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.
February 18, 1998 98-07
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Powerade 64 ounce Lemon-Lime with jagged ice
labels. Recall #F-251-8.
CODE 7343CC.
MANUFACTURER The Minute Maid Company, for Coca-Cola at
United Packers, Inc., Chattanooga, Tennessee.
RECALLED BY Coca Cola USA Operations, Atlanta, Georgia by
fax on January 23, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION Alabama, California, Connecticut, Florida,
Georgia, Louisiana, Massachusetts,
Mississippi, North Carolina, Ohio, South
Carolina, Tennessee, Virginia.
QUANTITY 9,352 cases (8 bottles per case) were
distributed.
REASON Product contain undeclared FD&C Yellow No. 5.
_______________
PRODUCT Star Market brand White Corn Tortilla Chips,
packed in 10 ยด oz. bags. Recall #F-252-8.
CODE Product codes: SEPTD22; NOV10D; and NOV24C.
MANUFACTURER Keystone Food Products, Inc., Easton,
Pennsylvania.
RECALLED BY Manufacturer, by letter on October 24, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION New England states.
QUANTITY Firm estimates none remains on the market.
REASON The product is contaminated with cheese curls
that contain dairy ingredients, monosodium
glutamate, FD&C Yellow 5 Lake & FD&C Yellow 6
Lake, which are not declared on the tortilla
chips labeling.
_______________
PRODUCT Canned Kippered Snacks manufactured between
May 26 and August 5, 1997:
a) Kippered Snacks Herring in Dijon Mustard
Sauce under the Brunswick label
b) Kippered Snacks Herring in Louisiana Hot
Sauce under the Brunswick label
c) Kippered Snacks Golden Smoked Herring under
the Brunswick label
d) Kippered Snacks Herring under the following
labels: Brunswick, Viking Delight, Season,
King Oscar, Spirit of Norway, and Western
Family
e) Kippered Snacks Herring, No Salt Added
under the Season label. Recall #F-253/257-8.
CODE Codes are embossed on the lids of cans in
addition to being printed on the outer case.
Each can is overwrapped, code is not visible
on cans unless overwrap is removed.
Brunswick Brands:
Dijon Mustard: (yellow wrapper UPC
66613-16906)
Case Code: 7X1160, 7X2160, 7X1161, 7X2161,
7X1163, 7X2163, 7X1211, 7X2211, 7X1212, 7X2212
Can Code: I7X1160D, I7X2160D, I7X1161D,
I7X2161D, I7X1163D, I7X2163D, I7X1211D,
I7X2211D, I7X1212D, I7X2212D
Louisiana Hot Sauce: (orange wrapper UPC
66613-19306) Case Code: 7X1156, 7X2156,
7X1157, 7X2157, 7X1162, 7X2162, 7X1195,
7X2196, 7X1196, 7X2196, 7X1197, 7X2197,
7X1211, 7X2211
Can Code: I7X1156L, I7X2156L, I7X1157L,
I7X2157L, I7X1162L, I7X2162L, I7X1195L,
I7X2195L, I7X1196L, I7X2196L, I7X1197L, AISLE,
I7X1211L, I7X2211L
Herring Kippered Snacks (Regular) (UPC
66613-17506)
Case Code: 7X1147, 7X2147, 7X1148, 7X2148,
7X1150, 7X2150, 7X1153, 7X2153, 7X1163,
7X2163, 7X1164, 7X2164, 7X1168, 7X2168,
7X1169, 7X2169, 7X1170, 7X2170, 7X1171,
7X2171, 7X1174, X2174, 7X1175, 7X1175, 7X2175,
7X1176, 7X2176, 7X1177, 7X2177, 7X1178,
7X2178, 7X1182, 7X2182, 7X1183, 7X2183,
7X1184, 7X2184, 7X1185, 7X2185, 7X1189,
7X2189, 7X1190, 7X2190, 7X1191, 7X2191,
7X1213, 7X2213
Can Code: I7X1147R, I7X2147R, I7X1148R,
I7X2148R, I7X2148R, I7X1150R, I7X2150,
I7X1153R, I7X2153R, 17X1163R I7X2163R,
I7X1164R, I7X2164R, I7X1168R, I7X2168R,
I17X2169, I7X1170R, I7X2170R, I7X1171R,
I7X2171R, I7X1174R, I7X2174R, I7X1175R,
I7X2175, I7X1176R, I7X2176R, I7X1177R,
I7X2177R, I7X1178R, I7X2178R, I7X1182R,
I7X2182R, I7X1183R, I7X2183R, I7X1184R,
I7X2184R, I7X1185R, I7X2185R, I7X1189R,
I7X2189R, I7X1190R, I7X2190R, I7X1191R,
I7X2191R, I7X1213R, I7X2213R
Golden Smoked (UPC 66613-18106)
Case code: 7X1188, 7X2188, 7X1192, 7X2192,
7X1196, 7X2196, 7X1197, 7X2197, 7X1198,
7X2198, 7X1199, 7X2199, 7X1202, 7X2202,
7X1205, 7X2205, 7X1206, 7X2206, 7X1210,
7X2210, 7X1212, 7X2212, 7X1213, 7X2213
Can Code: J7X1188S, J7X2188S, J7X1192S,
J7X2192S, J7X1196S, J7X2196S, J7X1197S,
J7X2197S, J7X1198S, J7X2198S, J7X1199S,
J7X2199S, J7X1202S, J7X2202S, J7X1205S,
JX2205S, J7X1206S, J7X2206S, J7X1210S,
7X2210S, J7X1212S, J7X2212S, J7X1213S,
J7X2213S
Private Label:
Viking Delight Kippered Snacks (UPC
73196-00350)
Case Code: 7X1197S, 7X2197
Can Code: J7X1197S, J7X2197S
Season Kippered Snacks, No Salt Added (UPC
70303-02485)
Case Code: 7X1188, 7X2188, 7X1189, 7X1189,
Can Code: J7X1188Z, J7X2188Z, J7X1189Z
Season Kippered Snacks (UPC 70303-02388)
Case Code: 7X2189, 7X1190, 7X2190, 7X1191,
7X2191
Can Code: J7X2189Z, J7X1190S, J7X2190S,
J7X1191S, J7X2191S
King Oscar Kippered Snacks (UPC 71140-00400)
Case Code: 7X2197,7X1198, 7X2198, 7X1199,
7X2199, 7X1206, 7X2206, 7X1195, 7X2195
Can Code: J7X2197S, J7X1198S, J7X2198S,
J7X1199S, J7X2199S, J7X1206S, J7X2206S,
J7X1195S, J7X2195S
Spirit of Norway Kippered Snacks (UPC
71140-00345)
Case Code: 7X1195, 7X1211, 7X2195, 7X2209
Can Code: J7X1195S, J7X1211S, J7X2195S,
J7X2209S
Western Family Kippered Snacks (UPC
15400-03586)
Case Code: 7X1183 and 7X2183
Can Code: I7X1183R and I7X2183R.
MANUFACTURER Connors Brothers, Ltd., New Brunswick, Canada.
RECALLED BY Connors Brothers, Inc., So. Portland, Maine
(importer), by fax on September 4, 1997
followed by letter. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 63,233 cases of 18 and 4,081 cases of 24 were
distributed.
REASON Some of the product was packed in defective
cans which could not preserve the integrity of
the product.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS
III ===========
_______________
PRODUCT Gliadel Wafer (Polifeprosan 20 with Carmustine
Implant), 7.7 mg carmustine/wafer, in units of
8 wafers individually packaged, Rx indicated
for use as a adjunct to surgery to prolong
survival in patients with recurrent
glioblastoma multiform for whom surgical
resection is indicated. NDC #IS 0075-9995-0107.
Recall #D-065-8.
CODE Lot #K97A1.
MANUFACTURER Guilford Pharmaceuticals, Inc., Baltimore,
Maryland.
RECALLED BY Rhone Poulenc Rorer Pharmaceuticals, Inc.,
Collegeville, Pennsylvania, by telephone on
December 12, 1997, followed by letter dated
December 16, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 41 units (8 wafers each) and 17 partial units
(less than 8 wafers) remained on market at
time of recall initiation.
REASON Excess breakage of wafers.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ========
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Plasma;
d) Source Leukocytes. Recall #B-534/537-8.
CODE Unit #53GN08468.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated October 28,
1997. Firm-initiated recall complete.
DISTRIBUTION Maryland and New Jersey.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
reported that arm cleansing was not performed
prior to venipuncture.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh
Frozen Plasma; d) Recovered Plasma.
Recall #B-538/541-8.
CODE Unit a) 40GR62762, 40GR67544, 40GS72959,
40GS76514, 40GR83691, 40GS87090, 40GV70465,
40GS98427, 40GR01028, 40GS11608, 40GF05377,
40LR04051, 40GK07515; b) 40GS98427, 40GR01028
c) 40GS11608; d) 40GR62762, 40GR67544,
40GS72959, 40GS76514, 40GR83691, 40GS87090,
40GV70465, 40GS98427, 40GR01028, 40GF05377,
40LR04051, 40GK07515.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by letters dated September 1,
1997, October 1 and 24, 1997, December 31,
1997, or January 8, 1998. Firm-initiated
recall complete.
DISTRIBUTION Illinois, Iowa, Mississippi, Tennessee,
California.
QUANTITY a) 13 units; b) 2 units; c) 1 unit; d) 12
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 and was subjected to
additional retesting.
_______________
PRODUCT Platelets, Pheresis. Recall #B-547-8.
CODE Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance (301)
827-6220 for individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by letters dated September 1,
1997, and October 1, 1997. Firm-initiated
recall complete.
DISTRIBUTION Illinois, Mississippi, Massachusetts.
QUANTITY 51 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.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Plasma;
d) Recovered Plasma. Recall #B-550/553-8.
CODE Unit numbers: a) 53FR20337, 53T59552,
53L99552, 53J07133, 53J02113, 53G15103,
53J91857, 53G49232
b) 53FR20337, 53J02113, 53J91857
c) 53J91857; d) 53FR20337, 53T59552, 53J07133,
53J02113, 53G15103, 53G49232.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter or fax on July 24,
1997 or July 16, 1997. Firm-initiated recall
complete.
DISTRIBUTION Maryland, New York, California.
QUANTITY a) 8 units; b) 3 units; c) 1 unit; d) 6 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, and was reentered
incorrectly.
_______________
PRODUCT Platelets, Pheresis. Recall #B-561-8.
CODE Unit #11317-9887.
MANUFACTURER United Blood Services, El Paso, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on January 1, 1998. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III =======
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-524-8.
CODE Unit #10523-9031.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on January 28, 1997. Firm-initiated
recall complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
Whole Blood which may have had an extended
collection time.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-532/533-8.
CODE Unit numbers: 4764334, 4764335, 4764336,
4764337, 4764339, 4764345, 4764347, 4764348,
4764349, 4764350, 4764354, 4764357, 4764359,
4592343.
MANUFACTURER National Naval Medical Center, Bethesda,
Maryland.
RECALLED BY Manufacturer, by telephone on February 8,
1996. Firm-initiated recall complete.
DISTRIBUTION District of Columbia.
QUANTITY 14 units of each component were distributed.
REASON Blood products were incorrectly tested for the
hepatitis B surface antigen (HbsAg).
_______________
PRODUCT Red Blood Cells. Recall #B-546-8.
CODE Unit #05X72675.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated September 29,
1997, and November 4, 1997. Firm-initiated
recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit was distributed.
REASON Blood product tested initially reactive for
the hepatitis B surface antigen (HBsAg), and
had no retesting performed.
_______________
PRODUCT a)Reagent Red Blood Cells Ortho Coombs
Control; b) Reagent Red Blood Cells
Surgiscreen. Recall #B-554/555-8.
CODE Lot numbers: a) K222; b) 3SS790.
MANUFACTURER Ortho Diagnostic Systems, Inc., Raritan,
New Jersey.
RECALLED BY Manufacturer, by letter dated May 13, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and Japan.
QUANTITY a) 1,028 kits; b) 225 kits were distributed.
REASON Red Blood Cells were found to exhibit
hemolysis.
RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS II ==========
_______________
PRODUCT Normal Saline Syringe, disposable,
polypropylene, piston-type syringe.
Recall #Z-297-8.
CODE Catalog #: RAS-03-06, Lot #: 5061-0417-1133,
EXP 10/17/97.
MANUFACTURER ROCAP, Woburn, Massachusetts.
RECALLED BY ROCAP, Inc., Orlando, Florida, by telephone
beginning May 29, 1997. Firm-initiated recall
complete.
DISTRIBUTION Connecticut, Illinois, Maryland, Pennsylvania.
QUANTITY 960 syringes were distributed.
REASON Normal saline syringe was labeled as: 0.9%
Sodium Chloride, USP, 3.0 ml fill in 6.0 ml
syringes. However, the product was filled
into 3.0 ml syringes instead of 6.0 ml
syringes making the syringe size incorrect.
_______________
PRODUCT Normal Saline Syringe, disposable
polypropylene, piston-type syringe.
Recall #Z-298-8.
CODE Catalog #: RAS-01-03, Lot #: 5001-0516-1027,
EXP 11/16/97.
MANUFACTURER ROCAP, Woburn, Massachusetts.
RECALLED BY ROCAP, Orlando, Florida, by telephone July 24,
1997. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 960 syringes were distributed.
REASON Normal saline syringe was labeled as: 0.9%
Sodium Chloride, USP, 1.0 ml fill in 3.0 ml
syringes. However, the fill volume of the
product was incorrect since it was actually
filled with 3.0 ml of 0.9% Sodium Chloride,
USP.
_______________
PRODUCT Normal Saline Syringe, disposable
polypropylene, piston-type syringe.
Recall #Z-299-8.
CODE Catalog #: RAS-01-03, Lot #: 5001-0507-1234,
EXP 11/07/97
MANUFACTURER ROCAP, Inc., Woburn, Massachusetts.
RECALLED BY ROCAP, Inc, Orlando, Florida, by telephone on
August 29, 1997. Firm-initiated recall
complete.
DISTRIBUTION Ohio.
QUANTITY 960 syringes were distributed.
REASON Normal saline syringe was labeled as: 0.9%
Sodium Chloride, USP, 1.0 ml fill in 3.0 ml
syringes. However, the fill volume of the
product was incorrect since it was actually
filled with 3.0 ml of 0.9% Sodium Chloride,
USP.
_______________
PRODUCT IVAC Space Saver Volumetric Infusion Pumps:
a) Model 597; b) Model 598; c) Model 599.
Recall #Z-300/302-8.
CODE All serial numbers.
MANUFACTURER Alaris Medical Systems, Inc. (formerly IVAC
Corp.), San Diego, California.
RECALLED BY Alaris Medical Systems, Inc., San Diego,
California, by letter dated April 11, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 28,000 units were distributed.
REASON The devices are subject to over infusion due
to the wear of the camming surfaces, causing
the opening of the IV tubing to become
smaller, therefore, reducing the loading gap.
_______________
PRODUCT Techstar XL 6 French Percutaneous Vascular
Surgery Device (PVS), indicated for the
percutaneous delivery of sutures for closing
the common femoral artery access site of
patients who have undergone diagnostic
catherization procedures using 5 to 6 Fr.
Sheaths: a) Catalog No. TXL-431-06;
b) Catalog No. TXLS-432-06.
Recall #Z-311/312-8.
CODE 1563 1641 1713 1720 1776 1564 1700
1714 1722 1778 1632 1704 1717 1727
1779 1634 1705 1718 1774 1497 1565
1671 1673 1711 1060 1091 1130 1363
1369 1559 1062 1093 1135 1364 1552
1561 1063 1102 1143 1366 1552 1068
1089 1107 1362 1367 1557 1098.
MANUFACTURER Perclose, Inc., Menlo Park, California.
RECALLED BY Manufacturer, by letter faxed on November 22,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 3,933 units were distributed.
REASON The product was manufactured with out-of-
specification components.
_______________
PRODUCT Cobe-Gambro-Hospal brand Acid Concentrate for
Bicarbonate Dialysis, Product #BAC-403X.
Recall #Z-325-8.
CODE 715605C, 716201C, 720307C, 723401C, 724802C.
MANUFACTURER Gambro Healthcare, Deland, Florida.
RECALLED BY Manufacturer, by letter on October 17, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 2,383 cases were distributed.
REASON The acid concentrate label incorrectly
identifies the magnesium and chloride
concentration.
_______________
PRODUCT Opteon brand Femoral Stems, indicated for use
in skeletally mature individuals undergoing
primary or secondary surgery for proximal
femoral fractures where prosthetic replacement
is determined by the surgeon to be the
preferred treatment. Recall #Z-326-8.
CODE All lots manufactured prior to 9/22/97.
MANUFACTURER Exatech, Inc., Gainesville, Florida.
RECALLED BY Manufacturer, by telephone on September 22,
1997. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Argentina.
QUANTITY 608 stems were distributed.
REASON The device is subject to fracture (breakage)
near the laser "alignment" marking.
_______________
PRODUCT Sterile ENT Knives and Burs in a plastic tray
with lids and sealed in a primary peep pouch:
a) MICRO ENT KNIVES, List No. A907060,
Model Nos. 14-58230, 14-58231, 14-58232,
14-58234;
b) MICRO-CRAFT AND HELIX BURS, List No.
A871727, Model Numbers with the following
common prefixes: "31-xxxx" and "9xxx-++".
Recall #Z-327/328-8.
CODE a) All lots manufactured from August 11, 1997
to November 6, 1997; b) All lots manufactured
from August 11, 1997 to November 6, 1997.
MANUFACTURER Xomed Surgical Products, Inc., Jacksonville,
Florida.
RECALLED BY Manufacturer, by letter on November 12, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 22,856 units were distributed.
REASON The sterility of the devices has been
compromised as evidenced by loss of package
integrity.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III =========
_______________
PRODUCT Triumph Vascular Access Ports:
a) SSA-16-I Triumph 1 Vascular Access Ports,
B) 8 SSD-16-I Triumph Vascular Access Ports.
RECALL #Z-293/294-8.
CODE Lot numbers: a) 50717D; b) 524126B.
MANUFACTURER ACT Medical, Inc., Walthlam, Massachusetts.
RECALLED BY Horizon Medical Products, Inc., Manchester,
Georgia, by telephone on February 21, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY a) 39 ports; b) 166 ports were distributed.
REASON The devices were packaged with a size 8 French
Introducer instead of size 10 French
Introducer as labeled.
_______________
PRODUCT Bartels Toxi-Titer Diluent, in-vitro
diagnostic, Catalog #B1029-70B.
Recall #Z-324-8.
CODE Lot #7M375-2.
MANUFACTURER Bartels, Inc., Issawuah, Washington.
RECALLED BY Manufacturer, by fax and by telephone on
January 28, 1998. Firm-initiated recall
complete.
DISTRIBUTION Colorado, Illinois, Oklahoma, Oregon,
Pennsylvania, Wisconsin.
QUANTITY 18 units were distributed.
REASON Bacterial contamination.
_______________
PRODUCT 2-0 Chromic Gut Suture (3.5 Metric), DT-12
37mm 27" 67 cm), Sterile, Type C, Absorbable,
Surgical Suture USP, Diamond Point.
Recall #Z-313-8.
CODE Lot #951824.
MANUFACTURER Sherwood-Davis & Geck, Manati, Puerto Rico.
RECALLED BY Sherwood-Davis & Geck, Hazelwood, Missouri, by
letter dated December 16, 1997, followed by
visit. Firm-initiated recall ongoing.
DISTRIBUTION New York, Illinois, Connecticut, Louisiana,
Puerto Rico, Georgia.
QUANTITY 59 cartons were distributed.
REASON Some of the foil envelopes containing the
sutures were labeled Chromic Gut Size 3-0 but
actually contained size 2-0.
END OF ENFORCEMENT REPORT FOR FEBRUARY 18, 1998. BLANK PAGES
MAY FOLLOW.
####
End of Enforcement Report for
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