZ38296, 19GF63312, and
19LS00199;
b) Units 19GH32634 and 19GZ54064;
c) Units 19GH25248, 117T30776, and 19GR21359.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Nashville, TN, by telephone and by letter dated June 9, 2003. Firm initiated recall is complete.
REASON
Blood products, which were manufactured from whole blood units in which the corresponding red blood cells contained clots, were distributed
VOLUME OF PRODUCT IN COMMERCE
18 units.
DISTRIBUTION
TN, KY, and AL.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0904-5.
CODE
Unit 27LT27190.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA, by telephone on November 1, 2004 and by letter dated November 3, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WV.

_______________________________
PRODUCT
Cryoprecipitated AHF. Recall # B-0905-5.
CODE
Unit GJ98736.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on November 15, 2004. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from whole blood in which the associated red blood cells contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0918-5.
CODE
Unit number: 19GK86461.
RECALLING FIRM/MANUFACTURER
American Red Cross, Tennessee Valley Region, Nashville, TN, by telephone and letter, dated April 7, 2004. Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with coagulase negative Staphylococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS- CLASS III

_______________________________
PRODUCT
a) Red Blood Cells for further manufacture into
non-injectable products. Recall # B-0737-5;
b) Human Serum for further manufacture into
non-injectable products. Recall # B-0738-5.
CODE
a) and b) Unit BT104584.
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank Inc., Memphis, TN, by telephone on June 18, 2003. Firm initiated recall is complete.
REASON
Blood products, processed from a unit of whole blood that had not been tested for viral markers, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL and TX.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0833-5.
CODE
Units: KJ69674, KJ69632, LF65478, LF65476, LR62167.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by fax on September 1, 2004. Firm initiated recall is complete.
REASON
Blood products, with hematocrits potentially above the acceptable limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Platelet Pheresis, Leukoreduced. Recall # B-0857-5.
CODE
Unit: 53LP45266.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone on June 1, 2004. Firm initiated recall is complete.
REASON
Platelet Pheresis, possibly contaminated with bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.

_______________________________
PRODUCT
Red Blood Cells (Apheresis). Recall # B-0891-5.
CODE
Units KC66017 and E96516, and E98394.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by telephone on September 13, 2004 and by letter dated September 30, 2004. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Fresh Frozen Plasma, Pheresis. Recall # B-0907-5.
CODE
Units 26FQ18378, 26FQ18379, 26FQ18419, 26FQ18407, 26FQ18415, 26FR02483.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Gulf Coast Region, Mobile, AL, by letters dated July 13, 2000 and July 14, 2000. Firm initiated recall is complete.
REASON
Unlicensed blood products, labeled with the firm's license number, were distributed in interstate commerce.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
NY and TN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0910-5.
CODE
Unit 12FZ32146.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on March 3, 2004 and by letter dated March 12, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose body temperature was not properly recorded, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0911-5.
CODE
Unit 12LW95749.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on October 5, 2004 and by letter dated October 12, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a low body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
a) Compumedics E-Series Digital Amplifier System part
number 8008-0001-01 and 8008-0001-02, manufactured
by Compumedics Limited, Australia. Recall # Z-0652-05;
b) Nonin Xpod Oximeter model numbers 3011 and 3012,
distributed for use with the Compumedics E-Series
Digital Amplifier. Recall # Z-0653-05.
CODE
All codes.
RECALLING FIRM
Compumedics USA, Ltd., El Paso, TX, by letter on February 24, 2005. Firm initiated recall is ongoing.
REASON
Under specific conditions, the housing of the pulse oximeter connected to the amplifier can become excessively warm causing a burn upon contact with skin.
VOLUME OF PRODUCT IN COMMERCE
1,376 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) ABSOLOK Extra Absorbable Ligating Clip cartridges,
small, code AP100. Ten cartridges are packaged per box.
Recall # Z-0654-05;
b) ABSOLOK Extra Absorbable Ligating Clip cartridges,
medium, code AP200. Ten cartridges are packaged
per box. Recall # Z-0655-05;
c) ABSOLOK Extra Absorbable Ligating Clip cartridges,
medium/large, code AP300. Ten cartridges are
packaged per box. Recall # Z-0656-05.
d) ABSOLOK Extra Absorbable Ligating Clip cartridges,
large, code AP400. Ten cartridges are packaged
per box. Recall # Z-0657-05.
CODE
a) Lot: SL2102, exp. date 07/08; SL2116, exp. date 07/08;
SL2123, exp. date 07/08; SM7266, exp. date 07/08;
SP2618, exp. date 07/08; TB2043, exp. date 01/09;
TB2044, exp. date 01/09; TB2199, exp. date 01/09;
TB2333, exp. date 01/09; TB7971, exp. date 01/09;
TD7873, exp. date 01/09; TG8166, exp. date 01/09;
TJ2047, exp. date 07/09; TJ2331, exp. date 07/09;
TJ8306, exp. date 07/09; TK8398, exp. date 07/09;
TL2243, exp. date 07/09; TL2352, exp. date 07/09;
and TP7672, exp. date 07/09.
b) Lot: SK2046, exp. date 07/08;
SK2054, exp. date 07/08; SL2103, exp. date 07/08;
SL2111, exp. date 07/08; SL2112, exp. date 07/08;
SL2117, exp. date 07/08; SL2128, exp. date 07/08;
SM2549, exp. date 07/08; SM2621, exp. date 07/08;
TA2977, exp. date 01/09; TA7272, exp. date 01/09;
TA7585, exp. date 01/09; TB2644, exp. date 01/09;
TB7702, exp. date 01/09; TC2648, exp. date 01/09;
TC7050, exp. date 01/09; TD2574, exp. date 01/09;
TE2828, exp. date 01/09; TE7186, exp. date 01/09;
TG2562, exp. date 01/09; TG2789, exp. date 01/09;
TH2052, exp. date 07/09; TH2350, exp. date 07/09;
TH7091, exp. date 07/09; TJ2137, exp. date 07/09;
TJ2506, exp. date 07/09; TJ7414, exp. date 07/09;
TL2620, exp. date 07/09; TL7452, exp. date 07/09;
TP7673, exp. date 07/09; UA2003, exp. date 01/10;
UA2244, exp. date 01/10; UA2309, exp. date 01/10;
UA2440, exp. date 01/10; UA2608, exp. date 01/10;
UA2822, exp. date 01/10; and UA2823, exp. date 01/10.
c) Lot: SK2037, exp. date 07/08; SK2055, exp. date 07/08;
SL2104, exp. date 07/08; SL2118, exp. date 07/08;
SL2445, exp. date 07/08; SM2135, exp. date 07/08;
SP2530, exp. date 07/08; SP2711, exp. date 07/08;
TA2840, exp. date 01/09; TB2335, exp. date 01/09;
TC7957, exp. date 01/09; TD2044, exp. date 01/09;
TD2280, exp. date 01/09; TD2664, exp. date 01/09;
TD2938, exp. date 01/09; TE7512, exp. date 01/09;
TG7713, exp. date 01/09; TG7825, exp. date 01/09;
TG7936, exp. date 01/09; TK2477, exp. date 07/09;
TK7626, exp. date 07/09; TL2169, exp. date 07/09;
TL7265, exp. date 07/09; TP7279, exp. date 07/09;
UA2517, exp. date 01/10; UA2747, exp. date 01/10;
UA2932, exp. date 01/10; and UA7902, exp. date 01/10.
d) Lot: TE7978, exp. date 01/09; TE8279, exp. date 01/09;
TE2018, exp. date 01/09; TG2223, exp. date 01/09;
TG7067, exp. date 01/09; TL7643, exp. date 07/09;
SK2036, exp. date 07/08; SL2110, exp. date 07/08;
SM2078, exp. date 07/08; SM2353, exp. date 07/08;
TA7932, exp. date 01/09; TB2334, exp. date 01/09;
TE2375, exp. date 01/09; and TE2486, exp. date 01/09.
RECALLING FIRM/MANUFACTURER
Ethicon Endo-Surgery, Cincinnati, OH, by letter, dated February 28, 2005. Firm initiated recall is ongoing.
REASON
The product is being recalled because the possibility exists that the sterility of the ligating clips may have been compromised by a tear in the ABSOLOK Extra packaging.
VOLUME OF PRODUCT IN COMMERCE
56,934 devices.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATHFINDER RSV DIRECT ANTIGEN DETECTION SYSTEM 79674 IN VITRO TEST DIAGNOSTIC USE. Side of kit states Bio-Rad 3, boulevard Raymond Poincare France. Recall # Z-0659-05.
CODE
Lot # & Expiration dates: 1L044 3/31/03; 2C047 7/31/03; 2H049 9/30/03; 2L050 9/30/03; 2M051 9/30/03; 2M052 11/30/03; 3D053 10/31/04; 3H0055 10/31/04; 3K0054 10/31/04; 4A0056 7/5/2005.
RECALLING FIRM
Bio-Rad Laboratories, Inc, Redmond, WA, by letters on January 25-27, 2005 and January 31, 2005. Firm initiated recall is complete.
REASON
New instructions to recommend against using samples with visibly high level of blood.
VOLUME OF PRODUCT IN COMMERCE
1,547 kits.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Hill-Rom Total Care SpO2RT pulmonary therapy bed system, Model 1900. Recall # Z-0661-05.
CODE
All beds modified [to convert other beds to the TotalCare SpO2RT pulmonary therapy bed systems] with upgrade kids P1950A01 or P1950A02 between February 2002 and November 2004.
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letter dated March 1, 2005. Firm initiated recall is ongoing.
REASON
Siderails may stay up without latching into place.
VOLUME OF PRODUCT IN COMMERCE
228 beds.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
a) Nellcor brand Pulse Oximeter, Model NPB290,
MALLINCKRODT, Made in Ireland.
Recall # Z-0662-05;
b) Nellcor Puritan Bennett brand Pulse Oximeter,
Model NPB295, Made in Ireland;
Recall # Z-0663-05;
c) Nellcor brand OxiMax Pulse Oximeter,
model number N-595 Made in Ireland;
Recall # Z-0664-05;
d) Nellcor brand Pulse Oximeter, model N-395,
Made in Ireland; Recall # Z-0665-05.
CODE
All units with serial numbers beginning with G01844386.
RECALLING FIRM
Nellcor Puritan Bennett, Pleasanton, CA, by letters on October 18, 2004, and December 9, 2004. Firm initiated recall is ongoing.
REASON
The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.
VOLUME OF PRODUCT IN COMMERCE
56,471 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Terumo Advanced Perfusion System 1 (with 6 inch
diameter roller pump), Catalog number 801041.
Recall # Z-0666-05;
b) Terumo Advanced Perfusion System 1 (with 4 inch
diameter roller pump), Catalog number 801040.
Recall # Z-0667-05.
CODE
a) Serial numbers 0028 through 0527 and
0700 through 0874;
b) Serial numbers 0030 through 0587 and
0700 through 0975.
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp, Ann Arbor, MI, by letters dated March 17, 2005. Firm initiated recall is ongoing.
REASON
The pumps will stop, show an overspeed error message, and will not restart using routine procedures if the user reduces the pump speed to zero RPM while the pump is operating in pulse mode.
VOLUME OF PRODUCT IN COMMERCE
1,509 pumps.
DISTRIBUTION
Nationwide and Internationally.

END OF ENFORCEMENT REPORT FOR APRIL 6, 2005

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