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U.S. Department of Health and Human Services

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Enforcement Report for May 19, 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 19, 2004
04-20

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Sunridge Farms brand All Natural Yogurt Raisins in 8 oz
plastic bags; 12 packages per case. Recall # F-195-4.
CODE
3240321, UPC Code: 0-86700-68084 or 0-86700-68073-5.
RECALLING FIRM/MANUFACTURER
Falcon Trading Co., Santa Cruz, CA, by press release, letter, e-mail, fax, telephone and visits on March 4, 2004. FDA initiated recall is complete.
REASON
Packages labeled as All Natural Yogurt Raisins actually contain almonds.
VOLUME OF PRODUCT IN COMMERCE
2,376 bags.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Autumn Trails Delight - a trail mix product in flexible
plastic bag labeled in part "Gray Squirrel Nut CO. Autumn
Trails Delite", Net Wt. 16 oz. Recall # F-196-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Gray Squirrel Nut Co, St. Ignatius, MT, by press release and telephone on April 9, 2004. FDA initiated recall is ongoing.
REASON
Trail Mix contains undeclared peanuts, milk, and color additives.
VOLUME OF PRODUCT IN COMMERCE
4,459/16 oz. packages.
DISTRIBUTION
MT, ID, and WY.

_______________________________
PRODUCT
Hood Cultured Fat Free Buttermilk, One quart cardboard
container. Recall # F-203-4.
CODE
Code: Dec 30.
RECALLING FIRM/MANUFACTURER
H. P. Hood, Inc., Chelsea, MA, by letter dated December 18, 2003. Firm initiated recall is complete.
REASON
Fat-free Buttermilk actually contains egg nog.
VOLUME OF PRODUCT IN COMMERCE
465 cases (16 units/case).
DISTRIBUTION
CT, MA, and RI.
 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
a) Lucerne' Orange Creme Yogurt-Low Fat in 8 oz Tub.
Recall # F-197-4;
b) Lucerne' Orange Creme Yogurt-Low Fat in 8 oz Tub.
Recall # F-198-4.
CODE
a) Best Before 3/14, 3/28, 4/02, 4/11, 4/19, 4/24, 5/02,
UPC 21130 07761;
b) Best Before 3/15, 3/22, 3/29, 4/5, 4/17, 4/23, 4/25,
4/27, 5/8, UPC 21130 07785.
RECALLING FIRM/MANUFACTURER
Safeway Stores, Inc., Pleasanton, CA, by e-mail, telephone and fax on March 19, 2004. Firm initiated recall is complete.
REASON
The products contain undeclared FD&C Yellow # 6.
VOLUME OF PRODUCT IN COMMERCE
374,916/12 packages per case.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Harmony brand Oriental Party Mix, a) 13 lbs-C90, Item #
00104, b) 22 lbs. bulk, Item # 87065, c) 8.5 oz. zip
bag, Item # 25556. Recall # F-199-4;
b) Harmony brand Oriental Rice Crackers, a) 6 lbs-C90, Item
# 00118, b) 5 oz zip bag Item # 25630. Recall # F-200-4.
CODE
a) Code Dates Involved: a) from 2G23 to 4D02, b) from 2G16
to 4D02, c) use by 10AP03 to use by 10JA05;
b) Code Dates Involved: a) from 2G16 to 4D02, b) use by
9AP03 to use by 2JA05.
RECALLING FIRM/MANUFACTURER
Harmony Foods Corp., Santa Cruz, CA, by letters on April 2, 2004. Firm initiated recall is ongoing.
REASON
These products contain undeclared FD&C Yellow #6.
VOLUME OF PRODUCT IN COMMERCE
20,859 cases.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Cut Green Beans (frozen), in bags labeled "SYSCO Classic
Fresh Frozen Cut Green Italian Beans", Net Wt. 32 ozs.,
Product of Canada. Product packed in cases of 12. Cases
labeled SYSCO Classic Fresh Frozen Romano Beans. UPC CODE
0-74865-07851-1. Recall # F-202-4.
CODE
01/2006 CR1 B40073 (stamped on bag).
RECALLING FIRM/MANUFACTURER
Sysco Food Services of Syracuse, Warners, NY, by letters dated April 5, 2004. FDA initiated recalls is complete.
REASON
Frozen cut green beans contain procymidone residue
VOLUME OF PRODUCT IN COMMERCE
49 cases x 12.
DISTRIBUTION
Nationwide.
 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
Min-Tran Dietary Supplement Tablets in bottles of 330 and
800 tablets per bottle. Recall # F-188-4.
CODE
Code L318, Best Used By 09-05.
RECALLING FIRM/MANUFACTURER
Standard Process, Inc., Palmyra, WI, by telephone on December 15, 2003, and by letter on December 16, 2003. Firm initiated recall is complete.
REASON
Min Train Tablets are contaminated with mold.
VOLUME OF PRODUCT IN COMMERCE
1024 bottles of 800 count bottles; 4974 bottles of 330 count bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
PAN DE ORO 6.5" FLOUR TORTILLA 24/1 doz White Stick on
label on bulk cartons. Recall # F-201-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Severence Foods, Inc., Hartford, CT, by telephone on April 9, 2004. Firm initiated recall is ongoing.
REASON
Tortillas do not bear complete ingredient statements.
VOLUME OF PRODUCT IN COMMERCE
63 cases.
DISTRIBUTION
MA, and CT.
 

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Zyprexa (Olanzapine) tablets, 20 mg, 60 count bottle, Rx
only. NDC 0002-4420-60. Recall # D-168-4.
CODE
Lot numbers/Expiration Dates: 7ED11A Exp: 05/05; 7ED80A Exp: 06/05; 7EE34A Exp: 07/05; 7EE35A Exp. 07/05; 7ED85A Exp: 07/05; 7ED86A Exp: 07/05; 7ED87A Exp: 07/05; 7EJ26A Exp: 07/05; 7EJ28A Exp: 11/05; 7EJ29A Exp: 11/05; 7EJ31A Exp: 11/05; 7EJ32A Exp: 11/05; 7EJ33A Exp: 11/05.
RECALLING FIRM/MANUFACTURER
TXRX, Humble, TX, by letter on April 14, 2004. Firm initiated recall is ongoing.
REASON
Counterfeit: An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE
63 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Ibuprofen Tablets USP, 200 mg, 50 tablets and 100 coated
Tablets. Also sold under brands: Medic Ibuprofen tablets
and Family Dollar Savings Ibuprofen I-B. Recall # D-170-4.
CODE
Lot Number/Expiration Date: Lot A475905, Exp. Date 12/2005.
RECALLING FIRM/MANUFACTURER
Pharmaceutical Formulations Inc., Edison, NJ, by letters on April 13, 2004. Firm initiated recall is ongoing.
REASON
Adulterated Presence of Foreign Tablets.
VOLUME OF PRODUCT IN COMMERCE
3,597,253.
DISTRIBUTION
Nationwide.
 

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Premarin (conjugated estrogens tablets USP), 1.25 mg, 1000
count bottles, Rx only. NDC 0046-0866-91. Recall # D-147-4.
CODE
A44299 Exp. 12/2005.
RECALLING FIRM/MANUFACTURER
Richmond Division of Wyeth, Richmond, VA, by letter on April 8, 2004. Firm initiated recall is ongoing.
REASON
Dissolution Failure; 9 month stability.
VOLUME OF PRODUCT IN COMMERCE
9,217 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Microgestin Fe 1.5/30, (norethindrone acetate and
ethinyl estradiol tablets, USP and ferrous fumarate
tablets), 28-Day Regimen, Each green tablet (21)
contains 1.5 mg norethindrone acetate and 30 mcg ethinyl
estradiol, each brown tablet (7) contains 75 mg ferrous
fumarate, 6 Tablet Dispensers, 28 tablets each, Rx only,
NDC 52544-631-28. Recall # D-149-4;
b) Microgestin Fe 1/20, (norethindrone acetate and ethinyl
estradiol tablets, USP and ferrous fumarate tablets),
28-Day Regimen, Each white tablet (21) contains 1 mg
norethindrone acetate and 20 mcg ethinyl estradiol, each
brown tablet (7) contains 75 mg ferrous fumarate, 6
Tablet Dispensers, 28 tablets each, Rx only. NDC 52544-
630-28. Recall # D-150-4.
CODE
a) Lot 63103H03, Exp. Date July 2005;
b) Lot 63003M03, Exp. Date July 2005.
RECALLING FIRM/MANUFACTURER
Watson Pharmaceuticals, Inc., Corona, CA, by letter on or about April 1, 2004. Firm initiated recall is ongoing.
REASON
Defective container; film/foil separation of blister packaging.
VOLUME OF PRODUCT IN COMMERCE
33,374 cartons.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Clear brand Lice Egg Remover (Stainless Steal Comb and
Activated Enzyme Mousse) 2 Fl. Oz. (59.1 ml) pump
dispenser. Recall # D-169-4.
CODE
Lot Number/Expiration Date: Lot CM1001, 04/2007.
RECALLING FIRM/MANUFACTURER
International Chemical, Inc., Amherst, NY, by telephone and letter on April 26, 2004. Firm initiated recall is ongoing.
REASON
Mislabeling: Dispensing container of Lice Egg Remover Mousse was inadvertently labeled as Lice Killing Shampoo.
VOLUME OF PRODUCT IN COMMERCE
3,216 units (268 cases of 12).
DISTRIBUTION
Nationwide.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0971-4;
Red Blood Cells, Leukocytes Reduced. Recall # B-0972-4;
Plasma. Recall # B-0973-4;
Recovered Plasma. Recall # B-0974-4.
CODE
a) and c) Unit 29GH23522;
b) and d) Units 29GH31592, 29GV46982, 29GL60563, 29GL58582.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by facsimile dated October 1, 2002, and by letter dated October 8, 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
10 units.
DISTRIBUTION
CA, VA, MD, NC, and DC.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1096-4.
CODE
Unit 20LN17501.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Lewis and Clark Region, Boise, ID, by facsimile transmission dated November 22, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor due to behavior associated with an increased risk of infection with the human immunodeficiency virus (HIV) or the hepatitis B virus (HBV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1133-4.
CODE
Unit numbers: 02GMIA9345, 02GMIB0175, 02GMIB0616, 02GMIB1333, 02GMIB1746, 02GMIB2451, 02GMIB2990, 02GMIB3751, 02GMIB4272, 02GMIB5088, 02GMIB5584, 02GMIB6320,
02GMIB6781, 02GMIB7619, 02GMIB8089, 02GMIB8891, 02GMIB9415,
02GMIC0282, 02GMIC0782, 02GMIC1632, 02GMIC2080, 02GMIC2878,
02GMIC3358, 02GMIC4072, 02GMIC5314, 02GMIC5789, 02GMIC6548,
02GMIC7022, 02GMIC8485, 02GMIC9565, and 02GMID0815.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Walker, MI, by facsimile on September 10, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
31 units.
DISTRIBUTION
Austria.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1166-4.
CODE
Units 02FX14033, 02FX13685.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Wichita, KS, by telephone and letter dated March 20, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX, and KS.
_____________________________
PRODUCT
Source Plasma. Recall # B-1217-4.
CODE
Unit 00YARD7489.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Fayetteville, AR, by facsimile dated January 31, 2001. Firm initiated recall is complete.
REASON
Source Plasma, which tested negative for the hepatitis B surface antigen (HbsAg), but was collected from a donor who subsequently tested repeatedly reactive for HbsAg, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Source Plasma. Recall # B-1218-4.
CODE
Units 01YARC4191, 01YARC4578, 01YARC5137, 01YARC5437, 01YARC6030, 01YARC6286.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Fayetteville, AR, by facsimile dated August 1, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
MI.
_____________________________
PRODUCT
Source Plasma. Recall # B-1237-4.
CODE
Unit numbers: WF0080876, WF0081121, WF0081457, and WF0081634.
RECALLING FIRM/MANUFACTURER
DCI Biologicals Wichita Falls, LLC, Wichita Falls, TX, by facsimile, dated October 10, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
KY.

_______________________________
PRODUCT
a) Fresh Frozen Plasma. Recall # B-1238-4;
b) Plasma Frozen. Recall # B-1239-4.
CODE
a) Units: 004L48803, 004GF29211, 004G45538, 004E57175,
004L54038, 004J50649;
b) Units: 004FS53489, 004V02079, 004S50290, 004S50296.
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA, by telephone on October 20, 2003, and by letter dated October 21, 2003. Firm initiated recall is complete.
REASON
Blood products, associated with units of Red Blood Cells assigned the "CLOT" designation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
MA, NH, and NY.

_______________________________
PRODUCT
Source Plasma. Recall # B-1240-4.
CODE
Units: N-55655-162, N-55668-162, F-01099-162, F-01502-162, F-01693-162.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, El Paso, TX, by facsimile on February 28, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
NC.
_____________________________
PRODUCT
Red Blood Cells. Recall # B-1241-4.
CODE
Unit number: GG00387.
RECALLING FIRM/MANUFACTURER
BloodSource-Merced County, Merced, CA, by telephone on January 18, 1998. 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
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1242-4;
b) Plasma, Frozen. Recall # B-1243-4.
CODE
a) and b) Unit 084KM04079.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Northern California Region, Oakland, CA, by letter dated January 22, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of cancer, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
_____________________________
PRODUCT
Source Plasma. Recall # B-1250-4.
CODE
Unit numbers: WF0080620, WF0081075, and WF0081254.
RECALLING FIRM/MANUFACTURER
DCI Biologicals Wichita Falls, LLC, Wichita Falls, TX, by facsimile, dated October 10, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for variant Creutzfeldt-Jakob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
KY.

_______________________________
PRODUCT
Platelets, Leukocytes Reduced. Recall # B-1251-4.
CODE
Unit number 33GT49143.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by letter on February 10, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer one of the medical history questions related to risk factors for Creutzfeldt-Jakob disease (CJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CT.
_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1253-4;
b) Platelets. Recall # B-1254-4.
CODE
a) and b) Unit number 4012460.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on March 6, 2001. 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
2 units.
DISTRIBUTION
NC, and TX.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1257-4.
CODE
Unit numbers: 163713147, 163713130.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AR, by telephone on May 1, 2003.
Manufacturing Firm: Blood Systems, Inc., Meridian, MS. Firm initiated recall is complete.
REASON
Blood products, which exceeded specifications for product volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MS.
_____________________________
PRODUCT
Source Plasma. Recall # B-1259-4.
CODE
Unit WLN005829.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Wilmington, DE, by facsimile, dated May 2, 2003. Firm initiated recall is complete.
REASON
Source Plasma, that tested negative for hepatitis C, but was collected from a donor that subsequently tested positive for hepatitis C by PCR testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Spain.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1260-4.
CODE
Unit 16363680.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc, Scottsdale, AZ, by facsimile on April 9, 2003, by telephone on April 18, 2003, and by letter dated May 2, 2003.
Manufacturing Firm: Blood Systems, Inc., Dba United Blood Services, Meridian, MS. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS, and Switzerland.
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1262-4.
CODE
Unit 163725952.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc, Scottsdale, AZ, by telephone on June 10, 2003.
Manufacturing Firm: Blood Systems, Inc., Dba United Blood Services, Meridian, MS. Firm initiated recall is complete.
REASON
Blood product, manufactured in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.

_______________________________
PRODUCT
Source Plasma. Recall # B-1263-4.
CODE
Units F06859162, F07035162.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corp., El Paso, TX, by facsimile on February 19, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unreliable donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Source Plasma. Recall # B-1264-4.
CODE
Units F00230162, F00659162, F01046162, F01301162.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corp., El Paso, TX, by facsimile on December 6, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Source Plasma. Recall # B-1265-4.
CODE
Units F00071162, F00589162, F01167162, F01303162, F06545162, F06729162.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corp., El Paso, TX, by facsimile on February 20, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unreliable donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Source Plasma. Recall # B-1266-4.
CODE
Unit numbers 923113, 923145, 923249, 923295, 923391, 923445, 9N1211, 9N1264, 9N1361, 9N1401, 9TK005, 9TK064, 9TK163, 9TK220, 9TK336, 9TK445, 9TK479, CDBZNZ, CDBZRR, CDBZZT, CDCBFK, CDCBGZ, CDCBML, CDCBPF, CDCCKC, CDCCPH, CDCCRJ, CDCFGL, CDCFJT, CDCCWV, CDCCZD, CDCDFT, CDCDJB, CDCDWV, and CDCDYT.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc. Little Rock, AK, by facsimile on December 3, 2001. 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
35 units.
DISTRIBUTION
IL and Switzerland.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1268-4.
CODE
Unit numbers: 16375-5330 and 16375-7125.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AR, by letter on November 13, 2003.
Manufacturing Firm: Blood Systems, Inc., Meridian, MS. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MS and AL.
_____________________________
PRODUCT
Red Blood Cells. Recall # B-1272-4.
CODE
Unit number: 224153528.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AR, by telephone on June 8, 2000, and by letter, dated July 10, 2000.
Manufacturing Firm: Blood Systems, Inc., Las Vegas, NV. Firm initiated recall is complete.
REASON
Blood Product, that was not properly quarantined after the donor reported a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 Unit.
DISTRIBUTION
NV.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1273-4.
CODE
Unit GG63262.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by telephone on February 28, 2003. Firm initiated recall is complete.
REASON
Blood product, that tested negative for Cytomegalovirus (CMV), but was collected from a donor who previously tested CMV positive, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Platelets. Recall # B-1274-4.
CODE
Unit LV35930.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by telephone on April 30, 2003. Firm initiated recall is complete.
REASON
Platelets, corresponding to red cells that were contaminated with Staphylococcus and implicated in an adverse transfusion reaction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
_____________________________
PRODUCT
Source Plasma. Recall # B-1275-4.
CODE
Units G05027040, G05216040, G05917040, G06697040, G09194040, G10141040, G10335040, G13018040, G13177040, G14342040, G14912040, G15267040, G15518040, G16080040, G32904040, G33117040, G33567040, G33791040, G35221040, G92990040, G93602040, G93858040, G94370040, G94735040, N06617040, and N06651040.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutics Corporation, Killeen, TX, by facsimile on December 11, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a history of unexplained needle marks, were distributed.
VOLUME OF PRODUCT IN COMMERCE
26 units.
DISTRIBUTION
NC, CA, and Germany.

_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1278-4.
CODE
Unit 71W547050.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Gainesville, FL, by facsimile on October 20, 2003. Firm initiated recall is complete.
REASON
Blood product, which had an unacceptable white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 Unit.
DISTRIBUTION
FL.
_____________________________
PRODUCT
Red Blood Cells. Recall # B-1279-4.
CODE
Unit LV11053.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by telephone on June 3, 2003. Firm initiated the recall is complete.
REASON
Blood product, that tested negative for Cytomegalovirus (CMV), but was collected from a donor who previously tested CMV positive, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1280-4.
CODE
Unit KC76624.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by telephone on September 10, 2003. Firm initiated the recall is complete.
REASON
Red Cells, manufactured with a volume that was below the firm's minimum specification, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
_____________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-1281-4;
b) Fresh Frozen Plasma. Recall # B-1282-4.
CODE
a) and b) Unit 53H01480.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Baltimore, MD, by telephone on September 24, 2003, and by letter dated September 25, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was taking the medication Enbrel, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.

_______________________________
PRODUCT
Source Plasma. Recall # B-1288-4.
CODE
Units LO092196, LO092605, LO091025.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Lorain, OH, by facsimile dated October 29, 2002. Firm initiated recall is complete.
REASON
Source Plasma, not tested for syphilis and unexpected antibodies, was distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NC.
_____________________________
PRODUCT
Recovered Plasma. Recall # B-1289-4.
CODE
Unit GE56269.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile dated January 13, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who subsequently reported taking the medication, Proscar, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
RI.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1290-4;
b) Platelets. Recall # B-1291-4;
c) Fresh Frozen Plasma. Recall # B-1292-4.
CODE
a), b) and c) Unit FT05643.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by telephone on September 19, 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 the subsequent disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
PA.
_____________________________
PRODUCT
a) Platelets. Recall # B-1293-4;
b) Fresh Frozen Plasma. Recall # B-1294-4.
CODE
a) and b) Units 02FC27818, 02LG11762.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Wichita, KS, by letters dated April 8, 2003, and May 12, 2003. Firm initiated recall is complete.
REASON
Blood products, corresponding to units of clotted red cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
TX, and KS.

_______________________________
PRODUCT
a) Platelets, Pheresis, Leukocytes Reduced.
Recall # B-1295-4;
b) Platelets, Pheresis, Leukocytes Reduced, Irradiated.
Recall # B-1296-4.
CODE
a) and b) Unit 01LZ37595.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, West Henrietta, NY, by telephone on June 24, 2003. Firm initiated recall is complete.
REASON
Platelets, with a low plasma volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NY.
_____________________________
PRODUCT
Source Plasma. Recall # B-1298-4.
CODE
Unit numbers: OT165990, OT166196, OT167383, OT167745,
OT168150, OT168456, OT169039, OT169204, OT169922, OT170383,
OT170699, OT171020, OT171373, OT171773, OT172394, OT172467, OT173043, OT173143, OT173646, OT173827, OT174337, OT174478, OT174933, OT175124, OT175553, OT176522, OT176702, OT177139, OT177344, OT177844, OT178096, OT178444, OT178666, OT179349, OT179548, OT181048, OT181253, OT187034, OT187620, OT188836, OT189182, OT190126, OT190560, OT192267, OT192480, OT193587, OT194176, OT194337, OT194927, OT195013, OT195668, OT195836,
OT196558, OT197320, OT197944, OT199244, OT199433, OT200186, OT200742, OT200918, OT202447, OT202792, OT202968, OT203327, OT203663, OT204364, OT204455, OT205123, OT205172, OT205898, OT205927, OT188000, and OT188342.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Odessa, TX, by facsimile on April 17, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on previous deferral for IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
73 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1304-4.
CODE
Unit 02LJ00581.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Wichita, KS, by letter dated May 2, 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
KS.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1308-4;
b) Recovered Plasma. Recall # B-1309-4.
CODE
a) and b) Unit 01GJ58532.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, West Henrietta, NY, by letters dated April 7, 2003, and April 10, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking Lupron, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NY and CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1310-4. Units (17 units)
CODE
Units 78819733, 78815803, 78814233, 74335008, 74339020, 77121165, 77124685, 78812963, 74333592, 74535893, 78816961, 78819184, 74332335, 74334407, 77121028, 77124456, 77126887.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Athens, OH, by facsimile dated July 9, 2002, and July 30, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from donors with a recent history of body piercing within the past 12 months, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1312-4.
CODE
Units FW096035, FW095897, FW095522, FW095319, FW095038, FW094497, FW094303.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Fort Wayne, IN, by facsimile dated March 18, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who was previously deferred for incarceration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1318-4;
b) Fresh Frozen Plasma. Recall # B-1319-4.
CODE
a) Unit number: 16LM61145;
b) Unit number: 16LM55380.
RECALLING FIRM/MANUFACTURER
The American Red Cross, Central Ohio Region, Columbus, OH, by letters dated February 23, 2004 and March 24, 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
OH.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1320-4;
b) Cryoprecipitated AHF. Recall # B-1321-4;
c) Recovered Plasma. Recall # B-1322-4.
CODE
a), b), and c) Unit 50LG82999.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH, by telephone on April 4, 2003, and by letter and facsimile dated April 16, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who engaged in high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OH, and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1323-4;
b) Cryoprecipitated AHF. Recall # B-1324-4;
c) Recovered Plasma. Recall # B-1325-4.
CODE
a) and b) Units 50LG88414, 50LG69283;
c) Unit 50LG88414.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH, by telephone on April 8, 2003, and by letter and facsimile dated April 9, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
CA, IL, OH, and Switzerland.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1326-4.
CODE
Unit number 31135-7497.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on August 25, 2003.
Manufacturing Firm: Blood Systems, Inc., Tupelo, MS. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.

_______________________________
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced. Recall #
B-1327-4.
CODE
Unit number 31135-7821.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on October 9, 2003.
Manufacturing Firm: Blood Systems, Inc., Tupelo, MS. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1328-4;
b) Fresh Frozen Plasma. Recall # B-1329-4.
CODE
a) and b) Unit number 31133-5450.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on January 9, 2003 and by letter on January 23, 2003.
Manufacturing Firm: Blood Systems, Inc., Tupelo, MS. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MS.

_______________________________
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced. Recall #
B-1331-4.
CODE
Unit number 31132-0954 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter on February 14, 2003.
Manufacturing Firm: Blood Systems, Inc., Tupelo, MS. Firm initiated recall is complete.
REASON
Blood product, that tested out of specification for hemoglobin, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MS.

_______________________________
PRODUCT
Source Plasma. Recall # B-1333-4.
CODE
Unit numbers 67775439, 67772834, 67766505, 67764747, 67750528, 67747481, 67742332, 67739660, 67734825, 67732685, 67726332, 67722099, and 67719310.
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by facsimile on November 22, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor that was previously deferred due to a risk factor for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Platelets Pheresis. Recall # B-1352-4.
CODE
Unit 18P58323.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by telephone on February 26, 2004. Firm initiated recall is complete.
REASON
Platelets Pheresis, with an unacceptably low volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1164-4;
b) Red Blood Cell, leukoreduced, autologous.
Recall # B-1165-4.
CODE
a) Units: 0428817, 0428818, 0428820, 0428821, 0428822,
0428823, 0428824, 0428825, 0428826, 0428827, 0428828,
0428829, 0428830, 0428831, 0428832, 0428833, 0428834,
0428835, 0428836, 0428837.
b) Units: 8573176, 8573177,8573178
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, MO, by telephone on January 22, 2004, and by letters dated January 28, 2004 and February 24, 2004. Firm initiated recall is complete.
REASON
Blood products, stored in coolers for periods in excess of the maximum storage time established during validation of the containers, were distributed.
VOLUME OF PRODUCT IN COMMERCE
23 units.
DISTRIBUTION
KS, and MO.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1235-4.
CODE
Units: 7077250, 7077251, 7077252, 7077253, 7077254, 7077256, 7077258, 7077259, 7077260, 7077261, 7077262, 7077263, 7077264, 7077265, 7077266, 7077267, 7077268
RECALLING FIRM/MANUFACTURER
Recalling Firm: Community Blood Center of Greater Kansas City, Kansas City, MO, by telephone on January 23, 2004, and by letters dated January 27, 2004 and February 24, 2004.
Manufacturing Firm: Community Blood Center of Greater Kansas City, Topeka, KS. Firm initiated recall is complete.
REASON
Blood products, manufactured from Whole Blood units that reached an unacceptable temperature during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units.
DISTRIBUTION
KS, and MO.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1252-4.
CODE
Unit number 33GK52252.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by telephone on January 14, 2004, and by letter on January 16, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer one of the medical history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CT.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Washed. Recall # B-1255-4.
CODE
Unit numbers: 22422-1355, 22422-0916, 22422-8187, 22422-3783, 22422-6052, and 22422-6050.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by telephone and letter on May 31, 2001. Firm initiated recall is complete.
REASON
Blood products, manufactured in expired processing bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
NV.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1256-4.
CODE
Unit numbers 50LJ713443 and 50LJ71131.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Western Lake Erie Region, Toledo, OH, by telephone and letter on January 28, 2004, and February 3, 2004. Firm initiated recall is complete.
REASON
Blood products, that did not have the complete amount of additive solution included, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1258-4.
CODE
Unit 163679466.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AR, by telephone on August 30, 2002, and by letter dated September 26, 2002.
Manufacturing Firm: Blood Systems, Inc., Meridian, MS. Firm initiated recall is complete.
REASON
Blood product, possibly out of controlled storage for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1261-4.
CODE
Unit 16363680.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc, Scottsdale, AZ, by facsimile on April 9, 2003, by telephone on April 18, 2003, and by letter dated May 2, 2003.
Manufacturing Firm: Blood Systems, Inc., Dba United Blood Services, Meridian, MS. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS, and Switzerland.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1267-4.
CODE
Unit number: 16367-7113.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AR, by telephone on August 15, 2002, and by letter on September 6, 2002.
Manufacturing Firm: Blood Systems, Inc., Meridian, MS. Firm initiated recall is complete.
REASON
Blood Product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 Unit.
DISTRIBUTION
MS.
_____________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1269-4.
CODE
Unit numbers: 16371-0696, 16371-0693, 16371-0695, and 16371-0698.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AR, by telephone on May 19, 2003.
Manufacturing Firm: Blood Systems, Inc., Meridian, MS. Firm initiated recall is complete.
REASON
Blood products, prepared more than eight hours after collection of the corresponding units of Whole Blood, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 Units.
DISTRIBUTION
MS.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1270-4.
CODE
Unit numbers: 16370-2521, 16369-5497, 16371-3951, and 16369-6182 (all units distributed as two split products).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AR, by telephone on February 6, 2003, and by letter on February 20, 2003.
Manufacturing Firm: Blood Systems, Inc., Meridian, MS. Firm initiated recall is complete.
REASON
Blood Products, collected on an apheresis machine where there was no documentation of evaluation of the filter assemblies as required, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 Units.
DISTRIBUTION
MS, and AL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1271-4.
CODE
Unit number 16371-7342.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AR, by telephone on April 3, 2003, and by letter on May 2, 2003.
Manufacturing Firm: Blood Systems, Inc., Meridian, MS. Firm initiated recall is complete.
REASON
Blood product, that was not properly quarantined after the donor of the product reported a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.
_____________________________
PRODUCT
a) Red Blood Cells. Recall # 1283-4;
b) Red Blood Cells, Leukocytes Reduced. Recall # 1284-4;
c) Platelets. Recall # B-1285-4;
d) Fresh Frozen Plasma. Recall #B-1286-4;
e) Recovered Plasma. Recall #B-1287-4.
CODE
a) Units: 5183297, 5183298, 5183302, 5183309, 5183319,
5183335, 5183355, 5183356, 5183359, 5183360, 5183362,
5183368, 5183379, 5183383, 5183389, 5183391, 5183392,
5183399, 5183401, 5183421, 5183422, 5183428, 5183435,
5183436, 5183450, 5183454, 5183462, 5183467, 5183469,
5183475, 5183483, 5183484, 5183485, 5183486, 5183487,
5183490, 5183491, 5183492, 5183494, 5183500, 5183504,
5183507, 5183521, 5183527, 5183538, 5183542, 5183544,
5183545, 5183551, 5183559, 5183560, 5183565, 5183566,
5183569, 5183571, 5183572, 5183577, 5183578, 5183579,
5183583, 5183591, 5183593, 5183598, 5183600, 5183611,
5183612, 5183614, 5183620, 5183623, 5183625, 5183627,
5183634;
b) Units: 5183227, 5183229, 5183239, 5183240, 5183247,
5183251, 5183260, 5183272, 5183283, 5183290, 5183307,
5183325, 5183409, 5183423, 5183464, 5183472;
c) Units: 5183227, 5183229, 5183239, 5183240, 5183247,
5183252, 5183283, 5183297, 5183298, 5183302, 5183309,
5183319, 5183325, 5183335, 5183355, 5183389, 5183392,
5183399, 5183401, 5183409, 5183421, 5183423, 5183428,
5183435, 5183436, 5183467, 5183484, 5183485, 5183486,
5183490, 5183491, 5183500, 5183504, 5183507, 5183527,
5183538, 5183544, 5183545, 5183551, 5183559, 5183560,
5183565, 5183566, 5183571, 5183572, 5183578, 5183579,
5183583, 5183591, 5183593, 5183598, 5183600, 5183611,
5183612, 5183614, 5183620, 5183623, 5183627, 5183634;
d) Units: 5183229, 5183239, 5183240, 5183247, 5183290,
5183307, 5183319, 5183325, 5183355, 5183379, 5183389,
5183392, 5183401, 5183507, 5183527, 5183538;
e) Units: 5183227, 5183252, 5183260, 5183272.
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood & Tissue Center, Austin, TX, by facsimile dated July 10, 2002, and by letter dated August 22, 2002. Firm initiated recall is complete.
REASON
Blood products, collected in expired collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
167 units.
DISTRIBUTION
TX, and FL.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1300-4;
b) Platelets. Recall # B-1301-4.
CODE
a) and b) Unit 3016032.
RECALLING FIRM/MANUFACTURER
Wellmont Health System, Kingsport, TN, by facsimile dated August 13, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose temperature was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1303-4.
CODE
Unit 02FC53951.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Wichita, KS, by letters dated April 14, 2003, and May 16, 2003. Firm initiated recall is complete.
REASON
Red Cells, created greater than eight hours after the collection of the Whole Blood unit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1311-4.
CODE
Units YM073373, YM073013, YM072637, YM072402, YM071852, YM071608, YM071147, YM070952, YM070496, YM070333, YM069704, YM069251, YM068944, YM068626, YM067397, YM066837, YM066134.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Ypsilanti, MI, by facsimile dated March 10, 2003. Firm initiated recall is complete.
REASON
Source Plasma, which tested negative for syphilis, but was collected from a donor who previously tested reactive for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced. Recall # B-1330-4.
CODE
Unit number 31134-8679.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on April 14, 2003.
Manufacturing Firm: Blood Systems, Inc., Tupelo, MS. Firm initiated recall is complete.
REASON
Blood product that was out of controlled storage for more than 30 minutes was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.

_______________________________
PRODUCT
Source Plasma. Recall # B-1332-4.
CODE
Unit number 35384458.
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by facsimile on September 17, 2002. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was collected from a donor that was previously deferred due to a risk factor for increased incidence of infection with human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1334-4.
CODE
Unit 0660109.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter dated January 27, 2004. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled as Kpa antigen negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
 

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Microwave Ovens (modified for visually-impaired users).
Recall # Z-0835/0840-04.
a) Brand name Magic Chef, Models DM81K, MC-1004;
b) Sharp, Models R-508AK, R-409AK;
c) Emerson brand "Talking" ovens (modified by Electronic
Technical Services);
d) Goldstar, Models MA1012W and MA1112W;
e) General Electric, Models JES1036WF and JES638WF;
F) E-Wave, Model EW6F6W.
CODE
None supplied.
RECALLING FIRM/MANUFACTURER
Electronic Technical Services, Ltd., Albuquerque, NM, by letter, beginning on April 28, 2004. Firm initiated recall is ongoing.
REASON
The modified household microwave oven products failed to comply with the Federal Performance Standard for Microwave Ovens.
VOLUME OF PRODUCT IN COMMERCE
491 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Titanium Dual Lumen Implantable Port with PASV Valve and
10F Silicone Catheter. Catalog No/Ref: PRTB10A, Model No.
M001PRTB10A. Recall # Z-0847-04.
CODE
916252, 917973.
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., Natick, MA, by letters dated March 29, 2004. Firm initiated recall is ongoing.
REASON
Catheters may not have adequate radiopacity for proper visualization under fluoroscopy.
VOLUME OF PRODUCT IN COMMERCE
72 units.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
Minstrel Patient Lift; a non-AC-powered patient lift; Model
Numbers HMB001-US and HMB002-US (with scale). Recall # Z-
0883-04.
CODE
All units with and without scales up to and including serial number MPLA0203A0464.
RECALLING FIRM/MANUFACTURER
Arjo, Inc, Roselle, IL, by visit and Customer Advisory Notice dated January 30, 2003. Firm initiated recall is complete.
REASON
The tension pin was not installed in spreader bar pivot bolt to prevent the pivot bolt from migrating out of the spreader bar, allowing the spreader bar to detach from the lift.
VOLUME OF PRODUCT IN COMMERCE
46 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) KCI TriaDyne Proventa Critical Care Therapy System,
Model number 308900. Recall # Z-0887-04;
b) KCI Therapulse II Air Suspension Therapy Bed, Model
Number 227080. Recall # Z-0888-04;
c) Burke Bariatric Bed, Model number 7064. Recall # Z-
0889-04;
d) KCI Underbed Inverter, Accessory to Powered Flotation
Therapy Bed, Model number 201189. Recall # Z-0890-04.
CODE
a) The following serial numbers: TDBK00029, TDBK00294,
TDBK00015, TDBK00291, TDBK00026, TDBK00027, TDBK00123,
TDBK00124, TDBK00125, TDBK00127, TDBK00128, TDBK00130,
TDBK00132, TDBK00136;
b) Serial numbers: TPLK00053, TPLK00052, TPLK00011,
TPLK00012, TPLK00013, TPLK00014, TPLK00015, TPLK00016,
TPLK00124, TPLK00128, TPLK00132;
c) Serial numbers: B7A94031025, B7A94031024, B7A94031023,
000000093101003, 000000093101005, B7A94031010,
B7A94031011, B7A94031012, B7A94031013, B7A94031014,
B7A94031015, B7A94031030, B7A94031031, B7A94031032,
0498107/335AGJ;
d) Serial numbers: IVAK00004, IVAK00023, IVAK00028,
IVAK00034, IVAK00033, IVAK00032, IVAK00055, IVAK00060,
IVAK00062, IVAK00063, IVAK00030, IVAK50000, IVAK00030,
IVAK00035, IVAK00027, IVAK00054, IVAK00037, IVAK00041,
IVAK00049, IVAK00044, IVAK00045, IVAK00046, IVAK00047,
IVAK00048, IVAK00038, IVAK00039, IVAK00042, IVAK00043,
IVAK00051, 000038251, 000038253, 000038295, 000038299.
RECALLING FIRM/MANUFACTURER
Kinetic Concepts, Inc., San Antonio, TX, by letter on March 22, 2004. Firm initiated recall is ongoing.
REASON
Battery outgassing of powered hospital beds.
VOLUME OF PRODUCT IN COMMERCE
78 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) STAT-Check, Adult Manual Emergency Resuscitator with
A.C.E./STAT-Check CO_ Indicator, Single Patient Use,
Non-Sterile, Rx only, Latex Free, Re-Order SC 9000
Series. Recall # Z-0891-04;
b) STAT-Check, Pediatric Manual Emergency Resuscitator with
A.C.E./STAT-Check CO_ Indicator, Single Patient Use,
Non-Sterile, Rx only, Latex Free, Re-Order SC-8000
Series, Recall # Z-0892-04;
c) A.C.E. STAT-Check CO_ Indicator, Single, Single Patient
Use, Non-Sterile, Rx only, Latex Free, Re-Order# SC200,
Recall # Z-0893-04;
d) STAT-Check Infant Disposable Manual Resuscitators, with
40 cmH_O Pressure Limiting System & Pressure Port
Adapter, Single Patient Use Non-Sterile, Re-Order SC7000
Series, Non Latex. Recall # Z-0894-04;
e) STAT-Check Infant Disposable Manual Resuscitators with
Built-in Pressure Monitor, with 40 cmH_O Pressure
Limiting System & Pressure Port Adapter, Single Patient
Use, Non-Sterile, Re-Order SC7100 Series, Non Latex.
Recall # Z-0895-04.
CODE
a) Model #SC9000B, Lot #4034-10, 4047-07, 4064-10;
Model #SC9000C, Lot #3295-03; Model #SC9001B, Lot #3290-
03, 3309-22, 4047-05, 4064-11, 4071-13; Model #SC9001C,
Lot #3290-04, 3309-24, 3349-05, 4034-04;
b) Model #SC8001B, Lot #3295-01, 4063-02, Model #SC8021C,
Lot #4054-04, Model #SC8121B, Lot #4040-01, Model
#8121C, Lot #4047-06;
c) Model #SC200, Lot #3254-03, 4020-01, 4040-09, 4043-05,
4056-05, 4063-07, 4064-20, 4078-03;
d) Model #SC7000B, Lot #4047-08;
e) Model #SC7101B, 4040-02, 4078-04, Model #SC7101C, Lot
#3295-04.
RECALLING FIRM/MANUFACTURER
Ventlab Corp, Mocksville, NC, by letter on March 26, 2004. Firm initiated recall is ongoing.
REASON
In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.
VOLUME OF PRODUCT IN COMMERCE
22,120 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Advantx 1 LC1, Model 46-279781P1, Angiographic X-ray
System. Recall # Z-0896-04;
b) Advantx 1 LC1, Model 45258230, Angiographic X-ray
System. Recall # Z-0897-04;
c) Advantx 1 LC2, Model 45562281, Angiographic X-ray
System. Recall # Z-0898-04;
d) Advantx 1 LC2, Model 2105657, Angiographic X-ray
System. Recall # Z-0899-04;
e) Advantx 1 SC, Model 36006617, Angiographic X-ray
System. Recall # Z-0900-04.
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
General Electric Med Systems, Waukesha, WI, by Field modification instructions on March 24, 2004. Firm initiated recall is ongoing.
REASON
Unintended movements of both the C-arc and the image intensifier have occurred due to shearing of the gear motor shaft as a result of the misalignment of the gearbox.
VOLUME OF PRODUCT IN COMMERCE
1,252 systems.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Baxter Renal Software Suite (Renal Link and PD Link).
Recall # Z-0901-04;
b) Renalsoft software system. Recall # Z-0902-04.
CODE
a) Product codes 5M5590, 5M5591, 5M5592, 5M5593, 5M5594,
5M5595, 5M5596, 5M5603, 5M5604, R5C4532, R5C4534,
5M5597, 5M5541, 5M5541R, all software versions;
b) Product code RENLSFT, all software versions.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Renal Div., McGaw Park, IL, by letters dated April 12, 2004. Firm initiated recall is ongoing.
REASON
There are software anomalies present that may increase the possibility of a medication error if the dialysis clinic software is used to track, record, or coordinate the administration of medications.
VOLUME OF PRODUCT IN COMMERCE
4,164 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Esprit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics. Recall # Z-0903-04.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Respironics California Inc., Carlsbad, CA, by technician visit on or about June 1, 2001. Firm initiated recall is complete.
REASON
Ventilator would spontaneously suspend ventilatory support to patients due to a hardware/software compatibility issue.
VOLUME OF PRODUCT IN COMMERCE
749 units.
DISTRIBUTION
Nationwide, and Internationally.

_______________________________
PRODUCT
UniCel Dxl 800 Access Immunoassay System, P/N 973100. Recall # Z-0904-04.
CODE
All software versions prior to version 1.4.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letters on March 29, 2004. Firm initiated recall is ongoing.
REASON
Software coding error may cause a fatal error message.
VOLUME OF PRODUCT IN COMMERCE
73.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
Coulter LH750 Hematology Analyzer. Part Number 6605632.
Recall # Z-0905-04.
CODE
Software versions 2A2 and 2B1.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letters on March 31, 2004. Firm initiated recall is ongoing.
REASON
If a customer enters a dilution factor for Sample B prior to the results from Sample A being transferred to the workstation, the predilute multiplication factor will be applied erroneously to the Sample A's results once they are received at the workstation.
VOLUME OF PRODUCT IN COMMERCE
981.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
Surgical Tubing Pack, Model: AMO Prestige Pack, Product Code OPO40. Recall # Z-0907-04.
CODE
Lot #/ Exp. date 3JR190 10/2006, 3KR128 11/2006, 3LR100 12/2006, 3MR002 12/2006, 3MR047 12/2006, 3MR048 12/2006, 3MR081 01/2007, 3MR082 01/2007, 4AR045 01/2007, 4AR050 01/2007, 4AR058 01/2007.
RECALLING FIRM/MANUFACTURER
Allergan Medical Optics, Inc., Santa Ana, CA, by letter on March 31, 2004. Firm initiated recall is ongoing.
REASON
The lots are being recalled because the tray lid may not be adequately sealed under the red arrow in the upper right corner of the package tray. The blue wrapping within the tray may not be sterile and may pose a potential risk of infection to the patient if used in a sterile field.
VOLUME OF PRODUCT IN COMMERCE
19,087.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Biliary Stent Introducer Set. Reorder (catalog) number SIS-
10. Recall # Z-0908-04.
CODE
Lot number W1733880.
RECALLING FIRM/MANUFACTURER
Wilson-Cook Medical Inc., Winston Salem, NC, by visit or fax on April 21, 2004. Firm initiated recall is ongoing.
REASON
The guiding catheter provided with the SIS-10 biliary stent introduction system may be a 5 French instead of the required 6 French guiding catheter.
VOLUME OF PRODUCT IN COMMERCE
23 pieces.
DISTRIBUTION
MO, NY, PA, Australia, Israel and England.

_______________________________
PRODUCT
a) Pinnacle3 Radiation Therapy Planning System, Model
Number 9200-9052A-ENG. Recall # Z-0911-04;
b) Pinnacle3 Radiation Therapy Planning System, Model
Number 9200-0613C-ENG. Recall # Z-0912-04;
c) Pinnacle3 Radiation Therapy Planning System, Part
Number 9104-2011A Rev. A. Recall # Z-0913-04;
d) Pinnacle3 Radiation Therapy Planning System, Part
Number 9104-0121C Rev. A. Recall # Z-0914-04;
e) Philips ADAC Pinnacle3 Radiation Therapy Planning
Software Packaage (Kit), Model Number 9200-0613B-ENG.
Recall # Z-0915-04;
f) Philips Pinnacle3 Radiation Therapy Planning Software
CD, Part Number 9104-0121B, Rev. A. Recall # Z-0916-04.
CODE
a) Version 7.0e;
b) Version 6.6c;
c) Version 7.0e, Rev. A;
d) Version 6.6c, Rev. A;
e) Version 6.4a, Rev. A;
f) Version 6.4a, Rev. A;
RECALLING FIRM/MANUFACTURER
ADAC Laboratories, Madison, WI, by telephone and letters dated March 3, 2004. Firm initiated recall is ongoing.
REASON
A software defect, relating to the motorized wedge functionality when using an Elekta linear accelerator, can result in incorrect dose delivery to the patient. Also, dose delivery in the wrong location may occur when using a Elekta Leksell headframe.
VOLUME OF PRODUCT IN COMMERCE
165 units.
DISTRIBUTION
Nationwide, Australia, Canada, China, and Korea.

_______________________________
PRODUCT
Welch Allyn AED 10 Defibrillator; a battery powered automated external defibrillator; Model AED 10, part numbers 970300 (defibrillator) and 970302 (defibrillator with soft shell carrying case). Recall # Z-0918-04.
CODE
Serial numbers 4613, 4888/4891, 4897, 6369/6386, 6396/6704, 6706, 6709/6743, 6745/6803, 6806, 6807, 6809, 6811, 6813/6832, 6836/6838, 6853/6855, 6912, 6914, 6917, 6921, 6922, 6924/6926.
RECALLING FIRM/MANUFACTURER
MRL, Inc., A Welch Allyn Company, Buffalo Grove, IL, by letters dated April 26, 2004. Firm initiated recall is ongoing.
REASON
A faulty component has been identified which could result in an intermittent shock button (button #3) failure on the AED10 defibrillator.
VOLUME OF PRODUCT IN COMMERCE
460 units.
DISTRIBUTION
Nationwide, and Internationally.

_______________________________
PRODUCT
VITEK GPS-107 Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. Recall # Z-0919-04.
CODE
Lot #P108X.
RECALLING FIRM/MANUFACTURER
BioMerieux, Inc., Hazelwood, MO, by letters dated April 20, 2004. Firm initiated recall is ongoing.
REASON
Some of the cards were stamped with an incorrect card code causing system to read and report the cards incorrectly.
VOLUME OF PRODUCT IN COMMERCE
1,760/20-card boxes.
DISTRIBUTION
Nationwide, China, and Switzerland.

_______________________________
PRODUCT
Opthalmic Laser, product number 8065-5000-1. Recall # Z-0923-04.
CODE
None.
RECALLING FIRM/MANUFACTURER
Alcon Research, Ltd., Fort Worth, TX, by service representative visit in May 2004. Firm initiated recall is ongoing.
REASON
Product may generate laser light flashback.
VOLUME OF PRODUCT IN COMMERCE
62.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Medtronic Gastro pH in a Box System, Model 43A008, Catalog Number 9043A0081. Recall # Z-0924-04.
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Medtronic Gastroenterology/Urology, Shoreview, MN, by letters dated April 28, 2004. Firm initiated recall is ongoing.
REASON
Inadequate wire insulation inside the plugs of the power cords of the devices may cause the power cords to short.
VOLUME OF PRODUCT IN COMMERCE
42 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) ACMI REF E-1F Electrohydraulic Lithotripsy Probe, 1.9 FR
x 120CM. Recall # Z-0925-04;
b) ACMI REF E-3F Electrohydraulic Lithotripsy Probe, 3 FR
x 120CM. Recall # Z-0926-04;
c) ACMI REF E-5F Electrohydraulic Lithotripsy Probe, 5 FR
x 60CM. Recall # Z-0927-04;
d) ACMI REF E-9F Electrohydraulic Lithotripsy Probe, 9 FR
x 60CM. Recall # Z-0928-04.
CODE
a) Lot Numbers: 1122753E to 1283804C;
b) Lot Numbers: 1122743E to 1269284B;
c) Lot Numbers: 1122733E to 1262504A;
d) Lot Numbers: 115823D to 1283724C.
RECALLING FIRM/MANUFACTURER
ACMI Corp., Southborough, MA, by letter dated April 30, 2004. Firm initiated recall is ongoing.
REASON
Product sterility may be compromised due to the lack of package seal integrity.
VOLUME OF PRODUCT IN COMMERCE
3,056 boxes.
DISTRIBUTION
Nationwide, and Internationally.

_______________________________
PRODUCT
Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid). Recall # Z-0935-04.
CODE
Lot M207140.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter on June 11, 2003. Firm initiated recall is complete.
REASON
Product was found to produce higher recoveries by about 7-12% compared to other lots.
VOLUME OF PRODUCT IN COMMERCE
9,126.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
a) Tachos DR - Implantable Cardioverter Defibrillator.
Model Number 335 572. Recall # Z-0941-04;
b) Tachos DR - Atrial Tx, Model Number 122 499.
Recall # Z-0942-04;
c) Tachos Atx, Model Number 334 342. Recall # Z-0943-04;
d) Deikos A+, Model Number 3340341. Recall # Z-0944-04.
CODE
a) Serial numbers: 78011709 - 78011712, 78011714 -
78011719, 78011725 - 78011729, 78011759 - 78011763,
78011769 - 78011778, 78011780 - 78011791, 78011793 -
78011829, 78011831, 78011833 - 78011864, 78011866 -
78011928, 78011930 - 78011937, 78011939 - 78011949,
78011951 - 78011981, 78011983 - 78011985, 78011987 -
78011988, 78019000 -78019014, 78019016 - 78019025,
78019027, 78019029 - 78019035, 78019037 - 78019051,
78019053 - 78019066, 78019068 - 78019081, 78019083,
78019084, 78019086 - 78019091, 78019096 - 78019099,
78019101 - 78019105, 78019107 - 780190122, 78019126 -
780190129, 78019131 - 78019140;
b) Serial numbers: 78012522, 78012524, 78012525, 78012548,
78012675, 78012677, 78012681, 78012683, 78012707,
78012709 - 78012712, 78012714, 78012715, 78012718,
78012719, 78012763, 78012767, 78012768, 78012771,
78012791, 78012792, 78012794, 78012804, 78012809,
78012815 - 78012820, 78012968, 78012987 - 78012989,
78013072 - 78013076, 78013092 - 78013094, 78013099,
78013100, 78013165 - 78013185, 78013194, 78013198,
78013200 - 78013204, 78013206, 78013207, 78013210,
78013217 - 78013220, 78013222, 78013224 - 78013227,
78013230 - 78013256, 78013258 - 78013262, 78013278,
78013282, 78013284, 78013285, 78013292, 78013297,
78013299, 78013315, 78013317, 78013321;
c) Serial numbers: 78050083 - 78050088, 78050091 -
78050095, 78050097, 78050098, 78050100, 78050103 -
78050105, 78050107, 78050109, 78050110, 78050113,
78050117 - 78050122, 78050124 - 78050128, 78050133 -
78050139, 78050142 - 78050144, 78050162 - 78050169;
d) Serial numbers: 78062958, 78062960, 78062961, 78062962,
78062997, 78063002.
RECALLING FIRM/MANUFACTURER
Biotronik, Inc., Lake Oswego, OR, by letters on April 29, 2004. Firm initiated recall is ongoing.
REASON
Potential for device to not deliver full amount of energy.
VOLUME OF PRODUCT IN COMMERCE
547.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Stylus Angled Knife - 52-2835 Clear Corneal Knife,
double bevel, parallel sides, angled, full handle, 2.85
Recall # Z-0945-04;
b) Stylus Angled Knife - 56-5361, Pilot Tip Knife, bevel
up, angled, full handled, 3.2mm and 56-5161, Pilot Tip
Knife, bevel up, angled, full handled, 5.2mm. Recall #
Z-0946-04;
c) Stylus Brand Angled Knife - 52-2661, Slit Knife, bevel
up, angled full handled, 2.65mm 52-2761, Slit Knife,
bevel up, angled, full handled, 2.75mm 52-2861, Slit
Knife, bevel up, angled, full handled, 2.85mm 52-2961,
Slit Knife, bevel up, angled, full handled, 3.0mm 52-
3261, Slit Knife, bevel up, angled, full handled, 3.2mm
52-3561, Slit Knife, bevel up, angled, full handled,
3.5mm 52-2662, Slit Knife, bevel up, angled, blade and
tip, 3.2mm 52-3262, Slit Knife, bevel up, angled, blade
and tip, 3.2mm. Recall Z-0947-04;
d) Stylus Brand Angled Knife - 52-2931, Slit Knife, double
bevel, angled, full handle, 3.0mm 52-3231, Slit Knife,
double bevel, angled, full handle, 3.2mm. Recall # Z-
0948-04;
e) Stylus Brand Angled Knife - 54-1010, Sharptome Crescent
Knife, bevel up, angled, full handled. 54-1031,
Sharptome Crescent Knife, double bevel, angled, full
handled. Recall # Z-0949-04;
f) Stylus Brand Angled Knives - 52-2912, Slit Knife,
parallel sides, bevel up, angled, full handle, 3.0mm 52-
3212, Slit Knife, parallel sides, bevel up, angled, full
handle, 3.2mm. Recall # Z-0950-04.
CODE
a) Model No. Lot # Exp. date 52-2835 M454660 2/2009 52-2835
M317210 7/2008;
b) Model No. Lot # Exp. date 56-5361 M262510 5/2008 56-5361
M309090 6/2008 56-5361 M309150 11/2008 56-5361 M439510
1/2009 56-5161 M317030 6/2008;
c) Model No. Lot # Exp.date 52-2661 M309600 5/2008 52-2662
M309610 8/2008 52-2661 M309620 8/2008 52-2661 M309630
8/2008 52-2661 M264510 3/2008 52-2761 M436360 12/2008
52-2761 M309720 9/2008 52-2761 M309730 9/2008 52-2761
M365020 10/2008 52-2761 M365030 11/2008 52-2861 M309770
5/2008 52-2861 M309780 7/2008 52-2861 M430490 12/2008
52-2861 M437160 1/2009 52-2861 M439540 1/2009 52-2861
M309790 8/2008 52-2861 M309810 9/2008 52-2961 M376790
8/2008 52-2961 M309860 6/2008 52-2961 M309870 7/2008
52-2961 M416990 10/2008 52-3261 M440600 2/2009 52-3261
M262580 3/2008 52-3261 M309940 7/2008 52-3261 M309960
8/2008 52-3261 M309970 8/2008 52-3561 M311070 4/2008
52-2662 M445610 2/2009 52-3262 M280120 3/2008;
d) Model No. Lot # exp. date 52-2931 M310120 7/2008 52-2231
M310180 8/2008 52-3231 M310190 6/2008;
e) Model No. Lot # Exp. Date 54-1010 M316220 9/2008 54-1010
M316160 7/2008 54-1010 M316180 7/2008 54-1031 M365220
10/2008;
f) Model No. Lot # Exp. date 52-2912 M314590 5/2008 52-3212
M359090 7/2008.
RECALLING FIRM/MANUFACTURER
Surgical Specialties Puerto Rico, Inc., Rincon, PR, by e-mail and fax from March 3, 2004 to April 1, 2004. Firm initiated recall is ongoing.
REASON
Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.
VOLUME OF PRODUCT IN COMMERCE
77,340 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
BioPince Full Core Biopsy Instrument packed in a Tyvek/plastic blister pack which is labeled as previously stated and also in a cardboard shelf carton. Recall # Z-0952-04.
CODE
Part Number/Lot Number: 360-1080-01, 24821;
360-1080-01, 30531; 360-1080-01, 30811; 360-1080-01, 30923; 360-1080-02, 24821; 360-1080-01, 31251; 360-1080-01, 32211; 360-1080-01, 32842; 360-1080-01, 32851-1;
360-1080-01, 32851-2; 360-1080-01, 33451;
360-1080-01, 33452; 360-1080-01, 33832; 360-1080-01, 34031; 360-1080-01, 34331; 360-1080-01, 34512; 360-1080-01, 34721; 360-1580-01, 30633; 360-1580-01, 31042; 360-1580-01, 32032; 360-1580-01, 32341; 360-1580-01, 32852; 360-1580-01, 33433; 360-1580-01, 33434; 360-1580-01, 34232; 360-1580-01, 34931; 360-1580-01, 32852-2; 360-2080-01, 30751;
360-2080-01, 30811; 360-2080-01, 31531; 360-2080-01, 33331; 360-2080-01, 33332; 360-2080-01, 34221; 360-2080-01, 34322; 360-2080-01, 34734; 360-2080-01, 34941; 363-1080-01, 32431; 364-1080-01, 34549; 364-1580-01, 34432; 370-1080-01, 33932; 370-1080-01, 35032; 370-1580-01, 34447; 370-1580-01, 35021.
RECALLING FIRM/MANUFACTURER
Medical Device Technologies, Inc., Gainesville, FL, by letter on March 2, 2004. Firm initiated recall is ongoing.
REASON
The outer plastic blister packaging material may be cracked thereby compromising the device's sterility barrier.
VOLUME OF PRODUCT IN COMMERCE
10,303.
DISTRIBUTION
Nationwide and Internationally.
 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
AcuSnare" Polypectomy Device. The SASM device prefix
denotes Soft AcuSnare Mini, Reorder (Catalog) number:
SASM -1. The ASM device prefix denotes Acu Snare Mini,
Reorder (Catalog) number: ASM-1. Due to the nitinol core
wire, the difference between these two products is
stiffness of the snare head wire. Recall # Z-0906-04.
CODE
SASM-1 Lot # W1834310;
ASM-1 Lot # W1834120.
RECALLING FIRM/MANUFACTURER
Wilson-Cook Medical, Inc., Winston Salem, NC, by visit and letter on April 21, 2004. Firm initiated recall is ongoing.
REASON
The snares inside the box labeled SASM-1 may actually be ASM-1 devices. The individual pouches may be correctly labeled ASM.
VOLUME OF PRODUCT IN COMMERCE
5 boxes/10 pouches per box.
DISTRIBUTION
MA, NY, and OK.

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PRODUCT
a) 955-3 BacFix Coldwelder. Recall # Z-0920-04;
b) 955-4 BacFix Coldwelder II with angled tip. Recall # Z-
0921-04;
c) 955-5 BacFix Coldwelder II with straight tip. Recall #
Z-0922-04.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Spinal Concepts, Inc, Austin, TX, by letter on April 1, 2002. Firm initiated recall is complete.
REASON
The instrument can break during surgery causing delay of surgery and/or fragments in the surgical site.
VOLUME OF PRODUCT IN COMMERCE
285 units.
DISTRIBUTION
Nationwide, and Germany, Japan, and Italy.

_______________________________
PRODUCT
a) Product is a surgical nasal/sinus surgical device
labeled as a RAD Frontal Finesse Bur, Reference Number
18-83070. Recall # Z-0953-04;
b) The product is a sheath meant to fit over a
Nasopharyngoscope and is labeled as EndoScrub 2 Sheaths.
Recall # Z-0954-04;
c) The product is a device used in adenoid surgery and is
labeled as Lusk Disposable Adenoid Curettes. Recall #
Z-0955-04.
CODE
a) Lot 26371200;
b) Lots 31396400 and 30722300;
c) Lot 30685400.
RECALLING FIRM/MANUFACTURER
Medtronic Xomed, Inc., Jacksonville, FL, by letter on January 29, 2004. Firm initiated recall is complete.
REASON
a) The curve in the shaft of the bur was only 15 degrees
not the labeled 40 degrees;
b) The sheaths in question have shafts that are one inch
longer than required for the endoscope specified on the
label;
c) The box label indicated that the product is size 2
whereas a size 4 was packed inside.
VOLUME OF PRODUCT IN COMMERCE
33 boxes.
DISTRIBUTION
Nationwide.

END OF ENFORCEMENT REPORT FOR MAY 19, 2004

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