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.

April 22, 1998 98-16

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Carole's Texas Edibles Black Eye Pea Salsa, a
Texas caviar, in 9 ounce and 16 ounce jars.
Recall #F-357-8.
CODE Lots with pull codes NOV27,97 and JUN19,98.
MANUFACTURER Henry's Dream, Houston, Texas.
RECALLED BY Carole's Food Specialties, Pearland, Texas, by
telephone on September 5, 1997, followed by visits
on September 12 and 20, 1997. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 183 9-ounce, 275 16-ounce and 6 32-ounce jars were
distributed.
REASON Product is an acidified food which was
manufactured without registration or process
filing.

_______________
PRODUCT Chocolate Candy Eggs wrapped in foil and contained
in 7 ounce cello bags.
Recall #F-450-8.
CODE None.
MANUFACTURER De Bas Chocolatier, Fresno, California.
RECALLED BY Starbucks Coffee Company, Seattle, Washington, by
telephone on March 18, 1998. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY 239 packages were distributed.
REASON Product contains undeclared almonds.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Canned Chicken of the Sea Whole Oysters, in 8
ounce cans. Recall F-333-8.
CODE OYBL TY2 6528.
MANUFACTURER Shinjin Mooslan Company, Ltd., Republic of Korea.
RECALLED BY Chicken of the Sea, International (formerly Van
Camp Seafood), San Diego, California, by letter
faxed on March 16, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION Colorado, Iowa, Illinois, Kansas, Kentucky,
Michigan, Ohio, South Dakota, Wisconsin.
QUANTITY 2,086 cases (12 cans per case) were distributed;
firm estimated little product remained on market
at time of recall initiation.
REASON Product is unfit for food in that it contains
insect and animal filth.

_______________
PRODUCT Clintec NuBasics Complete Nutrition Chocolate
Splash, 250 Calories, 250 ml, a complete nutrition
diet drink for use as directed by a health care
professional. Recall #F-334-8.
CODE 7257EW992 (on cases) and 7257EWB1C992X (on cans)
Use By 14Sep98 (on cans).
MANUFACTURER Nestle Food Company, Nutritional Products
Division, Eau Claire, Wisconsin.
RECALLED BY Nestle Clinical Nutrition, Deerfield, Illinois, by
letter dated March 11, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 516 cases (24 cans per case) were distributed.
REASON The product is misbranded, in that, some cans are
labeled as NuBasics "Plus" instead of NuBasics
"Regular".

RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II =======
_______________
PRODUCT Hawaiian Tropic Herbal Aloe with Tea Tree Oil
Aromatherapy, promoted as a skin moisturizer
lotion, in 16 fluid ounce containers.
Recall #F-446-8.
CODE Lot numbers: 11011997, 11021997, 11031997.
MANUFACTURER Tanning Research Laboratories, Inc., Ormond Beach,
Florida.
RECALLED BY Manufacturer, by mail or fax with memorandum dated
January 15, 1998. Firm-initiated recall ongoing.
DISTRIBUTION Florida, Kentucky, South Carolina, Hawaii, and
international.
QUANTITY Approximately 3,150 boxes (12 bottles per case)
were distributed.
REASON Product may be contaminated with Burkholderia
cepacia.

_______________
PRODUCT Boraxo brand Waterless Hand Cleaners: a) Boraxo
Lotion Waterless Hand Cleaner with Pumice, 1
gallon, Item 388;
b) Boraxo Waterless Hand Cleaner Gel - Mechanic's
Strength with Pumice, Item 364;
c) Boraxo Waterless Hand Cleaner Gel - Mechanic's
Strength, 16 oz., Item 357, 4 lb. 8 oz., Item 356.
Recall #F-447/449-8.
CODE a) G016I2 574, I266I2 852, K256I2 1029, F267I2
413; b) K116I2 986; c) F067I2 368A (16 oz); K196I2
1019, B137I2 095, H157I2 557, H187I2 557 (4 lb 8
oz).
MANUFACTURER International Chemical, Inc., Amherst, New York.
RECALLED BY Dial Corporation, Scottsdale, Arizona, by
telephone beginning on November 6, 1997, followed
by letter dated November 6, 1997. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY 29,545 cases were distributed.
REASON The products may be contaminated with Burkholderia
cepacia.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS
III ==========
_______________
PRODUCT Resacol Tablets, OTC analgesic product that is
supposed to contain 325 mg of acetaminophen and 65
mg of caffeine, in bottles of 30.
Recall #D-116-8.
CODE Lot #960607 EXP 7/98.
MANUFACTURER Lex Pharmaceutical Corporation, Medly, Florida.
RECALLED BY Lyren Pharmaceutical Corporation, Caguas, Puerto
Rico (own label distributor), by letter.
Firm-initiated recall ongoing.
DISTRIBUTION Puerto Rico.
QUANTITY Approximately 2,862 bottles were distributed.
REASON Misbranding - Active ingredient strength
incorrectly labeled: Acetaminophen declared at
.325 mg per tablet sand caffeine at .65 mg
(decimal point incorrectly added in front of each
active ingredient).

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma. Recall #B-519/521-8.
CODE Unit #42M10310.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letter dated January 8 and 17,
1996. Firm-initiated recall complete.
DISTRIBUTION Ohio and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were incorrectly tested for the
human immunodeficiency virus type 1 (anti-HIV-1.

_______________
PRODUCT Red Blood Cells. Recall #B-816-8.
CODE Unit #2263299.
MANUFACTURER Central Texas Regional Blood and Tissue Center,
Austin, Texas.
RECALLED BY Manufacturer, by telephone on October 28, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who had
no hematocrit check recorded during screening.

_______________
PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes
Removed; c) Platelets; d) Fresh Frozen Plasma; e)
Source Leukocytes; f) Recovered Plasma. Recall
#B-835/840-8.
CODE Contact FDA, Center for Biologics Evaluation and
Research, Office of Compliance (301) 827-6220 for
individual unit numbers recalled.
MANUFACTURER Central Indiana Regional Blood Center, Inc.,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by telephone and by letter dated
June 30, 1997. Firm-initiated recall complete.
DISTRIBUTION Indiana, Massachusetts, Utah, New Jersey,
Switzerland.
QUANTITY a) 31 units; b) 1 units; c) 20 units; d) 5 units;
e) 3 units; f) 26 units were distributed.
REASON Blood products tested negative for HBsAg, HIVAG,
HTLV, or Hbc but collected from donors who
initially tested reactive for HBsAg, HIVAG, HTLV,
or HBc, with units not retested in duplicate, and
donors were incorrectly reentered.

_______________
PRODUCT Red Blood Cells. Recall #B-847-8.
CODE Unit #38-19932.
MANUFACTURER Michigan Community Blood Centers, Saginaw,
Michigan.
RECALLED BY Manufacturer, by letter on June 26, 1997.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with a
history of Hashimoto's Disease.

_______________
PRODUCT Allergenic Extracts: a) Birch Mix PRW
b) Mold Mix #4. Recall #B-851/852-8.
CODE a)Lot # B97J0222; b) Lot # A07J0130.
MANUFACTURER Bayer Corporation, Bayer Pharmaceutical Division,
Allergy Products, Spokane, Washington.
RECALLED BY Manufacturer, by telephone on March 19-20, 23-24, 1998. Firm-initiated recall ongoing.
DISTRIBUTION Delaware, Georgia, Iowa, Illinois, Indiana,
Michigan, Missouri, Nevada, New York, Ohio,
Pennsylvania, Virginia, Washington state,
Wisconsin, Maryland, Spain.
QUANTITY a) 18 50-ml vial; b) 18 50-ml vials were
distributed.
REASON Allergenic extract products were mislabeled in
that Birch PRW contained Mold Mix #4, and Mold Mix
#4 contained Birch Mix PRW.

_______________
PRODUCT Platelets. Recall #B-863-8.
CODE Unit #20001400.
MANUFACTURER Ashford Blood Bank, Inc., Ashford Medical Center,
Santurce, Puerto Rico.
RECALLED BY Manufacturer, by telephone on July 11, 1997.
Firm-initiated recall complete.
DISTRIBUTION Puerto Rico.
QUANTITY 1 unit was distributed.
REASON Blood product tested initially reactive for the
antibody to the Hepatitis B surface antigen
(HBsAg), and antibody to the Hepatitis B core
antigen (HBc), with no confirmatory test.

_______________
PRODUCT Fresh Frozen Plasma. Recall #B-864-8.
CODE Unit #0101861.
MANUFACTURER Ashford Blood Bank, Inc., Ashford Medical Center,
Santurce, Puerto Rico.
RECALLED BY Manufacturer, by telephone on October 30, 1996.
Firm-initiated recall complete.
DISTRIBUTION Puerto Rico.
QUANTITY 1 unit was distributed.
REASON Blood product tested initially reactive for the
antibody to the Hepatitis B surface antigen
(HBsAg), and antibody to the Hepatitis B core
antigen (HBc), with no confirmatory test.

_______________
PRODUCT Platelets. Recall #B-869-8.
CODE Unit #1453295.
MANUFACTURER Central Kentucky Blood Center, Lexington,
Kentucky.
RECALLED BY Manufacturer, by telephone on January 9, 1998.
Firm-initiated recall complete.
DISTRIBUTION Kentucky.
QUANTITY 1 unit was distributed.
REASON Platelets were prepared from a unit collected from
a donor who had taken aspirin within 24 hours of
donation.

_______________
PRODUCT Red Blood Cells. Recall #B-870-8.
CODE Unit #1411732.
MANUFACTURER Central Kentucky Blood Center (CKBC), Lexington,
Kentucky.
RECALLED BY Manufacturer, by letter dated January 9, 1998.
Firm-initiated recall complete.
DISTRIBUTION Kentucky.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
traveled to an area designated as endemic for
malaria.

_______________
PRODUCT Red Blood Cells. Recall #B-879-8.
CODE Unit #0103864.
MANUFACTURER Ashford Blood Bank, Inc., Ashford Medical Center,
Santurce, Puerto Rico.
RECALLED BY Manufacturer, by telephone on September 2, 1997.
Firm-initiated recall complete.
DISTRIBUTION Puerto Rico.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor in which
viral marker testing (HIV-1/2, HBsAg, HTLV-1, Hbc
HCV) was not conducted.

_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-880/881-8.
CODE Unit #06GF02934.
MANUFACTURER American Red Cross, Los Angeles, California.
RECALLED BY Manufacturer, by letter on August 28, 1996, and
September 10, 1996. Firm-initiated recall
complete.
DISTRIBUTION California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a
history of cancer.

_______________
PRODUCT Source Plasma. Recall #B-882-8.
CODE Unit #65279410.
MANUFACTURER Bio-Blood Components, Inc., Columbus, Ohio.
RECALLED BY Manufacturer, by letter dated February 3. 1998,
followed by fax. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was not quarantined after the donor
provided information regarding a previous positive
test for HIV.

________________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-883/884-8.
CODE Unit numbers: a) 06FT31765, 06FT30927
b) 06FT31765.
MANUFACTURER American Red Cross, Los Angeles, California.
RECALLED BY Manufacturer, by letter dated August 26, 1996.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY a) 2 units; b) 1 unit was distributed.
REASON Blood products were collected from a donor who
reported travel to an area designated as endemic
for malaria.

_______________
PRODUCT Platelets. Recall #B-885-8.
CODE Unit #06LP46162.
MANUFACTURER American Red Cross, Los Angeles, California.
RECALLED BY Manufacturer, by telephone on September 27, 1996.
Firm-initiated recall complete.
DISTRIBUTION Puerto Rico.
QUANTITY 1 unit was distributed.
REASON Platelets were prepared from a unit collected from
a donor who had taken aspirin or piroxicam within
three days of donation.

_______________
PRODUCT Red Blood Cells. Recall #B-886-8.
CODE Unit #0101148.
MANUFACTURER Ashford Blood Bank, Inc., Santurce, Puerto Rico.
RECALLED BY Manufacturer, by telephone on July 5, 1996.
Firm-initiated recall complete.
DISTRIBUTION Puerto Rico.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a autologous
donor in which viral marker testing (HIV-1/2,
HBsAg, HTLV-1, HBc, HCV) was not conducted, and
was distributed for homologous use.

_______________
PRODUCT Recovered Plasma. Recall B-887-8.
CODE Unit #0102132.
MANUFACTURER Ashford Blood Bank, Inc., Santurce, Puerto Rico.
RECALLED BY Manufacturer, by telephone on December 30, 1996.
Firm-initiated recall complete.
DISTRIBUTION Puerto Rico.
QUANTITY 1 unit was distributed.
REASON Blood product was incorrectly labeled as Fresh
Frozen Plasma and distributed for transfusion.

_______________
PRODUCT Recovered Plasma. Recall #B-890-8.
CODE Unit #53H45983.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by fax on December 19, 1997, and by
letter on January 27, 1998. Firm-initiated recall
complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product tested negative for the hepatitis B
surface antigen (HBsAg), but was collected from a
donor who previously tested repeat reactive for
HBsAg, with no confirmatory testing.

_______________
PRODUCT Platelets, Pheresis. Recall #B-891-8.
CODE Unit #06KS18020.
MANUFACTURER American Red Cross, Los Angeles, California.
RECALLED BY Manufacturer, by telephone on January 13, 1997.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product had an unacceptable platelet count.

_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-892/893-8.
CODE Unit #06GV45023.
MANUFACTURER American Red Cross, Los Angeles, California.
RECALLED BY Manufacturer, by letter dated March 4, 1997.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a
history of cancer.

_______________
PRODUCT Platelets, Pheresis. Recall #B-894-8.
CODE Unit #06KN07097.
MANUFACTURER American Red Cross, Los Angeles, California.
RECALLED BY Manufacturer, by letter dated March 13, 1997.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
received a tattoo within 12 months of donation.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma; d) Recovered Plasma.
Recall #B-895/898-8.
CODE Unit #06GH31724, 06GH22840; b) 06GH31724,
06GH22840; c) 06GH31724; d) 06GH22840.
MANUFACTURER American Red Cross, Los Angeles, California.
RECALLED BY Manufacturer, by letter dated August 11 or 12,
1997. Firm-initiated recall complete.
DISTRIBUTION California, Idaho, Texas.
QUANTITY a) 2 units; b) 2 units; c) 1 unit; d) 1 unit was
distributed.
REASON Blood products were collected from a donor with a
history of cancer.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Platelets. Recall #B-775-8.
CODE Unit #42M83002.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letter dated July 2, 1996.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of Whole
Blood identified as a difficult draw.

_______________
PRODUCT Red Blood Cells. Recall #B-860-8.
CODE Unit #18GH27779.
MANUFACTURER American Red cross, Lansing, Michigan.
RECALLED BY Manufacturer, by telephone and letter on January
8, 1998. Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
exceeded the donation acceptance criteria for body
temperature.

_______________
PRODUCT Red Blood Cells. Recall #B-888-8.
CODE Unit #20001420.
MANUFACTURER Ashford Blood Bank, Inc., Ashford Medical Center,
Santurce, Puerto Rico.
RECALLED BY Manufacturer, by telephone on July 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION Puerto Rico.
QUANTITY 1 unit was distributed.
REASON Blood product with an extended expiration date was
distributed.

_______________
PRODUCT a) Fresh Frozen Plasma; b) Cryoprecipitated AHF.
Recall #B-908/909-8.
CODE Contact FDA, Center for Biologics Evaluation and
Research, Office of Compliance (301) 827-6220 for
individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, Los Angeles,
California.
RECALLED BY Manufacturer, by letters between April 1 and 28,
1997. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY a) 46 units; b) 17 units were distributed.
REASON Blood products were stored at an unacceptable
temperature.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma. Recall #B-911/913-8.
CODE Unit #53C90705.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by telephone on August 21, 1997,
followed by letter dated September 2, 1997, and by
fax on August 27, 1997. Firm-initiated recall
complete.
DISTRIBUTION Pennsylvania, District of Columbia, California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were incorrectly tested for the
hepatitis B surface antigen (HBsAg).

_______________
UPDATE Recall #B-560-8, Red Blood Cells, Unit #17182
-2574, recalled by Blood Systems, Inc., which
appeared in the April 8, 1998 Enforcement Report
is being recinded. The information was previously
reported as Recall B-271-8, in the December 3,
1997, Enforcement Report.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
==========
_______________
PRODUCT Plazlyte Sterilization System, a low temperature
gas plasma sterilization system used to sterilize
flat surgical stainless steel medical instruments
in Tyvek and Tyvek/Mylar packaging, marketed as an
alternative to ETO sterilization.
Recall #Z-491-8.
CODE Model ABT 1.0, All serial numbers.
MANUFACTURER AbTox, Inc., Mundelein, Illinois.
RECALLED BY Manufacturer, by letter March 31, 1998.
Firm-initiated recall ongoing. See also FDA talk
paper T98017, April 2, 1998.
DISTRIBUTION Nationwide.
QUANTITY 163 units were distributed.
REASON The sterilization system can leave copper and zinc
salt residues on ophthalmic devices sterilized in
the system. These compounds are corrosive to
mucous membranes and the human cornea. The device
defect presents a high risk of serious adverse
health consequences.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Bard 9 Fr 30 cc RediGuard IAB (Intra-Aortic
Balloon) Catheter and Introducer Kit, Indicated
for use in: refractory left ventricular failure,
cardiogenic or septic shock, unstable refractory
angina, impending infarction, etc. Models:
a) R930D-Used with Datascope Adapter. Introducer
No Sidearm
b) R930DS-Used with Datascope Adapter. Introducer
with SideArm
c) R930U- Supplied with three adapters for use in
pumps: Datascope, Arrow, Bard. Introducer No
Sidearm
d) R30US- Supplied with three adapters for use in
pumps: Datascope, Arrow, Bard. Introducer With
Sidearm. Recall #Z-476/479-8.
CODE Model Serial Numbers
R930D AU80007, AU80014, AU80047
R930D SAU80005, AU80004, AU80024,
AU80049
R930U AU80225
R30US AU80227, AU80230, AU80218.
MANUFACTURER Bard Cardiac Assist Products, C.R. Bard, Inc.,
Chelmsford, Massachusetts.
RECALLED BY Manufacturer, by telephone on March 24, 1998,
followed by letter on March 26, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Missouri, Pennsylvania, Kansas.
QUANTITY 11 units were distributed.
REASON Balloon membrane scored or cut causing helium to
leak.

_______________
PRODUCT Becton Dickinson SafetyGlide Needle.
Recall #Z-497-8.
CODE Reorder #305905, Lot #7C905.
MANUFACTURER Becton Dickinson Industrial Site, Columbus,
Nebraska.
RECALLED BY Becton Dickinson and Company, Franklin Lakes, New
Jersey, by a "Hold Memo" and by telephone on June
3, 1997, by letter faxed on June 4, 1997, and by
certified mail on June 11, 1997. Firm-initiated
recall complete.
DISTRIBUTION New Jersey, California, Alabama, Florida.
QUANTITY 50,400 units were distributed.
REASON The "safety", a plastic piece that extends to
cover the syringe, breaks at the hinge region with
a lower rate than the firms specifications allow.

_______________
PRODUCT True/Flex Trauma Cortical Bone Screws:
a) Catalog Nos. 06-4524, 06-4528, 06-4532,
06-4536, 06-4540, 06-4544, 06-4548, 06-4552,
06-4556, 06-4560, 06-5535, 06-5540, 06-5545,
06-5550, 06-5555, 06-5565, 06-5570, 06-5575,
06-5580
b) Catalog Nos. 07-4524, 07-4536, 07-4540,
07-4548, 07-4552, 07-4556, 07-4560, 07-5540,
07-5545, 07-5565, 07-5570, 07-5575, 07-5580.
Recall #Z-499/500-8.
CODE Multiple lot numbers manufactured between 3/97 and
1/98: a) 68 lots within the lot number range
252261 through 311561
b) 26 lots within the lot number range 27183
through 31260.
MANUFACTURER North East Surgical Tool Company, Pembroke,
Massachusetts.
RECALLED BY Encore Orthopedics, Austin, Texas, by letter dated
March 5, 1998. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Japan.
QUANTITY Distribution consisted of 1,371 units with Catalog
Numbers 06-4524/5580, of which 244 units were
defective, and 269 units with Catalog Numbers
07-4524/5580, of which 160 were defective.
REASON There is a potential for inadequate thread
engagement with the cortical bone due to the
threads not starting close enough to the screw
head.

_______________
PRODUCT Model 750vs Bear Cub Infant Pressure Ventilator,
used to provide ventilatory support to neonates
and pediatric patients up to 30 kg. Recall #Z-512-8.
CODE All serial numbers.
MANUFACTURER Bear Medical Systems, Inc., Riverside, California.
RECALLED BY Manufacturer, by fax followed by certified mail
between March 9 and 18, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 952 units were distributed.
REASON The inspiratory pressure and PEEP/CPAP control
valves may jam or are difficult to adjust.

_______________
PRODUCT Model TED 60T Portable Oxygen Monitor, a
microprocessor based oxygen concentration analyzer
for use in respirators, incubators, and other
medical equipment. Recall #Z-514-8.
CODE Devices have individual serial numbers:
158133-158232 158441-158540
159005-159104 159264-159363
159633-159732 160139-160233.
MANUFACTURER Teledyne Electronic Technologies Analytical
Instruments (TET/AI), City of Industry,
California.
RECALLED BY Manufacturer, by telephone and/or fax on June 27,
1996. Firm-initiated recall complete.
DISTRIBUTION New York, California, Florida, Michigan, Illinois,
Ohio, West Virginia, Texas, Kentucky, Georgia,
Missouri, New Hampshire, Massachusetts, Louisiana,
Kansas, Tennessee, and international.
QUANTITY 571 units were distributed.
REASON The device gave inaccurate (high) oxygen reading,
caused by a defective capacitor.

_______________
PRODUCT Artromot-SB (Shoulder bedmount) Continuous Passive
Motion Devices, exerciser, used for post-operative
continuous mobilization of the shoulder joint.
Recall #Z-515-8.
CODE Serial numbers:
93460 93470 94480 94490
93461 93471 94481 94491
93462 93472 94482 94492
93463 93473 94483 94493
93464 93474 94484 94494
93465 93475 94485 94495
93466 93476 94486 94496
93467 93477 94487 94497
93468 93478 94488 94498
93469 93479 94489 94499.
MANUFACTURER ORMED GmbH (The HUG Group), D-79100 Freiburg I.B.
(Germany).
RECALLED BY Orthopedic Medical Products, Inc. doing business
as ORMED, Pennsauken, New Jersey, by letter on or
about August 15, 1997, followed by telephone.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 40 units were distributed.
REASON The weld joint of the units may fatigue resulting
in rupture of the device.

_______________
PRODUCT Glucometer Dex Blood Glucose Test Sensors, Product
Code 3610, intended for use in the Glucometer Dex
Instrument system to determine blood glucose
levels. Recall #Z-516-8.
CODE The following lot numbers were distributed in the
United States: 1A075AA, 1A076AA, 2A076AA,
1A077AA, 1A078AA, and 1A078BA; Exp. February 1999.
The following lot numbers were distributed outside
of the United States: 1A052AA, 1A059AA, 1A061AA,
1A062AA, 1A062BA, 1A065AA, 1A066AA, 1A067AA,
1A070AA, 1A070BA, 1A071AA, 1A073AA, 1A074AA,
1A074BA, 1A075AA, 1A076AA, 1A077AA, 1A078AA,
1A078BA, 1B072AA, 1B079AA, 1T048AA, 1T048AB,
1T053AA, 1T056AA, 1T058AA, 1T063AA, 1T069AA,
1T069BA, 2A061AA, 2A066AA, 2A067AA, 2A070AA,
2A073AA, 2A074AA, 2A074BA, 2A076AA, 2A085AA,
2B072AA, 2T048AA, 2T053AA, 2T054AA, 2T056AA,
2T058AA, 2T063AA, 3A065AA, 3A067AA, 3T058AA,
3T063AA, 4T058AA, 5T058AA, AT034AA, AT035AA,
AT035BA, AT036AA, AT037AA, AT038AA, AT039AA,
AT040AA, AT040BA, AT041AA, AT046AA, AT049AA,
BT036AA, BT039AA, BT041AA, BT046AA, CR037BA,
CT036AA, and CT046AA.
MANUFACTURER Bayer Corporation, Mishawaka, Indiana.
RECALLED BY Bayer Corporation, Elkhart, Indiana, by letter
dated December 22, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 550,000 packages of 50 sensors were distributed.
REASON The device will not fill properly and can give
results which fall outside of the acceptable range
before its expiration date.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT COBAS Integra Reagent Creatine Kinase-MB, in-vitro
diagnostic regent system intended for use on COBAS
Integra for the quantitative determination of
catalytic activity of CK-MB in serum and plasma.
Recall #Z-501-8.
CODE Catalog #0737402, Lot #E2640.
MANUFACTURER Roche Diagnostic Systems, Kaiseraugst,
Switzerland.
RECALLED BY Roche Diagnostic Systems, Sommerville, New Jersey,
by letter and telephone on July 28, 1997.
Firm-initiated recalls complete.
DISTRIBUTION Massachusetts, Pennsylvania, Florida, Texas.
QUANTITY 18 units were distributed; firm estimates none
remains on the market.
REASON This lot was showing a decreased recovery for the
control serum of about 20%.

_______________
PRODUCT Roche brand Integra Ethanol Reagent, in-vitro
diagnostic reagent system. Recall #Z-502-8.
CODE Product #0737550, Lot numbers: E1633, E1633A,
E1740.
MANUFACTURER Roche Diagnostics, Kaiseraugst, Switzerland.
RECALLED BY Roche Diagnostic Systems, Somerville, New Jersey,
by telephone on January 28, 1997, September 12,
1997 and on February 20, 1997. Firm-initiated
recall complete.
DISTRIBUTION Massachusetts, Rhode Island, New Jersey, New York,
Pennsylvania, District of Columbia, South
Carolina, Georgia, Iowa, Texas, Israel, Australia,
Switzerland.
QUANTITY 425 kits were distributed; firm estimates none
remains on the market.
REASON the Ethanol reagent was unstable causing patient
data to be outside the normal ranges.

_______________
PRODUCT Onsite (.01%) for Alcohol Test, provides rapid
detection of alcohol in saliva or urine.
Recall #Z-503-8.
CODE Catalog No. 00302, Lot Nos. 60601, 60602.
MANUFACTURER Toxilab, Inc., Irvine, California.
RECALLED BY Roche Diagnostic Systems, Sommerville, New Jersey,
by letter on February 3, 1997, and September 11,
1997. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 407 kits were distributed; firm estimates none
remains on the market.
REASON An incorrect desiccant packet was placed in the
test kits that may have caused false positive
results if exposed to high heat and humidity.

_______________
PRODUCT Synergy Quad Media Plates, an agar screen
recommended for use in predicting the synergistic
contribution of an amino glycoside and vancomycin
when testing enterococcal isolates requiring
combination therapy.
Recall #Z-504-8.
CODE Product #02-474, Lot #5597 EXP 5/27/97.
MANUFACTURER Remel Limited Partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone on April 2, 1997.
Firm-initiated recall complete.
DISTRIBUTION Michigan and Virginia.
QUANTITY 20 units were distributed.
REASON The vancomycin used in the agar was subpotent.

_______________
PRODUCT Staph Latex Kit, a rapid slide latex agglutination
test for detection of coagulase associated with S.
Aureus In primary cultures. Recall #Z-505-8.
CODE Catalog No. 21-143, Lot No. L10057.
MANUFACTURER Remel Limited Partnership, Immunodiagnostics
Division, Augusta, Georgia (now closed).

RECALLED Remel Limited Partnership, Lenexa, Kansas, by
telephone on December 28, 1996 and December 31,
1996. Firm-initiated recall complete.
DISTRIBUTION Oklahoma, California, Illinois, Massachusetts,
Michigan, Iowa, Florida, Utah, Missouri, Texas,
Virginia, Pennsylvania, Georgia, Tennessee, New
York, Maryland, Kansas, Alabama and Australia.
QUANTITY 61 units were distributed.
REASON Some quality control and patient isolates gave
false negative results.

_______________
PRODUCT Brain Heart Infusion Agar with Vancomycin Media
Plates, for use as an agar screen for the
detection of vancomycin resistance in enterococci.
Recall #Z-506-8.
CODE Catalog No. 01-176, Lot No. 5550.
MANUFACTURER Remel Limited Partnership, Lexena, Kansas.
RECALLED BY Manufacturer, by telephone on May 30, 1996 and
June 6, 1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 3,850 units were distributed.
REASON The plates may have growth of Enteroccus Faecalis
which may interfere with the test.

_______________
PRODUCT Roche Reagent for BUN, in-vitro diagnostic liquid
reagent intended for use on COBAS Chemistry
systems for the quantitative determination of
blood urea nitrogen in serum:
a) Product Code 47380; b) Product Code 47381.
Recall #Z-507/508-8.
CODE Lot Numbers: a) 001, 002, 003;
b) 001, 002, 003.
MANUFACTURER Medical Analysis Systems, Inc., Camarillo,
California.
RECALLED BY Roche Diagnostic Systems, Somerville, New Jersey,
by letter on February 14, 1997. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Amount Shipped:
a) lot 001 - 2195 kits
lot 002 - 2195 kits
lot 003 - 1086 kits
lot 004 - 17 kits
b) lot 001 - 394 kits
lot 002 - 398 kits
lot 003 - 1390 kits.
REASON That there was a carryover from the previous test
that falsely depressed the BUN results.

_______________
PRODUCT Immulite ANTI-TPO AB Test Kit, indicated for
in-vitro diagnostic use in the clinical diagnosis
of thyroid disease.
Recall #Z-509-8.
CODE Kit Lot #120 EXP 6/30/98.
MANUFACTURER EURO/DPC Ltd., Wales, United Kingdom.
RECALLED BY Diagnostic Products Corporation, Los Angeles,
California, by telephone on February 2, 1998,
followed by visit on February 5, 1998.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 17 kits were distributed.
REASON Patient samples had falsely elevated positives.

END OF ENFORCEMENT REPORT FOR APRIL 22, 1998. BLANK PAGES MAY FOLLOW.

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End of Enforcement Report for