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
07/25/1995
ENFORCEMENT REPORT FOR 07/26/95
July 26, 1995 95-30
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
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PRODUCT Food Club Vanilla Cream Sandwich Cookies, 21 ounces.
Recall #F-687-5.
CODE 152 (Julian date) EXP 10/95.
MANUFACTURER Seaboard Bakeries, Inc., Toa Baja, Puerto.
RECALLED BY Manufacturer, by telephone June 9, 1995. Firm-initiated
recall complete.
DISTRIBUTION Puerto Rico.
QUANTITY 64 boxes (24 packages per box) were distributed.
REASON Packages contained strawberry cream filled cookies instead
of vanilla cream filled cookies.
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PRODUCT Vegetable Shortening, partially hydrogenated soybean and
cottonseed oil with mono- and diglycerides, in 3 pound cans,
under the following labels: Janet Lee, can code MAY176Z;
Best Choice, can code MAY 1796Z; Parade, can code MAY176Z,
Red & White Quality, can code May176Z; Jay C, can code
143Z5; Flair, can code 143Z5; Krasdale, can code 143Z5;
Kroger, can code MAY 171996Z; Piggly Wiggly, can code
MAY176Z; Nature's Best, can code 143Z5; Best Yet, can code
MAY1796Z; Town House, can code 143Z5; Schnucks, can code
143Z5; ShurFine, can code 143Z5; Wegmans, can code MAY
1796Z. Recall #F-689-5.
CODE Case code 143Z5. Can codes vary with the product label.
MANUFACTURER Kraft Food Ingredients Corporation, Champaign, Illinois.
RECALLED BY Kraft General Foods, Inc., Northfield, Illinois, by letters
dated June 19, 1995. Firm-initiated recall complete.
DISTRIBUTION Colorado, Florida, Michigan, Minnesota, Louisiana, Virginia,
Indiana, New York, Kentucky, Missouri, South Carolina,
Nebraska, Maryland, Kansas, Oklahoma, Vermont.
QUANTITY 1,842 cases (12 cans per case) were distributed.
REASON The vegetable shortening may have an off-odor or off-flavor
due to fat oxidation.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
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PRODUCT Bard PTFE Vascular Grafts, Thinwall Straight, intended for
use as a bypass conduit in the reconstruction of occluded or
diseased blood vessels. Recall #Z-853-5.
CODE Item numbers: BTW06010 6mm x 10cm, BTW06020 6mm x 20cm,
BTW06030 6mm x 30cm, BTW06040 6mm x 40cm, BTW06050 6mm x
50cm, BTW06060 6mm x 60cm, BTW06070 6mm x 70cm, BTW06080 6mm
x 80cm, BTW08010 8mm x 10cm, BTW08020 8mm x 20cm, BTW08030
8mm x 30cm, BTW08040 8mm x 40cm, BTW08050 8mm x 50cm,
BTW08060 8mm x 60cm, BTW08070 x 70cm, BTW08080 8mm x 80cm.
MANUFACTURER Bard Vascular Systems Division, Billerica, Massachusetts.
RECALLED BY Bard Vascular Systems Division, Haverhill, Massachusetts, by
telephone August 5, 1994, and by letters August 5 and 12,
1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Ireland, Italy.
QUANTITY 1,397 units were distributed.
REASON Longitudinal "crack" in the wall.
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PRODUCT Cardiac Pulse Generators, Models 8220E, 8223E, 8224, 8232.
Recall #Z-874/877-5.
CODE Specific, individually serial numbered units.
MANUFACTURER Telectronics Pacing Systems, Miami Lakes, Florida.
RECALLED BY Telectronics Pacing Systems, Englewood, Colorado, by letter
in April 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Europe.
QUANTITY 23 units.
REASON Devices may contain defective flex circuits, which can cause
an intermittent or permanent "no output" condition. Defect
attributed to inadequate brazing of the "L" clips to the
flex circuit.
_______________
PRODUCT Port-A-Cath Dual Lumen Venous Access System with Silicone
Catheter: (a) Reorder Numbers: 21-8010 and 21-8010-22; (b)
Reorder Numbers: 21-8050 and 21-8050-22; (c) Reorder
Number: 21-8052. Recall #Z-879/881-5.
CODE All lots distributed prior to the recall.
MANUFACTURER Sims Deltec, Inc., St. Paul, Minnesota.
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RECALLED BY Manufacturer, by letters dated May 3, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 2,378 units were distributed.
REASON Possible leaks. The connector's plastic insert may puncture
a portion of the catheter on the portal outlet tube
_______________
PRODUCT Safco Supergrade Autochuck Handpiece Headcaps, Product
#WPHC, a component of the 4-hole Supergrade Plus Autochuck
Dental Handpiece, Product #WP4. Recall #Z-944/945-5.
CODE All WP4 handpieces or WTP Supergrade Autochuck Cartridges
purchased between 8/1/94 and 1/24/95.
MANUFACTURER Nakanishi Dental Manufacturing Company, Ltd., Kanuma-shi,
Tochigi-ken, Japan.
RECALLED BY Safco Dental Supply Company, Chicago, Illinois, by letter
June 16, 1995. Firm-initialed recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 791 handpieces and 383 replacement cartridges were
distributed affecting a total of 1,174 headcaps.
REASON The headcap may come off the handpiece during use.
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PRODUCT Service Manuals distributed with the Plumesafe 1202 (Part
#PSS1202) and Porta Plumesafe 602 (Part PPSS602) Smoke
Evacuators; and the instruction sheet distributed with the
Virosafe 12 (Part #VS12011 and VS12013) and Virosafe 6 (Part
numbers: SING VS6, VS0606011, VS06013) Smoke Evacuator
Filters. Recall #Z-946-5.
CODE All existing manuals and instructions making reference to
"antimicrobial" properties.
MANUFACTURER Medetek Devices, Inc., Buffalo, New York.
RECALLED BY Manufacturer, by letters issued June 9, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Connecticut, Florida, Georgia, Illinois, Iowa, Michigan,
Minnesota, Missouri, Nebraska, New Jersey, New York, North
Carolina, Oklahoma, Pennsylvania, Tennessee, Texas,
Virginia, Canada, Austria, Iceland, Italy, Malaysia.
QUANTITY 236 Lume/Porta Plumesafe devices and 88 ViroSafe filters.
REASON Service manual and instructions for these devices make
unsupported claims of anti-microbial properties.
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PRODUCT Single Chamber Cardiac Pulse Generators, Models 1206 and
1206M. Recall #Z-954/955-5.
CODE Specific, individually serial numbered units.
MANUFACTURER Telectronics Pacing Systems, Miami Lakes, Florida.
RECALLED BY Telectronics Pacing Systems, Englewood, Colorado, by letter
in April 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1 unit of Model 1206M and 179 units of Model 1206.
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REASON The pulse generators may contain defective ceramic substrate
pads, which can cause an open contact condition in the pacer
circuit and result in sudden loss of output.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
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PRODUCT Software for the ABL 500 and 600 Series Analyzers, blood/gas
analyzers used for measuring a patient's pH, pC02 and p02
from blood samples. Recall #Z-889/890-5.
CODE All lots in the following series: ABL 500/505/510/520/620.
The software will also be identified with a run number
ranging from run 1 #1 to run 119 #6.
MANUFACTURER Radiometer America, Copenhagen, Denmark.
RECALLED BY Radiometer America, Westlake, Ohio, by letter April 2, 1994.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,322 units were distributed.
REASON The entry of patient information is improperly sequenced,
and the analyzers may ignore the information and may not
calculate correctly the blood/gas results for the patient's
actual temperature.
_______________
PRODUCT EZ CH 50 Complement Reference Control Low IVD, Catalog #789-
008, intended to be used with EZ Complement reagents to
measure total complement activity in human serum by
immunochemical techniques. Recall #Z-891-5.
CODE Lot #10775 EXP 1/96.
MANUFACTURER Diamedix Corporation, Miami, Florida.
RECALLED BY Manufacturer, by letter dated March 22, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide, Spain, Canada, Germany, The Netherlands,
Venezuela.
QUANTITY 199 units were distributed.
REASON The low control was reported as being high.
_______________
PRODUCT Anti-RNP Microassay EIA IVD, 96 Test Set, intended for the
detection and quantitation of antibodies against the antigen
RNP in serum as an aid in the diagnosis, prognosis, and
monitoring of certain rheumatic autoimmune diseases:
(a) Anti-RNP Microassay, Catalog No. 783-271;
(b) Conjugate for Anti-RNP Microassay, Catalog No. 783-272;
(c) Negative Control for Anti-RNP Microassay,
Catalog No. 783-273;
(d) Calibrator for Anti-RNP Microassay, Catalog No. 783-274;
(e) Positive Control for Anti-RNP Microassay,
Catalog No. 783-275;
(f) Sample Diluent for Anti-ENA Microassay,
Catalog No. 783-246;
(g) Wash Concentrate for Microassay, Catalog No. 783-107;
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(h) Substrate for Microassay, Catalog No. 783-106;
(i) Stop Solution for Microassay, Catalog No. 783-108.
Recall #Z-892/900-5.
CODE Lot #70504Z, EXP 4/95.
MANUFACTURER Diamedix Corporation, Miami, Florida.
RECALLED BY Manufacturer, by letter October 24, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 394 sets were distributed; firm estimates none remains on
the market.
REASON The calibrator which contains both an Sm and RNP antigen was
not performing to specifications.
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PRODUCT Anti-SSB Microassay EIA IVD, Catalog #783-260 96 Test Set,
intended for the detection and quantitation of antibodies
against the antigen SSB(La) in serum as an aid in the
diagnosis and prognosis of certain rheumatic autoimmune
diseases:
(a) Antigen Wells for Anti-SSB Microassay,
Catalog No. 783-261;
(b) Conjugate for Anti-SSB Microassay, Catalog No. 783-262;
(c) Negative Control for Anti-SSB Microassay,
Catalog No. 783-263;
(d) Calibrator for Anti-SSB Microassay, Catalog No. 783-264;
(e) Positive Control for Anti-SSB Microassay,
Catalog No. 783-265;
(f) Sample Diluent for Anti-ENA Microassay,
Catalog No. 783-246;
(g) Wash Concentrate for Microassay, Catalog No. 783-107;
(h) Substrate for Microassay, Catalog No. 783-106;
(i) Stop Solution for Microassay, Catalog No. 783-108.
Recall #Z-901/909-5.
CODE Lot numbers: 71104, EXP 4/95, 61204 EXP 3/95.
MANUFACTURER Diamedix Corporation, Miami, Florida.
RECALLED BY Manufacturer, by letters dated August 26, 1994. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 214 sets from lot 71104, and 296 sets from lot 61204 were
distributed; firm estimates none remains on the market.
REASON The calibrator which contains SSB antibodies, was losing
activity.
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PRODUCT Anti Scl-70 Microassay EIA Test Set IVD, intended for the
detection and quantitation of antibodies against the antigen
Scl-70 in human serum as an aid in the diagnosis and
prognosis of scleroderma:
(a) Antigen Wells for Anti-SSB Microassay,
Catalog No. 783-281;
(b) Conjugate for Anti-SSB Microassay,
Catalog No. 783-282;
-5-
(c) Negative Control for Anti-SSB Microassay,
Catalog No. 783-283;
(d) Calibrator for Anti-SSB Microassay,
Catalog No. 783-284;
(e) Positive Control for Anti-SSB Microassay,
Catalog No. 783-285;
(f) Sample Diluent for Anti-ENA Microassay,
Catalog No. 783-246;
(g) Wash Concentrate for Microassay,
Catalog No. 783-107;
(h) Substrate for Microassay, Catalog No. 783-106;
(i) Stop Solution for Microassay, Catalog No. 783-108.
Recall #Z-910/918-5.
CODE Lot #70604, EXP 4/95.
MANUFACTURER Diamedix Corporation, Miami, Florida.
RECALLED BY Manufacturer, by letter dated September 30, 1994. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 108 sets were distributed; firm estimates none remains on
the market.
REASON A high incidence of non-specific positive results.
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PRODUCT Software for the Electra 900 Automatic Coagulation Timer,
for the Electra 900C Automatic Coagulation Timer, for the
Electra 1000C Automatic Coagulation Timer, and for the
Electra 1000C Automatic coagulation with bar code station,
used to test different chemical clotting factors using human
blood plasma. Recall #Z-953-5.
CODE Software version 5.0E and declining numerical versions for
any of the above instruments.
MANUFACTURER Medical Laboratories Automation, Inc., (MLA), Pleasantville,
New York.
RECALLED BY Manufacturer, by letters during September 1993, and May and
June 1994. Firm-initiated field correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY 2,763 units were distributed.
REASON Software defect.
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PRODUCT Plastic Solution Containers for EML Series Analyzers.
Recall #Z-990/1001-5:
CODE Type S1565, Lot Nos. JK-1, JK-2, JK-3, JK-4, JM-1;
Type S1575, Lot Nos. JK-1, JK-2, JK-3, JM-1;
Type S4901, Lot Nos. JK-4, JK-5, JK-6, JK-7,
JK-8, JK-9, JK-10, JK-11, JK-12, JK-13, JK-14,
JK-15, JK-16, JK-17, JK-18, JK-19, JK-20,
JK-21, JM-1, JM-2, JM-3, JM-4, JM-5;
Type S4931, Lot No. JK-1;
Type S4915, Lot Nos. JH-6, JH-7, JK-1, JK-2,
JK-3, JK-4, JK-5, JM-1;
Type S5345, Lot Nos. JK-1, JK-2, JK-3, JK-4, JM-1, JM-2;
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Type S1585, Lot Nos. JK-1, JK-2, JM-1;
Type S1595, Lot Nos. JK-1, JK-2;
Type S4921, Lot Nos. JK-1, JK-2, JK-3, JK-4,
JK-5, JK-6, JK-7, JK-8;
Type S4935, Lot No. JK-1;
Type S5375, Lot No. JM-1;
Type S4945, Lot No. JM-1.
MANUFACTURER Radiometer America, Copenhagen, Denmark.
RECALLED BY Radiometer America, Westlake, Ohio, by letter May 1, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 15,887 containers were distributed.
REASON The gasket behind the foil inlet seal of the adapter that
connects the bottle to the analyzer may not be seated
properly. If this happens, it may seal the container
completely, thus preventing air from entering into the
container (to replace the volume of solution used).
_______________
PRODUCT AxSYM Reaction Vessels, List #08A75-01, in-vitro diagnostic
used to hold the patient's sample and the reagents for
miroparticle enzyme immunoassays utilizing the AxSYM
processing center. Recall #Z-1004-5.
CODE Lot numbers: A05007822 through A05025430.
MANUFACTURER Nypro, Gurnee, Illinois.
RECALLED BY Abbott Laboratories, Abbott Park, Illinois, by telephone and
letter June 20, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 99,151 cartons were distributed.
REASON The use of these lots of reaction vessels may cause
imprecise patient results.
_______________
UPDATE Siemens Medical Systems Quantum 2000, QAD1 and QAD PV
Ultrasound Systems, Recall #Z-924/925-5, which appeared in
the July 5, 1995 Enforcement Report, should read:
REASON: The device's power cable female connector may be
subject to overheating, resulting in a burning odor.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
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PRODUCT Burns Veterinary Supply brand Sterile Penicillin G Procaine
Suspension USP, in 250 ml vials, an injectable antibiotic.
Recall #V-035-5.
CODE Lot #4034-02 EXP 1/96.
MANUFACTURER Norbrook Laboratories, Ltd., Northern Ireland.
RECALLED BY Manufacturer, by telephone June 5, 1995. Firm-initiated
recall complete.
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DISTRIBUTION California.
QUANTITY Approximately 650 vials.
REASON Non-suspendability.
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End of Enforcement Report for July 26, 1995. Blank pages may follow.
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