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.
ENFORCE
01/24/1996
ENFORCEMENT REPORT FOR 01/24/95
January 24, 1996 96-04
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Ground Round Restaurant Apple Crisp, packaged
in 2 pound aluminum tray with cardboard cover.
Recall #F-146-6.
CODE 5421 and 5383 ink jet sprayed on master
cartons only.
MANUFACTURER Basic American Frozen Foods, Brockton,
Massachusetts.
RECALLED BY Manufacturer, by electronic mail on October
25, 1995. Firm-initiated field correction
(relabeling) complete.
DISTRIBUTION Northeast states to Midwestern states.
QUANTITY 1,084 cases were distributed.
REASON Product contains undeclared walnuts.
_______________
PRODUCT Eden's Whole Pitted Sun Dried Malatya
Apricots, packaged in 16 ounce clear poly
bags. Recall #F-147-6.
CODE None.
MANUFACTURER Elmas a.s., Istanbul, Turkey.
RECALLED BY Eden International, Inc., Blue Island,
Illinois, by letter dated November 30, 1995.
Firm-initiated field correction (relabeling)
ongoing.
DISTRIBUTION Ohio, Illinois, Florida, Michigan, Colombia.
QUANTITY Approximately 56-84 one-pound bags were
distributed.
REASON Product contains undeclared sulfites.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Holiday Assorted Butter Cookies, in 3 pound 8
ounce metal tins with a picture of "Santa's
Workshop" on the side and a red lid.
Recall #F-145-6.
CODE UPC #70453-11123. All tins with red lid and
"Santa's Workshop" depicted on the side of the
tin.
MANUFACTURER Maurice Lennell Cooky Company, Chicago,
Illinois.
RECALLED BY Manufacturer, by telephone on December 14,
1995, followed by visit. Firm-initiated field
correction (relabeling) ongoing.
DISTRIBUTION Northeastern United States.
QUANTITY 600 cases (10 tins per case) were distributed;
firm estimated that 150 tins remained on
market at time of recall initiation.
REASON Product contains undeclared food colors (FD&C
Yellow #5, #6, and #40, and Blue #1).
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Waldbaum's Peppermint Starlights Candy, in 10
ounce plastic bags. Recall #F-144-6.
CODE None.
MANUFACTURER Cendee, Plainview, New York.
RECALLED BY Waldbaum's, Inc., Central Islip, New York, by
memorandum December 18, 1995. FDA-initiated
recall ongoing.
DISTRIBUTION New York.
QUANTITY Undetermined.
REASON Product contains undeclared FD&C Red #40 and
falsely represents the product as containing
FD&C Yellow #5 and #6 when in fact it does
not.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Myochrysine (Gold Sodium Thiomalate) Injection
50 mg/ml, in 10 ml multi-dose vials, used for
rheumatoid arthritis, under the Merck and King
Pharmaceuticals label. Recall #D-077-6.
-2- CODE Lot numbers: 0481T EXP 1/96, 1049T EXP 4/96,
0250V EXP 11/96, 1373V EXP 2/97, 0775W EXP
10/97, 0367A EXP 6/98, 0697B EXP 8/99, 1013A
EXP 2/99 (King label), 0482T EXP 1/96, 1085T
EXP 5/96, 0249V EXP 11/96, 0113W EXP 8/97,
1665W EXP 9/98, 0912A EXP 5/99, 0820B EXP
9/99, 1544A EXP 6/99 (King label), 0738T EXP
2/96, 1780T EXP 3/96, 0778V EXP 11/96, 0594W
EXP 8/97, 0133A EXP 11/98, 0017B EXP 2/99,
0249B EXP 8/99.
MANUFACTURER Merck and Company, Inc., West Point,
Pennsylvania.
RECALLED BY Manufacturer, by letter dated December 18,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Spain, Peru.
QUANTITY Approximately 90,000 unit packages remained on
market at time of recall initiation.
REASON Product does not meet antimicrobial
effectiveness test.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Sodium Iodide I-131 Solution for Oral
Therapeutic Use, in 100 mCi and 50 mCi vials,
used for the treatment of hyperthyroidism and
selected cases of carcinoma of the thyroid.
Recall #D-078-6.
CODE Lot #K049 EXP 1/17/96.
MANUFACTURER CIS Bio International, Subsidiary of Compagnie
ORIS Industrie SA, Cedex, France.
RECALLED BY CIS-US, Inc., subsidiary of CIS Bio
International, Bedford, Massachusetts, by
letter dated December 15, 1995. Firm-
initiated field correction complete.
DISTRIBUTION Nationwide.
QUANTITY 71 100-mCi vials and 55 50-mCi vials were
distributed.
REASON Some packages contained a package insert for
Sodium Iodide I-131 Capsules.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT I.V. Extension Sets with "T" Connectors:
(a) Abbott Extension Set with "T" Connector,
Syringe Administration Set, List 4612;
(b) Abbott LifeShield Extension Set with "T"
Connector and Pre-pierced Reseal Injection
Site, List 11572;
-3- (c) Abbott LifeShield (LAV) Microbore
Extension Set with Luer Activated Valve and
"T" Connector, List 11749,
(d) Abbott Extension Set with "T" Connector,
List Rx 17084;
(e) Abbott LifeShield Extension Set 6 Inch
with Pre-pierced Reseal "T" Connector and Luer
Activated Valve, List Rx 11869;
Recall #Z-321/325-6.
CODE Lot numbers: (a) 02-169-HG, 03-213-HG,
03-214-HG, 03-215-HG, 03-216-HG, 03-128-HG,
03-193-HG, 04-007-HG, 04-056-HG, 04-164-HG,
04-165-HG, 04-166-HG, 04-167-HG, 05-188-HG,
05-189-HG, 05-190-HG, 05-202-HG, 05-300-HG,
05-301-HG, 06-140-HG, 06-189-HG;
(b) 01-175-HG, 02-058-HG, 02-126-HG,
03-006-HG, 03-122-HG, 04-026-HG, 05-007-HG,
05-227-HG, 05-191-HG, 05-293-HG, 05-294-HG,
06-086-HG, 06-134-HG, 07-013-HG;
(c) 04-195-HG;
(d) 04-193-HG, 80-235-H1, 91-078-H1;
(e) 03-194-HG, 04-188-HG, 05-249-HG,
06-084-HG, 08-027-HG, 10-233-HG, 93-279-HG.
MANUFACTURER Abbott Laboratories, Laurinburg, North
Carolina (HG lot suffix); Abbott Health
Products, Barceloneta, Puerto Rico (H1 lot
suffix).
RECALLED BY Abbott Laboratories, Abbott Park, Illinois, by
letters dated December 8, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 2,120,180 units were distributed; firm
estimated that 135,000 - 150,000 units
remained on market at time of recall
initiation.
REASON Some of the extension sets leak and disconnect
between the male fitment of the device and the
luer fitment of the I.V. access device.
_______________
PRODUCT System 97, a helium charged, mobile Intra-
Aortic Balloon Pump (IABP), Catalog #0998-00-
0104-X, for use as a patient aid during pre-,
intra-, or post- operative open heart surgery;
use within patients demonstrating unstable
angina; use within patients with left main
artery occlusion or poor left ventricle
function: (a) Power Supply; (b) Front End
Board; (c) Solenoid Driver Board.
Recall #Z-332/334-6.
-4- CODE Serial numbers: (a) 1020, 1045, 1104, 1123,
1125, 1126, 1128, 1129, 1134-1143, 1145-1147,
1149, 1152, 1154, 1155, 1157, 1158, 1160-1173,
1175, 1176, 1178, 1181-1190, 1193-1203, 1205,
1206, 1228, 1230-1254, 1256-1292, 1294-1314,
1316-1371, 1373, 1374, 1380-1384, 1386, 1392,
1411, 1442, 1444, 1454, 1456, 1461, 1463,
1509, 1550, 1571, 2008, 2047, 2048, 1389,
1392, 1400, 1441, 1447, P0011, P0013, P0014,
P0016-P0018, P0022, P0023;
(b) P0001-P0024 and 1001-1608 with the
following exceptions: P0003-P0006, P0012,
1005, 1007, 1080, 1100, 1129, 1159, 1293,
1297, 1347, 1443, 1453, 1459, 1474, 1476,
1479, 1496, 1499-1505, 1507-1534, 1527,
1530-1539, 1545-1555;
(c) 1551, 1553-1556, 1559-1586, 1588-1623,
2000-2067, 2069, 2070, 2072-2077, 2080, 2084,
2088-2092, 2126, 2139.
MANUFACTURER Datascope Corporation, Paramus, New Jersey.
RECALLED BY Manufacturer, by letter beginning August 31,
1995, followed by visit. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 259 units; (b) 554 units; (c) 153 units
were distributed;
REASON The system may fail because of the following
component failures:
Power Supply: Failure of a zener diode,
designated at VR9 in the system power supply,
which can result in a "Power On" condition
which cannot be switched off by normal means.
Front End Board: Intermittent contact in the
solder joints of certain surface mount trim
resistors, may lead to such problems as loss
of blood pressure wave form, inability to zero
the blood pressure channel, loss or inaccuracy
of the shuttle transducer gain, no ECG wave
form, no pacer detection, inaccuracy of the
external pressure output or an analog to
digital (A/D) converter failure.
Solenoid Driver Board: A solder flux left
beneath the integrated circuit, created the
possibility of a conductive path which can
result in a short circuit of the board.
_______________
PRODUCT 3M Sarns brand Perfusion System 9000 Gas Flow
System, used to provide and monitor CO2 flow
to the patient during cardiopulmonary bypass.
Recall #Z-335-6.
-5- CODE All serial numbers.
MANUFACTURER Sarns 3M Health Care, Ann Arbor, Michigan.
RECALLED BY Manufacturer, by letter sent on or about July
24, 1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 500 units.
REASON The relay controlling the CO2 flow can
experience random failure and latch in the
"on" position, causing CO2 gas to continue to
flow after completion of the pre-bypass CO2
flush of the perfusion circuit.
_______________
PRODUCT Duopulse and Unipulse Dental Laser System,
used in dental surgery. Recall #Z-336/337-6.
CODE None.
MANUFACTURER Excel/Quantronix Corporation, Hauppauge, New
York.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan December 28, 1995.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide, Germany, Korea.
QUANTITY 213 units were distributed.
REASON Noncompliance with performance standards for
laser products in that the operator's manuals
lacked adequate calibration procedures and the
devices had several labeling noncompliances.
_______________
PRODUCT Tempo/Tingle Timers Installed with Diagnostic
X-Ray Systems, used to regulate the duration,
and to some extent, the amount of exposure to
x-radiation. Recall #Z-346-6.
CODE None.
MANUFACTURER Tingle X-Ray Products, Inc., Vance, Alabama.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan January 3, 1996. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 17 timers.
REASON Devices were not tested for accuracy in
accordance with the specifications, and did
not bear proper certification and
identification labels, as required by 21 CFR
1020.30(d).
_______________
PRODUCT ImmunoCard Helicobacter pylori Test Kit,
Catalog #710030, a rapid enzyme immunoassay
for the detection of IgG antibodies to
Helicobacter pylori in human serum and plasma.
Recall #Z-347-6.
-6- CODE Lot numbers and EXP dates: Lot Nos.
710030.007 9/26/96 and 710030.008 11/29/96 (on
boxes);
7851.007 10/10/96, 7581.008 12/13/96
(conjugate enzymes).
MANUFACTURER Meridian Diagnostics, Inc., Cincinnati, Ohio.
RECALLED BY Manufacturer, by telephone on November 14,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Italy, Russia, Puerto Rico.
QUANTITY 175 test kits of lot #710030.007 and 57 test
kits of lot #710030.008 were distributed.
REASON The enzyme conjugate in the kit was prepared
at the wrong dilution, resulting in an
improper sensitivity of the tests.
_______________
PRODUCT Captia Rubella-M EIA Test Kit,
Product #801-165. Recall #Z-348-6.
CODE Lot #34K0104.
MANUFACTURER Centocor, UK Ltd., United Kingdom.
RECALLED BY Centocor, Inc., Malvern, Pennsylvania, by
letter June 23, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 200 kits were distributed.
REASON There is a higher incidence of
equivocal/positive results than anticipated.
_______________
PRODUCT Critikon Brand Protectiv and Protectiv-Plus
I.V. Catheter Safety System, various gauge and
lengths of IV needle sets, packed in Tyvek
blister packs which act as sterility barriers:
(a) Product No. 3042; (b) Product No. 3050;
(c) Product No. 3055; (d) Product No. 3056;
(e) Product No. 3057; (f) Product No. 3060;
(g) Product No. 3065; (h) Product No. 3066;
(i) Product No. 3067. Recall #Z-349/357-6.
CODE This recall affects ONLY those products where
each individual package's seven character
code, located on the peel tab, has a code
which falls into the following ranges:
"3124Y9X" through "3654Y9X" and "0015Y9X"
through "0705Y9X" where the first four digits
are the Julian date, "Y" can be any letter,
and "X" can be any number.
MANUFACTURER Johnson and Johnson Company, formerly known as
Critikon, Inc., Southington, Connecticut.
RECALLED BY Johnson and Johnson, formerly Critikon, Inc.,
Tampa, Florida, by letter mailed on April 10,
1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
-7- QUANTITY 778,191 catheters were distributed.
REASON An opening may be present in the clear plastic
portion of the blister package, therefore
compromising the sterile barrier of the
package.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III =======
_______________
PRODUCT Cellfree Interleukin-2 Receptor (IL-2R) Bead
Assay Kit, Catalog #AK3120, for the
quantitative measurement of Interleukin-2
Receptor Level in Human Serum.
Recall #Z-358-6.
CODE Lot #6029 EXP 3/13/94.
MANUFACTURER T Cell Diagnostics, Inc., Cambridge,
Massachusetts.
RECALLED BY Manufacturer, by letter dated January 28,
1994. Firm-initiated recall complete.
DISTRIBUTION Massachusetts, Texas, Connecticut, Louisiana,
Greece.
QUANTITY 20 kits were distributed.
REASON Controls provided with the product were not
meeting the assigned ranges and fell below
specified limits.
_______________
PRODUCT Glucometer Encore Test Strips, used to measure
glucose in whole blood. Recall #Z-360-6.
CODE Product Code 2250, Lot numbers: A90C5, B95C5,
C95C5.
MANUFACTURER Bayer Corporation, Elkhart, Indiana.
RECALLED BY Manufacturer, by letter July 7, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 45,451 cartons.
REASON Subject lots may fail to give blood glucose
reading, and the Glucometer Encore meter will
display an E-3 error code.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS I
_______________
PRODUCT Warbex Famphur Pour-On for Cattle, for control
of cattle grubs and reduction of lice
infestations. Recall #V-004-6.
CODE Lot #950658.
MANUFACTURER PM Resources, Bridgeton, Missouri.
RECALLED BY Mallinckrodt Veterinary, Inc., Mundelein,
Illinois, by telephone on November 20, 1995,
and by press release. Firm-initiated recall
ongoing.
-8- DISTRIBUTION Nebraska, Iowa, North Dakota, South Dakota,
Colorado, Kansas, Wyoming, Texas.
QUANTITY 1,996 (499 cases) were distributed.
REASON Product is contaminated with isazophos, an
organophosphate turf insecticide.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
========
_______________
UPDATE The correct recall number for Baciferm 50
Medicated Bacitracin Zinc Premix Type A
Medicated Article, in 50 pound bags which
appeared in the January 10, 1996 Enforcement
Report is V-005-6.
-9-
END OF ENFORCEMENT REPORT FOR JANUARY 24, 1996. BLANK PAGES MAY
FOLLOW.
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