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
01/08/1992
Recalls and Field Corrections: January 8, 1992
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
NONE
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
NONE
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
NONE
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COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: DDAVP Injection (Desmopressin Acetate), 4 mgc/ml, in 1 ml
ampule, ten 1 ml ampules per unit carton, shipper
carton contains 50 unit cartons, an Rx antidiuretic
hormone. Recall #D-140-2.
Code: Lot #QM9598 EXP 1/93.
Manufacturer: Ferring Pharmaceuticals, Malmo, Sweden.
Recalled by: Rhone Poulenc Rorer, Fort Washington, Pennsylvania, by
telephone December 6, 1991, followed by letter December
10, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 1,949 unit cartons were distributed.
Reason: Front panel of carton states "Preservative Free." Rear
panel declares chlorobutanol as preservative which the
product does contain.
----
Product: Whole Blood. Recall #B-074-2.
Code: Unit numbers: 4256873, 4256885.
Manufacturer: Blood Bank Naval Hospital Long Beach, Department of
the Navy, Long Beach, California.
Recalled by: Manufacturer, by telephone December 24, 1990. Firm-
initiated recall complete.
Distribution: New Jersey.
Quantity: 2 units.
Reason: Blood components, which tested repeatably reactive for
the antibody to the human immunodeficiency virus, type 1
(anti-HIV-1), were distributed.
----
Product: (a) Red Blood Cells; (b) Platelets;
(c) Cryoprecipitated AHF; (d) Fresh Frozen Plasma;
(e) Recovered Plasma. Recall #B-075/079-2.
Code: Unit numbers: (a) 31C01142, 31C02790, 31C04046, 31C14148,
31C16315, 31F23510, 31G06328, 31G68272, 31G71807, 31G91100,
31H05395, 31S07348, 31S09633, 31S11959, 31S14017, 31S15953,
31T53794; (b) 31C16315;
(c) 31C02790, 31C14148, 31S09633, 31S15953;
(d) 31G91100, 31H05395;
(e) 31C01142, 31C02790, 31C04046, 31C14148, 31C16315,
31S14017, 31S15953, 31T53794.
-2-
Manufacturer: American Red Cross Blood Services, Buffalo, New York.
Recalled by: Manufacturer, by letters in June and July 1991.
Firm-initiated recall ongoing.
Distribution: New York, California, Georgia, Illinois, Pennsylvania,
North Carolina, Switzerland.
Quantity: (a) 17 units; (b) 1 unit; (c) 4 units; (d) 2 units;
(e) 8 units.
Reason: Blood products, collected from donors who had histories
of self-injected drug use, unspecified hepatitis, or
jaundice, were distributed.
----
Product: Platelets. Recall #B-081-2.
Code: Unit numbers: 19GG26079, 19GG26082, 19GG26084, 19KK77530,
19KK77531, 19KK77535, 19KK77537, 19KK77538, 19KK77540,
19KK77542, 19KK77547, 19Z43458, 19Z43460, 19Z43464,
19Z43465, 19Z43467, 19Z43468, 19Z43470, 19Z43472, 19Z43473,
19Z43478, 19Z43480, 19Z43482, 19Z43483, 19Z43485, 19Z43496.
Manufacturer: American Red Cross Blood Services, Paducah, Kentucky.
Recalled by: Manufacturer, by telephone April 9, 1991. Firm-initiated
recall complete.
Distribution: Kentucky.
Quantity: 26 units.
Reason: Blood products labeled with incorrect expiration dates
were distributed.
----
Class III -
Product: Tylenol, OTC acetaminophen, 80 mg, chewable tablets for
children, one chewable tablet per unit dose packette with
250 unit dose packettes per folding carton (intermediate
carton), 4 folding cartons per shipping carton.
Recall #D-139-2.
Code: Lot #HDM573 EXP 5/94.
Manufacturer: McNeil Consumer Products, Fort Washington, Pennsylvania.
Recalled by: Manufacturer, by letter December 13, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 2,384 folding cartons (596 cases) were distributed.
Reason: Some units of 250 unit dose tablets (80 mg) were
packaged in cartons labeled Tylenol Tablets (325 mg).
----
Product: Phenergan Suppositories, Rx, 12.5 mg, packaged 12 units in
a unit carton with 12 unit cartons making up a shelf pack
(intermediate packaging) and 12 shelf packs comprising a
shipper carton. Recall #D-141-2.
Code: Lot #1910171.
Manufacturer: Wyeth-Ayerst Laboratories, Frazier, Pennsylvania.
-3-
Recalled by: Wyeth-Ayerst Laboratories, St. Davids, Pennsylvania, by
telephone followed by visit. Firm-initiated field
correction complete.
Distribution: Nationwide.
Quantity: 47,856 unit cartons (3,988 shelf packs) were distributed.
Reason: Some correctly labeled unit packs of 12.5 mg strength were
packed in shelf packs labeled 25 mg.
----
Product: Whole Blood. Recall #B-080-2.
Code: Unit #27FC07342.
Manufacturer: American Red Cross Blood Services, Johnstown, Pennsylvania.
Recalled by: Manufacturer, by telephone February 1, 1991. Firm-
initiated recall complete.
Distribution: Pennsylvania.
Quantity: 1 unit.
Reason: Blood product, labeled with an incorrect expiration
date and the incorrect anticoagulant, was distributed.
----
EXTENSION Dyazide Capsules (Triamterene 50 mg, Hydrochlorothiazide
NOTICE: 25 mg), Recall #D-035-2, manufactured by Smithkline
Beecham Pharmaceuticals Co., Cidra, Puerto Rico,
which appeared in the November 13, 1991, Enforcement Report
has been extended to include additional lots. These lots
can be identified in that the last 4 characters of the lot
numbers being recalled are as follows: 6E90, 7E90, 8E90.
----
DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
Product: Reflex DDD, Model 8222, Dual Chamber, Multiprogrammable
Pulse Generator with Telemetry. Recall #Z-101-2.
Code: All serial numbers.
Manufacturer: Telectronics Pacing Systems, Inc., Englewood, Colorado.
Recalled by: Manufacturer, by memorandum to sales representatives
October 18, 1991 regarding unimplanted units and by
letter November 11 and 26 to physicians and hospital
administrators. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 2,364 units were distributed.
Reason: Cracking or fracture of the ceramic terminal assembly
post. The cracking or fracturing causes a loss of
hermeticity and subsequent loss of output.
----
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Class II -
Product: A.T.H.S. Latex Disposable Examination Gloves, 100 per
box, 2,000 per case. Recall #Z-102-2.
Code: None.
Manufacturer: Phoenix Medical Service, Inc., St. Paul, Minnesota.
Recalled by: Manufacturer, by letter October 28, 1991. Firm-initiated
recall ongoing.
Distribution: Minnesota.
Quantity: 459 cases were distributed.
Reason: Product failed FDA leak test.
----
Product: Del Med brand Blood Component Recipient Set, packaged 1
unit per box, 48 boxes per case, used for intravenous
administration of blood or blood components;
(b) Blood Set with Large Filter, packaged 1 unit per box,
48 boxes per case, used for intravenous administration of
blood or blood components;
(c) Non-Vented IV Administration Set, packaged 1 unit
per box, 48 boxes per case, used for intravenous
administration of IV fluids;
(d) Plasma Transfer Set with Two Spikes, packaged 2 units
per box, 48 boxes per case, used for the transfer of
plasma from the blood bag to transfer packs;
(e) Plasma Transfer Set with Needle Adapter and Spike
packaged 2 units per box, 48 boxes per case, used to
transfer plasma from blood bag to plasma collection
container with rubber stopper. Recall #Z-105/109-2.
Code: Product Nos. Lot Nos.
(a) 03-110-00 8K-002-04
(b) 03-118-00 8K-007-04
(c) 03-131-00 8J-016-04
(d) 03-220-00 8J-017-04
(e) 03-220-30 8J-018-04.
Manufacturer: DelMed, Inc., Ogden, Utah (sterilizer, shipper, release
tester); DelMed, Inc., SA, Soyapango, San Salvador,
El Salvador, California (clamp, unit).
Recalled by: CharterMed, Inc., Lakewood, New Jersey, by letter mailed
out on September 30, 1991. Firm-initiated recall ongoing.
Distribution: (a) California, Kansas, New Jersey, Ohio, Maryland,
New York, Georgia; (b) Florida; (c) Massachusetts;
(d) Washington state, Maryland, Ohio, Tennessee, Florida,
New Jersey, Mississippi, California, New York;
(e) Florida, Pennsylvania, Maryland, New York, California,
Texas.
Quantity: (a) 7,440 units; (b) 240 units; (c) 2,400 units;
(d) 6,816 units; (e) 3,360 units were distributed.
-5-
Reason: Products contain defective roller clamps which may break
during use or not completely prevent flow through the
tubing. This may result in interrupted or unrestricted flow
of solution through the tubing.
----
Product: Tape Electrodes, with Medtronic and OEM labeling:
(a) Part #1650 - Holter/Stress Transparent Tape Electrode;
(b) Part #1620 - Huggable (R) Tape Electrode;
(c) Part #1675 - High Performance ECG Monitoring Electrode
Recall #Z-116/118-2.
Code: Medtronic Product Nos. Lot Nos.
1650-005 N 30 MAY 92 D, 30 MAY 92 E
07 JUN 92 B, 28 JUN 92 C
28 JUN 92 E, 04 JUL 92 A
1620-001 N 07 JUN 92 D, 07 JUN 92 E
04 JUL 92 C, 04 JUL 92 D
1620-003 N 30 MAY 92 E, 07 JUN 92 A
1675-030 14 JUN 92 D
5201 28 JUN 92
5202 07 JUN 92
OEM Label Product No. Lot Nos.
18366 14 JUN 92 B, 14 JUN 92 C
220041G2 21 JUN 92 C
24938-401 07 JUN 92 B
392015-001 21 JUN 92 B, 21 JUN 92 C
H997 21 JUN 92 D, 21 JUN 92 E
28 JUN 92 E.
Manufacturer: Medtronic Andover Medical, Haverhill, Massachusetts.
Recalled by: Manufacturer, by letter April 4, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 793,053 units were distributed.
Reason: Non-uniform silverplating on stud of ECG may cause poor
trace quality.
----
Product: Stryker Power Cord, Part Number 277-702-19, a component
distributed with the following endoscopy equipment:
System SE3, arthroscopy system consoles, part numbers
266-702, 266-792; cameras 777, 590, and 578; light source
220-130; and insufflator 620-20. Recall #Z-134-2.
Code: No specific codes are identified. All of the above
products which were shipped between March 15 and May 3,
1991, may contain a cord which is suspected as being
improperly wired.
Manufacturer: Stryker Corporation, Endoscopy Division, San Jose,
California.
Recalled by: Stryker Corporation, Kalamazoo, Michigan, by letter
May 20, 1991. Firm-initiated recall complete.
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Distribution: Nationwide, Canada, Hong Kong, Argentina, Brazil, Japan,
Venezuela.
Quantity: Power cords in 531 finished product units remained in
commerce at time of recall.
Reason: The clear-colored (female) connector end of the cord
assembly has live (brown) and neutral (blue) wires
reversed.
----
Product: GE Computers for computerized tomographic (CT) systems:
(a) Models 46-301394G4 & G14 Computers for CT
Independent Consoles (CT-IC);
(b) Models 46-301394G5 & G15 Computers of CT Operator
Consoles (CT-OC);
(c) Model 46-301394G31 Computers for (CT-OC);
(d) Model 46-301394G33 Computers for (CT-IC).
Recall #Z-150/153-2.
Code: All serial numbers of the CT system computers made prior
to October 14, 1991.
Manufacturer: GE Medical Systems, Waukesha, Wisconsin.
Recalled by: Manufacturer, by letter October 25, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 413 units were distributed.
Reason: The imaging, patient, and other hospital information for
one patient exam may be mismatched with the images from
different CT exams.
----
Product: Baxter Temperature Probes, Catalog numbers MR560, MF561,
MR565; and Accessory Packs with Catalog #MR746.
Recall #Z-201-2.
Code: All lot numbers from March 1989 to October 1991.
Manufacturer: Fisher and Paykel Electronics, Ltd., Auckland, New Zealand.
Recalled by: Baxter Healthcare Corporation, Pharmaseal Division,
Valencia, California. Firm-initiated recall ongoing.
Distribution: Nationwide
Quantity: 756 probes and 4 accessory packs which contain probes
were distributed.
Reason: The temperature probe may short circuit, which may result
in incorrect airway temperature display on humidifier heater
base.
----
Product: Companion 2801 Portable Volume Ventilator, used to
provide support for ventilator dependent patients in both
the hospital and home care settings. Recall #Z-216-2.
Code: All serial numbers.
Manufacturer: Puritan-Bennett, Portable Ventilator Division, Boulder,
Colorado.
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Recalled by: Manufacturer, by letter December 16, 1991. Firm-initiated
field correction ongoing.
Distribution: Nationwide, Canada, England, Puerto Rico, Argentina, Italy.
Quantity: 1,200 units were distributed.
Reason: Various failure modes, which appear to be associated
with breakage of the roll pin which holds the crank arm to
the motor output shaft, can result in the device failing
to function as intended.
----
Product: Healthy Kleaner, The Good for Your Skin Kleaner, in 2, 4,
and 8 ounce sizes, labeled uses are for removal of
permanent ink, adhesive, heavy oil, tar, glue, caulking
and other oily grime from skin and many other surfaces.
Recall #Z-220-2.
Code: None.
Manufacturer: The GreenSpan, Inc., Boulder, Colorado.
Recalled by: Manufacturer, by telephone in mid-December 1991, to be
followed by letter. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 29 cases of 8 ounce bottles and 7 cases of 4 ounce
bottles were distributed.
Reason: The device makes medical claims in that it can be used
to remove bandage adhesive, and is distributed without
an approved 510(k).
----
Product: SynchroMed Infusion Pump:
(a) Model 8611H; (b) Model 8615; (c) Model 8610H/8502;
(d) Model 8611H/8502, designed to contain and to
administer parenteral drugs to a specific site.
Recall #Z-221/224-2.
Code: Serial range from DAA000004R to DAA00084OR, SJ1203199R
to SJ120444OR and VZ1201342R to VZ1201486R. Not all
serial numbers in these ranges are the numbers of
recalled devices.
Manufacturer: Medtronic Neurological, Minneapolis, Minnesota.
Recalled by: Medtronic, Inc., Minneapolis, Minnesota, by letter
dated October 24, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide, Argentina, Australia, Canada, Hong Kong, Japan,
Mexico, The Netherlands.
Quantity: 1,181 pumps were distributed.
Reason: The devices may exhibit flow rates in excess of accuracy
claims of plus or minus 15 percent due to pump tubing
deviating from required inner diameter size.
----
-8-
Product: Stryker Compact Endoscopy Organizer, Part #240-75,
a cart with 4 shelves which holds a complete endoscopy
system including a camera, VCR and monitor.
Recall #Z-227-2.
Code: All product ever distributed.
Manufacturer: Practical Design, Safety Harbor, Florida.
Recalled by: Stryker Corporation, Kalamazoo, Michigan, by letter
July 25, 1991. Firm-initiated recall complete.
Distribution: Nationwide and Canada.
Quantity: 301 carts were distributed.
Reason: The caster (wheels) on the Endoscopy Organizer have the
propensity to fall off (over time) at the rivet flange joint.
This joint, responsible for holding the wheel housing to
the frame of the compact Endoscopy Organizer, is being
worn by the sharp edge of the column bolt head.
----
Product: Omni-Fit Series II Cup Insert, a modular acetabular cup
component of total hip replacement system, packaged in
cartons of one, a Rx sterile device. Recall #Z-228-2.
Code: Catalog #2041-2850, case code CADW (43 units);
Catalog #2041-2862, case code CADY (18 units).
Manufacturer: Disanto Machine & Tool Company, Stamford, Connecticut.
Recalled by: Osteonics, Corporation, Allendale, New Jersey, by
telephone September 25, 1991, followed by letter
October 11, 1991. Firm-initiated recall ongoing.
Distribution: Arkansas, Florida, Massachusetts, Michigan, Minnesota,
North Carolina, Nebraska, Texas, Virginia, Wisconsin.
Quantity: 61 units were distributed.
Reason: There is a manufacturing error in the location of the
positioning groove on the metal shell face.
----
Class III -
Product: IVION Burette IV Sets. Recall #Z-133-2.
Code: Catalog No. Lot No.
IV3A03 F7018A, F7019B, F7032, F7053A, F7054,
F7076, F7095, F7106, F7107, F7128, F7129,
F7131, F7161, F7162A
IV3A03#603 F7094, F7123
IV3A05 F6971A, F6997, F6998, F7051B, F7057,
F7058, F7092, F7093, F7119, F7120, F7158,
F7159, F7165, F7166, F7233A
IV3A06 F6973, F6974, F6993, F6994A, F7006,
F7007, F7039A, F7060A, F7061, F7078,
F7086, F7097, F7098, F7103, F7104, F7110,
F7111, F7125, F7134, F7195
IV3A08 F7023A, F7085, F7146
-9-
IV3A09#601 F6982, F6983, F7064A, F7065, F7147,
F7148, F7180, F7181
IV3A11#273 F7114, F7143
IV3A12 F7024A, F7025, F7074, F7171
IV3A13 F7003A, F7068, F7157
IV3D05 F7170
IV3D06 F7005, F7069, F7070A
IV3D07 F7113, F7155
IV3D08 F7028A, F7091, F7156
IV3D08#618 F7082
IV3D10 F7000, F7009, F7016, F7029, F7030, F7080,
F7141
IV3D11#611 F6981, F7001A, F7034A, F7067A, F7116,
F7142.
Manufacturer: Ivion Corporation, Broomfield, Colorado.
Recalled by: Manufacturer, by telephone November 27, 1991, followed
by letter November 30, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide, Canada.
Quantity: Firm estimates 3,000 cases (20 sets per case) remain
on the market.
Reason: The device may leak between the burette cylinder and the
bottom cap juncture.
----
Product: COBE Waste Handling Option (WHO) Accessory.
Recall #Z-217-2.
Code: Catalog numbers: 018737-000 and 333250-000, all serial
numbers.
Manufacturer: CGH Medical, Inc., Lakewood, Colorado
Recalled by: Manufacturer, by letter November 1, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Australia, Belgium, Canada.
Quantity: 1,051 units were distributed.
Reason: A higher than anticipated failure rate of two components
result in leaking dialysate around the "boot" and valve
of the assembly.
----
Product: Baxter Fenwal Blood Component Infusion Set, a Rx sterile
13" infusion set with a female luer used for the
syringe push of small volume blood components.
Recall #Z-218-2.
Code: Product #4C2223, lot numbers: U139337, U140863, U141663,
U143347, U145301, U145292.
Manufacturer: Baxter Healthcare Corporation of Puerto Rico,
Aibonito, Puerto Rico.
Recalled by: Baxter Healthcare Corporation, Deerfield, Illinois, by
letter October 29, 1991. Firm-initiated field correction
ongoing.
Distribution: Nationwide, Canada, Colombia, England, Belgium, Spain,
The Netherlands, Germany, Mexico.
-10-
Quantity: 67,488 sets were distributed; firm estimates 30 percent
or the product remains on the market.
Reason: The labeling states that the infusion set contains a 80
micron filter when it actually contains a 170-260 micron
standard blood filter.
----
Medical Device Safety Alerts:
Product: In-vitro diagnostic products. Items (a-f) under the
IMMCO label, items (g-i) under Behring Diagnostics label,
and item (j) under Whittaker Bioproducts label:
(a) Antinuclear Antibody (ANA) Test (HEp-2 cells);
(b) Antinuclear Antibody (ANA) Test (Mouse Liver Sections);
(c) Anti-Native DNA Antibody Test (Crithidia luciliae);
(d) Autoantibody Test System (Mouse Kidney/Stomach
Sections);
(e) Anti-Skin Antibody Test (Monkey/Guinea Pig
Esophagus Sections);
(f) Anti-Skin Antibody Test (Monkey Esophagus Sections);
(g) AFT Systems I Kit (small);
(h) AFT System I Kit (large);
(i) AFT System I Reagent Package for Metpath;
(j) Anti-human IgG conjugate (fluorescein labeled) 2 liter
bulk plasma packs. Safety Alert #M-009/018-2.
Code: All lot and catalog numbers.
Manufacturer: IMMCO Diagnostics, Inc., Buffalo, New York.
Alerted by: Manufacturer, by letter October 25, 1991.
Distribution: Nationwide, Germany, Ireland, Austria, Switzerland,
Canada, Hong Kong.
Quantity: 79 in-vitro diagnostic kits bearing the IMMCO label;
923 AFT System I Kits (small);
3,150 AFT System I Kits (large);
28 AFT System I Reagent Packages for Metpath;
16.2616 liters Anti-human IgG conjugate (fluorescein
labeled) in 2 liter bulk plasma packs were distributed;
firm estimates 75 percent of the product remains on
the market.
Reason: Product contain fluorescein labeled anti-human IgG
conjugate which becomes unstable when stored in direct
light for prolonged periods of time. This may result in
autoantibody test results with a reduced staining
intensity, reduced titers, or false negative reactions.
----
Product: Thora-Seal III (TS-III) underwater chest drainage systems:
(a) Thora-Seal III Underwater Chest Drainage System,
Product #8884-713308;
(b) Thora-Seal III Replacement Collection Bottle,
Product #8884-713900;
(c) Thora-Seal III Autotransfusion Chest Drainage System,
Product #8884-713192;
-11-
(d) Thora-Seal III Autotransfusion Chest Drainage Unit,
Product #8884-713176. Safety Alert #M-022/025-2.
Code: All lots.
Manufacturer: Sherwood Medical, St. Louis, Missouri.
Alerted by: Manufacturer, by letter November 13, 1991.
Distribution: Nationwide, Canada, Argentina, Australia, Hong Kong,
UK, France, Germany, Italy, Hollans.
Quantity: 178,000 units were distributed.
Reason: Both the collection bottle and the suction control bottle
in the devices may develop cracks in the area beneath the
manifold which may not be visible unless the bottles are
removed from the manifold, and which could result in an
air leak.
-12-
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