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
08/10/1994
Recalls and Field Corrections: Foods -- Class I -- 08/10/1994
August 10, 1994 94-32
RECALLS AND FIELD CORRECTIONS: CLASS I
===================================
_______________
PRODUCT Queso Prensado Semi-Soft Cheese, 1 pound and 5 pound pieces,
and 40 pound blocks. Recall #F-750-4.
CODE 40201 stamped on individually wrapped pieces of cheese. The
cases shipped by recalling firm labeled 01-20-94 Vat 01.
MANUFACTURER Specialty Cheese Company, Inc., Lebanon, Wisconsin.
RECALLED BY Specialty Cheese Company, Inc., Lowell, Wisconsin, by
letter April 15, 1994. Firm-initiated recall complete.
DISTRIBUTION Florida, New Jersey, Wisconsin.
QUANTITY 1,428.85 pounds were distributed; firm estimated 240 pounds
remained on the market at time of recall.
REASON Product is contaminated with Listeria monocytogenes.
_______________
PRODUCT Las 3 Carabelas Queso Blanco Semi-Soft Cheese, random weight
packages of about 5 pounds each. Recall #F-751-4.
CODE 41263 on the 5 pound packages and 05-06-94 VAT 03 on the
product cases.
MANUFACTURER Specialty Cheese Company, Inc., Reeseville, Wisconsin.
RECALLED BY Specialty Cheese Company, Inc, Lowell, Wisconsin, by letter
and telephone May 24, 1994. Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 1,220 pounds were distributed.
REASON Product is contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Sweet Dairy Whey, dried whey, in 50 pound bags.
Recall #F-753-4.
CODE Lot numbers: 4148, 4149, 4151, 4152, 4154, 4172, 4179.
MANUFACTURER Stella Foods, Inc., Almena, Wisconsin.
RECALLED BY Manufacturer, by telephone June 30, 1994. Firm-initiated
recall complete.
DISTRIBUTION Minnesota.
QUANTITY 68,063 pounds were distributed.
REASON Two product lots are contaminated with Salmonella uganda and
the other lots were manufactured under conditions whereby
they may have become contaminated by Salmonella uganda.
_______________
PRODUCT Lemon Flavored Vitamin C Tablets, 100 mg ascorbic acid per
tablet, in bottles of 300, 1,000 and 5,000.
Recall #F-761-4.
CODE All lots.
MANUFACTURER Garden State Nutritionals, Fairfield, New Jersey.
RECALLED BY Mueller Sports Medicine, Inc., Prairie du Sac, Wisconsin, by
telephone July 7 and 8, 1994. Firm-initiated field
correction (relabeling) ongoing.
DISTRIBUTION Nationwide, The Netherlands, Ireland, Germany.
QUANTITY 437 300-tablet bottles, 271 1000-tablet bottles, and 28
5000-tablet bottles were distributed.
REASON Product contains undeclared FD&C Yellow #5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Maple Nut Ice Cream, in 3 gallon containers.
Recall #F-758-4.
CODE 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, followed
by letter May 25, 1994. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY Firm estimates very little, if any, product remains on the
market.
REASON Product contains undeclared walnuts.
RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II
=====================
______________
PRODUCT Johnson's No More Tangles, in 12 fluid ounce and 7 fluid
ounce plastic spray-on bottles, used as a spray-on detangler
after shampoo. Recall #F-749-4.
CODE Lot numbers: 0744L, 0754L, 0746L (12 ounce bottles); 0784L,
0794L, 0804L, 0814L (7 ounce bottles).
MANUFACTURER Johnson & Johnson Consumer Products, Inc., Los Piedros,
Puerto Rico.
-2- RECALLED BY Johnson & Johnson Consumer Products, Inc., Skillman, New
Jersey, by telephone April 8-11, 1994, and by letter April
18, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 56,000 bottles of lots 0744 and 0754 were distributed.
REASON Product was contaminated with Pseudomonas cepacia bacteria.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Amoxicillin Oral Suspension, Rx synthetic antibiotic: (a)
125 mg/5 ml, 80 ml package size; 125 mg/5 ml, 100 ml package
size; 125 mg/5 ml, 150 ml package size; (b) 250 mg/5 ml, 100
ml package size, under the following labels: Biocraft,
Rugby, Moore, Schein, Harber, IDE Star brand, United
Research. Recall #D-339/340-4.
CODE Lot numbers: 31367, 31364, 31368, 31369, 31371, 31373. All
lots bear 2/1/97 EXP date.
MANUFACTURER Biocraft Laboratories, Inc., Elmwood Park, New Jersey.
RECALLED BY Biocraft Laboratories, Fair Lawn, New Jersey, by telephone
February 23-24, 1994, and by letter March 2-3, 1994 for lot
31367; by telephone and or fax April 26 1994 through April
29, 1994, and by letter May 6, 1994, for remaining lots.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 18,060 bottles of lot 31367, 9,765 bottles of lot 31364,
14,803 bottles of lot 31368, 15,372 bottles of lot 31369,
9,732 bottles of lot 31371, 10,123 bottles of lot 31373 were
distributed.
REASON Products do not meet assay specifications after
reconstitution.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Chemdec Syrup, Carbinozamine Maleate, 4 mg, Pseudoephedrine
Hydrochloride, 60 mg, in 4 ounce bottles, packaged under the
H.N. Norton Co label. Recall #D-338-4.
CODE Lot #6738.
MANUFACTURER H.N. Norton Company, Shreveport, Louisiana.
RECALLED BY Manufacturer, by telephone. Firm-initiated recall complete.
DISTRIBUTION Florida, Texas, Virginia.
QUANTITY 348 bottles were distributed.
REASON Label incorrectly stated "Antihistamine/Antitussive" instead
of "Antihistamine/Decongestant."
_______________
PRODUCT A/T/S Erythromycin 2% Topical Solution - 2% Acne Topical
Solution, Rx antibiotic, dermatologic solution.
Recall #D-341-4.
CODE Lot #0160023 EXP 8/95.
MANUFACTURER Paco Pharmaceuticals, Lakewood, New Jersey.
-3- RECALLED BY Hoechst-Roussel, Somerville, New Jersey (distributor), by
letter march 23, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 85,492 bottles were distributed.
REASON Superpotency.
_______________
PRODUCT Vitamin A Palmitate 15 mg (50,000 USP units), in bottles of
100 and 1000 soft-gel capsules, Rx, under the Schein, URL,
and Rugby labels. Recall #D-342-4.
CODE 55598, 56228, 56989, 59361, 58295, 59970, with expiration
dates ranging from 12/94 to 3/96.
MANUFACTURER Banner Pharmacaps, Inc., Elizabeth, New Jersey.
RECALLED BY Manufacturer, by telephone May 18 and 19, 1994, followed by
letter May 19, 1994, and on or about June 22, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Alabama, Michigan, New Jersey, New York, Ohio, Pennsylvania,
Hong Kong.
QUANTITY 793,200 of lot 55598, 924,200 of lot 56228, 917,000 of lot
56989, 922,300 of lot 58295, 863,700 of lot 59361, 892,200
of lot 59970 (bottles or capsules) were distributed.
REASON Subpotency.
_______________
UPDATE Eucerin Dry Skin Care Moisturizing Lotion, Recall #D-337-4,
which appeared in the August 3, 1994, Enforcement Report
should read:
RECALLED BY: Biersdorf, Inc., Norwalk, Connecticut.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Platelets for Further Manufacture; (b) Recovered Plasma.
Recall #B-355/356-4.
CODE Unit numbers: F70170, F73059.
MANUFACTURER Holmes Regional Medical Center, Melbourne, Florida.
RECALLED BY Manufacturer, by telephone and by letters of January 24,
1994 and February 9, 1994. Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 2 units of each component.
REASON Blood products, that tested negative for the antibody to the
human immunodeficiency virus type 2 (anti-HIV-2), but were
collected from donors who previously tested repeatedly
reactive for anti-HIV-2, were distributed.
_______________
PRODUCT Platelets. Recall #B-388-4.
CODE Unit #32LH54252.
MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin.
RECALLED BY Manufacturer, by letter November 30, 1993. Firm-initiated
recall complete.
DISTRIBUTION Wisconsin.
-4- QUANTITY 1 unit.
REASON Blood product corresponding to the same unit of Red Blood
Cells implicated in a case of post transfusion Yersinia
enterocolitica infection was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-390-4.
CODE Unit #2260236.
MANUFACTURER Kenner Army Hospital Blood Bank, Fort Lee, Virginia.
RECALLED BY Manufacturer, by letter June 3, 1994. Firm-initiated recall
complete.
DISTRIBUTION New Jersey.
QUANTITY 1 unit.
REASON Blood product collected from an ineligible donor due to ear
piercing less than 12 months prior to donation was
distributed.
_______________
PRODUCT Platelets. Recall #B-392-4.
CODE Unit numbers: 0356136, 0356142, 0356147, 0356153, 0356155,
0356161.
MANUFACTURER Bergen Community Regional Blood Center, Paramus, New Jersey.
RECALLED BY Manufacturer, by telephone September 13, 1993. Firm-
initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 6 units.
REASON Blood products labeled with incorrect expiration dates were
distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-393-4.
CODE Unit numbers: 92-2470 and 92-2473.
MANUFACTURER Perth Amboy General Hospital, Perth Amboy, New Jersey.
RECALLED BY Manufacturer, by telephone November 10, 1993, followed by
letter December 7, 1993. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 2 units.
REASON Blood product untested for viral markers was distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Recovered Plasma. Recall #B-373-4.
CODE Unit #17GH60565.
MANUFACTURER The American National Red Cross, St. Paul, Minnesota.
RECALLED BY Manufacturer, by letter September 16, 1993. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product, corresponding to a unit of Red Blood Cells
which was implicated in a case of post transfusion
Pseudomonas fluorescens infection, was distributed.
-5- _______________
PRODUCT Recovered Plasma. Recall #B-389-4.
CODE 32LH54252.
MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin.
RECALLED BY Manufacturer, by fax November 19, 1993. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Recovered Plasma, corresponding to a unit of Red Blood Cells
implicated in a case of post transfusion Yersinia
enterocolitica infection, was distributed for further
manufacture into injectable products.
_______________
PRODUCT Source Plasma. Recall #B-391-4.
CODE Unit 23356INJ.
MANUFACTURER Blood and Plasma Research, Inc., Beaumont, Texas.
RECALLED BY Manufacturer, by telephone December 15, 1993. Firm-
initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 1 unit.
REASON Blood product untested for viral markers was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-395/397-4.
CODE Unit #03FL23161.
MANUFACTURER American National Red Cross, Atlanta, Georgia.
RECALLED BY Manufacturer, by telephone July 20, 1993. Firm-initiated
recall complete.
DISTRIBUTION Georgia, California, Pennsylvania.
QUANTITY 1 unit of each component.
REASON Blood products, which were collected from a donor who had
received the Mumps, Measles, and Rubella (MMR) vaccine
within 4 weeks of the donation, were distributed.
_______________
PRODUCT Red Blood cells. Recall #B-398-4.
CODE Unit #12085-9849.
MANUFACTURER United Blood Services, Blood Systems, Inc., Albuquerque, New
Mexico.
RECALLED BY United Blood Services (UBS), Blood Systems, Inc., El Paso,
Texas, by telephone June 8, 1993. Firm-initiated recall
complete.
DISTRIBUTION Texas, New Mexico.
QUANTITY 1 unit.
REASON Blood product which was labeled with an incorrect expiration
date was distributed.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-415-4.
CODE Unit numbers: 40P28121, 40P28158, 40P28231, 40P28477,
40P28526, 40P28537, 40P28559, 40P28615.
-6- MANUFACTURER The American National Red Cross, Peoria, Illinois.
RECALLED BY Manufacturer, by telephone March 2, 1994, and by letter
dated march 14, 1994. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 8 units.
REASON Blood products lacking required statements on the container
label were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT 3300 Patient Controlled Analgesia Pump. Recall #Z-1048-4.
CODE All serial numbers below 9768.
MANUFACTURER Graseby medical Ltd., Watford, England.
RECALLED BY Marcal Medical, Inc., Millersville, Maryland, September 7,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Georgia.
QUANTITY 20 devices.
REASON An electrical disturbance causes the pump to resume
administering the dosing regime after a failure and alarm;
and a software defect causes the pump to restart the dosing
regime from the beginning which may cause a risk of
overinfusion.
_______________
PRODUCT GE PDS 3000 Adult Respiration Modules 46-206587G1, 46-
207437G1, 46-213120G1, 46-213120G2. Recall #Z-1087-4.
CODE All serial numbers.
MANUFACTURER General Electric Medical Systems, Milwaukee, Wisconsin.
RECALLED BY Manufacturer, by letter June 15, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 527 units were distributed prior to 4/1/82.
REASON Product labeling fails to provide adequate directions for
use and the devices pose an unwarranted risk of injury to
patients, because the product is not labeled to warn against
the hazards of unprotected electrode lead wires being
connected to electrical power sources.
_______________
PRODUCT Model AI5200(S) Diagnostic Ultrasound Imaging System with
color monitor and doppler option, indicated specifically for
the examination of the urinary system and the male
reproductive structures to detect abnormalities.
Recall #Z-1107-4.
CODE All units with software version 2.3.
MANUFACTURER Acoustic Imaging Technologies Corporation, Phoenix, Arizona.
RECALLED BY Manufacturer, by letters mailed beginning October 22, 1993.
Firm-initiated field correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY 219 units were distributed.
-7- REASON An incorrect measurement of blood flow will result in an
incorrect diagnosis thereby delaying treatment or
prescribing unnecessary therapy due to improper software
validation.
_______________
PRODUCT Diagnostic Ultrasound Imaging Systems, indicated
specifically for the examination of the urinary system and
the male reproductive structures to detect abnormalities:
(a) Model 5200(A) without Doppler Option; (b) Model 5200(B)
with Doppler Option. Recall #Z-1108/1109-4.
CODE (a) All units with software version 4.21; (b) All units with
software version 5.53.
MANUFACTURER Acoustic Imaging Technologies Corporation, Phoenix, Arizona.
RECALLED BY Manufacturer, by letter November 8, 1993. Firm-initiated
field correction complete.
DISTRIBUTION Nationwide, Australia, Brazil, Canada, Germany, Hong Kong,
Korea, Italy.
QUANTITY 611 units were distributed.
REASON The patient will receive twice the established ISPTA level
and will result in local tissue heating due to improper
software validation.
_______________
PRODUCT 5 cc Syringes included in: (a) Spinal Anesthesia Trays;
(b) Saddle Block Anesthesia Trays. Recall #Z-1149/1150-4.
CODE (a) Lot Numbers K99999 through and including K3P414; Product
Codes P4500C, P4501C, P4503C, P4504C, P4505C, P4509C,
P4510C, P4511C, P4513C, P4514C, P4519C, P5504D, P5514D,
P5515D, P5524A, P6504D, P6514D, and P6524A.
(b) Lot numbers K99999 through and including K3P414; Product
Codes P4517C, P4518C, P5516D, P5517D, P5518D, and P5528A.
MANUFACTURER Baxter Healthcare Corporation, Cleveland, Mississippi.
RECALLED BY Pharmaseal, Division of Baxter Healthcare Corporation,
Valencia, California, by letter June 21, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY Approximately 418,230 units were distributed.
REASON Syringes have inaccurately graduated markings.
_______________
PRODUCT Endopath Probe Plus II Hand Control Pistol Handle and
Endopath Plus II Hand Control Pencil Handle, single patient
use disposable product used in electrosurgery: (a) Model
EPH02; (b) Model EPH04. Recall #Z-1158/1159-4.
CODE Lot numbers: (a) EM5312, EP5024, GB4779, GB4967, GB4999,
GB5157, GB5523, GC4964, GC5174, GC5215, GC5230, GC5461,
GD4233; (b) GA5304, GB5194, GB5299, GC5098, GC5228, GD4235,
GD4301.
MANUFACTURER Torrington Company, Waterbury, Connecticut (contract
manufacturer).
-8- RECALLED BY Ethicon Endosurgery, Cincinnati, Ohio, by letter April 26,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 12,881 units were distributed since 11/1/93.
REASON The electrosurgery pencils can be inadvertently activated to
cut and coagulate body tissues during surgery.
_______________
PRODUCT Bard Lab System Plus EP Laboratory (Software) Upgrade,
Version 2.55, designed to be used in conjunction with a
computer and amplifier to accept, process, and record
signals from surface ECG leads, intracardiac electrode
catheters, and blood pressure transducers.
Recall #Z-1160-4.
CODE All units bear the item number 200749 on the outer bag
label. Lot numbers: 27KD0442, 27KD0035.
MANUFACTURER Bard Electrophysiology Division, C.R. Bard, Inc., Haverhill,
Massachusetts.
RECALLED BY Manufacturer, by letter January 13, 1994. Firm-initiated
field correction ongoing.
DISTRIBUTION Arkansas, Connecticut, Indiana, Massachusetts, New York,
Kansas, California, Washington, D.C. and international.
QUANTITY 45 copies of Version 2.55 software.
REASON Software program crashes when user requests a routine, by
hot key F12, to diagnose sudden arrhythmias with loss of
stored patient data.
_______________
PRODUCT Special order suture products (D Specials) consisting of
sutures and needles: Catalog numbers: (a) D8376;
(b) D-7362; (c) D-8241; (d) D-8228; (e) D-8056; (f) D-8431;
(g) D-8356; (h) D-8356; (i) D-6809; (j) DC427; (k) D-2991;
(l) D-5329; (m) D-4037; (n) D-8216; (o) D-2631; (p) D-8468;
(q) D-8354; (r) D-7222; (s) D-7074; (t) D-6962.
Recal #Z-1162/1181-4.
CODE (a-h) Prolene (Polypropylene Sutures) Nonabsorbable:
D-8234/Lot #EM6160; D-7362/Lot #EB6134;
D-8241/Lot #EP6134; D-8228/Lot #EM6147;
D-8356/Lot #EH6247; D-8376/Lot #EH6202;
D-8056/Lot #EK6185; D-8431/Lot #EH6818;
(i-n) Surgical Steel Sutures Nonabsorbable:
D-6809/Lot #EM6106; DC427/Lot #EM6100;
D-2991/Lot #EL6151; D-5329/Lot #EL3041;
D-4037/Lot #EK6151; D-8216/Lot #EM6142;
(o) Cotton Radiopaque Umbilical Tape:
D-2631/Lot#EM6239;
(p-q) Ethibond Extra (Polyester Suture Nonabsorbable:
D-8468/Lot #EM6109, D-8353/Lot #'s EM6805, EM6063;
(r) Chromic Gut Sutures Absorbable: D-7222/Lot #EM6084;
(s) Silk Sutures Nonabsorbable: D-7074/Lot #EH6243;
(t) PDS (Polydioxanone Sutures), Absorbable:
D-6962/Lot #;s EM6322, EK6284.
-9- MANUFACTURER Ethicon, Inc., a Johnson & Johnson Company, Somerville, New
Jersey.
RECALLED BY Manufacturer, by letter February 11, 1994. Firm-initiated
recall complete.
DISTRIBUTION Tennessee, Iowa, Michigan, Hawaii, Alabama, Arizona,
Florida, Illinois, Georgia, Pennsylvania, Maryland,
Virginia, California, Delaware, North Carolina, South
Carolina, Canada, Japan, Italy.
QUANTITY 2,688 tyvek packages were shipped.
REASON One of four sides of the packets was unsealed, which may
compromise the sterility.
_______________
PRODUCT Combitube Esophageal Tracheal Double Lumen Airway, intended
for emergency intubation to provide ventilation whether
placed into the esophagus or the trachea. Recall #Z-1182-4.
CODE Catalog # Lot # EXP Date
5-18541 018613 1999-03
5-18541 018615 1999-03.
MANUFACTURER Sheridan Catheter Corporation, Argyle, New York.
RECALLED BY Manufacturer, by telephone March 28, 1994, faxed March 30,
1994. Firm-initiated recall complete.
DISTRIBUTION Illinois, Massachusetts, Ohio, Tennessee, Utah, Canada,
Europe.
QUANTITY 548 units of lot 018613 and 325 units of lot 018615 were
distributed.
REASON The connector was produced with a frosted finish instead of
a gloss finish resulting in the connector not fitting snugly
in the device.
_______________
PRODUCT Pediatric Disposable Anesthesia Breathing Circuit.
Recall #Z-1183-4.
CODE Catalog Numbers Lot Numbers
2000PF 2E421, 2M211, 2N099
2002PF 2E422, 2M210
370807 2D151, 2F310, 2J500, 2K193, 2M380
370815 2E267, 2F270, 2G391
3708101 2D229
3708111 2C153, 2D371, 2G406, 2M455
3708122 2E363, 2J417
3708125 2G390
3708149D 2C265, 2E392, 2F321, 2H580, 2J586A
372006 2K436
372007 2D244, 2E396, 2F040, 2J425
372046 2M214
372083 2K491
3720101 2D352
3720109 2E130
3720169D 2D193
3720191 2F343, 2N036
3720201 2M472
-10- 3720220D 2J562
372900 2F145, 2H596, 2J520, 2K542, 2M174
372904 2E399, 2N432
372963 2F263
3729235 2N320
3738130 2K381A
375200 2J280
375202 2H576
375225D 2H575, 2M212
3752164 2D374, 2J579
3752205 2J278
422045 2F298, 2G448
432906 2E405
442006 2M426
225-3708-800 2C425, 2D414, 2E182, 2E289,
2E379, 2H595, 2J630, 2M175, 2M377
225-3708-802 2E180, 2E377, 2G323, 2H597, 2K509
225-3708-804 2C426, 2D210, 2D286, 2D415, 2E181,
2F072, 2F183, 2G240, 2H272, 2H599,
2K485, 2K653
225-3708-806 2D211, 2E151, 2E378, 2K510
225-3720-800 2C464, 2E156, 2E290, 2G254, 2J080,
2J583, 2K511
225-3720-802 2F136, 2J164, 2J587, 2D213
225-3720-804 2C465, 2F137, 2F309, 2G253, 2J158, 2J588
MANUFACTURER Intertech Resources, Inc., Fort Myers, Florida.
RECALLED BY Manufacturer, by letters of March 10, 1994, and April 18,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Two to three thousand may remain on the market.
REASON The tubing can split and a leak may occur in the circuit.
_______________
PRODUCT Breast Transilluminator, Lintroscan Model 200G used for the
detection of changes in the breast. Recall #Z-1184-4.
CODE Serial numbers: 080792-02, 082492-03, 082492-04, 01092-05,
01092-06, 01092-07.
MANUFACTURER Lintronics Technologies, Inc., Tampa, Florida.
RECALLED BY Manufacturer, by telephone mid November 1993. Firm-
initiated recall complete.
DISTRIBUTION Illinois, Ohio, Georgia, Florida, Virginia.
QUANTITY 6 units.
REASON Product labeling fails to bear adequate directions for use.
FDA has concluded that transillumination for the examination
of the breast is not clinically effective for the diagnosis
or detection of breast cancer or other breast abnormalities
or conditions.
_______________
PRODUCT Computer Software Versions 4.3 and 4.3.1 used in Triad,
Biad, Monad, Triad XLT, and Biad XLT Nuclear Imaging
Systems. Recall #Z-1185/1186-4.
-11- CODE The Triad and Biad serial numbers begin with 1 and the
Triad XLT and Biad XLT begin with 2. The first two Triad
XLT's manufactured were manufactured with serial numbers
beginning with a 1.
MANUFACTURER Trionix Research Laboratory, Inc., Twinsburg, Ohio.
RECALLED BY Manufacturer, by letter March 14, 1994. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 385 units were distributed.
REASON Software versions 4.3 and 4.3.1 lack validation.
_______________
PRODUCT Venous bloodlines: (a) Multiple Arterial and Venous
Bloodlines under NMC label, Catalog No. beginning with 03;
(b) Multiple Arterial and Venous Bloodlines under Baxter
label, Catalog No. beginning with 96.
Recall #Z-1187/1188-4.
CODE (a) Lot numbers beginning with M9, M0, M1, M2A, M2B, M2C,
R9, R0, R1, R2A, R2B, and R2C; (b) Lot numbers beginning
with M9, M0, M1, M2A, M2B, M2C, R9, R0, R1, R2A, R2B, AND
R2C.
MANUFACTURER National Medical Care, McAllen, Texas.
RECALLED BY National Medical Care, Rockleigh, New Jersey, letter January
25, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Taiwan, India, Uruguay, Venezuela.
QUANTITY (a) 3,272,098 units; (b) 588,228 units were distributed.
REASON Certain bloodlines exhibit "cloudy" (opaque) tube segments
that have been associated with bubble formation during use.
_______________
PRODUCT AMSCO Quantum 3080 RL (Return to level feature) and 3080 SP
Solutions for positioning feature) Surgical Tables:
(a) BL 58728-230/Quantum 3080RL, battery powered (USA &
export);
(b) BL 58728-200/Quantum 3080RL, A/C powered (USA & export);
(c) BL 57727-330/Quantum 3080RL/SP, battery powered
(domestic);
(d) BL 57727-200/Quantum 3080RL/SP, battery powered
(export);
(e) BL 56726-330/Quantum 3080RL/SP, battery powered
(export);
(f) BL 56726-200/Quantum 3080RL/SP, A/C powered (export).
Recall #Z-1196/1201-4.
CODE All tables bearing serial numbers between B418392016 through
B406894001, inclusively.
MANUFACTURER American Sterilizer Company (AMSCO), Montgomery, Alabama.
RECALLED BY American Sterilizer Company, Pittsburgh, Pennsylvania, by
letter May 26, 1994. Firm-initiated recall field correction
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 2,169 tables.
-12- REASON Due to a software defect, there is a potential for
unanticipated gradual tilting of the seat portion of the
tables when returned to the level position, under certain
conditions.
_______________
UPDATE Kodak Mammography Film, Recall #Z-1121/1124-4, which
appeared in the August 3, 1994, Enforcement Report should
read: MANUFACTURER: Kodak - Colorado Division, Windsor,
Colorado.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT Sterile Penicillin G Procaine bulk pharmaceutical, packaged
in 15 kg triple polyethylene bags in fiberboard drums, for
use in human and veterinary parenterals. Recall #V-058-4.
CODE 62 lots - 1992 manufacture
W 459 W 460 A 461 A 462 A 463 A 464
A 465 A 466 A 468 A 470 A 471 A 473
A 474 A 475 A 476 A 477 A 478 A 479
A 480 A 481 A 483 A 484 A 485 A 486
A 487 A 488 A 489 A 490 A 491 A 492
A 493 A 494 A 495 A 496 A 497 A 498
A 499 A 500 A 503 A 504 A 505 A 508
A 509 A 510 A 511 A 515 A 516 A 517
A 518 A 519 A 520 A 521 A 522 A 550
A 554 A 558 A 575 A 576 A 577 A 579
A 580 A 584.
MANUFACTURER Hoechst A.G., Frankfurt, Germany.
RECALLED BY Roussel UCLAF, Montvale, New Jersey, by letter on or about
May 14, 1993. Prior to this date multiple fax ant telephone
calls had taken place. Firm-initiated recall complete.
DISTRIBUTION New York, Missouri.
QUANTITY 74,370 BU (kilos) were distributed.
REASON Lack of assurance of sterility.
-13-
END OF ENFORCEMENT REPORT FOR AUGUST 10, 1994. BLANK PAGES MAY
FOLLOW.
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