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
05/19/1993

Recalls and Field Corrections: Foods -- Class I -- 05/19/1993

May 19, 1993 93-20

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________________
PRODUCT Chunk Light Tuna and Solid White Tuna, in 6-1/8 ounce metal
cans, in shrink wrapped packages of 4, 6, or 8 cans.
Recall #F-227-3.
CODE All lots shrink wrapped by Westgate Packaging and Storage
Company.
MANUFACTURER Westgate Packaging and Storage Company, Long Beach,
California (repacker).
RECALLED BY Van Camp Seafood Company, Inc., San Diego, California, by
telephone February 11, 1993. Firm-initiated recall
complete.
DISTRIBUTION Washington state, Oregon, Alaska, Montana, California,
Nevada, Hawaii, Idaho, Utah.
QUANTITY 518,063 cases were distributed.
REASON Product in punctured or cut cans has the potential to
become contaminated with Clostridium botulinum bacteria or
spores with subsequent production of neurotoxin.
_______________
PRODUCT Mrs. Grissom's Salads ready to eat cheese products,
packaged in clear rigid plastic tubs: (a) Cheese Spread,
in 7 ounce, 12 ounce and 24 ounce tubs; (b) Chunky Cheese
Spread, in 12 ounce tubs. Recall #F-270/271-3.
CODE May 1 and May 9.
MANUFACTURER Mrs. Grissom's Salads, Inc., Nashville, Tennessee.
RECALLED BY Manufacturer, by notice distributed March 4 and 24, 1993.
Firm-initiated recall complete.
DISTRIBUTION Alabama, Illinois, Indiana, Kentucky, Mississippi,
Tennessee.
QUANTITY (a) 6,920 7-ounce tubs, 4,079 12-ounce tubs, 1,409 24-ounce
tubs; (b) 4,785 12-ounce tubs were distributed; firm
estimates none remains on the market.
REASON Product is contaminated with Listeria monocytogenes.

_______________
PRODUCT New Zealand Turner brand vacuum packed Smoked Mussels in
plastic pouches (a) 8 ounces; (b) 4 ounces; (c) Frozen Half
Shell New Zealand Green Shell Mussels in bulk cases.
Recall #F-286/288-3.
CODE All lots.
MANUFACTURER Kiwi Mussels Ltd., Nelson, New Zealand.
RECALLED BY Turner Seafood International, Inc., Newport Beach,
California, by telephone on or about December 28, 1992, and
extended by letters on February 4 and 24, 1993. Firm-
initiated recall complete.
DISTRIBUTION California, Colorado, Florida, Georgia, Illinois, Kansas,
Maryland, Maine, Michigan, North Carolina, Nevada,
Oklahoma, Oregon, Pennsylvania, Texas, Utah.
QUANTITY 309 cases were distributed; firm estimates none remains on
the market.
REASON Product is contaminated with Listeria monocytogenes.

_______________
PRODUCT Fresh Crabmeat in 16 ounce plastic cups: (a) Jumbo Lump
Crabmeat; (b) Special Crabmeat; (c) Claw Crabmeat.
Recall #F-320/322-3.
CODE None.
MANUFACTURER NTT Seafood, Inc., Southport, Florida.
RECALLED BY Manufacturer, by telephone March 15, 1993, and by letter
March 16, 1993. Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY (a) 120 pounds; (b) 252 pounds; (c) 22 pounds were
distributed.
REASON Product is contaminated with Listeria monocytogenes.

_______________
PRODUCT Enteral feeding formulations with color-check (blue and
orange) and ultralan (regular no color) used as complete
nutrition supplements, packaged in 1 liter bottles:

-2- (a) Isolan Medical Food;
(b) Introlan Medical Food;
(c) Nitrolan Medical Food
(d) Fiberlan Medical Food
(e) Isolan Blue Medical Food
(f) Introlan Blue Medical Food
(g) Nitrolan Blue Medical Food
(h) Fiberlan Blue Medical Food
(i) Ultralan Blue Medical Food
(j) Isolan Orange Medical Food
(k) Introlan Orange Medical Food
(l) Nitrolan Orange Medical Food
(m) Fiberlan Orange Medical Food
(n) Ultralan Orange Medical Food
(o) Ultralan Medical Food. Recall #F-323/337-3.
CODE All lots.
MANUFACTURER Imperial Flavours, Inc., Ontario, Canada.
RECALLED BY Elan Pharma (MA), Inc., Cambridge, Massachusetts, by letter
March 4 & 11, 1993. Firm-initiated recall ongoing.
DISTRIBUTION California, Michigan, Minnesota, Maryland, Pennsylvania,
North Carolina, Rhode Island, Washington state, New York,
Massachusetts, Connecticut, New Hampshire.
QUANTITY (a-d) 78,976 cases (6 bottles per case); (e-n) 5,937 cases
(6 bottles per case); (o) 5,630 cases (6 bottles per case)
were distributed; firm estimates 10-30 percent of these
amounts remains on the market.
REASON Products are superpotent in potassium content.

_______________
PRODUCT Swedish Fontina Cheese, 1 cheese wheel, approximately 12
pounds coated in red wax per case. Recall #F-339-3.
CODE 920817, 920627, 92415, 92042.
MANUFACTURER Gallstad Dairy, Gallstad, Sweden.
RECALLED BY A.V. Ollson Trading Company, Inc., Greenwich, Connecticut,
by letters of April 6 and 7, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 7,090 cases were distributed.
REASON Product is contaminated with Listeria monocytogenes.

_______________
PRODUCT Smoked, sliced Nova Salmon and Nova Chips, sliced-smoked.
Recall #F-340/341-3.
CODE Case coded "2", which indicates week of manufacture with
the firm's fiscal year that begins in February.
MANUFACTURER Springfield Smoked Fish Company, Inc., Springfield,
Massachusetts.
RECALLED BY Manufacturer, by letter on 4/1/93. Firm-initiated recall
ongoing.
DISTRIBUTION Eastern United States including Massachusetts, Connecticut,
New York, New Jersey, Ohio, Florida.

-3-QUANTITY 624 pounds were distributed.
REASON Product is contaminated with Listeria monocytogenes.

_______________
PRODUCT Individually Cooked Quick Frozen Shrimp in various package
sizes, under the following labels: Brilliant Family Pack,
Meijer Cookes Salad Shrimp and A & P Peeled and Cleaned
Cooked Shrimp. Recall #F-342-3.
CODE Date codes NE2032N through NE3502N.
MANUFACTURER New England Shrimp Company, Ayer, Massachusetts.
RECALLED BY Manufacturer, by letter January 29, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 50,272 cases were distributed.
REASON Product is contaminated with Listeria monocytogenes.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________________
PRODUCT Kool-Aid Koolbursts Soft Drink, orange flavor, in 6.75
fluid ounce plastic squeeze bottles. Recall #F-319-3.
CODE Lot numbers: 2288W, 2289W, 2290W (first 5 characters on
carton code), case code date 42/92 (last 4 characters on
case).
MANUFACTURER Kraft General Foods, Inc., General Foods USA, Winchester,
Virginia.
RECALLED BY Kraft General Foods, Inc., Glenview, Illinois, by letter
April 23, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Alabama, Louisiana, North Carolina, South Carolina,
Florida, Georgia, Tennessee, Mississippi, Virginia.
QUANTITY 5,857 cases (6 bottles per case) were distributed; firm
estimates 40 percent of the product remains on the market.
REASON Product is contaminated with copper.

_______________
PRODUCT Harrisburg Dairies brand Lemon Tea Cooler, in 1 gallon
plastic containers, half-gallon and pint paper cartons.
Recall #F-338-3.
CODE All product manufactured before 4/15/93.
MANUFACTURER Harrisburg Dairies, Inc., Harrisburg, Pennsylvania.
RECALLED BY Manufacturer, by letter dated April 16, 1993, and by visits
on April 19-20, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania.
QUANTITY Firm estimates none remains on the market.
REASON Product contains undeclared FD&C Yellow No. 5.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________________
PRODUCT Trail Mix, Recall #F-314-3.
CODE Uncoded. All product is under recall.

-4-MANUFACTURER California Products of New Jersey, East Brunswick, New
Jersey.
RECALLED BY Manufacturer, by visit. Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 320 2.5-ounce bags.
REASON Product contains sulfites that are not declared on the
label.

________________
PRODUCT Light n' Lively Dipped Vanilla Frozen Dessert Bars, 12 bars
(1.75 fluid ounces each) per carton. Recall #F-318-3.
CODE All lots.
MANUFACTURER Kraft General Foods Frozen Products, Avon, New York.
RECALLED BY Kraft General Foods, Inc., Glenview, Illinois, by letter
April 14, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Vermont, Maine, New York, Massachusetts, Pennsylvania, New
Jersey.
QUANTITY 7,865 cases were distributed; firm estimates that 50
percent of the product remains on the market.
REASON Product labeled as nonfat when it contains 6 percent fat.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________________
PRODUCT Kapseals Dilantin (Phenytoin Sodium) with 1/4 gr
Phenobarbital, in 100 and 1,000 capsule bottles, 16 mg;
(b) Kapseals Dilantin (Phenytoin Sodium) with 1/2 gr
Phenobarbital, in 100 and 1,000 capsule bottles, 32 mg.
Recall #D-265/266-3.
CODE All lots.
MANUFACTURER Warner-Lambert Company, Lititz, Pennsylvania.
RECALLED BY Warner-Lambert Company, Morris Plains, New Jersey, by
letter January 25, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY (a) 153,645 bottles; (b) 309,014 bottles were distributed.
REASON Products do not meet dissolution specifications.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________
PRODUCT Soothers Throat Drops Cherry Flavor, 25 drops per bag, for
temporary relief of occasional minor irritation, pain, sore
mouth, and sore throat or pain associated with canker
sores. Recall #D-264-3.
CODE Lot numbers: 03062E41 EXP 6/94, 03062E42 EXP 6/94.
MANUFACTURER Halls Limited (Warner-Lambert) Halls Brothers, Manchester,
England.
RECALLED BY Warner-Lambert Company, Morris Plains, New Jersey, by
letter January 21, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 19,968 bags were distributed.

-5-
REASON Packaging mix-up. Some packs contain both Soothers Throat
Drops and Halls Plus Cough Tablets.

_______________
PRODUCT Literature promoting Accurate's capability to compound unit
dose bronchodilator medications, Rx new drugs without
approved drug applications, as follows:
Brochure titled "The Accurate Pharmacy Unit-Dose
Bronchodilator Medication Program for the Home Aerosol
Therapy Patient";
Single Sheets titled "Aerosol Therapy Services" and "Cardio
Pulmonary Services";
Pamphlets titled "Unit Dose Bronchodilator Medications For
The Home Aerosol Therapy Patient" and "Unit Dose Has A New
Look;
"Any type of advertising or promotional literature that
implies or suggests that Accurate would compound medication
pursuant to a prescription." Recall #D-267-3.
CODE All literature distributed.
MANUFACTURE Accurate Medical Equipment and Supply Pharmacy.
RECALLED BY Manufacturer, by letter July 24, 1992. Firm-initiated
field correction complete.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Literature promoted firm's capability to compound drugs is
regarded by FDA as labeling for unapproved new drugs.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I
_______________
PRODUCT (a) Autogenous Vaccines: Acinetobacter calcoaceticus-
antitratum, Branhamella catarrhalis, Bacillus cereus,
Bacteroides fragilis, Bordetella pertussis, Campylobacter
jejuni, Candida Albicans, Chlamydia Trachomatis,
Citrobacter freundii, coccidioides immitis (early and late
antigens), Corynebacterium pseudodiphtheriticum,
Corynebacterium xerosis, Corynebacterium parvum,
Escherichia coli, Enterobacter cloacae, Enterococcus,
Gardnerella vaginalis, Haemophilus influenzae, Heliobacter
pylori, Klebsiella pneumoniae, Klebsiella pneumoniae 1 & 2,
Mycoplasma arthritidis, Mycoplasma fermentans, Mycoplasma
genitalium, Mycoplasma pneumoniae, Propionibacterium acnes,
Proteus mirabilis, Proteus Vulgaris, Pseudomdonas
aeruginosa, Salmonella enteriditis, Shigella Flexneri,
Staphylococcus aureus, Staphylococcus epidermidis,
Staphylococcus haemolyticus, Steptococcus faecalis,
Stereptococcus pneumoniae, Streptococcus sanguis Type I &
II, Treponema pallidum, Yersinia entercolitica, Alpha
Streptococcus, and Beta Streptococcus; (b) Bacterial
Antigens;

-6- (c) Viral Antigens: Adenovirus, Cytomegalovirus, Common
Wart Virus, Coxsackievirus A-9, Coxsackievirus B-2,
Coxsackievirus B-3, Coxsackievirus B-5, Coxsackievirus B-6,
Dengue Virus Type 1, Epstein-Bar Virus, Herpes Virus 1&2,
Herpes Virus Type 6, Influenza Virus Type C, Influenza
Virus Type B, Lymphocytric Choriomenigitic Virus, Rubeola
Virus, Mixed Coxsackie-ECHO Virus, Mumps Virus, Plantar
Wart Virus, Pneumococcus, Polio Virus 1, 2, 3, Respiratory
Syncytial Virus, Rotavirus, Rubella Virus, and Varicella
Zoster Virus; (d) Parasitic Antigens: Ascaris, Entameoba
histolytica, Giardia lamblia, and Pityrosporium sp.
Recall #B-229/232-3.
CODE None.
MANUFACTURER Valley Microbiology Services, Palo Alto, California.
RECALLED BY Manufacturer, by letter dated July 30, 1992. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, New Zealand.
QUANTITY Undetermined.
REASON Autogenous vaccines and bacterial, viral, and parasitic
antigens, which were adulterated and misbranded, were
distributed for sublingual or injectable administration.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-153/154-3.
CODE Unit numbers: (a) 1376782; (b) 1389866, 1390599.
MANUFACTURER Department of the Army, Womack Army Community Hospital
Blood Bank, Fort Bragg, North Carolina.
RECALLED BY Manufacturer, by telephone. Firm-initiated recall
complete.
DISTRIBUTION (a) New York, New Jersey; (b) New York, Pennsylvania.
QUANTITY (a) 1 unit; (b) 2 units.
REASON Blood products which tested negative for the antibody to
human immunodeficiency virus type 1 (anti-HIV-1), but were
collected from donors who previously tested repeatedly
reactive for anti-HIV-1, tested initially reactive for
anti-HIV-1, or labeled with incorrect expiration date, were
distributed.

________________
PRODUCT Red Blood Cells, Deglycerolized. Recall#B-161-3.
CODE Unit numbers: TM0100274, TM0100288.
MANUFACTURER Personal Blood Storage of Hilton Head Island, Inc.,
Columbia, South Carolina.
RECALLED BY Manufacturer, by telephone January 5, 1992. Firm-initiated
recall complete.
DISTRIBUTION South Carolina.
-7-
QUANTITY 2 units.
REASON Blood products, labeled with incorrect expiration dates,
were distributed.

_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Platelets;
(d) Fresh Frozen Plasma; (e) Recovered Plasma.
Recall #B-212/216-3.
CODE Unit numbers: (a) 33J1350, 33K27101; (b) 33F33553,
33G13682, 33G23279, 33G43191, 33G97580, 33H30954, 33J01549,
33J40096, 33J84311, 33KL28392, 33KR43375, 33L11524,
33L75465, 33N64720, 33N79550, 33S05809, 33S11426, 33T23489;
(c) 33F33553, 33G02024, 33H30954, 33J01549, 33KL28392,
33L11524, 33N64720, 33T23489;
(d) 33G02024, 33H30954, 33J01549, 33KL28392;
(e) 33F33553, 33G13682, 33G23279, 33G43191, 33G69127,
33G97580, 33H06091, 33J40096, 33J84311, 33KG23579,
33KR43375, 33KS63288, 33L11524, 33L75465, 33N64720,
33N79550, 33S05809, 33S11426, 33T23489.
MANUFACTURER American Red Cross Services, Farmington, Connecticut.
RECALLED BY Manufacturer, by letters sent between January 22, 1991, and
October 10, 1991. Firm-initiated recall ongoing.
DISTRIBUTION (a) Connecticut; (b) Connecticut, New York; (c)
Connecticut; (d) Connecticut; (e) New York, California,
North Carolina, The Netherlands.
QUANTITY (a) 2 units; (b) 18 units; (c) 8 units; (d) 4 units; (e) 19
units.
REASON Blood products collected from donors who engaged in high
risk behavior, previously tested repeatedly reactive for
the antibodies to human immunodeficiency virus type-1
(anti-HIV-1), or had histories of hepatitis or jaundice,
were distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________
PRODUCT Red Blood Cells. Recall #B-155-3.
CODE Unit numbers: 1390026, 1390027, 1390028, 1390029, 1390031,
1390036, 1390037, 1390040.
MANUFACTURER Department of the Army, Womack Army Community Hospital
Blood Bank, Fort Bragg, North Carolina.
RECALLED BY Manufacturer, by letter February 7, 1992. Firm-initiated
recall complete.
DISTRIBUTION New Jersey.
QUANTITY 8 units.
REASON Red Blood Cells labeled with incorrect expiration date were
distributed.
-8-RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________
PRODUCT Abbott Vision Hemoglobin Test Pack, an in-vitro diagnostic
for the determination of hemoglobin. Recall #Z-537-3.
CODE Lot #70764A400 EXP 7/1/93.
MANUFACTURER Abbott Laboratories, Diagnostics Division, North Chicago,
Illinois.
RECALLED BY Abbott Laboratories, Diagnostics Division, Abbott Park,
Illinois, by telephone February 15, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Italy, Japan, Singapore, Australia, Germany.
QUANTITY 3747 cartons of 10 testpacks each were distributed; firm
estimates none remains on the market.
REASON This lot number gives a low specimen result, which may not
reflect the patient's true hemoglobin level.

_______________
PRODUCT Sharplan CO2 Surgical Laser Systems: (a) Model 734; (b)
Model 1040; (c) Model 1060. Recall #Z-538/540-3.
CODE All serial numbers.
MANUFACTURER Sharplan Lasers, Inc., Allendale, New Jersey.
RECALLED BY Manufacturer, by letter February 7, 1992. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 817 units were distributed.
REASON Casters with bearing housings of 60 mm diameter and
attached to the laser with three screws may be subject to
damage and failure which can cause the laser to fall over.

_______________
PRODUCT Super Sun F73-7.5 Sunlamps. Recall #Z-541-3.
CODE Serial numbers: Undetermined.
MANUFACTURER Alisun America, Ltd., McHenry, Illinois.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan March 29, 1993. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 13 units were distributed.
REASON Noncompliance with the performance standards for sunlamp
products in that the products are not equipped with a timer
system precluding the setting of exposure times greater
than the appropriate Maximum Recommended Exposure Time
(MRET) for the product, the product labeling does not
include an appropriate exposure schedule and MRET, and no
initial or model change reports were submitted for the
products.

-9-
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________
PRODUCT Kodak Amerlex-M High Sensitivity Unconjugated Estriol RIA
Kit, an in-vitro diagnostic used to measure unconjugated
estriol in human serum or plasma. Recall #Z-532-3.
CODE Product Nos. IM5041 and IM5044, Lots 510 and 520;
MANUFACTURER Clinical Diagnostic Ltd., Cardiff, Wales, United Kingdom.
RECALLED BY Eastman Kodak Company, Clinical Products Div., Rochester,
New York, by telephone September 11, 1992, followed by
letter dated September 16, 1992. Firm-initiated field
correction complete.
DISTRIBUTION Nationwide.
QUANTITY 160 kits were distributed; firm estimates that all units
were corrected.
REASON The label on the tray holding the standards has the value
of the units reversed, that is, the values of the ng/ml was
transposed with the values of nmol/L.

_______________
PRODUCT Amerlite Progesterone Assay Kit, an in-vitro-diagnostic
used to measure the amount of progesterone in human serum
or plasma. Recall #Z-533-3.
CODE Product Nos. 2079 and 0079, Lot 340.
MANUFACTURER Clinical Diagnostic Ltd., Cardiff, Wales, United Kingdom.
RECALLED BY Eastman Kodak Company, Clinical Products Div., Rochester,
New York, by telephone between August 18-20, 1992. Firm-
initiated field correction complete.
DISTRIBUTION Michigan, California.
QUANTITY 4 kits were distributed; firm estimates none remains on the
market.
REASON Two of the standards in vials identified with letters B and
F, 2 nmol/L and 160 nmol/L respectively, were labeled to
contain 3 ml but actually contained 1 ml.

_______________
PRODUCT Kodak HCG/UE3 Multiconstituent Control Sera Kit, used to
measure unconjugated estriol and human chorionic
gonadotropin. Recall #Z-534-3.
CODE Product No. QAS 116, Lot #1 EXP 1/94.
MANUFACTURER Clinical Diagnostic Ltd., Cardiff, Wales, United Kingdom.
RECALLED BY Eastman Kodak Company, Clinical Products Div., Rochester,
New York, by telephone followed by letter July 14, 1992.
Firm-initiated field correction complete.
DISTRIBUTION Nationwide.
QUANTITY 200 kits were distributed.
REASON The package insert had misprinted the Expected Ranges
Values of the standards for the assay.

-10-_______________
PRODUCT Amerlite Digoxin Assay Kits, an in-vitro diagnostic used to
measure the amount of digoxin in human serum or plasma.
Recall #Z-535-3.
CODE Product Nos. LAN2700 (144 test units) and LAN0700 (240 test
units), Lots Nos. 46, 47, 47a, 48, 48a. The lot number of
the standards, a component of the kit, is 7.
MANUFACTURER Clinical Diagnostic Ltd., Cardiff, Wales, United Kingdom.
RECALLED BY Eastman Kodak Company, Clinical Products Division,
Rochester, New York, by telephone followed by letter May 1,
1992. Firm-initiated recall complete.
DISTRIBUTION Texas, California.
QUANTITY 2 kits were distributed.
REASON The values of the lot 7 standards have changed since their
initial calibration.

______________
PRODUCT Amerlite Analyzer Application Software Version 8.2U.
Recall #Z-536-3.
CODE Catalog No. 140-3971, serial Nos. 82-0846, 82-0851,
82-0863, 82-0867, 82-0892, 82-0900, 82-0903.
MANUFACTURER Clinical Diagnostic Ltd., Cardiff, Wales, United Kingdom.
RECALLED BY Eastman Kodak Company, Clinical Products Division,
Rochester, New York, by telephone October 2, 1992, followed
by letter. Firm-initiated recall complete.
DISTRIBUTION Texas, Tennessee, New York, Connecticut, California.
QUANTITY 7 disks were distributed; firm estimates none remains on
the market.
REASON Version 8.2 used for analyzers in Europe and allowing for
editing of the standard curve was mislabeled as Version
8.2U used for the U.S. market and does not allow editing of
the standard curve.

_______________
UPDATE The Enforcement Report dated April 28, 1993 incorrectly
labeled recall number Z-476-3 as the Nellcor N-250 Pulse
Oximeter/ECG Monitor Manual. It should read:
PRODUCT Nellcor N-1000 Pulse Oximeter/ECG Monitor. Recall #Z-476-3.
CODE All serial numbers distributed between 3/25/88 and 10/4/91.
MANUFACTURER Nellcor, Inc., Chula Vista, California.
RECALLED BY Nellcor, Inc., Hayward, California, by letter of October 4,
1991, followed by telephone calls from January 18 through
May 8, 1992. Firm-initiated field correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY 8,803 units were distributed.
REASON The alarm silence switch has a hard plastic insert which
had been determined to be contacting soldered connections
on the circuit board underneath when pressed. After many
pushes the insert would push the soft solder across the
board and short a nearby circuit, causing a malfunction in
the alarm.
-11-MEDICAL DEVICE SAFETY ALERTS:
_______________
PRODUCT Ventak AICD Automatic Implantable Cardioverter
Defibrillators: (a) Model 1550; (b) Model 1555; (c) 1600.
Safety Alert #N-051/053-3.
CODE Units distributed from May 1991 to end of March 1993.
MANUFACTURER Cardiac Pacemakers, Inc., St. Paul, Minnesota.
ALERTED BY Manufacturer, by letter April 8, 1993.
DISTRIBUTION Nationwide and international.
QUANTITY 1,641 units were distributed.
REASON Some of these models contain suspect capacitors which may
result in patients receiving shocks at heart rates below
the programmed rate cutoff due to oversensing.

MASS SEIZURE:
_______________
PRODUCT Omnitron 2000 High Dose Rate Remote Afterloader System (a
device intended to provide brachytherapy treatment to cancer
patients through the delivery of high doses of radiation),
including all in-process components, raw materials, and the
labeling and promotional literature associated with the
article (93-666-817/8).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the article's manufacture, packing,
storage, and installation are not in conformity with
applicable requirements under the current good manufacturing
practice regulations.
FIRM Omnitron International, Inc., Houston, Texas.
FILED April 29, 1993; U.S. District Court for the Southern
District of Texas, Houston Division; Civil #H-93-1288,
FDC #66700.
SEUZED May 4, 1993 - goods valued at approximately $4.5 million.

-12-

END OF ENFORCEMENT REPORT FOR MAY 19, 1993. BLANK PAGES MAY FOLLOW.
####