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U.S. Department of Health and Human Services

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Enforcement Report for May 12, 2004

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 12, 2004
04-19

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Breakfast cookie in a plastic container, 2 cookies individually wrapped in each plastic container, labeled “Harry and David Up With The Sun BREAKFAST COOKIES NET WT 4.5 OZ”. 32 packages/case. Recall # F-189-4.
CODE
BEST BY dates of 2/07/04 , 2/10/04 , 04/15/04 , 4/16/04 .
RECALLING FIRM/MANUFACTURER
Harry & David, Medford , OR , by voice mail on March 8, 2004 . Firm initiated recall is complete.
REASON
Cookies contain undeclared pecans and almonds.
VOLUME OF PRODUCT IN COMMERCE
438 cases containing 14,016 packages.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
GUSTO brand PRESERVED THAI DESSERTS PINEAPPLE, NET WEIGHT 200 GMS. and 35 GMS. PRODUCT OF THAILAND . Product is packed in a plastic container. Recall # F-190-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Gusto Food, Inc., Maspeth , NY , by letters on March 24, 2003 and November 18, 2003 . New York State initiated recall is complete.
REASON
Undeclared sulfites based on NYSDAM sampling & analysis.
VOLUME OF PRODUCT IN COMMERCE
8 cartons (24 units per carton).
DISTRIBUTION
NY and FL.
_____________________________
PRODUCT
APRICOT MUFFIN MIX, 13 oz. and 15 oz., plastic bags. Sold under the following labels:
1) Uncle Charlies Products Inc., “Breakfast Style Muffin Mix Apricot”.
2) Al’s Gourmet Favorites, “Breakfast Style Muffin Mix Apricot”.
3) The New York Store “Gourmet Muffin Mix Apricot”.
4) Swedish Hill Vineyards “Breakfast Style Muffin Mix Apricot”.
5) Amish Wedding Foods “Breakfast Style Muffin Mix Apricot”.
6) Cookie Expressions “Breakfast Style Muffin Mix Apricot”.
7) Bemus Bay Coffee Cafe “Breakfast Style Muffin Mix Apricot”.
Recall # F-191-4.
CODE
CODE Pro All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Uncle Charlies, Akron , NY , by letters dated October 29, 2003 . New York State initiated recall is complete.
REASON
Apricot Muffin Mix contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) Stew Leonard's Seafood Salad, 16 oz. clear plastic container UPC 71962-18856. Recall # F-192-4;
b) Stew Leonard's LITE Seafood Salad, 16 oz. clear plastic UPC 71962-18824. Recall # F-193-4.
CODE
a) and b) Product date coded prior to 2/15/04 .
RECALLING FIRM/MANUFACTURER
Stew Leonards Inc, Norwalk , OH , by telephone on February 4, 2004 , and by press release on February 5, 2004 . Firm initiated recall is complete.
REASON
The product contains undeclared ingredients including snow crab.
VOLUME OF PRODUCT IN COMMERCE
41 cases.
DISTRIBUTION
CT, and NY.
_____________________________
PRODUCT
Homarus brand Norwegian cold smoked salmon packed into a large green/red/white cryo-vac bag with a red/green/white/black label printed in part: “HOMARUS***NORWEGIAN SALMON INGREDIENTS: SALMON, SALT, SUGAR, NATURAL WOOD SMOKE***.” Each cold smoked piece of salmon is packaged into these bags, each with a weight range of 2 to 3 lbs. Two bags are packaged and sold in a white/blue/grey cardboard box printed in part: “SeaSpecialities***KEEP REFRIGERATED AT 38 OR BELOW MAY BE FROZEN FOR EXTENDED SHELF LIFE***PREMIUM QUALITY SMOKED SALMON SLICED DELI BOARD 2 x 3 Lb.***.” Recall # F-194-4.
CODE
27029, 27012.
RECALLING FIRM/MANUFACTURER
Florida Smoked Fish Co, Miami, FL, by letters on October 15, 2003, October 22, 2003, and October 28, 2003. Florida State initiated recall is complete.
REASON
Surveillance sample collected and analyzed by the Florida Department of Agriculture and Consumer Services confirmed the presence of Listeria monocytogenes in the product lots.
VOLUME OF PRODUCT IN COMMERCE
2,719 lbs.
DISTRIBUTION
FL, GA, PA, and CA.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_____________________________
PRODUCT
a) SOTATOL HCl TABLETS (sotalol hydrochloride),120 mg, 100 TABLETS, Rx only, Distributed under the Par label. NDC 49884-583-01. Recall # D-154-4.
b) ACYCLOVIR TABLETS, 400 mg, Rx only, 100 TABLETS, NDC 49884-566-01. Recall # D-155-4.
CODE
a) Lot Numbers/Expiration Dates: DL151, expiration date: MAY 2005; DL521, expiration date: MAY 2005; DL531, expiration date: MAY 2005; DN921, expiration date: JULY 2005; DN931, expiration date: JULY 2005; DN941, expiration date: JULY 2005; DS561, expiration date: JULY 2005; DS571, expiration date: JULY 2005;
b) Lot Numbers/Expiration Dates: DL151, expiration date: MAY 2005; DL521, expiration date: MAY 2005; DL531, expiration date: MAY 2005; DN921, expiration date: JULY 2005; DN931, expiration date: JULY 2005; DN941, expiration date: JULY 2005; DS571, expiration date: JULY 2005 , DS561, expiration date. July 2005.
RECALLING FIRM/MANUFACTURER
Par Pharmaceutical , Spring Valley , NY , by letters on 3/12/04 . FDA initiated recall is ongoing.
REASON
Mislabeling: some bottles of "ACYCLOVIR TABLETS 400 mg" were affixed with an additional outer label (outsert) over the base label incorrectly identifying the product as "SOTALOL HCL TABLETS, 120 mg".
VOLUME OF PRODUCT IN COMMERCE
30,523 bottles of 100 tablets.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Z-Cof DM Liquid, Each 5mL/one teaspoon contains: Dextromethorphan HBr 15mg, Pseudoephedrine HCl 32mg, and Guaifenesin 200mg, 16 fl oz (473)mL bottles , Alcohol free, No antihistamine, Grape Flavor, Rx Only. NDC 65224-619-16. Recall # D-156-4.
CODE
Lot number 40318.
RECALLING FIRM/MANUFACTURER
Elge, Inc, Rosenberg , TX , by telephone and letter on April 14, 2004 . Firm initiated recall is ongoing.
REASON
Misprint in package insert; insert indicates dosage administration as Adults and children 2 years of age and older rather than Adults and children 12 years of age and older.
VOLUME OF PRODUCT IN COMMERCE
6,139 pints .
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Nubain Injection (Nalbuphine Hydrochloride), 10 mg per mL injection, 10 mL Multiple Dose Vial, For Intramuscular, Subcutaneous or Intravenous Use, Rx Only. NDC 63481-508-05. Recall # D-158-4.
CODE
MPK585A1, exp. date 8/31/04 .
RECALLING FIRM/MANUFACTURER
Endo Pharmaceuticals Inc., Chadds Ford , PA , by letters on April 9, 2004 . Firm initiated recall is ongoing.
REASON
Product contains metal particles.
VOLUME OF PRODUCT IN COMMERCE
31,298 vials.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
BiCNU (carmustine for injection): Formerly known as (sterile carmustine [BCNU]), 100 mg and Diluent, Rx only. NDC 0015-3012-38. Recall # D-160-4.
CODE
Lot LCE16; Exp. FEB 2005.
RECALLING FIRM/MANUFACTURER
Bristol Myers Squibb Co. C.P.O., Mount Vernon , IN , by letters dated April 8, 2004 . Firm initiated recall is ongoing.
REASON
Short fill; vial did not meet net content specifications.
VOLUME OF PRODUCT IN COMMERCE
29,803 vials.
DISTRIBUTION
Nationwide, and International.
_____________________________
PRODUCT
Wellskin Facial Cream, (octinoxate 5%; avobenzone 2%), SPF 15, 14% Glycolic Complex. NDC 64760-008-01. Recall # D-161-4.
CODE
Lot Number: 119304.
RECALLING FIRM/MANUFACTURER
Genesis Pharmaceutical, Inc., Hazel Park , MI , by telephone and letter on April 8, 2004 . Firm initiated recall is ongoing.
REASON
Mislabeling: The jars of labeled sunscreen were mispackaged with nightcream which product has no sunscreen properties.
VOLUME OF PRODUCT IN COMMERCE
233.
DISTRIBUTION
Nationwide and Canada .

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_____________________________
PRODUCT
Lorazepam Tablets, USP, 0.5 mg, 60 count, 100 count and 500 count bottles, Rx only. Recall # D-157-4.
CODE
Lot number/Expiration Date: Lot 47500 exp. 6/04.
RECALLING FIRM/MANUFACTURER
Mutual Pharmaceutical Co., Inc., Philadelphia , PA , by letters on April 8, 2004 . Firm initiated recall is ongoing.
REASON
Stability Failure: 18 month CRT stability time period.
VOLUME OF PRODUCT IN COMMERCE
851,900 tablets.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Altace (Ramipril) Capsules, 1.25 mg, unit dose pack (10s/10 to a box - 100 units), Rx only. NDC 61570-110-56. Recall # D-159-4.
CODE
Lot Number/Expiration Date: Lot No. 1053616, expiration 08/2004.
RECALLING FIRM/MANUFACTURER
King Pharmaceuticals Inc, Bristol , TN , by letter on April 26, 2004 . Firm initiated recall is ongoing.
REASON
Mislabeling: Product dosage labeling missing on a unit dose package.
VOLUME OF PRODUCT IN COMMERCE
2,696 units.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Acyclovir Tablets, USP, 800 mg tablets, 100 count bottles. NDC 0172-4268-60. Recall # D-164-4.
CODE
Lot numbers/Expiration Dates: 116009A (03/2005) and 113874A (03/2005).
RECALLING FIRM/MANUFACTURER
IVAX Pharmaceuticals, Miami , FL , by letter on April 27, 2004 . Firm initiated recall is ongoing.
REASON
Tablets crumbling.
VOLUME OF PRODUCT IN COMMERCE
5,906 bottles.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
AVONEX Injection (Interferon beta-1a), 30 mcg/0.5mL Prefilled Syringe, in administration dose packs of 1 and 4, RX only, For IM Injection Once-A-Week, Sterile. NDC 59627-002-06. Recall # D-165-4.
CODE
Lot Numbers / Expiration Date: P30027 June 2005 , P30028 June 2005 , P30029 June 2005 , P30030 June 2005 , P30031 June 2005 , P30032 June 2005 , P30033 July 2005 , P30034 July 2005 , P30036 July 2005 , P30038 July 2005, P30039 August 2005.
RECALLING FIRM/MANUFACTURER
Biogen Idec MA Inc., Cambridge , MA , by letter on April 29, 2004 . Firm initiated recall is ongoing.
REASON
Syringes exceed the specification for aggregrates.
VOLUME OF PRODUCT IN COMMERCE
32,784 (4 packs).
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Nystatin Oral Suspension USP, 100,000 Units/mL, packaged in 60 ml bottles (NDC # 0472-1320-02) and 16 ounce bottles (NDC #0472-1320-16). Rx only. Recall # D-166-4.
CODE
Lot Numbers/Expiration Dates: QH3260 (60 mL) EXP 09/05, QH3260 (16 oz.) EXP 03/05, QH3259 (16 oz.) EXP 03/05.
RECALLING FIRM/MANUFACTURER
Alpharma USPD, Baltimore , MD , by letter dated April 5, 2004 . Firm initiate recall is ongoing.
REASON
Superpotent.
VOLUME OF PRODUCT IN COMMERCE
217,998 units.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
PREMARIN (conjugated estrogens tablets USP), 0.625 mg, 5,000 count bottles, Rx. NDC #0046-0867-95. Recall # D-167-4.
CODE
Lot Number/Expiration Date: A15477, Exp. 09/04.
RECALLING FIRM/MANUFACTURER
Richmond Division of Wyeth, Richmond , VA , by letter on April 30, 2004 . Firm initiated recall is ongoing.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
3,491 bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_____________________________
PRODUCT
a) Red Blood Cells (apheresis), Leukoreduced. Recall # B- 1092-4;
b) Red Blood Cells (apheresis), Leukoreduced, Irradiated.
Recall # B-1093-4.
CODE 
a) and
b) Unit 12801-3649.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Albuquerque , NM , by letter dated February 26,2004 . Firm initiated recall is ongoing.
REASON
Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NM.
_____________________________
PRODUCT
Source Plasma. Recall # B-1116-4.
CODE
Unit numbers: 02GMIC9069, 02GMIC8689.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Walker , MI , by facsimile on January 15, 2004 . 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
2 units.
DISTRIBUTION
Austria
_____________________________
PRODUCT
Platelets. Recall # B-1118-4.
CODE
Unit number: 18GM08262.
RECALLING FIRM/MANUFACTURER
American Red Cross, Great Lakes Region, Lansing , MI , by telephone on December 30, 2003 , and by letter, dated December 31, 2003 . Firm initiated recall is complete.
REASON
Blood product, associated with an air contaminated red cell unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OK.
_____________________________
PRODUCT
Platelets Pheresis, Leukocytes Removed. Recall # B-1142-4.
CODE
Unit numbers: 41FP34043, 41FP34385, 41GP51940, 41GP52041, and 41FP36606.
RECALLING FIRM/MANUFACTURER
American Red Cross, Alabama Region, Birmingham , AL , by letter, dated January 10, 2002 . Firm initiated recall is complete.
REASON
Blood products, were inappropriately distributed in two bags.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
AL .
_____________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-1160-4.
CODE
Unit 02FE10432.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Central Plains Region, Wichita , KS , by fax and letter dated July 9, 2003 . Firm initiated recall is complete.
REASON
Blood product, collected from a donor who disclosed travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_____________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced. Recall # B- 1161-4;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated.
Recall # B-1162-4.
CODE 
a) Unit number: 41FP36537;
b) Unit number: 41FP36335.
RECALLING FIRM/MANUFACTURER
American Red Cross, Alabama Region, Birmingham , AL , by letter, dated January 10, 2002 . Firm initiated recall is complete.
REASON
Blood products were inappropriately distributed in a single storage bag.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AL.
_____________________________
PRODUCT
Source Plasma. Recall # B-1167-4.
CODE
Unit 02GMIE3952.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Walker, MI, by facsimile dated October 9, 2002. Firm initiated recall is complete.
REASON
Source Plasma, lacking assurance of sterility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.
_____________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-1170-4.
CODE
Unit 200341746.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated May 29, 2003. Manufacturer: Blood Systems, Inc., Lafayette, LA. Firm initiated recall is complete.
REASON
Platelets, with a platelet count above the firm’s specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.
_____________________________
PRODUCT
Platelets, Leukocytes Reduced. Recall # B-1173-4.
CODE
Units GP55010, GP55019, GP55016, GP55005, GP55007.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by telephone on December 31, 2002. Firm initiated recall is complete.
REASON
Blood products, that were labeled leukoreduced but were not tested to determine the white blood cell count as required in the firm’s standard operating procedures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
PA.
_____________________________
PRODUCT
Red Blood Cells, leukoreduced, irradiated. Recall # B-1174-4.
CODE
Units: 231486809, 231486815.
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Billings, MT, by telephone on May 6, 2003. Firm initiated recall is complete.
REASON
Blood products, whose irradiated status were not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MT.
_____________________________
PRODUCT
a) Red Blood Cells. Recall # B-1175-4;
b) Red Blood Cells Leukocytes Reduced. Recall # B-1176-4;
c) Platelets Leukocytes Reduced. Recall # B-1177-4;
d) Platelets Pooled. Recall # B-1178-4;
e) Platelets Pooled Leukocytes Reduced. Recall # B-1179-4.
CODE
a) Units 0876891, 0834735, 0682350, and 0673899;
b) Units 0942312, 0901353, 0866718, and 0871777;
c) Units 0942312, 0901353, and 0866718;
d) U nit 0079834;
e) Unit 0082376.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by letters dated June 10, 2003, and January 7, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had resided in a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units.
DISTRIBUTION
OH.
_____________________________
PRODUCT
a) Red Blood Cells. Recall B-1180-4;
b) Cryoprecipitated AHF. Recall # B-1181-4;
c) Plasma Cryoprecipitate Reduced. Recall # B-1182-4.
CODE
a), b), and c) Unit 2040039.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by telephone on October 8, 2003, by facsimile on November 2, 2003, and/or by letter dated November 18, 2003. Firm initiated recall is complete.
REASON
Blood products, which tested negative for infectious diseases by viral marker screening tests but were identified by the donor for confidential unit exclusion, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
KY and Switzerland.
_____________________________
PRODUCT
a) Red Blood Cells. Recall # B-1184-4;
b) Platelets. Recall # B-1185-4;
c) Cryoprecipitated AHF. Recall # B-1186-4;
d) Recovered Plasma. Recall # B-1187-4.
CODE
a), b), c), and d) Unit 3166918.
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood & Tissue Center, Austin, TX, by letter dated April 16, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had a history of intravenous drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
TX and FL.
_____________________________
PRODUCT
Red Blood Cells. Recall # B-1188-4.
CODE
Unit KL00722.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile dated February 28, 2003. Firm initiated recall is complete.
REASON
Blood product, which tested negative for the cytomegalovirus (CMV) but was collected from a donor who previously tested positive for CMV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
_____________________________
PRODUCT
a) Platelets. Recall # B-1189-4;
b) Fresh Frozen Plasma. Recall # B-1190-4.
CODE
a) and b) Unit FW06276.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by telephone on July 29, 2002. Firm initiated recall is complete.
REASON
Blood products, in which the corresponding Red Blood Cells were positive for coagulase negative staphylococcus and implicated in a transfusion reaction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA.
_____________________________
PRODUCT
a) Red Blood Cells. Recall # B-1191-4;
b) Platelets. Recall # B-1192-4.
CODE
a) and b) Unit GP49936.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by telephone on July 2, 2002. Firm initiated recall is complete.
REASON
Blood products, in which the corresponding and implicated in a transfusion reaction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA.
_____________________________
PRODUCT
Platelets. Recall # B-1193-4.
CODE
Unit L81323.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Rapids, MI, by facsimile on March 1, 2004. Firm initiated recall is complete.
REASON
Blood product, in which the corresponding Red Blood Cells contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
_____________________________
PRODUCT
Red Blood Cells. Recall # B-1195-4.
CODE
Units 200326205, 200346790.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on July 11, 2003, and by letter dated August 7, 2003. Manufacturer: Blood Systems, Inc., Lafayette, LA. Firm initiated recall is complete.
REASON
Blood products, that failed to meet the minimum specification for product volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA and TN.
_____________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced. Recall # B- 1196-4;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated.
Recall # B-1197-4.
CODE
a) Units: 200302771, 200306294, 200306318, 200308415, 200309314, 200314336-split 1 & 2, 200316541, 200317055- split 1 & 2, 200324375, 200324398, 200324452, 200326620, 200326791, 200332875, 200333063, 200343963, 204040341, 204046911, 204054851, 204055171, 204060543, 204065908- split 1 & 2, 204070316-split 1 & 2, 204070921, 200306315-split 2, 200313332-split 2, 204070810-split 2, 204072335-split 2, 204073383-split 2, 204076190-split 2, 204077095-split 2;
b) Units: 200302771, 200308944, 200316541, 200306321 .
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated July 2, 2003. Manufacturer: Blood Systems, Inc., Lafayette, LA. Firm initiated recall is complete.
REASON
Blood products, which yielded a platelet count that was below the acceptable limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
39 units.
DISTRIBUTION
LA, MS, and TX.
_____________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-1198-4.
CODE
Unit 18P58006.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by telephone on February 6, 2004. Firm initiated recall is complete.
REASON
Platelets, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
_____________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1199-4.
CODE
Unit 200323059.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale , AZ , by telephone on May 9, 2003 or by facsimile on June 13, 2003 . Manufacturing Firm: Blood Systems, Inc., Lafayette , LA. Firm initiated recall is complete.
REASON
Blood products, collected from donors who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA and Switzerland .
_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1202-4;
b) Red Blood Cells Pheresis, Leukocytes Reduced Units.
Recall # B-1203-4;
c) Platelets Pheresis, Leukocytes Reduced. Recall # B- 1204-4;
d) Platelets Pheresis, Leukocytes Reduced, Irradiated.
Recall # B-1205-4.
CODE
a) Units 200333109, 200333115, 200333120, 200333121;
b) Units 200333104-split 1 & 2, 200333106;
c) Units 200333116-split 1 & 2, 200333097, 200333107, 200333111, 200333119;
d) Unit 200333117.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale , AZ , by telephone on May 19 and 22, 2003, and by letter dated June 16, 2003 . Manufacturing Firm: Blood Systems, Inc., Lafayette , LA. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose health history regarding exposure to SARS was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units.
DISTRIBUTION
LA, MS, and TX.
_____________________________
PRODUCT
Platelets. Recall # B-1207-4.
CODE
Unit numbers: T12510, T12511, T12512, T12513, T49125, T49126, T49139, T49140, T49142, T49317, T49318, T49327, T49331, T12447, T12457, T12869, T49259, T49264, T49268, T49269, T49276, T49281, T49374, T49378, T49380, T49383, T49384, T49385, T49392, T49522, T64893, T64896, T64897, T64962, T64971, T12458, T12870, T12871, T49517, T49528, T49532, T49538, T49539, T49386, T49271, T49513, T49527, T49531, T64970, T12421, T12423, T12427, T12444, T12448, T12449, T12451, T12452, T12521, T12523, T12562, T12563, T12569, T12570, T12573, T12574, T12575, T12577, T12578, T12708, T12712, T12720, T12771, T12773, T12775, T12789, T12790, T12794, T12810, T12812, T12814, T12815, T12816, T12817, T12819, T12823, T12824, T12825, T12835, T12838, T12840, T12862, T12864, T12866, T12868, T12876, T49127, T49130, T49134, T49135, T49136, T49141, T49261, T49262, T49263, T49266, T49277, T49278, T49280, T49311, T49329, T49332, T49347, T49393, T49441, T49442, T49443, T49444, T49446, T49447, T49448, T49502, T49504, T49505, T49512, T49516, T49530, T49534, T49537, T49545, T49547, T49548, T49549, T49551, T49554, T49555, T64892, T64894, T64895, T64898, T64899, T64902, T64903, T64904, T64905, T64906, T64909, T64919, T64923, T64924, T64926, T64928, T64974, T64976, T64977, T64978, T81910, T81913, T81914, T81916, W90060, W90065, W90066, W90067, W90074, W90079, W90082, W90083, W90093, W90100, W90102, W90117, W90118, W90119, W90120, W90122, W90151, W90159, W90162, W90163, W90166, W90167, W90177, W90238, W90322, W90323, W90324, W90326, W90327, W90329, W90331, W90332, W90333, W90334, W90336, W90337, W90338, W90339, W90340, W90343, W90344, W90346, W90347, W90348, W90350, W90351, W90380, W90381, W90382, W90383, W90385, W90386, W90391, W90404, W90168, W90081, W90087, W90088, W90084, W90098, W90094, W90164, W90165, W90171, W90173, W90176, W90406, W90408, W90061, W90064, W90069, W90070, W90071, W90072, W90073, W90076, W90146, W90148, W90149, and W90150.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers , Traverse City , MI , by letter on January 29, 2004 . Firm initiated recall is complete.
REASON
Platelets were distributed with a possibly decreased platelet count.
VOLUME OF PRODUCT IN COMMERCE
239 units.
DISTRIBUTION
MI.
_____________________________
PRODUCT
Whole Blood. Recall # B-1208-4.
CODE
Unit number R12801.
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Bank, Springfield , IL , by facsimile on January 28, 2003 . Firm initiated recall is complete.
REASON
Blood product, that tested negative for antibodies to human immunodeficiency virus (anti-HIV), but was collected from a donor that previously tested repeatedly reactive for anti-HIV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
_____________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1209-4.
CODE
Unit number G90770.
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank, Inc., Rockford , IL , by telephone and letter on February 19, 2004 . Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with coagulase negative Staphylococcus sp. Bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WI.
_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1210-4;
b) Platelets, Leukocytes Reduced Irradiated. Recall # B- 1211-4;
c) Platelets, Leukocytes Reduced. Recall # B-1212-4.
CODE
a) U nit numbers 0939800 and 0920610;
b) U nit number 0939800;
c) Unit number 0920610.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center , University of Cincinnati Medical Center, Cincinnati , OH , by letters on June 6, 2003 , and January 7, 2004 . Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
OH, and KY.
_____________________________
PRODUCT
Platelets. Recall # B-1213-4.
CODE
Unit number 2038122.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington , KY , by letter on February 1, 2004 . 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
KY.
_____________________________
PRODUCT
Platelets. Recall # B-1214-4.
CODE
Unit number 0807811.
RECALLING FIRM/MANUFACTURER
LifeShare, Inc., Elyria , OH , by telephone on February 2, 2004 , and by letter on March 1, 2004 . 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
OH.
_____________________________
PRODUCT
Red Blood Cells. Recall # B-1215-4.
CODE
Unit number 5185107.
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center , Austin , TX , by telephone on August 9, 2002 . Firm initiated recall is complete.
REASON
Blood product was not properly quarantined after receipt of information that made the donor of the product ineligible due to a risk factor for infection with human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_____________________________
PRODUCT
Platelet Pheresis, Leukoreduced (split product). Recall # B-1216-4.
CODE
Units: 20407-7627-01, 20407-7627-02.
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Lafayette , LA , by letter dated September 11, 2002 . Firm initiated recall is complete.
REASON
Blood products, which were labeled “leukoreduced”, although a White Blood Count (WBC) had not been performed on them, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA.
_____________________________
PRODUCT
Red Blood Cells. Recall # B-1219-4; Recovered Plasma. Recall # B-1220-4.
CODE
a) and b) Unit number 2301050.
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center , Austin , TX , by letter on March 20, 2003 . Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible donor based on a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX, and Switzerland .
_____________________________
PRODUCT
a) Red Blood Cells. Recall # B-1221-4;
b) Recovered Plasma. Recall # B-1222-4.
CODE
a) and b) Unit number 9314978.
RECALLING FIRM/MANUFACTURER
The Blood Center , New Orleans , LA , by telephone and facsimile on October 9, 2002 . Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible donor based on the subsequent disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA, and Switzerland .
_____________________________
PRODUCT
Red Blood Cells. Recall # B-1223-4.
CODE
Unit number 9919171.
RECALLING FIRM/MANUFACTURER
The Blood Center , New Orleans , LA , by telephone on August 18, 2003 . Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Platelets that was pooled and was possibly contaminated with Staphylococcus sp. Bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.
_____________________________
PRODUCT
Red Blood Cells. Recall # B-1224-4.
CODE
Unit numbers: 3197069, 3197071, 3197076, 3197077, 3197078, 3197079, 3197080, 3197081, 3197082, 3197083, 3197084, 3197085, 3197086, 3197087, 3197088, and 3197090.
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City , Kansas City , MO , by letters on February 16, 2004 , and March 9, 2004 . Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood more than 8 hours after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
KS, and MO.
_____________________________
PRODUCT
Source Plasma. Recall # B-1225-4.
CODE
Unit numbers 01GMIA1503, 01GMIA1820, 01GMIA3412, 01GMIA3774, 01GMIA5464, 01GMIA5858, 01GMIA7603, 01GMIB0212, 01GMIB4059, 01GMIB4413, 01GMIB5373, 01GMIB6053, and 01GMIB6646.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Walker , MI , by facsimile on May 16, 2001 . Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an unsuitable donor due to recent ear piercing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units.
DISTRIBUTION
Austria .
_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1226-4;
b) Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-1227-4;
c) Fresh Frozen Plasma. Recall # B-1228-4.
CODE
a) Unit numbers 02FK10622, 02FK10623, 02FK10624, 02FK10625, 02FK10626, 02FK10627, 02FK10630, 02FK10631, 02FK10632, 02FK10633, 02FK10634, 02FK10635, 02FK10636, 02FK10637, 02FK10638, 02FK10641, 02FK10642, 02FK10643, 02FK10644, 02FK10645, 02FK10647, 02FK10649, 02FK10650, 02FK10651, 02FK10652, 02FK10653, 02FK10654, 02FK10655, 02FK10656, 02FK10657, 02FK10658, 02FK10661, 02FK10662, 02FK10663, 02FK10664, 02FK10665, 02FK10666, 02FK10667, 02FK10668, and 02FK10669;
b) Unit numbers 02FK10639, 02FK10640, and 02FK10648;
c) Un it numbers 02FK10649, 02FK10652, and 02FK10657.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Central Plains Region, Wichita, KS, by telephone on September 10, 2002, and by letter on September 18, 2002. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood that were collected in the incorrect size collection bag, were distributed.
VOLUME OF PRODUCT IN COMMERCE
46 units.
DISTRIBUTION
KS, OK, CA, and AL.
PRODUCT 
Red Blood Cells, Leukocytes Reduced. Recall # B-1229-4.
CODE
Unit 21KM50929.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland , OR , by letter dated April 1, 2003 . Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_____________________________
PRODUCT
Source Plasma. Recall # B-1230-4.
CODE
Units: WF0080642, WF0080806, WF0081157, WF0081329, WF0081855, WF0082151, WF0082398, WF0082626, WF0082792, WF0083060, WF0083289, WF0083555.
RECALLING FIRM/MANUFACTURER
DCI Biologicals Wichita Falls Inc., Wichita Falls , TX , by fax on October 10, 2002 . Firm initiated recall is complete.
REASON
Blood Products, collected from donor whose health history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
KY.
_____________________________
PRODUCT
Source Plasma. Recall # B-1231-4.
CODE
Units: WF0080229, WF0080411, WF0080882, WF0080902, WF0082227, WF0082358, WF0082904, WF0083142, WF0083483, WF0083649, WF0084306, WF0085220, WF0085439, WF0085948, WF0086376, WF0086656.
RECALLING FIRM/MANUFACTURER
DCI Biologicals Wichita Falls Inc., Wichita Falls , TX , by fax dated October 1, 2002 . Firm initiated recall is complete.
REASON
Blood Products, collected from donor considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units.
DISTRIBUTION
KY.
_____________________________
PRODUCT
Red Blood Cells, leukoreduced. Recall # B-1232-4.
CODE
Unit 20030-2727.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lafayette , LA , by telephone and letter on October 10, 2002 and October 25, 2002 . Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was not adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA, and Switzerland .
_____________________________
PRODUCT
Source Plasma. Recall # B-1234-4.
CODE
Units WF0080734, WF0083353, WF0083737, WF0083820, WF0084323.
RECALLING FIRM/MANUFACTURER
DCI Biologicals Wichita Falls, LLC, Wichita Falls , TX , by facsimile on August 30, 2002 . Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
KY.
_____________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1236-4.
CODE
Unit 5191958.
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood & Tissue Center , Austin , TX , by telephone on December 11, 2002 . Firm initiated recall is complete.
REASON
Blood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_____________________________
PRODUCT
Red Blood Cells. Recall # B-1244-4.
CODE
Unit: 20030-8755.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lafayette , LA , by letter dated February 25, 2003 . Firm initiated recall is complete.
REASON
Blood product, collected from a donor visited an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.
_____________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-1245-4.
CODE
Unit: 084J 35090.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern California Region, Oakland , CA , by letter dated November 6, 2000 . Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_____________________________
PRODUCT
Red Blood Cells, Leukoreduced Reduced. Recall # B-1246-4.
CODE
Unit number: 163724172.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale , AZ , by telephone on April 11, 2003 . Manufacturing Firm: Blood Systems, Inc., Meridian , MS . Firm initiated recall is complete.
REASON
Blood product, that was labeled leukoreduced prior to receipt of the leukoreduction assay results, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.
_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Irradiated. Recall # B-1248-4;
b) Recovered Plasma. Recall # B-1249-4.
CODE
a) and b) Unit number: 163699068.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale , AZ , by telephone on May 13, 2003 , by facsimile on May 19, 2003 , and by letter, dated June 9, 2003 . Manufacturing Firm: Blood Systems, Inc., Hattiesburg , MS . Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor whose sexual partner lived in an area with increased risk for human immunodeficiency virus (HIV) Group O, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MS, and Switzerland .

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

 _______________________________ 
PRODUCT 
Red Blood Cells, Leukocytes Removed. Recall # B-1129-4.
CODE
Unit number: 41LP28571.
RECALLING FIRM/MANUFACTURER
American Red Cross, Alabama Region, Birmingham , AL , by telephone on April 25, 2002 , and by letter dated May 3, 2002 . Firm initiated recall is complete.
REASON
Blood product, which failed red cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL .
_____________________________
PRODUCT
Platelets Pheresis, Irradiated. Recall # B-1130-4.
CODE
Unit numbers: 22KG75128, 22LE01688.
RECALLING FIRM/MANUFACTURER
American Red Cross, Penn-Jersey Region, Philadelphia , PA , by telephone on January 5, 2004 , and by letter, dated January 8, 2004 . Firm initiated recall is complete.
REASON
Blood products, not stored under continuous agitation and controlled temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ.
_____________________________
PRODUCT
Red Blood Cells. Recall # B-1163-4.
CODE
Units: 5107945, 5107946, 5107947, 5107948, 5107949, 5107950, 5107951, 5107952, 5107953, 5107955, 5107957, 5107958, 5107959, 5107960, 5107961, 5107962.
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, MO, by letter dated February 17, 2004 . Firm initiated recall is complete.
REASON
Blood products, exposed to shipping temperature above acceptable limits, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
KS and MO.
_____________________________
PRODUCT
Source Plasma. Recall # B-1168-4.
CODE
Units 03RMIB2437, 03RMIB2753.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Kentwood , MI , by facsimile dated July 23, 2003 . Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who was not properly asked the medical history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
_____________________________
PRODUCT
Source Plasma. Recall # B-1169-4.
CODE
Unit 02GMIA8485.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Walker , MI , by facsimile dated April 29, 2002 . Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria .
_____________________________
PRODUCT
Red Blood Cells, Apheresis, Leukocytes Reduced. Recall # B-1171-4.
CODE
Unit 200348734.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale , AZ , by telephone on July 7, 2003 . Manufacturing Firm: Blood Systems, Inc., Lafayette , LA. Firm initiated recall is complete.
REASON
Red Cells, that were below the acceptable range for absolute RBC volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated. Recall # B-1172-4.
CODE
Units 21KF35238, 21FL73965, 21KJ83908.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland , OR , by letter dated April 10, 2003 . Firm initiated recall is complete.
REASON
Red Cells, that lacked assurance of proper storage temperatures due to improper documentation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
WA.
_____________________________
PRODUCT
Source Plasma. Recall # B-1183-4.
CODE
Unit HKCKKT.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Louisville , KY , by letter dated December 5, 2003 . Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
_____________________________
PRODUCT
Source Plasma. Recall # B-1194-4.
CODE
Units: 43722846, 43051649, 42599364, 42595243, 27195222, 27191675, 25835328, 25834468, 25832341, 23778771, 23777590, 23776036, 23775022, 23773226, 23770683, 23769113, 23767713, 23764767, 23763067, 19693361, 19692135, 20058067, 20057121, 20054779, 20053819, 20052041, 20050986, 21768781, 21767937, 21765186, 21762888, 20770365, 20769321, 20765873, 20764135, 20762773, 17124584, 17123839, 79352697, 79351515, 79029629, 79028684, 79026529, 79022132, 79021159, 79018395, 79016636, 79014809, 79013093, 79010795, 78729964, 78728172, 78726987, 78724761, 78723986, 74224869, 74222803, 74027880, 74025350, 74023615, 74021123, 70018905, 70017731, 70014686, 70012637, 70011210, 69958182, 69956003, 69955174, QP25028, QP24243, and 20767174.
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Muskego , MI , by facsimile on January 30, 2004 . Firm initiated recall is complete.
REASON
Blood products, which tested negative for infectious diseases by viral marker screening tests, but were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
72 units.
DISTRIBUTION
CA.
_____________________________
PRODUCT
Recovered Plasma. Recall # B-1200-4.
CODE
Unit 200322897.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale , AZ , by telephone on May 9, 2003 or by facsimile on June 13, 2003. Manufacturing Firm: Blood Systems, Inc., Lafayette , LA. Firm initiated recall is complete.
REASON
Blood products, collected from donors who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA and Switzerland .
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1201-4.
CODE
Unit numbers: 200328709, 200318980.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale , AZ , by letter, dated June 24, 2003. Manufacturing Firm: Blood Systems, Inc., Lafayette , LA. Firm initiated recall is complete.
REASON
Blood products, incorrectly antigen typed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA.
_____________________________
PRODUCT
Platelets. Recall # B-1206-4.
CODE
Unit numbers: 200330273, 200330274, 200330276, 200330280, 200330282, 200330941, 200330946, 200332047, 200332054, 200332055, 200332058, 200332380, and 200334296.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale , AZ , by letter, dated June 23, 2003. Manufacturing Firm: Blood Systems, Inc., Lafayette , LA. Firm initiated recall is complete.
REASON
Blood products, that lacked assurance of proper storage temperatures due to lack of adequate documentation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units.
DISTRIBUTION
LA.
_____________________________
PRODUCT
Recovered Plasma. Recall # B-1233-4.
CODE
Unit 20030-2727.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lafayette , LA , by telephone and letter on October 10, 2002 and October 25, 2002 . Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was not adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA, and Switzerland .
_____________________________
PRODUCT
Red Blood Cells. Recall # B-1247-4.
CODE
Unit: E42654.
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton , CA , by telephone on October 27, 1998 and by letter dated December 7, 1998 . Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose body temperature was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

 _______________________________ 
PRODUCT 
Medtronic MiniMed Paradigm Quick-set Plus Infusion Sets. Models MMT-359S6; MMT-359S9; MMT-359L6 and MMT-359L9. (Differences in models is variation in length, 6 versus 9 MM.). Recall # Z-0910-04.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Medtronic MiniMed, Northridge , CA , by letters from March 2-5, 2004 . Firm initiated recall is ongoing.
REASON
Possibility of interrupted insulin flow.
VOLUME OF PRODUCT IN COMMERCE
1,676,546 units.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
VITEK GPS-107Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. Recall # Z-0917-04.
CODE
Lot #B28E.
RECALLING FIRM/MANUFACTURER
bioMerieux Inc, by letters dated April 20, 2004 . Firm initiated recall is ongoing.
REASON
Some of the cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly.
VOLUME OF PRODUCT IN COMMERCE
1,990/20-card boxes.
DISTRIBUTION
Nationwide and International.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

 _______________________________ 
PRODUCT 
Kreiger Tables, X-Ray tables for use with C-Arm X-Ray systems. Recall # Z-0819/0825-04.
CODE
Model Numbers: APS-1000, APS-1010, APS-1020T, APS-1020L, APS-1030, APS-1040, and APS-1050.
RECALLING FIRM/MANUFACTURER
Krieger Medical, Inc., Woburn , MA , by letter on April 28, 2004 . Firm initiated recall is ongoing.
REASON
An incorrect identification label and the failure of certification testing program resulted in tables not complying with the U.S. Federal performance standard.
VOLUME OF PRODUCT IN COMMERCE
351 units.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Concha IV Plus Heated Humidifier. Recall # Z-0929-04.
CODE
All products manufactured with software 11738 -rev.03, Version V13.6, 252 A. This represents all units currently in the field.
RECALLING FIRM/MANUFACTURER
Hudson Respiratory Care Inc, Temecula , CA , by visit beginning on February 20, 2004 . Firm initiated recall is ongoing.
REASON
Software malfunction.
VOLUME OF PRODUCT IN COMMERCE
1049.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 14 cm, Diameter: 11 mm, Product Number 72401450. Recall # Z-0930-04;
b) AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 16 cm, Diameter: 11 mm, Product Number 72401451. Recall # Z-0931-04.
CODE
a) Lot/serial number 361100/001-005;
b) Lot/serial number 361101/001-005.
RECALLING FIRM/MANUFACTURER
American Medical Systems, Minnetonka , MN , by letters, dated April 29, 2004 . Firm initiated recall is ongoing.
REASON
The product is mislabeled as to length.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
CA, TX, PR, Costa Rica and Taiwan .
_____________________________
PRODUCT
a) AMPLICOR HPV Master Mix Analyte Specific Reagent
HPV MMX), Catalog number 03582841190. Recall # Z-0933-04;
b) AMPLICOR HPV Microwell Plate Analyte Specific Reagent
MWP); catalog 03579229190. Recall # Z-0934-04.
CODE
a) Lot E11927; exp. 10/04;
b) Lot E12989; exp. 7/04.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis , IN , by phone on March 10, 2004 . FDA initiated recall is complete.
REASON
Marketed without PMA or 510(k) approval.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
FL, and VA.
_____________________________
PRODUCT
LIFEPAK 12 defibrillator/monitor. Recall # Z-0938-04.
CODE
Part numbers VLP12, UVLP12, EVLP12, DVLP12, AVLP12, and any of these may have five to eight digits after the base number. Serial numbers can be obtained from the firm or FDA’s Seattle District Recall Coordinator.
RECALLING FIRM/MANUFACTURER
Medtronic Physio Control Corp, Redmond , WA , by letters on April 6, 2004 . Firm initiated recall is ongoing.
REASON
Potential for display to go blank due to an electrical component that may fail due to mechanical shock of vibration of the defibrillator.
VOLUME OF PRODUCT IN COMMERCE
2,885 devices.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
SenoScan True View Digital Mammography System. Recall # Z-0939-04.
CODE
Serial Numbers: 9800-0103-001, 9800-0104-001, 0900-0104-002, 9800-0104-003, 9800-0203-001, 9800-0204-001, 9800-0204-002, 9800-0204-004, 9800-0204-005, 9800-0303-003, 9800-0402-003, 9800 0403-001, 9800-0502-001, 9800-0602-001R, 9800-0603-001, 9800-0603-002, 9800-0901-001R, 9800-0903-001, 9800-1001-001, 9800-1003-003, 9800-1003-004, 9800-1102-003, 9800-1102-007, 9800-1103-001, 9800-1103-002, 9800-1103-003, 9800-1103-004, 9800-1103-005, 9800-1103-006, 9800-1103-007, 9800-1103-008, 9800-1103-009, 9800-1103-011, 9800-1103-012, 9800-1202-003, 9800-1203-001, 9800-1203-002.
RECALLING FIRM/MANUFACTURER
Fischer Imaging Corporation, Denver , CO , by letter on April 19, 2004 . Firm initiated recall is ongoing.
REASON
X-ray tube may overheat after high usage because of mis-wired thermal switch circuit.
VOLUME OF PRODUCT IN COMMERCE
37 units.
DISTRIBUTION
Nationwide, Mexico , and France .

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

 _______________________________ 
PRODUCT 
Brand name: Stylus 2-0 Polyviolene Double Armed with T Taper needles. Common name: 20- Polyviolene (white braided coated polyester) with T Taper needles (double armed). Recall # Z-0936-04.
CODE
Model number DB513, Lot number M384030 exp. 7/08.
RECALLING FIRM/MANUFACTURER
Surgical Specialties Corp, Reading , PA , by email on August 26, 2003 . Firm initiated recall is complete.
REASON
Sterilization method incorrect.
VOLUME OF PRODUCT IN COMMERCE
2 boxes.
DISTRIBUTION
Japan .
_____________________________
PRODUCT
Magnetic Resonance Imaging System Core Software, Software installed in all of the following: Flexart MRI System, Visart MRI System, Exelart / Exelart P2 / Exelart P3 SPIN & Exelart VANTAGE MRI Systems. Recall # Z-0937-04.
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Toshiba American Med Sys Inc, Tustin, CA, by letters and visits beginning on May 6, 2004. Firm initiated recall is ongoing.
REASON
Software anomaly. The region of the body was scanned, was different than programmed.
VOLUME OF PRODUCT IN COMMERCE
50.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
K-Assay Lp(a) Control. Recall # Z-0940-04.
CODE
Lot D407.
RECALLING FIRM/MANUFACTURER
Kamiya Biomedical Company, Seattle , WA , by letters on March 30, 2004 . Firm initiated recall is ongoing.
REASON
Assay result not consistent with the assigned control value.
VOLUME OF PRODUCT IN COMMERCE
16.
DISTRIBUTION
CA, PA, MN, GA, and MI.

END OF ENFORCEMENT REPORT FOR MAY 12, 2004

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