FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

September 18, 2002
02-37

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

_______________________
PRODUCT
Aura Cacia Rich Moisturizing Shampoo packaged in 12 and 32-fl. oz. bottles. Recall # F-756-2.
CODE
12-oz. bottles - Lots 2170 and 2171
32-oz. bottles - Lots 2171 and 2172.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Frontier Natural Brands, Norway, IA, by telephone on July 12, 2002. Firm initiated recall is ongoing.
REASON
The product is contaminated with Enterobacter gergoviae.
VOLUME OF PRODUCT IN COMMERCE
5,752 bottles.
DISTRIBUTION
Nationwide and Canada.

_______________________
PRODUCT
a) Tuna Salad sandwiches. Recall # F-757-2;
b) Pimento Cheese sandwiches. Recall # F-758-2.
CODE
Expiration date (7 days from production date).
RECALLING FIRM/MANUFACTURER
M&F Distributing Company, Inc., Bedford, IN, by printing new labels and removing and destroying the affected products beginning July 17, 2002. FDA initiated recall complete.
REASON
a) Tuna salad sandwiches contained undeclared FD&C Yellow No. 5. b) Pimento cheese sandwiches contained undeclared FD&C Yellow No. 5 and Yellow No. 6.
VOLUME OF PRODUCT IN COMMERCE
Approx. 30 sandwiches.
DISTRIBUTION
IN.

_______________________
PRODUCT
a) "Besitos de Coco" (Coconut Kisses, a sweet baked product),
in 6 oz plastic containers. Recall # F-759-2.
b) Aguada brand Bizcocho de Zanahorias (Carrot Cake) in 10 oz and 12 oz packages. Product packed in round aluminum molds with clear plastic lids. Recall # F-760-2.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Oasis de Aguada, Inc., Aguada, Puerto Rico, by in-person visit on July 2, 2002. Firm initiated recall is ongoing.
REASON
a) The Besitos de Coco contain undeclared FD& C yellow #5 and #6. b) The Bizcocho de Zanahorias contains undeclared FD&C Yellow #5 and #6 and FD&C Red # 40.
VOLUME OF PRODUCT IN COMMERCE
1,861 units.
DISTRIBUTION
Puerto Rico.

_______________________
PRODUCT
Sabrosos Pilones" brand, pineapple/coconut flavored lollypops. Recall # F-761-2.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Silgra Bakery, Inc., Santa Isabel, Puerto Rico, by fax and telephone on March 21, 2002. Firm initiated recall is complete.
REASON
The product contained undeclared FD&C Yellow No. 5, FD&C Yellow No. 6, and FD&C Red No. 40.
VOLUME OF PRODUCT IN COMMERCE
1,152 units.
DISTRIBUTION
Puerto Rico.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

_______________________
PRODUCT
Mountain Dew in 12 oz. aluminum cans. Recall # F-755-2.
CODE
April 15 02 1645ES101.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pepsi Cola Bottling aka National Beverages, Inc., Orlando, FL, by e-mail on October 17, 2001.
Manufacturer: Pepsi Cola Bottling, Orlando, FL. Firm initiated recall is complete.
REASON
Mountain Dew may be contaminated with equipment cleaning fluid.
VOLUME OF PRODUCT IN COMMERCE
7200 cases.
DISTRIBUTION
FL.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

*****CORRECTION*****

The ER of September 3, 2002, Recall No. D-398-2, Zerit Capsules, listed an incorrect Reason for Recall. The correct reason is: Capsule mixup; 20 mg or 30 mg capsules may be in bottles labeled as containing 40 mg capsules.

_______________________
PRODUCT
Liquid Oxygen, USP, Medical, Cryogenic Home Units (models BP-21 and BP-41). Recall # D-411-2.
CODE
Lot 08060239.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Health Care Solutions, Inc., Weirton, WV, by telephone on August 15, 2002. Firm initiated recall is ongoing.
REASON
Good Manufacturing Practice (GMP) deviations including, but not limited to, failure to test for purity and identity.
VOLUME OF PRODUCT IN COMMERCE
5 tanks.
DISTRIBUTION
WV.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

_______________________
PRODUCT
Desyrel Tablets (Trazodone HCL), 100 mg, 100 count bottles, Rx only. Recall # D-401-2.
CODE
Lot # 0M03491, Exp. 11/02
Lot # 0M03491A, Exp. 11/02
Lot # 0E02305, Exp. 05/02.
RECALLING FIRM/MANUFACTURER
Recalling Firm: AmeriSource Health Services Corp., Columbus, OH, by letter and fax on August 20, 2002.
Manufacturer: Mead Johnson & Co., Evansville, IN. Firm initiated recall is ongoing.
REASON
Lack of content uniformity-subpotent tablets (stability 18 month) by manufacturer-Mead Johnson Pharmaceuticals, A Bristol-Myers Squibb Co.
VOLUME OF PRODUCT IN COMMERCE
1,857 bottles.
DISTRIBUTION
Nationwide.

_______________________
PRODUCT
Softsoap Antibacterial Liquid Hand Soap (with hand pump) Rainforest Series (triclosan), 7.5 FL OZ (221 mL) bottles. Recall # D-402-2.
CODE
Rainforest product:
SKU Number 127800
Code dates 2134,2135,2136
Rainforest product mixed product displays:
SKU Number: 102781
Code Dates: 2158, 2161.
RECALLING FIRM/MANUFACTURER
Colgate-Palmolive Co., Piscataway, NJ, by letters starting on July 2, 2002. Firm initiated recall is ongoing.
REASON
Cross contamination with another soap product (contains undeclared ingredients: aloe vera, fragrance, glycerin, hydrolyzed silk).
VOLUME OF PRODUCT IN COMMERCE
19,293 cases.
DISTRIBUTION
Nationwide.

_______________________
PRODUCT
Betamethasone Dipropionate Ointment USP (Augmented) 0.05%, 0.64 mg, 15g (0.53 oz) and 45g (1.59 oz) tubes, Rx only. Recall # D-408-2.
CODE
a) Lot Number L105039;
b) Lot Number L004054.
RECALLING FIRM/MANUFACTURER
Alpharma Uspd, Inc., Lincolnton, NC, by letter on January 31, 2002. Firm initiated recall is ongoing.
REASON
Subpotent.
VOLUME OF PRODUCT IN COMMERCE
a) 8574 units;
b) 5802 units.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I

_______________________
PRODUCT
Corneas, Human Tissue for Transplantation, Recall # B-1832-2.
CODE
ID numbers 10-017-00-1172-OS and 10-017-00-1172-OD.
RECALLING FIRM/MANUFACTURER
Lions Eye Bank of Oregon, Portland, OR, by e-mail on June 28, 2002 and by telephone and letter on July 26, 2002. Firm initiated recall is complete.
REASON
Tissue for transplantation was processed from a donor who was found to test positive for hepatitis C virus (HCV) subsequent to distribution.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
Italy.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_______________________
PRODUCT
Red Blood Cells, Recall # B-0240-2.
CODE
Units LT13783 (parts 1 and 2).
RECALLING FIRM/MANUFACTURER
Recalling Firm: San Diego Blood Bank, San Diego, CA, by letter dated February 21, 2002.
Manufacturer: North Coastal Donor Center, Vista, CA.
Firm initiated recall is complete.
REASON
Blood products, which failed quality control testing for red blood cell volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________
PRODUCT
Source Plasma, Recall # B-1642-2.
CODE
Units CCBWKR, CCBVNF, CCBVDL, CCBTJH, CCBSRB, CCBRVZ, CCBRBW, CCBQNJ, CCBPTX, CCBNPR, CCBMNC, CCBLYR, CCBKPG, CCBKCK, CCBHSZ, CCBHDK, CCBCGT, 978046, 93I578, 93H912, 93G575, 9XM742, 9XM436, 9XM112, 9XL815, 9XL527, 9XL218, 9XK858, 9XK505, 9TZ711, 9TZ044, 9TY785, 9Q1449, 9Q0773, 9Q0621, 9Q0096, 9QZ566, 9M1195, 9LZ516, 9LY913, 9LY276, 9LX503, 9HH252, 9HG569, 9GT182, 9GS989, 9GS160, 9GR845, 9EH635, 9EH416, 9EG759, 9EG535, 9EE019, 9ED844
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Kansas City, MO, by fax dated November 20, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of using hard drugs, were distributed.
VOLUME OF PRODUCT IN COMMERCE
54 units.
DISTRIBUTION
IL.

_______________________
PRODUCT
a) Platelets, Pheresis, Recall # B-1843-2.
b) Platelets, Pheresis, Irradiated, Recall # B-1844-2.
CODE
a) Units 9154841, 9155441, 9165141, 9164851, 9164401, 9163641, 9163111, 9162771, 9162351- part 1, 9162031, 9160271-part 1, 9159971, 9159351, 9159151-part 1, 9158751, 9158401, 9157781, (parts 1 and 2 except as noted);
b) Units 9162351, 9160271, 9159151.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on July 2, 2002. Firm initiated recall is complete.
REASON
Platelets, collected from a donor who ingested an aspirin containing product within the past 36 hours, were distributed.
VOLUME OF PRODUCT IN COMMERCE
34 units.
DISTRIBUTION
IN.

_______________________
PRODUCT
Platelets, Recall # B-1845-2.
CODE
Unit R85586.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, t/a Miller Memorial Blood Center, Bethlehem, PA, by letter dated November 14, 2001. Firm initiated recall is complete.
REASON
Platelets, collected from a donor who ingested an aspirin containing product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________
PRODUCT
Red Blood Cells, Recall # B-1846-2.
CODE
Units LN96013 (A and B).
RECALLING FIRM/MANUFACTURER
NBAH Blood Center, New Brunswick, NJ, by telephone on July 24, 2001. Firm initiated recall is complete.
REASON
Blood products, that failed quality control testing for red cell volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ.

_______________________
PRODUCT
a) Red Blood Cells, Recall # B-1847-2;
b) Platelets, Recall # B-1848-2;
c) Fresh Frozen Plasma, Recall # B-1849-2.
CODE
a) Units R44248, R29068, H57223, H16369;
b) Units R44248, H57223;
c) Units R44248, R29068.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, t/a Miller Memorial Blood Center, Bethlehem, PA, by letter dated August 29, 2000. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking Prednisone and Ceftin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
PA and GA.

_______________________
PRODUCT
a) Red Blood Cells, Recall # B-1851-2.
b) Platelets, Recall # B-1852-2.
CODE
a) Units R94360, R89749, R89750, C25449, T58163, R94331,
R94389, C25446, T58130, R94304, R94425 , C25459, C25458, R94298, R94271, C25453, C25445, R94314, R94310, T57528, C25447, C25456, T57824, T57822, T57835, T57533, T57527, R94272, R94279, C25455, R94333, T58160, R94330, T56491, R94324, R94348, C25450, T58119;
b) Units R94360, R94304, R94298, R94271, R94272, R94279,
R94330, T56496.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, t/a Miller Memorial Blood Center, Bethlehem, PA, by letter dated March 1, 2001. Firm initiated recall is complete.
REASON
Blood products, manufactured in a manner that compromised their sterility, were distributed.
VOLUME OF PRODUCT IN COMMERCE
46 units.
DISTRIBUTION
PA and NJ.

_______________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1860-2;
b) Recovered Plasma, Recall # B-1861-2.
CODE
a) and b) Unit number 18226-1628.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by fax on June 7, 2002 and by letter on June 28, 2002.
Manufacturer: Blood Systems, Inc., Cheyenne, WY.
Firm initiated recall is ongoing.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a reported history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WY and Switzerland.

_______________________
PRODUCT
a) Red Blood Cells, Recall # B-1895-2;
b) Platelets Pooled, Leukocytes Reduced, Recall # B-1896-2;
c) Fresh Frozen Plasma, Recall # B-1897-2.
CODE
a) and c) Unit number 0666843;
b) Pool number 0079562.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by fax on March 12, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units, 1 pool.
DISTRIBUTION
OH and KY.

_______________________
PRODUCT
Red Blood Cells, Recall # B-1910-2.
CODE
Unit number 31127-3647.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on February 15, 2000 and by letter on March 8, 2000.
Manufacturer: Blood Systems, Inc., Tupelo, MS.
Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.

_______________________
PRODUCT
a) Red Blood Cells, Recall # B-1917-2.
b) Recovered Plasma, Recall # B-1918-2.
CODE
a) and b) Unit LL06031.
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by Questionable Plasma Inquiry on January 22, 2002 and by letter dated February 20, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________
PRODUCT
Saphenous Vein Allografts Tissues, Recall # B-1923-2.
CODE
Tissues 6088627, 6103286, 6103294.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by letter dated August 8, 2002.
Firm initiated recall is complete.
REASON
Tissues for transplant were collected from a donor who had not been properly evaluated.
VOLUME OF PRODUCT IN COMMERCE
3 tissues.
DISTRIBUTION
MI, MN and NJ.

_______________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1926-2.
CODE
Units 040GR61357 and 040LW18210.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Heart of America Region, Peoria, IL, by telephone on June 11, 2002 and by letter dated June 12, 2002. Firm initiated recall is complete.
REASON
Blood products, incorrectly labeled as being crossmatch compatible, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.

_______________________
PRODUCT
Red Blood Cells, Recall # B-1929-2.
CODE
Unit number 20280-4361.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on May 16, 2000.
Manufacturer: Blood Systems, Inc., Lafayette LA.
Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood that was stored at an improper temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.

_______________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1930-2.
CODE
Unit number 20399-0176.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter on March 1, 2001.
Manufacturer: Blood Systems, Inc., Lafayette LA.
Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to use of an unknown medication, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.

_______________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1931-2.
CODE
Unit number 20399-0172.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter on March 10, 2001.
Manufacturer: Blood Systems, Inc., Lafayette LA.
Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to medication with an antibiotic, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.

_______________________
PRODUCT
Source Plasma, Recall # B-1932-2.
CODE
Unit numbers BYGYBM, BYGXPH, BYGWZP, BYGWPJ, BYGWCV, BYGVRK, BYGVGS, BYGTWM, BYGTLH, BYGSZG, BYCHZK, BYCHNY, BYCFZR, BYCFGL, BYGXTR, BYGXJR, BYGWWD, BYGWLJ, BYGVYC, BYGVPB, BYGVCT, BYGTPF, BYGTDR, BYGSRS, BYCHSP, BYCHGV, and BYCFLF.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Bio-Services, Inc., King of Prussia, PA, by letter on April 19, 2002.
Manufacturer: Aventis Bio-Services, Inc., Charlotte, NC.
Firm initiated recall 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
27 units.
DISTRIBUTION
IL.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

_______________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated, Recall # B-0359-2.
CODE
Unit numbers E60831 and E71691.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by letter dated July 8, 2002. Firm initiated recall is complete.
REASON
Blood products that were out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.

_______________________
PRODUCT
a) Red Blood Cells, Recall # B-1838-2.
b) Platelets, Recall # B-1839-2.
CODE
a) and b) Unit T40541.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, t/a Miller Memorial Blood Center, Bethlehem, PA, by telephone on January 25, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who failed to answer the question regarding having had any shots or vaccinations in the past 6 weeks, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ and PA.

_______________________
PRODUCT
Source Plasma, Recall # B-1850-2.
CODE
Unit numbers CN042103 and CN042482.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Sera-Tec Biologicals L.P., Charlotte, NC, by letter on January 22, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor based on previous elevated testing for alanine aminotransferase (ALT), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC.

_______________________
PRODUCT
Source Plasma, Recall # B-1853-2.
CODE
Unit number CN043594.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Sera-Tec Biologicals L.P., Charlotte, NC, by letter on February 11, 2002. Firm initiated recall is complete.
REASON
Blood product, that tested negative for the antibody to hepatitis C virus (anti-HCV), was collected from a donor that subsequently tested repeatedly reactive to anti-HCV, was not properly quarantined, and was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.

_______________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated, Recall # B-1854-2.
CODE
Unit numbers E71730 and E71717.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by letter dated July 8, 2002. Firm initiated recall is complete.
REASON
Blood products that were out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.

_______________________
PRODUCT
a) Red Blood Cells, Recall # B-1901-2;
b) Platelets for Further Manufacture, Recall # B-1902-2.
c) Recovered Plasma, Recall # B-1903-2.
CODE
a); b) and c) Unit 4104844.
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center,Augusta, GA, by letter dated April 30, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received a bone transplant, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
GA and Switzerland.

_______________________
PRODUCT
Red Blood Cells, Recall # B-1911-2.
CODE
Unit number 20401-0802.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on June 14, 2001.
Manufacturer: Blood Systems, Inc., Lafayette LA.
Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to medication with an antibiotic, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.

_______________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1912-2.
CODE
Unit number 20400-6355 (distributed as 2 split units).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on June 6, 2001.
Manufacturer: Blood Systems, Inc., Lafayette LA.
Firm initiated recall is complete.
REASON
Blood product, collected on an apheresis machine where there was no documentation of evaluation of the filter assemblies as required, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA.

_______________________
PRODUCT
Red Blood Cells, Recall # B-1928-2.
CODE
Unit number 20401-0726.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on June 8, 2001.
Manufacturer: Blood Systems, Inc., Lafayette LA.
Firm initiated recall is complete.
REASON
Blood product, that tested out of specification for hematocrit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.

_______________________
PRODUCT
Reagent Red Blood Cells of the following types: Recall # B-1933-2.
a) Panocell-10;
b) Panocell-10, Ficin treated;
c) Panoscreen;
d) Panoscreen, Ficin treated.
CODE
a) Lot numbers 38975 and 38978;
b) Lot number 38975-E;
c) Lot numbers 38976 and 38977;
d) Lot number 38976-E.
RECALLING FIRM/MANUFACTURER
Immucor, Inc., Norcross, GA, by letter on October 30, 2000.
Firm initiated recall is complete.
REASON
Reagent red blood cells were distributed that may have been contaminated with microorganisms.
VOLUME OF PRODUCT IN COMMERCE
6 lots.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

*****CORRECTION*****
The Enforcement Report dated August 21, 2002, Recall No. Z-1229-2, listed an incorrect Distribution as nationwide. The correct distribution is: Foreign markets only.

_______________________
PRODUCT
SSCOR Suction Unit Model 2314. Recall # Z-1242-2;
SSCOR Suction Unit Model 2314B. Recall # Z-1243-2;
SSCOR Suction Unit Model 2315. Recall # Z-1244-2.
CODE
All Codes.
RECALLING FIRM/MANUFACTURER
Sscor, Sun Valley, CA, by "Urgent Field Correction" letter. Notice to the distributor and the firm's European representatives was sent on June 25, 2002. Notice to end users was sent on July 15, 2002. Firm initiated recall is ongoing.
REASON
Overheats and fails to suck.
VOLUME OF PRODUCT IN COMMERCE
4105.
DISTRIBUTION
Nationwide and Saudi Arabia.

_______________________
PRODUCT
Vanish Point Blood Collection Tube Holder, packaged 10 units per sleeve, 25 sleeves per case. Recall # Z-1280-2.
CODE
11 lots recalled:
RTI Lot number/Abbott Lot number
D152A/700126S
D158A/710166S
D166A/720076S
D167A/720086S
D169A/720146S
D170A/720196S
D171A/720206S
D172A/730046S
D173A/730056S
D174A/730126S
D181A/730286S.
RECALLING FIRM/MANUFACTURER
Retractable Technologies, Inc., Little Elm, TX, by letter on May 1, 2002. Firm initiated recall is ongoing.
REASON
Unexpected premature retraction is possible.
VOLUME OF PRODUCT IN COMMERCE
951,750 units.
DISTRIBUTION
Nationwide and Canada and Africa.

_______________________
PRODUCT
Misys Laboratory. Recall # Z-1281-2.
CODE
Versions 5.2, 5.23 and 5.3.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems Inc., Tuscon, AZ, by fax on April 23, 2002. Firm initiated recall is ongoing.
REASON
Software anomaly regarding cell counts.
VOLUME OF PRODUCT IN COMMERCE
469.
DISTRIBUTION
Nationwide, and Internationally.

_______________________
PRODUCT
LIFEPAK 12 defibrillator/monitor. The particular part is the therapy connector - this connector allows hard paddles, disposable electrode cables, or internal-paddle cables to be easily connected or disconnected to the device.
Recall # Z-1282-2.
CODE
Serial numbers are non-continuous and can be obtained from the SEA-DO Recall Coordinator.
RECALLING FIRM/MANUFACTURER
Medtronic Physio-Control Corp., Redmond, WA, by letter on July 11, 2002. Firm initiated recall is ongoing.
REASON
Potential for interrupted pacing or defibrillator functions.
VOLUME OF PRODUCT IN COMMERCE
5494.
DISTRIBUTION
Nationwide.

_______________________
PRODUCT
Model 8870 Software Application Card for the Model 8840 N’Vision Handheld Clinician programmer. Recall # Z-1284-2.
CODE
All units are involved.
RECALLING FIRM/MANUFACTURER
Medtronic, Inc., Neurological Division, Minneapolis, MN, by letter dated June 10, 2002. Firm initiated recall is ongoing.
REASON
An incorrect drug administration rate can be programmed into SynchroMed or SynchroMed EL implantable infusion pumps due to defective software.
VOLUME OF PRODUCT IN COMMERCE
34 Model 8870 Application Cards.
DISTRIBUTION
Europe and the Middle East.

_______________________
PRODUCT
Mysis Commercial Laboratory. Recall # Z-1285-2.
CODE
Versions 3.2.0; 3.2.2; 3.2.3, 3.3.0, 3.3.1a, 3.3.1, 3.4.0, 3.4.1b, and 3.4.1a.
RECALLING FIRM/MANUFACTURER
Mysis Healthcare Systems, Inc., Plano, TX, by fax on May 28, 2002. Firm initiated recall is ongoing.
REASON
Software anomaly: a result for an accesion number came across the interface as negative but should have been Do Not Result (DNR).
VOLUME OF PRODUCT IN COMMERCE
44.
DISTRIBUTION
Nationwide.

_______________________
PRODUCT
HP Deskjet 970Cxi Printer connected as an accessory to the Elan ATAC 8000 Random Chemistry Analyzer. Recall # Z-1288-2.
CODE
HP Deskjet 970Cxi Printer connected as an accessory to the Elan ATAC 8000 Random Chemistry Analyzer.
RECALLING FIRM/MANUFACTURER
Elan Diagnostic Smithfield, RI, by recall notification directly from HP issued June 2002. Customers are provided instructions for identifying the effected cord and replacement. Firm initiated recall is ongoing.
REASON
Printer power cord may crack and cause electric shock.
VOLUME OF PRODUCT IN COMMERCE
29.
DISTRIBUTION
Nationwide.

_______________________
PRODUCT
VACUTAINER Brand Luer Adapters (Catalog #367290).
Recall # Z-1291-2.
CODE
Catalog #367290
Lot #'s 1242595 and 1284859.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co., Franklin Lakes, NJ, by how on April 23, 2002.
Manufacturer: Becton Dickinson & Co., Sumter, SC.
Firm initiated recall is ongoing.
REASON
Needle Separated from the Hub.
VOLUME OF PRODUCT IN COMMERCE
3,690,000 units estimated in commerce.
DISTRIBUTION
Nationwide.

_______________________
PRODUCT
Power supply cord sold with and used with Spacelabs Medical Models 90342, 90344, 90346, 90348, and 90479 telemetry systems/receiver housings. Recall # Z-1292-2/Z-1301-2.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Spacelabs Medical, Inc., Redmond, WA, by letter dated June 28, 2002.
Manufacturer: Winegard Company, Burlington, IA.
Firm initiated recall is ongoing.
REASON
Power supply cord not UL or CSA approved.
VOLUME OF PRODUCT IN COMMERCE
759 power supplies.
DISTRIBUTION
Nationwide.

_______________________
PRODUCT
Misys Commercial Laboratory. Recall # Z-1318-2.
CODE
Versions 3.3.0, 3.3.1, 3.4.0 and 3.4.1a.
RECALLING FIRM/MANUFACTURER
Mysis Healthcare Systems, Inc., Plano, TX, by fax May 15, 2002.
REASON
Software anomaly. If the deformatter begins to process data prior to all patient result records or orders being extracted from the flat files, the remaining results or orders will not be extracted. This can result in data being processed out of sequence into the Mysis Commercial Laboratory System.
VOLUME OF PRODUCT IN COMMERCE
7.
DISTRIBUTION
TX, FL, NY, MN, NC and PA.

_______________________
PRODUCT
a) MediSense ExacTech Blood Glucose Test Strips (50 Count)
NDC 57599-7103-2. Recall # Z-1319-2;
b) MediSense ExacTech Blood Glucose Test Strips(100 Count)
NDC 57599-7174-2. Recall # Z-1320-2;
c) MediSense ExacTech RSG Blood Glucose Test Strips(50
Count) NDC 57599-7542-4. Recall # Z-1321-2.
CODE
a) NDC 57599-7103-2 Lot Number: 45874;
b) NDC 57599-7174-2 Lot Number: 45874;
c) NDC 57599-7542-4 Lot Number: 45852.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Inc., Medisense Products, Bedford, MA, by letter on August 5, 2002.
Manufacturer: Medisense UK Limited Abingdon Oxon.
Firm initiated recall is ongoing.
REASON
Blood Glucose Test Strip May Give False High Readings.
VOLUME OF PRODUCT IN COMMERCE
6,241 Boxes (50 test strips/box).
DISTRIBUTION
Nationwide.

_______________________
PRODUCT
Optetrak 1/2 Tibial Augmentation Block Implants, (Classification name: knee joint patellofemoral polymer/metal/polymer semi-constrained). Recall # Z-1326-2.

Product is intended to be implanted during total knee joint replacement surgery where augmentation of the standard implant components is required.
CODE
All serial numbers less than 0260014 for the following products:

Part Description	Catalog Number
1/2 Tibial Augmentation Block, Sz 0 X 5 mm	204-60-05
1/2 Tibial Augmentation Block, Sz 0 X 8 mm	204-60-08
5mm Tibial Augmentation 1/2 Block Sz.1	204-61-05
8mm Tibial Augmentation 1/2 Block Sz.1	204-61-08
11mm RL, LM Tibial Augmentation 1/2 Block Sz.1	204-61-88
11mm RM, LL Tibial Augmentation 1/2 Block Sz.1	204-61-89
5mm Tibial Augmentation 1/2 Block Sz.2	204-62-05
8mm Tibial Augmentation 1/2 Block Sz.2	204-62-08
11mm RL, LM Tibial Augmentation 1/2 Block Sz.2	204-62-88
11mm RM, LL Tibial Augmentation 1/2 Block Sz.2	204-62-89
5mm Tibial Augmentation 1/2 Block Sz 3	204-63-05
8mm Tibial Augmentation 1/2 Block Sz 3	204-63-08
11mm RL, LM Tibial Augmentation 1/2 Block Sz 3	204-63-88
11mm RM, LL Tibial Augmentation 1/2 Block Sz 3	204-63-89
5mm Tibial Augmentation 1/2 Block Sz 4	204-64-05
8mm Tibial Augmentation 1/2 Block Sz 4	204-64-08
11mm RL, LM Tibial Augmentation 1/2 Block Sz 4	204-64-88
11mm RM, LL Tibial Augmentation 1/2 Block Sz 4	204-64-89
5mm Tibial Augmentation 1/2 Block Sz 5	204-65-05
8mm Tibial Augmentation 1/2 Block Sz 5	204-65-08
11mm RL, LM Tibial Augmentation 1/2 Block Sz 5	204-65-88
11mm RM, LL Tibial Augmentation 1/2 Block Sz 5	204-65-89.

RECALLING FIRM/MANUFACTURER
Exactech, Inc., Gainesville, FL, by letter on May 21, 2001.
Firm initiated recall is complete.
REASON
Compromise of sterility barrier packaging.
VOLUME OF PRODUCT IN COMMERCE
1828.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

_______________________
PRODUCT
Hill-Rom brand Affinity Three birthing bed. Recall # Z-1283-2.
CODE
All beds with a serial number of D196AA4617 or lower.
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letter on June 11, 2002.
Firm initiated recall is complete.
REASON
Calf support mounting screws may loosen and back out, allowing the calf support to become unstable/fall off.
VOLUME OF PRODUCT IN COMMERCE
4,473 beds.
DISTRIBUTION
Nationwide and Internationally.

_______________________
PRODUCT
Stryker Howmedica Osteonics V40TM Femoral Head, 26mm Diameter, (5o40’ Taper). Recall # Z-1287-2/Z-1288-2.
CODE
Device : V40TM Femoral Head, 26mm Diameter, (5o40’ Taper)
Catalog #: 6260-5-226
Lot #’s: BZDJPR, BZEHYR, CABHVR, CABHWR, CABPZR, CABRCR, CABRDR,
CABRER, CACNGR, CAFFKR, CAFFLR, CAFFNR, CAFFPR, CAFFRR, CAFFSR,
CAFFUR, CAGBMR, CAGBNR, CAGBOR, CAGBRR, CAGBSR, CAGBVR, CAGBWR,
CAGSJR, CAGSKR, CAGSNR, CAHMER, CAHMFR, CAHUWR, CAHUYR, CAJEPR,
CAJERR, CAJESR, CAJETR, CASUBR, CATJKR, CATJLR, CAVFMR, CAVFNR,
CAVGBR, CAVGDR, CAVGDR, CAVMSR, CAVMTR, CAVMUR, CAWKOR
Expiration Dates:
12/2006 (Lot #’s: CABHWR, CAGBWR, CAHMFR, CAJEPR, CAJERR, CAJESR, CAJETR)
1/2007 (Lot #’s BZDJPR, BZEHYR, CABHVR, CABPZR, CABRCR, CABRDR, CABRER, CACNGR, CAFFKR, CAFFLR, CAFFNR, CAFFPR, CAFFRR, CAFFSR, CAFFUR, CAGBMR, CAGBNR, CAGBOR, CAGBRR, CAGBSR, CAGBVR, CAGSJR, CAGSKR, CAGSNR, CAHMER, CAHUWR, CAHUYR)
2/2007 (Lot #’s CASUBR, CATJKR, CATJLR, CAVFMR, CAVFNR, CAVGBR, CAVGDR, CAVGDR, CAVMSR, CAVMTR, CAVMUR, CAWKOR)
Device: 2o52’ Taper Femoral Head, 26mm Diameter +0mm
Catalog #: 6280-0-126
Lot #’s: 6089722R, 6314756R, 6877383R, 6902451R, 6902452R,
6978671R, 6978672R, CADULR, CADUMR, CAJDER, CAJDHR, CAJHIR
Expiration Dates:
1/2007 (Lot #’s 6089722R, 6877383R, 6902451R, 6902452R, 6978671R, 6978672R, CADULR, CADUMR, CAJDER, CAJDHR, CAJHIR)
3/2007 (Lot # 6314756R)
RECALLING FIRM/MANUFACTURER
Howmedica Osteonics Corp., Rutherford, NJ, by letters dated May 15 and 29 and June 5, 2002. Firm initiated recall is ongoing.
REASON
Product mix up. Skirted heads in Non-skirted packaging.
VOLUME OF PRODUCT IN COMMERCE
125.
DISTRIBUTION
NJ.

_______________________
PRODUCT
a) Stryker Howmedica Osteonics Unitrax® C-Taper Neck Adjustment Sleeve (Adapter for Unipolar Head). Recall # Z-1289-2.
b) Stryker Howmedica Osteonics Unitrax® V40TM Std. Sleeve 5o 40’ Modular Adapter (Neck Adjustment Sleeve. Recall # Z-1290-2.
CODE
a) Unitrax® C-Taper Neck Adjustment Sleeve 6942-7-065
Lot 7153061
b) Unitrax® V40TM Std. Sleeve 5o 40’ Modular Adapter 6942-6-065 Lot 7153072
RECALLING FIRM/MANUFACTURER
Howmedica Osteonics Corp., Rutherford, NJ, by letters on April 1, 2002.
Firm initiated recall is complete.
REASON
Product package mixup. Incorrect taper.
VOLUME OF PRODUCT IN COMMERCE
38.
DISTRIBUTION
NJ and Canada.

_______________________
PRODUCT
Flexima Ureteral Stent System Kit as follows:
See Code Section. Recall # Z-1302-2/Z-1311-2.
CODE
Boston Scientific/Medi-Tech Flexima RegularUreteral Stent System
Kit as follows:

Catalog # Product
Gauge/length Lots Affected

27-410 USK/6/20/Reg 3309365
3654511
3871346

27-411 USK/6/22/Reg 3007121
3127119
3323329
3477054
3532532
3550119
3644298
3661611
3687166
3821902
3933757

27-412 USK/6/24/Reg 3073644
3323330
3480623
3533784
3548206
3821903
3766772

27-413 USK/6/26/Reg 3089476
3153194
3238115
3323338
3394293
3538046
3673635
3821904
3852712

27-414 USK/6/28/Reg 3480624
3544701
3683352
3871347

27-415 USK/8/20/Reg 3075354

27-416 USK/8/22/Reg 2984060
3149041
3685263
3935558

27-417 USK/8/24/Reg 3136719
3323596
3484096
3533785
3558400
3685287
3751452
3821906
3888130
3908810

27-418 USK/8/26/Reg 3251321
3276534
3534002
3690325
3881927

27-419 USK/8/28/Reg 3142848
3359543
3552848
3591057
3888131

Catalog #	Product Gauge/length	Lots Affected
27-410	USK/6/20/Reg	3309365 3654511 3871346
27-411	USK/6/22/Reg	3007121 3127119 3323329 3477054 3532532 3550119 3644298 3661611 3687166 3821902 3933757
27-412	USK/6/24/Reg	3073644 3323330 3480623 3533784 3548206 3821903 3766772
27-413	USK/6/26/Reg	3089476 3153194 3238115 3323338 3394293 3538046 3673635 3821904 3852712
27-414	USK/6/28/Reg	3480624 3544701 3683352 3871347
27-415	USK/8/20/Reg	3075354
27-416	USK/8/22/Reg	2984060 3149041 3685263 3935558
27-417	USK/8/24/Reg	3136719 3323596 3484096 3533785 3558400 3685287 3751452 3821906 3888130 3908810
27-418	USK/8/26/Reg	3251321 3276534 3534002 3690325 3881927
27-419	USK/8/28/Reg	3142848 3359543 3552848 3591057 3888131

RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp./Medi-Tech, Watertown, MA, by letter on June 5, 2001.
Manufacturer: Medi-Tech, a division of Boston Scientific Corp., Spencer, IN. Firm initiated recall is ongoing.
REASON
Outer carton multi language label incorrectly identifies the device as Biliary instead of Ureteral Stent.
VOLUME OF PRODUCT IN COMMERCE
946.
DISTRIBUTION
The Netherlands.

_______________________
PRODUCT
a) Cryosurgery System-Welch Allyn. Recall # Z-1312-2;
b) LM-900 Leisegang Cryosurgery System. Recall # Z-1313-2.
CODE
a) Cryosurgery System-Welch Allyn
Catalog No. 88372
Serial Numbers: 010201 to 050215; 110101 to 110103
b) LM-900 Leisegang Cryosurgery System
Catalog Number: 50501 and 50502
Serial Numbers: 12744 to 13500.
RECALLING FIRM/MANUFACTURER
Coopersurgical, Inc., Trumbull, CT, by letter on August 1, 2002.
Firm initiated recall is complete.
REASON
Tip may separate from Cryogun when pressure is released during operation.
VOLUME OF PRODUCT IN COMMERCE
767.
DISTRIBUTION
Nationwide and Canada, Guatamala, Costa Rica, Mexico, Manila and Istanbul.

_______________________
PRODUCT
a) Microstream Smart CapnoLine Oral/Nasal O2/CO2 Cannula.
Recall # Z-1314-2;
b) Microstream Smart CapnoLine Nasal O2/CO2 Cannula.
Recall # Z-1315-2.
c) MAC-Line Smart Oral Nasal 02/CO2 Cannula. Recall # Z-1316-2;
d) MAC-Line Smart Nasal O2/C02Cannula. Recall # Z-1317-2.
CODE

Description                              Oridion PN
O2/CO2 Nasal FilterLine Adult            006912
O2/CO2 Nasal FilterLine Adult Long       007739
O2/CO2 Nasal FilterLine Pediatric        006913
O2/CO2 Nasal FilterLine Pediatric Long   007740
Smart CapnoLine Adult                    007264
Smart CapnoLine Intermediate             007265
Smart CapnoLine Pediatric                007266
Smart CapnoLine O2 Adult                 007267
Smart CapnoLine O2 Adult Long            007741
Smart CapnoLine O2 Intermediate          007268
Smart CapnoLine O2 Intermediate Long     007742
Smart CapnoLine O2 Pediatric             007269
Smart CapnoLine O2 Pediatric Long        007743
Smart MacLine Adult                      007601
Smart MacLine Intermediate               007602
Smart MacLine Pediatric                  007603
Smart MacLine O2 Adult                   007604
Smart MacLine O2 Intermediate            007605
Smart MacLine O2 Pediatric               007606
Nasal MacLine O2 Adult                   007609
Nasal MacLine O2 Pediatric               007610
PRIVATE LABEL:
Nellcor Puritan Bennet US & Tyco Europe (OEM)
Description                       Oridion PN     NPB PN
O2/CO2 Nasal FilterLine Adult     006899         063568
O2/CO2 Nasal FilterLine Pediatric 006900         063569
Smart CapnoLine Adult             007341         064093
Smart CapnoLine Intermediate      007342         064094
Smart Capnoline Pediatric         007343         064095
Smart CapnoLine O2 Adult          007344         064842
Smart CapnoLine O2 Intermediate   007345         064843
Smart CapnoLine O2 Pediatric      007346         064844
PRIVATE LABEL:
MPC (Medtronic PhysioControl Corp) (OEM)
Description                       Oridion PN     MPC PN
O2/CO2 Nasal FilterLine Adult     006903         006903
O2/CO2 Nasal FilterLine Pediatric 006905         006905
Smart CapnoLine Adult             007354         007354
Smart CapnoLine Intermediate      007355         007355
Smart Capnoline Pediatric         007356         007356
Smart CapnoLine O2 Adult          007357         007357
Smart CapnoLine O2 Intermediate   007358         007358
Smart CapnoLine O2 Pediatric      007359         007359

RECALLING FIRM/MANUFACTURER
ORIDION MEDICAL LTD., Jerusalem, by telephone/in person on July 18, 2002. Firm initiated recall is complete.
REASON
Oral Nasal Cannula missing holes for the delivery of supplemental oxygen.
VOLUME OF PRODUCT IN COMMERCE
8668 cases (25 units/cs).
DISTRIBUTION
Nationwide.

END OF ENFORCEMENT REPORT FOR SEPTEMBER 18, 2002

####

Enforcement Report Index | FDA News Page | FDA Home Page

Office of Public Affairs
Hypertext uploaded by clb 2002-SEP-19.