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
11/20/1990
FDA Enforcement for the week of November 21, 1990
FDA ENFORCEMENT REPORT
FOR NOV. 20, 1990
December 21, 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.
Product: (a) Hard Candy packaged in 16 ounce bags;
(b) Soft Candy packaged in 8 ounce bags.
Recall #F-003/004-1.
Code: (a) Sell By May 91; (b) Not coded.
Manufacturer: Wilson Candy Company, Rocky Mount North Carolina.
Recalled by: Manufacturer, by telephone October 12, 1990.
Firm-initiated recall ongoing.
Distribution: North Carolina, Indiana.
Quantity: (a) 599 cartons (24 bags per carton); (b) 16 cartons
(24 bags per carton) were distributed.
Reason: Products contain undeclared FD&C Yellow No. 5.
----
-1-
Product: Peanut butter products and large peanut granules:
(a) Creamy Stabilized Peanut Butter;
(b) Crunchy Natural Peanut Butter;
(c) Crunchy Stabilized Peanut Butter;
(d) Creamy Old Fashioned Peanut Butter;
(e) Crunchy Old Fashion Peanut Butter;
(f) Creamy Natural Peanut Butter;
(g) Dark Roast Creamy Stabilized Peanut Butter;
(h) Old Fashion Peanut Butter;
(i) Dark Roasted Peanut Granules. Recall #F-017/025-1.
Code: Peanut butter products are not coded. All lots shipped
between April and mid-July 1990. Peanut granules -
lot #T-188 0122 D.
Manufacturer: Peanut Corporation of America (PCA), Gorman, Texas.
Recalled by: Peanut Corporation of America, Lynchburg, Virginia,
by telephone and letter September 14, 1990. Firm-
initiated recall ongoing.
Distribution: Nationwide.
Quantity: 1,303 boxes - 50 pound Creamy Stabilized Peanut Butter;
56 boxes - 50 pound Crunchy Natural Peanut Butter;
5,648 pails - 35 pound Creamy Stabilized Peanut Butter;
402 pails -35 pound Crunchy Stabilized Peanut Butter;
14 pails - 35 pound Creamy Old Fashioned Peanut Butter;
14 pails - 35 pound Crunchy Old Fashioned Peanut Butter;
15 pails - 35 pound Creamy Natural Peanut Butter;
75 pails - 35 pound Crunchy Natural Peanut Butter;
40 pails - 35 pound Dark Roast Creamy Stabilized Peanut
Butter;
260 tubs - 12/3 Pound Creamy Stabilized Peanut Butter;
76 tubs - 12/3 Pound Crunchy Stabilized Peanut Butter;
112 tubs - 6/5 pound Creamy Stabilized Peanut Butter;
2 tubs - 6/5 pound Crunchy Stabilized Peanut Butter;
10 tubs - 6/5 pound Creamy Natural Peanut Butter;
1 tub - 6/5 pound Old Fashioned Peanut Butter;
11 drums - 475 pound Crunchy Old Fashioned Peanut Butter;
8 drums - 475 pound Creamy Natural Peanut Butter;
3 drums - 475 pound Crunchy Natural Peanut Butter;
166 boxes 30 pound Dark Roasted Peanut Granules
were distributed.
Reason: Products exceed FDA established tolerance level for
aflatoxin.
----
Product: Superbrand Fudge bars, 2-1/2 ounce bars.
Recall #F-030-1.
Code: Lot #93 4550.
Manufacturer: Borden, Inc., Greenville, South Carolina.
Recalled by: Manufacturer, by telephone May 10, 1990. Firm-initiated
recall ongoing.
Distribution: South Carolina, Alabama, Florida, Kentucky, Georgia.
Quantity: 1,394 cases (6 twelve packs/case) were distributed;
firm estimates none remains on market.
-2-
Reason: Product causes burning of the mouth.
----
Product: (a) Sugarless Chocolate Covered Raisins;
(b) Sugarless Chocolate Covered Almonds.
Recall #F-031/032-1.
Code: All lots.
Manufacturer: Georgia Nut Company, Skokie, Illinois.
Recalled by: Frontier Fruit and Nut Company, Norton, Ohio, by letter
May 27, 1990. Firm-initiated recall complete.
Distribution: Ohio, Indiana, Pennsylvania.
Quantity: Approximately 2,500 pounds were distributed;
firm estimates none remains on the market.
Reason: Product is not sugarless, contains sucrose.
----
Product: Pillsbury Double Chocolate Great Additions Brownie
Mix, in 21.25 ounce boxes. Recall #F-033-1.
Code: FOKXX where XX is any number from 12 to 23.
Manufacturer: Pillsbury Inc., Minneapolis, Minnesota.
Recalled by: Manufacturer, by memorandum October 1, 1990.
Firm-initiated recall ongoing.
Distribution: Indiana, Kentucky, Michigan, Ohio, Pennsylvania.
Quantity: 12,600 cases were distributed.
Reason: Some boxes of double chocolate chip brownie mix may
actually contain walnut brownie mix.
----
CORRECTION: Fresh Chicken Shell Eggs Grade A and AA, Recall #F-697-0,
which appeared in the November 7, 1990 Enforcement Report
should read:
Product: Fresh Chicken Shell Eggs, Grade A & AA, under
the Esbenshade Farms brand, "Fresh and Natural";
Dutchlaan Farms brand distributed by Kayser Dairy, Inc.,
Clifton, New Jersey; Farmer Doyle's brand, distributed
by Doyle's Double A Farm, Prospect, Connecticut; and Heidi's
Dairy brand, distributed by Heidi's Dairy, Patchogue,
New York.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Kraft Free Rancher Nonfat Dressing, in 8 fluid ounce
bottles. Recall #F-026-1.
Code: UPC #21000-64678. Best when used by: DEC 26 90 C -*-*,
DEC 27 90 C -*-*, DEC 28 90 C -*-*, JAN 01 91 C -*-*,
-3-
JAN 02 91 C -*-*, JAN 09 91 C -*-*.
Manufacturer: Kraft USA, Champaign, Illinois.
Recalled by: Kraft Inc., Glenview, Illinois, by visit September 10,
1990. Firm-initiated recall ongoing.
Distribution: Eastern two-thirds of the United States.
Quantity: 34,173 cases were distributed; firm estimates little,
if any, of the dressing remains on the market.
Reason: Product is contaminated with Lactobacillus bacteria.
----
Product: Kraft Reduced Calorie Ranch Dressing and Kraft Rancher's
Choice Ranch Reduced Calorie Dressing, in 8 fluid ounce
bottles. Recall #F-027-1.
Code: Reduced Ranch UPC 21000-64353, Best when used by:
JAN 03 91 L -*-*, JAN 04 91 -*-*, FEB 22 91 L -*-*;
Ranchers Choice UPC 21000-64362, Best when used by:
FEB 27 91 J -*-*.
Manufacturer: Kraft USA, Buena Park, California.
Recalled by: Kraft Inc., Glenview, Illinois, by telephone September
27, 1990 followed by visit. Firm-initiated recall
ongoing.
Distribution: California, Nevada, Oregon, Washington state, Hawaii.
Quantity: 18,706 cases (12 bottles/case) were distributed.
Reason: Product is contaminated with Lactobacillus bacteria.
----
Product: Kraft Free Catalina Nonfat Dressing, in 8 fluid ounce
bottles. Recall #F-028-1.
Code: UPC 21000-64679, Best if used by: FEB 27 91 C -*-*.
Manufacturer: Kraft USA, Champaign, Illinois.
Recalled by: Kraft, Inc., Glenview, Illinois, by telephone September
14, 1990 followed by visit. Firm-initiated recall ongoing.
Distribution: Illinois, Iowa, Missouri, Michigan, Indiana, Kentucky,
Ohio, Pennsylvania, Wisconsin, North Dakota, Minnesota,
West Virginia, South Carolina.
Quantity: 3,565 cases (12 bottles/case) were distributed; firm
estimates 33 percent remains on market.
Reason: Product is contaminated with yeast.
----
Product: Reduced Calorie 1000 Island Dressing, in 1 gallon plastic
bottles or 55 gallon drums:
Sweet 'N Low Lite 1000 Island Reduced Calorie Dressing,
in 1 gallon bottles;
Gold Crest Lite Thousand Island Dressing, in 55 gallon drums;
Classic Pourable Thousand Island Dressing, in 1 gallon
and 55 gallon drums;
All Kitchens Lite Thousand Island Dressing, in 1 gallon
bottles;
Golbon Bonded Quality Pourable Thousand Island Dressing,
in 1 gallon bottles;
-4-
Keith's Pourable Thousand Island Dressing, in 1 gallon
bottles;
Pocahontas Pourable Thousand Island Dressing, in 1 gallon
bottles. Recall #F-029-1.
Code: MFG APR 3090 through MFG JUL0290.
Manufacturer: Hudson Industries, Inc., Troy, Alabama.
Recalled by: Manufacturer, by telephone July 16, 1990. Firm-initiated
recall complete.
Distribution: Alabama, Arkansas, California, Florida, Georgia, Kentucky,
Mississippi, Nebraska, New York, North Carolina, Oklahoma,
South Carolina, Tennessee, Texas, Virginia.
Quantity: Firm estimates none remains on market.
Reason: Product is contaminated with lactobacillus bacteria.
----
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Oral prescription drugs, distributed by
UDL Laboratories, in unit dose packages, 100 tablets/
capsules per shelf carton, 10 cartons per case:
(a) Ergoloid Mesylates Oral tablets, 1.0 mg, for
treatment of patients with an idiopathic decline in
mental capacity;
(b) Meclofenamate Sodium Capsules, 50 mg, for treatment
of rheumatoid arthritis and osteoarthritis;
(c) Meclofenamate Sodium capsules, USP, 100 mg, for
treatment of rheumatoid arthritis and osteoarthritis.
Recall #D-110/112-1.
Code: Lot numbers: (a) 8S370, 9A606, 9I242, 9V879, 9A542, 9F896,
9M503;
(b) 9H065, 0A028; (c) 9H072, 0B101, 9M490.
Manufacturer: Bolar Pharmaceutical, Inc., Copiague, New York.
Recalled by: UDL Laboratories, Inc., Rockford, Illinois (repacker), by
letter August 17, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: (a) 43,005 unit cartons; (b) 1,057 unit cartons;
(c) 1,049 unit cartons were distributed; firm estimates
50 percent of the product remains on market.
Reason: (a) Lack of assurance of manufacture in conformity with
conditions approved in the Abbreviated New Drug Application;
(b&c) Products lack assurance of bioequivalence.
----
-5-
Product: Xactdose Thioridazine HCl Oral Solution, USP, 100 mg/
3.4 ml, in unit dose cups, an Rx psychotropic for
management of manifestations of psychotic disorders.
Recall #D-122-1.
Code: Lot #908601, 912601.
Manufacturer: Pharmaceutical Basics, Inc., Morton Grove, Illinois.
Recalled by: Xactdose, Inc., South Beloit, Illinois (repacker), by
letter November 9, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 519 shelf cartons were distributed; firm estimates 25
percent remains on market.
Reason: Subpotent.
----
Class III -
Product: (a) Avan (Dimenhydrinate) Capsules, 50 mg, in 100
capsule bottles, an OTC drug used for the prevention
and treatment of nausea and vomiting associated with
motion sickness, under the Stewart Jackson Pharmacal
label;
(b) Allerhist (Phenylpropanolamine HCl 75
mg)/Chlorpheniramine Maleate 8 mg) Capsules, in 100 capsule
bottles, an OTC drug used for the treatment of allergic
rhinitus and cold symptoms, under the Clint Pharmaceuticals
label;
(c) APAP (Acetaminophen) Capsules, 500 mg, in 100 capsule
bottles, an OTC drug product for pain relief, under the IDE
Star label. Recall #D-106/108-1.
Code: Lot numbers: (a) SJA8901A EXP 12/91;
(b) CCV9003A EXP 2/92;
(c) PA9001A EXP 3/92, PA9002A2 3/92.
Manufacturer: D.M. Graham Laboratories, Inc., Hobart, New York.
Recalled by: Manufacturer, by telephone October 18-19, 1990.
Firm-initiated field correction ongoing.
Distribution: (a&b) Tennessee; (c) New York.
Quantity: (a) 4,320 bottles; (b) 991 bottles; (c) 720 bottles
were distributed.
Reason: The product labels do not indicate all of the
tamper-resistant features of the products.
----
Class III -
Product: UDL brand Iodinated Glycerol with Codeine Phosphate Liquid,
30 mg, 10 mg/5 ml, in unit dose cups, 10 cups/tray, 5
trays/case, an Rx schedule V controlled drug,
expectorant/antitussive/mucolytic for symptomatic relief
of non-productive coughs. Recall #D-109-1.
-6-
Code: Lot #005015.
Manufacturer National Pharmaceutical Company, Baltimore, Maryland.
UDL Laboratories, Inc., Largo, FLorida (packer).
Recalled by: UDL Laboratories, Inc., Rockford, Illinois, by letter
June 25, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 628 cases were distributed; firm estimates 10 percent
remains on market.
Reason: The product insert lists the wrong potency for codeine
phosphate, 15 mg instead of 10 mg.
----
Product: Nystatin Powder for preparation of oral suspension
150 million unit package, an Rx product used for
intestinal and oral cavity infection. Recall #D-113-1.
Code: All lots.
Manufacturer: Lederle Laboratories Division, Pearl River, New York.
Recalled by: Manufacturer, by letter on or about October 10, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 51,295 were distributed; firm estimates 5 percent
remains on market.
Reason: Product does not meet loss on drying specifications.
----
Product: Organon brand Arduan (Pipecuronium Bromide 10 mg/10 ml
vial), For Injection, in boxes of six 10 ml vials, an
Rx single ingredient, skeletal muscle relaxant, long acting.
Recall #D-114-1.
Code: 0010490446 EXP 7/92 on boxes, 490446 on vials,
0030590446 EXP 7/92 on boxes, 590446 on vials.
Manufacturer: Organon Inc., West Orange, New Jersey.
Recalled by: Manufacturer, by letter October 30, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Puerto Rico.
Quantity: 3,361 boxes of 6 vials (lot 490446), 1,180 boxes
of 6 vials (lot 590446) were distributed.
Reason: Product does not meet potency specifications.
----
Product: Nalfon Tablets, Tablet #1900, Fenoprofen Calcium Tablets,
USP 600 mg, in bottles of 100 and 500 tablets, an Rx
immediate action coated tablet for relief of rheumatoid
arthritis and osteoarthritis. Recall #D-115-1.
Code: Lot numbers: 1CX44A EXP 8/92, 1EW78A EXP 2/93,
2MU07A EXP 4/93, 2PG08A EXP 9/93, 3AH21C EXP 3/94.
Manufacturer: Eli Lilly & Company, Indianapolis, Indiana.
Recalled by: Manufacturer, by letter September 28, 1990. Firm-
initiated recall ongoing.
Distribution: Nationwide.
-7-
Quantity: 4,067 bottles of 500 of lot 1CX44A; 21,207 bottles of
100 of lot 1EW78A; 4,136 bottles of 500 of lot 2MU07A;
4,069 bottles of 500 of lot 2PG08A and 619 bottles of
500 of lot 3AH21C were distributed.
Reason: Product does not meet dissolution test specifications.
----
Product: Adapin (doxepin hydrochloride) Capsules, an antianxiety and
antidepressant Rx drug formerly marketed by Pennwalt Corp.,
Prescription Division, and currently marketed by Fisons
Pharmaceuticals:
(a) 10 mg, in bottles of 30, 100 and 1,000 capsules;
(b) 25 mg, in bottles of 4 & 9 capsules (profession samples),
30, 100, 1,000 and 5,000 capsules;
(c) 50 mg, in bottles of 4 & 9 capsules (profession samples),
100, 1,000 and 5,000 capsules;
(d) 75 mg, in bottles of 30, 100 and 1,000 capsules;
(e) 100 mg, in bottles of 30, 100 and 1,000 capsules;
(f) 150 mg, in bottles of 50. Recall #D-116/121-1.
Code: All lots.
Manufacturer: Smith, Kline and French Labs, Philadelphia, Pennsylvania.
Recalled by: Fisons Corporation, Rochester, New York (repacker), by letter
dated October 8, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Puerto Rico, Canada.
Quantity: 2,344,781 various size bottles were distributed; firm
estimates 22,070 bottles remain on market.
Reason: Some lots failed USP dissolution testing.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: (a) Kirschner Wires - diameter sizes - .028, .035,
.045, .062 (inches);
(b) Steiman Pins - diameter sizes 5/64, 3/32, 7/64,
1/8, 9/64, 5/32, 3/16 (inches). Products are used in
trauma surgery, as a temporary implant in reconstructive
surgery of the lower extremities. Recall #Z-037/038-1.
Code: Catalog Nos. Lot Nos. Size
659M 50-0903-5S .045" x 9"
811M 50-0907-6S 7/64" x 9"
815M 50-0904-6S .062" x 9"
895M 50-0905-4S 5/64" x 9"
930M 50-0905-5S 5/64' x 9"
934M 50-0911-4S 3/16" x 9"
969M 50-0905-6S 5/64" x 9"
973M 50-0907-5S 7/64" x 9"
008P 50-0903-6S .045" x 9"
-8-
232P 50-0908-6S 1/8" x 9"
578P 50-0906-5S 3/32" x 9"
621P 50-0904-1S .062" x 9"
645P 50-0907-4S 7/64" x 9"
599M 50-0402-1S
592M 50-0906-5S
829M 50-0401-6S
813M 50-0903-6S
777M 50-0907-4S
814M 50-0904-5S
774M 50-0404-1S
773M 50-0403-1S
660M 50-0904-6S
812M 50-0911-5S
772M 50-0402-1S
770M 50-0401-1S
942M 50-0404-1S
962M 50-0403-6S
889M 50-0401-1S
941M 50-0403-1S
961M 50-0402-6S
891M 50-0403-1S
890M 50-0402-1S
968M 50-0904-6S.
Manufacturer: Kirschner Medical Corporation, Timonium, Maryland.
Recalled by: Manufacturer, by letter July 16 and 18, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 1,257 units were distributed.
Reason: Product exhibits visible traces of surface corrosion.
----
Product: Drake Willock 480 Ultrafiltration control single patient
delivery system for hemodialysis:
(a) Drake Willock 480 Ultrafiltration Control: Acetate,
Bicarbonate, Variable Sodium and High Flow;
(b) Drake Willock 480 Ultrafiltration Control: Bedside,
Bedside with Heater;
(c) Dialysate Control Modules with UF Control.
Recall #Z-065/067-1.
Code: All 480 models with ultrafiltration control capability
with serial number less than 9704.
Manufacturer: CD Medical, Inc., subsidiary of the Dow Chemical Company,
Portland, Oregon.
Recalled by: Manufacturer, by letter August 29, 1990. Firm-initiated
field correction ongoing.
Distribution: Nationwide and international.
Quantity: 3,762 units were distributed.
Reason: The operator's UF system check did not detect failure
leak modes (positive pressure dialysate leaks) which
could lead to patient weight gain during hemodialysis.
In addition, the dialysate pressure alarm allowed the alarm
to be set significantly beyond the last reading on the gauge.
-9-
----
Product: Advantx Fluoroscopic Control/Generator, a component of
Diagonstic Fluoroscopic X-Ray Systems. Recall #Z-068-1.
Code: Model 146-275911.
Manufacturer: General Electric Company, Milwaukee, Wisconsin.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan August 3, 1990. Firm-initiated field correction
ongoing.
Distribution: Nationwide.
Quantity: 1,250 units were distributed.
Reason: Data base files on these systems may contain incorrect
values leading to excessive x-ray exposure.
----
Product: (a) Zimmer Anatomic Hip System Cone Provisional 14/15 mm
Right; (b) Zimmer Anatomic Hip System Cone Provisional
12/13 mm Right, used during pre-operative procedures
to determine the correct size implants to use during
an operation. Recall #Z-069/070-1.
Code: Product No. Lot No.
(a) 6601-23-02 07219300
(b) 6601-21-02 07219200.
Manufacturer: Nemco, Inc., Hicksville, Ohio.
Recalled by: Zimmer, Inc., Warsaw, Indiana, by letter September 17, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: (a) 100 pieces were distributed; firm estimates 85 pieces
remain on market; (b) 100 were distributed.
Reason: Product mix-up -- Provisionals labeled 14/15 mm
actually contain 12/13 mm sizes.
----
Product: Zenith Chiorpractic Adjusting Tables:
(a) Zenith II Hylo, Models 210, 220, 320, 440;
(b) Zenith Verti-Lift, Models 240VL, 260VL, 360VL, 460VL.
Recall #Z-075/076-1.
Code: All units purchased prior to 1984.
Serial numbers (a) 50000/54040; (b) VL1000/VL1407.
Manufacturer: Williams Manufacturing Company, Elgin, Illinois.
Recalled by: Manufacturer, by letters of October 19 and 31, 1990.
Firm-initiated field correction ongoing.
Distribution: Nationwide, England, Canada, Switzerland, Japan, The
Republic of South Africa.
Quantity: Approximately 3,500 tables were distributed.
Reason: Tables equipped with certain control switches may
cause injury if the movement of the table continues even
though the switch has been released).
----
-10-
Product: Medline Dynacor Sterile Skin Scrub Kit, used to prepare
a patient's skin for surgical procedures. Recall #Z-077-1.
Code: Catalog #3D70250, Lot #0H-0701.
Manufacturer: Medline Industries, Inc., Mundelein, Illinois.
Recalled by: Manufacturer, by telephone and letter October 5, 1990.
Firm-initiated recall ongoing.
Distribution: Ohio.
Quantity: 52 cases were distributed with the firm estimating that
all of the product was captured before use.
Reason: Lack of adequate sterilization.
----
Product: EdenTec Apnea Monitor Patient Cable, Models 4008 and
4012. Recall #Z-079/080-1.
Code: Model numbers: 4008 and 4012.
Manufacturer: EdenTec Corporation, Eden Prairie, Michigan.
Recalled by: Manufacturer, by letter October 5, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 10,306 units were distributed.
Reason: Product may cause false heart and respiration readings
by the monitor due to varying resistance in the cables.
----
Product: Lifepak 9 Defibrillator/Monitor, for treating heart
or arrhythmias with standard external defibrillation
paddles or optional internal defibrillation paddles.
Recall #Z-081-1.
Code: All serial numbers below 3991.
Manufacturer: Physio-Control Corporation, Redmond, Washington.
Recalled by: Manufacturer, by implementation of technical service
update (TSU) 144 on/about May 7, 1990. Firm-initiated
field correction ongoing.
Distribution: Nationwide and international.
Quantity: Approximately 2,300 units are subject to field correction.
Reason: The device may "lock-up" when power is turned on or during
use, and was also found to contain a high voltage diode that
is subject to failure.
----
Product: Model CB7-D C-Arm Fluoroscopic X-Ray System.
Recall #Z-099-1.
Code: Serial numbers: N/A.
Manufacturer: International Medical Systems, Inc., Riverside, California.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan November 6, 1990. Firm-initiated field correction
ongoing.
Distribution: Nationwide.
Quantity: Approximately 99 units were distributed.
-11-
Reason: Under certain conditions the x-ray field automatically
opens to the maximum radiographic size without being
specifically selected by the operator.
----
CORRECTION: Please substitute Model No. SCT-3000 TC for Model No.
SCT-3000 TE as listed under Recall #Z-917-0 which appeared
in the October 10, 1990 Enforcement Report. Model No.
SCT-3000 TE was never introduced into commerce. Model No.
SCT-3000 TC was part of the recall but was inadvertently
omitted.
----
Class III -
Product: API 20E System for in-vitro diagnostic use (microtube
system) for identification of Enterobacteriaceae and
other Gram-Negative Bacteria. Recall #Z-071-1.
Code: Lot #274280-4, Catalog #8886-010258.
Manufacturer: API Analytab Products, Plainview, New York.
Recalled by: Manufacturer, by letter September 14, 1990. Firm-
initiated recall ongoing.
Distribution: Nationwide, Puerto Rico, Canada, Mexico.
Quantity: 2,825 units were distributed; firm estimates less than
1 percent remains on the market.
Reason: The Melibiose and Amygdalin substrates are reversed
and may lead to misdiagnosis.
----
Product: Cobe Topical Cooling device (TCD), a sterile single-
use Rx pad used for topical cooling of the heart
during cardiovascular surgery. Recall #Z-078-1.
Code: Catalog #027130-300, Lot #03U0558.
Manufacturer: Cobe Laboratories, Inc., Cardiovascular Division,
Arvada, Colorado.
Recalled by: Manufacturer, by telephone October 8, 1990. Firm-
initiated recall ongoing.
Distribution: Maine, New Jersey, Pennsylvania.
Quantity: 8 cases (3 pads per case) were distributed.
Reason: Eight cases were inadvertently mislabeled as "adolescent"
instead of "adult" pads.
----
VETERINARY PRODUCTS
NONE
Medical Device Safety Alert:
Product: Century Saf-Lift, Model SL-10 used with Centry SAF-KARY
(Century Manufacturing Company, Aurora, NE), a
-12-
permanently mounted patient lifting device for trans-
ferring patients in and out of Century whirlpool bathing
systems. Safety Alert #M-002-1.
Code: Units manufactured between 1966 and 1990.
SL-10 Saf-Lift (1st generation, pin/slot latch),
serial numbers 166-00001 through 481-16176;
Saf-Lift (2nd generation, bar/hook latch), serial numbers:
481-16177 through 390-29314.
Manufacturer: Century Manufacturing Company, Aurora, Nebraska.
Alerted by: Malmros Holding, Inc., Morton Grove, Illinois, by
letter dated October 19, 1990.
Distribution: Nationwide, Canada, Germany, England, Australia.
Quantity: Approximately 28,500 units were distributed; firm
estimates 24,000 units remain on the market.
Reason: The safety latch can be displaced into an open position
by the patient's arm or body at specific seat-to-lift
angles, or by foreign objects such as washcloths, towels.
----
Injunction Actions Filed:
Against: Tsue Chong Company, Inc., and Kenneth L. Louie,
President, Seattle, Washington.
Product: Various Chinese Noodle Products (90-533-419).
Charge: Adulterated - Products being manufactured and stored
under insanitary conditions whereby they may have
become contaminated with filth.
Filed: September 27, 1990 - U.S. District Court for the
Western District of Washington, Civil #90-1358C,
INJ #1240.
----
Seizure Actions Filed:
Product: Medical Oxygen USP (90-533-218).
Charge: Adulterated - The methods used in, and the controls
used for, its manufacture, processing, packaging, or
holding did not conform to and were not operated or
administered in conformity with current good manufacturing
practice regulations.
Firm: Medical Mart, Idaho Falls, Ohio.
Filed: July 5, 1990 - U.S. District Court for the District of
Idaho; Civil #90-0340 E EJL, FDC #65879.
----
Product: Assorted Food Products (90-534-825 et al).
Charge: Adulterated - Products held under insanitary conditions
whereby they may have become contaminated with filth.
Firm: Mills Bros. International, Inc., Seattle, Washington.
Filed: September 28, 1990 - U.S. District Court for the
-13-
Western District of Washington; Civil #C90-1361 WD,
FDC #65948.
----
Product: IQF Scallops (90-534-471).
Charge: Adulterated - Product consists in part of decomposed
product.
Firm: Alaska Sea Pack, Anchorage, Alaska and/or Seafresh Inc.,
Seattle, Washington and/or Wards Cove Packing Company,
Seattle, Washington.
Filed: September 7, 1990 - U.S. District Court for the Western
District of Washington; Civil #90-1269Z, FDC #65914.
----
Product: Sun Tanning Beds (90-553-527).
Charge: Misbranded - Lack of required warning labels and
adequate directions for use.
Firm: Tantrific Sun, Springfield, Missouri.
Filed: November 7, 1990 - U.S. District Court for the Western
District of Missouri, Southern Division;
Civil #90-3489-CV-S-2, FDC #65963.
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Product: Disposable Syringes (90-551-557/560).
Charge: Syringes leak and manufacturer did not adhere to
current good manufacturing practices to assure sterility.
Firm: NeedlePoint Guard, Inc., Grand Island, Nebraska.
Filed: October 29, 1990 - U.S. District Court for the District of
Nebraska; Civil #CV 90-0-729; FDC #65950.
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Product: Various Foods (90-604-702).
Charge: Adulterated - Products were held under insanitary
conditions whereby they may have become contaminated
with filth.
Firm: Antones Import Company, Houston, Texas.
Filed: October 29, 1990 - U.S. District Court for the Southern
District of Texas, Houston Division; Civil #H90-3351,
FDC #65945.
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Disposition of Prosecution:
Defendant Wendell W. Williams, DVM, doing business as Robertson
County Veterinary Clinic, Hearne, Texas.
Product: Veterinary Drugs (85-467-177).
Nature of The receipt in interstate commerce of an unapproved
Charges: new animal drug and its delivery for pay and the
shipment in interstate commerce of an unapproved new
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animal drug.
Disposition: On September 24, 1990 Dr. Williams pled guilty to two
misdemeanor counts. Sentencing was handed down on November
8, 1990. He was sentenced to 2 years probation on each
count to run concurrently and fined $2,500 per court for a
total of $5,000; U.S. District court for the Western
District of Texas, Waco Division; Criminal #W-90-CR021,
MISC #889.
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