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
04/16/1991
FDA Enforcement for the week of 4/16/91
FDA ENFORCEMENT REPORT
FOR APRIL 16, 1991
April 17, 1991
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.
Product: Southern Belle brand Ready To Eat Sandwiches:
(a) Barbeque Beef Sandwich, 4 ounces;
(b) Ham N Cheese Poboy Sandwich, 6 1/2 ounces.
Recall #F-292/293-1.
Code: (a) Pull Dates B2, B5, B9 and B12;
(b) Pull Dates B7, B8 and B9.
Manufacturer: Southern Belle Sandwich Company, Inc., Baton Rouge,
Louisiana.
Recalled by: Manufacturer, by oral communication February 6, 1991
followed by visit. Firm-initiated recall ongoing.
Distribution: Louisiana, Florida, Mississippi, Alabama.
Quantity: Approximately (a) 2,120 units; (b) 2,737 units
were distributed.
Reason: Products contaminated with Listeria monocytogenes.
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-1-
Product: Ham Salad 95% Fat Free Low Cholesterol Sandwich.
Recall #F-314-1.
Code: Good thru 02/23/91 and Good thru 03/01/91.
Manufacturer: NSI/Griswold Company, Golden Valley, Minnesota.
Recalled by: Manufacturer, by memorandum February 27, 1991.
Firm-initiated recall ongoing.
Distribution: Minnesota.
Quantity: 460 units were distributed.
Reason: Product is contaminated with Listeria monocytogenes.
----
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.
Product: Various jellies in 1/2 ounce size units:
(a) Strawberry Jelly; (b) Grape Jelly;
(c) Mixed Fruit Jelly. Recall #F-305/307-1.
Code: Lot numbers: 1210990, 12101090, 12101190.
Manufacturer: Crystal Foods, Inc., Cleveland, Ohio.
Recalled by: Manufacturer, by letter February 12, 1991. Firm-initiated
recall ongoing.
Distribution: Ohio, Michigan, Illinois.
Quantity: 300 cases (25 units/case) were distributed; firm estimates
none remains on the market.
Reason: Product contains unapproved, non-permitted food colors.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Various ginseng products in containers labeled in part:
(a) "Jinbee Pollen Tonic for Tea";
(b) "Te De Ginseng Koreano";
(c) "Caramelos Y Chicles De Ginseng";
(d) "Korean Powder In Capsules For Tea";
(e) "Korean Ginseng Essence For Tea";
(f) "Panax Ginseng Extractum". Recall #F-308/313-1.
Code: Jin Bee Pollen Tonic-Lot #120789. All other products
have bar codes only.
Manufacturer: Dai Wang Pharmaceutical Company, Ltd., Seoul, Korea.
Recalled by: Aldo Nicola, Coamo, Puerto Rico (distributor), by visit
January 15, 1991. Firm-initiated recall ongoing.
Distribution: Puerto Rico.
-2-
Quantity: 1,420 units of different ginseng products were distributed.
Reason: False and misleading claims.
----
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Diphenhydramine Hydrochloride Capsules, 50 mg, in 1,000
capsule bottles, an OTC product used as an antihistaminic
and as a nighttime sleep aid. Recall #D-295-1.
Code: Control numbers: 01294C, 01558C, 01559C, 01963C, 02560C,
02561C, 02827C, 02828C, 03040C, 03598C.
Manufacturer: Danbury Pharmacal, Inc., Carmel, New York.
Recalled by: Manufacturer, by FAX and by letters dated February 27
and 28, 1991. Firm-initiated recall ongoing.
Distribution: New York.
Quantity: 6,601 bottles were distributed.
Reason: Lack of tamper resistant packaging features.
----
Product: Source Plasma. Recall #B-193-1.
Code: Unit #54474.
Manufacturer: Yale Blood Plasma, Inc., Albuquerque, New Mexico.
Recalled by: Manufacturer, by telephone February 7, 1991.
Firm-initiated recall complete.
Distribution: New York.
Quantity: 1 unit.
Reason: Blood component, which tested initially reactive
for the antibody to the human immunodeficiency virus,
type 1 (anti-HIV-1), was distributed.
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Recovered
Plasma. Recall #B-203/205-1.
Code: Unit numbers: (a) 01E00954, 01F71259, 01G92539, 01J70801,
01K81892; (b) 01F71259; (c) 01E00954, 01F71259, 01G92539,
01J70801, 01K81892.
Manufacturer: American Red Cross Blood Services, Rochester, New York.
Recalled by: Manufacturer, by letters dated between August 8, 1990
and October 10, 1990 and by telephone between March
29, 1990 and September 19, 1990. Firm-initiated recall
ongoing.
-3-
Distribution: (a) New York, Pennsylvania; (b) Florida, New York;.
(c) California, Switzerland.
Quantity: (a) 5 units; (b) 1 unit; (c) 5 units.
Reason: Blood products drawn from donors who 1) admitted to
intravenous (IV) drug use, 2) were exposed to hepatitis
A and B infected individuals or 3) donated four times
within 56 days, were distributed.
----
Class III -
Product: Menthol Eucalyptus Cough Suppressant Tablets,
packaged in retail bags of 30 tablets/bag or
individually wrapped tablets in bulk, in the
following flavors:
Regular 6.1 mg Menthol and 5.3 mg Eucalyptus Oil/Tablet;
Ice Blue 10.0 mg Menthol and 5.1 mg Eucalyptus Oil/tablet;
Cherry 6.1 mg Menthol and 5.3 mg Eucalyptus Oil/Tablet;
Honey Lemon 8.4 mg Menthol and 7.2 mg Eucalyptus Oil/Tablet,
under the following labels: Rite Aid; Treasury.
Recall #D-281-1.
Code: Lot numbers: 284, 288, 289, 294, 296, 298, 299, 304,
307, 308, 310, 313, 316, 320, 324, 332, 333, 336, 337,
346, 347, 352, 358, 361, 369, 370.
Manufacturer: Beacon Sweets, Inc., Morresville, North Carolina.
Recalled by: Manufacturer, by letter February 14, 1991. Firm-initiated
recall ongoing.
Distribution: North Carolina, Illinois, Washington state, Minnesota.
Quantity: Undetermined.
Reason: Product is subpotent for menthol and Eucalyptus oil
ingredients.
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Recovered
Plasma. Recall #B-206/208-1.
Code: Unit numbers: (a) 01X31890, 01J72534, 01X35018;
(b) 01X31890, 01J72534, 01G96291, 01X35018;
(c) 01X31890, 01J72534, 01G96291.
Manufacturer: American Red Cross blood Services, Rochester, New York.
Recalled by: Manufacturer, by letters between August 8, 1990 and October
10, 1990 and by telephone March 29, 1990 and September
19, 1990. Firm-initiated recall ongoing.
Distribution: (a) New York, Pennsylvania; (b) Florida, New York;
(c) California, Switzerland.
Quantity: (a) 3 units; (b) 4 units; (c) 3 units.
Reason: Blood products drawn from donors who 1) were exposed to
hepatitis A infected individuals or 2) donated four times
within 56 days, were distributed.
----
-4-
MEDICAL DEVICES AND RADIOLOGY
Class I -
Product: LIFEPAK 10 Defibrillator/Monitor. Recall #Z-475-1.
Code: Part #804200- (All dash numbers and serial numbers).
Manufacturer: Physio Control Corporation, Redmond, Washington.
Recalled by: Manufacturer, by letter January 2, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: Approximately 7,642 units were distributed.
Reason: The portion of the LIFEPAK 10 on/off power knob surrounding
the switch shaft and retainer clip may develop a crack and
allow the knob to rotate without activating or de-activating
the on/off switch, or allow it to select another battery
position.
----
Class II -
Product: Alpine Air Electronic Air Purifier, Alpine Model 150.
Recall #Z-261-1.
Code: Serial numbers: 1000 through 41303.
Manufacturer: Alpine Air Products, Inc., Minneapolis Minnesota.
Recalled by: Manufacturer during sales meeting May 31, 1990
followed by June 1990 promotional publication.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 40,303 units were distributed.
Reason: The device may generate ozone in excess of the 0.5 limit
established in 21 CFR 80.1415 for devices which generate
ozone by design or as a by-product.
----
Product: Models CI-2200 and CI-2202 Liquid Particle Counters,
a quality control and process control product.
Recall #Z-280-1.
Code: Undetermined.
Manufacturer: Climet Instruments Company, Redlands, California.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan February 8, 1991. Firm-initiated field correction
ongoing.
Distribution: California.
Quantity: 1 unit.
Reason: Noncompliance with the performance standard for laser
products in that they lack safety interlocks to prevent
access to laser radiation during maintenance procedures.
----
-5-
Product: Model EX 200L Semi Conductor Wafer Inspection Test
Station, used for quality control. Recall #Z-281-1.
Code: Undetermined.
Manufacturer: Inspex Inc., Waltham, Massachusetts.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan February 8, 1991. Firm-initiated field correction
ongoing.
Distribution: Nationwide.
Quantity: 6 units were distributed.
Reason: Noncompliance with performance standard for laser
products in that it lacks the appropriate warning
logotype for its class.
----
Product: Candela SPTL - Dermatology Laser System Mark I and II
configured with the 3 MM/5MM interchangeable handpiece.
Recall #Z-282/283-1.
Code: Serial numbers 0001 through 2185.
Manufacturer: Candela Laser Corporation, Wayland, Massachusetts.
Recalled by: Manufacturer, by letter November 9, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 179 units were distributed.
Reason: Noncompliance with performance standard for laser products
in that the gauge rod may bend causing inaccurate power
reading or altering calibration.
----
Product: Angiographic catheters, a class II restricted medical
device used to introduce radiographic contrast solution
into a blood vessel during an angioplasty procedure:
(a) Digiflex Catheters (white); (b) Selective Catheters;
(c) Digiflex Soft Catheters (white); (d) Digiflex Selective
Catheters; (e) Digiflex Catheters (white);
(f) Selective Catheters. Recall #Z-304/309-1.
Code: (a) All catalog numbers beginning with the numbers 31;
(b) All catalog numbers beginning with the numbers 36.
Lot numbers with no expiration date or expiration dates
prior to January 1992;
(c) All catalog numbers beginning with the numbers 31;
(d) All catalog numbers beginning with the numbers 36.
Lot numbers with no expiration date or expiration
dates prior to January 1991.
(e) All catalog numbers beginning with the letter D.
(f) All catalog numbers beginning with the letters MN and
SN.
Manufacturer: Boston Scientific Corporation, Medi-Tech Inc., Watertown,
Pennsylvania.
Recalled by: Manufacturer, by letters of December 28, 1990 and
January 2, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
-6-
Quantity: 199,100 catheters were distributed; firm estimates that
20 percent of this amount remains on the market.
Reason: Device may become brittle causing breakage during
preparation for use or during use.
----
Product: Teletrace II Model 9444 ECG Receiver System.
Recall #Z-332-1.
Code: Serial numbers: XL0000118R through XL0000214R.
Manufacturer: Medtronic, Inc., Minneapolis, Minnestoa.
Recalled by: Manufacturer, by letter November 12, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Canada, Australia, Europe.
Quantity: 57 units were distributed.
Reason: Patient data may be lost during transfer by the device
due to a software error.
----
Product: Small knee Patellas, part number 1254-SM01, 1264-SM01, and
1274-SM01. The product is patellar component used in the
Plus System Total Knee (replacement). Recall #Z-345/347-1.
Code: All lots.
Manufacturer: Orthomet, Inc., Minneapolis, Minnesota.
Recalled by: Manufacturer, by telephone December 7, 1990, and by letters
December 10, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Japan, Sweden, Austria, Spain, Switzerland,
Germany, Belgium, Taiwan.
Quantity: 2,500 units were distributed.
Reason: Using a small patellar component with a large or extra-large
femoral component may result in the patellar component
dropping into the intercondylar notch at ranges above
90 degrees. Over time this can lead to irregular wear of
the patellar with the potential for cracking.
----
Product: Burdick Interpretive Electrocardiographs, Models E500 and
E600. Recall #Z-351/352-1.
Code: All E500 units with software revision v.1017 and all
E600 units with software revision v.1010.
Manufacturer: Mortara Instrument, Inc., Milwaukee, Wisconsin.
Recalled by: Siemans-Burdick, Milton, Wisconsin, by field service
memorandum September 20, 1989. Firm-initiated field
correction ongoing.
Distribution: Nationwide, Canada, Indonesia.
Quantity: 134 Model E500 units and 122 Model E600 units.
Reason: A defect in the software revision causes the device to lose
the capability of noting that an electronic pacemaker is in
place.
----
-7-
Product: Cooling Units (a) CU 2000; used in the Tomoscan T3XX
and SRC X-ray tubes; (b) CU 3000 used in the Philips MRC
X-ray tube. The cooling units are components used in the
MRC/SRC X-ray tube assembly; Recall #Z-441/442-1.
Code: (a) PEI #9806 602 22002; (b) PEI #9806 602 60002.
Cooling oil hose #4512 148 53191 or 4512 148 44452.
Manufacturer: Philips Medical Systems, Hamburg, West Germany.
Recalled by: Philips Medical Systems North America, Shelton, Connecticut,
by letter October 16, 1990. Firm-initiated field correction
ongoing.
Distribution: Nationwide.
Quantity: (a) 74 units; (b) 4 units were distributed.
Reason: Faulty cooling hose may swell and fall apart.
----
Product: Sterile, disposable, single-use tips packed in clear
plastic pouches and placed 25 pouches in a cardboard box
which reads in part, "*** Periotemp 25 Periotemp Probe
Tips Sterile Probe Tips ***." The tips were shipped as an
accessory to the Periotemp Electronic Monitor which is used
in periodontal procedures to measure temperature in gums.
Recall #Z-450-1.
Code: Lot #3290P5.
Manufacturer: Abiodent, Danvers, Massachusetts.
Recalled by: Manufacturer, by telephone October 12, 1990 followed by
letter October 30, 1990. Firm-initiated recall complete.
Distribution: Washington, D.C.
Quantity: 1 box of 25 tips was distributed.
Reason: Product was labeled as being sterile but was not sterilized.
----
Product: Foley Catheters, 75 cc ribbed balloon, medium length,
round tip, teflon coated, 24 FR. Recall #Z-453-1.
Code: Catalog 1237524, lot numbers 39AAB043, 39CAB048.
Manufacturer: Bard Urological Division, C.R. Bard, Inc., Moncks Corner,
South Carolina.
Recalled by: Bard Urological Division, C.R. Bard, Inc., Covington,
Georgia, by telephone and letter November 15, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide and Canada.
Quantity: 79 units were distributed.
Reason: The catheter balloon could spontaneously deflate.
----
Product: Mr. MAX Plus Magnetic Resonance Whole Body Imaging Systems
with Head Holder: (a) Model 9300HE; (b) Model 9300HG.
Recall #Z-528/529-1.
Code: (a) 59 systems can be identified by the serial number of the
Head Holder. The affected serial number range is 24762YM7
-8-
to 24820YM3. Thirty systems without serial numbers on
the Head Holders are identified by the serial numbers on
the operators console:
Model #46-282269G1 operators consoles with serial numbers
15860YMO through 15868YM3, 28273YM1, 28285YM5, 28286YM3.
Model #P9301AE operators consoles with serial numbers
24261YM0, 24278YM4, 24288YM3 through 24303YM0.
(b) Serial numbers: 30302YM4 through 30342YM0, 30345YM3
through 30401YM1, 30768YM6, 35740YM0 through 35751YM7,
35753YM3 through 35839YM0, 39995YM6 through 40017YM6,
40019YM2 through 40047YM3, 40054YM9 through 40068YM9,
40070YM5, 40072YM1 through 40076YM2, 40082YM0 through
40094YM5, 48626YM6 through 48648YM0, 48650YM6 through
48725YM6, 55443YM6, 56894YM9 through 56895YM6, 59047YM1
through 59082YM8, 60797YM8.
Manufacturer: Yokogowa Medical Systems, Ltd., Tokyo, Japan.
Recalled by: GE Medical Systems, Waukesha, Wisconsin, by letter
February 11, 1991. Firm-initiated field correction
ongoing.
Distribution: Nationwide and international.
Quantity: 512 units were distributed.
Reason: The mirror and/or bracket can catch on the front of the
coil during exit from the coil and cause the support
bracket to fracture which could cause the mirror to
fall on the patient's head or face.
----
Product: Ciba-Corning Cal Gas, Gas Standard for Calibration of
blood gas analyzers and system, 5% CO2, 12% 02, Balance N2,
Ciba Corning Part No. 477434. 20 std. cu ft. (560 std.
liters) in ED disposable cylinder. Recall #Z-530-1.
Code: 102910 EXP 10/93.
Manufacturer: Scott Medical Products, Plumsteadville, Pennsylvania.
Recalled by: Manufacturer, by telephone January 18, 1991. Firm-
initiated recall ongoing.
Distribution: Massachusetts.
Quantity: 80 cylinders were distributed.
Reason: The concentration of gases in the cylinders differed
from the expected values as stated on the labeling.
----
Product: Model 2111 Cortac Cortical Electrodes, an Rx medical
device is used in electrocorticography (ECoG)
monitoring and stimulation. Recall #Z-534-1.
Code: All lots.
Manufacturer: PMT Corporation, Chanhassen, Minnesota.
Recalled by: Manufacturer, by sending revised manual on February 22, 1991.
Firm-initiated field correction ongoing.
Distribution: Nationwide and international.
Quantity: Approximately 1,500 units were distributed.
-9-
Reason: The device was marketed for general distribution with
labeling for uses allowed only under the firm's IDE
(Investigational Device Exemption). The device is intended
only for use during surgical procedures.
----
Product: (a) Starcam 2000; (b) Starcam 3000 Data Acquisition and
Imaging Processing System Software.
Recall #Z-536/537-1.
Code: All serial numbers.
Manufacturer: GE Medical Systems, Waukesha, Wisconsin.
Recalled by: Manufacturer, by letter September 1990. Firm-initiated
field correction ongoing.
Distribution: Nationwide, Belgium, Chile, England, Scotland, Italy,
Japan.
Quantity: 366 units were distributed.
Reason: A software error could cause incorrect computation of
curve statistics which could lead to misdiagnosis and
error in treatment.
----
Class III -
Product: Becton Dickinson 50 ml Vacutainer brand Culture Tubes,
for in-vitro diagnostic use in detecting the presence
of microorganisms in the blood (qualitative).
Recall #Z-350-1.
Code: Lot numbers: OB416 EXP 8/91; OC450 EXP 9/91; OC451 EXP
9/91; OC452 EXP 9/91; OC453 EXP 9/91.
Manufacturer: Becton Dickinson Vacutainer Systems, Broken Bow, Nebraska.
Recalled by: Becton Dickinson Vacutainer Systems, Rutherford, New
Jersey, by memorandum July 26, 1990, by telephone July 30,
1990 and by letter Ausust 2, 1990. Firm-initiated recall
ongoing.
Distribution: Nationwide and England.
Quantity: 111,400 units were distributed.
Reason: The product tube label which should be blue colored and
read 45 ml is white colored and reads 40 ml, however, the
media formulation and draw volume (5 ml) is correct.
----
Product: Scott Medical Products for Calibration of Blood Gas
Analyzers and Systems, 5% C02, 40% N20, Balance 02
(oxygen). Recall #Z-531-1.
Code: Lot #043639.
Manufacturer: Scott Medical Products, Plumsteadville, Pennsylvania.
Recalled by: Manufacturer, by relabeling defective units. Firm-initiated
field correction complete.
Distribution: Texas.
Quantity: 19 cylinders were distributed.
-10-
Reason: The cylinders were labeled as containing 5% C02, 40%
N20, Balance N2 (nitrogen) instead of 5% of C02, 40% N20,
Balance 02.
----
Product: Glucose (Trinder) Test Kit (25 test), an in-vitro
diagnostic enzymatic procedure used for the quantitative
colorimetric determination of the glucose concentration in
serum. Recall #Z-535-1.
Code: Catalog #G545-25, Lot #89179, EXP 9/90.
Manufacturer: Flemming Gmbh, County Clare, Ireland (reagent).
Recalled by: Stanbio Laboratory, Inc., San Antonio, Texas by telephone
September 27, 1989. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 192 kits were distributed.
Reason: Test kit's reagent vial lacks ingredient Sodium Azide,
which acts as a preservative in this reagent to inhibit
bacterial growth.
----
Product: Sigma Diagnostics Compquick CH50, an in-vitro diagnostic
used to determine total hemolytic complement activity in
human serum, packaged (a) in 18/3-ml size, Reagent
Vials/Kits, Catalog #SH400-A, Product #S6020;
(b) In 100/3 ml Size. Reagent Vials/Kits, Catalog #SH400-B,
Product #S6020. Recall # Z-538/539-1.
Code: Lot numbers: (a) 120H-4360 EXP 1/28/91;
(b) 120H-4361 EXP 1/28/91.
Manufacturer: Sigma Diagnostics, St. Louis, Missouri.
Recalled by: Manufacturer, by letter January 10, 1991. Firm-initiated
recall complete.
Distribution: Nationwide and Canada.
Quantity: (a)35 cartons; (b) 6 cartons were distributed.
Reason: Box labels shows an incorrect expiration date.
----
Product: Sigma Diagnostics (a) Direct Bilirubin Kit,
Product #553-A;
(b) Total Bilirubin Kit, Product #552-A, in-vitro
diagnostic kits used to determine increased levels of
bilirubin that are associated with various liver diseases.
Recall # Z-540/541-1.
Code: Lot # (a) 110H-6047, EXP 3/92; (b) 110H-6038, EXP 3/92.
Manufacturer: Sigma Diagnostic, Inc., St. Louis, Missouri.
Recalled by: Manufacturer, by FAX January 31, 1991, by telephone January
31, 1991 through February 1, 1991 and follow-up letters
February 4, 1991. Firm-initiated recall ongoing.
Distribution: (a) 24 kits and (b) 59 kits were distributed.
Quantity: Nationwide, Canada, South Africa.
-11-
Reason: The product history files revealed an excess amount of
substrate in the bilirubin substrate vials in each kit.
----
VETERINARY PRODUCTS
Class I -
NONE
Class II -
NONE
Class III -
CORRECTION: Recall #V-58/067-1, which appeared in the March 27, 1991
Enforcement Report should be amended to include the
following:
Product: Amino Acid Bolus with Lactobacillus, 50-bolus jars, 1/2-oz.
and 1/4-oz. boluses, oral administration, for use as a
balanced supplement for cattle, sheep and goats when normal
dietary intake of protein, vitamins, and minerals is
reduced. Product is labeled under the following labels:
Lacto-Amino Bolus, manufactured for VEDCO, Inc.,
St. Joseph, MO; Xerobac Lacto-Amino Bolus, Xeroferm
Laboratories, Portland, OR; and Coop Amino Acid Bolus with
Lactobacillus, manufactured for Farmland Industries, Inc.,
Kansas City, MO. Recall #V-068-1.
Code: All lot numbers. Interstate Foods uses a 4-digit Julian
date code. Whenever subbatches are involved, a letter is
used at the end of the Julian date code.
Manufacturer: Interstate Foods Marketing Ltd., Richmond, Missouri.
Recalled by: Manufacturer, by letters October 4, 1990 through
December 19, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide
Quantity: 420 half ounce bolus jars and 144 1/4 ounce bolus jars.
Reason: Total lack of CGMP'S and firm manufacturing numerous
unapproved new animal drugs.
----
Medical Device Safety Alerts:
Product: (a) Hewlett-Packard Defibrillator/Monitor Model numbers:
43100A, 43110A, 43120A; (b) Hewlett-Packard Defibrillator
Model 43130A; (c) Hewlett-Packard Cardiac Monitor Model
43200A. Safety Alert #M-016/018-1.
Code: All serial numbers.
Manufacturer: Hewlett-Packard Co., McMinnville, Oregon.
Alerted by: Manufacturer, by letters of March 7-8, 1991.
Distribution: Nationwide and international.
Quantity: Approximately 28,000 units were distributed.
-12-
Reason: The energy selector switch may fail, the K1 relay
may fail and/or the batteries may not last the two year
battery life expectancy.
----
Product: Aircast brand Cryo/Cuff Compression Dressing, an
orthopedic knee device used to aid in prevention of edema
in the knee area. Safety Alert #M-019-1.
Code: Catalog #11-A -- All lots.
Manufacturer: Aircast Inc, Summit, New Jersey.
Alerted by: Manufacturer, by letter September 27, 1990.
Distribution: Nationwide and international.
Quantity: 4,621 units were distributed.
Reason: Risk of excessive compression if used in combination with
elastic bandaging.
----
Seizure Actions Filed:
Product: Various Medical Devices composed in whole or in part
of Proplast II or Proplast HA includes: blocks, sheets,
preformed facial, and orthopedic implants (90-451-984/989,
90-451-990/993, 91-582-713).
Charge: Adulterated - Products were manufactured in non-conformity
with good manufacturing practice regulations;
Misbranded - Failure to report reportable incidents under
21 CFR 803 (medical device reporting).
Firm: Oral Surgery Marketing, Inc. and NovaMed, Inc., Houston,
Texas.
Filed: March 7, 1991 - U.S. District Court for the Southern
District of Texas, Houston Division; Civil #H-91-0610,
FDC #66055.
----
Product: Multiple food products: Bulgur Wheat, Basmati Rice,
Lentil Beans, Pita Bread (91-610-421).
Charge: Adulterated - Products were prepared, packed and held
under insanitary conditions.
Firm: Ziyad Brothers, Division of Syrian Bakery and Grocery,
Inc., Chicago, Illinois.
Filed: April 3, 1991 - U.S. District Court for the Northern
District of Illinois, Eastern Division,
Civil #91C1976, FDC #66080.
----
Product: USP Oxygen (91-575-177).
Charge: Current good manufacturing practice deficiencies.
Firm: Eastern Welding Supply, Inc., Knoxville, Tennessee.
Filed: March 11, 1991 - U.S. District Court for the Eastern
District of Tennessee; Civil #3-91-133; FDC #66039.
----
-13-
Product: USP Oxygen (90-575-171).
Charge: Current good manufacturing practice deficiencies.
Firm: Price-Bass Company, Inc., Nashville, Tennessee.
Filed: February 1, 1991 - U.S. District Court for the Middle
District of Tennessee; Civil #3-91-0086, FDC #66011,
66012, 66013.
----
Product: Fujinon Yag Laser Model FLS 300Y (90-604-521 and
90-603-866).
Charge: Adulterated - Product is classified as Class III
device and may not be distributed without approval of
an application for premarket approval and is not exempt
from such approval. Product is further adulterated
in that an exemption has been granted under 21 USC
360j(g) and the person having custody of the devices is
not the person named in the exemption.
Firm: Plum Management, Dallas, Texas.
Humana Hospital Medical City, Dallas, Texas
Filed: February 20, 1991 - U.S. District Court for the
Northern District of Texas, Dallas Division;
Civil #CA3-91-0376-B, FDC #65960 (90-603-866);
U.S. District Court for the Northern District of
Texas, Dallas Division; Civil #CA3-91-0377-H,
FDC #65964 (90-604-521).