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 28, 1998 98-04
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I =============
_______________
PRODUCT The correct recall number for First Harvest
sprout products which appeared in the October
29, 1997, Enforcement Report is F-058/064-8.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ============
_______________
PRODUCT Rolls in soft cello with twist tie closure, 12
rolls per package:
a) Tea Rolls labeled in part "DANISH BAKERY
LARSENS TEA ROLLS INGREDIENTS: ** 12pk. Net
Wt. 14 oz.***"
b) Wheat Rolls labeled in part "DANISH BAKERY
LARSENS WHEAT ROLLS INGREDIENTS: ** 12pk. Net
Wt. 14 oz.***".
c) Rolls half-and-half labeled in part
"QFC**BELLEVUE, WA **PACKED ON ** SELL BY **
ROLLS « WHEAT-1/2 WHITE 12 PACK INGREDIENTS:
** NET WT 10 oz.***".
Recall #F-121/123-8.
CODE 10-3 through 11-6 inclusive.
MANUFACTURER Larsens Brothers Danish Bakery, Lynwood,
Washington.
RECALLED BY Manufacturer, by press release on November 4,
1997, followed by telephone and letter.
Firm-initiated recall complete.
DISTRIBUTION Washington state.
QUANTITY Firm estimates none remains on the market.
REASON Products contains undeclared milk powder.
_______________
UPDATE Ferrous Fumarate, Recall #F-222/223-8, which
appeared in the January 28, 1998, Enforcement
Report is a completed recall.
RECALLS AND FIELD CORRECTIONS: BIOLOGIC -- CLASS II ========
_______________
PRODUCT Platelets, Pheresis. Recall #B-445-8.
CODE Unit #KZ45809.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone on October 3, 1997.
Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor
taking the drug depakote.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Plasma;
d) Recovered Plasma. Recall #B-450/453-8.
CODE Unit numbers: (a) 053GJ88430, 53FH44015,
53J99432, 53FH29743, 53FH27955, 53FH19774,
53H18061, 53Y05190, 53R38381, 53F35989,
53F32106
b) 53FH44015, 53J99432, 53FH29743, 53FH27955,
53FH19774, 53H18061, 53F32106
c) 53FH29743, 53H18061, 53Y05190, 53F35989
d) 053GJ88430, 53FH44015, 53J99432,
53FH27955, 53FH19774, 53R38381, 53F32106.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letters dated August 15 and
18, 1997. Firm-initiated recall complete.
DISTRIBUTION Maryland, District of Columbia, Virginia,
California, Massachusetts.
QUANTITY a) 11 units; b) 7 units; c) 4 units; d) 7
units were distributed.
Reason Blood products tested negative for the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1), but were collected from a
donor who previously tested repeatedly
reactive for anti-HIV-1, Western blot negative.
_______________
PRODUCT Source Plasma. Recall #B-457-8.
CODE Unit numbers: XL37826, XL38160, XL38865.
MANUFACTURER Community BioResources, Inc., Fayettesville,
Arkansas.
RECALLED BY Manufacturer, by letter dated October 24,
1997. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 3 units were distributed.
REASON Blood products were collected from a donor
with a history of hepatitis.
_______________
PRODUCT a)Red Blood Cells; b) Platelets;
c) Fresh Frozen Plasma.
Recall #B-458/460-8.
CODE Unit #2004533.
MANUFACTURER LifeShare, Inc., Elyria, Ohio.
RECALLED BY Manufacturer, by letter on May 13, 1997.
Firm-initiated recall complete.
DISTRIBUTION Ohio and Massachusetts.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
with a history of hepatitis.
_______________
PRODUCT Red Blood Cells. Recall #B-465-8.
CODE Unit #49LL03223.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.
RECALLED BY Manufacturer, by telephone on October 7, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected in a manner that
compromises the sterility of the unit.
_______________
PRODUCT Red Blood Cells. Recall #B-466-8.
CODE Unit #49LL02567.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.
RECALLED BY Manufacturer, by telephone on September 30,
1997. Firm-initiated recall complete.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a overweight
Whole Blood unit.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-470/471-8.
CODE Unit numbers: a) 40GR83703, 40GL53618,
40FR10312, 40GS29880; b)40GR83703, 40GL53618,
40GS29880.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by letter dated September 1,
1997 or October 24, 1997. Firm-initiated
recall complete.
DISTRIBUTION Iowa, Illinois, California.
QUANTITY 7 units were distributed.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type 1 (HIV-1) but were collected from a donor
who previously tested repeatedly reactive for
the antibody and was subjected to additional
retesting.
_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-473/474-8.
CODE Unit #40GF09906.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by letter dated September 1,
1997. Firm-initiated recall complete.
DISTRIBUTION Iowa and Illinois.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type 1 (HIV-1), but were collected from a
donor who previously tested repeatedly
reactive for the antibody, and was subjected
to additional retesting.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-476/477-8.
CODE Unit numbers: 40GN22922, 40GX10868.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by letter dated September 1,
1997. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 2 units of each component were distributed.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type 1 (HIV-1), but were collected from a
donor who previously tested repeatedly
reactive for the antibody, and was subjected
to additional retesting.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-478/479-8.
CODE Unit #40FF15953.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by letters dated September 1,
1997, and October 24, 1997. Firm-initiated
recall complete.
DISTRIBUTION California.
Quantity 1 unit of each component was distributed.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type 1 (HIV-1), but were collected from a
donor who previously tested repeatedly
reactive for the antibody, and was subjected
to additional retesting.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III =======
_______________
PRODUCT Red Blood Cells. Recall #B-396-8.
CODE Unit #49LH28187.
MANUFACTURER American Red Cross, Tulsa, Oklahoma.
RECALLED BY Manufacturer, by telephone on September 22,
1997. Firm-initiated recall complete.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit was distributed.
REASON Blood product with an extended expiration date
was distributed.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-461/462-8.
CODE Unit #2027066.
MANUFACTURER LifeShare, Inc., Elyria, Ohio.
RECALLED BY Manufacturer, by telephone on April 14, 1997,
and by letter dated April 22, 1997.
Firm-initiated recall complete.
DISTRIBUTION Ohio and Florida.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were not quarantined after
receiving post donation information concerning
flu-like symptoms.
RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS II ==========
_______________
PRODUCT Vas-Cath Soft-Cell Dual Lumen Straight and
Pre-Curved Chronic Hemodialysis Catheters,
indicated for use in attaining prolonged or
short-term vascular access for hemodialysis,
hemoperfusion or apheresis therapy via the
jugular or subclavian vein.
Recall #Z-271-8.
CODE All lots of the following product code
numbers: 5531620, 5533120, 5500131, 5532192,
5533622, 5500106, 5535190, 5536232, 5531120,
5534120, 5500128, 5531692, 5500138, 5535620,
5500103, 5535732, 5532120, 5533690, 5500109,
5500119, 5500137, 5535120, 5536190, 5500125,
5531690, 5533190, 5500100, 5531232, 5533192,
5536120, 5535192, 5500132, 5531190, 5534190,
5500101, 5532232, 5534192, 5535122, 5536192,
5532190, 5533730, 5531122, 5531732, 5533692,
5536122, 5535692, 5531730, 5533230, 5532122,
5500122, 5500120, 5535622, 5535730.
MANUFACTURER Vas-Cath, Inc., Mississauga, Canada.
RECALLED BY Manufacturer, by letter dated November 22,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 82,811 units were distributed.
REASON The extension tubing may split.
______________
PRODUCT Allograft Heart Valve and Conduit.
Recall #Z-283-8.
CODE Identified by the following donor numbers:
BA9412009, BA9410020, BA9411015, BA9411014,
BA9504016, BA9508029, BA9504018, BA9502004,
BA9504019, BA9508001, BA9502011, BA9512003,
BA9606006, BA9601016, BA9603003, BA9604004,
BA9604016, CA9609038, CA9610025, CA9706090,
CA9706077, CA9706075, CA9705064, CA9709007,
CA9710062, CA9710022, CA9705002, CA9702039.
MANUFACTURER Dohneny Eye & Tissue Transplant Bank,
Los Angeles.
RECALLED BY Manufacturer, by telephone on November 26,
1997 and letter on December 4, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Georgia.
QUANTITY Undetermined.
REASON Repeatedly reactive viral marker seriological
testing.
_______________
PRODUCT a) Evolution One Latex Examination Gloves with
Omega-Shield Coating; b) Synetron Latex
Examination Gloves with Omega-Shield Coating.
Packs contain power-free latex exam gloves.
Recall #Z-290/291-8.
CODE SY977 and EV2050.
MANUFACTURER Hartalega SDN BHD, Kuala Lumpur, Malaysia.
RECALLED BY Microflex Medical Corporation, Reno, Nevada,
by letter on January 16, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 175,000 packages were distributed.
REASON The device is labeled for an intended use not
included in the existing 510(k) or PMA.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III =========
_______________
PRODUCT Hip Stem: a) Natural-Hip CoCr DRG Stem,
Catalog #7352-75-004;
b) Apollo Hip Non-Porous Stem, Size 5, Catalog
#7370-00-005. Recall #Z-278/279-8.
CODE Lot numbers: a)130872; b) 1309395.
MANUFACTURER Asulzer Orthopedics, Inc., Austin, Texas.
RECALLED BY Manufacturer, by letters on December 1, 1997.
Firm-initiated recall complete.
DISTRIBUTION Florida, Missouri, New York, Texas.
QUANTITY a) 4 units; b) 1 unit was distributed.
REASON A natural-Hip CoCr DRG System Stem, Size 4,
was found in a box labeled as an Apollo Hip
Non-Porous Stem, Size 5, and vice versa.
_______________
PRODUCT Campylobacter Agar with 5 Antimicrobics and
10% Sheep Blood (Blaser), which is a selective
medium for the primary isolation of
Campylobacter jejuni from stool specimens.
Recall #Z-288-8.
CODE Catalog No. 4321727, Lot No. J4RBCB.
MANUFACTURER Becton Dickinson Microbiology Systems,
Cockeysville, Maryland.
RECALLED BY Becton Dickinson Microbiology Systems, Sparks,
Maryland, by letter on or about November 4,
1997. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Canada, Taiwan.
QUANTITY 60,260 units were distributed; firm estimated
that 1,322 units remained on market at time of
recall initiation, however, the product is now
expired.
REASON Product fails to provide the expected result
of partial inhibition of control organisms
over time.
MEDICAL DEVICE SAFETY ALERTS: ===============================
_______________
PRODUCT Baxter Healthcare PAC-X and PAC-X Xtra Cycler
Dialysis Machines, used in hospital and home
patient setting to automatically move
dialyzing fluid into and out of a patient's
peritoneal cavity through a sterile disposable
tubing system:
a) 8PAC-X Cycler Dialysis Machine, Catalog
numbers 5C4396, 120 volt; 5C4400, 115 VAC;
5C4401, 220/240 volt; b) 8PAC-Xtra Cycler Dialysis
Machine, Catalog numbers 5C4394, 120 volt;
5C4402, 115 VAC; 5C4403, 220/240 VAC; 5C4404,
220/240 volt; 5C4405, 100 volt, (Japanese).
Safety Alert #N-001/002-8.
CODE All serial numbers.
MANUFACTURER Baxter Healthcare Corporation, Largo, Florida.
ALERTED BY Baxter Healthcare Corporation, McGaw Park,
Illinois by letter, dated December 16, 1997.
DISTRIBUTION Nationwide and international.
QUANTITY 1,228 PAC-X units and 6,622 PAC-Xtra units
were distributed between 1988 and November
1994. All units are estimated to remain on
the market.
REASON A pediatric patient had received an overfill
of peritoneal dialysis solution and that the
cause may have been incorrect set up and
operation by the caregiver.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III ================
_______________
PRODUCT Conofite Cream 2% - topical antifungal for
dogs and cats. - Responsible firm on the label
is Pitman-Moore, Inc. (Schering-Plough
recently acquired Mallinckrodt Animal Health,
which in turn has previously purchased
Pitman-Moore). Recall #V-021-8.
CODE LOT #006215 EXP 2/00.
MANUFACTURER Mallinckrodt Animal Health (now known as
Schering-Plough), Bray, Ireland.
RECALLED BY Schering-Plough Animal Health Corporation,
Union, New Jersey, by letter on December 8,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,930 units were distributed.
REASON Product failed stability testing - product
was superpotent and subpotent.
SEIZURES: ===================================================
_______________
PRODUCT Star-Otic, OTC Ear Solution (97-768-021).
CHARGES New Drug and Misbranded - Product is an
unapproved new drug and its labeling fails to
bear adequate directions for use.
LOCATION Stellar Pharmacal Corporation, Pompano Beach,
Florida.
FILED December 23, 1997 - U.S. District Court for
the Southern District of Florida; Civil No.
97-7586-CIV-HURLEY; FDC 67219.
SEIZED January 14, 1998 - Goods valued at $181,500.
END OF ENFORCEMENT REPORT FOR JANUARY 28, 1998. BLANK PAGES MAY FOLLOW
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End of Enforcement Report for
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