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U.S. Department of Health and Human Services

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Enforcement Report for June 30, 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.


June 30, 2004
04-26

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Country Farms Old Fashioned Wheat Bread, Net Wt 16 oz. (1 Lb.). Recall # F-264-4.
CODE
All codes with a BEST IF PURCHASED BY APR 30 or earlier.
RECALLING FIRM/MANUFACTURER
Earthgrains Baking Companies, Inc., St. Louis, MO, by telephone on April 19, 2004, and by press release and e-mail on April 20, 2004. Firm initiated recall is complete.
REASON
The PRODUCT contains undeclared buttermilk.
VOLUME OF PRODUCT IN COMMERCE
Approx 50, 919 loaves.
DISTRIBUTION
AZ.

_______________________________
PRODUCT
FISHER/REX, Chicken Salad Sandwich, Keep Refrigerated, Net Wt. 3.75 ozs. (106g). Recall # F-265-4.
CODE
Manufacturer labels finished products with a "sell by" date. The finished PRODUCT sandwiches are either packaged in a vacuum package or an oxygen permeable package. A 28 day sell by date is applied to sandwiches packaged in vacuum packages. A 10 day sell by date is applied to sandwiches packaged in oxygen permeable packages. Management is unsure what code would be involved in the recall.
RECALLING FIRM/MANUFACTURER
Fishers Bakery and Sandwich Co., Inc, Raleigh, NC, by visits between April 7, 2004 thru April 13, 2004. Firm initiated recall is complete.
REASON
The product's label does not list all subingredients of salad dressing including egg yolks and does not list the subingredients of bread including flour derived from wheat.
VOLUME OF PRODUCT IN COMMERCE
424/3.75 oz. sandwiches.
DISTRIBUTION
NC and SC.

_______________________________
PRODUCT
POUNDED YAM (flour), Nigerian Style, packed under the following labels: (1) "Pride of Africa"; (2) "Loty" brand; (3) "Tropical Foods El Platanero". productions are sold in 2 lb., 4 lb., 5 lb., 10 lb., and 20 lb. plastic and paper bags. Recall # F-267-4.
CODE
Product is not coded.
RECALLING FIRM/MANUFACTURER
Raymond Hadley Corporation, Spencer, NY, by press release and letter dated March 26, 2004 and by letter on April 27, 2004. New York State initiated recall is complete.
REASON
Product contains undeclared sulfites based on the New York State Department of Agriculture & Markets? analysis.
VOLUME OF PRODUCT IN COMMERCE
576,440 pounds.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
a) Stonington Sea PRODUCTs Smoked Atlantic Salmon Sliced,
Vacuum Packed, Net Wt. 4 oz. Recall # F-268-4;
b) Stonington Sea PRODUCTs Smoked Atlantic Salmon Sliced,
Vacuum Packed, Net Wt. 8 oz. Recall # F-269-4;
c) Stonington Sea PRODUCTs Smoked Atlantic Salmon Sliced,
Vacuum Packed, Net Wt. 12 oz. Recall # F-270-4;
d) Stonington Sea PRODUCTs Smoked Atlantic Salmon, Sliced
Filet on Board, Various weights. Recall # F-271-4;
e) Stonington Sea PRODUCTs Smoked Atlantic Salmon, Unsliced
Filet on Board, Various weights. Recall # F-272-4.
CODE
Use by Date: 05/08/04.
RECALLING FIRM/MANUFACTURER
Stonington Sea products, Inc., Stonington, ME, by telephone on May 11, 2004 and by letter on May 12, 2004. Firm initiated recall is complete.
REASON
PRODUCT is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
77 lbs.
DISTRIBUTION
ME, MA, MN, NJ, and NY.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
Disney Winnie the Pooh brand COMPLETE Multi Vitamin, Children?s Multiple Vitamin and Mineral Supplement, 60 chewable tablets. Prod. No. 13551. Recall # F-261-4.
CODE
All lots on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
NBTY, Inc., Bohemia, NY, by telephone on May 24-25, 2004, and by letters dated May 25, 2004. Firm initiated recall is ongoing.
REASON
Labeling of this dietary supplement containing iron lacked the required "WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately".
VOLUME OF PRODUCT IN COMMERCE
1,336 cases (12 units per case).
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) CHANDAN MOUTH FRESHNER, 5 IN 1, MUKHWAS TIN, Net Wt. 200
grams. The product is packaged in rigid plastic
containers (tins) labeled in part, "*** CHANDAN MOUTH
FRESHENER *** 5 IN 1 MUKHWAS TIN *** GULAB MUKHWAS ***
POONA MUKHWAS *** GARDEN COURT *** PINEAPPLE MUKHWAS ***
SPECIAL MUKHWAS *** PRODUCT OF INDIA ***". Recall # F-
262-4;
b) Chandan brand SILVER TIN 4 IN 1, Net Wt. 150 gram.
(MUSK MILAN). The PRODUCT is packaged in rigid plastic
containers (tins) labeled in part, "*** Chandan SILVER
TIN 4 IN 1 *** SOFTY SILVER *** LAKNAW SILVER ***
CHOCLATE SILVER *** CHANDAN SILVER ***". Recall # F-
263-4.
CODE
All PRODUCTs on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Shah Impex, New York, NY, by Urgent Food Recall notices on January 22, 2004. FDA initiated recall is complete.
REASON
Mouth fresheners contain non-permitted and undeclared color additives.
VOLUME OF PRODUCT IN COMMERCE
22 cases.
DISTRIBUTION
NY.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
FISHER/REX, Pimento cheese sandwich, which contains white bread. Net Wt. 3.75 ozs. (106g). Recall # F-266-4.
CODE
Manufacturer labels finished products with a "sell by" date. The finished product sandwiches are either packaged in a vacuum package or an oxygen permeable package. A 28 day sell by date is applied to sandwiches packaged in vacuum packages. A 10 day sell by date is applied to sandwiches packaged in oxygen permeable packages. Management is unsure what code would be involved in the recall.
RECALLING FIRM/MANUFACTURER
Fishers Bakery and Sandwich Co., Inc, Raleigh, NC, by visits between April 7, 2004 thru April 13, 2004. Firm initiated recall is complete.
REASON
The product's label does not list the subingredients of bread including flour derived from wheat.
VOLUME OF PRODUCT IN COMMERCE
812/3.75 oz. sandwiches.
DISTRIBUTION
NC and SC.

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Medical Air, USP, Air, Compressed, Various cylinder sizes. Recall # D-193-4.
CODE
DATE LOT CODE 10/1/2003 WV00Q274A 10/2/2003 WV00Q275A 10/6/2003 WV00Q279A 10/9/2003 WV00Q282A 10/9/2003 WV00Q282B 10/9/2003 WV00Q282C 10/10/2003 WV00Q283A 10/13/2003 WV00Q286A 10/13/2003 WV00Q286B 10/13/2003 WV00Q286C 10/13/2003 WV00Q286D 10/15/2003 WV00Q288A 10/16/2003 WV00Q289A 10/20/2003 WV00Q293A 10/21/2003 WV00Q294A WV00Q294B WV00Q294C 10/24/2003 WV00Q297A 10/27/2003 WV00Q300A WV00Q300B WV00Q300C WV00Q300D 10/28/2003 WV00Q301A 10/30/2003 WV00Q303A WV00Q303B 11/4/2003 WV00Q308A WV00Q308B WV00Q308C WV00Q308D 11/5/2003 WV00Q309A WV00Q309B 11/6/2003 WV00Q310A 11/7/2003 WV00Q311A 11/12/2003 WV00Q316A 11/13/2003 WV00Q317A 11/14/2003 WV00Q318A WV00Q318B WV00Q318C WV00Q318D WV00Q318E 11/17/2003 WV02Q321A 11/18/2003 WV00Q322A 11/20/2003 WV00Q324A WV00Q324B 11/24/2003 WV00Q328A WV00Q328B 11/25/2003 WV00Q329A WV00Q329B WV00Q329C WV00Q329D 12/2/2003 WV00Q336A WV00Q336B 12/3/2003 WV00Q337A 12/8/2003 WV00Q342A WV00Q342B WV00Q342C WV00Q342D WV00Q342E 12/9/2003 WV00Q343A WV00Q343B 12/10/2003 WV00Q344A 12/12/2003 WV00Q346A WV00Q346B WV00Q346C 12/15/2003 WV00Q349A 12/16/2003 WV00Q350A WV00Q350B 12/17/2003 WV00Q351A 12/23/2003 WV00Q357A WV00Q357B WV00Q357C WV00Q357D 12/29/2003 WV00Q363A 12/30/2003 WV00Q364A 12/31/2003 WV00Q365A 1/5/2004 WV00R005A WV00R005B 1/6/2004 WV00R006A 1/7/2004 WV00R007A WV00R007B 1/8/2004 WV00R008A 1/12/2004 WV00R012A WV00R012B 1/14/2004 WV00R014A WV00R014B 1/15/2004 WV00R015A 1/16/2004 WV00R016A WV00R016B 1/20/2004 WV00R020A 1/21/2004 WV00R021A WV00R021B 1/22/2004 WV00R022A WV00R022B 1/23/2004 WV00R023A 1/28/2004 WV00R028A WV00R028B WV00R028C WV00R028D 1/29/2004 WV00R029A WV00R029B 2/3/2004 WV00R034A WV00R034B WV00R034C 2/4/2004 WV00R035A WV00R035B 2/5/2004 WV00R036A 2/6/2004 WV00R037A 2/9/2004 WV00R040A 2/10/2004 WV00R041A 2/11/2004 WV00R042A WV00R042B 2/12/2004 WV00R043A 2/16/2004 WV00R047A WV00R047B WV00R047C WV00R047D WV00R047E 2/17/2004 WV00R048A 2/18/2004 WV00R049A WV00R049B 2/19/2004 WV00R050A 2/20/2004 WV00R051A WV00R051B 2/27/2004 WV00R058A WV00R058B 2/28/2004 WV00R059A WV00R059B WV00R059C WV00R059D 3/1/2004 WV00R061A WV00R061B WV00R061C 3/2/2004 WV00R062A 3/3/2004 WV00R063A WV00R063B 3/5/2004 WV00R065A 3/8/2004 WV00R068A 3/10/2004 WV00R070A 3/12/2004 WV00R072A WV00R072B WV00R072C 3/15/2004 WV00R075A 3/16/2004 WV00R076A 3/17/2004 RV00R077A 3/19/2004 WV00R079A WV00R079B 3/22/2004 WV00R082A WV00R082B 3/25/2004 WV00R085A WV00R085B WV00R085C WV00R085D 3/29/2004 WV00R089A WV00R089B WV00R089C 3/30/2004 WV00R090A 4/1/2004 WV00R092A WV00R092B WV00R092C 4/5/2004 WV00R096A WV00R096B WV00R096C WV00R096D.
RECALLING FIRM/MANUFACTURER
Southern California Airgas, Inc., Lakewood, CA, by letter dated May 6, 2004. Firm initiated recall is ongoing.
REASON
Good Manufacturing Practice (GMP) Deviation.
VOLUME OF PRODUCT IN COMMERCE
4,175 cylinders.
DISTRIBUTION
CA, NV, AZ.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Advicor Extended-Release Tablets (Niacin extended release and Lovastatin tablets), 500 mg/20 mg, 90 tablet bottles, NDC 60598-006-90. Recall # D-194-4.
CODE
Lot 0303100001 Exp. 1/05.
RECALLING FIRM/MANUFACTURER
Kos Pharmaceuticals, Co, by letter on March 31, 2004. Firm initiated recall is ongoing.
REASON
Failed Content Uniformity testing.
VOLUME OF PRODUCT IN COMMERCE
3,864 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Bisacodyl 10mg Laxative Suppositories, Each containing 10mg Bisacodyl USP, 12 suppositories, NDC 58298-130-12. This product was also sold under two other brand labels: (1) The Magic Bullet, units of 12 and 100, NDC 57648-002-12, and NDC 57648-002-01 and (2) Qualitest, units of 12, NDC 0603-8086-11. Recall # D-195-4.
CODE
All Un-expired Lot Numbers.
RECALLING FIRM/MANUFACTURER
Elge, Inc, Rosenberg, TX, by letter on May 27, 2004. Firm initiated recall is ongoing.
REASON
Stability Failure-Bisacodyl USP.
VOLUME OF PRODUCT IN COMMERCE
70,983 units.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1360-4;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-1361-4;
c) Fresh Frozen Plasma. Recall # B-1362-4.
CODE
a) Unit 41GQ85089;
b) Units 41GQ02366, 41GQ00829, 41GQ92266, 41FQ87938,
41FQ88753, 41GQ95446, 41GQ93737, 41GQ90736, 41GQ87206;
c) Units 41FQ88753, 41FQ87938.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Alabama Region, Birmingham, AL, by telephone on March 7, 2002, or by letters dated March 12, 2002 and April 12, 2002. Firm initiated recall is complete.
REASON
Blood products, mislabeled as a licensed transfusable product and/or as collected from a volunteer donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
AL and TX.

_______________________________
PRODUCT
Human Tissue for Transplantation (Corneas). Recall # B-1372-4.
CODE
Cornea # 2004-04-6031, 2004-04-6032.
RECALLING FIRM/MANUFACTURER
Heartland Lions Eye Bank, Northwoods Office Complex, Kansas City, MO, by telephone on April 27 and 28, 2004 and by letter dated April 27, 2004. Firm initiated recall is complete.
REASON
Human tissue for transplantation, that tested negative for hepatitis prior to distribution, but was subsequently found to test repeatedly reactive for anti-hepatitis C virus (anti-HCV) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 corneas.
DISTRIBUTION
TX and MO.

_______________________________
PRODUCT
Human Cornea Tissue. Recall # B-1436-4.
CODE
Tissues 2004-04-5003, 2004-04-5004.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Heartland Lions Eye Banks, Columbia, MO, by telephone on May 6, 2004, and by letter dated May 6, 2004.
Manufacturer: Heartland Lions Eye Bank, Berkeley, MO. Firm initiated recall is complete.
REASON
Human tissue for transplantation, that tested negative for hepatitis prior to distribution, but was subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1445-4;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-1446-4;
c) Red Blood Cells, Leukocytes Reduced, Irradiated.
Recall # B-1447-4.
CODE
a) Units 4235804, 4235826, 4235829, 4232323, 4235810,
8418826, 4232740, 4238140, 4232514, 4232517, 4232519,
4235013, 4232729, 4232786, 4232799, 4232800, 4235126,
4235132, 4233011, 4235818, 4232322, 4235875, 3923184,
4232720, 4232737, 3923189, 4232320, 4232324, 4235803,
4232513, 4235874, 4235008, 4232750, 4235129, 4233010,
8418801, 4235033, 4235037, 4235039, 3923191, 4232318,
4235828, 4232520, 4235871, 4235017, 4232726, 4232775,
4232790, 4235125, 4235128, 4233014, 4233015, 4233017;
b) Units 8286304, 4232551, 4235014, 4232319, 4232550,
4235022, 4233008, 4235045, 4234795, 4235808, 4235811,
4235814, 4235878, 4235817, 4235877, 4232563, 4238101,
4238106, 4238116, 4235872, 4235881, 4235009, 4235879,
4235031, 4234797, 4235825, 4235822, 4235823, 4232555,
4238107, 3930435, 4234800, 4235027, 4234798, 4235876,
4235883, 8418807, 8418816, 4235021, 4235036, 4238014,
3930471, 3923193, 4235882, 4235019, 4232762, 4238024,
4237827, 4235880, 4237833, 4232515, 4238131, 4232747;
c) Unit 4232764.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on November 28, 2003, and by letter dated December 17, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose arm scrubs were incorrectly performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
103 units.
DISTRIBUTION
IN.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1523-4.
CODE
Unit number: L434487 (2 parts).
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Rapids, MI, by facsimile on April 8, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to the use of the drug, Relafen, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-1524-4.
CODE
Unit 11LN03949.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Missouri-Illinois Region, Saint Louis, MO, by telephone on September 18, 2003, and by letter dated September 22, 2003. Firm initiated recall is complete.
REASON
Platelets, with a decreased platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MO.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1526-4;
b) Recovered Plasma. Recall # B-1527-4.
CODE
a) and b) Unit 24GZ11568.
RECALLING FIRM/MANUFACTURER
American National Red Cross, River Valley Region, Louisville, KY, by telephone, e-mail, or facsimile on September 11, 2003, or by letter dated September 17, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor whose blood donation record contained contradictory Confidential Unit Exclusion stickers, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IN and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1528-4;
b) Fresh Frozen Plasma. Recall # B-1529-4;
c) Recovered Plasma. Recall # B-1530-4.
CODE
a) Units 2327082, 2326154, 2323585, 1704149, 1702729;
b) Units 2323585, 1704149;
c) Units 2326154, 1702729.
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX, by facsimile dated August 26, 2003. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis but were collected from a donor who disclosed a previous positive test for hepatitis and was improperly reinstated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units.
DISTRIBUTION
TX, DC, and Switzerland.

_______________________________
PRODUCT
Source Plasma. Recall # B-1539-4.
CODE
Unit numbers: ST323408, ST323790, ST324131, and ST324474.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., San Antonio, TX, by facsimile on June 26, 2003. Firm initiated recall is complete.
REASON
Blood products were not properly quarantined after the donor disclosed a history of travel to an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1540-4;
b) Recovered Plasma. Recall # B-1541-4.
CODE
a) and b) Unit number: 042K55575.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by telephone on December 17, 2003, facsimile on December 18, 2003, and by letters on December 19, 2003, January 28, 2004, and February 2, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH and Switzerland.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1542-4.
CODE
Unit number R20952.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeast Wisconsin, Inc., Milwaukee, WI, by telephone on December 11, 2002, and by letter on December 13, 2002. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was collected from an unsuitable donor due to the application of a tattoo, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WI.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1543-4;
b) Recovered Plasma. Recall # B-1544-4.
CODE
a) and b) Unit number LS86931.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeast Wisconsin, Inc., Milwaukee, WI, by facsimile on November 29,2002, by telephone on December 18, 2002, and letter on December 24, 2002. Firm initiated recall is complete.
REASON
Blood products collected from an ineligible donor based on the disclosure of a family member diagnosed with Creutzfeldt-Jakob Disease (CJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WI and Switzerland.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1545-4.
CODE
Unit number FW44987C.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeast Wisconsin, Inc., Milwaukee, WI, by telephone on October 28, 2002, and by letter on November 18, 2002. Firm initiated recall is complete.
REASON
Blood PRODUCT, collected in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WI.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1363-4.
CODE
Units 41GQ02366, 41GQ00829, 41GQ95446, 41GQ93737, 41GQ92266, 41GQ90736, 41GQ87206, 41GQ85089.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Alabama Region, Birmingham, AL, by facsimile on March 6, 2002. Firm initiated recall is complete.
REASON
Blood products, mislabeled as a licensed transfusable PRODUCT and/or as collected from a volunteer donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
CA, and Switzerland.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1364-4.
CODE
Unit 3944956.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN., by telephone and facsimile on March 29, 2004. Firm initiated recall is complete.
REASON
Blood product, that was not quarantined after receiving information concerning a post donation infection in the arm used for blood donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1448-4;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-1449-4.
CODE
a) Units 4235116, 4235120, 4233016, 4233019, 4235381,
3930484, 4232757, 4232776, 4235121, 4235134, 4233009,
4233012, 4233018, 4237829, 4237831, 4237844, 3930482,
4235124, 4235815;
b) Units 4235379, 4235041, 4235820, 4238121, 4237837,
3933070, 4232559, 4238096, 3930435, 4238014, 3930471,
4237827.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on November 28, 2003, and by letter dated December 17, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose arm scrubs were incorrectly performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
31 units.
DISTRIBUTION
IN.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

_______________________________
PRODUCT
a) Tecan clinical workstation; Tecan Genesis 150 front end,
Roche catalog number 03585379001. Recall # Z-0996-04;
b) Tecan clinical workstation; Tecan Genesis 150/8 TCW
front end COBAS (FEC), Roche catalog number 0360053001.
Recall # Z-0997-04;
c) Tecan clinical workstation; Tecan Genesis 150 back end,
Roche catalog number 03585352001. Recall # Z-0998-04.
CODE
a) Serial numbers 5524, 6177, 6224, 6376, 6393, 6395, 6397,
6557, 7150, 7349, 7350, 7594, 7616 and 7724;
b) Serial numbers 6178, 7629, 7698, 7744, 7753, 7754, 7755
and 7768.
c) Serial numbers 5583, 5606, 6372, 6394, 6396, 6398, 6558,
7210, 7574, 7595 and 7615.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by bulletin dated March 5, 2004. Firm initiated recall is ongoing.
REASON
If the files are not periodically purged from the TCW computer, it may result in patient identification/sample results.
VOLUME OF PRODUCT IN COMMERCE
29 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Tecan clinical workstation; 10-410 Tecan Genesis 150
back end, Roche catalog number 03585352001.
Recall # Z-0999-04;
b) Tecan clinical workstation; 10-415 Tecan Genesis 150
front end, Roche catalog number 03585379001.
Recall # Z-1000-04;
Tecan clinical workstation; Tecan Genesis 150/8 front
end COBAS, Roche catalog number 03600530001.
Recall # Z-1001-04.
CODE
a) All units (serial numbers 5583, 5606, 6372, 6394, 6396,
6398, 6558, 7210, 7574, 7595 and 7615);
b) All units (serial numbers 5524, 6177, 6224, 6376, 6393,
6395, 6397, 6557, 7150, 7349, 7350, 7594, 7616 and
7724);
c) All units (serial numbers 6178, 7629, 7698, 7744, 7753, 7754, 7755 and 7768).
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN., by press release on May 7, 2004, and letter dated May 5, 2004. Firm initiated recall is complete.
REASON
Tecan software has the potential to match the patient with a different patient?s test result.
VOLUME OF PRODUCT IN COMMERCE
31 units.
DISTRIBUTION
Nationwide.

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
VerifyNow Asprin Assay Kit Part No. 85034. Recall # Z-1018-04.
CODE
Assay Device Lot WD0034, Kit Lots W17105, W17140.
RECALLING FIRM/MANUFACTURER
Accumetrics, Inc., San Diego, CA, by letters on May 10, 2004. Firm initiated recall is ongoing.
REASON
Test results too low in control.
VOLUME OF PRODUCT IN COMMERCE
4,500 kits.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Infant Ventilators with Electronic Manometer. Models IV-100B; IV-200 and IV-200 SAVI. Recall # Z-1032-04.
CODE
Ventilators with production serial numbers beginning with a "00" prefix.
RECALLING FIRM/MANUFACTURER
Sechrist Industries, Inc., Anaheim, CA, by letter on May 20, 2004. Recall notification contains a test method to be used to identify defective units. Return notification that ventilator is defective will result in replacement of the electronic manometer. Firm initiated recall is ongoing.
REASON
Electronic manometer malfunctions. Manometer may be illegible. The alarm for power failure may function only briefly, or not at all.
VOLUME OF PRODUCT IN COMMERCE
240 ventilators or manometers.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Power Heart AED Automatic External Defibrillator,
Model 9200 RD. Recall # Z-1033-04;
b) Power Heart Automatic External Defibrillator,
Model 9210 RD. Recall # Z-1034-04.
CODE
a) Serial Numbers: 300122, 300226, 300450, 300672, 300855,
301848, 303845, 304550, 305544, 306004, 306420, 306426,
306474, 306500, 306572, 306585, 306586, 306615, 306663,
306685, 306691 through 306810, 307433, 308131 through
308530, 308839, 309180, 309218, 309236, 309426, 309438
309930, 309944, 309959, 309971 through 310170, 310181,
310411 through 310490, 310571 through 310610, 310691
through 311170, 311211 through 312170, 312211 through
312290, 312651 through 316050, 316518, 316691 through
316730, 316853, 316862, 316949, 316961, 316964, 316973,
317056, 317058, 317106, 317123, 317131, 317180, 317183,
317185, 317189, 317191, 317207, 317266, 317270, 317278,
318171 - 318190, 318211 through 318330, 318347, 318371
through 318410, 318419, 318424, 318427, 318433, 318435,
318439, 318446, 320691 through 320930, and the following
individual serial numbers separated by commas: 268231-
02-35, 74414-1602, 74414-0213, 74777-0802, 75180-0246,
75180-0189, 75180-0088, 75180-0045, 75180-0608, 75180-
0241, 75180-0083, 75180-0059, 75180-0123, 75180-0097,
75180-0040, 75180-0103, 75180-0109, 75180-0096, 75180-
0060, 75180-0090, 75180-0091, 75180-0114, 75180-0100,
75180-0046, 75180-0047, 75180-1866, 75180-0111, 75180-
0048, 75180-0085, 75180-0057, 75180-0073, 75180-0113,
75180-0237, 75180-0086, 75180-0239, 75180-0225, 75180-
0606, 75180-0226, 75180-0980, 75180-0099, 75180-0061,
75180-0041, 75180-0112, 75180-0094, 75180-0076, 75180-
0107, 75180-0002, 75180-1000, 75180-0049, 75180-0101,
75180-0079, 75180-0400, 75180-0607, 75180-0102, 75180-
0058, 75180-0106, 75180-0062, 75180-0120, 75180-0069,
75180-0082, 75180-0072, 75180-0039, 75180-0121, 75180-
0071, 75180-0074, 75180-0117l, 75180-0037, 75180-0240,
75180-0119, 75180-0063, 75180-0050, 75180-0238, 75180-
0108, 75180-0093, 75180-0077, 75180-0087, 75180-0236,
75180-0067, 75180-0065, 75180-0056, 75180-0095, 75180-
0105, 75180-0110, 75180-0044, 75180-0122, 75180-0115,
75180-0092, 75180-0075, 75180-0068, 75180-0084, 75180-
0104, 75180-0080, 75180-0098, 75180-0118, 75180-0116,
75180-0244, 75180-0081, 75180-0078, 75180-0070, 75180-
0042, 75180-0089, 75180-0064, and 75180-0043;
b) Serial Numbers: 300122,300226, 300450, 300672, 300855,
301848, 303845, 304550, 305544, 306004, 306420, 306426,
306474, 306500, 306572, 306585, 306586, 306615, 306663,
306685, 306691 through 306810, 307433, 308131 through
308530, 308839, 309180, 309218, 309236, 309426, 309438,
309561, 309691 through 309894, 309897, 309903 through
309908, 309913, 309915, 309917, 309922, 309924, 309929,
309930, 309944, 309959, 309971 through 310170, 310181,
310411 through 310490, 310571 through 310610, 310691
through 311170, 311211 through 312170, 312211 through
312290, 312651 through 316050, 316518, 316691 through
316730, 316853, 316862, 316949, 316961, 316964, 316973,
317056, 317058, 317106, 317123, 317131, 317180, 317183,
317185, 317189, 317191, 317207, 317266, 317270, 317278,
318171 - 318190, 318211 through 318330, 318347, 318371
through 318410, 318419, 318424, 318427, 318433, 318435,
318439, 318446, 320691 through 320930, and the following
individual serial numbers separated by commas: 268231-
02-35, 74414-1602, 74414-0213, 74777-0802, 75180-0246,
75180-0189, 75180-0088, 75180-0045, 75180-0608, 75180-
0241, 75180-0083, 75180-0059, 75180-0123, 75180-0097,
75180-0040, 75180-0103, 75180-0109, 75180-0096, 75180-
0060, 75180-0090, 75180-0091, 75180-0114, 75180-0100,
75180-0046, 75180-0047, 75180-1866, 75180-0111, 75180-
0048, 75180-0085, 75180-0057, 75180-0073, 75180-0113,
75180-0237, 75180-0086, 75180-0239, 75180-0225, 75180-
0606, 75180-0226, 75180-0980, 75180-0099, 75180-0061,
75180-0041, 75180-0112, 75180-0094, 75180-0076, 75180-
0107, 75180-0002, 75180-1000, 75180-0049, 75180-0101,
75180-0079, 75180-0400, 75180-0607, 75180-0102, 75180-
0058, 75180-0106, 75180-0062, 75180-0120, 75180-0069,
75180-0082, 75180-0072, 75180-0039, 75180-0121, 75180-
0071, 75180-0074, 75180-0117l, 75180-0037, 75180-0240,
75180-0119, 75180-0063, 75180-0050, 75180-0238, 75180-
0108, 75180-0093, 75180-0077, 75180-0087, 75180-0236,
75180-0067, 75180-0065, 75180-0056, 75180-0095, 75180-
0105, 75180-0110, 75180-0044, 75180-0122, 75180-0115,
75180-0092, 75180-0075, 75180-0068, 75180-0084, 75180-
0104, 75180-0080, 75180-0098, 75180-0118, 75180-0116,
75180-0244, 75180-0081, 75180-0078, 75180-0070, 75180-
0042, 75180-0089, 75180-0064, and 75180-0043.
RECALLING FIRM/MANUFACTURER
Cardiac Science, Inc., Minneapolis, MN, by letter dated May 24, 2004. Firm initiated recall is ongoing.
REASON
Some of the high voltage capacitors in the recalled external defibrillators have had extended charge times resulting in self-test failures following which the defibrillator cannot be used/cannot be turn on.
VOLUME OF PRODUCT IN COMMERCE
6,167 defibrillators.
DISTRIBUTION
Nationwide and Internationally.

END OF ENFORCEMENT REPORT FOR JUNE 30, 2004

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