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
06/18/1991
FDA Enforcement for the week of 6/19/91
FDA ENFORCEMENT REPORT
FOR JUNE 19, 1991
June 19, 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: (a) Roney Oatman Inc. 5% Soft Serve Artificial Vanilla
flavored Ice Milk, in 2-1/2 gallon plastic bags;
(b) Sundae Shoppe Fudge Swirl Ice Cream, artificial
flavor added in 5 quart plastic bucket.
Recall #F-425/426-1.
Code: (a) 315; (b) 085.
Manufacturer: Roney Oatman, Inc., Aurora, Illinois.
Recalled by: Manufacturer, by telephone March 28, 1991 and
April 2, 1991. Firm-initiated recall complete.
Distribution: Illinois, Wisconsin, Indiana.
Quantity: (a) 117.5 cases; (b) 1,584 cases were distributed;
firm estimates none remains on the market.
Reason: Product is contaminated with Listeria monocytogenes.
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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: Large earthenware platter and bowl, dark green glazed,
made in Italy:
(a) Platter, round and measures approximately 15 inches
(top diameter); (b) Bowl, measures approximately 14-1/2
inches (top diameter). Recall #F-379/380-1.
Code: Style numbers: (a) 17517; (b) 17518.
Manufacturer: Lamas de Simone Giacomo, Italy.
Recalled by: Macy's California Inc., San Francisco, California, by
instructing its retail stores to remove products from
retail sale on November 19, 1990 and by posting signs
in its retain stores on February 1, 1991. Firm-
initiated recall ongoing.
Distribution: California.
Quantity: (a) 42 units; (b) 42 units were distributed.
Reason: The product contains excessive leachable lead.
----
Product: Snapple Fruit Punch, in 16 ounce glass bottles, a
non-carbonated fruit flavored soft drink.
Recall #F-427-1.
Code: CT62402922354 through CT62402922359 and continuing
on with CT62402920000 through CT62402920056.
Manufacturer: New England Contract Packaging Company, Westbury,
Connecticut.
Recalled by: Unadulterated Foods Corporation, doing business as
Snapple Natural Beverage Company, Valley Stream,
New York, by telephone April 4, 1990 followed by
letter. Firm-initiated recall ongoing.
Distribution: New York.
Quantity: Firm estimates that less than 300 cases (24 bottles/case)
remain on the market.
Reason: The product contains glass fragments.
----
Product: Various fruit juice products:
(a) Orange Juice from Concentrate, 3, 4, 6, 8, 16, 32,
64, and 128 ounce sizes, packaged under the brand names
of Orchard Grove, Spartan, Dairy Fresh, Taylors, Land O'
Lakes, Bridgeman, Sun Ripe, Grove Fresh, Borden,
Colteryahn, Shur Fresh, Fame London's Best-Ever, McDonald,
Country Fresh, Flavor Fresh, Melody Farms, Sunborn and
Dairy Fresh;
(b) Orange Juice with Sweetener, in 16, 64, 96 and 128 ounce
sizes, packaged under the brand names of Sunborn, Citrus
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King, Pure Maid, Save Rite and a No-Brand label;
(c) Orange Juice Concentrate, in 32 ounce paper carton under
the Orchard Grove brand label;
(d) Pineapple - Orange Juice, in 4, 6 and 16 ounce plastic
or multiple packaging under the Orchard Grove SunBorn and
Dairy Fresh labels;
(e) Orange- Grapefruit Juice, in 4 ounce plastic container
under the Orchard Grove brand label;
(f) Grapefruit Juice, in 4, 6, 8, 16, 32 and 64 ounce
sizes, in paper, plastic and multiple packaging under
Orchard Grove, Dairy Fresh, Best-Ever, Country Fresh,
SunBorn, Flavor Fresh and Melody Farms labels;
(g) Apple Juice, in 4, 6, 16, 32 and 64 ounce plastic or
multiple packaging under the Orchard Grove, Flavor Fresh,
Dairy Fresh, Country Fresh, SunBorn, McDonald and
Melody Farms labels;
(h) Apple Cranberry Juice, in 4 ounce plastic cup under
the Orchard Grove label;
(i) Pineapple Juice, in 4, 6, and 32 ounce plastic or
multiple packaging under Orchard Grove label;
(j) Fruit Punch Juice, in 3 and 4 ounce multiple packages
under the Orchard Grove label;
(k) Fruit Punch Juice with Honey, in 4 ounce multiple
package under the Orchard Grove label;
(l) Grape Juice, in 3, 4, 6, 16 and 32 ounce plastic and
multiple packaging under Orchard Grove and SunBorn labels;
(m) Tomato Juice, in 4 ounce plastic cup under Orchard
Grove label;
(n) Grape - Apple Juice, in 4 ounce plastic cup under
Orchard Grove label;
(o) Grape - Apple Juice with Honey, in 4 ounce plastic
cup under Orchard Grove label;
(p) Apricot Nectar, in 4 ounce plastic cup under
Orchard Grove label;
(q) Cranberry Cocktail, in 4 ounce plastic cup under the
Orchard Grove label;
(r) Peach Nectar, in 4 ounce plastic cup under the
Orchard Grove label;
(s) Prune Juice, in 4 ounce plastic cup under the Orchard
Grove label;
(t) 10% Orange Drink, in 16 and 32 ounce plastic packages
under SunBorn and Orchard Grove labels;
(u) 50% Orange Drink, in 4, 6, and 8 ounce paper
and plastic packages under Orchard Grove label;
(v) 50% Orange Drink with Calcium, in 4 or 8 ounce
paper package under Orchard Grove label.
Recall #F-400/421-1.
Code: All product with an expiration date of 4/16/91 or
earlier, or a Julian date of 056 or smaller. Note:
Product produced in 1990 and still in the market would
have a Julian date of 365 or smaller.
Manufacturer: Peninsular Products Company, Inc., Lansing, Michigan.
-3-
Recalled by: letter dated March 22, 1991. Firm-initiated recall
ongoing.
Distribution: Nationwide.
Quantity: Unknown.
Reason: Products contain Natamycin, a nonpermitted food additive and
Orange Juice products contain added pulp wash solids.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Luck's Pinto Beans Seasoned with Pork, in 15 ounce
cans. Recall #F-422-1.
Code: P---E (FG or H)/B271S.
Manufacturer: Lucks Inc., Seagrove, North Carolina.
American Home Food Products, Inc., New York, New York,
by letter April 29, 1991. Firm-initiated recall ongoing.
Distribution: Kentucky, South Carolina, North Carolina, Tennessee,
Virginia, West Virginia.
Quantity: 8, 417 cases (24 cans/case) were distributed; firm
estimates that more than 5, 000 cases remain on
the market.
Reason: The product has an off-odor.
----
Product: Ski brand Naturally Flavored Citrus Soda, in 12 ounce
aluminum cans, in 16 ounce returnable green glass bottles,
in 20 ounce non-returnable green glass bottles a carbonated
orange soft drink made with real citrus juices.
Recall #F-424-1.
Code: N2391 EV (12 oz cans); N24 and N29 (16 oz bottle caps);
N21 (20 oz bottle cap).
Manufacturer: Tri-State Double Cola Bottling Company, Inc.,
Evansville, Indiana.
Recalled by: Manufacturer, by visit beginning January 28, 1991.
Firm-initiated recall complete.
Distribution: Illinois, Kentucky, Indiana.
Quantity: 16,392 12 ounce cans; 432 16 oz bottles;
11,424 20 oz bottles were distributed.
Reason: The product has an off-odor.
----
COSMETICS
NONE
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HUMAN DRUGS AND BIOLOGICS
Class I -
Product: Three aspirin based products, each containing two
promotional tablets of an acetaminophen based product,
Alka-Seltzer Advanced Formula. All three products are in
effervescent tablet form and contain aspirin as an active
ingredient along with other active ingredients, OTC
products in promotional packaging only:
(a) Alka-seltzer (Original formula, packed 24 tablets per
carton plus the two promotional tablets;
(b) Flavored Alka-seltzer, packed 24 tablets per carton
plus the two promotional tablets;
(c) Alka-seltzer Plus Cold Medicine, packed 36 tablets per
carton plus the two promotional tablets.
Recall #D-437/439-1.
Code: All lots.
Manufacturer: Miles, Inc., Elkhart, Indiana.
Recalled by: Manufacturer, by letter April 19, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 2,248,416 cartons; (b) 527,148 cartons; (c) 5,234,544
cartons were distributed; firm estimates that
approximately 25 percent for all three products remain
on the market.
Reason: Promotional packages of the products contain a sample of
a non-aspirin pain reliever and are labeled in a
manner that may be potentially confusing and
hazardous to aspirin-sensitive consumers.
----
NONE
Class II -
Product: Liquid Antacid for Heartburn Acid Indigestion, in 12
ounce plastic bottles, an OTC product under the following
labels: Hydro May Liquid Antacid, distributed by Schein
Pharmaceutical, Inc., Medi$ave Regular strength Antacid
Liquid, distributed by Medi$ave Pharmacal; T.D.R. Alge-Tex
Liquid Antacid, distributed by Texas Drug Reps.
Recall #D-431-1.
Code: J1494C EXP 9/91.
Manufacturer: Pennex Products Company, Inc., Verona, Pennsylvania.
Recalled by: Manufacturer, by telephone January 26, 1990. Firm-
initiated recall ongoing.
Distribution: Louisiana, New York, Texas.
Quantity: 808 dozen units were distributed; firm estimates
217 dozen units remain on the market.
Reason: Bacterial contamination with Enterobacter Cloacae.
----
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Product: Carbamazepine Tablets, USP 200 mg, an Rx product
used to control and preclude epileptic episodes.
Recall #D-440-1.
Code: Lot numbers: 81E0494, 81G0705, 81J01006, 81A01350.
Manufacturer: Pharmaceutical Basics, Inc. (PBI), Denver, Colorado.
Recalled by: Goldline Laboratories, Fort Lauderdale, Florida, (repacker)
by letter on or about March 18, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 4,086 unit dose boxes were distributed..
Reason: Lack of assurance of bioequivalency and Abbreviated
New Drug Application discrepancies.
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Recovered
Plasma. Recall #B-242/244-1.
Code: Unit #17R59093.
Manufacturer: American Red Cross Blood Services, St. Paul, Minnesota.
Recalled by: Manufacturer, by telephone January 8, followed by
letter January 16, 1991. Firm-initiated recall complete.
Distribution: Minnesota, Wisconsin, California.
Quantity: 1 unit of each component.
Reason: Blood components, drawn from a donor who was diagnosed
with mononucleosis, were distributed for transfusion.
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitated
AHF; (d) Fresh Frozen Plasma; (e) Recovered Plasma.
Recall #B-257/261-1.
Code: Unit numbers: (a) 14F27691, 14F30912;
(b) 14F27691, 14F30912; (c) 14F30912; (d) 14F27691;
(e) 14F30912.
Manufacturer: American Red Cross, Yakima, Washington.
Recalled by: Manufacturer, by letter February 21, 1991. Firm-initiated
recall ongoing.
Distribution: Washington state, California.
Quantity: (a) 2 units; (b) 2 units; (c) 1 unit; (d) 1 unit;
(e) 1 unit.
Reason: Blood products collected from a donor with history of
jaundice were distributed.
----
Product: Platelets. Recall #B-271-1.
Code: Unit #3228877.
Manufacturer: Central Indiana Regional Blood Center, Inc., Indianapolis,
Indiana.
Recalled by: Consignee returned unit to firm for correction and later
reissued. Recall complete.
Distribution: Indiana.
Quantity: 1 unit.
-6-
Reason: Blood component was distributed labeled with an
incorrect expiration date.
----
Product: Source Plasma. Recall #B-282-1.
Code: Unit #N46647-81.
Manufacturer: Alpha Therapeutics Corporation, Charlotte, North Carolina.
Recalled by: Manufacturer, by FAX January 18 and 21, 1991. Firm-
initiated recall complete.
Distribution: California and Spain.
Quantity: 1 unit.
Reason: Blood component, which tested repeatably reactive
for the antibody to the human immunodeficiency virus,
type 1 (anti-HIV-1) was distributed.
----
Class III -
Product: Thyroid Tablets, USP 130 mg, in 1000 tablet bottles,
an Rx product under the Jones Medical Industries and
Goldline Laboratories labels. Recall #D-429-1.
Code: Lot #X767 EXP 12/93.
Manufacturer: JMI Canton Pharmaceuticals, Inc., Canton, Ohio.
Recalled by: Manufacturer, by telephone January 6, 1991. Firm-
initiated recall complete.
Distribution: Ohio.
Quantity: 336 bottles were distributed; firm estimates none
remains on the market.
Reason: Product does not meet content uniformity specifications.
----
Product: Oxygen, USP, compressed medical gas, repacked into
size "D" and "E" cylinders, intended for prescription use.
Recall #D-430-1.
Code: Lot #04421391D.
Manufacturer: Big Three Industries, Longview, Texas.
Recalled by: Manufacturer, by visit and by telephone May 2, 1991.
Firm-initiated recall ongoing.
Distribution: Texas.
Quantity: None.
Reason: Current good manufacturing practice deficiencies.
----
Product: Adapin Capsules (Doxepin Hydrochloride) Antianxiety and
Antidepressant, an Rx drug distributed under the Fisons
Pharmaceuticals label:
(a) 10 mg in bottles of 100 & 1000;
(b) 25 mg in bottles of 100 & 1000;
(c) 75 mg in bottles of 100 & 1000;
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(d) 100 mg in bottles of 100 & 1000;
(e) 150 mg in bottles of 50. Recall #D-432/436-1.
Code: Lot numbers: (a) ZM0295 EXP 10/91;
(b) ZN0210 EXP 02/92 (100s), ZM0297 EXP 12/91
(100 & 1000s);
(c) ZM0382 EXP 11/91;
(d) ZM0300 EXP 08/91 (100s) ZM0301 EXP 2/92, ZM0302
EXP 02/92 (1000s);
(e) ZM0440 EXP 12/91.
Manufacturer: Smith Kline & French, Philadelphia, Pennsylvania.
Recalled by: Fisons Corporation, Rochester, New York (repacker), by
letters dated May 22, 1991. Firm-initiated recall
ongoing.
Distribution: Nationwide.
Quantity: 86,189 bottles of various sizes/strengths were distributed.
Reason: Products lack assurance of meeting dissolution specifications
through expiration date.
----
Product: (a) 2% Xylocaine with Epinephrine 1:100,000;
(b) 2% Xylocaine with Epinephrine 1:150,000;
(c) 4% Citanest with Epinephrine 1:200,000, Rx
products used as dental anesthetics.
Recall #D-441/443-1.
Code: Lot numbers: 0175001150 EXP 7/91, 0175001151 EXP 7/91
0175911159 EXP 5/91, 0175911160 EXP 5/91, 0175001120
EXP 7/91, 0175001121 EXP 7/91, 0175001147 EXP 7/91,
0175001148 EXP 7/91, 0175001149 EXP 7/91, 0175002034
EXP 8/91;
(b) 0180001117 EXP 7/91;
(c) 0540911140 EXP 5/91.
Manufacturer: Astra Pharmaceutical Products, Inc., Westborough,
Massachusetts.
Recalled by: Manufacturer, by letter May 16, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: (a) 36,369 units of 100 cartridges; (b) 3,715 units
of 100 cartridges; (c) 3,625 units of of 100 cartridges
were distributed.
Reason: Products are subpotent for the Epinephrine and pH
is lower than specification.
----
DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
NONE
Class II -
Product: Video Duodenoscope, designed for endoscopic diagnosis and
treatment in the duodenum: (a) Model JF-V10;
(b) Model TJF-V10. Recall #Z-563/564-1.
-8-
Code: All serial numbers.
Manufacturer: Olympus Optical Co. Ltd., Tokyo, Japan.
Recalled by: Olympus Corporation, Lake Success, New York, by
letter May 31, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide, Canada, Argentina, Brazil, Chile, Venezuela,
Mexico.
Quantity: (a) 172; (b) 101 units were distributed.
Reason: The labeling does not give adequate warning to alert the
user that the distal tips of these devices are 10 mm
longer than the tips of comparable instruments.
----
Product: Angioscope, intended only for endoscopic observation of the
interior blood vessels of the peripheral vasculature:
(a) Model PF-8; (b) Model PF-14; (c) Model PF-22;
(d) Model PF-28. Recall #Z-647/650-1.
Code: All serial numbers.
Manufacturer: Olympus Optical Company, Ltd., Tokyo, Japan.
Recalled by: Olympus Corporation, Lake Success, New York, by
letter May 31, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide, Canada, Brazil, West Germany.
Quantity: (a) 5 units; (b) 167 units; (c) 111 units; (d) 165
units were distributed.
Reason: The instruction manual indicated the use of the
angioscope in the bile duct, bronchus, ureter, etc.
but it is only intended for the application of angioscopy.
----
Product: Cobalt 60 Teletherapy units, used to treat cancer patients:
(a) Theratron 780 Cobalt 60 Teletherapy Unit (780);
(b) Theratron 780C Cobalt 60 Teletherapy Unit (T780C);
(c) Theratron Phoenix Cobalt 60 Teletherapy Unit;
(d) Theratron 1000 Cobalt 60 Teletherapy Unit (T1000).
Recall #Z-697/700-1.
Code: All serial numbers.
Manufacturer: Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd (AECL Medical), Ontario, Canada.
Recalled by: Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd (AECL Medical), Carrollton, Texas, by
Service Bulletin CSB-90-2 dated August 10, 1990 and by
User Bulletin CUB-91-01 dated February 13, 1991.
Firm-initiated field correction ongoing.
Distribution: Nationwide and international.
Quantity: (a) 425 unit; (b) 125 units; (c) 52 units; (d) 11 units
were distributed.
Reason: Seizure of the rotating union may occur and cause damage
to the connecting air hose which can result in failure of
the source drawer pneumatics system.
----
-9-
Product: Cobalt 60 Teletherapy devices and linear accelerator
teletherapy devices used to treat cancer patients:
(a) Theratron 60 (T60) Cobalt 60 Teletherapy Device;
(b) Theratron 80 (T80) Cobalt 60 Teletherapy Device;
(Includes units refurbished to original T80
specifications which are identified by firm as
T80R.)
(c) Theratron 765 (T765) Cobalt 60 Teletherapy Device;
(d) Theratron 780 (T780) Cobalt 60 Teletherapy Device;
(e) Theratron 780C (T780C) Cobalt 60 Teletherapy Device;
(f) Eldorado 6 (E6) Cobalt 60 Teletherapy Device;
(g) Eldorado 8 (E8) Cobalt 60 Teletherapy Device;
(h) Eldorado 76 (E76) Cobalt 60 Teletherapy Device;
(i) Eldorado 78 (E78) Cobalt 60 Teletherapy Device;
(j) Phoenix Cobalt 60 Teletherapy Device;
(k) Therac 6 (T6) Linear Accelerator Teletherapy Device;
(l) Therac 20 (T20) Linear Accelerator Teletherapy
Device;
(m) Therac 25 (T25) Linear Accelerator Teletherapy
Device. Recall #Z-701/713-1.
Code: All serial numbers.
Manufacturer: Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd (AECL Medical), Ontario, Canada.
Recalled by: Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd (AECL Medical), Carrollton, Texas, by
(a-j) CUB-87-1 dated July 7, 1987; (k) AUB6-87-1;
(l) AUB20-87-1; (m) AUB25-87-2 all dated May 1, 1987.
Firm-initiated field correction complete.
Distribution: Nationwide and international.
Quantity: 1,296 units were distributed.
Reason: Any transparent accessory tray or device that intercepts
either IDI/SSD light or the collimator field light beam may
cause a distortion of either the scaler reading or the size
of the field light image.
----
Product: Cobalt 60 Teletherapy Devices with single digital timers,
used to treat cancer patients:
(a) Theratron 80 (T80) Cobalt 60 Teletherapy Device
(Includes units refurbished to original T80
specifications which are identified by firm as T80R.)
(b) Theratron 780 (T780) Cobalt 60 Teletherapy Device;
(c) Eldorado 6 (E6) Cobalt 60 Teletherapy Device;
(d) Eldorado 8 (E8) Cobalt 60 Teletherapy Device;
(e) Eldorado 76 (E76) Cobalt 60 Teletherapy Device;
(f) Eldorado 78 (E78) Cobalt 60 Teletherapy Device.
Recall #Z-714/719-1.
Code: All serial numbers.
Manufacturer: Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd (AECL Medical), Ontario, Canada.
-10-
Recalled by: Theratronics International Ltd., Carrollton, Texas,
by User Bulletin CUB-90-1 dated January 30, 1990 and by
Service Bulletin CSB-90-1 dated February 26, 1990.
Firm-initiated field correction ongoing.
Distribution: Nationwide and international.
Quantity: (a) 314 units; (b) 425 units; (c) 84 units;
(d) 47 units; (e) 8 units; (f) 57 units were distributed.
Reason: The single digital timers on the above models are
susceptible to ESD (electrostatic discharge) which may cause
timer failures resulting in possible radiation treatment
errors.
----
Product: Lifepak 10 Defibrillator/Monitor, a stand alone external
medical device. Recall #Z-739-1.
Code: All units shipped prior to March 21, 1991.
Manufacturer: Physio Control Corporation, Redmond, Washington.
Recalled by: Manufacturer, by letter March 29, 1991 and memorandum
dated April 12, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 8,292 units were distributed.
Reason: The ECG connector, its mounting hardware and/or the
printed circuit board connection may be damaged when
the patient cable is connected and then impacted with
significant force; and the switch dome can be lodged
under the edge of the switch panel vessel.
----
Product: Lutrepulse Pump and Injection Kit, a battery powered
infusion pump drug delivery system for the prescription
drug Gonadorelin Acetate:
(a) Lutrepulse Pump Kit; (b) Lutrepulse (Gonadorelin
Acetate 0.8 mg) for Injection kit; (c) Lutrepulse
(Gonadorelin Acetate 3.2 mg) for Injection Kit.
Recall #Z-746/748-1.
Code: Lot numbers: (a) All pump kits with 9 volt Lithium
batteries; (b) 10J001 EXP 8/91, 10M002 EXP 8/92;
(c) 10M001 EXP 7/91, 10N002 EXP 7/92.
Manufacturer: Ferring Biotechnik, Kiel, West Germany (pump);
Ferring Arzneeimittel GmbH, Kiel, West Germany (injection).
Recalled by: Ortho Pharmaceutical Corporation, Raritan, New Jersey, by
letter dated April 16, 1991. Firm-initiated field
correction ongoing.
Distribution: Nationwide, Puerto Rico.
Quantity: Firm estimates 1,194 injection kits and 256 pump kits
remain on the market.
Reason: The 9 volt Lithium battery contained in these kits may
fail prematurely, causing the pump to fail.
----
-11-
Product: Advent Ventilator PEEP Valve, Part number 6750-0020-700.
Recall #Z-750-1.
Code: All codes.
Manufacturer: Maurepas Cedex, France.
Recalled by: Ohmeda, Madison, Wisconsin by letter May 8, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 607 units were distributed.
Reason: An excessive lubricant was used during the assembly of
the PEEP valve. The excessive lubricant may partically
occlude the gas delivery hole of the valve causing the
actual PEEP being delivered to the patient to be less than
the PEEP level set by the caregiver.
----
Product: Keystone Axialtome Fluro Model 5200. Recall #Z-754-1.
Code: Serial numbers: AX100 and AX101.
Manufacturer: Keystone X-Ray Inc., Langhorne, Pennsylvania.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan May 9, 1991. Firm-initiated field
correction complete.
Distribution: Pennsylvania.
Quantity: 2 units were distributed.
Reason: Noncompliance with performance standard for
diagnostic X-ray products in that it does not have
certification labels and model number identification and
information to the users and field limitation on
radiographic x-ray systems other than general purpose.
----
Product: Fetal Bovine Serum (FBS), blood product used for
biological or human research purposes, or for the
production of various Human or animal biological and/or
diagnostic products: (a) Catalog #14-501B, 500 ml;
(b) Catalog #14-501C, 50 ml. Recall #Z-763/764-1.
Code: Lot numbers: 0M1418 and 0M1446.
Manufacturer: Whittaker Bioproducts, Inc., Walkersville, Maryland.
Recalled by: Manufacturer, by telephone April 17, 1991. Firm-
initiated recall ongoing.
Distribution: New Jersey, New York, Michigan, Maryland, Colorado,
California, Pennsylvania.
Quantity: 528.60 liters of lot 0M1418 and 1,082.28 liters of
lot 0M1446 were distributed.
Reason: The Fetal Bovine Serum (FBS) has been imported illegally
into the United States labeled as human serum from Brazil.
----
-12-
Class III -
Product: EBV-M Kit, an in-vitro diagnostic kit used to detect
IGM antibody to Epstein-Barr viral Capsid Antigen
(EB-VCA) by the indirect fluorescent antibody (IFA)
method. Recall #Z-740-1.
Code: Product #37185, Lot numbers: 143091 EXP 8/91, 143203
EXP 8/91, 143235 EXP 9/91, 143472 EXP 9/91 143479 EXP 10/91,
143480 EXP 9/91.
Manufacturer: Organon Teknika Corporation, Durham, North Carolina,
Recalled by: Manufacturer, by letter dated March 19, 1991. Firm-
initiated recall ongoing.
Distribution: Nationwide, Belgium, Japan, France, Greece, Italy,
Spain, Sweden, Turkey, Saudi Arabia, Brazil, Uruguay,
Venezuela, The Netherlands.
Quantity: 2,419 kits were distributed; firm estimates 25 percent
remain on the market.
Reason: Some slides were found to exhibit variability and loss
of fluorescence which could result in inaccurate
interpretation of the test.
----
Product: Tetra-Tube RIA T4 Diagnostic Kit, an in-vitro
diagnostic kit used to quantitatively determine total
serum thyroxine by solid phase radioimmunoassay.
(a) Product No. 38002 (100 test kit);
(b) Product No. 38003 (500 test kit).
Recall #Z-758/759-1.
Code: Lot numbers: (a) 139179 EXP 1/20/91, 141640 EXP 2/17/91;
(b) 139178 EXP 1/20/91, 141654 EXP 2/17/91.
Manufacturer: Organon Teknika Corporation, Durham, North Carolina.
Recalled by: Manufacturer, by letter dated January 17, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide, Canada, Mexico, The Phillipines.
Quantity: 389 kits were distributed.
Reason: There is an upward shift in control recoveries which
could result in falsely elevated patient values.
----
Product: Automated APTT, an in-vitro diagnostic reagent used to
determine activated partial thromboplastin times.
Recall #Z-762-1.
Code: Product #35512, lot #101541 EXP 2/93.
Manufacturer: Organon Teknika Corporation, Durham, North Carolina.
Recalled by: Manufacturer, by letter dated January 17, 1991.
Firm-initiated recall ongoing.
Distribution: California, Georgia, Illinois, Missouri, North Carolina,
New Jersey, Wisconsin, Canada.
Quantity: 3,331/10 vial boxes were distributed; firm estimates
that all product has been used or removed from the
market.
-13-
Reason: The discovery of unacceptable clotting times after reagent
rehydration.
----
Medical Device Safety Alerts:
Product: Minix, Minix ST and Micro Minix single chamber
multiprogrammable implantable pulse generators:
(a) Minix (Models 8340/41/41M/42);
(b) Minix ST (Model 8330/31/31M);
(c) Micro Minix (Model 8360). Safety Alert #M-022/024-1.
Code: All of the identified models of pacemakers shipped prior
to 12/7/90.
Manufacturer: Medtronic, Inc., Minneapolis, Minnesota.
Alerted by: Manufacturer, by letter May 6, 1991.
Distribution: Nationwide and international.
Quantity: 43,229 pacemakers were distributed.
Reason: A failure that results in prolonged asynchronous pacing
or delay in restoring permanent pacing mode and parameters
after the magnet or the 9710/9710A programming head is
removed.
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Seizure Action Filed:
Product: Eggplant (91-610-531).
Charge: Product contains the pesticide Methamidophos in excess
of the established tolerance level.
Firm: Robee Produce, Pomano, Florida (grower).
Auster Company, Chicago, Illinois (dealer).
Field: 5-24-91 - U.S. District Court for the Northern District
of Illinois, Eastern Division; Civil #91C3231, FDC #66171.