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
08/06/1991
Enforcement Report for August 7, 1991
August 7, 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: Butter Reddies, portion control butter service for use
by the food service industry, packed in unlabeled trays
containing either 90 or 72 patties per tray, and sold in
15 pound cartons. Paper label on top of butter patties
says Bell or Main Street. Recall #F-500-1.
Code: 150, 151, 157, 158 stamped on shipping case only.
Manufacturer: Cabarrus Creamery Company, Concord, North Carolina
(bulk butter); Kay's Ice Cream Company, Knoxville, Tennessee
(Cream).
Recalled by: Dairy Sales, Coatesville, Pennsylvania, by telephone
June 28, 1991, followed by letter July 9, 1991.
Firm-initiated recall ongoing.
Distribution: Pennsylvania.
-1-
Quantity: 1,211 cartons.
Reason: Product manufactured without heat treatment using cream
contaminated with Listeria monocytogenes.
----
Product: Bulk Butter in 68 pound cubes. Recall #F-507-1.
Code: 100-143-01 through 100-143-05.
Manufacturer: Cabarrus Creamery Company, Inc., Concord, North Carolina.
Recalled by: Manufacturer, by telephone June 28, 1991. Firm-initiated
recall complete.
Distribution: Pennsylvania.
Quantity: 271 bulk cubes were distributed.
Reason: Product was manufactured without heat treatment using cream
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: C J's Treats, Juice Filled Stix, Waxed Jumbo Stix, packed
in 7/8 ounce bags. Recall #F-503-1.
Code: All packages not identified as containing FD&C Yellow #5.
Manufacturer: Glenn Confection Division, Buffalo, New York.
Recalled by: M & M Distributing Company, La Plume, Pennsylvania, by
visit beginning March 3, 1991. Firm-initiated recall
complete.
Distribution: Pennsylvania.
Quantity: Approximately 975 packages were distributed.
Reason: Product contains undeclared FD&C Yellow #5.
----
Product: Fresh Yellow Fin Tuna (five fish headed and gutted,
each fish weighing 107 pounds, 151 pounds, 120 pounds,
101 pounds and 110 pounds). Recall #F-506-1.
Code: None.
Manufacturer: Imported from Ecuador.
Recalled by: Poseidon Enterprises, Inc., Charlotte, North Carolina,
by telephone May 24 and 28, 1991. Firm-initiated recall
ongoing.
Distribution: North Carolina, South Carolina.
Quantity: Approximately 400 pounds were distributed.
Reason: Product is decomposed.
----
-2-
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Barcelona Foods brand dried fruit and nut mixes
in plastic bags:
(a) 3 ounce Rainey Lake Fruit Bowl;
(b) 3 ounce Rainey Lake Fruit and Fiber;
(c) 3 ounce I Love Fruit 'N Nuts;
(d) 2-3/4 ounce and 3 ounce Fruit 'N Nuts;
(e) 3 ounce Rainey Lake I Love Fruit 'N Nuts;
(f) 3 ounce Tropical Trail Mix;
(g) 3-1/2 ounce Just Fruit;
(h) 3-1/4 ounce Rainey Lake Honey Sweet;
(i) 3 ounce Rainey Lake Tropical Rainbow.
Recall #F-429/437-1.
Code: Not coded.
Manufacturer: Barcelona Nut Company, Baltimore, Maryland.
Recalled by: Manufacturer, by placing stickers on products to be
completed by March 22, 1991. Firm-initiated field
correction complete.
Distribution: Virginia, Washington, D.C., Connecticut, New Jersey,
Massachusetts, Maryland.
Quantity: Firm estimates all units were corrected.
Reason: Product labeling failed to declare the presence
of an artificial color.
----
Product: Slush Puppy Ice Poppies, in 1 ounce and 2 ounce plastic
sheaths, flavored ice items. Recall #F-501-1.
Code: The shipping cases are identified with date, 4-9-91.
Manufacturer: American Food Products, Inc., Cincinnati, Ohio.
Recalled by: Manufacturer, by telephone May 20, 1991, followed by visit.
Firm-initiated recall ongoing.
Distribution: Ohio, Pennsylvania, Mississippi.
Quantity: Approximately 5,220 of the 24 count cartons and 100
cases of the 2 ounce product were distributed; firm
estimates none remains on the market.
Reason: Product is contaminated with yeast.
----
Product: Flamingo brand Assorted Tropical Fruit Nectars in 10
ounce cans. Recall #F-502-1.
Code: All lots
Manufacturer: Multi Fruit C.A., Yaracuy, Venezuela.
Recalled by: Blanditos Food, Miami, Florida, by telephone November 6,
1990. Firm-initiated recall ongoing.
Distribution: Florida.
Quantity: 1,980 cases were distributed.
-3-
Reason: Product contained in defective cans.
----
Product: Sunnyfresh Citrus Punch Drink. Recall #F-504-1.
Code: SELL BY MAY 22.
Manufacturer: Juiceland, Inc., Detroit, Michigan.
Recalled by: Manufacturer, by visit. Firm-initiated recall complete.
Distribution: Michigan.
Quantity: 407 cases (8 bottles per case) were distributed.
Reason: Product labeled as containing 68 ounces but packaged
in 64 ounce bottles.
----
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Clenbuterol Tablets, 20 mcg, in 100 tablet bottles, an
illegal veterinary product which is being marketed as a
human anabolic steroid alternative. Recall #D-513-1.
Code: All lots.
Manufacturer: Pacifico Enterprises, Dayton, Ohio (distributor).
Recalled by: Distributor, by letter July 8, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 78 bottles were distributed.
Reason: Product is an unapproved new drug.
----
Product: Recovered Plasma. Recall #B-347-1.
Code: Unit numbers LZ01636, LZ01673.
Manufacturer: National Health Guard, Inc., Fort Lauderdale, Florida.
Recalled by: Manufacturer, by telephone March 21, 1991, and by
letter March 22, 1991. Firm-initiated recall ongoing.
Distribution: Florida.
Quantity: 2 units.
Reason: Recovered Plasma, which tested repeatably reactive
for the antibody to the hepatitis C virus (anti-HCV)
and which was distributed for further manufacture into
non-injectable products, was not labeled as reactive
for anti-HCV.
----
-4-
Product: Recovered Plasma. Recall #B-349-1.
Code: Unit numbers: 1582375, 1588059, 1600092.
Manufacturer: Palm Beach Blood Bank, Inc., West Palm Beach, Florida.
Recalled by: Manufacturer, by letter April 4, 1991. Firm-initiated
recall ongoing.
Distribution: Florida.
Quantity: 3 units.
Reason: Blood products, which tested repeatably reactive for the
antibody to the hepatitis C virus (anti-HCV), but
labeled as non-reactive for anti-HCV, were distributed.
----
Product: (a) Red Blood Cells; (b) Platelets. Recall #B-350/351-1.
Code: Unit numbers: (a) 374770, 424478; (b) 424478.
Manufacturer: Belle Bonfils Memorial Blood Center, Denver, Colorado.
Recalled by: Manufacturer, by letter February 6, 1991. Firm-
initiated recall complete.
Distribution: Colorado.
Quantity: (a) 2 units; (b) 1 unit.
Reason: Blood components, which were: 1) not tested for the
antibody to the human immunodeficiency virus, type 1
(anti-HIV-1); or 2) improperly tested for the antibody to
the human T lymphotropic virus, type 1 (anti-HTLV-1); or
3) tested initially reactive for anti-HTLV-I, were
distributed.
----
Product: (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-353/354-1.
Code: Unit #1029105.
Manufacturer: Logan Regional Hospital, Logan, Utah.
Recalled by: Intermountain Health Care Blood Services, Salt Lake
City, Utah, by letters of May 20 and 23, 1991.
Firm-initiated recall complete.
Distribution: Utah, Florida, New Jersey, Massachusetts.
Quantity: 1 unit of each component.
Reason: Blood products, which tested initially reactive for the
antibody to the human immunodeficiency virus type 1
(anti-HIV-1), were distributed.
----
Product: Platelets, Pheresis. Recall #B-355-1.
Code: Unit #272456.
Manufacturer: Community Blood Center, Dayton, Ohio.
Recalled by: Consignee discovered labeling error and notified the
recalling firm on January 15, 1991. Recall complete.
Distribution: Ohio.
Quantity: 1 unit.
Reason: Blood product labeled with an incorrect expiration
date was distributed.
----
-5-
Product: Whole Blood. Recall #B-356-1.
Code: Unit #W11120.
Manufacturer: Hendrick Medical Center, Abilene, Texas.
Recalled by: Manufacturer, by telephone November 30, 1990. Firm-
initiated recall ongoing.
Distribution: Texas.
Quantity: 1 unit.
Reason: Blood product which tested repeatably reactive for
the antibody to the human immunodeficiency virus type 1
(anti-HIV-1), was distributed for transfusion.
----
Product: Source Plasma. Recall #B-357-1.
Code: Unit numbers: N-39698, N-39812, N-39881, N-40014, N-40098,
N-39655.
Manufacturer: San Juan Plasma, Inc., Farmington, New Mexico.
Recalled by: Manufacturer, by telephone April 30, 1991. Firm-
initiated recall ongoing.
Distribution: California.
Quantity: 6 units.
Reason: Source Plasma, which tested non-reactive for the
hepatitis B surface antigen (HBsAg) and the antibody to
the human immunodeficiency virus type 1 (anti-HIV-1) but
was collected from a donor who previously tested reactive
for either HBsAg or anti-HIV-1, was released.
----
Class III -
Product: ProSom Estazolam Tablets, 2 mg, in 100 tablet bottles,
an Rx oral Schedule IV controlled drug for short-term
management of insomnia. Recall #D-511-1.
Code: Lot numbers: 48-895-AF-21, 48-895-AF-22.
Manufacturer: Abbott Laboratories, Abbott Park, Illinois.
Recalled by: Manufacturer, by telephone July 19, 1991, followed by
letter July 23, 1991. Firm-initiated recall ongoing.
Distribution: Illinois, Wisconsin, Michigan, Ohio, Indiana, Kentucky.
Quantity: 264 bottles were distributed; firm estimates 75 percent
of the product remains on the market.
Reason: Some of the tablets bear the identification code "UC"
instead of the correct code "UD".
----
Product: Heparin Sodium Injection USP, 1000 USP units/ml, in
30 ml vials, an Rx injectable for intravenous and
subcutaneous use for anticoagulant therapy.
Recall #D-512-1.
Code: Catalog #01930, lot #910525 EXP 11/92.
Manufacturer: Smith & Nephew SoloPak, Elk Grove Village, Illinois.
Recalled by: Manufacturer, by telephone July 18, 1991, followed by
letter July 22, 1991. Firm-initiated recall ongoing.
-6-
Distribution: New Jersey, Nevada, Washington state, Arizona, Florida,
Oklahoma, California, Tennessee, Oregon, Arkansas.
Quantity: 360 cases (25 vials per case) were distributed; firm
estimates 316 cases remain on the market.
Reason: Superpotency.
----
Product: Vivotif Berna Typhoid Vaccine, Live Oral Ty21a.
Recall #B-287-1.
Code: Lot #115382A EXP 10/91.
Manufacturer: Swiss Serum and Vaccine Institute, Berne, Switzerland.
Recalled by: Berna Products Corporation, Coral Gables, Florida, by
letter, telephone and FAX February 11, 1991. Firm-
initiated recall ongoing.
Distribution: Nationwide.
Quantity: 18,900 units were distributed.
Reason: Product was misbranded in that it was distributed
containing an unapproved package insert.
----
Product: Red Blood Cells. Recall #B-294-1.
Code: Unit numbers MWBB 61992, MWBB 62007, MWBB 62021,
MWBB 62984.
Manufacturer: Metropolitan Washington Blood Banks, Inc., Silver Spring,
Maryland.
Recalled by: Consignee returned three units for relabeling December 26,
1990 and 1 unit had been transfused. Recall complete.
Distribution: Maryland and Washington, D.C.
Quantity: 4 units.
Reason: Blood products collected from a donor who tested
initially reactive for the antibody to the human
immunodeficiency virus type-1 (anti-HIV-1); or
labeled with wrong expiration dates, were distributed.
----
Product: Recovered Plasma. Recall #B-352-1.
Code: Unit numbers: 374770, 424478, 481642.
Manufacturer: Belle Bonfils Memorial Blood Center, Denver, Colorado.
Recalled by: Manufacturer, by letter February 6, 1991 and by
telephone March 8, 1991 followed by letter April 5, 1991.
Firm-initiated recall complete.
Distribution: Pennsylvania, California, Missouri.
Quantity: 3 units.
Reason: Blood components, which were: 1) not tested for the
antibody to the human immunodeficiency virus, type 1
(anti-HIV-1); or 2) improperly tested for the antibody to
the human T lymphotropic virus, type 1 (anti-HTLV-1);
or 3) tested initially reactive for anti-HTLV-1, were
distributed.
----
-7-
DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
NONE
Class II -
Product: Theratron Cobalt 60 Teletherapy Unit:
(a) Theratron 60 Cobalt 60 Teletherapy Unit (T60);
(b) Theratron 80 Cobalt 60 Teletherapy Unit (T80),
includes units refurbished to original specifications
which are identified by Theratronics as T80R's);
(c) Theratron 780 Cobalt 60 Teletherapy Unit (T780).
Recall #Z-694/696-1.
Code: All T60 and T80 units and Serial Numbers 1 through 8 for
T780 units.
Manufacturer: Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd (AECL Medical), Ontario, Canada.
Recalled by: Theratronics International, Ltd., Carrollton, Texas,
by CUB - 90-2 dated July 7, 1990. Firm-initiated recall
ongoing.
Distribution: Nationwide and international.
Quantity: 455 units were distributed.
Reason: The spring pins may collapse and shear which would
allow the gantry to rotate freely.
----
Product: (a) Software Versions V01, V02 and V03 for Theratronics'
Theraplan treatment planning system with central
processor PDP 11/34 and 200 Series;
(b) Software Versions V01, V02, V03, V04, V05, V06 and
V07 for Theratronics' TP-11 treatment planning
systems. Recall #Z-720/721-1.
Code: All units.
Manufacturer: Theratronics International, Ltd., formerly Atomic
Energy of Canada, Ltd. (AECL Medical), Kanata, Ontario
Canada (components).
Recalled by: Theratronics International, Ltd., Carrollton, Texas,
by a document titled "Software Hazard Report" dated
March 30, 1987. Firm-initiated field correction ongoing.
Distribution: Nationwide.
Quantity: 252 software versions were distributed.
Reason: The computer prompt may request units of radiation activity
of mgm units instead of the required computation of mCi
dosage units. This may result in an error in the
radiation treatment given to the patient.
----
Product: SLT Fiber Optic Adaptor, used for various surgical
procedures. Recall #Z-735-1.
Code: Serial numbers: Undetermined.
-8-
Manufacturer: Ximed Medical Systems, Santa Clara, California.
Recalled by: Manufacturer. FDA approved the firm's corrective action plan
May 24, 1991. Firm-initiated field correction ongoing.
Distribution: Unknown.
Quantity: 3 units were distributed and were returned to manufacturer.
Reason: Noncompliance with the performance standards for laser
products in that the device may defeat the interlocks
on the SLT laser system.
----
Product: Search N Stim Electronic Acupuncture (device), model
SW-103, used to help reduce pain and improve vitality.
Recall #Z-757-1.
Code: All lots.
Manufacturer: Marco Polo Industries & Merchandising Company, LTD.,
Kowloon, Hong Kong.
Recalled by: Damark International, Inc., Minneapolis, Minnesota, by
letter dated May 23, 1991. Firm-initiated recall complete.
Distribution: Nationwide.
Quantity: 48 units were distributed.
Reason: Unapproved medical device sold to general public by mail
order.
----
Product: Lasercut HP Laser Cutting Systems. Recall #Z-783-1.
Code: Serial numbers 101 through 117.
Manufacturer: Lasercut Inc., North Branford, Connecticut.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan June 19, 1991. Firm-initiated field
correction ongoing.
Distribution: Pennsylvania, Massachusetts, Ohio, Connecticut,
North Carolina, New Jersey, New York, Tennessee,
Iowa.
Quantity: 17 units were distributed.
Reason: Noncompliance with the performance standard for laser
products in that they failed to have warning logotypes,
certification, aperture, and noninterlocked protective
labels. Also, the "Caution-use of controls..." statement
was not included in the sales brochure.
----
Product: Coilcath Hemodialysis Catheters:
(a) CVC 300 Coilcath Dual Lumen Hemodialysis Catheter,
40 cm length;
(b) CVC 305 Coilcath Dual Lumen Hemodialysis Catheter with
introducer kit, 40 cm length;
(c) CVC 310 Coilcath Dual Lumen Hemodialysis Catheter,
36 cm length;
(d) CVC 315 Coilcath Dual Lumen Hemodialysis Catheter
with introducer kit, 36 cm length;
-9-
(e) CVC 301 Coilcath Catheter Extension with injection
caps. Recall #Z-808/812-1.
Code: All lot numbers.
Manufacturer: Strato Medical Corporation, Beverly, Massachusetts.
Recalled by: Manufacturer, by telephone May 2, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 275 units were distributed.
Reason: Product is mislabeled. Also the firm's investigational
device exemption (IDE) submission has not been approved
by the Food and Drug Administration.
----
Product: Autotransfusion kits and accessories:
(a) Product AT2000 Kit, in cardboard outer box colored
blue and white labeled in part "Impraflo autotransfusion
kit AT 2000 for whole blood salvage";
(b) Product AT2100, paratubing set which is plastic tubing
for blood suctioning;
(c) Product AT2120 ACD-A: Bottle of Anticoagulant;
(d) Product AT2200 Hanger: Attachment for IV pole
(e) Product AT3510 Kit: Components in two trays,
canister and tubing trays;
(f) Product AT3515: Same as 3510 except two drain tubes
are 3/16";
(g) Product AT3519 Kit: Same as 3510 except two wound
drain tubes are 1/4";
(h) Product AT3600 Kit: Contains 600 ml drainage/
reinfusion canister with discard adapter in a tray
sterilized for single use. Recall #Z-815/822-1.
Code: All lots.
Manufacturer: Impra, Inc., Tempe, Arizona.
Cytosol Laboratories, Inc., Braintree, Massachusetts
(Product AT 2120).
Recalled by: Impra Inc., Tempe, Arizona, by letter January 14, 1991,
and by telephone January 8, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Germany, France, United Kingdom,
Switzerland, Belgium.
Quantity: (a) 2,410 units; (b) 723 units; (c) 845 units;
(d) 280 units; (e) 59 units; (f) 168 units; (g) 21 units;
(h) 88 units were distributed.
Reason: Documentation deficiencies were noted in the
manufacturing process.
----
Product: Intra-Aortic Balloon Catheters Mansfield Sidewinder SL
(Single Lumen) and Sidewinder DL (Double Lumen), used in
the circulatory assistance of patients with compromised
blood pumping capability:
-10-
(a) Catalog #3296 (with Introducer DL Kit Catalog #3442),
DL, 9.5 F, 40 cc;
(b) Catalog #3296-NC (with Introducer DL Kit Catalog
#3443-NC), DL, 9.5 F, 40 cc guidewire not heparin coated;
(c) Catalog #3299 (with Insertion Kit Catalog #3452),
DL, 9 F, 30 cc;
(d) Catalog #3140 SL, 10 F, 40 cc. Recall #Z-823/826-1.
Code: Lot numbers: (a) 3781, 36667, 36673, 35491, 35490, 36492,
32184, 900668, 31634, 30605, 29912, 25040, 21726, 21640,
20831, 20139, 20140, 18959, 18699, 18435, D050A, D030N,
C140H;
(b) 33473, 35110, 900526, 900529;
(c) 35534, 33908;
(d) 36309, 33236, 31633, 31388.
Manufacturer: Boston Scientific Corporation, Mansfield, Massachusetts.
Recalled by: Boston Scientific Corporation, Watertown, Massachusetts, by
telephone June 7, 1991, followed by letters of June 13 and
14, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: Approximately 2,220 units were distributed. FDA estimates
50 percent remains on the market.
Reason: The balloon may not unfurl completely when inflation is
attempted.
----
Product: Multiflex Modules known as Slow TimeShare (STS)
Units, used for switching products for feeding laser output
from one industrial workstation to another and for welding
and drilling applications. Recall #Z-830-1.
Code: Undetermined.
Manufacturer: Luminics Ltd., Norwichshire, England.
Recalled by: Luminics Corporation, Livonia, Michigan. FDA approved the
firms corrective action plan June 28, 1991. Firm-initiated
field correction ongoing.
Distribution: Nationwide.
Quantity: 22 units were distributed.
Reason: Noncompliance with performance standard for laser
products in that assembly wear was discovered resulting
in incomplete shutter closure.
----
Product: Airborne Neonatal Transport Incubator, Model 20-H
equipped with 4" Rhombus Casters, Part #367A32C100WZLD37
(without brakes) and Part #367H32C100WZLD37 (with
brakes). Recall #Z-869-1.
Code: Serial Numbers 0197XF, 0199XF, 0200XF, 0201XF, 0204XF,
0205XF, 0206XF, 0215XF, 0202XG, 0208XG, 0209XG, 0210XG,
0211XG, 0203XH, 0207XH, 0212XH, 0213XH, 0214XH, 0216XH,
0217XJ, 0219XK, 0220XK, 0221XK, 0223XK, 0224XK, 0225XL,
0226XL, 0227XL, 0230XL, 0231XL, 0232XL, 0233XL, 0222XM,
0228XM, 0229XM, 0234XM, 0235YA.
Manufacturer: Rhombus Casters, Inc., Marlton, New Jersey.
-11-
Recalled by: International Biomedical, Inc., Austin, Texas, by
letter January 22, 1990. Firm-initiated recall complete.
Distribution: Nationwide.
Quantity: 257 casters were distributed. 148 of these casters
were used for initial manufacture of 37 incubators,
the remainder were sold as stock replacements.
Reason: The casters can unexpectedly disengage from the air/
oxygen cart and separate.
----
Product: Catheter Port Valves, used for maintaining a fluid-tight
seal around a dilitation catheter during angioplasty:
(a) Rotating Hemostatic Valve, Catalog #23242;
(b) Standard Hemostatic Valve, Catalog #23240;
(c) Duostat Rotating Hemostatic Valve, Catalog #23244;
(d) Guide Wire Accessory Kit (contains a Rotating Hemostatic
Valve), Catalog #22295. Recall #Z-872-1.
Code: Lot numbers: (a) 9110751 through 9122251 and 0010251 through
0030851; (b) 9110351 through 9122251 and 0010951
through 0011051; (c) 9110751 through 9122251 and
0010251 through 0030851; (d) 9110751 through 9122251 and
0010251 through 0030851.
Manufacturer: Advanced Cardiovascular Systems, Inc., Temecula,
California.
Recalled by: Manufacturer, by letter and by FAX April 3, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 69,664 units were distributed; firm estimates none
remains on the market.
Reason: The affected valves may not unseal when opened. This
failure to unseal can result in the failure of the
valve to properly flush air prior to use or can
restrict the introduction/movement of the catheter
system through the valve.
----
Product: Buchwald Wigness Central Venous Access Catheters:
(a) Buchwald Wigness (50 cm) Single Lumen Bidirectional
Valved Catheter and 8 French Introducer Kit, Model WBC 100;
(b) Buchwald Wigness (65 cm) Single Lumen Bidirectional
Valved Catheter and 8 French Introducer Kit, Model WBC 105.
Recall #Z-876/877-1.
Code: Lot numbers: (a) 016405, 019416, 010711;
(b) 015502, 012403, 012005.
Manufacturer: Strato Medical Corporation, Beverly, Massachusetts.
Recalled by: Manufacturer, by telephone September 27, 1990.
Firm-initiated recall ongoing.
Distribution: Unknown.
Quantity: 266 units were distributed.
-12-
Reason: Pressure exceeding the recommended maximum of 25 psi may
result in the small tubing valve of the catheter popping
out of the inlet valve. In addition, the firm had shipped
some units to Italy in May 1990, prior to receiving 510(k)
approval to market (September 21, 1990), and without the
appropriate export certificate.
----
Class III -
Product: Kodak Ektachem Clinical Chemistry Slides (TBIL), an
in-vitro diagnostic slide for use with Kodak Ektachem
Analyzers to quantitatively measure total bilirubin
(TBIL). Recall #Z-871-1.
Code: Catalog #154 2570, Lot #4204-0138-3469.
Manufacturer: Eastman Kodak Company, Clinical Products Division,
Rochester, New York.
Recalled by: Manufacturer, by letter June 3, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: Firm estimates 12 sodium cartridges packed in TBIL
cartons remain on the market.
Reason: Some sodium cartridges were inadvertently packaged in TBIL
boxes, i.e., boxes labeled as Clinical Chemistry Slide
(TBIL) may actually contain sodium slides.
----
Product: Kodak Ektachem (a) 500 Series; (b) 700 Series Analyzers
with (Product) PCS II accessory unit. Recall #Z-878/879-1.
Code: All lot numbers for Catalog numbers 8351058, 8407520,
1943083, 8195653, 8005290, 1687763, 1434851.
Manufacturer: Eastman Kodak Company, Clinical Products Division,
Rochester, New York.
Recalled by: Manufacturer, by letter April 3, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 1,064 were distributed in the United States and 50-60
were distributed internationally.
Reason: Some of the disposable tips may cause false low CO(2)
or falsely high AST results.
----
VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: E-Tex Range (700) Medicated, Anaplasmosis Free Choice
Medicated Block, 33-1/3 pounds, for ruminants only.
Recall #V-075-1.
-13-
Code: Product manufactured during the months of March and
April 1991.
Manufacturer: East Texas Feeds, Inc., Mineola, Texas.
Recalled by: Manufacturer, by telephone May 6, 1991. Firm-initiated
recall complete.
Distribution: Texas.
Quantity: 572 blocks were distributed; firm estimates none remains
on the market.
Reason: Free Choice Medicated Blocks is a new animal drug and
was being manufactured and distributed without the required
approved New Animal Drug Application.
----
Product: Kent Flav-R-Ized 20% Pig Nuggets A150 Medicated with
Apramycin, in 50 pound bags. Recall #V-076-1.
Code: Product #2348, lot #R 36.
Manufacturer: Kent Feeds, Inc., Rockford, Illinois.
Recalled by: Manufacturer, by telephone June 18, 1991 and
July 12, 1991. Firm-initiated recall ongoing.
Distribution: Illinois, Wisconsin.
Quantity: 405 bags were distributed; firm estimates 5 bags remain
on the market.
Reason: Feed was subpotent in Apramycin.
----
Medical Device Safety Alerts:
Product: Kodak Surecell Chlamydia Test Kits, an in-vitro
diagnostic test kit for use in a doctor's office
or clinical lab, for the diagnosis of Chlamydia:
(a) Kodak Surecell Chlamydia Test Kits, Catalog #193 7804;
(b) Kodak Surecell Chlamydia test Kits, Catalog #825 0003;
(c) Kodak surecell Chlamydia Test Kits, Catalog #196 8056.
Safety Alert #M-033/035-1.
Code: All lots.
Manufacturer: Eastman Kodak Company, Biological Diagnostics Clinical
Products Division, Rochester, New York.
Alerted by: Manufacturer, by letters of April 8 and 11, 1991.
Distribution: Nationwide and international.
Quantity: 28,970 kits were distributed; firm estimates 55 percent
of the kits remain on the market.
Reason: There is a potential for false positive results using
some Type I swabs due to an interaction with the swab
adhesive and Kodak Surecell Chlamydia Test Kit.
----
Seizure Actions Filed:
Product: Neomycin, an animal drug (91-597-322).
Charge: Lack of current good manufacturing practices and
failure to drug list.
-14-
Firm: RX Veterinary Products, Kansas City, Missouri.
Filed: July 2, 1991 - U.S. District Court for the Western
District of Missouri, Western Division;
Civil #91-0594-CV-W-6, FDC #66193.
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Product: Steviasweet Diet Tea, Assorted Flavors (91-331-516).
Charge: Adulterated - Product contains a food additive which is
unsafe and because there is no regulation prescribing the
conditions under which the additive may be safely used.
Firm: Steviasweet Company, Inc., Arlington, Texas.
Filed: June 4, 1991 - U.S. District Court for the Northern
District of Texas, Fort Worth Division; Civil #4-91-406-E,
FDC #66081.