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
07/31/1990
FDA Enforcement Report for the week of August 1, 1990
FDA ENFORCEMENT REPORT
FOR AUGUST 1, 1990
August 1, 1990
Recalls and Field Corrections:
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
-1-
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Source Plasma. Recall #B-151-0.
Code: Unit numbers: 221679, 483135, 625746, 625842, 626168.
Manufacturer: Montgomery Plasma Center, Inc., Montgomery, Alabama.
Recalled by: Manufacturer, by telephone on or about January 30, 1990
and by letter January 31, 1990. Firm-initiated recall
ongoing.
Distribution: North Carolina.
Quantity: 5 units were distributed.
Reason: Blood products which tested either 1) nonreactive for
the antibody to the human immunodeficiency virus (anti-
HIV-1) by EIA but collected from a donor who had
previously tested reactive for anti-HIV-1 by EIA or
2) non-reactive for hepatitis B surface antigen (HBsAg)
but collected from donors who had previously tested
repeatably reactive for HBsAg, were distributed.
----
Class III -
NONE
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: B-100 Argon Coagulator Disposable Footcontrol Pencil with
10 ft. Cord, a single-use, sterile, electrosurgical Rx
device used in the operating room during patient
surgery. Recall #Z-735/736-0.
Code: All lots of catalog numbers 4009 and 4010.
Manufacturer: Beacon Laboratories, Inc., Broomfield, Colorado.
Recalled by: Manufacturer, by letter July 2, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 2,362 pencils were distributed; firm estimates 600 pencils
remain on market.
Reason: The ceramic tip may fall off.
----
-2-
Product: Endopath Disposable Surgical Trocar, a laparoscopic device
designed to fit 10/11 mm probes, used by the surgeon
during surgery. Recall #Z-737-0.
Code: Catalog #T1011, lot numbers AP6882 and AP6884.
Manufacturer: Ethicon, Inc. - Cincinnati, Ohio.
Recalled by: Ethicon, Inc., Somerville, New Jersey, by letter
February 27, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 2,654 units were distributed; firm estimated 2,307 units
remained on market as of March 12, 1990.
Reason: The gasket may separate or tear and dislodge or cause
unintended desufflation.
----
Product: Vernitron Majestic Table Top Sterilizers, Models 8080,
V8000, or R816 a table top steam autoclave with an
8" x 8" x 16" chamber. Recall #Z-738/740-0.
Code: All of the above model numbers manufactured prior to 1985.
Manufacturer: Vernitron Better Built Corporation (OOB), Carlstadt,
New Jersey.
Recalled by: Vernitron Medical Products, also known as Ped-O-Jet
International, Dayton, New Jersey, by letter February
26, 1990. Firm-initiated field correction ongoing.
Distribution: Nationwide, Canada, Korea.
Quantity: Firm estimates fewer than 100 uncorrected units remain
on market.
Reason: The locking hub may detach from the unit at high pressure
as a projectile and may also cause a compromise of
sterility of the contents of the sterilizer.
----
Product: Entube Enteral Feeding Tubes, non-sterile disposable
devices intended for single patient use to deliver
complete or supplemental liquid diets into the stomach or
small bowel of patients having a functional G.I. tract:
(a) Enteral Feeding Tube with Stylet;
(b) Enteral Feeding Tube. Recall #Z-742/743-0.
Code: Product No. Lot No.
(a) 121245 0002
921245 0001.
Manufacturer: Entech, Inc., Lebanon, New Jersey.
Recalled by: Manufacturer, by letter March 26, 1990. Firm-initiated
recall ongoing.
Distribution: California, Georgia, Illinois, Minnesota, New York,
Texas, Missouri, Iowa, Wisconsin, North Dakota, Ohio.
Quantity: (a) 59 boxes (10 units/box); (b) 46 boxes (10 units/box)
were distributed.
Reason: The tungsten weighted tip can separate from the tube.
----
-3-
Product: AMS Dynaflex Penile Prosthesis, 15 mm diameter - all
lengths; part #72401148 (20 cm length) and part
#72401149 (22 cm length). Recall #Z-746-0.
Code: All lot numbers.
Manufacturer: American Medical Systems Inc., Minnetonka, Minnesota.
Recalled by: Manufacturer, by voice mail notice May 11, 1990 and by
telephone during the period from May 11, 1990 to about
May 16, 1990. Firm-initiated recall complete.
Distribution: Alabama, Arkansas, California, Florida, Georgia,
Indiana, Michigan, North Carolina, Ohio, Tennessee, Texas,
Wisconsin, Washington, D.C.
Quantity: 134 units or 67 pairs of the prostheses were distributed.
Reason: Device may leak hydraulic fluid after implantation.
----
Product: Sustain HA-Biointegrated Dental Implant System Fixed-
Detachable Abutment Heads, 4.0/4.7 mm diameter:
(a) Catalog #0440-4-05, 0.5 mm cuff length;
(b) Catalog #0440-4-15, 1.5 mm cuff length.
Recall #Z-749/750-0.
Code: Lot Numbers: (a) P0220-03; (b) P0220-04.
Manufacturer: Biointerfaces, Inc., San Diego, California.
Recalled by: Lifecore Biomedical/Orthomatrix, Inc., Minneapolis,
Minnesota, by telephone June 14-15, 1990 followed by
letter June 28, 1990. Firm-initiated recall ongoing.
Distribution: Maryland, New Mexico, The Netherlands.
Quantity: (a) 3; (b) 6 abutment heads were distributed.
Reason: Potential for the units to fracture at the base of the
abutment heads.
----
EXTENSION NOTE: Carter Products' Trojan Naturalube Ribbed Condoms,
Recall #Z-092/094-0, which appeared in the November 22,
1989 Enforcement Report has been extended to include
Trojan Naturalube Ribbed Condoms - 12's lot numbers
030989, X030989 and Trojan Naturalube Ribbed Condoms -
36's lot numbers 030989, 020889 and X020889.
----
Class III -
Product: Mon-A-Therm Airway Temperature Sensor. Recall #Z-747-0.
Code: Catalog #503-0640, lot numbers: 640LV50, 640AV50,
640EV50, 640FV60, 640JV70, 640LV50, 640MV60, 640MV61,
640A001, 640A002, 640A003, 640A004.
Manufacturer: Mon-A-Therm, Inc., New Athens, Illinois.
Recalled by: Mallinckrodt Medical, Inc., St. Louis, Missouri, by
letter July 2, 1990. Firm-initiated recall ongoing.
-4-
Distribution: Nationwide and international.
Quantity: 703 cases were distributed.
Reason: Individual pouches were inadvertently labeled as sterile.
The product is not intended to be used as a sterile
device.
----
Product: DGR Intraocular Lens, Model No. PA17-OUV.
Recall #Z-748-0.
Code: Lot #A04011, serial numbers: 9112534/36, 9112575/77.
Manufacturer: DGR, Inc., St. Petersburg, Florida.
Recalled by: Manufacturer, by telephone May 24, 1990. Firm-initiated
recall complete.
Distribution: Florida.
Quantity: 6 lenses were distributed; firm estimates none remains
on market.
Reason: The lens power is mislabeled as 21.0 instead of 21.5.
----
Product: Precept Bouffant Caps, packaged 125/dispenser and
4 dispensers per case. Recall #Z-752-0.
Code: Lot numbers 901001 - 936005 (all product distributed in
1989).
Manufacturer: Mars White Knight, Aqua Prieta, Somona, Mexico.
Recalled by: White Knight Healthcare, Asheville, North Carolina, by
letter September 25, 1989 followed by telephone.
Firm-initiated recall ongoing.
Distribution: Nationwide, Canada, Saudi, Arabia.
Quantity: Unknown.
Reason: Skin irritation in wearers of the device due to the
diammonium phosphate treatment necessary for these
devices to meet flammability requirements for wearing
apparel.
----
VETERINARY PRODUCTS
Class I -
Product: Bovi-Cu, Copper Disodium EDTA, in a 50:50 glycerine water
mix, in 100 ml vials, a nonprescription veterinary
product developed for the prevention of copper deficiency
in beef cattle and calves. Recall #V-049-0.
Code: All lots.
Manufacturer: Anthony Products Company, Arcadia, California.
Recalled by: Veterinary Research and Development, Inc., Truckee,
California, by letter dated June 15, 1990. Firm-initiated
recall ongoing. See also FDA press release P90-33,
June 14, 1990.
-5-
Distribution: California, Colorado, Idaho, Kansas, Missouri, Nebraska,
New Mexico, Oregon, Texas.
Quantity: 3,723 vials were distributed; firm estimates 2,211 vials
remain on market.
Reason: Copper toxicity in cattle following injection of
the product.
----
Class II -
NONE
Class III -
NONE