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
10/12/1994
Recalls and Field Corrections: Foods -- Class I -- 10/12/1994
October 12, 1994 94-41
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT French Vanilla Ice Cream, in 3 gallon containers.
Recall #F-819-4.
CODE All lots beginning with No. 4.
MANUFACTURER R. Bruce Fike & Sons, Dairy, Inc., Uniontown, Pennsylvania.
RECALLED BY Manufacturer, by letter dated July 8, 1994. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania, Maryland.
QUANTITY Undetermined.
REASON Product contains eggs and eggs are not declared on the
label.
_______________
PRODUCT Various butter products: (a) Sweet Cream Lightly Salted
Butter, 4 quarters, 16 ounces, under the Zander and Parade
labels; (b) IGA Butter, 4 quarters, 16 ounces.
Recall #F-867/868-4.
CODE Pull date NOV 7 94.
MANUFACTURER California Milk Producers, Artesia, California.
RECALLED BY Madison Dairy Produce Company, Madison, Wisconsin, by
telephone August 31, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Wisconsin (Zander's brand); Maine and New Hampshire (IGA
brand); Michigan (Parade brand).
QUANTITY 575 cases (36 1-pound packages) were distributed.
REASON Product is contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
========================
_______________
PRODUCT Escolar Fillets. Recall F-843-4.
CODE None.
MANUFACTURER Poseidon Enterprises, Inc., Charlotte, North Carolina.
RECALLED BY Manufacturer, by telephone June 2, 1994. Firm-initiated
recall complete.
DISTRIBUTION North Carolina, South Carolina.
QUANTITY Approximately 251 pounds were distributed.
REASON Product caused severe diarrhea and is unfit for food.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Ice Cream in 3 gallon containers:
(a) Pecan Praline Ice Cream; (b) Butter Pecan Ice Cream.
Recall #F-853/854-4.
CODE Products manufactured from 3/6/94 through 9/6/94.
MANUFACTURER Schneider's Dairy, Pittsburgh, Pennsylvania.
RECALLED BY Manufacturer, by letter dated August 26, 1994. Firm-
initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 300 containers were distributed.
REASON Product contains undeclared pecans.
_______________
PRODUCT Toasted Almond Fudge Ice Cream, in 3 gallon containers.
Recall #F-856-4.
CODE Product manufactured from 3/6/94 through 9/6/94.
MANUFACTURER Schneider's Dairy, Pittsburgh, Pennsylvania.
RECALLED BY Manufacturer, by letter dated August 26, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Pennsylvania.
QUANTITY 300 containers were distributed.
REASON Product contains undeclared almonds.
_______________
PRODUCT Ice cream in 3 gallon containers: (a) Peanut Butter Curl
Ice Cream; (b) Chocolate Peanut Butter Ice Cream.
Recall #F-857/858-4.
CODE Product manufactured from 3/6/94 through 9/6/94.
MANUFACTURER Schneider's Dairy, Pittsburgh, Pennsylvania.
RECALLED BY Manufacturer, by letter dated August 26, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Pennsylvania.
QUANTITY 300 containers were distributed.
REASON Product contains undeclared peanuts.
RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II
=====================
-2- _______________
PRODUCT Elle Colour, topical cream, in .75 g tubes. Product was
used as a hair dye for eyelashes and eyebrows, instead of as
a hair color touch-up: (a) elle COLOUR Black; (b) elle
COLOUR Blue-Black; (c) elle COLOUR Brown.
Recall #F-849/851-4.
CODE Reference numbers: (a) 670; (b) 671; (c) 672.
MANUFACTURER Life Cosmetics Laboratories, Tel Aviv, Israel.
RECALLED BY Dinur Cosmetics, Ltd., Brooklyn, New York, by letter July
21, 1994. Firm-initiated recall ongoing.
DISTRIBUTION New York, New Jersey, Georgia, Texas, California, Colorado,
Massachusetts, Florida, Michigan, North Carolina, Oklahoma,
Maryland, Connecticut.
QUANTITY Firm estimated that 50-100 tubes remained on market at time
of recall.
REASON Product's package does not contain a cautionary/warning
statement advising consumers not to use the product in the
area of the eyes.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Sulfasalazine Tablets, 500 mg, in 100 or 500 tablet bottles,
an anti-inflammatory for relief of ulcerative colitis, under
the following labels: Mutual, United Research Laboratories
(URL), Qualitest, Mason, IDE-Interstate, Genetco, Harber,
Purepac. Recall #D-405-4.
CODE All lots with EXP date of 2/95 or earlier.
MANUFACTURER Mutual Pharmaceutical Company, Inc., Philadelphia,
Pennsylvania.
RECALLED BY Manufacturer, by letter August 22, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Product not manufactured under proper controls.
RECALLS AND FIELD CORRECTIONS: DRUGS CLASS III
===========================
_______________
PRODUCT Phenazopyridine Hydrochloride,for symptomatic relief of
pain, burning, urgency, frequency, and other discomforts
arising from irritation of the lower urinary tract mucosa:
(a) 95 mg OTC, shipped in bulk; (b) 100 mg and (c) 200 mg,
Rx, in 30, 100 and 1,000 tablet bottles;
Methylene blue containing products, Rx products in tablet
form, urinary analgesic/antiseptic:
(d) Generic Unrised Tablets, PIN 9450, under the following
labels: Uri-Sep SC Blue - H.L. Moore Drug Exchange, in 10's
and 100's; USept Tablets - Pharmacist's Choice, Inc., in
100's and 1000's; Urinary Antiseptic Tablets - United
Research Laboratories, Inc., in 100's; Urinary Antiseptic
Tablets - Alphagen Laboratories, Inc., in 100's and 1000's;
-3- UAA Tablets - EMREX/Economed Pharmaceuticals, Inc., in 100's
and 1000's;
(e) Generic MD-20 Tablets, PIN 9455, under the following
labels: Uretron D/S- A.G. Marin Pharmaceuticals, in 4's and
100's; Urimar-T- Marnel Pharmaceuticals, Inc., in 8's, 25's,
and 100's; Urogesic-Blue- Edwards Pharmaceuticals, Inc., in
4's and 100's; Uro Blue - R.A. McNeil Company, in 8's, 20's,
25's, and 100's;
(f) Trac Tabs 2X Tablets, PIN 9458, under the following
labels: Trac Tabs 2X - Hyrex Pharmaceuticals, in 4's, 100's
and 1000's;
(g) Prosed D/S, PIN 9459. Firm packages these products in
bottles for private label customers under the following
brand names and sizes, under the following labels:
Prosed/DS- Star Pharmaceuticals, Inc., in 100's.
Isoxuprine Hhyrochloride Tablets, Rx product for oral
administration, (h) 10 mg; (i) 20 mg. Recall #D-396/404-4.
CODE (a-c) All lots;
(d) AORM EXP 6/96, AKMM EXP 12/95, AJVM EXP 11/95
AJIM EXP 11/95, (e) AOWM EXP 5/96 or 6/96, APBM EXP 6/96
AMYM EXP 4/96 AKOM EXP 12/95 or 1/96 or 2/96; (f) AOOM EXP
6/96, AKZM EXP 4/96; (g) AOLM EXP 5/96, AKCM, EXP 2/96;
(h) AJBM, EXP 9/95 or 11/95 or 1/96
(i) ALUM, EXP 2/96 or 4/96, AJAM, 9/95 or 11/95.
MANUFACTURER Manufacturing Chemists, Inc., Indianapolis, Indiana.
RECALLED BY Manufacturer, by letter August 24, 1994 (phenazopyridine HCL
product); by letter September 22, 1994 (all other products).
Firm-initiated recall complete.
DISTRIBUTION Georgia, New Jersey, Ohio, Michigan, Wisconsin, New York,
Pennsylvania, Louisiana, Mississippi, Florida, Tennessee.
QUANTITY Undetermined.
REASON Current good manufacturing practice deficiencies.
________________
PRODUCT Ethrane (Enflurane, USP), in 250 ml bottles, a general
inhalation anesthetic. Recall #D-406-4.
CODE Lot #G040J328.
MANUFACTURER Ohmeda Caraibe, Inc., Guayama, Puerto Rico.
RECALLED BY Ohmeda, Inc., Liberty Corner, New Jersey, by letter August
24, 1994. Firm-initiated field correction complete.
DISTRIBUTION Nationwide.
QUANTITY 774 bottles were distributed.
REASON Shipping case incorrectly labeled as 125 ml instead of
250 ml.
_______________
PRODUCT Bicillin CR, Penicillin G Procaine, 300,000 units/ml
injection, in 10 ml vials. Recall #D-001-5.
CODE Lot #2931823.
MANUFACTURER Wyeth-Ayerst Laboratories, West Chester, Pennsylvania.
RECALLED BY Manufacturer, by letter September 2, 1994. Firm-initiated
recall ongoing.
-4- DISTRIBUTION Nationwide.
QUANTITY 29,910 vials were distributed; firm estimates very little,
if any product remains on the market.
REASON Reports of clogging of the needle.
_______________
PRODUCT Unipen Injection, Nafcillin Sodium, Rx antibiotic, in 1 gram
vials and in 10 gram vials. Recall #D-002-5.
CODE Lot #2931858 (10 gram vial), 2931859 (1 gram vial).
MANUFACTURER Wyeth-Ayerst Laboratories, West Chester, Pennsylvania.
RECALLED BY Manufacturer, by letter September 9, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates that there is little product remaining on the
market.
REASON Presence of particulate matter in the product.
_______________
PRODUCT Glycopyrrolate Injection, USP, 0.2 mg/ml, in 5 ml vials,
indicated for use as a preoperative antimuscarinic.
Recall #D-003-5.
CODE Lot #P3D008 EXP 10/94, P3E016 EXP 11/94, P3H011 EXP 12/94,
P3K002 EXP 2/95, P3N004 EXP 4/95, P3N004P1 EXP 4/95,
P4A013 EXP 7/95.
MANUFACTURER Gensia Laboratories, Inc., Irvine, California.
RECALLED BY Manufacturer, by letter September 15, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 236,275 vials were distributed; FDA estimates
that 50,000 vials remained on the market at time of recall.
REASON Presence of particulate matter in the product.
_______________
PRODUCT Phenobarbital w/Belladonna Tablets (Rexatal Tablets), 160
mg, in 1000 count bottles, Rx, used as adjunctive therapy in
treatment of irritable bowel syndrome and acute
enterocolitis. Recall #D-004-5.
CODE Lot #B3625 EXP 8/95.
MANUFACTURER Richwood Pharmaceutical Company, Inc., doing business as
Rexar Pharmacal, Valley Stream, New York.
RECALLED BY Manufacturer, by telephone September 23, 1994, and by letter
dated September 8, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Florida, New York, Pennsylvania, Louisiana, New Mexico,
Michigan, California, Indiana, Georgia, Tennessee, Illinois,
Kentucky, New Jersey.
QUANTITY 2,966 bottles were distributed; firm estimates that little
product remains on the market.
REASON Product does not meet dissolution specifications for
phenobarbital ingredient.
-5- _______________
PRODUCT Extra Strength Bayer Enteric Aspirin Caplets, 500 mg, in 60
count bottles, compendia OTC analgesic product.
Recall #D-005-5.
CODE KL 363, KL 364, KL 370 EXP 8/95.
MANUFACTURER KV Pharmaceutical Company, St. Louis, Missouri.
RECALLED BY Sterling Health, Division of Sterling Winthrop, Inc., New
York, New York, by letter September 22, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 47,580 bottles were distributed; firm estimates 20-25% of
the product remained on the market at time of recall.
REASON Product does not meet dissolution specifications.
RECALLS AND FIELD CORRECTIONS: BIOLOGIC -- CLASS III
====================
_______________
PRODUCT Platelets, Pheresis. Recall #B-468-4.
CODE Unit numbers 20P06145A and 20P06145B.
MANUFACTURER American Red Cross Blood Services, Boise, Idaho.
RECALLED BY Manufacturer, by letter February 11, 1994. Firm-initiated
recall complete.
DISTRIBUTION Montana.
QUANTITY 2 units.
REASON Unlicensed blood products were distributed interstate.
_______________
PRODUCT (a) Coatagen(R) Antiglobulin Control Cells; (b) Coatagen(R)
Weak Antiglobulin Control Cells. Recall #B-001/002-5.
CODE Lot numbers: (a) 92071 and 92072; (b) 92073.
MANUFACTURER Organon Teknika Corporation, West Chester, Pennsylvania.
RECALLED BY Manufacturer, by letters dated February 14, 1992. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 990 units of lot 92071, 409 units of lot 92072, and 313
units of lot 92073.
REASON Reagent Red Blood Cells which were found to be hemolyzed
were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Unprotected lead wires and cables used with the following
monitors:
Ivy Bedside Monitors: Adult Models -- 101, 101B, 201, 202,
303D, 401, 402, 403D, 404, 405A, 405D;
Neonate Models: 301, 303A, 403, 405A, 405D.
Ivy Transport Monitors: Adult/Neonate Models -- 700, 701,
702, 703, 704, 705, 706. Recall #Z-1096-4.
CODE All serial numbers.
MANUFACTURER Ivy Biomedical Systems, Inc., Branford, Connecticut.
-6- RECALLED BY Manufacturer, by letter dated January 3, 1994 (a second
mailing was made September 1994). Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 8,527 monitors were distributed through November 1993.
REASON Device 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 Unprotected patient cables and leadwires, indicated for use
with medical device emergency care interconnect systems:
(a) Leadwires, multiple styles/sizes, sold unlabeled in
plastic bags;
(b) Patient Cables, multiple styles/sizes, sold one per
plastic bag. Recall #Z-1222/1223-4.
CODE None. All products distributed during the past 3 years.
MANUFACTURER Merit Industries, Costa Mesa, California.
RECALLED BY Manufacturer, by letters mailed in April through July 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 46,200 patient cables and 178,000 leadwires
were distributed between April 1991 and April 1994.
REASON Device labeling fails to provide adequate directions for use
and the devices pose an unwarranted risk of injury to
patients, because the products are not labeled to
contraindicate use with apnea monitors.
______________
PRODUCT (a) Hill-Rom Century Series Critical Care Hospital Bed,
Model P892 (no in-bed scale); (b) Model P894 (with in-bed
scale). Recall #Z-1247/1248-4.
CODE Serial numbers: (a) 53A25 through 55A70;
(b) 53B40 through 61B19.
MANUFACTURER Hill-Rom Company, Inc., Batesville, Indiana.
RECALLED BY Manufacturer, by issuing in-house instructions for
application of the reinforcement plate to its cadre of field
engineers on February 1991. Firm-initiated field correction
was completed in November 1992.
DISTRIBUTION Nationwide and international.
QUANTITY 1,026 beds were distributed.
REASON The pivot connection on holding head section of bed was
weakened and began failing when the firm made some beds with
an extra hole near the pivot point.
_______________
PRODUCT Baxter Intermate Infusion Devices, sterile single use
prescription devices used to provide uninterrupted flow of
medication over the labeled infusion period for ambulatory
patients requiring intravenous administration of
medications:
-7- (a) Baxter Intermate SV Elastomeric Infusion Systems:
Product Code 044050 - 50 ml/hour, Product Code 044120 - 100
ml/hr System, Product Code 044220 - 200 ml/hr System;
(b) Baxter Intermate LV Elastomeric Infusion Systems:
Product Code 049050 - 50 ml/hr System, Product Code 049100 -
100 ml/hr System, Product Code 049250 250 ml/hr System.
Recall #Z-1368/1369-4.
CODE (a) Product Code 044050, Lot Nos. 93N010, 94A008,
94B001, 94B014, 94C011, 94D009, 94D010, 94E007,
94F009, 94F010;
Product Code 044120: Lot Nos. 94A007, 94A010,
94A012, 94B009,94B010, 94B011, 94C002, 94C003,
94C004, 94D012, 94D013, 94D015, 94D016, 94E002,
94E012, 94E013, 94F005, 94F006, 94F008;
Product Code 044220: Lot Nos. 94A002, 94B002,
94C006, 94F004, 94DF005, 94E014, 94G001;
(b) Product Code 049050: Lot Nos. 94c010, 94D018,
94D019, 94E009, 94F011, 94F012;
Product Code 049100: Lot Nos. 94B007, 94C001,
94D007, 94D008, 95E005;
Product Code 049250: Lot Nos. 94B006, 94C012,
94D001, 94D002, 94E003, 94F001;
MANUFACTURER Baxter Healthcare Corporation, Irvine, California.
RECALLED BY Baxter Healthcare Corporation, Round Lake, Florida, by
letters of August 18 and 19, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 680,949 units were distributed; firm estimated that 40
percent of the product remained on the market at time of
recall.
REASON Shipping stress may crack the distal luer adapter stem at
area where the tubing is bonded to the leur. Subsequent
leaking or separation may occur.
_______________
PRODUCT Single Lumen Centermark Insertion Tray, peripherally
inserted central venous catheter insertion tray. Trays will
contain either an 18 gauge or a 20 gauge catheter.
Recall #Z-1410-4.
CODE Lot numbers: 03284R, 03294R, 04184, 05024.
MANUFACTURER Menlo Care, Inc., Menlo Park, California.
RECALLED BY Manufacturer, by telephone followed by visit. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,636 trays were distributed.
REASON The outer trays made from recycled 100% post consumer PET
(polyethylene trephthalate) may crack.
_______________
PRODUCT Kontron Sigma 44 Ultrasound Imaging System with High
Velocity Color Doppler, used for cardiac diagnostic purposes
to detect abnormal blood flow. Recall #Z-1413-4.
-8- CODE Catalog No. Serial No.
898600 431, 441, 442, 443, 444, 446, 447, 448,
453, 470, 473, 474, 481, 495, 496, 497,
498, 509, 510, 511.
MANUFACTURER Kontron Instruments S.A., France.
RECALLED BY Spectrum Instruments, Inc., Mahwah, New Jersey, by letter
January 29, 1993, followed by visit. Firm-initiated field
correction was completed March 1993.
DISTRIBUTION Nationwide and Canada.
QUANTITY 15 units.
REASON An electrical component was incorrectly designed which
caused the device to heat up and the power supply to fail.
_______________
PRODUCT 4:1 Cardioplegia Delivery Sets & Related Perfusion Packs,
used to stop the heart during open heart surgery:
(a) COBE 4:1 Cardioplegia Delivery Set, Catalog Number
027323-200
(b) Related Perfusion Pack, Catalog Number 020841-216
(c) Related Perfusion Pack, Catalog Number 020909-303
(d) Related Perfusion Pack, Catalog Number 020737-209
(e) Related Perfusion Pack, Catalog Number 020840-302
(f) Related Perfusion Pack, Catalog Number 020863-302
(g) Related Perfusion Pack, Catalog Number 027385-202
(h) Related Perfusion Pack, Catalog Number 032590-015
(i) Related Perfusion Pack, Catalog Number 027437-201
(j) Related Perfusion Pack, Catalog Number 027390-202
(k) Related Perfusion Pack, Catalog Number 027396-203
(l) Related Perfusion Pack, Catalog Number 027414-202
(j) Related Perfusion Pack, Catalog Number 027440-202
(k) Related Perfusion Pack, Catalog Number 027332-207.
Recall #Z-1414/1427-4.
CODE All lot numbers manufactured prior to lot #08Z0544.
MANUFACTURER COBE Cardiovascular, Inc., Arvada, Colorado.
RECALLED BY Manufacturer, by telephone beginning July 15, 1994 ,
followed by letter letter August 2, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 5,000 units were distributed.
REASON Two units were misassembled. The misassembly occurred when
two pieces of tubing (1/4" ID and 1/8" ID, respectively)
were reversed during manufacture. When the product is used
in this configuration, too much crystalloid and potassium
are administered to the patient.
_______________
PRODUCT Air Shields T 100 Disposable Ventilation Circuit.
Recall #Z-1437-4.
CODE Lot numbers 9135, 11/12 and 1112; Part No./Reorder No.
6735031.
MANUFACTURER Anamed International Corporation, Las Vegas, Nevada.
-9- RECALLED BY Air-Shields, Inc., Hatboro, Pennsylvania, by letter
September 1, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Puerto Rico, Belgium, Canada, Germany, Saudi
Arabia, Singapore, Sweden, and the UK.
QUANTITY 4,340 units were distributed.
REASON There is a partial occlusion located inside the large
fitting of the patient tube.
_______________
PRODUCT Quantum 2000/2000V Ultrasound Systems, used to project
ultrasound energy from a transducer in direct contact with
the body for the purpose of detecting abnormalities in soft
tissue structures and vessels. Recall #Z-1438/1439-4.
CODE All units. Serial numbers range from 1000 to 1498.
MANUFACTURER Siemens Medical Systems, Inc., Issaquah, Washington.
RECALLED BY Manufacturer, by letter September 1, 1994. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 499 units.
REASON The acoustic intensities may exceed the firm's
specifications.
_______________
PRODUCT MIDAS System, Models 2500, 5100 and 5500 with Case Data
Recorder (CDR) Physiological Monitor for Cardiac
Catherization Laboratories. Recall #Z-1440/1442-4.
CODE Product numbers: 925-5100-100, 925-5100-200, 925-5500-100,
925-5500-200, 925-2500-100, 925-2550-100, 925-5150-100,
925-5150-200, 925-2150-100.
MANUFACTURER PPG Industries, Biomedical Systems Division, Lenexa, Kansas.
RECALLED BY Manufacturer, by letter July 7, 1994. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide, France, Germany, Italy.
QUANTITY 298 systems were distributed.
REASON An erroneous value will be obtained when using the manual
method for calculating a Mitral Valve Gradient (MVG).
_______________
PRODUCT Axiom Knee Tibial Insert Trial, Model 2310-7530, used during
the surgical procedure to determine the proper size of the
tibial insert to be implanted. Recall #Z-1443-4.
CODE Lot #P89H2525.
MANUFACTURER Orthomet, Inc., Minneapolis, Minnesota.
RECALLED BY Manufacturer, by telephone between May 3, 1994 and May 31,
1994. Firm-initiated recall complete.
DISTRIBUTION Japan and one undetermined location.
QUANTITY 2 units were distributed.
REASON The product was incorrectly labeled as 75 mm x 30 mm, when
in fact they are 75 x 25mm trials.
-10- _______________
PRODUCT Canton Tube, size 16 FR, single lumen tube, 10 F. (305 cm)
long, graduate with self-sealing latex balloon and green
plastic connector, X-ray opaque code #2330-16.
Recall #Z-002-5.
CODE Lot numbers:
E310727 E314238 E320911 E321824 E323308 E324415
E310801 E314239 E320912 E321825 E323309 E324417
E310802 E314240 E320913 E321826 E323310 E324511
E311018 E314241 E320914 E321827 E323311 E324512
E311019 E314242 E320915 E321828 E323312 E324513
E311106 E314243 E320916 E321829 E323409 E324516
E311107 E314912 E321136 E322029 E323410 E324517
E311203 E314913 E321137 E322030 E323411 E504201
E311204 E314914 E321138 E322031 E323412 E504202
E311205 E314915 E321139 E322032 E323413 E504203
E311206 E314916 E321140 E322409 E323414 E504204
E311207 E314917 E321141 E322410 E323415 E504205
E311208 E314918 E321142 E322520 E323416 E504206
E311209 E314919 E321209 E322521 E323417 E504207
E311210 E314920 E321210 E322522 E323905 E504501
E311211 E314921 E321211 E322523 E323906 E504502
E311212 E315120 E321212 E322524 E323907 E504503
E311221 E315121 E321213 E322525 E323908 E504504
E311409 E315122 E321214 E322526 E323909 E504505
E311410 E315123 E321401 E322527 E323910 E921592
E311411 E315125 E321403 E322528 E323911 E921593
E311412 E315125 E321403 E322529 E323912 E921594
E312106 E32010I E321404 E322676 E323913 E921595
E312107 E320102 E321405 E322808 E323914 E921596
E312108 E320103 E321406 E322809 E324101 E921597
E312109 E320104 E321407 E322810 E324102 E921599
E3121l0 E320105 E321408 E322811 E324103 E921601
E312111 E320106 E321409 E322813 E324104 E921602
E312112 E320307 E321410 E322814 E324105 E921603
E312318 E320308 E3215l3 E322815 E324106 E921604
E312319 E320309 E321514 E322816 E324107 E921605
E312320 E320310 E321515 E322817 E324108 E921606
E312321 E320311 E321516 E322818 E324109 E921607
E312322 E32C312 E321517 E322819 E324110 E922675
E312323 E320607 E321518 E322820 E324203 E922677
E312324 E320608 E321519 E322821 E324204 E922678
E312325 E320609 E321520 E323005 E324205 E922679
E312501 E320610 E321521 E323006 E324206 E922680
E312502 E320611 E321723 E323007 E324207 E922681
E312602 E320612 E321724 E323008 E324208 E922682
E312603 E320613 E321725 E323009 E324209 E924601
E312604 E320614 E321726 E323010 E324210 E924602
E313405 E320615 E321727 E323011 E324211 E924603
E313406 E320616 E321728 E323012 E324212 E924801
E313407 E320907 E321729 E323304 E324225 E924802
-11- E313408 E320908 E321730 E323305 E324409 E924803
E313409 E320909 E321731 E323306 E324410 E924804
E314237 E320910 E321732 E323307 E324414.
MANUFACTURER Rusch U.K. Ltd., Buckinghamshire, England.
RECALLED BY Rusch, Inc., Duluth, Georgia, by letter May 2, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 17,962 tubes were distributed; firm estimates none remains
on the market.
REASON Leakage of mercury from the latex balloon unnecessarily
exposes patients to a hazardous substance and could prevent
the device from functioning properly.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Active Electrode Cable Cord HF-A-0335, used to provide an
ultrasound of internal tissues, and it is used often during
urological and gynecological operations. Recall #Z-1354-4.
CODE None.
MANUFACTURER Olympus Winter & IBE, Hamburg, Germany.
RECALLED BY Olympus America, Inc., Lake Success, New York, June 2, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 600 units.
REASON Reports of failure of the A-0335 cable involving sparking
and an explosion-like event which may result in fire and
patient/operator burns.
_______________
PRODUCT Precise hCG Test Kits used in the detection of human
chorionic gonadotropin (hCG) in urine specimens for the
early detection of pregnancy: (a) Catalog #496220;
(b) Catalog #496240. Recall #Z-1408/1409-4.
CODE Lot numbers: 3450, 3451, 3464, 3465, 3472, 3474, 3526.
MANUFACTURER Becton Dickinson Advanced Diagnostics, Sparks, Maryland.
RECALLED BY Manufacturer, by letter sent the week of July 25, 1994.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,456 kits were distributed.
REASON The kits have provided false positive results at the end of
the assay.
_______________
PRODUCT Silastic brand #7-2947 Medical Adhesive Silicone, Type A
sterile in 8 gram tubes, used for adhesion of pacemaker and
catheter leads. Recall #Z-1428-4.
CODE Lot numbers: HH112867, HH112868, HH112869, HH1122870,
HH112871, HH112872, HH112873, HH112874, HH112875, HH112876,
HH112877, HH112878, HH112879, HH112880, HH112884, HH112885,
HH112886.
MANUFACTURER Dow Corning Corporation, Hemlock, Michigan.
-12- RECALLED BY Manufacturer, by letter March 9 and 10, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION California, Florida, Illinois, Indiana, Massachusetts,
Minnesota, Texas, Utah, Washington state, Europe, Australia.
QUANTITY 17 lots were distributed. Each lot, with the exception of
lots HH112885 and HH112886 consisted of 47 cartons, each
holding 25 tubes. Lots HH112885 and HH112886 consisted of
46 cartons each.
REASON Device does not meet current sterility specifications.
_______________
PRODUCT Abbott IMx Stat CK-MB Assay System, a microparticle enzyme
immunoassay for the quantitative measurement of the MB
isoenzyme of creatine kinase in human serum or plasma to
assist in the diagnosis of acute myocardial infarction.
Recall #Z-001-5.
CODE All lots.
MANUFACTURER Abbott Laboratories, Inc., Abbott Park, Illinois.
RECALLED BY Manufacturer, by telephone beginning August 15, 1994, and by
fax to international accounts August 13, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimated that 4,488 packs remained on the market at
time of recall.
REASON The IMx STAT CK-MB assay could possibly obtain elevated CK-
MB results when using the IMx STAT CK-MB assay system. This
has the potential for inaccurate test results when doing a
quantitative measurement of the MB isoenzyme of creatine
kinase in a patient.
_______________
PRODUCT National Medical Care (a) Arterial Bloodlines; (b) Venous
Bloodlines, individually packaged in clear plastic bags, for
use during dialysis treatment. Recall #Z-003/004-5.
CODE Catalog No. Lot No.
(a) 03-7200-3 R4E012
(b) 03-7300-5 R4D030.
MANUFACTURER National Medical Care, Medical Product Division, Reynosa,
Mexico.
RECALLED BY National Medical Care, Rockleigh, New Jersey, by letter
dated August 8, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 29,424 units; (b) 24,648 units were distributed.
REASON Bloodlines were discolored and contaminated with herbicides.
-13-
END OF ENFORCEMENT REPORT FOR OCTOBER 12, 1994. BLANK PAGES MAY
FOLLOW.
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