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U.S. Department of Health and Human Services

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Enforcement Report for March 9, 2005

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.

March 9, 2005
05-10

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Flanagan Farms brand Whole Almonds, 2.5 ounce and 12 ounce packages. Recall # F-199-5.
CODE
Pull dates of: 04-18-05, 04-12-05, 03-28-05, 03-16-05, 02-20-05, 02-16-05, 02-13-05, 01-24-05, 01-23-05, 01-07-05, 01-11-05, 01-06-05. .
RECALLING FIRM/MANUFACTURER
Flanigan Farms, Inc, Culver City, CA, by letter on May 25, 2004, and Press release issued May 28, 2004. Firm initiated recall is complete.
REASON
The product was manufactured using almonds recalled by Paramount Farms due to their association with an outbreak of Salmonella Enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
22,918 pounds.
DISTRIBUTION
CA, NV, and AZ.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
Majestic Royal Jelly 1000 mg. Plus Ginseng, Made in the U.S.A., in bottles of 10 capsules and 30 capsules per bottle. Recall # F-194-5.
CODE
Lot # 1005004, NFS Code #1516-C, Exp 10/2007.
RECALLING FIRM/MANUFACTURER
Nutritional Food Supplements, Copiague, NY, by telephone, fax and mail on or about December 20, 2004. Firm initiated recall is complete.
REASON
The ginseng powder raw material supplied to the firm was found to be contaminated with pesticides.
VOLUME OF PRODUCT IN COMMERCE
1,400 bottles (30 capsules per bottle) and 700 bottles (10 capsules per bottle).
DISTRIBUTION
Jordan.

_______________________________
PRODUCT
Trader Joe's Masala Simmer Sauce, 15.25 oz glass jar. Recall # F-195-5.
CODE
Sku 061265, code 4030 production date 1/30/2004.
RECALLING FIRM/MANUFACTURER
Trader Joes Company, Monrovia, CA, by notice and press release beginning on November l, 2004. Firm initiated recall is complete.
REASON
The product contains glass fragments.
VOLUME OF PRODUCT IN COMMERCE
1,711 cases.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Similac Advance with Iron Formula Powder, 12.9 oz. can. The product is packaged as 6 cans per case for delivery to retail stores. Recall # F-198-5.
CODE
Lot number "20307RB" containing use by date f "1 SEP 2006" printed on the bottom of individual cans. The product can list number is 55958. The product case list number is 55957.
RECALLING FIRM/MANUFACTURER
Ross Products Division, Abbott Laboratories, Columbus, OH, by letter on February 2, 2005. Firm initiated recall is ongoing.
REASON
The product may contain rigid polyvinyl chloride plastic (PVC) foreign material.
VOLUME OF PRODUCT IN COMMERCE
82,986 cans.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
Streit's SINCE 1925 brand Potato Pancake LATKES MIX, NET WT. 6 OZ. (170 g). "PRODUCT OF CANADA" labeled product only (found on side of box below the Nutrition Facts Panel). The product is packaged in a box. INGREDIENTS: Dehydrated potato, potato starch, salt, dehydrogenated onion, hydrogenated cottonseed oil shortening, spice. --- NOTE: Boxes of the product labeled "PRODUCT OF USA" are not involved in recall. UPC barcode # 0 70227 50051 5. Recall
# F-196-5.
CODE
Item # 50051.
RECALLING FIRM/MANUFACTURER
Aron Streit Inc., New York, NY, by letter on January 24, 2005. Firm initiated recall is ongoing.
REASON
The product contains undeclared sulfites based on FDA's analysis.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
Icar Pediatric Suspension, Iron supplement, 4 fl ounces, NDC 63717-102-04. Recall # F-197-5.
CODE
Lot numbers: 2J03 exp 09/04, 2L09 exp 11/04, 3C02 exp 02/05, 3C03 exp 02/05, 3D02 exp 03/05, 3H04 exp 07/05, 3H05 exp 07/05, 3I02 exp 08/05, 3I03 exp 08/05, 3K05 10/05, 3K07 exp 10/05, L402002 exp 01/06, L403001 exp 02/06, L404001 exp 03/06.
RECALLING FIRM/MANUFACTURER
Cypress Pharmaceutical, Inc., Madison, MS, by letters on May 26, 2004 and June 4,2004. Firm initiated recall is complete.
REASON
Potential problems with dosage due to the precipitation of suspending agent.
VOLUME OF PRODUCT IN COMMERCE
46,846.
DISTRIBUTION
Nationwide.

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
CombiPatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, Rx only. Recall # D-138-5.
CODE
Lot 7364101, Exp. April 2005.
RECALLING FIRM/MANUFACTURER
Novartis Pharmaceuticals, Corp, East Hanover, NJ, by letters on December 9, 2004. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products.
VOLUME OF PRODUCT IN COMMERCE
20,057 packers (3 cartons of 8 units per carton).
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Vitrase (hyaluronidase injection) Ovine, 200 USP Units/mL, Rx only. Recall # D-140-5.
CODE
Lot W0002422.
RECALLING FIRM/MANUFACTURER
ISTA Pharmaceuticals Inc, Irvine, CA, by telephone on February 17, 2005. Firm initiated recall is ongoing.
REASON
An unvalidated and unapproved filter for final sterile filtration of the product appears to have been used in the manufacture of the lot.
VOLUME OF PRODUCT IN COMMERCE
4,446.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

*****CORRECTION*****

In the February 23, 2005 (05-08) Enforcement Report, Recall #-D-125-5 to D-128-5, under PRODUCT, the four (4) product strengths (50mg, 100mg, 150mg, and 200mg) was listed in 100 tablet bottles, the correct product description should be listed the dosage strengths in 100 tablet blister packs instead of 100 tablet bottles.
______________________________
PRODUCT
Junior's chewable (acetaminophen 160 mg) tablets, USP in 20 tablet bottles, bubblegum flavor labeled as Life brand, OTC, Recall # D-139-5.
CODE
Lots 3KE0967, 3KE0674, 4AE0013, 4AE0775 and 4BE0421; Exp. 09/15/2005.
RECALLING FIRM/MANUFACTURER
Perrigo Company, Allegan, MI, by telephone on February 4, 2005 and by fax on February 16, 2005. Firm initiated recall is ongoing.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
50,268 bottles.
DISTRIBUTION
Canada.

_______________________________
PRODUCT
Effervescent antacid and pain medication (aspirin 325 mg, citric acid 1000 mg and sodium bicarbonate 1916 mg), in 36 and 72 effervescent tablet packages packaged under Good Sense brand. Also sold under other brands as: American Fare brand; Eckerd brand; Equate brand; Family Dollar brand; Kroger brand; Major brand; Meijer brand; Pathmark brand; Rite Aid brand; Safeway brand; Today's Health brand; Top Care brand, and Western Family brand. Recall # D-141-5.
CODE
Lots 3EP0066, 3EP0067, 3EP0074, 3EP0075, 3EP0076, 3FP0001, 3FP0002, 3FP0003, 3FP0076, 3GP0001, 3GP0002, 3GP0026.
RECALLING FIRM/MANUFACTURER
Perrigo Company, Allegan, MI, by letter dated February 23, 2005. Firm initiated recall is ongoing.
REASON
Stability Failure: The product exceeded the firm's specification for salicylic acid at the 18 month stability period.
VOLUME OF PRODUCT IN COMMERCE
109,804 packages.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Red Cells (Apheresis) Leukocytes Reduced. Recall # B-0542-5.
CODE
Unit #200369403.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on December 16, 2003.
Manufacturer: Blood Systems, Inc., Lafayette, LA. Firm initiated recall is complete.
REASON
Red Cells, lacking quality control testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0543-5.
CODE
Unit #200373375.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on January 15, 2004.
Manufacturer: Blood Systems, Inc., Lafayette, LA. Firm initiated recall is complete.
REASON
Platelets, collected on equipment that had not been properly validated for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0544-5.
CODE
Unit numbers: 74932528, 74934652, 76679964, 76681400, 76683954, 76685316, and 76687365.      
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Seattle, WA, by facsimile on July 24, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to intravenous (IV) drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0547-5.
CODE
Unit number 38C20745.
RECALLING FIRM/MANUFACTURER
South Bend Medical Foundation, S. Bend, IN, by telephone on October 6, 2004. Firm initiated recall is complete.
REASON
Red Cells, without proper pre-transfusion testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.

_______________________________
PRODUCT
Source Plasma. Recall # B-0693-5.
CODE
Unit numbers: 19115870, 19114170, 19112565, 19111179, 10359259, 10357262, 10355183, 10353448, 09418479, 09238398, 09235915, 09234130, 08389749, 08387936, 08384904, 08383037, 08381064, 08818836, 08815408, 08814227, 09269668, 09268623, 09266315, 10341674, GP103728, GP103614, GP103346, GP102810, GP099403, GP099315, GP098913, GP098817, GP098499, GP098395, GP101872, GP101718, GP101660, GP101474, GP101368, GP100991, GP100771, GP100679, GP100442, GP100359, and GP106383. 
RECALLING FIRM/MANUFACTURER

Bio-Blood Components, Inc., Gary, IN, by facsimile on October 20, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor that was subsequently determined to have multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.      
45 Units.
VOLUME OF PRODUCT IN COMMERCE
45 units.
DISTRIBUTION
IL, CA, and Germany.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
Recall # B-0701-5;
b) Platelets Pheresis Leukocytes Reduced.
Recall # B-0702-5.
CODE
a) Units O4G58905, 04GR23384A, 04FP70983,
04GJ14606, 04GL67536, 04GP56152, 04GR23123,
04KC27716, 04KE42414, 04FR84423, 04G58901,
04G58917, 04M24720, 04F17794, 04F18787,
04G59158, 04J63988, 04LE52384, 04M24740,
04N29857, 04S62142, 04Z08114, 04Z08120,
32KS11787, 32KS11800, 104FP70974, 04E73133,
04E73147, 04E73521, 04E73530, and 2057247;
b) Units 104FP70974, 2057247, 04GR23384A,
04FP70983, 04GJ14606, 04GL67536, 04GP56152,
04GR23123, 04KC27716, and 04KE42414.
RECALLING FIRM/MANUFACTURER
UMass Memorial Medical Center, Worcester, MA, by letters dated January 7, 14, and 18, 2005. Firm initiated recall is ongoing.
REASON
Blood products, which were inadequately irradiated due to a malfunction of the irradiation device, were distributed.
VOLUME OF PRODUCT IN COMMERCE
41 units.
DISTRIBUTION
MA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0707-5.
CODE
Unit number 26118-6197.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on September 24, 2003. 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
1 unit.
DISTRIBUTION
AR

_______________________________
PRODUCT
Source Plasma. Recall # B-0710-5.
CODE
Unit number: 73671305.        
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Seattle, WA, by facsimile on April 5, 2002. Firm initiated recall is complete.
REASON
Blood product, untested for hepatitis B surface antigen (HBsAg), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0711-5.
CODE
Unit numbers 83730108, 83727856, 83724206.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Spokane, WA, by facsimile on February 13, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jacob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0712-5.
CODE
Unit numbers 78868489 and 78869318.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc. Yakima, WA, by facsimile on February 13, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jacob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0713-5.
CODE
Unit numbers 78866089, 78867154, 90010828, 90013799, 90015083, 90016448, 90151903, 90152931, and 90155123.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Yakima, WA., by facsimile on June 26, 2003. 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
9 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Source Plasma, Recall # B-0714-5.
CODE
Unit numbers 370476487 and 370477760.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Medford, OR, by facsimile on October 23, 2003. 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
2 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
a) Platelets. Recall # B-0715-5;
b) Fresh Frozen Plasma. Recall # B-0716-5.
CODE
a) and b) Unit number FS58231.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on October 28, 2004. Firm initiated recall is complete.
REASON
Blood products, associated with a unit of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0719-5;
b) Fresh Frozen Plasma. Recall # B-0720-5.
CODE
a) and b) Unit number 6484395.
RECALLING FIRM/MANUFACTURER
Community Blood Bank, Inc., Rancho Mirage, CA, by telephone and facsimile on November 9, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to behavior known to increase risk of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0722-5.
CODE
Unit number 2750142.
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by facsimile on February 12, 2003. 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
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0723-5.
CODE
Unit number 04N28784.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by facsimile and letter on November 17, 2004. 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
MA.

_______________________________
PRODUCT
Platelets. Recall # B-0725-5.
CODE
Unit number KM16089.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on October 8, 2004. Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with Streptococcus sp. Bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
a) Platelets Pheresis. Recall # B-0726-5;
b) Fresh Frozen Plasma (Apheresis). Recall # B-0727-5.
CODE
a) and b) Unit number 07FM09202.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Arizona Region, Tucson, AZ, by telephone on September 22, 2004, and by letter on October 22, 2004. Firm initiated recall is complete.
REASON
Blood products, possibly contaminated with Staphylococcus sp. bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AZ.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0728-5.
CODE
Unit number 04GP57124 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone and letter on October 14, 2004. Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with yeast, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0731-5.
CODE
Unit number 6019620.
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by facsimile on May 6, 2003. Firm initiated recall is complete.
REASON
Blood Product, that was labeled leukoreduced but was not tested to determine the white blood cell count as required in the firm's standard operating procedures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.

_______________________________
PRODUCT
Source Plasma. Recall # B-0732-5.
CODE
Unit numbers: 52497940, 52424847,52402975, 52400919, 33060569, 33055190, 33052311, 33047003, 33045412, 32990508, 32977004, and 32975475.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc, Spokane, WA, by facsimile on December 18, 2002. Firm initiated recall is complete.
REASON
Blood products collected from a donor who had been previously deferred by another center, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0733-5.
CODE
Unit V06866.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter dated September 17, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which door suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0735-5.
CODE
Units XR74373, and XR75519.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Fargo, ND, by facsimile on February 9, 1998. Firm initiated recall is complete.
REASON
Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0708-5.
CODE
Unit number 26118-6197.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by facsimile on September 25, 2003. 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
1 unit.
DISTRIBUTION
Switzerland.

_______________________________
PRODUCT
Source Plasma. Recall # B-0709-5.
CODE
Unit number 91238440.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Everett, WA, by facsimile on March 13, 2003. Firm initiated recall is complete.
REASON
Blood product, that tested negative for hepatitis B surface antigen (HbsAg), was not quarantined after the donor of the product subsequently tested reactive for HbsAg and was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated. Recall # B-0717-5.
CODE
Unit numbers 108LJ26166 (distributed as two split products), 108LJ26167, and 108LJ26164.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Arizona Region, Tucson, AZ, by telephone on October 18, 2004, and by letter on October 19, 2004. Firm initiated recall is complete.
REASON
Blood products, exposed to extended shipping times, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
AZ.

_______________________________
PRODUCT
Source Plasma. Recall # B-0718-5.
CODE
Unit number VA-149255.
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA, by facsimile on November 2, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0724-5.
CODE
Unit number 150248525.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX, by telephone on January 5, 2004. Firm initiated recall is complete.
REASON
Blood product that was possibly out of controlled storage for more than 30 minutes was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-0729-5.
CODE
Unit number 3022486.
RECALLING FIRM/MANUFACTURER
Wellmont Health System, Kingsport, TN, by telephone on December 3, 2003. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-0730-5.
CODE
Unit number 9009110A.
RECALLING FIRM/MANUFACTURER
Wellmont Health System, Kingsport, TN, by telephone on April 19, 2004. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributedl.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

_______________________________
PRODUCT
a) Heparin Lock Flush Solution. Recall # Z-0545-05;
b) Sodium Chloride Injection USP. Recall # Z-0546-05.
CODE
All lots remaining on the market.
RECALLING FIRM/MANUFACTURER
IV Flush LLC, Rowlett, TX, by letter on January 26, 2005 and February 16, 2005. Firm initiated recall is ongoing.
REASON
Device marketed without 510(k) clearance and is suspected to be contaminated with P. Fluorescens.
VOLUME OF PRODUCT IN COMMERCE
Approximately 4,028 cases of 120 syringes each.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Sterile Empty Vials for Allergenic Extracts, 100ml size. Recall # Z-0567-05.
CODE
Item #SE08160, Lot 9406.
RECALLING FIRM/MANUFACTURER
Greer Laboratories, Inc., Lenoir, NC, by telephone and letter on January 28, 2005. Firm initiated recall is ongoing.
REASON
Product may not be sterile.
VOLUME OF PRODUCT IN COMMERCE
2,157 vials.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Model 8100 Series Medley Medication Safety System Pump Module. Recall # Z-0568-05.
CODE
Serial Numbers 2326101 thru 9861567.
RECALLING FIRM/MANUFACTURER
Alaris Medical Systems Inc, San Diego, CA, by letter on November 15, 2004. Firm initiated recall is ongoing.
REASON
The device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module.
VOLUME OF PRODUCT IN COMMERCE
55,200 units.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
Flexiflo Quantum Enteral Pump. Recall # Z-0570-05.
CODE
Serial #1061305 through 1061455, Serial #1061486 through 1061505, Serial # 1061507 through 1061512, Serial #1061705 through 1061726.
RECALLING FIRM/MANUFACTURER
Ross Products Division Abbott Laboratories, Columbus, OH, by telephone and letter on August 18, 2004. Firm initiated recall is ongoing.
REASON
Pumps were manufactured with an incorrect circuit board that may cause an increase in the feed rate and flush frequency of fluids.
VOLUME OF PRODUCT IN COMMERCE
199 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. Recall # Z-0571-05.
CODE
All units with the Serial Numbers 24578 and lower.
RECALLING FIRM/MANUFACTURER
Maquet, Inc, Bridgewater, NJ, by letter on January 3, 2005. Firm initiated recall is ongoing.
REASON
Failures of the air and oxygen gas modules occurred because of misuse/non-compliance of directions.
VOLUME OF PRODUCT IN COMMERCE
7,905 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Varcella Zoster ELISA kit for the detection of IgG antibodies to varicella zoster virus in human serum, Catalog No.: 4620. Recall # Z-0572-05.
CODE
Lot # 111261.
RECALLING FIRM/MANUFACTURER
Diasorin, Inc., Stillwater, MN, by telephone on September 10, 2003. Firm initiated recall is ongoing.
REASON
Varicella Zoster ELISA kit assay was producing invalid runs on the ETI-Max 3000 automated microtiter plate instrument and/or false negative results.
VOLUME OF PRODUCT IN COMMERCE
99 kits.
DISTRIBUTION
AL, CA, IL, KS, MA, MI and NJ.

_______________________________
PRODUCT
a) BioTek brand Automated Microplate Reader;
Model Elx800, Roche catalog number 21045059001.
Recall # Z-0573-05;
b) BioTek brand Automated Microplate Reader;
Model Elx808, Roche catalog number 03145387001.
Recall # Z-0574-05.
CODE
All serial numbers pre-programmed with HCV singlet and HCV duplicate parameters by Roche for use with the Roche HCV test version 2-0.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp, Indianapolis, IN, by letters dated February 15, 2005. Firm initiated recall is ongoing.
REASON
The parameters loaded in the analyzer for the hepatitis C virus do not match those in the package insert, and patient results may be reported out as false positives or false negatives.
VOLUME OF PRODUCT IN COMMERCE
216 units.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
Homedics PowerDent battery powered toothbrush, Model HD-30, individually packaged; Made in China; UPC 31262-00789, Deals Nothing Over A Dollar SKU #100608494. The individually packaged toothbrushes are packaged 49 per case labeled as Decent Trading Adult Battery Operated Toothbrush. Recall # Z-0575-05.
CODE
All lots distributed between 10/22/04 and 2/3/05.
RECALLING FIRM/MANUFACTURER
Deals Nothing Over A Dollar, Earth City, MO, by e-mail on February 16, 2005. Firm initiated recall is ongoing.
REASON
A defective seal allows water into the handle of the toothbrush via the bristles, and rusty water seeps back out of the toothbrush around the bristles.
VOLUME OF PRODUCT IN COMMERCE
10,535 toothbrushes.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Access Immunoasay Systems Digoxin Reagent. Recall # Z-0576-05.
CODE
Lots 323171; 416110; 417703 and 419534.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letters on February 23, 2005. Firm initiated recall is ongoing.
REASON
Variability in results on Patient and QC results of 20-25%, high and low.
VOLUME OF PRODUCT IN COMMERCE
4,352.
DISTRIBUTION
Nationwide and Canada.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

*****CORRECTION*****

In the March 2, 2005 (05-09) Enforcement Report, Recall # Z-0555-05 should read as follows:

_______________________________
PRODUCT
Cypher Sirolimus-eluting Coronary Stent on Raptor Over-the-Wire Delivery System (CWSxxxxx), and Cypher RX Sirolimus-eluting Coronary Stent on RaptorRail Rapid Exchange Delivery System (CXSxxxxx). (CORRECTION) Recall # Z-0555-05.
CODE
All Cypher product CWSxxxxx and CXSxxxxx available for inspection at U.S. hospitals between 11/17/2004 and 12/16/2004. (CORRECTION)
RECALLING FIRM/MANUFACTURER
Cordis Corporation, Miami Lakes, FL, by letter on November 16, 2004. All Cypher product at U.S. hospitals was inspected between 11/17/2004 and 12/16/2004 for potential incorrect expiration date on Inventory Control Stickers applied at hospitals. None were found. Firm initiated Field Inspection is complete. All product involved in the inspection has expired. (CORRECTION)
REASON
Inventory control stickers had incorrect expiration date. The stickers stated the expiration date was November 2004 instead of October 2004.
VOLUME OF PRODUCT IN COMMERCE
29,133 Stents inspected. (CORRECTION)
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
ReliOn Insulin Syringe 0.5cc 30 Gauge 5/16 inch (8mm) Needle (U-100 Insulin). NDC 81306-0515-23. Recall # Z-0569-05.
CODE
Batch # 4083690.
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Company, Franklin Lakes, NJ, by letters on October 22, 2004. Firm initiated recall is ongoing.
REASON
Syringes labeled as 5/16 inch product (30 ga) actually contained the 1/2 inch product (28 ga).
VOLUME OF PRODUCT IN COMMERCE
1,543,000 syringes.
DISTRIBUTION
AR.

END OF ENFORCEMENT REPORT FOR MARCH 9, 2005

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