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
08/24/1994
Recalls and Field Corrections: Foods -- Class I -- 08/24/1994
August 24, 1994
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Various cheese products: Goat Milk Cheese, in 5 ounce
wheels as follows: (a) Chevre; (b) Chevre Herb; (c) Chevre
Pepper; (d) Chevre Chive; (e) Chevre Dill; Fromage Blanc
Goat Milk Cheese, in 5 ounce, 4 pound, 5 pound and 10 pound
packages as follows: (f) Fromage Blanc; (g) Fromage Blanc
Chive; (h) Fromage Blanc Basil; (i) Fromage Blanc Garlic;
Chevre Logs, 5 ounce, 11 ounce, and 2.2 pounds as follows:
(j) Natural; (k) Pepper; (l) Herb; (m) Dill; (n) Chive; Goat
Milk Cheddar, 8 ounces and 5 pounds; (o) Feta, 4 ounces and
5 pounds; (p) Fromage A Trois Torta, slices and whole
packages, approximately 3.5 pounds for each, but may vary.
Recall #F-785/801-4.
CODE All product shipped between May 2, 1994, and June 14, 1994.
MANUFACTURER Cypress Grove Chevre, McKinleyville, California.
RECALLED BY Manufacturer, by letter faxed June 15, 1994. Firm-initiated
recall complete.
DISTRIBUTION California, Colorado, Georgia, Illinois, Massachusetts,
Michigan, New York, Oregon, Texas.
QUANTITY Approximately 5,682.4 pounds were distributed between 5/2/94
and 6/14/94.
REASON Products are contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Koala Sparkling Kiwi Lime and Grapefruit flavored fruit
juice beverage, made with mineral water and fruit juices, in
12 fluid ounce cans. Recall #F-781-4.
CODE 4131CBP10:54 through 4131CBP13:20.
MANUFACTURER Seven-up Bottling Company, doing business as Capital
Beverage Packers Sacramento, California.
RECALLED BY Koala Springs International, Inc., Fremont, California, by
fax July 15, 1994. Firm-initiated recall ongoing.
DISTRIBUTION California, Colorado, Hawaii, Idaho, Montana, Oregon, Utah,
Washington state, New Mexico, Texas, The Philippines.
QUANTITY 19,848 cases (6 4-packs per case) were distributed.
REASON Product is contaminated with glass fragments.
_______________
PRODUCT Alcohol-Free Mouthwash, Clear Mint, in 32 fluid ounce
bottles. Recall #F-783-4.
CODE GF3193.
MANUFACTURER Bausch & Lomb, Inc., Greenville, South Carolina.
RECALLED BY Bausch & Lomb, Inc., Rochester, New York, by letter July 22,
1994. Firm-initiated recall ongoing.
DISTRIBUTION California, Colorado, Utah, Washington state.
QUANTITY 3,738 bottles were distributed.
REASON Product is contaminated with Pseudomonas aeruginosa.
_______________
PRODUCT Ceramic Mugs, with dark black glaze. Recall #F-784-4.
CODE All lots.
MANUFACTURER Pioneer Pottery Company, East Liverpool, Ohio.
RECALLED BY Manufacturer, by telephone June 7, 1994. Firm-initiated
recall complete.
DISTRIBUTION Ohio, Florida.
QUANTITY 473 mugs were distributed.
REASON Product contains excessive levels of leachable lead.
_______________
PRODUCT Carrageenan, PNG (Philippine Natural Grade), Shemberg brand,
in 50 pound and 25 kg bags as follows:
(a) BenGel MBF-192; (b) BenGel MBF-200K; (c) BenGel MBF-592;
(d) BenGel S-100; (e) Benlacta CM-888; (f) Benlacta CM-61B;
(g) Benlacta K1-16B; (h) Benlacta EX-9332; (i) Benlacta EX-
9401; (j) Benlactel MPS-50; (k) Benlacta S-100.
Recall #F-802/812-4.
CODE (a) JDV-019 through JDV-023; (b) 921210/7, 921024/1,
921207/1, 930225/2, JDV-003 through JDV-006, JDV-012 through
JDV-014, JDV-016 through JDV-018; (c) JCO-015, JCO-018, JCO-
019, JCQ-031, JCQ-032, JDY-026 through JDY-029, JDV-016,
JDV-017, JDX-036, JDV-039, 921024/2; (d) 921026/1, 930220/1,
931211/2; (e) 921118/9, 930216/1 through 930216/5, 931115/1
through 931115/5, 931214/1 through 931214/3, 931214/5,
-2- 931227/2; (f) 921209/27 through 921209/31, 930112/1,
930112/9 through 930112/13, 930722/1 through 930722/3,
931019/1 through 931019/9, 931124/2, 931124/4; (g) 930528,
JDV-015, 921026/1; (h) 931124/6 through 931124/8; (i) JDQ-
001; (j) 931106; (k) 930220/7, 930811/1 through 930811/4.
MANUFACTURER Shemberg Marketing Corporation, Cebu City, Philippines.
RECALLED BY Shemberg USA, Searsport, Maine, by telephone from
approximately February 15, 1994 to April 15, 1994. Firm-
initiated recall complete.
DISTRIBUTION Missouri, New Jersey, Mississippi, Illinois, Maine, Iowa,
Wisconsin, Pennsylvania, Florida, Minnesota, Indiana, Ohio,
California, Oregon.
QUANTITY Approximately 330,000 pounds were distributed from January
1993 to March 1994.
REASON Product contains ethylene chlorhydrin, an unsafe food
additive.
_______________
PRODUCT Frozen Oman Rock Lobster Tails packaged in 40 pound cases.
Recall #F-815-4.
CODE Lot numbers and tail sizes: 7967 (2 oz), 7968 (3 oz), 7969
(4 oz), 7970 (5 oz), 7971 (6 oz), 7972 (7 oz), 7973 (8 oz).
MANUFACTURER East Fish Processing L.L.C., Ajaman, United Arab Emirates.
RECALLED BY Empress International Ltd., Port Washington, New York, by
telephone July 28, 1994. Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 217 cases were distributed; firm estimates that most of the
distributed product has been consumed.
REASON Product is contaminated with Salmonella.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Peanut Butter Fudge and Peanut Butter Curl Ice Cream, in 3
gallon containers. Recall #F-779/780-4.
CODE All product manufactured during 2/19/94 through 5/19/94.
MANUFACTURER Reinhold Ice Cream Company, Pittsburgh, Pennsylvania.
RECALLED BY Manufacturer, by telephone May 19, 1994. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY Firm estimates none remains on the market.
REASON Product labeling fails to declare the presence of peanuts.
_______________
PRODUCT Mahi-Mahi Fresh Fish. Recall #F-813-4.
CODE None.
MANUFACTURER P&D International Trading Company, Los Angeles, California
(shipper).
RECALLED BY Inland Seafood, Atlanta, Georgia, by telephone June 30,
1994. Firm-initiated recall complete.
DISTRIBUTION Alabama, Georgia, South Carolina.
-3- QUANTITY Approximately 241 pounds were distributed.
REASON Product is decomposed.
_______________
PRODUCT Bi-Lo Canned Cola, in 12 fluid ounce cans. Recall #F-814-4.
CODE Item #131-0903 (24/12 ounce flats); Item #131-0887 (12 pack
case); Item 131-1703 (24 pack case).
MANUFACTURER Independent Beverage Corporation, Charlotte, North Carolina.
RECALLED BY Bi-Lo, Inc., Mauldin, South Carolina, by E-Mail June 2,
1994. Firm-initiated recall complete.
DISTRIBUTION Georgia, South Carolina, North Carolina.
QUANTITY Approximately 20,000 assorted cases, 6 packs, 12's and 24's
were distributed.
REASON Declares calories as 0 when in fact it contains 160
calories.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Acephen Acetaminophen Suppositories USP (pediatric), 120 mg,
foil wrapped for rectal administration, a nonprescription
product. Recall #D-347-4.
CODE Lot #3104-6 EXP 4/95.
MANUFACTURER G & W Laboratories, Inc., South Plainfield, New Jersey.
RECALLED BY Manufacturer, by letter April 8-11, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 23,370 boxes of 12 were distributed.
REASON Product does not meet dissolution specifications.
_______________
PRODUCT Miacalcin (Calcitonin-Salmon), injection, synthetic, in 2 ml
multi-dose vials, Rx, indicated for hypercalcemia, post-
menopausal osteoporosis, and Paget's disease.
Recall #D-348-4.
CODE Lot #675U6534 EXP 10/95.
MANUFACTURER Schering-Plough Corporation, Manati, Puerto Rico.
RECALLED BY Sandoz Pharmaceuticals Corporation, East Hanover, New
Jersey, by letters sent March 25, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 42,014 vials were distributed.
REASON Some vials were found to be unlabeled.
_______________
PRODUCT Benzonatate 100 mg, USP soft gelatin capsules in bottles of
100, Rx indicated for the symptomatic relief of cough, under
the following labels: Aligen, Martec, H.L. Moore, Qualitest,
Sidmak, U.R. L. Recall #D-349-4.
-4- CODE 60302 60661 60710 60845 60904 60923 60303
60680 60711 60869 60905 60304 60681 60760
60870 60906 60305 60682 60761 60884 60921
60660 60709 60844 60885 60922.
MANUFACTURER Banner Pharmacaps, Inc., Elizabeth, New Jersey.
RECALLED BY Manufacturer, by letter July 13, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION New Jersey, Wyoming, Louisiana.
QUANTITY Undetermined.
REASON Product does not meet dissolution specifications.
_______________
PRODUCT Clozaril, Clozapine 25 mg tablets in blister packaging of
100 (Sandopaks), Rx schizophrenia treatment.
Recall #D-350-4.
CODE Lot #079U4459 EXP 1/97.
MANUFACTURER Sandoz Pharmaceutical Corporation, East Hanover, New Jersey.
RECALLED BY Manufacturer, by fax March 25, 1994, followed by a hardcopy
sent the same day. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Puerto Rico.
QUANTITY 6,239 Sandopaks were distributed.
REASON Some of the unit dose blisters had no printing.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Triamterene and Hydrochlorothiazide Capsules, 50 mg, in
bottles of 100 and 1,000, an antihypertensive.
Recall #D-351-4.
CODE Lot numbers: 1990 lots 1-0E35 through 18-0E35, except lot
12-0E35; 1991 lots 1-1E35 through 10-1E35.
MANUFACTURER Penn Labs, Inc., subsidiary of Smithkline Beecham, Cidra,
Puerto Rico.
RECALLED BY Rugby Laboratories, Norcross, Georgia, by letter July 5,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Undetermined.
QUANTITY Approximately 297 million capsules were manufactured.
REASON Some lots do not meet dissolution specification through the
expiration date.
_______________
PRODUCT Sulfamethoxazole, 400 mg and Trimethoprim 80 mg Tablets, in
boxes of 100, Rx antibiotic. Recall #D-346-4.
CODE Lot #485-03 EXP 2/95.
MANUFACTURER Lemmon Company, Sellersville, Pennsylvania.
RECALLED BY Auro Pharmaceuticals, Inc., Williamsville, New York
(repacker/responsible firm), by letter August 8, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION California, Florida, Indiana, Michigan, New York,
Pennsylvania.
-5- QUANTITY 361 boxes of 100 tablets each were distributed between
3/4/93 and 6/28/93. Firm estimated that 96 boxes remained
on market at time of recall.
REASON Presence of a yellow powder in a blister strip.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Source Leukocytes.
Recall #B-431/433-4.
CODE Unit numbers: (a) 01K92912-6; (b) 01K92912-6, 01V85396-1,
01V85410-9; (c) 01M85746-6.
MANUFACTURER Civitan Regional Blood Center, Inc., Gainesville, Florida.
RECALLED BY Manufacturer, by telephone December 14, 1993, followed by
letter. Firm-initiated recall complete.
DISTRIBUTION Alabama, Ohio, Florida.
QUANTITY (a) 1 unit; (b) 3 units; (c) 1 unit.
REASON Blood products that either tested repeatedly reactive for
antibodies to human immunodeficiency virus types 1 and 2
(anti-HIV-1/2) or tested repeatedly reactive for the
antibody to hepatitis B core antigen (anti-HBc) were
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Zoll Defibrillators, used for the purposes of converting
ventricular fibrillation (VF), a cardiac rhythm incompatible
with life, to sinus rhythm or other cardiac rhythms capable
of producing hemodynamically significant heart beats:
(a) Zoll PD 1200 Pacemaker/Defibrillator;
(b) Zoll D 900. Recall #Z-115/116-4.
CODE (a) All serial numbers lower than 859; (b) All serial
numbers lower than 3682.
MANUFACTURER Zoll Medical Corporation, Burlington, Massachusetts.
RECALLED BY Manufacturer, by letter June 10, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 7,090 units; (b) 1,635 units were distributed.
REASON Depleted or damaged batteries can compromise operation of
the defibrillator.
_______________
PRODUCT Electrode Lead Wires, 2.0 mm which have exposed metal pins.
These lead wires were sold under Nortech's and Empi's brand
names and are used with TENS and NMES (neuro-muscular
electrical stimulation) devices. The product numbers of the
Nortech lead wires are 86602136, 86604000, 86604018,
86604036, 86604037, 86604048, 86604060, 86604136, 86604148,
86604160. The product numbers of the Empi lead wires are
193012, 193013, 198060, 198061, 198086, 198087, 198136.
Recall #Z-548-4.
-6- CODE All lots/codes.
MANUFACTURER Empi, Inc., St. Paul, Minnesota.
RECALLED BY Manufacturer, by letter July 7, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Mexico.
QUANTITY 4,099 Empi brand lead wires and 5,137 Nortech brand lead
wires were distributed.
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 Simplastin L Thromboplastin Reagent, in-vitro diagnostic
reagent intended for use in the determination of prothrombin
time: (a) Product #59552, 300 tests; (b) Product #59553,
1000 tests. Recall #Z-1151/1152-4.
CODE Lot numbers: (a) 103121, 103123, 103125, 103201, 103226;
(b) D01059, D01160, 103116, 103118, 103119, 103120, 103227,
103231, 103235.
MANUFACTURER Organon Teknika Corporation, Durham, North Carolina.
RECALLED BY Manufacturer, by voice mail messages and by letter November
19, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide, The Netherlands, Canada.
QUANTITY 9,222 kits were distributed.
REASON The reagent may give unusually prolonged Prothrombin times
in some Coumadin patient specimens with INR's greater than
3.0. This would result in a potential error in diagnosis
and/or treatment.
_______________
PRODUCT Reaction Cuvettes, Model 751060, used to hold specimen
samples for chemical analyses performed using the firm's
Express 550 and Express Plus spectrophotometrs.
Recall #Z-1202-4.
CODE Cavity 40 -- All lots; Cavity 43 -- All lots manufactured
between January 18 and February 16, 1993.
MANUFACTURER Vermont Plastics, Inc., Montpelier, Vermont (contract
manufacturer).
RECALLED BY Ciba Corning Diagnostics Corporation, Oberlin, Ohio, by
letter February 24, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 593 boxes of 100 magazines were distributed. Each magazine
holds 13 cuvettes, each cuvette consists of 5 wells.
REASON The device was found to have been manufactured with square
corners instead of the customary rounded corners, which may
cause reagent carry-over, potentially effecting test
results.
_______________
PRODUCT Sunbronze Cosmos 85/2 Tanning Beds. Recall #Z-1228-4.
CODE Model Sunbronze Cosmos 85/2.
-7- MANUFACTURER European Sun Systems, St. Louis, Missouri.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan July 1, 1994. Firm-initiated field correction ongoing.
DISTRIBUTION Texas.
QUANTITY 10 units.
REASON The remanufactured sunlamp products failed to incorporate
timers and their quality control failed to indicate a check
for installation of compliant timers.
_______________
PRODUCT Air-Shields Transilluminators, used to deliver visible light
through the body tissue of infants in the placement of
I.V.'s and in the diagnosis of pneumothorax:
(a) Part #LT90700 (120); (b) Part #LT91500 (220-240V);
(c) Part #LT96000 (100V). Recall #Z-1234/1236-4.
CODE Serial numbers: TRA 00017-TRA 00118.
MANUFACTURER Endura Plastics, Kirtland, Ohio (component supplier).
RECALLED BY Lumitrex, Inc., Strongsville, Ohio, by letters of August 19,
1993, and December 1, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania.
QUANTITY 100 units were distributed; firm estimates that 29 units
remained on market at time of recall.
REASON A plastic clip inside the transilluminator was manufactured
utilizing an incomplete drying process. This causes the
clip to be weak.
_______________
PRODUCT Sarns 8000 Line Occluder, Part #16418, indicated to control
the flow of blood through the venous line.
Recall #Z-1239-4.
CODE Serial numbers 1001 - 1039.
MANUFACTURER Sarns 3M Health Care, Ann Arbor, Michigan.
RECALLED BY Manufacturer, by letter October 22, 1993. Firm-initiated
recall complete.
DISTRIBUTION California, Delaware, Indiana, Kentucky, Massachusetts,
Michigan, New Jersey, New York, North Carolina, Ohio,
Pennsylvania, South Carolina, Tennessee, Washington state,
Washington, D.C., Singapore, Hong Kong, Canada, Germany,
Japan, Australia, Scotland, Italy.
QUANTITY 39 units were distributed.
REASON The knob used to control gradual blood flow was incorrectly
designed, resulting in inadequate control of blood flow in
some units.
_______________
PRODUCT Sarns Air Sensors, air bubble detectors: (a) Part #13540,
3/8"; (b) Part #15020, 1/4". Recall #Z-1240/1241-4.
CODE Serial numbers: (a) 1053, 1055, 1074, 1104, 1152, 1203,
1282, 1605, 1608, 1763, 1832, 1910, 1914, 2092, 2145, 2178,
2324, 2442, 2479, 2688, 2723, 2736, 2742, 2748, 2778, 3107,
3170-3398, 3400, 3402, 3403, 3420; (b) 1041, 1058,
1223-1266.
-8- MANUFACTURER Sarns 3M Health Care, Ann Arbor, Michigan.
RECALLED BY Manufacturer, by letter April 14, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 273 units; (b) 46 units were distributed.
REASON An electrical short may occur in some units rendering these
units nonfunctional.
_______________
PRODUCT Report Master II Version 2.0C, software data diskette for
Gemstar II Chemistry System. A software program that
charts, flags, calculates and stores blood test chemistry
results: (a) Part #402275; (b) Part #402276.
Recall #Z-1258/1259-4.
CODE Revision C, version 2.0.
MANUFACTURER Schiapparelli Biosystems, Inc., Fairfield, New Jersey.
RECALLED BY Manufacturer, by letter November 11, 1993. Firm-initiated
field correction complete.
DISTRIBUTION Nationwide.
QUANTITY 87 copies were distributed.
REASON A false BUN/Creatine ratio may be calculated when either a
BUN or Creatine value has not been entered by the user.
_______________
PRODUCT Zoll Medical Corporation Internal Paddles, used for
defibrillation during open heart surgery. Recall #Z-1263-4.
CODE Model #PD2801, serial numbers: 446 through 455.
MANUFACTURER Zoll Medical Corporation, Burlington, Massachusetts.
RECALLED BY Manufacturer, by telephone February 27, 1992. Firm-
initiated recall complete.
DISTRIBUTION Illinois, Kentucky, Tennessee, Texas.
QUANTITY 10 units were distributed.
REASON A situation could allow an improperly routed wire to shorten
pins 9 and 10, causing the unit to fail.
_______________
PRODUCT Model 1000 Ophthalmic Laser Workstation, used in ophthalmic
surgery. Recall #Z-1271-4.
CODE Model 1000.
MANUFACTURER Phoenix Laser Systems, Inc., Fremont, California.
RECALLED BY Manufacturer. FDA approved the firm's corrective plan May
26, 1994. Firm-initiated recall complete.
DISTRIBUTION Florida, California.
QUANTITY 2 units.
REASON The device was found to lack an emission indicator for the
aiming beam, the warning logotype label carried inaccurate
HeNe output information, and the operator's manual lacked
calibration procedures.
_______________
PRODUCT ND:YAG Ophthalmic Laser System, used in posterior
capsulotomies. Recall #Z-1300-4.
-9- CODE Model LQ2106.
MANUFACTURER Laserex Systems, Adelaide, S.A., Australia.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan June 27, 1994. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 103 units.
REASON The joystick aiming beam control in the slitlamp was poorly
seated causing internal electrical wires to become
prematurely worn and broken. The condition could result in
accidental firing of the laser.
_______________
UPDATE Sharper Image Relaxation System, Recall #Z-1153-4 which
appeared in the August 3, 1994, Enforcement Report should
read:
RECALLED BY: Sharper Image Corporation, doing business as
The Sharper Image, San Francisco, California.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Abbott Test Pac RSV, Enzyme Immunoassay for the rapid
detection of respiratory syncytial virus from nasopharyngeal
washes, aspirates, and swabs.
Recall #Z-1260-4.
CODE List #2027-16, lot numbers: 82343M100 EXP 6/9/94, 82345M100
EXP 7/23/94.
MANUFACTURER Abbott Laboratories, Abbott Park, Illinois.
RECALLED BY Manufacturer, by telephone November 17, 1993, followed by
letter November 18, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Canada, Chile, Italy, Japan, Taiwan, Germany.
QUANTITY 285 kits were distributed; firm estimates none remains on
the market.
REASON The RSV reaction discs in the kits could provide false
positive results if the specimen is transported in saline.
_______________
PRODUCT Immunocytochemical assay in-vitro diagnostic kits which all
contain 6 ml vials of PAP Complex [Peroxidase (horseradish):
Anti-Peroxidase (rat) Complex] from the same bulk lot:
(a) Abbott ER-ICA Monoclonal, Immunocytochemical assay
for the detection of Human Estrogen Receptor in human breast
tissue, used as an aid in predicting patient response to
hormonal therapy and in the prognosis and management of
breast cancer patients, list #3087-18, 30 test kit;
(b) Abbott PgR-ICA Monoclonal, Immunocytochemical assay for
the detection of Human Progesterone Receptor in human breast
tissue, used as an aid in predicting patient response to
hormonal therapy and in the management of breast cancer
patients, list #2A08-18, 30 test kit;
-10- (c) Abbott PgR-ICA Monoclonal, For Investigational Use Only;
Immunocytochemical assay for the detection of Human
Progesterone Receptor in human breast tissue, list #6A74-18,
30 test kit. Recall #Z-1264/1266-4.
CODE Kit master lots: (a) 83845M200, EXP 09/14/94, 82483M200,
EXP 09/14/94; (b) 82177M300 EXP 07/27/94, (c) 83265M100, EXP
07/27/94, 83265M101 EXP 07/27/94.
MANUFACTURER Abbott Laboratories, Abbott Park, Illinois.
RECALLED BY Manufacturer, by telephone February 23, 1994. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 557 kits; (b) 396 kits; (c) 73 kits were distributed.
REASON Certain ER-ICA test kits were found to have flocculent
material in the PAP Complex and certain PgR-ICA test kits
were found to have microbial contamination in the PAP
Complex.
_______________
PRODUCT Kodak Ektachem Performance Verifier II and Diluent Set II,
Catalog #8231474, a lyophilized solution used for quality
control of the Ektachem analyzers marketed by Kodak. Recall
#Z-1267-4.
CODE Lot B1031 (use before 2/96).
MANUFACTURER Eastman Kodak Company, Rochester, New York.
RECALLED BY Manufacturer, by letter March 30, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY 2,941 boxes were distributed between 2/14/94 and 3/28/94.
REASON Some bottles of Performance Verifier I are labeled as
bottles of Performance II. Performance Verifier I and II
have differing properties and on diluting there is a color
difference.
_______________
PRODUCT HDL Cholesterol Kits used in conjunction with the HDLC slide
to quantitatively measure high density lipoprotein
cholesterol: (a) Kodak Ektachem HDL Cholesterol, CAT 146
3256, contains 100 tubes plus 1 bottle diluent and is used
with the Ektachem Mainframe analyzer;
(b) Ektachem DT HDL Cholesterol Kit, CAT 148 0664, contains
25 slides, 27 macro tubes, and one bottle of diluent used
with the desk top Ektachem analyzer; (c) Ektachem DT Micro
HDL Cholesterol Kit, CAT 133 5504, contains 25 slides, 27
micro tubes and one bottle of diluent used with the desk top
Ektachem analyzer. Recall #Z-1268/1270-4.
CODE (a) Kit #17 or above for Mainframe; (b) Macro Kit #76 or
above; (c) Micro Kit #27 or above.
MANUFACTURER Eastman Kodak Company, Rochester, New York.
RECALLED BY Eastman Kodak Company, Clinical Diagnostics Division,
Rochester, New York, by letters dated October 19 and 26,
1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Canada.
-11- QUANTITY Approximately 14,500 kits used on the mainframe Ektachem
analyzers and 14,500 kits used on the Desk Top models were
distributed between August and November 1993.
REASON The tubes are filled with a small quantity of dextran
sulfate which sticks to the top of the test tube cap. When
the test tube is opened, some of the dextran sulfate falls
out which results in a false test result.
MEDICAL DEVICE SAFETY ALERTS:
=============================================
_______________
PRODUCT Relay and Stride Models Pulse Generators:
(a) Relay Model 293-03 5mm Unipolar DDDR implantable, dual-
chamber multiprogrammable pulse generator; (b) Relay Model
294-03 VS-1 Unipolar/Bipolar DDR Implantable, dual-chamber
multiprogrammable pulse generator; (c) Stride Model 294-05
VS-1 Unipolar/Bipolar DDDR implantable, dual-chamber,
multiprogrammable pulse generator.
Safety Alert #N-052/054-4.
CODE Serial numbers below 51100.
MANUFACTURER Intermedics, Inc., a company of Sulzer Medica, Angelton,
Texas.
ALERTED BY Manufacturer, by letter July 8, 1994.
DISTRIBUTION Nationwide and international.
QUANTITY 8,607 units were distributed between 8/10/90 and 7/94.
REASON Certain pulse generators with serial numbers below 51100
have a possiblity of reverting to the VVI mode at a rate of
70 ppm (backup pacing) if programmed to one of several
specific ventricular pulse widths. Reversion could cause
symptoms requiring medical assistance in approximately 30-
40% of patients.
MASS SEIZURES:
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PRODUCTS Various Veterinary Drugs (S. 93-669-021, et al).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the articles' manufacture, processing,
packing, and holding do not conform to or, upon inspection,
failed to conform to and are not operated and administered
in conformity with current good manufacturing practice
requirements.
LOCATION Argent Chemical Laboratories, Inc., Redmond, Washington.
FILED July 29, 1994; U.S. District Court for the Western
District of Washington; Civ. #C94-1120; FDC #66900.
SEIZED August 11, 1994 - goods valued at approximately $109,270.
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PRODUCT Oxygen, U.S.P. (94-671-704).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the articles' manufacture, processing,
-12- packing, and holding do not conform to and are not operated
and administered in conformity with current good
manufacturing practice requirements.
LOCATION Welding and Therapy Services, Inc., doing business as
Industrial Oxygen Co., Louisville, Kentucky.
FILED July 26, 1994; U.S. District Court for the Western District
of Kentucky; Civ. #C-94 9466 L-M; FDC #66944.
SEIZED August 12, 1994 - goods valued at approximately $51,872.
SEIZURES:
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PRODUCT Frozen Crab Meat (94-557-175).
CHARGE Adulterated - The article consists in part of decomposed
crab meat.
LOCATION South Atlantic Cold Storage, Inc., Jacksonville, Florida.
FILED July 11, 1994; U.S. District Court for the Middle
District of Florida, Jacksonville Division; Civ. #94-662-
CIV-J-20; FDC #66996.
SEIZED July 26, 1994 - goods valued at approximately $47,000.
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PRODUCT Frozen Shrimp (94-713-500).
CHARGE Adulterated - The article consists in part of a decomposed
shrimp.
LOCATION Los Angeles Cold Storage, Los Angeles, California.
FILED July 12, 1994; U.S. District Court for the Central District
of California; Civ. #94-4660JS2; FDC #66995.
SEIZED July 20, 1994 - goods valued at approximately $21,428.
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PRODUCT Frozen Rock Lobster Tails (S. 94-682-248/9).
CHARGE Adulterated - The article consists in part of decomposed
seafood.
LOCATION National Freezers, Inc., Miami, Florida.
FILED June 30, 1994; U.S. District Court for the Southern District
of Florida; Civ. #94-1351-CIV-UNGARO-BENAGES; FDC #66960.
SEIZED July 28, 1994 - goods valued at approximately $46,500.
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END OF ENFORCEMENT REPORT FOR AUGUST 24, 1994. BLANK PAGES MAY
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