FDA

Enforcement Report

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

January 6, 1999
99-01

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

________
PRODUCT
I.M. Good Fruit Delight'n Nuts, dried fruit and nut trail mix, in 2 ounce and 5.2 ounce clear poly bags. Recall #F-113-9.

CODE
All "Sell-By-Dates" prior to "093099" (September 30, 1999) are affected by this recall.

MANUFACTURER
Peterson Nut Company, Cleveland, Ohio (supplier of bulk product).

RECALLED BY
I.M. Good, Inc., Canton, Ohio (repacker), by press release and by mailing corrected labels on or about August 4, 1998. Ongoing field correction (relabeling) resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
Ohio, Illinois, New Jersey, Indiana, Pennsylvania, West Virginia, New Mexico, Kansas, Florida, North Dakota, New York, Kentucky, Mississippi, North Carolina, Nebraska, Tennessee, Alabama, Iowa, Missouri.

QUANTITY
5,910 2-ounce bags and 3,800 5.2-ounce bags were distributed; firm estimated that 1,000 bags of product remained on market at time of recall initiation.

REASON
Product contains undeclared sulfites and FD&C Yellow No. 6.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-375/376-9.

CODE
Unit #53FE44539.

MANUFACTURER
American Red Cross Blood Services, Baltimore, Maryland.

RECALLED BY
Manufacturer, by letters dated July 22, 1998, and September 3, 1998. Firm-initiated recall complete.

DISTRIBUTION
District of Columbia.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products, for which the donor history record could not be located, were distributed.

________
PRODUCT
Source Plasma. Recall #B-379-9.

CODE
G20213-097, G21542-097, G21815-097, G22527-097, G25442-097, G25823-097, G31998-097, G32949-097, G37396-097.

MANUFACTURER
Alpha Therapeutic Corporation (ATC), San Diego, California.

RECALLED BY
Alpha Therapeutic Corporation (ATC), Los Angeles, California, by letter dated November 11 and 21, 1997. Firm-initiated recall complete.

DISTRIBUTION
Spain.

QUANTITY
9 units were distributed.

REASON
Blood products tested negative for the antibody to the human immunodeficiency virus types 1/2 (HIV-1/2), but were collected from a donor who previously tested repeatedly reactive for the antibodies, and HIV-1 Western blot indeterminate.

________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-380/381-9.

CODE
Unit #8000595.

MANUFACTURER
LifeShare, Inc., Elyria, Ohio.

RECALLED BY
Manufacturer, by telephone on November 25, 1997, and by letter dated January 16, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor taking the drug Daypro.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-382/384-9.

CODE
Unit #8003657.

MANUFACTURER
LifeShare, Inc., Elyria, Ohio.

RECALLED BY
Manufacturer, by letter dated May 21, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio and Florida.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor taking the drug Neurontin.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

________
PRODUCT
Platelets. Recall #B-385-9.

CODE
Unit #0491231.

MANUFACTURER
Blood Bank of Delaware, Newark, Delaware.

RECALLED BY
Manufacturer, by letter on December 22, 1997. Firm-initiated recall complete.

DISTRIBUTION
Maryland.

QUANTITY
1 unit of each component was distributed.

REASON
Blood product had an extended rest time.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Source Leukocytes for Manufacturing Use; d) Recovered Plasma. Recall #B-363/366-9.

CODE
Unit #3377630.

MANUFACTURER
Gulf Coast Regional Blood Center, Houston, Texas.

RECALLED BY
Manufacturer, by fax on June 17, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas, New Jersey, California, Switzerland.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were not quarantined after receiving information concerning post donation illness.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

________

Resuscitaire Radiant Warmer, Infant Radiant Warmer:
a) Resuscitaire Radiant Warmer, Model RW81;
b) Resuscitaire Radiant Warmer, Model RW82;
c) Resuscitaire Radiant Warmer, Model RW82VHA;
d) Resuscitaire Radiant Warmer, Model WMRW82;
e) Resuscitaire Radiant Warmer, Model WBR 81;
f) Resuscitaire Radiant Warmer, Model WBR82. 
Recall #Z-292/297-9.

CODE
Units with software versions prior to 1.061.

MANUFACTURER
Hill-Rom Air-Shields, formerly Air-Shields, Inc., a division of Vickers Medical, Hatboro, Pennsylvania.

RECALLED BY
Manufacturer, by letter dated June 12, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
2,095 units were distributed.

REASON
The device fails to control heater power due to a software error.

________
PRODUCT
VARIANT Express Elution Buffer 1, a component of the Variant Express reorder pack. Elution Buffer 1 is optimized to bind glycohemoglobins to the HPLC column. The Bio-Rad VARIANT Express provides an integrated method for the separation and determination of the relative percentage of glycohemoglobin in the whole blood. This reorder pack is for in vitro diagnostic use (outside the body). Recall #Z-302-9.

CODE
AA81495

MANUFACTURER
Bio-rad Laboratories, Hercules, California.

RECALLED BY
Manufacturer, by letter on November 24, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
California.

QUANTITY
252 units were distributed.

REASON
Inconsistent test results. Drift in values would make the controls go off.

________
PRODUCT
Heparin Flush 100u/ML, 0.9% NS, 3 cc in 12cc Syringe. Recall #Z-303-9.

CODE
Lot # 04800291 EXP 6/10/99.

MANUFACTURER
Central Admixture Pharmacy Services, Inc., Miami Lakes, Florida.

RECALLED BY
Central Admixture Pharmacy Services, Inc., Miami Lakes, Florida, by telephone on September 24, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arizona.

QUANTITY
8 cases were distributed.

REASON
Heparin syringes were labeled as saline flush syringes.

________
PRODUCT
Software for the Abbott AxSYM System, a fully automated immunoanalyzer. Recall #Z-331-9.

CODE
All software versions below 3.03.

MANUFACTURER
Abbott Laboratories, Irving, Texas.

RECALLED BY
Abbott Laboratories, Diagnostics Division, Abbott Park, Illinois, by sending upgrade kits in November 1997, and by letter on October 26, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
3,589 instruments with software versions below 3.03 were distributed.

REASON
Extra assay results from a previous run can appear with new sample results, as well as error messages, due to software defect in the internal result database management.

________
PRODUCT
I-125 SEEDS, CODE 6711, Iodine-125 Therapeutic for Interstitial Brachytherapy and I-125 RAPID STRAND, CODE 7000, Rigid Absorbable Permanent Implant Device containing I-125 Seeds for Brachytherapy Recall #Z-332/333-9.

CODE
Model 6711, Lot W82818 and RAPID Strand, Model 7000, sublots P8134C and P8137A, manufactured from lot W82818 RAPID Strand is under 510(k) K940632, product code 90IWI.

MANUFACTURER
Medi-Physics, Inc., Arlington Heights, Illinois.

RECALLED BY
Nycomed Amersham Imaging, Princeton, New Jersey, by telephone on December 9, 1998, followed by letter on December 16, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Pennsylvania, Georgia, New York, Texas, Wisconsin, Florida, Missouri, England.

QUANTITY
264 seeds and 33 strands were distributed.

REASON
Products are labeled with the wrong radioactivity range.

________
PRODUCT
PRESTILIX 1690 Tilting Radiological Tables, Models 825100G025, 825100G045, 825100G055, and 830240G015. Recall #Z-334/337-9.

CODE
All Serial Numbers.

MANUFACTURER
General Electric Medical Systems, Loncin, Belgium.

RECALLED BY
General Electric Medical System, Waukesha, Wisconsin, by field modification notice issued on November 24, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
224 units were distributed.

REASON
The spot film device (SFD) of the Prestilix Radiological Tables could fall on the operators of the tables. The support of the SFD does not have adequate strength and could fail due to metal fatigue with normal use. The SFD is located under the tables and would fall into a low-occupancy zone for operators if the support fails.

________
PRODUCT

Accuratome 3, Papillotome Triple Lumen, Accepts .035" 20mm
Cutting Wire, Standard Tip (Sterile Trays):
a) Accuratome 3, Papillotome Triple Lumen, Product Code 050064;
b) Accuratome 3, Papillotome Triple Lumen, Product Code 050071;
c) Accuratome 3, Papillotome Triple Lumen, Product Code 
ACC-32000-S.  Recall #Z-338/340-9.

CODE
Lot numbers: a) 88BIW003; b) 88AIW004; c) 012898-06.

MANUFACTURER
Wiltek Medical, Inc., Winston-Salem, North Carolina.

RECALLED BY
Manufacturer, by fax on March 4, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
227 trays were distributed.

REASON
The packaging of the product had visible evidence of cracks, therefore compromising the sterility of the product.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

________
PRODUCT
Omnifit Microstructured Screwless Acetabular Shells a) Omnifit PSL Microstructured Screwless Acetabular Shell(50 mm), Catalog No. 2074-0050; b) Omnifit Dual Geometry Microstructured Screwless Acetabular Shell (52 mm), Catalog No. 2072-0052. Recall #Z-316/317-9.

CODE
a) Serial No. RA3048; b) Serial No. RA3049.

MANUFACTURER
Osteonics Corporation, Allendale, New Jersey.

RECALLED BY
Manufacturer, by telephone on February 23, 1998. Firm-initiated recall complete.

DISTRIBUTION
a) Indiana, Nebraska, Minnesota, Tennessee, Washington sate, Kentucky, North Carolina, Alaska; b) Oregon, Tennessee, Arkansas, Pennsylvania, Kentucky, Michigan.

QUANTITY
a) 9 units; b) 11 units were distributed.

REASON
The PSL cups were labeled as Dual Geometry cups and vice versa.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II

________
PRODUCT
ProHeart Tablets (Moxidectin) heartworm prevention tablets for dogs, 30 mcg, 68 mcg, and 136 mcg. Recall #V-030-9.

CODE

All lots in distribution (27 lots)  
885F124  885F142  885F143  885F176  885F178  885L125  885L144 
885L145  885L151  885L168  885L169  885L198  885P126  885P146
885P147  885P148  885P149  885P150  885P152  885P153  885P154
885P165  885P166  885P167  885P170  885P171  885P174.

MANUFACTURER
Fort Dodge Animal Health, Fort Dodge, Iowa.

RECALLED BY
Manufacturer, by letter dated November 9, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
29,961 units were distributed.

REASON
Product is failing or is projected to fail stability tests. Products are subpotent.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III

________
PRODUCT
Milkbone Dog Biscuits - 12 oz. Tins. Item No. 44401 (Bone shaped tins) and Item No. 88209 (Snoopy bone-shaped tins). Recall #V-031-9.

CODE
No codes. Affected product was packaged on September 28, 1998, but this is not on the label.

MANUFACTURER
Nabisco, Inc., Buffalo, New York.

RECALLED BY
American Specialty Confections, Lancaster, Pennsylvania, by letter dated December 18, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
15,000 12-ounce tins were distributed.

REASON
Product is infested with Drug Store Beetles.

End of Enforcement Report for January 6, 1999.