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
02/19/1991
FDA Enforcement for the week of February 20, 1991.
FDA ENFORCEMENT REPORT
FOR FEB. 20, 1991
February 20, 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: Phoenix Cookies:
(a) Chocolate Chip Cookie;
(b) Oatmeal Raisin Cookie;
(c) Vanilla Cookie. Recall #F-688/690-0.
Code: All lots.
Manufacturer: Phoenix International Marketing Corporation, Sparks, Nevada.
Recalled by: Manufacturer, by letter May 15, 1990. Firm-initiated recall
ongoing.
-1-
Distribution: Nationwide.
Quantity: 1,311,559 cases were distributed.
Reason: Products made unsubstantiated drug claims and their
sugar content is well in excess of label claim.
----
Product: Our Family Mushrooms, Pieces and Stems, in 4 ounce
cans. Recall #F-132-1.
Code: Lot numbers: MBSP/SF/0621, MBSP/SF/0623, MBSP/SF/0624.
Manufacturer: Sam Yang Moolsan Company, Ltd, Republic of Korea
Recalled by: Worldwide Foods, Bloomington, Minnesota, by letter
November 29, 1990. Firm-initiated recall ongoing.
Distribution: North Dakota, Minnesota.
Quantity: 6,000 cases (24/4 ounce cans/case) were distributed.
Reason: Possible contamination with Staphylococcus aureus organisms.
----
Product: Pacific Friend Canned Mushrooms, Stems and Pieces,
in 4 ounce cans. Recall #F-133-1.
Code: Lot numbers 0618 and 0620.
Manufacturer: Mulsen Trading Company, Ltd., Seattle Washington
Recalled by: Manufacturer, by telephone and by letter December 27, 1990.
Firm-initiated recall ongoing.
Distribution: Oregon, Washington, Idaho, Akansas, California, Montana.
Quantity: 9,200 cases (24 cans/case) were distributed.
Reason: Possible contamination with Staphylococcus aureus organisms.
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Product: Milk and milk products under the Mathis Dairy label:
(a) Homogenized Whole Milk
(b) 2% Milk
(c) Skim Milk
(d) Chocolate Milk
(e) Buttermilk
(f) Half & Half
(g) Whip Cream
(h) Egg Nog
(i) Sun Up 2%. Recall #F-175/183-1.
Code: Buttermilk pull dates 1-27, 1-30 and all
other products pull dates: 1-8 and 1-11.
Manufacturer: Mathis Dairy, Decatur, Georgia
Recalled by: Manufacturer by telephone January 2, 1991 followed by
press release. Firm-initiated recall complete.
Distribution: Georgia.
Quantity: (a) 8732 gallons, (b) 8089 gallons, (c) 3798 gallons
(d) 1703 gallons, (e) undetermined, (f) 112 gallons,
(g) 185 gallons, (h) 1495 gallons; (i) undetermined, were
distributed.
-2-
Reason: Product is contaminated with alfatoxin.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Giant brand (a) Enriched White Sandwich Bread;
(b) Honey Wheat Bread, net wt 24 oz (1 lb 8 oz).
Recall #F-053/054-1.
Code: THU on plastic tag.
Manufacturer: Giant Food, Inc., Silver Spring, Maryland.
Recalled by: Giant Food, Inc., Landover, Maryland, by removing all
merchandise from shelves, by contacting media and
newspapers December 6, 1990 and by faxing list of
affected products December 10, 1990. Firm-initiated
recall complete.
Distribution: Maryland, Virginia and Washington, D.C.
Quantity: (a) 19,310 loaves; (b) 51,660 loaves were distributed.
Reason: Products were contaminated with sand.
----
Product: Lite Hand Cooked Gourmet Popcorn in 3/8 ounce metalized
bags. Recall #F-157-1.
Code: Lot numbers: JAN 11 JBC and JAN 11 JBDL.
Manufacturer: Lite Snak, Inc., Randolph, Massachuetts.
Recalled by: Boston Popcorn Company, Newton, Massachuetts by verbally
notifying delivery truck drivers to pick-up product from
distributors October 19, 1990. Firm-initiated recall
complete.
Distribution: Maine, New Hampshire, Connecticut, Massachuetts.
Quantity: Firm estimates none remains on the market.
Reason: Popcorn contained in bag labeled "microwave safe"
disintegrates when microwaved.
----
Product: Classic Milwaukee Brat Sauce in 18 ounce bottles:
(a) Original; (b) Spicy; (c) Beer In flavors.
Recall #F-196/198-1.
Code: (a) H1080 A or B, H1270 A or B, H1560 A or B, H1570 A or B,
H1670 A or B;
(b) H1080 A or B, H1280 A or B, H1560 A or B;
(c) H1090 A or B, H1280 A or B, H1570 A or B, H1660 A or B.
Manufacturer: Holsum Foods, Waukesha, Wisconsin.
Recalled by: Manufacturer, by letter September 11, 1990. Firm-initiated
recall ongoing.
Distribution: Wisconsin, Illinois.
-3-
Quantity: 11,511 cases (12 bottles/case) were distributed.
Reason: Product is contaminated with Lactobacillus bacteria.
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COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Red Blood Cells. Recall #B-103-1.
Code: Unit numbers: 2615622 and 2615629.
Manufacturer: Central Indiana Regional Blood Center, Indianapolis,
Indiana.
Recalled by: Manufacturer, by telephone August 7, 1990. Firm-initiated
recall complete.
Distribution: Indiana.
Quantity: 2 units.
Reason: Units drawn from donors living in malarial endemic areas
were distributed.
----
Product: Platelets, Pheresis. Recall #B-106-1.
Code: Unit #21P23374.
Manufacturer: American Red Cross Blood Services, Portland, Oregon.
Recalled by: Manufacturer, by relabeling product August 9, 1990.
Firm-initiated recall complete.
Distribution: Oregon.
Quantity: 1 unit.
Reason: Blood product labeled with incorrect expiration date
was distributed.
----
Product: Platelets, Pheresis. Recall #B-108-1.
Code: Unit #25P50063.
Manufacturer: American Red Cross Blood Services, Albany, New York.
Recalled by: Manufacturer, by relabeling product June 21, 1990.
Firm-initiated recall complete.
Distribution: New York.
Quantity: 1 unit.
Reason: Blood product labeled with incorrect expiration date
was distributed.
----
-4-
Product: Platelets, Pheresis. Recall #B-110-1.
Code: Unit #02P05719.
Manufacturer: American Red Cross Blood Services, Wichita, Kansas.
Recalled by: Manufacturer, by relabeling product January 3, 1990.
Firm-initiated recall complete.
Distribution: Kansas.
Quantity: 1 unit.
Reason: Blood product labeled with incorrect expiration date
was distributed.
----
Class III -
Product: Red Blood Cells. Recall #B-104-1.
Code: Unit #55E12071.
Manufacturer: American Red Cross, Little Rock, Arkansas.
Recalled by: Manufacturer, by relabeling product April 9, 1990.
Firm-initiated recall complete.
Distribution: Arkansas.
Quantity: 1 unit.
Reason: Blood product labeled with the incorrect expiration
date was distributed.
----
Product: Whole Blood. Recall #B-105-1.
Code: Unit #PL1466.
Manufacturer: South Bend Medical Foundation, Inc., South Bend, Indiana.
Recalled by: Manufacturer, by telephone September 19, 1989.
Firm-initiated recall complete.
Distribution: Minnesota.
Quantity: 1 unit.
Reason: Unit of Whole Blood drawn in a collection bag containing
CPD anticoagulant/preservative solution (21 day expiry)
but labeled as containing CPDA-1 anticoagulant/
preservative solution (35-day expiry) was distributed.
----
Product: Red Blood Cells. Recall #B-107-1.
Code: Unit #31C06718.
Manufacturer: American Red Cross Blood Services, Buffalo, New York.
Recalled by: Manufacturer, by relabeling product July 18, 1990.
Firm-initiated recall complete.
Distribution: New York.
Quantity: 1 unit.
Reason: Blood product labeled with incorrect expiration date
was distributed.
----
-5-
Product: Red Blood Cells. Recall #B-109-1.
Code: Unit #42J59976.
Manufacturer: American Red Cross Blood Services, Cleveland, Ohio.
Recalled by: Manufacturer, by relabeling product July 20, 1990.
Firm-initiated recall complete.
Distribution: Ohio.
Quantity: 1 unit.
Reason: Blood product labeled with incorrect expiration date
was distributed.
----
Product: Recovered Plasma. Recall #B-111-1.
Code: Unit Number: 894166.
Manufacturer: Lake Charles Memorial Hospital, Lake Charles, Louisiana.
Recalled by: Manufacturer, by telephone September 11, 1990. Firm-
initiated recall complete.
Distribution: Texas, Florida.
Quantity: 1 unit.
Reason: Unit which tested repeatably reactive for hepatitis B
surface antigen (HBsAg) was distributed.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
Product: CPI Vista Pacemakers: (a) Model 443 Implantable Pulse
Generator (single chamber);
(b) Model 445 Implantable Pulse Generator (single
chamber). Recall #Z-194/195-1.
Code: Serial numbers: (a) 720875, 720876, 720878-720884,
720895, 720897-720903, 720943, 720944, 720959, 720961,
720906-720909, 720911-720914;
(b) 721095, 721097-721110, 722404, 721876, 721877, 723477,
722375, 720925-720930, 721025-721032, 721041-721044,
722971, 722972, 721186, 721332-721338, 723955, 721339,
721450, 721452, 721453.
Manufacturer: Cardiac Pacemakers, Inc., St. Paul, Minnesota.
Recalled by: Manufacturer, by letter December 21, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 82 units were distributed.
Reason: Pacemakers may exhibit early and rapid battery depletion
with a corresponding reduction in pulse amplitute. In
addition, the potential exists for other devices in this
group to malfunction if the capacitor fails.
----
-6-
Class II -
Product: Biflow nasal masks and cannulas:
(a) Comfort Cannula, product code 103000;
(b) Biflow Nasal Mask with 7' Kink Resistant Tubing,
product code 103004;
(c) Comfort Cannula with 7' Kink Resistant Tubing,
product code 103005;
(d) Comfort Cannula with 14' Kink Resistant Tubing,
product code 103015;
(e) Comfort Cannula with 25' Kink Resistant Tubing,
product code 103025. Recall #Z-215/219-1.
Code: Lot numbers: 200016, 200122, 200298, 200299, 200423,
300401, 300696, 300697, 301220, 301221, 27898, 30188,
32698, 300698;
(b) 200057, 200123, 200124, 200300, 200301, 200302,
200303, 200424, 200425, 200426, 200427, 200607, 300402,
300403, 300404, 300699, 301171, 301228, 301264, 27896,
27910, 29105, 32699, 34604;
(c) 200058, 200059, 200304, 200305, 200428, 200429,
200430, 200431, 200432, 200510, 300405, 300407, 300700,
300701, 300702, 300703, 301205, 301222, 27899, 27911,
28719, 29099, 30861, 34605, 35766;
(d) 200116, 200125, 301172, 301173, 27905, 35531, 35767;
(e) 200117, 200126, 200306, 200434, 200620, 301174,
301202, 301203, 27900, 29958, 33393, 35768.
Manufacturer: Marquest Medical Products, Inc., Englewood, Colorado.
Recalled by: Manufacturer, by letter December 21, 1990 and
January 4, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 2,320 cases (50 units/case except item (e) which have
25 units/case) were distributed.
Reason: The product may have a restriction to gas flow impeding
the delivery of supplemental oxygen.
----
Product: Adult Nonconductive Disposable Anesthesia Circuit,
product code GM320L, an Rx single-patient use device for
gas and/or temperature monitoring. Recall #Z-220-1.
Code: Lot numbers: 300144, 300629, 300630, 300631.
Manufacturer: Marquest Medical Products, Inc., Englewood, Colorado.
Recalled by: Manufacturer, by letter December 21, 1990.
Firm-initiated recall ongoing.
Distribution: Texas, Louisiana.
Quantity: 249 cases (20 units/case) were distributed.
Reason: The device was misassembled so that the inspiration
and expiration limbs were reversed.
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-7-
Product: Xenon rebreathing systems, single use devices that
serve as a conduit in administering Xenon-133 gas for
steady state and washout lung perfusion diagnostic
studies:
(a) Xenon Rebreathing System with Mouthpiece and
Noseclip, Model #0133;
(b) Xenon Rebreathing System with Face Mask, Model #0134;
Recall #Z-235/236-1.
Code: Lot numbers: 90816A, 90921A, 90925B.
Manufacturer: File Rite Products, Inc., Staten Island, New York
(component).
Recalled by: AMICI, Inc., Spring City, Pennsylvania, by letter
on or about October 30, 1989. Firm-initiated recall
complete.
Distribution: Nationwide.
Quantity: Firm estimates none remains on the market (270 systems
were returned).
Reason: A weakness in the neck of the bag can cause a tear,
resulting in a Xenon leak.
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Product: LIFEPAK9 Defibrillator/Monitor, Part #803800-
(all dash numbers). Recall #Z-238-1.
Code: All lot numbers.
Manufacturer: Physio-Control Corporation, Redmond, Washington.
Recalled by: Manufacturer, by letter November 9, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 5,958 units were distributed.
Reason: Immediately after a defibrillation discharge, the ECG
monitor may inappropriately display a flat trace
(resembling asystole) for a period of 10 seconds or
longer when monitoring through the 3-lead patient cable.
This could result in misdiagnosis or temporary delay
in patient care.
----
Product: LIFEPAK 10 Defibrillator/Monitor, part numbers affected
are 804200-14, 804200-15, 804200-16, 804200-18, 804200-20,
804200-21, 804200-23. Recall #Z-244-1.
Code: Lot numbers involved are noncontinuous starting with 6557
and ending with 7026:
Part No. Serial No.
804200-14 006557, 006562,
804200-15 007095 to 007104
804200-16 006957, 006968, 006969, 006972, 006973,
006975 to 006979, 006981 to 006983,
006986, 007080, 007083, 007085 to 007087,
804200-18 006142, 006143, 006145, 006147, 006988,
006992, 006994, 006999, 07000, 007004,
007006, 007011 to 007013, 007016,
-8-
804200-20 006941 to 006947, 006949 to 06956, 07113 to
007116, 007120 to 007124, 007128, 007130,
007132,
804200-21 007032 to 007034, 007036, 007037,
804200-23 006302 to 006305, 006307 to 006310, 006312
to 006314, 006316 to 006323, 006325, 006327
to 006330, 006333, 006335, 007018 to
007020, 007023, 007025, 007026.
Manufacturer: Physio Control Corporation, Redmond, Washington.
Recalled by: Manufacturer, by letter November 12, 1990. Firm-initiated
field correction ongoing.
Distribution: Nationwide and international.
Quantity: 109 units are affected.
Reason: An incorrect component has been installed in the printed
circuit boards which have the potential to latch-up at
power on causing functions such as (sync, QRS, volume,
ECG size, lead select and default) to be inoperable.
----
Product: Arrow-Howes Multi-Lumen Central Venous Catherization Kit,
product #AK-15703-A, used principally to administer
continuous or intermittent drugs, high volume or viscous
fluids, blood products or hyperalimentation nutrients to
seriously ill patients. Recall #Z-252-1.
Code: Lot #AK-1-299-0.
Manufacturer: Arrow International, Inc., Randleman, North Carolina.
Recalled by: Arrow International, Inc., Reading, Pennsylvania, by
telephone November 5 & 6, 1990 followed by letter
November 9, 1990. Firm-initiated recall complete.
Distribution: Nationwide, Canada.
Quantity: 3,155 kits were distributed; firm estimates none
remains on the market.
Reason: The label states that the kits contain a 60 cm spring
wire guide but may contain a 45 cm spring wire guide.
----
Product: FLEX 224 Resistor Trimmer, used for resistive trimming
of integrated circuits.. Recall #Z-253-1.
Code: Serial numbers: No. 1.
Manufacturer: Pacific Laser Corporation, Irvine, California.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan January 18, 1991. Firm-initiated field correction
ongoing.
Distribution: California.
Quantity: 1 unit.
Reason: Noncompliance with performance standard for laser products
in that the protective interlock system is inadequate.
----
-9-
Product: Olympus Balloon Catheter Model B7-2C, designed for
endoscopic treatment of problems such as hemorrhage,
obstructions, collection of foreign bodies, and in x-ray
photography using contrast media. Recall #Z-258-1.
Code: All lots.
Manufacturer: Olympus Optical Company, Ltd., Tokyo, Japan.
Recalled by: Olympus Corporation, Lake Success, New York, by telephone
on or about September 4, 1990. Firm-initiated recall
ongoing.
Distribution: Utah, Florida, Georgia, New York.
Quantity: 6 pieces were distributed.
Reason: The device was marketed from May 1990 to September 1990
without 510(k) approval.
----
Class III -
Product: IDS640 Integration Display & Storage Monitor, (in
particular the Princeton Graphic Ultrasync 12 inch color
CRT Display Monitor Component). Recall #Z-239-1.
Code: Serial numbers beginning with either "KF" or "KW".
Manufacturer: Princeton Graphic Systems, Rosewell, Georgia (component).
Recalled by: Clinical Information Systems, Inc., Ann Arbor, Michigan,
by visit beginning March 1990. Firm-initiated recall
ongoing.
Distribution: Michigan, New York, North Carolina, Illinois,
California, Alabama.
Quantity: 110 systems were distributed.
Reason: The ultrasync display may go blank during use due to a
transistor failure.
----
Product: In-vitro Diagnostic Test Kit Activated AST Enzyme Set for
use in the quantitative determination of AST activity in
serum or plasma. AST determination is a liver function
test:
(a) Catalog No. 7070; (b) Catalog No. 8175 (bulk
packaging). Recall #Z-245/246-1.
Code: Lot numbers: (a) 1049 EXP 7/92, 1050 EXP 10/92 (Lot 1049
contains lot 45 EXP 7/92 of Reagent Aspartate and Lot 47
EXP 10/92 of Reagent Enzyme;
(b) 1028 EXP 10/92 (Lot 1028 contains Lot 46A EXP 10/92 of
Reagent Aspartate and Lot 47A EXP 10/92 of Reagent
Enzyme).
Manufacturer: AM Diagnostics (formerly American Monitor Corporation)
Indianapolis, Indiana. Components of Lot 47 and 47A of
Reagent Enzyme supplied by: Lee Scientific, Inc.,
St. Louis, Missouri.
Recalled by: AM Diagnostics, Indianapolis, Indiana, by telephone
December 6 & 7, 1990 and by letter December 6, 1990.
Firm-initiated recall complete.
-10-
Distribution: Nationwide and international.
Quantity: (a) 217 kits were distributed; firm estimates 139 kits
remain on the market;
(b) 46 kits were distributed; firm estimates 23 kits
remain on the market.
Reason: Lots 47 and 47A of the enzyme reagent in the kits
contain an above specification level of aspartate
aminotransferase (AST). This causes the Parallel, Excel
and Prospective Clinical Chemistry analyzers to show an
alinear test response.
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VETERINARY PRODUCTS
NONE