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
06/11/1991
FDA Enforcement for the week of 6/12/91
FDA ENFORCEMENT REPORT
FOR JUNE 12, 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.
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: Ceramic dinnerware sets that include dinner plates, salad
plates, soup palates, serving bowls, and platters,
Pesaro pattern - (a) Dinner Plate; (b) Salad Plate;
(c) Soup Plate; (d) 15" Bowl; (e) Platter;
Firenze pattern: (f) Dinner Plate; (g) Salad Plate;
(h) Soup Plate; (i) 15" Bowl; (j) Two Handle Shallow Bowl;
(k) Platter. Recall #F-387/397-1.
-1-
Code: Style numbers: (a) 88042; (b) 88040; (c) 88001;
(d) 88032; (e) 88031; (f) 88041; (g) 88009;
(h) 88043; (i) 88034; (j) 88005; (k) 88029.
Manufacturer: Maioliche il Bargello di Melani Anna Maria, Firenze, Italy.
Recalled by: Macy's California, Inc., San Francisco, California
(importer), by removing dinnerware sets from retail
store shelves November 19, 1990 and by posting signs
in retail stores beginning February 1, 1991. Firm-
initiated recall ongoing.
Distribution: California.
Quantity: (a) 46 units; (b) 33 units; (c) 24 units; (d) 5 units;
(e) 6 units; (f) 48 units; (g) 36 units; (h) 25 units;
(i) 5 units; (j) 4 units; (k) 6 units were distributed.
Reason: High leachable levels of lead and cadmium in the product.
----
Product: Walgreen's A thru Z Jr. Children's Chewable Multi-
vitamin/Mineral Formula, in 60 tablet bottles.
Recall #F-399-1.
Code: Item #505411, lot #9J0P EXP 8/91.
Manufacturer: Xcel Laboratories, Inc., Kalamazoo, Michigan.
Recalled by: Walgreen Company, Deerfield, Illinois, by electronic
messages April 19, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 6,650 bottles were distributed.
Reason: The product substituted cupric sulfate, which is an
irritant to the mucous membrane, for cupric oxide.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Snapple Orange Iced Tea, in 16 ounce glass bottles with
metal screw cap and stick on label. Recall #F-398-1.
Code: CT504222INV or T504222INZ printed on metal screw cap.
Manufacturer: Rumac Packaging Company, Trenton, New Jersey (bottler).
Recalled by: Snapple Natural Beverage Company, Ridgewood, New York,
by telephone September 4, 1990 followed by letter.
Firm-initiated recall complete.
Distribution: New York, New Jersey, Connecticut.
Quantity: 2,791 cases (24 bottles per case) were distributed.
Reason: Product has an off taste and had an oily substance.
----
-2-
Product: Liquid multi-vitamin supplement drops packed in 1 2/3 ounce
containers:
(a) Triple Vitamin Drops with Fluoride, 0.5 mg, an
Rx product;
(b) Bio-Poly-Sol with Iron. Recall #F-384/385-1.
Code: Lot numbers: (a) 004636 EXP 6/92; (b) 010632 EXP 12/92.
Manufacturer: Hi-Tech Pharmacal Company, Inc., Amityville, New York.
Recalled by: Manufacturer. Firm-initiated recall ongoing.
Distribution: Ohio.
Quantity: (a) 1,440 units; (b) 1,440 units were distributed;
firm estimates none remains on the market.
Reason: A unit of Bio-Poly-Sol with Iron lot number 010632 was found
in a box labeled Triple Vitamin Drops with Floride 0.5 and a
unit of Triple Vitamin Drops with Floride 0.50 mg lot 004636
was found in a box labeled Bio-Poly-Sol with Iron.
----
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-231/232-1.
Code: Unit numbers: 10H03604, 10J03977.
Manufacturer: American Red Cross, Springfield, Missouri.
Recalled by: Manufacturer, by letters of February 5 and 6, 1991
and by telephone December 19, 1990. Firm-initiated recall
complete.
Distribution: Arkansas, Missouri, California.
Quantity: 2 units of each component.
Reason: Blood products collected from donors who reported use of
intravenous drugs or a history of hepatitis, were
distributed.
----
Product: Recovered Plasma. Recall #B-246-1.
Code: Unit #21714.
Manufacturer: Marietta Memorial Hospital, Marietta, Ohio.
Recalled by: Manufacturer, by letter March 18, 1990. Firm-initiated
recall complete.
Distribution: Pennsylvania.
Quantity: 1 unit.
-3-
Reason: Blood component, which tested non-reactive for
antibody to the human immunodeficiency virus type
1 (anti-HIV-1) but collected from a donor who
previously tested repeatably reactive for anti-HIV-1,
was distributed.
----
Product: Platelets, Pheresis. Recall #B-249-1.
Code: Unit #16P31275.
Manufacturer: American Red Cross, Columbus, Ohio.
Recalled by: Consignee notified the firm by telephone December 31,
1989. Recall complete.
Distribution: Ohio.
Quantity: 1 unit.
Reason: Blood products labeled with incorrect expiration
dates, were distributed.
----
Product: Source Plasma. Recall #B-253-1.
Code: Unit numbers: N16590-133 and N16652-133.
Manufacturer: Hattiesburg Plasma Center, Inc., Hattiesburg, Mississippi.
Recalled by: Manufacturer, during November 1990. Firm-initiated
recall complete.
Distribution: California, Texas.
Quantity: 2 units.
Reason: Source Plasma collected from a donor who participated
in high-risk behavior was distributed.
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Recovered
Plasma. Recall #B-265/267-1.
Code: Unit #27026-1742.
Manufacturer: United Blood Services, Division of Blood Systems
Inc., Texarkana, Texas.
Recalled by: Manufacturer, by telephone followed by letter
December 5, 1990 and by letter of March 28, 1991.
Firm-initiated recall ongoing.
Distribution: Arkansas, North Carolina.
Quantity: 1 unit of each component.
Reason: Blood components, collected from a donor who admitted
to intravenous (IV) drug use, were distributed.
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-268/270-1.
Code: Unit #09R24827.
Manufacturer: American Red Cross, Omaha, Nebraska.
-4-
Recalled by: Manufacturer, by letter July 13, 1990. Firm-initiated
recall ongoing.
Distribution: Nebraska, California.
Quantity: 1 unit of each component.
Reason: Blood products collected from a donor, who experienced
an occupational needlestick exposure two months prior
to donation, were distributed.
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen
Plasma; (d) Recovered Plasma. Recall #B-272/275-1.
Code: Unit numbers: (a) 53T02522, 53L29642; (b) 53L29642;
(c) 53L29642; (d) 53T02522, 53G81925, 53H07803,
53R21650, 53M49267.
Manufacturer: American Red Cross, Baltimore, Maryland.
Recalled by: Manufacturer, by letters of February 15, 17 and 22, 1991.
Firm-initiated recall ongoing.
Distribution: Maryland, Pennsylvania, California.
Quantity: (a) 2 units; (b) 1 unit; (c) 1 unit; (d) 5 units.
Reason: Blood products which tested non-reactive for
hepatitis B surface antigen (HBsAg), but were collected
from donors who had previously tested repeatably
reactive for HBsAg, were distributed.
----
Product: Platelets. Recall #B-276-1.
Code: Unit #21S96001.
Manufacturer: American Red Cross Blood Services, Portland, Oregon.
Recalled by: Consignee notified the firm on November 30, 1990.
Recall complete.
Distribution: Oregon.
Quantity: 1 unit.
Reason: Blood product labeled with incorrect expiration date
was distributed.
----
Product: Platelets. Recall #B-277-1.
Code: Unit #21S72085.
Manufacturer: American Red Cross Blood Services, Portland, Oregon.
Recalled by: Manufacturer, by telephone April 11, 1990. Firm-
initiated recall complete.
Distribution: Oregon.
Quantity: 1 unit.
Reason: Blood product which tested positive for syphilis was
distributed for transfusion.
----
Product: Platelets Pheresis. Recall #B-281-1.
Code: Unit #41KP02993.
-5-
Manufacturer: American Red Cross Blood Services, Huntsville, Alabama.
Recalled by: Consignee notified the firm, by telephone June 29, 1990.
Recall complete.
Distribution: Alabama.
Quantity: 1 unit.
Reason: Blood product labeled with incorrect expiration date
was distributed.
----
Class III -
Product: (a) Whole Blood; (b) Red Blood Cells;
(c) Cryoprecipitated AHF; (d) Platelets; (e) Recovered
Plasma. Recall #B-218/222-1.
Code: Unit numbers: (a) 1033374; (b) 1028646, 2024453, 1268397;
(c) 1028646, 1268397; (d) 2024453; (e) 1028646, 2024453,
1268397.
Manufacturer: LifeSource, Glenview, Illinois.
Recalled by: Manufacturer, by telephone March 18, 1991 and by
letter March 19, 1991. Firm-initiated recall complete.
Distribution: Illinois, California.
Quantity: (a) 1 unit; (b) 3 units; (c) 2 units; (d) 1 unit;
(e) 3 units.
Reason: Blood components, which were collected from a donor
who had previously tested repeatably reactive for the
antibody to the Human Immunodeficiency Virus Type 1
(anti-HIV-1) by EIA, were distributed.
----
Product: Red Blood Cells. Recall #B-245-1.
Code: Unit numbers: 45F58033, 45F58054, 45F58056, 45F58058,
45F58059, 45F58062.
Manufacturer: American Red Cross Blood Services, Waterloo, Iowa.
Recalled by: Manufacturer, by telephone January 4, 1991. Firm-
initiated recall complete.
Distribution: Iowa.
Quantity: 6 units.
Reason: Blood products, incorrectly tested for the antibody to
the hepatitis C virus (anti-HCV), were distributed for
transfusion.
----
Product: Fresh Frozen Plasma. Recall #B-247-1.
Code: Unit numbers: 50G67323, 50G67341, 50G67344, 50G67346,
50H73226.
Manufacturer: American Red Cross Blood Services, Toledo, Ohio.
Recalled by: Consignee notified the manufacturer, by telephone
July 3, 1990. Recall complete.
Distribution: Ohio.
Quantity: 5 units.
-6-
Reason: Blood products, labeled with incorrect expiration dates,
were distributed for transfusion.
----
Product: Recovered Plasma. Recall #B-248-1.
Code: Unit #01693.
Manufacturer: Ephrata Community Hospital, Ephrata, Pennsylvania.
Recalled by: Manufacturer, by letter April 3, 1991. Firm-initiated
recall complete.
Distribution: Pennsylvania.
Quantity: 1 unit.
Reason: Blood component, which tested repeatably reactive for
hepatitis B surface antigen (HBsAg) was distributed.
----
Product: Red Blood Cells. Recall #B-250-1.
Code: Unit #16H48551.
Manufacturer: American Red Cross, Columbus, Ohio.
Recalled by: Consignee notified the firm by telephone February 27, 1990.
Recall complete.
Distribution: Ohio.
Quantity: 1 unit.
Reason: Blood product labeled with incorrect expiration
dates, was distributed.
----
Product: Erasable-Programmable-Read-Only Memory (EPROM)
Computer Chips Numbers 15829-01, l5829-02, 15829-03,
15829-04, 15829-05 for use in the Haemonetics
Plasmapheresis Collection System. Recall #B-262-1.
Code: PCS Model 06001-CP - All serial numbers.
Manufacturer: Haemonetics Corporation, Braintree, Massachusetts.
Recalled by: Manufacturer, by telephone March 13, 1991 followed by
letter March 14, 1991. Firm-initiated field correction
ongoing.
Distribution: California, New York, Arizona, Illinois.
Quantity: 2,490 PCS's were distributed.
Reason: Defective computer chips caused no plasma separation
to occur during the first operating cycle.
----
Product: Red Blood Cells. Recall #B-263-1.
Code: Unit #401527.
Manufacturer: Belle Bonfils Memorial Blood Center, Denver, Colorado.
Recalled by: Manufacturer, on March 6, 1991. Firm-initiated
recall complete.
Distribution: Colorado.
Quantity: 1 unit.
-7-
Reason: Blood component was distributed labeled with an
incorrect expiration date.
----
Product: Surgiscreen Reagent Red Blood Cells. Recall #B-264-1.
Code: Lot #3SS400, Cell #2 EXP 11/20/90.
Manufacturer: Ortho Diagnostics Systems, Inc., Raritan, New Jersey.
Recalled by: Manufacturer, by letter November 2, 1990. Firm-
initiated recall complete.
Distribution: Nationwide.
Quantity: 550 packages were distributed.
Reason: Le(a+b+) Reagent Red blood Cells labeled as Le(a+b-)
were distributed.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
Product: Software for Theraplan and TP-11 Cancer Treatment:
(a) Software Versions V048B-B and V05-PRx ("x" - 1, 2, 3
and 4) for Theratronics' Theraplan Treatment Planning
Systems;
(b) Software Versions V08B-B and V09-RPx for Theratronics'
TP-11 Treatment Planning Systems. Recall #Z-670/671-1.
Code: All units.
Manufacturer: Theratronics International, Ltd., formerly Atomic Energy
of Canada, Ltd. (AECL Medical), Ontario, Canada.
Recalled by: Theratronics International, Ltd., Carrollton, Texas,
by Urgent Software Bulletin November 23, 1990 and by
telephone November 26, 1990. Firm-initiated field
correction ongoing.
Distribution: California, Maryland and international.
Quantity: 97 disks were distributed.
Reason: The software program may not accurately calculate the
Cobalt 60 decay time and this may result in incorrect
radiation treatment of the patient and therefore improper
cancer treatment.
----
Class II -
Product: Theratron Phoenix Teletherapy (Cobalt 60) Unit, used
to treat cancer patients. Recall #Z-722-1.
Code: All units.
Manufacturer: Theratronics International, Ltd., formerly Atomic Energy
of Canada, Ltd. (AECL Medical), Ontario, Canada.
Recalled by: Theratronics International, Ltd., Carrollton, Texas,
by User Bulletin CUB-90-3 dated July 3, 1990.
Firm-initiated recall ongoing.
-8-
Distribution: Nationwide and international.
Quantity: 7 of 13 units distributed nationally have been
retrofitted. 39 units distributed internationally.
Reason: The single digital treatment timer on the Phoenix model
is susceptible to ESD (Electrostatic discharge) which
may cause timer failures resulting in a possible error
in radiation dose given to patients.
----
Product: Fanuc Laser Models C-1000, C-1500, C-2000 and C-3000,
used for industrial purposes. Recall #Z-723/726-1.
Code: Serial numbers: Not determined.
Manufacturer: Fanuc, USA Corporation, Elk Grove Village, Illinois.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan May 16, 1991. Firm-initiated field
correction ongoing.
Distribution: Nationwide.
Quantity: 30 units were distributed.
Reason: Noncompliance with performance standards for laser
products with respect to safety interlocks, instructions
for installation and system integration, and labeling for
noninterlocked protective housings.
----
Product: Model MiniPro Laser Light Show Projector.
Recall #Z-727-1.
Code: Serial numbers: None.
Manufacturer: Laser Productions, Miami Beach, Florida.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan May 16, 1991. Firm-initiated field
correction ongoing.
Distribution: Florida.
Quantity: 1 unit was distributed.
Reason: Noncompliance with performance standards for laser products
in that it had inadequate output aperture masking, interlock
and aperture labels.
----
Product: Companion 2801 Volume Ventilator, used for support for
ventilator dependant patients in the hospital home care
center settings. Recall #Z-728-1.
Code: Serial numbers: 000102DE through 001173DE, 001246DE,
000040PI, 000042PI, 000058PI.
Manufacturer: Puritan-Bennett, Portable Ventilator Division,
Boulder, Colorado.
Recalled by: Manufacturer, by letter May 1, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Canada, England, Puerto Rico, Argentina,
Italy.
Quantity: 740 units were distributed.
-9-
Reason: The internal battery can short cut, leading to potential
exposure of patient or caregiver to fumes; delay in alarm;
and system failure.
----
Product: Image Intensifier to OEC-Diasonics Models (a) DXR-5;
(b) DXR-10; (c) Model 902 Mobile C-Arm Imaging Systems.
X-ray systems used in applications of fluoro imaging.
Recall #Z-729/731-1.
Code: Serial numbers: (a) 5C9001 through 5C9005, 5C9007 through
5C9011, 5C9013 through 5C9034, 5CP6109, 5CP9/6048, 5CP9012,
5CP9036 through 5CP9081, 5X6119, 5X9001 through 5X9017 and
5X9019 through 5X9024;
(b) 10C90002 through 10C9013, 10C9016 through 10C9019,
10CP9001, 10CP9020 through 10CP9064, 10X9001 and 10X9003
through 10X9014 and 10X9019;
(c) 2061, 2192/9, 2283, 2324CP, 9001 through 9047, 9049CP
9050CP through 9053CP, A003 and A007.
Manufacturer: OEC-Diasonics, Inc., Salt Lake City, Utah.
Recalled by: Manufacturer, by Field Service Bulletin (FSB) #90-017 dated
10/3/90. Firm-initiated field correction ongoing.
Distribution: Nationwide, England, Japan, Germany, Poland, China,
Canada, Equadore, Taiwan, Kenya.
Quantity: Approximately 245 units were distributed.
Reason: The device was found to be hanging by partial unwound
helicoils.
----
Product: Dual Cuff Control Valve, for activating air pressure
to inflatable tourniquets used to create a bloodless
surgical field during surgery. Recall #Z-732-1.
Code: All lots of the product sold since January 1, 1987.
Manufacturer: A.B. Stille - Werner, Stockholm, Sweden.
Recalled by: DePuy, Warsaw, Indiana, by letters of April 12 and 15, 1991
Firm-initiated recall ongoing.
Distribution: Nationwide and Japan, Canada, Korea.
Quantity: 75 units were distributed.
Reason: Premature wear to the internal valve components may cause
detrimental leakage of pressure from the tourniquet cuff
during usage.
----
Product: Vertical Cassette Stand with automatic cassette centering
and collimator sensing:
(a) CS3 Model Nos. 51-761 and 51-779;
(b) CS4 Model Nos. 55-424 and 55-432. Recall #Z-733/734-1.
Code: Serial numbers (not in numerical order):
(a) 1001 - 9999 (Model #51-761), 345 - 9999 (Model 31-779);
(b) 1002 - 1057 (Model 55-424), 1003 - 1023 (Model 55-432).
Manufacturer: Hans-Pausch Rontgengeratebau, GmbH, Erlangen, West Germany.
-10-
Recalled by: Siemens Medical Systems Inc., Iselin, New Jersey, by
memorandum during mid-1988. Firm-initiated field correction
ongoing.
Distribution: Nationwide, Puerto Rico, Canada.
Quantity: (a) 317 units; (b) 24 units were distributed.
Reason: The cassette positioning bar may release inadvertently
and cause injury to patients or staff.
----
Product: Abbott TestPack Plus Strep A Diagnostic Kit, a rapid
immunoassay for the qualitative detection of Group A
Streptococcal antigen from throat swab specimens or
confirmation of presumptive positive Group A Streptococcal
colonies recovered from culture. Recall #Z-736-1.
Code: Lot numbers: 50065M100, 50383M200, 50454M200, 50517M100,
50539M300, 50539M301, 50539M302, 50550M300, 50551M300,
50551M301, 50552M300, 50553M300, 50554M300, 50768M100,
50776M100, 50887M200, 50931M200, 50931M201, 50931M202,
50932M200, 51050M100, 51051M100, 51052M100, 51053M100,
51061M300, 51679M100, 51679M101.
Manufacturer: Abbott Laboratories, Diagnostics Division, Abbott Park,
Illinois.
Recalled by: Manufacturer, by letter April 15, 1991 and by FAX
April 22, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 3,747 20-test kits and 22,545 40-test kits were
distributed; firm estimates 20 percent remains on
the market.
Reason: A potential exists for false positive results which
exceeds the firm's current specificity claim.
----
Product: X-ray Controls and High Voltage Generators:
(a) Model No. UD150B; (b) Model No. UD150K.
Recall #Z-737/738-1.
Code: All serial numbers.
Manufacturer: Shimadzu Corporation, Gardena, California.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan May 6, 1991. Firm-initiated field
correction ongoing.
Distribution: Nationwide.
Quantity: (a) 141 units; (b) 75 units were distributed.
Reason: Noncompliance with performance standards for x-ray products
in that they do not have certification labels, model
number ID, date of manufacture, or product serial numbers.
----
Product: (a) Sophy Camera DS7 System; (b) Sophy Camera DSX
System. Recall #Z-743/744-1.
-11-
Code: Serial numbers: (a) 313/1016 and above;
(b) 301/1002 and above.
Manufacturer: Sopha Medical, France.
Recalled by: Sopha Medical Systems, Inc., Columbia, Maryland, by
letters of April 12, 1991 and May 7, 1991.
Firm-initiated field correction ongoing.
Distribution: Nationwide and international.
Quantity: 350 systems were distributed.
Reason: The detector/gantry assembly can mechanically travel beyond
pre-set parameters or move in a fashion not expected by the
operator.
----
Class III -
Product: High Cholesterol Calibrator, a component of Kit
Catalog #115641, used to determine serum cholesterol
levels. Recall #Z-741-1.
Code: Lot numbers: K31JK, M49JK, D58LK.
Manufacturer: Ciba Corning Diagnostics Corporation, Oberlin, Ohio.
Recalled by: Manufacturer, by letter dated February 15 and 18, 1991
Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 1,303 kits were distributed.
Reason: The high cholesterol calibrator (400mg/dl) has
a loss of activity that can result in elevated test values,
causing inaccurate test results.
----
VETERINARY PRODUCTS
NONE