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
06/26/1990
FDA Enforcement for the week of June 27, 1990
FDA ENFORCEMENT REPORT
FOR JUNE 27, 1990
June 27, 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
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COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
NONE
Class III -
CORRECTION: Recall #B-148-0 which appeared in the June 6, 1990
Enforcement Report should read:
Product: DuPont Human Immunodeficiency Virus Type 1 (HIV-1)
Elisa, Microplate Test Kits, lot 240E0127, expiring May 7,
1990 thru and including lot 268E0224, Expiring August 12,
1990. Recall #B-148-0.
Quantity: 3,953 kits were distributed.
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MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: Zinetics Graphprobe 24 Disposable pH Probe with Internal
Reference, intended for 24 hour monitoring of esophageal
pH in ambulatory patients. Recall #Z-606/609-0.
Code: All lots of the following catalog numbers:
10-245, Single Channel; 10-247A, Dual Channel 5 cm
Sensor Spacing; 10-247B, Dual Channel 15 cm Sensor Spacing;
10-247C, Dual Channel 21 cm Sensor Spacing.
Manufacturer: Zinetics Medical, Inc., Salt Lake City, Utah.
Recalled by: Manufacturer, by letter April 25, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 1,500 probes were distributed; firm estimates 400 remain
on market.
Reason: Product cannot be calibrated prior to use.
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-2-
Product: Sandhill Schuster Probe, a single use, disposable Rx
rectosphincteric manometry balloon probe available for
use with the Sandhill Anorectal Manometry Kit. Probes
are packaged separately and sent along with each kit sold,
and are also sold as a separate unit. Recall #Z-610-0.
Code: Lot numbers 0389, 0489, 0589, 0689, 0789, 0889.
Manufacturer: Sandhill Scientific, Inc., Littleton, Colorado (probe);
Faultless Rubber Company, Ashland, Ohio (balloon component).
Recalled by: Sandhill Scientific, Inc., Littleton, Colorado, by letter
November 27, 1989. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 251 probes were distributed; firm estimates none remains
on market.
Reason: Some balloons were cracked and failed to inflate
properly.
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Product: Cobe Spectra Blood Component Separator, a microprocessor
controlled device intended to separate and collect blood
components from both donors and patients.
Recall #Z-621/623-0.
Code: The following serial numbers apply to Field Service Bulletin
(FSB) Number #9:
FSB #9 - All Spectra equipment catalog numbers (0950000-000
through -005), Serial Numbers:
(a) Heatsink/Power Board change: from serial number
01S00028 to 01S00324;
(b) CCM (Collect Concentration Monitor) change:
from serial number 01S00028 to 01S00322;
(c) Centrifuge Driver CCA (Circuit Card Assembly) change:
from serial number 01S00028 to 01S00313.
NOTE: Certain serial numbered machines within the above
listed ranges will not require field action if the changes
have been already made in the field as a result of FSB-09
change validation or recent repair. These are as
follows: Machines numbered 01S00166, 01S00167, 01S00169,
01S00291, 01S00297, 01S00298, and 01S00299 at HemaCare;
01S00067, 01S00112, 01S00113, 01S00114, 01S00132, 01S00164,
and 01S00265 at Portland ARC; and 01S00033, 01S00038,
01S00122, 01S00239, 01S00242, and 01S00243 at M.D. Anderson
have all been upgraded and functionally tested as part of
the validation of FSB #9.
Manufacturer: Cobe Laboratories, Inc., Lakewood, Colorado.
Recalled by: Manufacturer, by letter February/March, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: Approximately 324 units are involved.
Reason: Power board failures, random false alarms, and the collect
concentration monitor may come apart during operation.
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Product: Conmed Pleura-Gard Autotransfusion Harvesting Unit, a
sterile Rx device designed for post-operative reinfusion
of autologous blood. Recall #Z-655-0.
Code: Catalog #661-2650 -- All lots.
Manufacturer: Conmed Corporation, Utica, New York.
Recalled by: Manufacturer, by telephone and by FAX May 17, 1990 followed
by letter May 18, 1990. Firm-initiated recall ongoing.
Distribution: Illinois, South Carolina, Pennsylvania, Virginia, Ohio and
international.
Quantity: 122 cases (5 boxes/case) were distributed; firm estimates
31 cases remain on market.
Reason: The product has defective packages which may compromise
the sterility of the device.
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Product: Cobe AEPS (Air Emboli Protection System) Level Sensor
Mount Kit, an attachment kit used to detect low fluid level
in the Cobe Oxygenator Reservoir. Kit consists of
the following:
(a) Level Transducer Holder, Catalog #043-220-200;
(b) AEPS Attachment Plate, Catalog #043-220-300;
(c) Cobe Computerized Perfusion Controller (CPC), Catalog
numbers: 043-650-000, 043-650-001, 043-650-004, 043-650-500,
043-650-501, 043-650-502, 043-650-504;
(d) Cobe Air Emboli Protection System (AEPS), Catalog
numbers: 043-630-000, 043-630-001 through 043-630-005,
043-630-007, 043-650-900 through 043-630-905, 043-630-907.
Recall #Z-672-0.
Code: Lot numbers: (a) 02U13673, 01U13686, 01U13672, 01U13653,
01U13628, 04U13603, 03U13662, 04U13604;
(b) 03U13629, 01U13654, 12T13632;
(c) CPC609W, CPC618W, CPC619W, CPC620W, CPC621W, CPC622W,
CPC623Y, CPC626Y, CPC627Y, CPC628Y, CPC629Y, CPC630Y,
COC631Y, CPC632Y, CPC634Y, CPC635Y, CPC636Y, CPC638Z,
CPC639Z, CPC640Z, CPC641Z, CPC642Z, CPC643Z, CPC644Z,
CPC646Z, CPC647Z;
(d) AEPS182F, AEPS356N, AEPS357N, AEPS376P, AEPS423R,
AEPS486S, AEPS487S, AEPS488S, AEPS489S, AEPS490S, AEPS492S,
AEPS493T, AEPS494T, AEPS495T, AEPS496T, AEPS497T, AEPS498T,
AEPS499T, AEPS500T, AEPS501T, AEPS502T.
Manufacturer: Cobe Laboratories, Inc., Cardiovascular Division,
Arvada, Colorado.
Recalled by: Manufacturer, by letter May 18, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: (a) 371 units; (b) 14,000 units; (c) 26 units;
(d) 21 units were distributed.
Reason: System may fail to detect a low level condition in the
oxygen reservoir when mounted in the new disposable stick-on
mounting bracket.
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Product: (a) Transducer-Tipped Pressure Monitoring Catheter, Model
110-4, in plastic tray within a Tyvek pouch, size 4F,
sterile, for single use only;
(b) OLM Intracranial Pressure Monitoring Kit, Model 110-4B,
packaged with 8 other components in a plastic tray within
a tyvak pouch, sterile, for single use only.
Recall #Z-674/675-0.
Code: Serial numbers: (a) 5713-01, 5713-04, 5713-06, 5713-07,
5713-08, 5713-09, 5713-10, 5713-11, 5713-12, 5713-15,
5713-16;
(b) 6500-01, 6500-02, 6500-09, 6500-10, 6500-11, 6500-12,
6500-13, 6500-15, 6500-16.
Manufacturer: Camino Laboratories, Inc., San Diego, California.
Recalled by: Manufacturer, by telephone October 19, 1989. Firm-initiated
recall complete.
Distribution: (a) Japan; (b) Arkansas.
Quantity: (a) 9 units; (b) 11 units were distributed; firm estimates
none remains on market.
Reason: The tranducer tip may move when subjected to mechanical
stress, which could result in inaccurate readings and drift
the pressure waveforms as displayed on a monitoring device.
----
Class III -
Product: Cobe Patient Monitoring Trifurcate Sets, a single-use
sterile Rx device used for patient fluid administration.
Recall #Z-673-0.
Code: catalog #039-823-599, lot #02U9105.
Manufacturer: Cobe Laboratories, Inc., Cardiovascular Division,
Arvada, Colorado.
Recalled by: Manufacturer, by letter May 18, 1990. Firm-initiated recall
ongoing.
Distribution: Kansas, Florida, Oregon.
Quantity: 550 sets were distributed.
Reason: The sets may contain "bifurcate" instead of "trifurcate"
administration sets.
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VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: Amvet Atropine Sulfate, 1/120, Injectable Sterile Solution,
100 ml, indicated for use in dogs and cats as a treatment to
block the effects of organophosphate insecticides and
chlolinergic drugs on the central and peripheral nervous
system. Recall #V-045-0.
-5-
Code: Lot #1950.
Manufacturer: Amvet Pharmaceuticals, division of American Veterinary
Products, Inc., Fort Collins, Colorado.
Recalled by: Manufacturer, by letters of April 27, 1990 and May 17,
1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 5,610 units were distributed.
Reason: Subpotency.
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Product: Amvet Cyanocobalamin 1000 and 3000, 100 ml sterile
injectable solution, an Rx veterinary drug indicated for
use in vitamin B12 deficiency associated with cobalt
deficiency in cattle and sheep and for vitamin B12
deficiency associated with inadequate vitamin B12 intake or
intestinal malabsorption in swine. Recall #V-046-0.
Code: Lot numbers: B12 1000 - 1954, 1957, 1960;
B12 3000 - 1955, 1956.
Manufacturer: Amvet Pharmaceuticals, division of American Veterinary
Products, Fort Collins, Colorado.
Recalled by: Manufacturer, by letters dated April 27, 1990 and
May 17, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 22,238 units were distributed.
Reason: Subpotency.
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Product: Iron Hydrogenated Dextran Injection, an Rx veterinary
drug in 100 ml vials, indicated for the prevention and
treatment of anemia due to iron deficiency in baby pigs,
under the Durvet, Vedco, and Agrilabs labels.
Recall #V-047-0.
Code: Lot #891362-1.
Manufacturer: Veterinary Laboratories, Inc., Lenexa, Kansas.
Recalled by: Manufacturer, by letter May 29, 1990. Firm-initiated
recall ongoing.
Distribution: Missouri.
Quantity: 10,028 bottles were distributed.
Reason: Product was not manufactured in conformance with
current good manufacturing practice regulations and may
by pyrogenic.
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Class III -
NONE
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Medical Device Safety Alerts:
Product: Air-Shields Vickers Infant Isolette Incubators that are
"RAM (Remote Alarm Module) Ready":
(a) Model C100; (b) Model C200; (c) Model C100QT;
(d) Model C200QT. Safety Alert #M-051/054-0.
Code: All models that are "RAM Ready".
Manufacturer: Air-Shields Vickers, Hatboro, Pennsylvania.
Alerted by: Manufacturer, by letter on or about April 20, 1990.
Distribution: Nationwide and international.
Quantity: Firm estimates 3,800 to 3,950 units remain in use.
Reason: Product may cause skin burns due to the inadvertent
connection of an incorrect skin temperature probe into
the REMOTE ALARM module receptacle of the Isolette Infant
Incubator.