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
05/29/1990
FDA Enforcement for the week of May 30, 1990
FDA ENFORCEMENT REPORT
FOR MAY 30, 1990
May 30, 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 -
Product: (a) Platelets (expired); (b) Recovered Plasma.
Recall #B-127/128-0.
Code: Unit numbers: (a) MC18462, MC15995; (b) MC13536, MC15736,
MC18312, MC18437, MC18462, MC20667, MC21444, MC21602,
MC21859, MC22326.
Manufacturer: Medical Center Hospital (MCH), Odessa, Texas.
Recalled by: Manufacturer, by letter January 16, 1990. Firm-initiated
recall complete.
Distribution: (a) California; (b) Florida.
Quantity: (a) 2 units; (b) 10 units were distributed.
Reason: Blood products were distributed which tested 1)
repeatably reactive for HBsAg, 2) nonreactive for
the antibody to the human immunodeficiency virus,
type 1 (anti-HIV-1) by EIA but collected from donors
who had previously tested repeatably reactive for anti-
HIV-1 by EIA.
----
Product: Cobe Spectra Tubing Set.
Recall #B-145-0.
Code: Extended Life Platelet Tubing Set Catalog #777003-000, all
lots with an "S" in the lot number, and all lot numbers
beginning with 01T, 02T, 03T, 04T.
Manufacturer: Cobe Laboratories, Inc., Lakewood, Colorado.
Recalled by: Manufacturer, by letter January 16, 1990. Firm-initiated
recall complete.
Distribution: Nationwide and international.
Quantity: 8,454 sets were distributed.
Reason: Tubing sets were misassembled during manufacture which
resulted in the inversion of two lines connecting "y"
connectors and the collection bags.
----
Class III -
Product: Recovered Plasma. Recall #B-129-0.
Code: Unit numbers: MC11720, MC15076, MC15084.
Manufacturer: Medical Center Hospital, Odessa, Texas.
Recalled by: Manufacturer, by letter January 16, 1990. Firm-initiated
recall complete.
Distribution: Florida, California.
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Quantity: 3 units were distributed.
Reason: Recovered plasma was distributed which tested initially
reactive for the hepatitis B surface antigen.
----
Product: Cobe Spectra Tubing Sets: (a) Platelet Set;
(b) White Blood Cell Set. Recall #B-146/147-0.
Code: (a) Catalog #777004-000, lot numbers: 08S15379,
02T15378; (b) Catalog #777006-000, lot numbers:
01T15394, 01T15388.
Manufacturer: Cobe Laboratories, Inc., Lakewood, Colorado.
Recalled by: Manufacturer, by January 16, 1990. Firm-initiated
recall complete.
Distribution: Nationwide and international.
Quantity: (a) 456 sets; (b) 228 sets were distributed.
Reason: Tubing sets were misassembled during manufacture which
resulted in the inversion of two lines connecting "y"
connectors and the collection bags.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: Model 5800 CADD-PCA Ambulatory Infusion Pump, an Rx
medical device intended for use as a pain management device.
Recall #Z-504-0.
Code: Serial numbers 800501 through 804510.
Manufacturer: Pharmacia Deltec, Inc., St. Paul, Minnesota.
Recalled by: Manufacturer, by letter January 24, 1990. Firm-initiated
field correction ongoing.
Distribution: Nationwide and Canada.
Quantity: 2,757 pumps were distributed.
Reason: Software error -- If the drug concentration entered into
the pump program is four mg/ml, the device will report
"MG Given" to be one-half the dose actually delivered.
----
Product: Ballard Medical Products' Heimlich Micro Trach Transtracheal
Oxygen Delivery System, a single-use, sterile, 5F or 6F
non-toxic catheter, intended to permit administration of
low flow oxygen to patients during surgery:
(a) Catalog No. 170; (b) Catalog No. 171;
(c) Catalog No. 175; (d) Catalog No. 176.
Recall #Z-545/548-0.
Code: Lot numbers: (a) 7 12 89 0021, D90-017, D90-022, D90-028;
(b) D89-102, D90-016, D90-026, D90-032;
(c) 7 12 89 0220, D90-018, D90-027;
(d) D89-103, D90-014, D90-015, D90-021, D90-025, D90-033.
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Manufacturer: Ballard Medical Products, Midvale, Utah.
Recalled by: Manufacturer, by letter March 23, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Canada, Puerto Rico.
Quantity: 2,395 units were distributed.
Reason: The catheter may kink within the trachea.
----
Product: Medtronic Model 5866-9 Adaptor Kit containing an adaptor
(part 149039-G01) which is used with various non-Medtronic
leads to provide a compatible connection to a Medtronic
Implantable Pulse Generator. Recall #Z-552-0.
Code: Lot #J89064064.
Manufacturer: Medtronic, Inc., Minneapolis, Minnesota.
Recalled by: Manufacturer, by letter and facsimile March 16, 1990.
Firm-initiated recall ongoing.
Distribution: Florida, Kentucky, Austria, Great Britain, The Netherlands,
Spain, France, Italy, Portugal, West Germany.
Quantity: 175 kits were distributed.
Reason: An incorrect adaptor part that has a smaller inner
diameter in the female opening than the correct part
was placed in a portion of kits during packaging.
----
Product: (a) Models SCL-5130, SCL-5125, SCL 5025; (b) Model SPL-2120
Laser Workstations, used for job shop application for
cutting prototype parts, primarily automotive.
Recall #Z-611/612-0.
Code: Serial numbers: (a) HAY-0123 (SCL-5130), AAY-0106H
(SCL-5125), HAY-0164H, HAY-0175H, HAY-0188H, HAY-0195H
(SCL-5025); (b) HAY-0151H.
Manufacturer: Utilase Systems, Inc., Detroit, Michigan.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan April 19, 1990. Firm-initiated field correction
ongoing.
Distribution: Michigan, North Carolina, Illinois.
Quantity: 8 units were distributed.
Reason: Noncompliance with the performance standard for laser
products in that they lacked identification, certification
and other required labels. Also, the user manual did not
contain all the required information.
----
Product: Alpha MC-9 Series Mobile C-Arm Image Intensified Unit,
used for fluoroscopy with spot x-ray film capacity.
Recall #Z-613-0.
Code: Serial numbers: MC7719, MC7721, MC7717, MC7711, MC7718,
MK7722, MC7724, MC8314.
Manufacturer: Instrumentarium Imaging, Inc., Milwaukee, Wisconsin.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan March 20, 1990. Firm-initiated field correction
ongoing.
Distribution: Pennsylvania, Ohio, Kentucky, Delaware, Michigan.
Quantity: 8 units were distributed.
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Reason: Noncompliance with the Performance Standard for X-Ray
Products 21 CFR 1020.31 (g)(l) "Field limitation and
alignment for spot-film devices." The field size was
not maintained when switching from fluoroscopy to
radiography.
----
Product: Alpha MC-9R C-Arm Image Intensified Unit, used for
job shop application for cutting prototype parts,
primarily automotive. Recall #Z-614-0.
Code: Serial number MC8314.
Manufacturer: Instrumentarium Imaging, Inc., Milwaukee, Wisconsin.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan March 30, 1990. Firm-initiated field correction
ongoing.
Distribution: Michigan.
Quantity: 1 unit was distributed.
Reason: Noncompliance with the performance standard for x-ray
products. The area of noncompliance include performance
specifications corresponding to mA and kV not meet the
accuracy statement at various kV settings.
----
Product: Fisher Diagnostics Sera Chem Clinical Chemistry
Control Serum (Bovine) Unassayed Level II, used as a
reference sample, intended to be used as if it were a
clinical specimen (a positive control), intended for
estimating the precision and analytical bias in
equipment used in the determination of a number of
clinical analysis. Recall #Z-615-0.
Code: Catalog #3111-84, Lot #N1280799 EXP 8/1/91.
Manufacturer: Instrumentation Laboratory, Division of Fisher
Scientific Company, Inc., Orangeburg, New York.
Recalled by: Manufacturer, by letter November 8, 1989. Firm-initiated
recall ongoing.
Distribution: Texas, Washington state, Tennessee, New Jersey, New York,
Pennsylvania, California.
Quantity: 1,027 packages were distributed.
Reason: The product does not meet the label claim of 48 hours
stability for Creatine Kinase (CK).
----
Product: 3M PI-55 Urological 4.8 mm Surgical Staples, for use
in the creation of a continent ideal reservoir (Kock
Pouch) for urinary bladder replacement. Recall #Z-616-0.
Code: JUL 89 104 89601.
Manufacturer: 3M Edumex, Juarez, Mexico.
Recalled by: 3M Medical-Surgical Division, St. Paul, Minnesota, by
telephone beginning April 4, 1990. Firm-initiated
recall complete.
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Distribution: North Carolina, Illinois, Texas, California.
Quantity: 13 boxes of 12 individually-packaged staple cartridges
per box were distributed.
Reason: The staples were removed from the wrong end of the cartridge,
which has differentiated ends because a hole for the
locking pin is in one end.
----
Product: Medtronic Cardiac Sling, Model 7703PE, used during
cardiopulmonary bypass to hold the heart in an elevated
position. Recall #Z-626-0.
Code: Lot #PE89051140.
Manufacturer: Wilshire Foam Products, Inc., Carson, California.
Recalled by: Medtronic, Inc., Fridley, Minnesota, by visit during
July 1989. Firm-initiated recall complete.
Distribution: Wisconsin, Missouri.
Quantity: 20 units were distributed.
Reason: The cardiac sling may shed fibers of polyurethane material
into the surgical wound due to improper die cutting of
the holes in the sling body.
----
Product: Zenith-Cox Flexion Chiropractic Tables:
(a) Model 90 (fixed height table);
(b) Model 95 (variable height table). Recall #Z-627/628-0.
Code: Consecutive serial numbers 60454 through 62038, all units
built between June 1988 and April 1989.
Manufacturer: Williams Manufacturing Company, Elgin, Illinois.
Recalled by: Manufacturer, by letter April 17 and 23, 1990.
Firm-initiated field correction ongoing.
Distribution: Nationwide and international.
Quantity: (a) 70 tables; (b) 298 tables were distributed; firm
estimates 90 percent remains on market.
Reason: One or more bolts in the caudal support linkage may
work out during use, causing the caudal section of the
table to suddenly drop to the floor.
----
Class III -
Product: Dental Implant Impression Post, a component of the
Interpore IMZ Osteointegrated Implant System, used for
making dental fitting impressions. Recall #Z-625-0.
Code: Catalog #8425, lot #9281.
Manufacturer: Eberle Medizin, Technische Elemente GMBH, Wermberg,
West Germany.
Recalled by: Interpore International, Irvine, California, by telephone
November 8, 1989 followed by letter November 20, 1989.
Firm-initiated recall ongoing.
Distribution: California, Florida, Ohio, Oregon.
Quantity: 17 posts were distributed.
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Reason: Size 3.3 x 2 mm posts were erroneously packaged and
labeled as size 4.0 x 2 mm posts.
----
Product: Gas Cylinders for CDI Model 520 Calibrator, used to
calibrate the CDI Model 200 and Model 300 Extracorporeal
Blood Gas Monitors:
(a) CDI Gas I/Gas 1, Model No. 7210 Components
Concentration Contents 30.25 liters;
(b) CDI Gas II, Model No. 7240 Components Concentration
Contents 30.25 liters. Recall #Z-633/634-0.
Code: Lot numbers: (a) 013509, 033399, 053419, 080100, 120170,
153629; (b) 010050, 020240, 053479, 060040, 083399.
Manufacturer: Chilton Metals, Chilton, Wisconsin.
Recalled by: CDI/3M Health Care, Irvine, California, by letter March 15,
1990. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 1,573 cylinders were distributed.
Reason: The threads on the devices were not compatible with
the threads on the CDI Model 520 Calibrator causing gas
leakage which may result in miscalibration of the monitors.
----
VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: MVI Lincomycin Premix for Swine and Chickens, 10 grams
per pound, in 50 pound bags. Recall #V-043-0.
Code: All lots.
Manufacturer: Mountaire Vitamins, Inc., North Little Rock, Arkansas.
Recalled by: Manufacturer, by letter February 19, 1990. Firm-
initiated field correction complete.
Distribution: Texas, Georgia.
Quantity: Firm estimated 20 bags remained on market.
Reason: The product label failed to contain the required
warning and caution statements regarding the six-day
pre-slaughter withdrawal period, guaranteed analysis,
and directions for use.
----
Class III -
Product: Dexamethasone Tablets, USP, 0.25 mg, in 1,000 tablet
bottles, a veterinary Rx drug indicated for use as an
anti-inflammatory agent in cats and dogs, under the
following labels: Osborn Essar Corporation, Phoenix
Pharmaceutical, Professional veterinary Labs, VEDCO,
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Tech America, Central Vet Supply, The Butler Company.
Recall #V-044-0.
Code: Lot numbers: 206-138, 206-140, 206-141, 206-142,
206-143, 206-144, 206-146, 206-153.
Manufacturer: Sanofi Animal Health, Inc., La Seur, Minnesota.
Recalled by: Sanofi Animal Health, Inc., Ft. Dodge, Iowa, by letter
April 20, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Canada.
Quantity: 12,300 bottles were distributed.
Reason: Lots 146 and 153 are superpotent. The rest are subpotent.
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Medical Device Safety Alerts:
Product: Digit, Ear, and Flexible Sensors used with the LIFESTAT
1600 pulse oximeter:
(a) Digit sensor, Part No. 804343-00;
(b) Ear Sensor, Part No. 804582-00;
(c) Flexible Sensors (adult, pediatric, infant and
neonate), Part numbers 804554-00, 804635-00,
804634-00, 804633-00. Safety Alert #M-048/050-0.
Code: All sizes. These assemblies are not serialized.
Manufacturer: Physio Control Corporation, Redmond, Washington (digit
sensors); Honeywell Corporation, Juarez, Mexico (all
other sensors).
Alerted by: Physio Control Corporation, Redmond, Washington, by
letter April 16, 1990.
Distribution: Nationwide and international.
Quantity: 5,362 (finger/hand); 1,817 (ear/hand); 6,285 (adult/flex);
4,523 (pediatric/flex); 1,107 (infant/flex); 2,998
(neonate/flex) sensors were distributed.
Reason: When a Physio-Control sensor is used with Ohmeda pulse
oximeter models 3700, 3710, 3740, patient burns may occur
at the sensor site.