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
03/09/1994
Recalls and Field Corrections: Foods -- Class II -- 03/09/1994
March 9, 1994 94-10
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Bakery products produced from 1-18-94 through 1-25-94,
including cinnamon rolls, apple strudel, bear claws,
butterhorns, raspberry danish and apple danish. Products
are packaged in a variety of sizes and under six different
brand names. Some product was shipped in bulk with no
labeling. Products include:
(a) Cinnamon Raisin Rolls:
Product #919 -- 10 ounces, under the following labels:
Williams', Snyder's, Franz;
Product #903, Giant Cinnamon Raisin Rolls, 28 ounces, under
the following labels:
Williams', Snyder's, Franz;
Product #907 -- Cinnamon Raisin Rolls, 12 ounces 2-pack,
under the following labels:
Williams', Snyder's, Franz;
(b) Texas Cinnamon Rolls, 64 ounces, under the following
labels:
Product #917, Williams', Snyder's, Franz. This product was
also distributed in bulk with no labeling.
(c) Apple Strudel, 22 ounces, under the following labels:
Product #916 -- Williams', Snyder's, Franz, McKenzie Farms
Bakery,
Product #865 -- Apple Strudel, individual, 3.75 ounces,
under the following labels:
Franz, Snyders, Williams, Jana's Classics; (d) Bear Claws under the following labels:
Product #693 -- individual, 3.75 ounces, Franz, Snyders,
Williams, Jana's Classics;
Product #915 -- Williams' Bear Claws, 18 ounces,
Snyder's Bear Claws, 12 ounces, Franz Bear Claws, 12
ounces, McKenzie Farms Bakery Country Pastries Bear Claws,
10 ounces;
(e) Danish Butterhorns, under the following labels:
Product #904, 10-pack, labeled
(labeling for this product is printed directly on poly
bags):
Franz Premium Quality Danish Butterhorns, 18 Ounces. Also
packaged under the Snyder's and Williams' labels.
Product #902, Danish Butterhorns, 4-packs, labeled:
Williams' Danish Butterhorns 16 ounces,
Snyder's Danish Butterhorns, 16 ounces,
Franz Danish Butterhorns, 16 ounces,
Bakery S Naturally Delicious, distributed by Safeway
Stores, Inc. Oakland, CA
Albertsons Danish Butterhorns 4 pack, 16 ounces. Also
distributed in bulk with no labeling;
(f) Product #953, Raspberry Danish, 6-Pack, labeled:
Williams' Raspberry Danish, 12 ounces;
Snyder's Raspberry Danish flour, 15 ounces;
Franz Raspberry Danish, 15 ounces;
Product #914, Raspberry Danish, 10 ounces, labeled:
Williams' Raspberry Delight, 10 ounces;
Snyder's Raspberry Danish, 10 ounces;
Franz Raspberry Danish, 10 ounces,
(g) Product #913, Apple Danish, 10 ounces labeled:
Williams' Apple Delight, 10 ounces;
Snyder's Apple Danish, 12 ounces,
Franz Apple Danish, 10 ounces,
McKenzie Farms Bakery Country Pastries Apple Danish, 10
ounces. Recall #F-291/297-4.
CODES All products bear pull dates of JAN 27, JAN 29, JAN 30, JAN
31, FEB 2, or FEB 3 corresponding to production dates of
1-18-94, 1-20-94, 1-21-94, 1-22-94, 1-24-94, and
1-25-94.
MANUFACTURER Snyder's Bakery. Inc., Yakima, Washington.
RECALLED BY United States Bakeries, Inc., Portland, Oregon, by visit
beginning January 28, 1994. Firm-initiated recall complete.
DISTRIBUTION Oregon, Washington state.
QUANTITY Approximately 75,000 units of product were distributed. Six
day's production were recalled, totalling for each product:
Product #919 9647 units
Product #903 2878 units
Product #907 4077 units
Product #917 1504 units
Product #916 3667 units
Product #865 5220 units
Product #693 3235 units
-2- Product #915 3768 units
Product #904 4646 units
Product #902 28244 units
Product #953 806 units
Product #914 3837 units
Product #913 3445 units.
REASON Products contained undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I -------------------------
_______________
PRODUCT Alupent (Metaproterenol sulfate USP), Inhalation Aerosol
with mouth piece, used as a bronchodilator.
Recall #D-121-4.
CODE Lot numbers: 930729A EXP 7/95, 930730A EXP 7/95, 930731A
EXP 7/95.
MANUFACTURER 3-M Pharmaceuticals, Inc., Northridge, California.
RECALLED BY Boehringer-Ingelheim Pharmaceuticals, Inc., Ridgefield,
Connecticut, by letter sent on or about January 26, 1994.
Firm-initiated recall ongoing. See also FDA press release
P94-6, February 4, 1994.
DISTRIBUTION Nationwide.
QUANTITY 218,843 canisters were distributed; firm estimates 98,000
canisters remain on the market.
REASON Product does not meet particle size distribution
specification.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II -------------------------
_______________
PRODUCT Various drug products:
(a) Folic Acid, USP 1 mg, in high density polyethylene
(HDPE) bottles of 100, 500 and 1,000 tablets, Rx anti-anemic
under the following labels: Pioneer, Major, Goldline, and
URL:
(b&c) Dicyclomine Hydrochloride Tablets, 10 mg and 20 mg, Rx
anti-spasmodic and anti-cholinergic agent used to relieve
smooth muscle spasm of the GI tract, under the following
labels: Pioneer, Par-Med, Best, Major, Qualitest, H.L.
Moore, Schein, Bentu, Harber, URL, Goldline, Genetco and
Geneva;
(d&e) Chlorzoxazone, (Chlorzoxazone, 250 mg and
Chlorzoxazone, 500 mg USP, in HDPE bottles of 100, 500, and
1000 tablets, Rx muscle relaxant, under the following
labels: Pioneer, Goldline, and QRP;
(f) Carisoprodol, 350 mg USP, in HDPE bottles of 100, 500
and 1000 tablets, Rx muscle relaxant, under the following
labels: Pioneer, Par-Med, Major, Qualitest, IDE, Harber,
Goldline, URL, Genetco;
(g&h) Methocarbamol (USP, 500 mg and USP 750 mg), in HDPE
bottles of 100, 500, and 100 tablets, Rx muscle relaxant,
under the following labels: Pioneer, Par-Med, Major,
-3- Goldline, Qualitest, IDE, and URL;
(i) Cryproheptadine 4 mg, in HDPE bottles of 100 capsules,
Rx decongestant under the Pioneer label.
Recall #D-150/158-4.
CODE All lots.
MANUFACTURER Pioneer Pharmaceuticals, Irvington, New Jersey.
RECALLED BY Manufacturer, by letter May 18, 1993. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates none remains on the market.
REASON Abbreviated new drug application discrepancies.
_______________
PRODUCT Sulfasalazine Tablets, USP, 500 mg, in 100 tablet boxes, Rx
oral anti-inflammatory for the treatment of mild to moderate
ulcerative colitis. Recall #D-180-4.
CODE Lot numbers: 2C715, 2H877, 2J179, 2S497, 3A750, 3F138,
3K578, 4A039.
MANUFACTURER Lederle Laboratories, Inc., Pearl River, New York.
RECALLED BY UDL Laboratories, Inc., Rockford, Illinois (repacker), by
letter January 28, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 34,300 cartons of 100 unit dose tablets were distributed;
firm estimates that 35-40 percent of the product remains on
the market.
REASON Product does not meet dissolution specifications.
_______________
PRODUCT Sulfasalazine Tablets, 500 mg, in bottles of 100, Rx oral
anti-inflammatory for treatment of mild to moderate
ulcerative colitis. Recall #D-181-4.
CODE All unexpired lots.
MANUFACTURER Lederle Laboratories, Inc., Pearl River, New York.
RECALLED BY Allscrips Pharmaceuticals, Inc., Vernon Hills, Illinois
(repacker), by letter January 31, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION California, New Mexico, Pennsylvania, Missouri, Indiana,
Florida, New Hampshire, West Virginia, Ohio, South Dakota.
QUANTITY 410 bottles were distributed; firm estimates 25 percent of
the product remains on the market.
REASON Product does not meet dissolution specifications.
_______________
PRODUCT Hydrocodone Bitartrate 5 mg /Acetaminophen 500 mg Tablets,
in bottles of 15, 20, 30, 40, 100, 50, 10, 6, 24, 12, 25,
and 16, Rx product for use as a pain reliever.
Recall #D-182-4.
CODE All unexpired lots.
MANUFACTURER Halsey Drug Company, Inc., Brooklyn, New York.
RECALLED BY Allscrips Pharmaceuticals, Inc., Vernon Hills, Illinois
(repacker), by letters February 9, 1994. Firm-initiated
recall ongoing.
-4- DISTRIBUTION Nationwide.
QUANTITY 2,898 bottles of 15, 6,483 bottles of 20, 2,168 bottles of
30, 116 bottles of 40, 62 bottles of 100, 40 bottles of 50,
2,482 bottles of 10, 302 bottles of 6, 663 bottles of 24,
766 bottles of 12, 20 bottles of 25 and 6 bottles of 16
tablets were distributed; firm estimates that 35 percent of
the product remains on the market.
REASON Abbreviated new drug application discrepancies.
_______________
PRODUCT Oxygen Home Use Tanks. Recall #D-183-4.
CODE None.
MANUFACTURER Northeast Airgas, Fitchburg, Massachusetts.
RECALLED BY Diversified Medical Equipment Services, Fitchburg,
Massachusetts, by visit December 21, 1993. Firm-initiated
recall complete.
DISTRIBUTION Massachusetts.
QUANTITY 190 pounds.
REASON Recalling firm mistakenly transfilled liquid argon into
several home use liquid oxygen tanks.
_______________
PRODUCT Ergoloid Mesylates, 1 mg oral tablets, used for symptomatic
relief of decline in mental capacity. Recall #D-184-4.
CODE Vangard lot numbers: 1585-019 EXP 1/94, 1585-020 EXP 5/94,
1585-021 EXP 7/94, 1585-022 EXP 8/94, 1585-023 EXP 10/94,
1585-024 EXP 4/95, 1585-025 EXP 4/95.
MANUFACTURER Danbury Pharmacal, Inc., Carmel, New York.
RECALLED BY Vangard Labs, Inc., Glasgow, Kentucky (repacker), by letters
dated January 24 and 31, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 10,335 boxes of 100 tablets were distributed.
REASON Product does not meet USP content uniformity specifications.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ------------------------
_______________
PRODUCT Demerol, hydrochloride (meperidine hydrochloride injection,
USP), 100 mg/1 ml, 100 mg per ml. Recall #D-149-4.
CODE Lot numbers: M420KJ, M120KL.
MANUFACTURER Sanofi Winthrop Pharmaceuticals, McPherson, Kansas.
RECALLED BY Corporate Headquarters, New York, New York, by letter
December 31, 1993. Firm-initiated field correction
complete.
DISTRIBUTION Undetermined.
QUANTITY 19,661 units of lot M420KJ, 2,788 units of lot M120KL.
REASON The CII Drug Enforcement Administration symbol was omitted
from the unit carton. It is present on the vial and insert.
-5- _______________
PRODUCT Various drug products:
(a) Anti-Tussive (Caramiphen Edisylate 40
mg/Phenylpropanolamine 75 mg), in HDPE bottles of 50, 100,
500, and 1000 immediate release capsules, Rx cough
suppressant, under the following labels: Pioneer, Best,
Par-Med and Quality Research Pharmaceuticals;
(b) Papaverine (Papaverine HCL 150 mg), in HDPE bottles of
100, and 1000, extended release capsules, Rx,
Intracovernosal, under the following labels: Pioneer,
Harber, Goldline, and Richie;
(c) Decongestabs (Phenylpropanolamine HCl, 40 mg,
Phenylephrine HCl 10 mg, Phenyltoloxamine Citrate 15 mg,
Chlorpheniramine Maleate 5 mg), in HDPE bottles of 100, 500,
and 100 tablets, Rx, decongestant, under the following
labels: Pioneer, Par-Med, Major, Best, and URL;
(d) Pioten, (Brompheniramine Maleate, USP 12 mg,
Phenlyephrine Hdyrochloride, USP 15 mg, Phenylpropanolamine
HCl 15 mg), in HDPE bottles of 100, 500, and 1000 extended
release tablets, Rx decongestant, under the following
labels: Pioneer, Par-Med, Major, Best, Harber, G.S.
Ruckstuhl and Genetco;
(e&f) Cyclandelate, (Cyclandelate 200 mg) and Cyclandelate
400 mg), in HDPE bottles of 100, 400 and 1000 capsules, Rx
vasodilator, under the following labels: Pioneer, par-Med,
Best, Major, Rugby, H.L. Moore, Schein, IDE, Goldline,
Genetco, and Qualitest;
(g) Chlordiazepoxide/Clidinium, USP, 10 mg and 25 mg, in
HDPE bottles of 100, 500, 1000 immediate release capsules,
Rx drug with anti-anxiety and sedative actions, under the
following labels: Pioneer, IDE, Goldline, URL, Par-Med, and
Major;
(h) Nuvites, (vitamins C, B1, B2, B6, B12) in HDPE bottles
of 100 and 500 tablets, Rx vitamin supplement, under the
following labels: Pioneer, Everett Laboratories and
Qualitest;
(i) Therax, Theophylline 130 mg, Hydroxyzine HCl 10 mg,
Ephedrine Sulfate 25 mg, in HDPE bottles of 100, 500 and 100
tablets, Rx bronchodilator, under the following labels:
Pioneer, Best, IDE, Schein, Genetco, Qualitest, and Rugby;
(j) Chlorzoxazone, (Chlorzoxazone, 250 mg w/APAP), in HDPE
bottles of 100, 500, and 1000 tablets, Rx muscle relaxant,
under the following labels: Pioneer, Goldline, and QRP;
(k) Dimenhydrinate, 50 mg, in packages of 100's and HDPE
bottles of 1000 tablets, nonprescription antiemetic, under
the following labels: Pioneer, Goldline, and H.L. Moore;
(l) Brinogeburanube Nakeatem 4 mg and USP 750 mg), in HDPE
bottles of 100 , 500, and 1000 tablets, Rx muscle relaxant,
under the following labels: Pioneer, Par-Med, Major,
Goldline, Qualitest, IDE, and URL;
(m) Ferrous Fumarate w/DSS, in HDPE bottles of 100 and 1000,
Timed Release Capsules, nonprescription iron supplement,
under the following labels: Pioneer, IDE, URL and Genetco;
-6- (n) Chlorpheniramine Maleate, 4 mg in HDPE bottles of 100
and 1000 tablets, nonprescription antihistamine, under the
following labels: Pioneer, Goldline, Harber, and Genetco;
(o) Iodoquinol 650 mg, in bottles of 100 only, Rx anti-
amebiasis, exclusively under the Consolidated Midland
Corporation label;
(p) Fumatrin Forte, in HDPE bottles of 60 tablets, Rx
therapeutic Hematinic with Vitamins, exclusively under the
Reid-Provident label;
(q) Ferrous Fumarate, in bulk only, nonprescription iron
supplement;
(r) Yohimbine, in bulk tablets, nonprescription dietary
supplement, contract manufactured exclusively for
Consolidated Midland Corporation;
(s) Diphenhydramine 25 mg, in HDPE bottles of 100 capsules,
Rx anti-histaminic under the Pioneer label;
(t) Diphenhydramine, 50 mg, in HDPE bottles of 100 capsules,
Rx anti-histaminic under the Pioneer label;
(u) Paindrin, in HDPE bottles of 60 and 100 tablets,
nonprescription analgesic under the pioneer label.
Recall #D-159/179-4.
CODE All lots.
MANUFACTURER Pioneer Pharmaceuticals, Irvington, New Jersey.
RECALLED BY Manufacturer, by letter May 18, 1993. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates none remains on the market.
REASON Current good manufacturing practice deficiencies.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ---------------------
_______________
PRODUCT (a) Red Blood Cells: (b) Red Blood Cells, Leukocytes
removed; (c) Whole Blood Mod, Platelets removed; (d)
Platelets; (e) Cryoprecipitated AHF; (f) Fresh Frozen
Plasma; (g) Recovered Plasma. Recall #B-142/148-4.
CODE Unit numbers: (a) E42643, E80919, FM13026, FM13289,
FM26255, KC91889, LM39879, LM44183, LM45848, LM46198,
LM46444, LM58584, LM75690, N17548, N20576, S13853;
(b) E75727, KC87857;
(c) N16358, W15049;
(d) E42643, E75727, E80919, FM13289, FM26255, KC87857,
KC91889, KC98682, LM39879, LM44183, LM46198, LM46444,
LM58584, LM75690, N16358, N17548, W15049;
(e) FM13289, LM75690;
(f) E80919, FM26255, KC87857, KC91889, S13853;
(g) E42643, E75727, FM13026, FM13289, LM39879, LM44183,
LM45848, LM46198, LM46444, LM58584, LM75690, N17548, N20576.
MANUFACTURER Mid-South Regional Blood Center, Memphis, Tennessee.
RECALLED BY Manufacturer, by letters on various dates between June and
August 1993. Firm-initiated recall ongoing.
DISTRIBUTION Florida, Illinois, Missouri, Texas.
-7- QUANTITY (a) 16 units; (b) 2 units; (c) 2 units; (d) 17 units; (e) 2
units; (f) 5 units; (g) 13 units.
REASON Blood products tested negative for the antibody to human
immunodeficiency virus type 1 (anti-HIV-1), but were
collected from donors who previously tested repeatedly
reactive for anti-HIV-1.
_______________
PRODUCT Recovered Plasma. Recall #B-160-4.
CODE Unit numbers: 1388762, 1402923, 1405905, 1463090.
MANUFACTURER Mississippi Blood Services, Inc., Jackson, Mississippi.
RECALLED BY Manufacturer, by telephone and letter between April 1 and 7,
1993. Firm-initiated recall ongoing.
DISTRIBUTION California, New York, North Carolina.
QUANTITY 4 units.
REASON Blood products 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.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III --------------------
_______________
PRODUCT (a) Red Blood Cells; (b) Whole Blood Mod, PLT removed; (c)
Platelets; (d) Cryoprecipitated AHF; (e) Fresh Frozen
Plasma; (f) Recovered Plasma. Recall #B-149/154-4.
CODE Unit numbers: (a) FM10987, FM13132, KC45136, N16630; (b)
N15411, N17903, N19708, N20753; (c) FM10987, FM13132,
KC45136, N15411, N16630, N17903, N19708, N20753;
(d) KC45136; (e) FM13132; (f) FM10987, KC45136, N16630.
MANUFACTURER Mid-South Regional Blood Center, Memphis, Tennessee.
RECALLED BY Manufacturer, by letters on various dates between June and
August 1993. Firm-initiated recall ongoing.
DISTRIBUTION Tennessee, Missouri.
QUANTITY (a) 4 units; (b) 4 units; (c) 8 units; (d) 1 unit;
(e) 1 unit; (f) 3 units.
REASON Blood products tested negative for the antibody to human
immunodeficiency virus type 1 (anti-HIV-1), but were
collected from donors who previously tested repeatedly
reactive for anti-HIV-1.
_______________
PRODUCT Red Blood Cells. Recall #B-155-4.
CODE Unit 1285807.
MANUFACTURER The New York Blood Center, New York, New York.
RECALLED BY Manufacturer, by telephone August 8, 1990. Firm-initiated
recall complete.
DISTRIBUTION New York.
QUANTITY 1 unit.
REASON Blood product, untested for viral markers, was distributed
for transfusion.
-8- _______________
PRODUCT Recovered Plasma. Recall #B-156-4.
CODE Unit numbers: TM0833, TM7103, TM9726.
MANUFACTURER Timken Mercy Medical Center, Canton, Ohio.
RECALLED BY Manufacturer, by letter August 22, 1990. Firm-initiated
recall complete.
DISTRIBUTION Maryland.
QUANTITY 3 units.
REASON Blood products tested negative for the antibody to human
immunodeficiency virus type 1 (anti-HIV-1), but were
collected from a donor who previously tested repeatedly
reactive for anti-HIV-1.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II -----------------------
_______________
PRODUCT Diala-Kits restricted disposable sterile devices bearing the
Rx legend, containing supplies used by dialysis centers and
hospitals during dialysis procedures:
Catalog numbers: (a) 46-5010-7; (b) 46-5050-3; (c)
46-5072-7; (d) 46-5100-6; (e) 46-5210-3; (f) 46-5231-9; (g)
46-5020-6; (h) 46-5070-1; (i) 46-5080-0; (j) 46-5110-5; (k)
46-5220-2; (l) 46-5240-0; (m) 46-5021-4; (n) 46-5071-9; (o)
46-5090-9; (p) 46-5200-4; (q) 46-5230-1; (r) 46-5250-9.
Recall #Z-261/278-4.
CODE All lots of the 18 catalog numbers.
MANUFACTURER National Medical Care, McAllen, Texas.
RECALLED BY National Medical Care, Rockleigh, New Jersey, by letter
October 19, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,043 cases (24 kits per case) were distributed; firm
estimates that 75 cases remain on the market.
REASON Lack of an approved 510(k).
_______________
PRODUCT Chin Bone Plate Components of Osteomed M3 Rigid Fixation
System, designed to fixate genioplsties.
Recall #Z-279/283-4.
CODE Part No. Description Lot No.
210-0040 4 mm chin bone plate 93267 and 93314
210-0042 6 mm chin bone plate 93268
210-0044 8 mm chin bone plate 93269
210-0046 10 mm chin bone plate 93270
210-0048 12 mm chin bone plate 93245
MANUFACTURER Enterprise Industries, North Hollywood, California.
RECALLED BY Osteomed Corporation (OC). Irving, Texas, by telephone June
1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 557 plates were distributed; firm estimates none remains on
the market.
REASON Plates are potentially subject to cracking and breaking
before/and after implantation due to insufficient pre-bend
radius.
-9- _______________
PRODUCT Profect Grand Medical brand Laparotomy Sponges, disposable,
sterile, radiopaque, 18" x 18", packed in cases containing
20 pouches, 5 sponges each, used during surgical procedures.
Recall #Z-307-4.
CODE Lot numbers: 202890, 202891, 202892.
MANUFACTURER Network Trading Corporation, doing business as Grand Medical
Products, Houston, Texas.
RECALLED BY Manufacturer, by letter January 20, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 200 cases of lot 202890, 177 cases of lot 202891, 10 cases
of lot 2022892 were distributed.
REASON Products have the potential to be nonsterile.
_______________
PRODUCT ICS Profile and Profile II with software revision levels
2.2 and 2.4, used for research and clinical applications:
(a) Profile; (b) Profile II. Recall #Z-342/343-4.
CODE: Catalog numbers: (a) 6603596, 6603597, 6603598, 6603664,
6603872, 6603873, 6603874, 6603875, 6604133, 6604134,
6604135, 6604136;
(b) 6603949, 6603950, 6603951, 6603952, 6603953, 6603954,
6603955, 6603956, 6604126, 6604127, 6604128, 6604129,
6604130, 6604131, 6604132, 6604133, 6604730, 6604731,
6604732, 6604733, 6604734, 6604735, 6604736, 6604737,
6604738, 6604739, 6604740, 6604741, 6604742, 6604743,
6604744, 6604745.
MANUFACTURER Coulter EPICS, Miami Lakes, Florida.
RECALLED BY Coulter Corporation, Miami, Florida, by letters of June 5,
1992 and April 20, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Argentina, Australia, Japan, Puerto Rico,
Mexico.
QUANTITY 491 units were distributed.
REASON It is possible for the number of events (counts) in the
histograms obtained during run-time and from listmode data
to differ.
_______________
PRODUCT Fonar Ultimate 3000 and B-3000M Magnetic Resonance Imaging
Scanners, used in production of images of multiple planes in
the head and body. Recall #Z-344-4.
CODE Serial numbers: 1181, 1183, 1184, 1162, 1100, 1038, 1024,
1170, 1165, 1177, 1187, 1186, 1179.
MANUFACTURER Fonar Corporation, Melville, New York.
RECALLED BY Manufacturer. As of December 3, 1993, all units were
retrofired except serial #1186 and #1187. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide, Korea, Mexico.
QUANTITY 13 units were distributed.
REASON Defective electrical insulation in the gradient amplifier
may cause a short resulting in the overheating and melting
of the wires.
-10- _______________
PRODUCT Introducer Catheters contained in the Vena Cava Filter
Systems, permanently implanted devices designed to protect
the patient against pulmonary embolism:
(a) Catalog #50-100, 24F Stainless Steel Greenfield Filter
System;
(b) Catalog #50-300, 12F Titanium Greenfield Filter System-
Jugular;
(c) Catalog #50-301, 12F Titanium Greenfield Filter System-
Femoral;
(d) Catalog #50-525, 24F Stainless Steel Greenfield
Introducer Catheter. Recall #Z-347/350-4.
CODE Lot numbers: (a) 30839-59498; (b) 31769-73521; (c) 31337-
79724; (d) 30345-53137.
MANUFACTURER Medi-tech Division, Boston Scientific Corporation,
Watertown, Massachusetts.
RECALLED BY Manufacturer, by letter September 2, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 23,000 units.
REASON A defective inner sheath of the introducer catheter may
become brittle, crack and embolize within the patient.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ----------------------
_______________
PRODUCT Fresh Lens 04, -1.75 Power, Rx extended wear contact lens.
Recall #Z-252-4.
CODE Lot numbers: WC1700752 EXP 7/94.
MANUFACTURER Bausch & Lomb, Inc., Waterford, Ireland.
RECALLED BY Bausch & Lomb Inc., Rochester, New York, by letter December
23, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 29 cartons were distributed.
REASON Blister packs containing the lenses were labeled with an
incorrect lot number and lens power, while the carton was
labeled with the correct lot number and lens power.
_______________
PRODUCT Premier Deluxe Hot Bead Sterilizer, (a) Model 110; (b) 220
volt models, used in the sterilization of small hand held
metallic instruments. Recall #Z-259/260-4.
CODE Serial numbers: (a) 8450, 9926; (b) 91110, 91265.
MANUFACTURER Premier Medical, Division of Premier Dental Products
Company, Philadelphia, Pennsylvania.
RECALLED BY Permier Dental Products Company, Inc., Norristown,
Pennsylvania, by letter June 25, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimates 900 uncorrected units remain on the market.
REASON Overheating caused by the insulation board pressing against
the thermostat contacts causing the circuit to remain closed
after they reach 435 degrees Fahrenheit.
-11- _______________
PRODUCT Coulter 4C Plus Normal Cell Control and Tripack Kits, for
in-vitro diagnostic use:
(a) 4C Plus Normal 9x3.3ml; (b) 4C Plus Tripak 9x3.3ml.
Recall #Z-284/285-4.
CODE (a) Part #7546923, Kit lot #767F;
(b) Part #7546771, Kit lot numbers: 103442K, 103443K,
103444K.
MANUFACTURER Coulter Corporation, Hialeah, Florida.
RECALLED BY Coulter Corporation, Miami, Florida, by letter on or about
February 22, 1993. Firm-initiated field correction
complete.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimates none remains on the market.
REASON The assigned red blood cell (RBC) value for the STKS system
was incorrectly typed under the table of Expected Results.
_______________
PRODUCT Coulter Software included with the 4C Plus Coulter Cell
Control, for in-vitro diagnostic use. Recall #Z-286-4.
CODE Part #7547003, Kit Lot #106734K EXP 8/16/93, Vial numbers:
Abnormal Low - 643; Normal - 079100; Abnormal High - 084300.
MANUFACTURER Coulter Corporation, Diagnostics Group, Hialeah, Florida.
RECALLED BY Coulter Corporation, Miami, Florida, by letter dated July
13, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Germany, Turkey.
QUANTITY 219 kits were distributed; firm estimates none remains on
the market.
REASON A change in the lot numbering system caused a
diskette/instrument interface incompatibility. The control
diskette contained within the kit failed to produce correct
lot numbers, assigned value, and expected range comparisons
when monitoring Coulter MD series system performance with
the controls.
_______________
PRODUCT Coulter GAMMA-GT Reagent, for the quantitative determination
of gamma-glutamyl transpeptidase activity in serum.
Recall #Z-287-4.
CODE Part #2907084. All lots.
MANUFACTURER Trace America, Inc., Clayton Victoria, Australia.
RECALLED BY Coulter Corporation, Miami, Florida, by letter beginning
July 14, 1993. Firm-initiated field correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimates all units have been corrected.
REASON Incorrect directions for use were provided to customers.
_______________
PRODUCT Coulter Chemistry Control Level I, for in-vitro diagnostic
use. Recall #Z-288-4.
CODE Kit lot numbers 150006K3 150006K4. Vial lot #155001 EXP
10/14/94.
-12- MANUFACTURER Ciba-Corning Diagnostics Corporation, Irvine, California.
RECALLED BY Coulter Corporation, Miami, Florida, by letter October 6,
1993. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 286 kits of lot 150006K3 and 2 kits of lot 150006K4 were
distributed.
REASON The Sodium (NA) and Potassium (K) values were reversed on
the table of assigned values. In addition, the SI value for
Phosphorous was assigned to Sodium (duplicated).
_______________
PRODUCT Coulter Maxm with Software below level 6A, an automated
hematology instrument. Recall #Z-291/296-4.
CODE Catalog numbers: 6604568, #6604569, 6604570, 6705243,
6705244, 6705245.
MANUFACTURER Coulter Corporation, Hialeah, Florida.
RECALLED BY Coulter Corporation, Miami, Florida, by letter April 19,
1993. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 315 machines remain uncorrected.
REASON Specimens containing fibrin threads, cell fragments, or
other debris can cause a transient or partial blockage of
the aperture and may produce an erroneously low count.
_______________
PRODUCT Sarstedt Tissue Culture Flask, sterile, 25cm2/50 ml, used to
examine propagate, nourish, or grow cells and tissue
cultures. Recall #Z-358-4.
CODE Lot #3242082.
MANUFACTURER Sarstedt, Inc., Newton, North Carolina.
RECALLED BY Manufacturer, by telephone, followed by letter dated
November 17, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Missouri and Canada.
QUANTITY 4 cases (500 units per case) were distributed.
REASON The packaging exam performed on the lot revealed two
leakers.
_______________
PRODUCT5 Coulter Maxm with Software below level 6A, an automated
hematology instrument. Recall #Z-359/364-4.
CODE Catalog numbers: 6604568, 6604569, 6604570, 6705243,
6705244, 6705245.
MANUFACTURER Coulter Corporation, Instruments Group, Hialeah, Florida.
RECALLED BY Coulter Corporation, Miami, Florida, by letter beginning May
26, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 315 machines remain uncorrected.
REASON Software errors. When manually entering sample
identification numbers, two conditions can occur which may
result in sample mis-identification. During sample
analysis, if a flowcell block or initial count failure is
detected, a purge cycle is performed. When this occurs the
identification of a specimen awaiting analysis may be lost.
-13- MASS SEIZURE:
=============================================================
_______________
PRODUCT Lentils and various other foods in rodent-susceptible
containers which have been in interstate commerce
(94-674-255, et al).
CHARGE Adulterated - While held for sale after shipment in
interstate commerce, the articles have been held under
insanitary conditions whereby they may have become
contaminated with filth.
LOCATION I.F.M. Spice Co., Inc., and Berhanu International Ltd.,
St. Louis, Missouri.
FILED February 23, 1994; U.S. District Court for the Eastern
District of Missouri, Eastern Division; Civil #4:CV347MLM;
FDC #66935.
SEIZED February 25, 1994 - goods valued at approximately $12,000.
SEIZURE:
==================================================================
_______________
PRODUCT Plasma products intended for the manufacture of in-vitro
diagnostic products and labeled, in part, Source Plasma
(Human), Human Plasma, and Plasmaflasche (94-661-765/9).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the articles' manufacture, packing, and
storage are not in conformity with good manufacturing
practice requirements for blood products. Misbranded - the
labeling for the product "Source Plasma (Human)" is false
and misleading because it implies that the products are
licensed and are suitable for use in manufacturing when, in
fact, the products are not licensed and not suitable for
further manufacturing; labeling for the product labeled as
"Human Plasma" is false and misleading because it does not
clearly distinguish such articles from "Plasma," a product
subject to licensure under the PHS Act, and suitable for
transfusion; and labeling for products lacking
identification of the collecting establishment is false and
misleading because labeling has been added which falsely
implies that the product is suitable for further
manufacture. The labels (Plasmaflasche) do not bear the
name and location of the manufacturer; and information
required to appear on the label or labeling of the products
other than those labeled as "Source Plasma (Human," is not
prominently placed thereon with such conspicuousness and in
such terms as to render it likely to be read and understood
by the ordinary individual under customary conditions of
purchase and use in that the products fail to bear the
proper article name and other required information.
LOCATION Abbott Laboratories Diagnostic Division, Abbott Park,
Illinois.
-14- FILED February 28, 1994; U.S. District Court for the Northern
District of Illinois, Eastern Division; Civil #94C 1219;
FDC #66925.
SEIZED February 28, 1994 - goods valued at approximately $316,000.
-15-
END OF ENFORCEMENT REPORT FOR MARCH 9, 1994. BLANK PAGES MAY
FOLLOW.
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