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
08/03/1994
Recalls and Field Corrections: Foods -- Class II -- 08/03/1994
AUGUST 3, 1994 94-31
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Pistachio Nut Ice Cream in 3 gallon containers.
Recall #F-757-4.
CODE All product manufactured during 2/19/94 through 5/19/94.
MANUFACTURER Reinhold Ice Cream Company, Pittsburgh, Pennsylvania.
RECALLED BY Manufacturer, by telephone beginning May 19, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Pennsylvania.
QUANTITY Firm estimates very little product remains on the market.
REASON Product contains undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Various flavored ice cream and yogurt in 3 gallon paperboard
containers: (a) Butter Pecan Ice Cream; (b) Praline Pecan
Ice Cream; (c) Praline Pecan Yogurt.
Recall #F-754/756-4.
CODE All product manufactured from 2/19/94 through 5/19/94.
MANUFACTURER Reinhold Ice Cream Company, Pittsburgh, Pennsylvania.
RECALLED BY Manufacturer, by telephone beginning May 19, 1994, and by
letter May 25, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania.
QUANTITY Firm estimates very little, if any, product remains on the
market.
REASON Products contain undeclared pecans. _______________
PRODUCT Ice Cream: (a) Toasted Almond Fudge; (b) Coconut Almond
Fudge, in 3 gallon containers. Recall #F-759/760-4.
CODE All product manufactured from 2/19/94 through 5/19/94.
MANUFACTURER Reinhold Ice Cream Company, Pittsburgh, Pennsylvania.
RECALLED BY Manufacturer, by telephone beginning May 19, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Pennsylvania.
QUANTITY Firm estimates very little, if any, product remains on the
market.
REASON Products contain undeclared almonds.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Pramoxine HCl Ointment 10 mg/g, in 1 ounce tubes, brand name
Anusol, topical non-Rx analgesic for hemorrhoidal use.
Recall #D-335-4.
CODE Lot #35711L EXP 2/96.
MANUFACTURER Warner-Lambert Company, Lititz, Pennsylvania.
RECALLED BY Warner-Lambert Company, Morris Plains, New Jersey, by letter
June 10, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 48,216 tubes were distributed; firm estimates none remains
on the market.
REASON Subpotency.
_______________
PRODUCT Operand Povidone-Iodine Ointment, in 1 gram packets,
nonprescription. Recall #D-336-4.
CODE Catalog #82-322, lot #39526 EXP 6/97.
MANUFACTURER Redi Products, Prichard, West Virginia.
RECALLED BY General Medical Manufacturing Company, Richmond, Virginia,
by letter September 17 and 30, 1993. Firm-initiated recall
complete.
DISTRIBUTION Undetermined.
QUANTITY 480 cartons were distributed; firm estimates none remains on
the market.
REASON Some boxes are mislabeled with an incorrect unit size (2.7
gm) and incorrect stock number.
_______________
PRODUCT Eucerin Dry Skin Care Moisturizing Lotion, fragrance free,
in 16 ounce plastic bottles. Recall #D-337-4.
CODE Lot #3327C, 3340C, 3341C EXP 12/96.
MANUFACTURER Conair Inc., Rantoul, Illinois.
RECALLED BY Manufacturer, by letters of June 14, 1994, and July 13,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 3,200 cases were distributed.
REASON Presence of an additional lotion product that has fragrance.
-2- RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Recovered Plasma. Recall #B-353-4.
CODE Unit #11FF09486.
MANUFACTURER The American National Red Cross, St. Louis, Missouri.
RECALLED BY Manufacturer, by letter June 1, 1993. Firm-initiated recall
complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product, which tested reactive for syphilis by the
Rapid Plasma Reagin (RPR) test, was distributed.
_______________
PRODUCT Source Leukocytes. Recall #B-354-4.
CODE Unit #9892362.
MANUFACTURER BloodCare, Dallas, Texas.
RECALLED BY Manufacturer, by letter June 10, 1993. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product, collected from an ineligible donor due to
acupuncture less than 12 months prior to donation, was
distributed.
_______________
PRODUCT Blood Bank Control System Computer Software, Version 3.1.
Recall #B-357-4.
CODE Version 3.1 released on the following dates 6/92, 7/92,
10/17/92, 1/29/93, 3/2/93, 7/93, 9/93, and 12/93.
MANUFACTURER Blood Bank Computer Systems, Inc., Puyallup, Washington.
RECALLED BY Manufacturer, by either telephone or letter on various dates
between July 1992 and February 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Florida, Illinois, Kansas, Ohio, Texas, Washington state.
QUANTITY 12 users have various versions installed.
REASON Computer software, that contained programming errors which
could potentially result in the release of unsuitable blood
products, was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitated
AHF; (d) Fresh Frozen Plasma. Recall #B-360/363-4.
CODE Unit numbers: (a) S08702703, S09033253, 2639301; (b)
8344580; (c) S15070533; (d) S08702703, 8334580.
MANUFACTURER Blood Care (formerly J.K. and Susie L. Wadley Research
Institute and Blood Bank), Dallas, Texas.
RECALLED BY Manufacturer, by letter January 6, 1994. Firm-initiated
recall complete
DISTRIBUTION Texas, Virginia.
QUANTITY (a) 3 units; (b) 1 unit; (c) 1 unit; (d) 2 units.
REASON Blood products collected from a donor who reported a history
of cancer were distributed.
-3- _______________
PRODUCT Red Blood Cells. Recall #B-369-4.
CODE Unit #32J39227.
MANUFACTURER The American National Red Cross, Madison, Wisconsin.
RECALLED BY Manufacturer, by letter January 10, 1994. Firm-initiated
recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit.
REASON Blood product, collected from an ineligible donor due to a
reported history of cancer, was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-370/371-4.
CODE Unit #50G31378.
MANUFACTURER The American National Red Cross, Toledo, Ohio.
RECALLED BY Manufacturer, by letter November 5, 1993. Firm-initiated
recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit of each component.
REASON Blood products collected from an ineligible donor due to a
reported history of cancer were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitated
AHF; (d) Recovered Plasma. Recall #B-377/380-4.
CODE Unit numbers: (a) 50G09881, 50G21320, 50G42375, 50G52922,
50G84919, 50G98932, 50J19142; (b) 50G21320; (c) 50G09881,
50G42375, 50G52922, 50G84919, 50G98932; (d) 50G09881,
50G21320, 50G42375, 50G52922, 50G84919, 50G98932, 50J19142.
MANUFACTURER The American National Red Cross, Toledo, Ohio.
RECALLED BY Manufacturer, by telephone June 1, 1993, and by letters date
June 2 and 23, 1993. Firm-initiated recall complete.
DISTRIBUTION Massachusetts, Ohio, Tennessee, California, Switzerland, The
Netherlands.
REASON Blood products, that tested negative for the antibody to the
human immunodeficiency virus type 1 (anti-HIV-1), but were
collected from a donor who previously tested repeatedly
reactive for anti-HIV-1, were distributed.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-381-4.
CODE Unit #50H22547.
MANUFACTURER The American National Red Cross, Toledo, Ohio.
RECALLED BY Manufacturer, by letter June 1, 1993. Firm-initiated recall
complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit.
REASON Blood product, containing anti-(Rho)D, but labeled as
negative for unexpected antibodies, was distributed.
-4- _______________
PRODUCT Platelets, Pheresis. Recall #B-387-4.
CODE Unit #13P51645-A.
MANUFACTURER American Red Cross Blood Services, Detroit, Michigan.
RECALLED BY Manufacturer, by telephone and letter November 24, 1993.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit.
REASON Blood product which was labeled with an incorrect expiration
date was distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Platelets, Pheresis. Recall #B-252-4.
CODE Unit #40P29186.
MANUFACTURER The American National Red Cross, Peoria, Illinois.
RECALLED BY Manufacturer, by telephone March 14, 1994. Firm-initiated
recall complete.
DISTRIBUTION Iowa.
QUANTITY 1 unit.
REASON An unlicensed blood product was distributed in interstate
commerce.
_______________
PRODUCT Red Blood Cells. Recall #B-358-4.
CODE Unit numbers: 28KS02988, 28KS02996, 28KS02997, 28KS03003,
28KS03005, 28KT03190, 28KT03192, 28KT03193, 28KT03197,
28KT03199.
MANUFACTURER American Red Cross Blood Services, Savannah, Georgia.
RECALLED BY Manufacturer, by letter October 1, 1993. Firm-initiated
recall complete.
DISTRIBUTION South Carolina.
QUANTITY 10 units.
REASON Blood products, incorrectly tested for hepatitis B surface
antigen (HBsAg), were distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-359-4.
CODE Unit numbers: M13456, M13459, M13866, M14619.
MANUFACTURER Medical Center of Delaware, Inc., doing business as
Christiana Hospital, Newark, Delaware.
RECALLED BY Manufacturer, by telephone April 22, 1994, followed by
letter April 25, 1994. Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 4 units.
REASON Blood products, tested for the antibody to hepatitis C virus
encoded antigen (anti-HCV) in a manner inconsistent with the
manufacturer's test kit instructions, were distributed.
-5- _______________
PRODUCT (a) Source Leukocytes; (b) Recovered Plasma.
Recall #B-364/365-4.
CODE Unit numbers: (a) 2639301; (b) S15070533, 2639301.
MANUFACTURER Blood Care (formerly J.K. and Susie L. Wadley Research
Institute and Blood Bank), Dallas, Texas.
RECALLED BY Manufacturer, by letter January 6, 1994. Firm-initiated
recall complete.
DISTRIBUTION California, Texas, Virginia.
QUANTITY (a) 1 unit; (b) 2 units.
REASON Blood products collected from a donor who reported a history
of cancer were distributed.
_______________
PRODUCT Platelets, Pheresis. Recall #B-366-4.
CODE Unit #C36733.
MANUFACTURER Northern Illinois Blood Bank, Rockford, Illinois.
RECALLED BY Manufacturer, by telephone April 21, 1994. Firm-initiated
recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON Blood product, which tested initially reactive for hepatitis
B surface antigen (HBsAg), was distributed.
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells. Recall #B-367/368-4.
CODE Unit numbers: (a) N68551, W97712; (b) FJ02793, LM62233,
LR08289, LR32282, LX07369, LX07394, LX08526, R77421, V16017,
W97729, Z87552, Z87573.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Milwaukee,
Wisconsin.
RECALLED BY Manufacturer, by telephone on September 4, 1992, September
22, 1993, and October 21, 1993. Firm-initiated recall
complete.
DISTRIBUTION Wisconsin.
QUANTITY (a) 2 units; (b) 12 units.
REASON Blood products labeled with incorrect expiration dates were
distributed.
_______________
PRODUCT Recovered Plasma. Recall B-372-4.
CODE Unit #50G31378.
MANUFACTURER The American National Red Cross, Toledo, Ohio.
RECALLED BY Manufacturer, by telephone October 29, 1993. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product collected from an ineligible donor due to a
reported history of cancer was distributed for further
manufacture into injectable products.
-6- _______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Platelets
Pheresis. Recall #B-374/376-4.
CODE Unit numbers: (a) 12FH73331 and 12GV01483;
(b) 12F67503, 12F67504, 12F67505, 12F67506, 12F67507,
12F67508, 12F67509, 12F67510, 12F67511, 12F67512, 12F67514,
12F67516, 12F67517, 12F67520, 12F67521, 12F67527, 12F67531,
12F67533, 12F67534, 12F67537, 12F67539, 12F67540,
12FH73328, 12FH73330, 12FJ67861, 12FJ67862, 12FJ67864,
12FJ67865, 12FJ67866, 12FJ67867, 12FJ67868, 12FJ67869,
12FJ67871, 12FJ67873, 12FJ67875, 12FJ67877, 12FJ67879,
12FJ67881, 12FJ67882, 12FJ67883, 12FJ67885, 12FJ67886,
12FJ67887, 12FP77159, 12FP77160, 12FP77161, 12FP77162,
12FP77163, 12FP77164, 12FP77166, 12FP77169, 12FP77170,
12FP77172, 12FP77173, 12FP77174, 12FP77175, 12FP77176,
12FP77177, 12FP77178, 12FP77179, 12FP77180, 12FP77181,
12FP77184, 12FP77185, 12FP77187, 12FP77190, 12FW03782,
12FW03783, 12FW03785, 12FW03787, 12FW03788, 12FW03798,
12FW03812, 12FZ04592, 12FZ04595, 12FZ04604, 12FZ04614,
12FZ04616, 12GM15718, 12GM15720, 12GM15725, 12GM15748,
12GM15750, 12Q86926, 12Q86927, 12Q86928, 12Q86931, 12Q86934,
12Q86936, 12Q86937, 12Q86939, 12Q86945, 12Q86947, 12Q86948,
12Q86954, 12Q86957, 12Q86958, 12Q86959, 12Q86962, 12Q86964,
12Q86968, 12Q86978, 12Q86985, 12Q86986, 12Q86987, 12Q86988,
12Q86989, 12Q86990, 12Z12273, 12Z12274, 12Z12275, 12Z12276,
12Z12277, 12Z12278, 12Z12280, 12Z12281, 12Z12282, 12Z12283,
12Z12284, 12Z12285, 12Z12286, 12Z12287, 12Z12288, 12Z12290,
12Z12293, 12Z12294, 12Z12295, 12Z12296, 12Z12297, 12Z12298,
12Z12299, 12Z12300, 12Z12301, 12Z12302, 12Z12303, 12Z12304,
12Z12305, 12Z12306, 12Z12307, 12Z12308, 12Z12309, 12Z12310,
12Z12311, 12Z12313, 12Z12314, 12Z12316, 12Z12317, 12Z12318,
12Z12319, 12Z12320, 12Z12321, 12Z12323, 12Z12324, 12Z12325;
(c) 12T69069, 12T69070, 12T69071, 12T69072, 12T69073,
12T69074.
MANUFACTURER American Red Cross Blood Services, Charlotte, North
Carolina.
RECALLED BY Manufacturer, by letters dated from September 28 through
October 1993. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY (a) 2 units; (b) 164 units; (c) 6 units.
REASON Blood products, incorrectly tested for hepatitis B surface
antigen (HBsAg), were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma;
(d) Recovered Plasma. Recall #B-383/386-4.
CODE Unit numbers: (a) 2274566, 4421446, 4420108, 8823973;
(b) 4421446, 4420108, 8823973; (c) 4421446; (d) 2274566,
4420108, 8823973.
MANUFACTURER Sarasota Community Blood Bank, Sarasota, Florida.
RECALLED BY Manufacturer, by letters of February 22 and 24, 1994. Firm-
initiated recall complete.
-7- DISTRIBUTION Florida.
QUANTITY (a) 4 units; (b) 3 units; (c) 1 unit; (d) 3 units.
REASON Blood products, which tested negative for the antibody to
the human immunodeficiency virus type 1 (anti-HIV-1) but
were collected from donors who previously tested repeatedly
reactive for anti-HIV-1, were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Kodak Mammography Film:
(a) Kodak Min-R E, 18 x 24 cm, Catalog No. 807 4148;
(b) Kodak Min-R E, 24 x 30 cm, Catalog No. 807 4577;
(c) Kodak Min-R M, 18 x 24 cm, Catalog No. 160 8785;
(d) Kodak Min-R M, 24 x 30 cm, Catalog No. 160 8801.
Recall #Z-1121/1124-4.
CODE: Min-R E film, 148 emulsion roll numbers.
Min-R M film, 109 emulsion roll numbers.
MANUFACTURER Eastman Kodak Company, Rochester, New York.
RECALLED BY Manufacturer, by letter May 4, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, The Bahamas, Costa Rica, Ecuador, El Salvador,
Honduras, Guam, Guatemala, Nicaragua, St. Maarten, N.
QUANTITY (a) 101,512 boxes; (b) 31,351 boxes; (c) 75,087; (d) 38,129
boxes.
REASON Some of the devices have been found to exhibit a cluster or
band of small pinpoint-like minus-density artifacts. The
significance of artifacts on film may be potentially
misinterpreted by the radiologist.
_______________
PRODUCT Nebulizer Adapter and Set, Respiratory Feed Set,
Ventilator Set for use with Humidifiers:
(a) IPI Disposable Nebulizer Adapter for use with 350 ml
Pour Bottles, Catalog number 1025; with 550 ml Pour Bottles,
Catalog number 1026; with 750 ml Pour Bottles, Catalog
number 1027; with 1000 ml Pour Bottles, Catalog number 1028
(b) Catalog number 1112, IPI Respiratory Feed Set w/Luer
Tip;
(c) Catalog number 1114, IPI Respiratory Therapy Set
(d) Catalog number 1114-S, IPI Connector Set for use with
"Baxter HLC 37" Heated Liquid Level Controller
(e) Catalog number 1114-VP, IPI Respiratory Therapy Set for
Vapor Phase
(f) Catalog number 1115, IPI Nebulizer Fill Set for use with
Gas Driven Nebulizers;
(g) Catalog number 1116, IPI Pediatric Ventilator Set for
use with 3/8" Inlet Ports;
(h) Catalog number 1118, IPI Respiratory Therapy Float Set
for Ultrasonic Cup use;
(i) Catalog number 1119, IPI Respiratory Ventilator Set for
use with Adult Cascade Humidifiers
-8- (j) Catalog number 1120, IPI Thermo-Trol Set for use with
Conchatherm Heaters;
(k) Catalog number 1122, IPI Respiratory Therapy Fluid
Transfer Sets with Luer Tip and Spring Loaded Clamp
(l) Catalog number 1124, IPI Respiratory Therapy Set-
Universal, with Spring Loaded Clamp for Ultrasonic or
Pneumatic Nebulizers;
(m) Catalog number 1125, IPI Nebulizer Fill Set with Spring
Loaded Clamp for use with Gas Driven Nebulizers;
(n) Catalog number 1126, IPI Pediatric Ventilator Set with
Spring Loaded Clamp, for use with 3/8" Inlet Ports
(o) Catalog number 1129, IPI Respiratory Ventilator Set with
Spring Loaded Clamp, for use with Adult Cascade Humidifiers.
Recall #Z-1134/1148.
CODE All lots of these devices shipped prior to June 14, 1994,
with lot numbers of D146 or older.
MANUFACTURER IPI Medical Products, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone July 6, 1994, followed by fax
July 7, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Belgium, England, The Netherlands,
Austria.
QUANTITY 779 cases were distributed; firm estimates 20 percent of the
product remains on the market.
REASON The packaging developed holes or incomplete seals during
shipment, compromising the sterility of the product.
________________
PRODUCT Sharper Image Relaxation System (referred to as S.I.R.
System). Recall #Z-1153-4.
CODE Product #NM200.
MANUFACTURER Synetic Systems, Inc., Seattle, Washington.
RECALLED BY Manufacturer, by electronic mail message sent June 30, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Australia, Japan, Mexico, Switzerland.
QUANTITY 887 units were manufactured.
REASON The firm failed to file a 510(k) Pre-Market Notification for
their S.I.R. System.
_______________
PRODUCT SofCare Companion Inflation Pumps, electric inflation pumps
for static air mattresses: (a) Model CP300; (b) Model
CP200; (c) CP100. Recall #Z-1189/1191-4.
CODE Serial numbers I39A01 through D49A24. Units distributed
from January 1994 to May 1994.
MANUFACTURER Apolo Enterprises, Ontario, California.
RECALLED BY Geymar Industries, Inc., Orchard Park, New York, by voice
mail May 20, 1994, and by letter May 24, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 1,071 units; (b) 6 units; (c) 10 units were distributed.
-9- REASON Repeated dropping of the inflation pump may cause
disengagement of internal support screws resulting in coil
assembly detachment from case housing.
_______________
PRODUCT Marquette Responder Defibrillator/Monitor: (a) Model 1500;
(b) Model 1250. Recall #Z-1193/1194-4.
CODE All serial numbers.
MANUFACTURER Marquette Electronics, Inc., Milwaukee, Wisconsin.
RECALLED BY Manufacturer, by letter June 13, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 1,346 units; (b) 736 units were distributed.
REASON The display screen of some units failed and other units
became totally inoperable. Also, occurring in some units
was a corruption of the flash memory rendering the devices
inoperable.
_______________
PRODUCT Life Scope L Patient Monitor, Model BSM 2101A, equipped with
software versions A1-08 and A1-10, indicataed for ECG, NIBP,
and Sa02 monitoring. Recall #Z-1195-4.
CODE All model BSM 2101A units.
MANUFACTURER Nihon Kohden, Inc., Saitana, Japan.
RECALLED BY Nihon Kohden America, Inc., Irvine, California, by letter
March 18, 1994. Firm-initiated field correction complete.
DISTRIBUTION Alabama, Arizona, California, Colorado, Florida, Georgia,
Maryland, Michigan, Nebraska, New Jersey, Ohio,
Pennsylvania, Texas, Washington state, Washington, D.C.
QUANTITY 43 units.
REASON The non-invasive blood pressure (NIBP) readings may be
inaccurate, producing false low readings. The likely result
of such an event, if undetected, would be a delay in, or
possibly incorrect treatment.
RECALLS AND FIELD CORRECTIONS -- DEVICES -- CLASS III
=====================
_______________
PRODUCT Intermediate Hi-Lo Cuffed Tracheal Tubes: (a) 6.5 mm (b)
Tracheal Tubes, Catalog #86449; (b) 7.5 mm Tracheal Tube,
Catalog #86451; (c) 7.0 mm Tracheal Tube, Catalog #86450.
Recall #Z-1125/1127-4.
CODE Lot numbers: (a) MJ11530; (b) MW10160; (c) MJ11530,
MW10160.
MANUFACTURER Mallinckrodt Medical, Inc., Argyle, New York.
RECALLED BY Manufacturer, by telephone, followed by letter June 16,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Venezuela, Canada
QUANTITY 18,330 units (6.5 mm), 23,900 (7.5 mm) units were
distributed.
-10- REASON The cases and individual 6.5 mm (lot MJ11530) and 7.5 mm
(lot MW10160) tracheal tubes may contain incorrectly labeled
inner boxes. Some of the inner boxes are labeled 7.0 mm
(lot MJ11530 and MW10160) but actually contain the 6.5 mm
and 7.5 mm tracheal tubes.
SEIZURES:
=================================================================
_______________
PRODUCT Synchronized Light/Sound Devices (which emit sequences of
computer controlled flashing lights and sounds through
special glasses and headphones and are promoted as
beneficial in affecting various physical and mental
functions such as relaxation, sleep, visualization,
energizing, and learning by altering the user's brainwave
patterns) (93-629-464).
CHARGES Adulterated - The articles are class III devices for which
there are no approved premarket approval applications in
effect, nor do the articles have investigational device
exemptions. Misbranded - The articles were not included in
a required list, nor were notices or other information
provided as required.
LOCATION Synetic Systems, Inc., Seattle, Washington.
FILED June 10, 1994; U.S. District Court for the Western District
of Washington; Civil #C94-883R; FDC #66918.
SEIZED June 14, 1994 - goods valued at approximately $50,000.
_______________
PRODUCT Yellow Fin Tuna Pieces (94-629-906).
CHARGE Adulterated - The article bears or contains a poisonous and
deleterious substance, histamine, which ordinarily renders
it injurious to health; and, it consists in part of
decomposed fish.
LOCATION Cityice Cold Storage Company, Seattle, Washington.
FILED May 10, 1994; U.S. District Court for the Western District
of Washington; Civil #94-707R; FDC #66967.
SEIZED May 23, 1994 - goods valued at approximately $2,500.
_______________
PRODUCT Sterile Gauze Bandages (94-710-913 et al).
CHARGES Adulterated - The articles' quality falls below that which
they purport and are represented to possess because the
articles purport to be sterile which is contrary to fact
since they are contaminated with mold, yeast, and bacteria.
Misbranded - The articles' labeling is false and misleading
since the product purports to be sterile and, in fact, the
product is not sterile.
LOCATION Medline Industries, Inc., Mundelein, Illinois.
-11- FILED July 25, 1994; U.S. District Court for the Northern
District of Illinois, Eastern Division; Civil #94C 4505;
FDC #66999.
SEIZED July 25, 1994 - goods valued at approximately $47,253.
-12-
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