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.

March 11, 1998 98-10

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ============
_______________
PRODUCT Thin Saltine Crackers under the Cracker Shoppe
label, in 16 ounce cardboard cartons. Recall #F-277-8.
CODE The cartons are branded with the following "BEST
WHEN PURCHASED BY" codes: "0039 JUN07 98 3W",
"0039 JUN 08 98 1W", "0039 JUN 08 98 2W", and
"0039 JUN 08 98 3W".
MANUFACTURER Wortz, Poteau, Oklahoma.
RECALLED BY Bremmer, Inc., Princeton, Kentucky, by press
release on February 11, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION Kansas, Ohio, Pennsylvania.
QUANTITY 315 display units (152,460 cartons) were
distributed.
REASON Product may contain pieces of metal.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ===========
_______________
PRODUCT Nestle Magic. Recall #F-278-8.
CODE All codes.
MANUFACTURER Whetstone Candy Company, St. Augustine, Florida.
RECALLED BY Nestle USA, Inc., Glendale, California, by
bulletin on October 2, 1997. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Product is adulterated under section 402(d)(1) of
the Food, Drug, and Cosmetic Act in that it
contains a nonnutritive foreign object.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ============
_______________
PRODUCT Aloe Vesta Protective Ointment, in 2 and 8 ounce
tubes, OTC, used as a barrier from external
moisture. Recall #D-097-8.
CODE Lot numbers 04D7 (2 oz & 8 oz), 05D7 (8 oz), 22D7
(8 oz).
MANUFACTURER Kutol Products Company, Cincinnati, Ohio (contract
manufacturer)
RECALLED BY ConvaTec, a Bristol-Myers Squibb Company,
Skillman, New Jersey, by letter on June 27, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY Amounts sold:
Lot 04D7 (2 oz.) 581 cases (13,944 tubes)
Lot 04D7 (8 oz.) 38 cases (456 tubes)
Lot 05D7 (8 oz.) 316 cases (3,792 tubes)
Lot 22D7 (8 oz.) 62 cases (744 tubes).
REASON Microbial contamination (Pseudomonas putida).

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
===========
_______________
PRODUCT Promotional literature for Natural efx OTC
moisturizing creams and dietary supplements in
product information sheets contained in
Distributor Kits and in company brochures:
a) Women's Wild Yam efx Moisturizing Skin Cream in
2 ounce jars;
b) Men's Wild Yam efx Moisturizing Skin Cream in 2
ounce jars;
c) Body Balancing 3, 360 mg Capsules, 90 capsules
per bottle
d) Body Balancing 4, 500 mg Capsules, 90 capsules
per bottle
e) Body Balancing 2, 500 mg Capsules, 90 capsules
per bottle
f) Body Balancing 1, 500 mg Capsules, 90 capsules
per bottle
g) Lipo efx, 500 mg Capsules, 90 capsules per
bottle
h) Plant efx, 220 mg Capsules, 90 capsules per
bottle
I) Gas efx, 360 mg Capsules, 90 capsules per
bottle
j) Oxy efx, 235 mg Capsules, 90 capsules per
bottle
k) Digest efx, 220 mg Capsules, 90 capsules per
bottle
l) Cleanz efx, 370 Capsules, 90 capsules per
bottle. Recall #D-085/096-8.
CODE Uncoded. All promotional labeling distributed
prior to May 1997.
MANUFACTURER Natural efx, Inc., Richardson, Texas.
RECALLED BY Manufacturer, by providing revised manuals to
distributors who renewed their annual registration
fees in November 1996 through April 1997, and by
letter dated May 19, 1997. Firm-initiated field
correction complete.
DISTRIBUTION Nationwide.
QUANTITY Product information sheets that made false and
misleading medical claims were included in
approximately 6,000 Distributor Kits distributed
between January and October 1996.
REASON Misbranding - Unapproved drug claims.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ========
_______________
PRODUCT a) Red Blood Cells; b) Platelets
C) Fresh Frozen Plasma; d) Recovered Plasma.
Recall #B-587/590-8.
CODE Unit numbers: a) 6088420, 6088423, 6088427
b) 6088420, 6088423, 6088427
c) 6088420, 6088423, 6088427; d) 6088420.
MANUFACTURER The Mount Sinai Medical Center, New York, New
York.
RECALLED BY Manufacturer, by telephone on November 10, 1997,
and by letters on October 21, 1997, and November
10, 1997. Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY a) 3 units; b) 3 units; c) 3 units; d) 1 unit was
distributed.
REASON Blood products tested repeat reactive for the
antibody to the Hepatitis B surface antigen
(HBsAg) with no confirmatory test.

_______________
PRODUCT Platelets, pheresis. Recall #B-591-8.
CODE Unit numbers: 7020428, 7020432, 7020438.
MANUFACTURER South Texas Blood & Tissue Center, San Antonio,
Texas.
RECALLED BY Manufacturer, by letter dated December 16, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Texas.
QUANTITY 3 units were distributed.
REASON Blood components were filtered with an unapproved
(unlicensed) disposable set.

_______________
PRODUCT Platelets-Pheresis, Leukocytes Reduced. Recall
#B-592-8.
CODE Unit numbers: 7019212, 7019213.
MANUFACTURER South Texas Blood and Tissue Center, San Antonio,
Texas.
RECALLED BY Manufacturer, by telephone on May 14, 1996.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 2 units were distributed.
REASON Blood products were labeled with an extended
expiration date.

_______________
PRODUCT Source Plasma. Recall #B-600-8.
CODE Unit numbers: 84416520, 84415905, 84411983, 84411099.
MANUFACTURER Bio-Blood Components, Inc., Columbus, Ohio.
RECALLED BY Manufacturer, by letter dated July 24, 1997.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 4 units were distributed.
REASON Blood products tested negative for viral markers
were collected from a donor who was deferred at
another center due to unsuitable HIV test results,
and were distributed after receipt of this
information.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma. Recall #B-601/603-8.
CODE Unit #03GN07576.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by telephone on February 1 and 2,
1996, followed by letter dated February 21, 1996.
Firm-initiated recall complete.
DISTRIBUTION Georgia and Florida.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested positive for syphilis.

_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-620/621-8.
CODE Unit #1164873.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, by letter dated November 25, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were drawn from an unsuitable
donor.

_______________
PRODUCT Platelets, Pheresis. Recall #B-629-8.
CODE Unit #03P91614.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by telephone on January 19, 1996.
Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON Blood product with a residual white blood cell
count that exceeded the acceptable value was
distributed labeled as leukoreduced.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Buffy Coat.
Recall #B-636/638-8.
CODE Unit #18FQ25959.
MANUFACTURER American Red Cross Great Lakes Region, Lansing,
Michigan.
RECALLED BY Manufacturer, by letter dated November 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION Michigan and New Jersey.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected in a manner that may
have compromised the sterility of the units.

_______________
PRODUCT a) Red Blood Cells; b) Platelets;
c) Cryoprecipitated AHF. Recall #B-639/641-8.
Code Unit #18FE44524.
MANUFACTURER American Red Cross Great Lakes Region, Lansing,
Michigan.
RECALLED BY Manufacturer, by letter dated November 10, 1997.
And by telephone on November 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION Michigan and Ohio.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected in a manner that may
have compromised the sterility of the units.

_______________
PRODUCT Platelets, Pheresis. Recall #B-642-8.
CODE Unit #16KF12186.
MANUFACTURER American Red Cross, Columbus, Ohio.
RECALLED BY Manufacturer, by letter dated October 29, 1997.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product was inappropriately prepared by
recording the incorrect volume on the label which
resulted in the product being distributed in one
platelet bag instead of two.

_______________
PRODUCT Red Blood Cells. Recall #B-643-8.
CODE Unit 4594294.
MANUFACTURER National Naval Medical Center, Bethesda, Maryland.
RECALLED BY Manufacturer, by telephone on September 4, 1997.
Firm-initiated recall complete.
DISTRIBUTION New Jersey and Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
reported travel to an area designated as endemic
for malaria.

_______________
PRODUCT HNA Classic Blood Bank Transfusion Computer
Software Program: a) PathNet Blood Bank
Transfusion (L-2300), Release #302-306
b) PathNet Worksystems (L-2812), Release #306
c) PathNet Blood Center (L-2510), Release #306.
Recall #B-650-8.
CODE Release #306.
MANUFACTURER Cerner Corporation, Kansas City, Missouri.
RECALLED BY Manufacturer, by telephone on February 20, 1998,
and by letter dated February 23, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 308 software packages were distributed.
REASON Intended warning messages alerting the user to the
potential release of ABO Rh incompatible units did
not appear when using the "Dispense Products"
function for emergency release.

_______________
PRODUCT Fresh Frozen Plasma. Recall #B-651-8.
CODE Unit #4764980.
MANUFACTURER National Naval Medical Center, Bethesda, Maryland.
RECALLED BY Manufacturer, by telephone on or about February 5,
1997. Firm-initiated recall complete.
DISTRIBUTION District of Columbia.
QUANTITY 1 unit was distributed.
REASON Blood product was not tested for the antigen to
the human immunodeficiency virus type 1 antigen
(HIV-1 Ag).

_______________
PRODUCT a) Red Blood Cells; b) Platelets;
c) Recovered Plasma. Recall #B-662/664-8.
CODE Unit #53J95647.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letters dated December 17 and 23,
1997. Firm-initiated recall complete.
DISTRIBUTION Maryland and California.
QUANTITY 1 unit of each component was distributed.
Reason Blood products, which tested negative for the
antibody to the human immunodeficiency virus type
1 (anti-HIV-1), but were collected from a donor
who previously tested repeatedly reactive for
anti-HIV-1.

_______________
PRODUCT a) Red Blood Cells; b) Platelets
c) Fresh Frozen Plasma
d) Cryoprecipitated AHF
e) Platelets, for further manufacture
f) Recovered Plasma. Recall #B-665/670-8.
CODE Unit numbers: a) 21F19765, 21F37319, 21F48655,
21F67965, 21F72235, 21M95379, 21S10595, 21GH46432,
21GM20340
b) 21F37319, 21F48655, 21F72235
c) 21F19765, 21F37319
d) 21GM20340, included in pool 21E06595
e) 21S10595
f) 21F48655, 21F67965, 21F72235, 21M95379,
21S10595, 21S53250, 21GH46432, 21GM20340.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by telephone on July 1, 1997,
followed by letter on August 4, 1997, and on
October 4, 1997. Firm-initiated recall complete.
DISTRIBUTION Oregon, Washington state, Kansas, California.
QUANTITY a) 9 units; b) 3 units; c) 2 units; d) 1 unit; e)
1 unit; f) 8 units were distributed.
REASON Blood products tested negative for the antibody to
the human immunodeficiency virus type 1
(anti-HIV-1), but were collected from a donor who
previously tested repeatedly reactive for
anti-HIV-1.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Platelets. Recall #B-596-8.
CODE Unit numbers: 49GF05480, 49GF05498, 49GF05508,
49S74704, 49X52909, 49Y45713.
MANUFACTURER American Red Cross Blood Services, Wichita Falls,
Texas.
RECALLED BY Manufacturer, by telephone on November 18, 1997,
and by letter dated December 9, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 6 units were distributed.
REASON Blood products were exposed to unacceptable
shipping temperatures.

_______________
PRODUCT Source Plasma. Recall #B-599-8.
CODE Unit numbers: 86040150, 86040167, 86040174,
86040181, 86040198, 86040204, 86040211, 86040228,
86040235, 86040242, 86040259, 86040266.
MANUFACTURER Bio-Blood Components, Inc., Columbus, Ohio.
RECALLED BY Manufacturer, by telephone on May 30, 1997. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 12 units were distributed.
REASON Blood products were untested for viral markers.

_______________
PRODUCT Red Blood Cells. Recall #B-604-8.
CODE Unit numbers 03GF24809 and 03GN04776.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by telephone on May 30, 1995,
followed by letter dated June 1, 1995. Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 2 units were distributed.
REASON Blood products were labeled with extended
expiration dates.

_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-623/624-8.
CODE Unit numbers: 6702690 and 2726331.
MANUFACTURER Central Indiana Regional Blood Center, Inc.,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by telephone on either October 13 or
24, 1997, and by letter dated November 8, 1997.
Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 2 units of each component were distributed.
REASON Blood products had extended expiration dates.

_______________
PRODUCT Platelets, Pheresis. Recall #B-630-8.
CODE Unit #03FG11925.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by telephone on May 19, 1997.
Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON Blood product was crossmatch incompatible was
labeled as compatible.

_______________
PRODUCT Platelets, Pheresis. Recall #B-634-8.
CODE 03P84439, 03P84712, 03P85903.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by letter dated June 26, 1995.
Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 3 units were distributed.
REASON Blood products were collected by apheresis at an
unacceptable temperature.

_______________
PRODUCT Red Blood Cells. Recall #B-635-8.
CODE Unit numbers: 03GV00716, 03GV00664, 03GR09869,
03GS06832, 03GJ22027, and 03GV00380.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by letter dated July 5, 1995.
Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 6 units were distributed.
REASON Blood products may have been labeled with extended
expiration dates.

_______________
PRODUCT Red Blood Cells. Recall #B-644-8.
CODE Unit numbers: 18S66777, 18FC90164, 18FQ19916,
18FQ20673, 18FS09518, 18GG13095, 18GH21961,
18GJ14960, 18Q95729, 18Q95842, 18S66730.
MANUFACTURER American Red Cross, Fort Wayne, Indiana.
RECALLED BY Manufacturer, by letters on August 25 and 27,
1997, and September 4, 1997. Firm-initiated
recall complete.
DISTRIBUTION Indiana, Michigan, Ohio.
QUANTITY 11 units were distributed.
REASON Blood products were exposed to unacceptable shipping temperatures.

_______________
PRODUCT Red Blood Cells, Irradiated. Recall #B-656-8.
CODE Unit #40FQ24234.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on November 24, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS
II =========
_______________
PRODUCT Zoll Autoclaveable Internal Handles, Catalog
#8004-0023, intended for use in conjunction with
Zoll's 1400/2000 Series Defibrillators to
defibrillate the heart during open chest surgical
procedures. Recall #Z-038-8.
CODE Serial numbers: N97F00978-N97F00979;
N97F00981-NP97F00999; N9701000-N97F01004;
N97F01009; N97F01011, N97F01014-N97F01020;
N97F01052-N970F01060.
MANUFACTURER Zoll Medical Corporation, Burlington,
Massachusetts.
RECALLED BY Manufacturer, by telephone on July 7 and 8, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Alabama, Alaska, Louisiana, Kansas, Tennessee,
Washington state.
QUANTITY 42 units were distributed.
REASON Lack of energy delivery to patient.

_______________
PRODUCT Futura Instrument Software for APTT Application,
an automated random access analyzer for in-vitro
diagnostic use in coagulation and fibrinolysis
testing in human plasma:
ACL Futura System, Model Numbers:
a) 0290001, ACL Futura (115 w/Barcode)
b) 0290011, ACL Futura (220 w/Barcode)
c) 0290111, ACL Futura (220 w/o Barcode)
d) 0290006, ACL Futura (Japanese w/Barcode)
0290021, ACL Futura (220V/barcode w/o comp)
0029101 (models with various power supply,
voltage and barcode options).
Recall #Z-213/218-8.
CODE Software versions prior to version 3.1.
MANUFACTURER Instrumentation Laboratory Company, Lexington,
Massachusetts.
RECALLED BY Manufacturer, by letter May 19, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 584 units were distributed.
REASON Software Problem caused false Short APTT (Activated Partial Thromboplastin Time).

_______________
PRODUCT DC Medical Correct-A-Count Needle Count and Sharps
Disposal System, foam strip needle counter
products:
a) Sterile Products with the Catalog Numbers:
20-0301 20-0302 20-0303 20-0401
20-0402 20-0701 20-0702 20-0102;
b) Non-Sterile Products with the Catalog Numbers:
20-4301 20-4302 20-4303 20-4305
20-4306 20-4401 20-4402 20-4701
20-4702 20-4103 20-4104.
Recall #Z-331/332-8.
CODE All lot date numbers between 01/01/97 and 05/31/97
identified with the above catalog numbers.
MANUFACTURER PSC, Inc., Louisville, Kentucky (component).
RECALLED BY DC Medical, Division of PSC Corporation,
Louisville, Kentucky, by telephone , followed by
letter dated June 20, 1997. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 1,990 cases (191,040 units) were distributed.
REASON The foam strip delaminated from the plastic box
causing possible needle stick injury to a health
care professional.

_______________
PRODUCT Siemens Servo Ventilator 300/300A, designed for
intensive care ventilation.
Recall #Z-357-8.
CODE Serial numbers 6175-10499.
Fuses, Siemens Part #61 89 7 52.
MANUFACTURER Siemens-Elema AG, Solna, Sweden.
RECALLED BY Siemens Medical Systems, Inc., Electromedical
Systems Group, Danvers, Massachusetts, by letter
on December 29, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,528 units were distributed.
REASON Premature failure of fuse which could cause loss
of power to the ventilator.

_______________
PRODUCT MCA and NOVA brand Hemodialyzers, a disposable
device used for hemodialysis:
a) MCA200, Catalog No. 201-855
b) Altra Nova200, Catalog No. 211-484G.
Recall #Z-358/359-8.
CODE Lot Numbers: a) 855970526A, 855970815A, 855970821;
b) 484970427B.
MANUFACTURER Althin Medical, Inc., Miami Lakes, Florida.
RECALLED BY Manufacturer, by letter on December 22, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Sweden
QUANTITY 9,706 units were distributed.
REASON The hemodialyzer headers may become lose.

_______________
PRODUCT Model Series Luxura 48, Sunlamp Tanning Products.
Model Luxura 48.
MANUFACTURER ProSun Tanning Industries, Inc., doing business as
Hapro, St. Petersburg, Florida.
RECALLED BY Manufacturer. FDA approved the firm's corrective
action plan on February 12, 1998. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 95 units were distributed.
REASON The sunlamp product failed to comply with 21 CFR
1040.20(d)(1)(iv) because the products failed to
include an adequate recommended exposure schedule.

_______________
PRODUCT Sunlamp tanning products:
a) Model Maximultysun; b) Model No. T180;
c) Model No. T200; d) Model Kombi;
e) Model Tristar 4000; f) Model Compact 4000; g)
Model Ringo. Recall #Z-363/369-8.
CODE None.
MANUFACTURER Helios Technologies, Inc., Aurora, Illinois.
RECALLED BY Manufacturer. FDA approved the firm's corrective
action plan on February 19, 1998. Firm-initiated
field correction ongoing.
DISTRIBUTI 82 units were distributed.
REASON The sunlamp products imported by Helios
Technologies Incorporated failed to comply with
the warning label and user instruction
requirements of the sunlamp performance standard
(21 CFR 1040.20).

_______________
PRODUCT Knightstar 320 bi-level respiratory system for the
support of spontaneously breathing patients
a) Model No. 320I/E, Serial Nos. 704230000 and
higher on units delivered in 1997;
b) Model No. 320B, Serial Nos. 704252000 through
706192050;
on units delivered in 1997.
c) Model No. 335, Serial Nos. 704040000 and higher
Recall #Z-375/377-8.
CODE a) Serial Nos. 704230000 through 711300000
b) Serial Nos. 704252000 through 706192050
c) Serial Nos. 704040000 through 711300000.
MANUFACTURER Nellcor Puritan Bennett, Inc., Lenexa, Kansas.
RECALLED BY Nellcor Puritan Bennett, Inc., Minneapolis,
Minnesota, by letter February 13, 1998.
Firm-initiated recall ongoing
DISTRIBUTION Nationwide and international.
QUANTITY 2,968 units were distributed.
REASON Some of the devices are delivering air pressures
that are not the same as the device settings.
The deviations have been positive or above the
pressure settings.

_______________
PRODUCT Becker External Drainage and Monitoring System
with Anti-Reflux Valve, used to provide the
physician with a closed system for draining
cerbrospinal fluid (CSF) from the lateral
ventricles of the brain or the lumbar subarachnoid
space for monitoring CSF pressure and flow.
Recall #Z-380-8.
CODE Catalog #25120, Lot numbers: 0672A EXP 2/28/02,
1186A Exp 5/30/02, 1299A EXP 6/30/02, 1477A EXP
7/30/02, 1478 EXP 8/30/02.
MANUFACTURER Medtronic PS Medical, Goleta, California.
RECALLED BY Manufacturer, by telephone or by visit beginning
on or about January 16, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION California, New Jersey, Virginia.
QUANTITY 39 units were distributed.
REASON A drawing error was discovered where the depiction
of the anti-reflux valve was inverted when
compared to the previous drawing revision.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT AIM Supracondylar Nail, Part #1812-20, indicated
for fracture fixation of the distal third of the
femur. Recall #Z-362-8.
CODE Lot #RY3647.
MANUFACTURER Depuy Ace Medical Company, El Segundo, California.
RECALLED BY Manufacturer, by telephone on January 14, 1998,
followed by letter dated January 15, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 50 nails were distributed.
REASON The cannula running through the complete length of
the nail was omitted during manufacture.

__________ AngioJet F105 Rapid Thrombectomy Catheters labeled
as being AngioJet LF140 Rapid Thrombectomy
Catheters, sterile, single-use, 5 French,
peripheral, vascular catheters.
Recall #Z-378-8.
CODE Lot 11667.
MANUFACTURER Possis Medical, Inc., Minneapolis, Minnesota.
RECALLED BY Manufacturer, by telephone on August 12, 1997.
Firm-initiated recall complete.
DISTRIBUTION California, Illinois, Kentucky, Massachusetts,
Michigan, South Carolina, Tennessee, Wisconsin.
QUANTITY 16 catheters were distributed.
REASON Device is mislabeled as to length.

_______________
PRODUCT dsDNA IgG/M Enzyme-Linked Immunosorbent Assay
(ELISA), Wampole Laboratories Product No. 427670
(Clark Laboratories Product No. 2327670), for
in-vitro diagnostic use.
Recall #Z-379-8.
CODE Lot No. 042.
MANUFACTURER Trinity Biotech, Jamestown, New York.
RECALLED BY Manufacturer, by letter dated February 3, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 277 kits were distributed.
REASON Index value of the positive control is above its
stated range on the vial label.

_______________
PRODUCT Various Enzyme Immunoassays (EIAs), in-vitro
diagnostic products labeled with Bartels Inc.:
a) Toxoplasma IgG EIA, Catalog No. B1029-310
b) Toxoplasma IgM EIA, Catalog No. B1029-315
c) Rubella IgG EIA, Catalog No. B1029-320
d) Rubella IgM EIA, Catalog No. B1029-325
e) Cytomegalovirus IgG EIA, Catalog No. B1029-330
f) Herpes Simplex Virus 1 IgG EIA, Catalog No.
B1029-340
g) Epstein-Barr Virus, IgM EIA, Catalog No.
B1029-365
h) Rubeola IgG EIA, Catalog No. B1029-380.
Recall #Z-381/388-8.
CODE Lot numbers: a) 2092; b) 2096;
c) 2084 and 2087; d) 2098; e) 2095
f) 2099; g) 2093; 2083, 2091.
MANUFACTURER Gull Laboratories, Inc., Salt Lake City, Utah.
RECALLED BY Bartels, Inc., The Diagnostics Division of
Intracel Corporationa, Issawuah, Washington, by
letter dated January 9, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, Ireland, Australia, Singapore.
QUANTITY a) 41; b) 7; c) 100 of lot 2084, 34 of lot 2087,
1 of lot 7HMDSN
d) 2; e) 10; f) 24; g) 4; h) 7; i) 99
j) 70 of lot 2083; 41 lot 2091 were distributed.
REASON Products contain conjugate which may
demonstrate decline in absorbance values over
time.

END OF ENFORCEMENT REPORT FOR MARCH 11, 1998. BLANK PAGES MAY FOLLOW.

End of Enforcement Report for