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
03/30/1994
Recalls and Field Corrections: Foods -- Class IIII -- 03/30/1994
March 30, 1994
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Flavored dried noodle soups in plastic foam cups,
individually encased in a labeled cardboard sleeve, packaged
12 cups to a shipping carton:
(a) Fantastic Noodles brand 3 flavors, Curry Vegetable,
Tomato Vegetable, and Miso Vegetable;
(b) Ramen Pride brand 3 flavors, Beef, Shrimp, Chicken;
(c) Campbell's brand 2 flavors, Chicken and Beef;
(d) Thrift Maid brand 2 flavors, Chicken and French Onion;
(e) Caldo Pronto brand, Beef flavor;
(f) Mr. Noodles brand 5 flavors, Garden Vegetable, Chicken,
Spicy Chicken, Beef, and Spicy Beef;
(g) Tradition brand 2 flavors, Chicken and Beef.
Recall #F-319/325-4.
CODE 25 OCT 3 through 15 NOV 3. All lots produced from 10/25/93
through 11/15/93.
MANUFACTURER Sanwa Foods, Inc., a Campbell Soup Company, City of
Industry, California.
RECALLED BY Manufacturer, by memorandum November 23, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Arkansas, California, Colorado, Florida, Georgia, Indiana,
North Carolina, New Jersey, New York, Pennsylvania, Texas,
Washington state.
QUANTITY 102,598 cases were distributed. On December 15, 1993 the
firm estimated that 87,000 cases remained on the market.
REASON Products contained metal fragments.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
==========================
_______________
PRODUCT Alupent Inhalation Aerosol Complete, Metaproterenol Sulfate
USP, 0.65 mg, 10 ml inhaler, Rx bronchodilator for the
relief of bronchospasm in asthma patients and other patients
with respiratory ailments. Recall #D-218-4.
CODE Lot #3337026 EXP 7/95.
MANUFACTURER 3M Health Care Specialty, St. Paul, Minnesota (responsible
firm).
RECALLED BY Allscrips Pharmaceuticals, Inc., Vernon Hills, Illinois
(relabeler), by letter February 8, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION California, Washington state, Georgia.
QUANTITY 50 canisters were distributed; firm estimates that 35% of
the product remains on the market.
REASON Product does not meet particle size distribution
specifications.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Tucks Pads 100's, non-Rx hygienic astringent wipe, in jars
of 100. Recall #D-206-4.
CODE Lot #43760L EXP 2/95.
MANUFACTURER Warner-Lambert Company, Lititz, Pennsylvania.
RECALLED BY Warner-Lambert Company, Morris Plaines, New Jersey, by
letter October 6, 1993. Firm-initiated recall complete.
DISTRIBUTION Massachusetts, Maine, Connecticut, New Jersey, New York,
Pennsylvania, Delaware, Maryland, Virginia, North Carolina,
South Carolina, Georgia, Florida, Alabama.
QUANTITY 15,048 jars were distributed.
REASON Presence of mold.
_______________
PRODUCT Doculax, docusate sodium 100 mg stool softener, in 100
capsule bottles. Recall #D-207-4.
CODE Lot #A31 EXP 9/95.
MANUFACTURER Chase Pharmaceutical Company, Newark, New Jersey.
RECALLED BY V.A. Packaging & Manufacturing Company, Inc., Perth Amboy,
New Jersey (repacker/responsible firm), by letter November
5, 1993. Firm-initiated recall complete.
DISTRIBUTION Undetermined.
QUANTITY 890 bottles were distributed.
REASON Product labeled Doculax (Docusate Sodium) Capsules contained
Doculax Plus Capsules (Docusate Sodium Casanthranol).
-2- ________________
PRODUCT NVE Revive Products:
(a) Revive Yourself Cold Tablets - 3 Way Cold Tablets (50 mg
phenylpropanolamine, 25 mg Ephedrine, 2 mg chlorpheniramine
maleate), non-Rx combination tablet, packaged in 25's, 50's
and 100's HDPE bottles, oral solid dosage form for use as
an adrenergic/anti-histamine;
(b) Revive Yourself Stimulant Caffeine Anhydrous - 20/20
Tablets (175 mg Caffeine), non-Rx single ingredient, oral
solid dosage form, packaged in HDPE bottles of 100, for use
as a stimulant;
(c) Revive Diet Aid with Grapefruit Extract - (25 mg
phenylpropanolamine with 25 mg grapefruit extract), non-Rx
single ingredient, oral solid dosage form, packaged in HDPE
bottles of 100 and 500, for use as an appetite suppressant.
(d) Revive Yourself Diet Aid Purple Spec Tablets - (75 mg
phenylpropanolamine HCl, time release), non-Rx single
ingredient, time release solid oral dosage form,
packaged in HDPE bottles of 100 and 500, for use as an
appetite suppressant;
(e) Revive Yourself Diet Aid Benzocaine Lozenge - (15 mg
Benzocaine), non-Rx single ingredient, solid oral dosage
form, packaged in HDPE bottles of 100 and 500, an anesthetic
marketed as an appetite suppressant;
(f) Revive Yourself Sleep Aid - (50 mg Diphenhydramine HCl),
non-Rx single ingredient, solid oral dosage form, packaged
in HDPE bottles of 100 and 500, an anti-histaminic for use
as a sleep aid;
(g) Revive Yourself Stimulant Caffeine Anhydrous - 40/40
Tablets (200 mg Caffeine round), non-Rx single ingredient,
solid oral dosage form, packaged in HDPE bottles of 100 and
500, for use as a stimulant;
(h) Revive Yourself Stimulant Caffeine Anhydrous - 357
Magnum Tablet (200 mg Caffeine, heart shaped), non-Rx single
ingredient, solid oral dosage form, packaged in HDPE bottles
of 500's, for use as a stimulant. Recall #D-208/216-4.
(NOTE: (h) above, is reportedly the same product as (g),
above, but is instead Heart Shaped, and bears a different
product number. The product name "357 Magnum is the product
name used in a catalog, but does not appear on the product
label);
(i) Revive Diet Aid Anoretic Tablets - White Mini-Tab (37.5
mg Phenylpropanolamine HCl), non-Rx single ingredient, solid
oral dosage form, packaged in HDPE bottles of 100's, 500's,
1000's, for use as an appetite suppressant.
Recall #D-208/216-4.
CODES (a) lot #930214 EXP 6/94; (b) lot #930810 EXP 5/94;
(c) lot #931618 EXP 7/94; (d) lot #931712 EXP 5/94;
(e) lot #931919 EXP 7/94; (f) lot #935708 EXP 4/94;
(g) lot #933309 EXP 5/94; (h) lot #930522 EXP 6/94;
(i) lot #931507 EXP 6/94.
-3- (Note: Product #5 and #33 above are the same product
reportedly, but are 2 different shaped products with name
variability.)
MANUFACTURER NVE, Inc., Newton, New Jersey.
RECALLED BY Manufacturer, by letter January 28, 1994. Firm-initiated
recall complete.
DISTRIBUTION Mississippi, Virginia, New Jersey, New York, Florida,
Pennsylvania, Alabama, Massachusetts, California.
QUANTITY (a) 545,511 tablets; (b) 244,900 tablets
(c) 168,951 tablets; (d) 283,400 tablets
(e) 169,935 tablets; (f) 310,400 tablets
(g) 114,964 tablets; (h) 358,486 tablets**
(i) 939,700 tablets**
**quantities quoted are representative of shipments to the
retail level only, a-g are wholesale and retail level sales.
REASON Manufacturing processes lacks validation.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Ornade Spansule Capsules (Phenylpropanolamine
Hydrochloride), in bottles of 500. Recall #D-217-4.
CODE Lot #1014N21 EXP 2/28/97.
MANUFACTURER Smith Kline Beecham, Philadelphia, Pennsylvania.
RECALLED BY Manufacturer, by telephone March 8, 1994, followed by letter
March 10, 1994. Firm-initiated recall complete.
DISTRIBUTION Florida, New York, Michigan, Missouri, Ohio, New Jersey.
QUANTITY 77 bottles were distributed.
REASON Incorrect expiration date.
_______________
PRODUCT Ru-Tuss Liquid Antihistaminic Decongestant, Phenylephrine
HCl 5mg, Chlorpheniramine Maleate 2 mg, packed in 1 pint
bottles, nonprescription cough and cold preparation.
Recall #D-219-4.
CODE Lot #07092 EXP 2/96.
MANUFACTURER Boots Pharamceuticals, Inc., Shreveport, Louisiana.
RECALLED BY Manufacturer, by letter March 17, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 8,128 bottles were distributed.
REASON Labeling does not bear complete warning statement required
by final OTC monograph.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Recovered Plasma. Recall #B-163-4.
CODE Unit numbers: CCH02009, CCH02068, CCH02127, CCH1775,
CCH1871, CCH1988.
MANUFACTURER National Medical Enterprises Hospital, Inc., doing business
as Century City Hospital, Los Angeles, California.
-4- RECALLED BY Manufacturer, by telephone November 16, 1993 and Fax
November 19, 1993. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 6 units.
REASON Recovered Plasma, collected from donors who: reported
histories of viral hepatitis; reported recent ear piercing,
acupuncture treatment or needlestick injury were
distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-169-4.
CODE Unit #3069322.
MANUFACTURER The Community Blood Center of Greater Kansas City, Kansas
City, Missouri.
RECALLED BY Manufacturer, by telephone March 19, 1993. Firm-initiated
recall complete.
DISTRIBUTION Missouri.
QUANTITY 1 unit.
REASON Blood product, which was exposed to unacceptable
temperatures, was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Red Blood Cells Leukocytes Removed.
Recall #B-175/176-4.
CODE Unit numbers: (a) 0237056, 0239106, 0245427; (b) 0241152.
MANUFACTURER Inland Northwest Blood Center, Spokane, Washington.
RECALLED BY Manufacturer, by letter August 10, 1993. Firm-initiated
recall complete.
DISTRIBUTION West Virginia, Washington state.
QUANTITY (a) 3 units; (b) 1 unit.
REASON Blood products which tested negative for the antibody to
human T lymphotropic virus type I (anti-HTLV-I), but were
collected from a donor who previously tested repeatedly
reactive for anti-HTLV-1, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma;
(d) Cryoprecipitated AHF; (e) Recovered Plasma.
Recall #B-178/182-4.
CODE Unit numbers: (a) 5861930, 7112525, 7325057, 7487502,
7684616, 7685171; (b) 5861930, 7685171; (c) 7112525; (d)
7325057, 7487502, 7684626; (e) 5861930, 7325057, 7487502,
7684616.
MANUFACTURER BloodCare (formerly J.K. and Susie L. Wadley Research
Institute and Blood Bank), Dallas, Texas.
RECALLED BY Manufacturer, by letters dated May 4, 1992 and June 23,
1992, and July 30, 1992. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania, New Jersey, Florida, Arizona.
QUANTITY (a) 6 units; (b) 2 units; (c) 1 unit; (d) 3 units; (e) 4
units.
-5- REASON Blood products collected from donors deferred due to:
history of ear piercing; history of exposure to hepatitis;
or living in a malarial area, were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Recovered Plasma. Recall #B-164-4.
CODE Unit numbers: CCH02050, CCH02061, CCH02064.
MANUFACTURER National Medical Enterprises Hospital, Inc., doing business
as Century City Hospital, Los Angeles, California.
RECALLED BY Manufacturer, by telephone November 16, 1993 and Fax
November 19, 1993. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 3 units.
REASON Recovered Plasma, collected from autologous donors who did
not meet the suitability criteria for allogenic use, in that
doners either: reported having a history of cancer; or
reported some form of unspecified liver disease were
distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-171-4.
CODE Unit #973024.
MANUFACTURER W.E. and Lela I. Stewart Regional Blood Center, Tyler,
Texas.
RECALLED BY Manufacturer, by telephone August 6, 1993. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product, positive for the Lea antigen, but labeled Lea
negative, was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-177-4.
CODE Unit #9822598.
MANUFACTURER BloodCare (formerly J.K. and Susie L. Wadley Research
Institute and Blood Bank), Dallas, Texas.
RECALLED BY Manufacturer, by telephone August 27, 1993. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product which tested reactive for a serologic test for
syphilis (STS) were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Dynascope Model HG-300 Pulse Oximeter Module, provides non-
invasive continuous measurement of oxygen saturation and
pulse rate. Recall #Z-304-4.
CODE All units. Serial numbers are non-continuous and range from
20100074 to 25100668.
-6- MANUFACTURER Fukuda Denshi, Ltd., Tokyo, Japan.
RECALLED BY Fukuda Denshi America Corporation, Redmond, Washington, by
telephone January 10, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 349 units.
REASON Electrostatic discharge from the environment can cause the
unit to malfunction, resulting in the superimposition of the
oxygen saturation waveform on the electrocardiogram waveform
and all other waveforms on the DS-3300 patient monitor.
_______________
PRODUCT Tuwave Pulsed Galvanic Stimulator and Transcutaneous Nerve
Stimulator, used to provide symptomatic relief of pain as
well as provide treatment to reduce edema. Recall #Z-411-4.
CODE Serial numbers 100-1085.
MANUFACTURER Staodyn, Inc., Longmont, Colorado.
RECALLED BY Manufacturer, by telephone beginning July 14, 1993, by voice
mail July 20, 1993, followed by letter. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 975 units.
REASON The keycaps of the control buttons may become wedged in the
"on" position.
_______________
PRODUCT Assorted IV Sets for use with Intelligent Pump intravenous
infusion pump:
(a) Catalog No. V7100, Intelligent Pump Add-On Set;
(b) Catalog No. V7105, 15 Drops/ml Intelligent Pump IV Set;
(c) Catalog No. V7105-15, 15 Drops/ml Intelligent Pump IV
Set;
(d) Catalog No. V7110, 15Drops/ml Intelligent Pump Primary
Additive IV Set;
(e) Catalog No. V7112, 15 Drops/ml with 1.2 Micron Filter
Intelligent Pump Primary Additive IV Set;
(f) Catalog No. V7115, 15 Drops/ml Intelligent Pump Primary
Additive IV Set with Low Pressure Timed Filter (0.22
Micron);
(g) Catalog No. V7120, 60 Drops/ml Intelligent Pump Measured
Volume Solution Administration Set;
(h) Catalog No. V7130, 15 Drops/ml Intelligent Pump Vented
Primary Additive IV Set;
(i) Catalog No. V7135-14, 15 Drops/ml Intelligent Pump
Vented Primary Additive IV Set with Low Pressure Timed
Filter (0.22 Micron);
(j) Catalog N. V7140, 60 Drops/ml Intelligent Pump Vented
Measured Volume Solution Administration Set;
(k) Catalog No. V7150, 60 Drops/ml Intelligent Pump Vented
Nitroglycerin IV Set;
(l) Catalog No. V7210, 15 Drops/ml Intelligent Pump Primary
Additive IV Set with Check Valve;
-7- (m) Catalog No. V7213, 60 Drops/ml Intelligent Pump Primary
Additive IV Set with Check Valve;
(n) Catalog No. V7215, 15 Drops/ml Intelligent Pump Primary
Additive IV Set with Check Value and Low Pressure Timed
Filter (0.22 Micron);
(o) Catalog No. V7220, 15 Drops/ml Intelligent Pump Measured
Volume Primary Additive Set with 150ml Buret;
(p) Catalog No. V7225, 15 Drops/ml Intelligent Pump Primary
Additive IV Set with Check Valve;
(q) Catalog No. V7225-10, 15 Drops/ml Intelligent Pump
Primary Additive IV Set with 2 Check Valves, 3 Injection
Sites and "Control" Clamp;
(r) Catalog No. V7225-20, 15 Drop[s/ml Intelligent Pump
Vented Primary Additive IV Set with Check Valve;
(s) Catalog No. V7230-14, 15 Drops/ml Intelligent Pump
Vented Primary Additive IV Set with Check Valve;
(t) Catalog No. V7235-14, 15 Drops/ml Intelligent Pump
Vented Primary Additive IV Set with Check Valve and Low
Pressure Timed Filter (0.22 Micron);
(u) Catalog No. V7300, Intelligent Pump Y-Type Blood Set
with Injection Site. Recall #Z-414/434-4.
CODE All lots.
MANUFACTURER MCGaw of Puerto Rico, Inc., Sabana Grande, Puerto Rico.
RECALLED BY McGaw, Inc., Irvine, California, by product advisory letter
dated October 14, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Caroline Islands, Canada.
QUANTITY (a) 63,155; (b) 22,782; (c) 83,638; (d) 896,414; (e) 73,362;
(f) 341,488; (g) 85,354; (h) 394,481; (i) 23,609;
(j) 105,341; (k) 74,025; (l) 2,237,352; (m) 34,357;
(n) 185,371; (o) 71,478; (p) 253,961; (q) 2,592;
(r) 101,483; (s) 473,211; (t) 23,033; (u) 106,283 units were
distributed.
REASON A dimensional change in the "cassette" portion of the tubing
set may cause the pump alarm to sound.
_______________
PRODUCT Olympus Series 200 Videobronchoscopes, provides a video
image of the trachea and bronchi:
(a) Model BF-200; (b) BF-P200; (c) Model BF-1T200.
Recall #Z-435/437-4.
CODE None.
MANUFACTURER Olympus Optical Company, Ltd., Tokyo, Japan.
RECALLED BY Olympus America, Inc., Lake Success, New York, by letter
January 19, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Connecticut, Florida, Canada.
QUANTITY 2 units.
REASON A variability in the manufacturing process could cause the
CCD chip to fail due to static electricity discharge. The
CCD chip is contained in the distal tip of the product and
is utilized to generate an electronic video signal of the
anatomical image. This failure would cause loss of the
image generated by the chip the heating of the distal end.
-8- _______________
PRODUCT Hudson Flow-Thru Small Volume Nebulizers, Catalog #1760,
indicated exclusively for the delivery of medical gases to
infant and neonatal patients. Recall #Z-438-4.
CODE All lots.
MANUFACTURER Hudson Respiratory Care, Inc., Temecula, California.
RECALLED BY Manufacturer, by letter February 11, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 125,723 units.
REASON A dislodged baffle may occlude the air flow to the patient
or result in over-pressurization of the patient.
_______________
PRODUCT Kendall Curity Disposable Laparotomy Sponges, Sterile,
Prewashed, Tray and Soft Pouches:
(a) 18" x 18" lap Sponges, Reorder numbers 6022 and 6522;
(b) 12" x 12" Lap Sponges, Reorder numbers 6034 and 6534;
(c) 18" x 4" Lap Sponges, Reorder numbers 6045 and 6545;
(d) 36" x 8" Lap Sponges, Reorder numbers 6056 and 6556.
Recall #Z-456/459-4.
CODE All lots.
MANUFACTURER Kendall Healthcare Products Company, Augusta, Georgia.
RECALLED BY Kendall Healthcare Products Company, Mansfield,
Massachusetts, by letter January 13, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 238,870 (Cases or units) were distributed.
REASON Some sponges were found to be non-sterile.
_______________
PRODUCT All Instruction Manuals and Dermal Procedure Videotapes for
the Model 1316-10 New Beginnings Dermal Transfer cannula
Set. Recall #Z-462/463-4.
CODE All revision (0, 1 and 2) of the Instruction Manual and all
copies of the Dermal Procedure videotape.
MANUFACTURER PMT Corporation, Chanhassen, Minnesota.
RECALLED BY Manufacturer, by telephone January 7, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 162 units of the device were distributed with instruction
manuals.
REASON Manuals and videotapes describe a new intended use
(tissue/dermal grafts) for which the firm does not have an
approved PMA.
_______________
PRODUCT Venous Bloodlines, intended to be used for hemodialysis
during dialysis treatment, under NMC label:
(a) Catalog #03-7300-1; (b) Catalog #03-9301-7;
(c) Catalog #03-9303-3; (d) Catalog #03-9305-8;
(e) Catalog #03-9307-4; (f) Catalog #03-9308-2;
(g) Catalog #03-9310-8;
-9- Packaged in Diala-kits:
(h) Catalog #46-3907; (i) Catalog #46-4402;
(j) Catalog #46-4840; (k) Catalog #46-6000;
(l) Catalog #46-6140; (m) Catalog # 93-4061;
under Baxter Label: (n) Catalog #5M 4462;
(o) Catalog #5M 4484; (p) Catalog #5M 4452.
Recall #Z-466/481-4.
CODE Lot numbers: (a) R2S017, R2S019, R2S020, R2S021, R2S026,
R2S028, R2S035, R2S038, R2S044, R2S050, R2S055, R2S056,
R2S057, R2S060, R2S107, R2S114, R2S115, R2S123, R2S132,
R2S133, R2S134, R2S139, R3A001, R3A007, R3A008; (b) RS2S029,
RS2S033, RS2S034, RS2S042, R2S065, RS2S105, RS2S122,
RS2S136, RS3A003; (c) RS2S002, RS2S003, RS2S005, RS2S010,
RS2S014, RS2S046, RS2S062; (d) RS2S047; (e) RS2S104,
RS2S117, RS2S124; (f) RS2S007; (g) RS2S008, RS2S039,
RS2S040, RS2S111; (h) M3B154, M3B160, M3B755, M3C755; (i)
MEA786, M3A781; (j) M3A760; M3A777, M3A771, M3A782, M3A791,
M3A723, M3A758, M3A743, M3A794; (k) M3C159, M3C149; (l)
M3B192, M3B714, M3B721, M3B741, M3B715; (m) M3C155, M3C168,
M3C172, M3C188; (n) R2S607, R2S611, R2S623, R2S625; (o)
R2S613, R2S621; (p) R3A603.
MANUFACTURER National Medical Care, Medical Products Division, McAllen,
Texas.
RECALLED BY National Medical Care, Rockleigh, New Jersey (responsible
firm), by letter May 20, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 361,860 bloodlines plus 17,420 Diala-kits were distributed.
REASON The devices which are labeled as pyrogen free were tested,
and pyrogens in excess of USP pyrogen limit were found.
_______________
PRODUCT Coulter S-Plus IV with Differential and related model
numbers:
(a) S-Plus with Differential, Part #6702398;
(b) S-Plus V; Part #6702398;
(c) S-Plus VI, Part No. 6702950;
(d) ST, Part No. 6704259;
(e) STKR, Part No. 6702881;
(f) STKS, Part Nos. 6704657, 6604388. Recall #Z-491/496-4.
CODE Catalog Numbers: (a) 6602261, 6602262, 6602263, 6602264,
6602650, 6602651, 6602652, 6602653, 6602901, 6602092,
6603099, 6603308, 6603309, 6603310, 6603311,
(b) 6602304, 6602305, 6602306, 6602307, 6602654, 6602655,
6602656, 6602657, 6603312, 6603313, 6603314, 6603315,
(c) 6602856, 6602857, 6603150, 6603151, 6603316, 6603317,
6603318, 6603319;
(d) 6603560, 6603561, 6603562, 6603563, 6603565, 6603566,
(e) 6602889, 6602890, 6602891, 6602892, 6602894, 6602895,
6602896, 6603410, 6603411;
(f) 6604024, 6640425, 6604026.
MANUFACTURER Coulter Limited, England (cuvettes).
-10- RECALLED BY Coulter Corporation, Miami, Florida, by letter May 27, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 3,289 units.
REASON An unknown buildup on Hgb cuvettes resulted in unexplained,
false, low Hgb test results.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Optichem Bilirubin Reagent System (1+3) + (2), intended for
the in-vitro quantitative determination of direct and total
bilirubin in serum with the Coulter Optichem Chemistry
Systems (a) Part #2906863; (b) Part #2906864.
Recall #Z-289/290-4.
CODE All lots, the most recent of which expires on 6/19/94.
MANUFACTURER Coulter Corporation, Diagnostics Group, Hialeah, Florida.
RECALLED BY Coulter Corporation, Miami, Florida, by letter June 11,
1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Guam, Canada.
QUANTITY Firm estimates none remains on the market.
REASON The labeled concentrations of the reagent components are
incorrect.
_______________
PRODUCT Dacos Creatinine Reagents A and B, for in-vitro diagnostic
use. Recall #Z-341-4.
CODE Kit lot number 15911, Part #2907083 EXP 12/94.
MANUFACTURER Trace Scientific Pty. Ltd., Clayton Victoria, Australia.
RECALLED BY Coulter Corporation, Miami, Florida, by letter dated July 9,
1993. Firm-initaited recall complete.
DISTRIBUTION California, Illinois, Indiana, Michigan, New York, Ohio,
Pennsylvania, Texas.
QUANTITY Firm estimates none remains on the market.
REASON The reagent labeled "A" should be labeled "B" and vice
versa.
_______________
PRODUCT Epics software:
(a) Epics XL, Epics XL-MCL Software Level 1.0, Part numbers:
6705457, 6705460, 6705461, 6705463, 6705785, 6705786,
6705787, 6705788, 6705789, 6705790, 6705791, 6705792,
6705793, 6705794, 6705795, 6705796;
(b) Epics Elite with Auto-Clone, Software level 3.25.
Recall #Z-365/366-4.
CODE Catalog numbers: (a) 6604713, 6604714, 6604721, 6604722,
6604723, 6604724, 6604725, 6604726, 6604983, 6604984,
6604985, 6604986, 6604987, 6604988, 6604989, 6604990,
6604991, 6604992, 6604993, 6604994, 6604995, 6604997,
6604998, 6604999; (b) 6912869.
MANUFACTURER Coulter Corporation, EPICS group, Miami Lakes, Florida.
-11- RECALLED BY Coulter Corporation, Miami, Florida, by letter June 9, 1993.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
REASON A software error was identified which can cause histogram
data to be misidentified under certain conditions.
_______________
PRODUCT Coulter 5C Cell Control, for in-vitro diagnostic use:
(a) Normal; (b) Abnormal I; (c) Abnormal II.
Recall #Z-367/369-4.
CODE All lots were recalled from use on JT and T-Series Coulter
instruments; not from use on more sophisticated Coulter
instruments, e.g. STK S; MAX M. The remaining codes would
have expired by May 1992.
MANUFACTURER Coulter Corporation, Diagnostics Group, Hialeah, Florida.
RECALLED BY Coulter Corporation, Miami, Florida, by letter April 16,
1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Canada, Brazil, Puerto Rico, Germany.
QUANTITY Firm estimates none remains on the market.
REASON An unidentified product defect has resulted in erroneous
out-of-specification values for the white blood cell
parameter.
_______________
PRODUCT Coulter 4C Plus Cell Control, Abnormal Low. These kits
include a diskette which provides for automatic recording of
quality control data. Recall #Z-370-4.
CODE Kit lot #106738K, Part #7547003, lot numbers: 064600
(abnormal low); 079500 (Normal); 084600 (Abnormal high).
MANUFACTURER Coulter Corporation, Diagnostics Group, Hialeah, Florida.
RECALLED BY Coulter Corporation, Miami, Florida, by letter July 20,
1993. Firm-initiated field correction complete.
DISTRIBUTION Nationwide, Canada, United Kingdom, Germany.
QUANTITY Firm estimates none remains on the market.
REASON An unformatted data diskette was included instead of a
diskette bearing control assay values.
_______________
PRODUCT OptiChem Bilirubin 2 Reagent, for in-vitro diagnostic use,
used in the determination of the level of total bilirubin on
patient serum and control samples. Recall #Z-371-4.
CODE Part #2906864, lot #7889F, EXP 3/21/94.
MANUFACTURER Coulter Corporation, Diagnostics Group, Hialeah, Florida.
RECALLED BY Coulter Corporation, Miami, Florida, by letter May 27, 1992.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates none remains on the market.
REASON Reported test values have demonstrated an unexplained,
incorrect, lowering of values.
-12- _______________
PRODUCT 4C Normal Cell Control, for in-vitro diagnostic use:
(a) 4C Tripack Cell Control 9x2 mL, Part No. 7546885;
(b) 4C Dual Pack Cell Control 8x2, Part No. 7546451;
Recall #Z-396/397-4.
CODE Lot numbers: (a) 34199K, 34200K, 34200K1, 34201K;
(b) 29206K.
MANUFACTURER Coulter Corporation, Diagnostics Group, Hialeah, Florida.
RECALLED BY Coulter Corporation, Miami, Florida, by letter November 19,
1991. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 1,895 kits were distributed.
REASON High WBC recovery and the inability to retrieve the labeled
assay values could result in changes in the values of the
assays.
_______________
PRODUCT Candela Dermatology Laser Systems:
(a) Candela Pigmented Lesion Laser System (PLDL), a
flashlamp excited dye laser used to treat benign superficial
pigmented lesions of the skin, Part #9914-00-0100;
(b) Candela Pigmented Lesion/Tatu Laser System (PLTL),
incorporates two separate lasers: the Pigmented lesion
laser, a flashlamp-exciated pulsed dye laser used to treat
benign superficial pigmented lesions of the skin and the
Tatulazr, a flashlamp-excited,Q-switched alexandrite laser
designed for the treatment of blue-black tattoos, Part
numbers: 9914-00-1000, 9914-00-0150, and 8901-00-5640).
Recall #Z-412/413-4.
CODE Serial numbers: (a) 0090, 0091, 0093, 0094, 0096, 0103,
0107, 0108, 0111; (b) 4099, 4110, 4114, 4122, 4130, 4131,
4140, 4146, 4150, 4151.
MANUFACTURER Candela Laser Corporation, Wayland, Massachusetts.
RECALLED BY Manufacturer, by notification package, dated November 16,
1993. Firm-initiated field correction ongoing.
DISTRIBUTION Arizona, Colorado, California, New York, Tennessee,
Wisconsin, Virginia, North Carolina, Texas, Ohio, West
Virginia, Japan, United Kingdom, Thailand, Korea.
QUANTITY 18 units.
REASON The design allowed for possible internal fires.
_______________
PRODUCT Herbert/Whipple Step Drill, used to drill small bones in the
hand or foot for fracture fixation procedures involving
fingers and toes. Recall #Z-452-4
CODE Lot numbers: 41463100, 42370400, 43317300.
MANUFACTURER North East Surgical Tool Company, Hanover, Massachusetts.
RECALLED BY Zimmer, Inc., Warsaw, Indiana, by letter November 2, 1992.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 159 drill bits.
-13- REASON The drill bits may break, split, fray, crack or twist.
_______________
PRODUCT Optima Toric - MTO Contact Lenses. Recall #Z-453-4.
CODE Lot numbers: SC219443, SC219473.
MANUFACTURER Bausch & Lomb Inc., Sarasota, Florida.
RECALLED BY Bausch & Lomb, Inc., Rochester, New York, by telephone
December 28, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 9 lenses.
REASON Each lot was packaged in the labeling of the other, thus the
lot number and the power is incorrect for the lens in the
package. Lot number SC219443 was to have an assigned power
of -0.75 diopter and lot number SC219473 was to have an
assigned power of +5.0 diopter.
_______________
PRODUCT Salmonella "O" Validation Antigen Group VI, in 5 ml vials.
Recall #Z-464-4.
CODE Lot numbers 1848-01 and 1848-02 EXP 12/95.
MANUFACTURER Roach Laboratories, Inc., Loganville, Georgia.
RECALLED BY Manufacturer, by letter November 16, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 25 vials were distributed.
REASON The antigen is not reactive in a manner described in the
product circular. The antigen does not react appropriately
with the polyvalent type of antiserum.
SEIZURES:
=================================================================
_______________
PRODUCT Sauerkraut in Glass Jars (93-718-826).
CHARGES Misbranded - The article's labeling is false and misleading
because it represents and suggests that the article is fresh
when, in fact, it is not fresh and contains chemical
preservatives; and, the article is fabricated from two or
more ingredients, and its label fails to bear the common or
usual name of each such ingredient.
LOCATION Flanagan Brothers, Inc., Bear Creek, Wisconsin.
FILED March 8, 1994; U.S. District Court for the Eastern District
of Wisconsin; Civil #94-C-0260; FDC #66917.
SEIZED March 16, 1994 - goods valued at approximately $5,200.
_______________
PRODUCT Dry Dog Food (94-740-807).
CHARGE Adulterated - The article consists in part of a filthy
substance because it contains rodent hairs, rodent excreta
pellets, and rodent gnawed paper; and it has been held under
insanitary conditions whereby it may have become
contaminated with filth.
-14- LOCATIONS Freight-A-Ranger, Inc., Forest View, Illinois, and Norfolk
and Southern Corporation, Chicago, Illinois.
FILED March 17, 1994; U.S. District Court for the Northern
District of Illinois, Eastern Division; Civil #94C 1650;
FDC #66945.
SEIZED March 17, 1994 - goods valued at approximately $61,647.
_______________
PRODUCT One-Step Endodontic Formula (93-638-093).
CHARGE New drug - No approval of an application is in effect for
such drug.
LOCATION Dental Clearing House, Simsbury, Connecticut.
FILED February 25, 1994; U.S. District Court for the District
of Connecticut; Civil #3:94CV287(AVC); FDC #66796.
SEIZED March 21, 1994 - goods valued at approximately
$3,500.
-15-
END OF ENFORCEMENT REPORT FOR MARCH 30, 1994. BLANK PAGES MAY
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