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.
December 3, 1997 97-49
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I =============
_______________
PRODUCT Dandee Sandwiches as follows:
a) Chicken Salad Sandwich
b) Egg Salad Sandwich
c) Cheeseburger Sandwich
d) Tuna Salad Sandwich
e) Ham & Cheese Sandwich
f) Cuban Sandwich. Recall #F-127/132-8.
CODE a) OCT06; b) OCT06 and OCT03
c) OCT07 and OCT05; d) OCT06 and OCT20
e) OCT21; f) OCT21.
MANUFACTURER Dandee Foods, Jacksonville, Florida.
RECALLED BY Manufacturer, by letter dated September 26,
1997. Firm-initiated recall complete.
DISTRIBUTION Florida and Georgia.
QUANTITY Approximately 240,000 to 270,000 sandwiches
are distributed weekly; firm estimated that
very little remained in commerce at time of
recall initiation.
REASON The products may be contaminated with Listeria
monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Vita Squares (Golden Neo-Life Diamite)
Multivitamin and Mineral Supplement.
Recall #F-126-8.
CODE Lot numbers: 469596 and 222949.
MANUFACTURER Natural Formulas, Inc., Hayward, California.
RECALLED BY Manufacturer, by telephone on July 7, 1997,
followed by letter. Firm-initiated recall
complete.
DISTRIBUTION California, Hong Kong, The Philippines.
QUANTITY Firm estimates none remains on the market.
REASON Product contained excessive levels of lead.
_______________
PRODUCT Chubby brand Pineapple Soda, in 8 ounce
plastic bottles. Recall #F-133-8.
CODE Not coded. All product containing the color
tartrazine.
MANUFACTURER S.M. Jaleel & Company, Ltd., Oropouche,
Trinidad, West Indies.
RECALLED BY J & W International Foods, Inc., Brooklyn, New
York, by letter dated October 30, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 632 cases (24 bottles per case) were
distributed.
REASON The product contains undeclared tartrazine
which can elicit reactions in individuals
sensitive to this color and which is unsafe
because it has not been certified as FD&C
Yellow No. 5 as required in 74.705(e).
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ========
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-077/078-8.
CODE Unit numbers: 04FJ54628, 04FJ46403,
04FJ29961.
MANUFACTURER American Red Cross Blood Services, Dedham,
Massachusetts.
RECALLED BY Manufacturer, by letter dated July 12, 1996.
Firm-initiated recall complete.
DISTRIBUTION Massachusetts.
QUANTITY 3 units of each component were distributed.
REASON Blood products were collected from a donor
taking the drug Methotrexate.
_______________
PRODUCT Source Plasma. Recall #B-093-8.
CODE Unit #22697H.
-2-
MANUFACTURER Bloomington Plasma, Inc., Bloomington,
Illinois.
RECALLED BY Manufacturer, by letter on June 16, 1997.
Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
was not tested for syphilis.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh
Frozen Plasma. Recall #B-136/138-8.
CODE Unit numbers: a) 10235-3189, 10228-8806,
10232-1932; b) 10232-1932, 10228-8806
c) 10235-3189.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated July 14, 1994. Firm-initiated
recall complete.
DISTRIBUTION Arizona and Texas.
QUANTITY a) 3 units; b) 2 units; c) 1 unit was
distributed.
REASON Blood products were collected from a
therapeutic donor diagnosed with Secondary
Erythrocytosis.
_______________
PRODUCT Platelets, Irradiated. Recall #B-153-8.
CODE Unit #29446-2267.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by letter dated October 15,
1997. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
whole blood identified as a difficult draw.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma. Recall #B-171/173-8.
CODE Unit #29104-4474.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated January 26, 1996. Firm-initiated
recall complete.
DISTRIBUTION Illinois and Mississippi.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
types 1 and 2 (anti-HIV-1/2), but were
collected from a donor who was deferred for
reporting HIV infection.
-3-
_______________
PRODUCT Platelet, Pheresis. Recall #B-199-8.
CODE Unit numbers: KZ45366, KZ45177, KZ44762,
KZ43745, KZ43422, KZ41868.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by letter dated September 10,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Virginia, Maryland, Mississippi.
QUANTITY 6 units were distributed.
REASON Blood products were collected from a donor who
reported travel to an area designated as
endemic for malaria.
_______________
PRODUCT Red Blood Cells. Recall #B-210-8.
CODE Unit #04KL74647.
MANUFACTURER American Red Cross Blood Services, Dedham,
Massachusetts.
RECALLED BY Manufacturer, by letter dated May 31, 1996.
Firm-initiated recall complete.
DISTRIBUTION New Hampshire.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
had no hemoglobin check performed during
screening.
_______________
PRODUCT Red Blood Cells. Recall #B-211-8.
CODE Unit #KF19875.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone on April 17, 1997.
Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
self-excluded.
_______________
PRODUCT Platelets. Recall #B-212-8.
CODE Unit #9020845.
MANUFACTURER Florida Blood Services, Inc., Tampa, Florida.
RECALLED BY Manufacturer, by telephone on August 13, 1996.
Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose
health history screening was inadequately
performed.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-215/216-8.
CODE Unit #9599039.
-4-
MANUFACTURER Florida Blood Services, Inc., Tampa, Florida.
RECALLED BY Manufacturer, by telephone on April 22, 1996.
Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who
had malaria within three years of donation.
_______________
PRODUCT Recovered Plasma. Recall #B-222-8.
CODE Unit numbers: 36019-8370, 36018-7225.
MANUFACTURER United Blood Services, Ventura, California.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona,
by letter dated March 18, 1997. Firm-
initiated recall complete.
DISTRIBUTION Switzerland.
QUANTITY 2 units were distributed.
REASON Blood product was collected from a donor with
an elevated ALT.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-226/227-8.
CODE Unit #12GH66247.
MANUFACTURER American Red Cross, Wilmington, North
Carolina.
RECALLED BY American Red Cross, Charlotte, North
Carolina, by telephone and letter on August
16, 1996. Firm-initiated recall complete.
DISTRIBUTION North Carolina and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
received a tattoo within twelve months of
donation.
_______________
PRODUCT Red Blood Cells. Recall #B-228-8.
CODE Unit #Y39727.
MANUFACTURER American Red Cross, Portland, Oregon.
RECALLED BY Manufacturer, by letter dated September 2,
1997. Firm-initiated recall complete.
DISTRIBUTION California.
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 a) Red Blood Cells; b) Platelets
c) Fresh Frozen Plasma
d) Source Leukocytes for Manufacture
e) Recovered Plasma. Recall #B-230/234-8.
-5-
CODE Unit numbers: a) 29GT70107, 29GT62663,
29GT58842, 29GG87374
b) 29GG87374; c) 29GT70107
d) 29GT58842; e) 29GT62663, 29GG87374.
MANUFACTURER American Red Cross Blood Services,
Norfolk, Virginia.
RECALLED BY Manufacturer, by letter between June 3 and 4,
1997. Firm-initiated recall complete.
DISTRIBUTION North Carolina, Virginia, California,
Massachusetts.
QUANTITY a) 4 units; b) 1 unit; c) 1 unit;
d) 1 unit; e) 2 units were distributed.
REASON Blood products were collected from a donor
with a history of cancer.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-235/236-8.
CODE Unit #03H05636.
MANUFACTURER American Red Cross Blood Services,
Miami, Florida.
RECALLED BY Manufacturer, by telephone on September 5,
1997, and by letter on September 8, 1997.
Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a
donor whose partner tested positive for
hepatitis C.
_______________
PRODUCT Red Blood Cells. Recall #B-237-8.
CODE Unit #25FS21515.
MANUFACTURER American Red Cross Blood Services, Syracuse,
New York.
RECALLED BY Manufacturer, by telephone on November 13,
1995. Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of
Platelets that was positive for Streptococcus
veridans, and implicated in a transfusion
reaction.
_______________
PRODUCT a) Red Blood Cells; b) Platelets
c) Fresh Frozen Plasma
d) Fresh Frozen Plasma, for further
manufacture
e) Cryoprecipitated AHF
f) Recovered Plasma. Recall #B-243/248-8.
-6-
CODE Unit numbers: a) 12FQ29146, 12FE49258,
12FC43655; b) 12FQ29146; c) 12FE49258; d)
12FQ29146 and 12FC52296; e&f) 12FC43655.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by letter dated September 15,
1997. Firm-initiated recall complete.
DISTRIBUTION North Carolina and California.
QUANTITY a) 3 units; b) 1 unit; c) 1 unit; d) 2 units;
e) 1 unit; f) 1 unit was distributed.
REASON Blood products were collected from a donor who
was taking the drug, Amantadine.
_______________
PRODUCT Platelets, Pheresis. Recall #B-249-8.
CODE Unit #12FM88745.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by letter dated August 4, 1997.
Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
received an MMR vaccine within three weeks of
donation.
_______________
PRODUCT a) Corneal Human Tissues; b) Scleral Human
Tissues. Recall #B-252/253-8.
CODE Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance (301) 827-6220
for individual unit numbers recalled.
MANUFACTURER Alabama Eye Bank, Inc., Birmingham,
Alabama.
RECALLED BY Manufacturer, by letter beginning October 1,
1997. Firm-initiated recall complete.
DISTRIBUTION Alabama, California, Florida, Georgia,
Illinois, Indiana, Michigan, Missouri, New
York, North Carolina, Ohio, South Carolina,
Tennessee, Lebanon.
QUANTITY a) 154 units; b) 21 units were distributed.
REASON Human tissues for transplant were not tested
for HIV-2.
_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma
c) Cryoprecipitate AHF; d) Recovered
Plasma. Recall #B-258/261-8.
CODE Unit numbers: 10229-6555, 10224-7119
b) 10229-6555; c) 10224-7119
d) 10224-7119.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
-7-
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona,
by letters dated January 22 and 30, 1996.
Firm-initiated recall complete.
REASON Blood Products were collected from a donor
with a history of Hepatitis.
_______________
PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF;
c) Recovered Plasma. Recall #B-267/269-8.
CODE Unit #21GK62763.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by letter dated January 8,
1997, by telephone on December 31, 1996, and
by letter on July 1, 1997. Firm-initiated
recall complete.
DISTRIBUTION Oregon, Washington state, Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
had a history of intravenous (IV) drug use.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh
Frozen Plasma. Recall #B-273/275-8.
CODE Unit #KL74136.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by letter dated September 9,
1997. Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected in a manner that
could compromise the sterility of the
products.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-276/277-8.
CODE Unit #KJ31838.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by letter dated August 25, 1997.
Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
traveled to an area considered endemic for
malaria.
_______________
PRODUCT Platelet Pool. Recall #B-280-8.
CODE Unit #03S00652.
MANUFACTURER American Red Cross Blood Services, Miami,
Florida.
-8-
RECALLED BY Manufacturer, by telephone on April 4, 1996.
Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III =======
_______________
PRODUCT Source Plasma. Recall #B-143-8.
CODE Unit numbers: AD0851, AD0864, AD0880.
MANUFACTURER Decatur Plasma, Inc., Decatur, Illinois.
RECALLED BY Manufacturer, by letter on June 13, 1997.
Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 3 units were distributed.
REASON Blood products were collected from donors who
were not tested for syphilis.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-146-8.
CODE Unit #29445-4963.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on August 22, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
whole blood identified as a difficult draw.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-147-8.
CODE Unit #29446-0970.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on August 26, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
whole blood identified as a difficult draw.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-150-8.
CODE Unit #29446-4191.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on September 2,
1997, and by letter on October 14, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
-9-
REASON Blood product was prepared from a unit of
whole blood identified as a difficult draw.
_______________
PRODUCT Cryo-poor Plasma. Recall #B-151-8.
CODE Unit #29446-3089.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on September 5,
1997, and by letter dated October 14, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
whole blood identified as a difficult draw.
_______________
PRODUCT Recovered Plasma. Recall #B-182-8.
CODE Unit #03V03703.
MANUFACTURER American Red Cross Blood Services, Miami,
Florida.
RECALLED BY Manufacturer, by letter on January 7, 1997.
Firm-initiated recall complete.
DISTRIBUTION Switzerland.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of
clotted Red Blood Cells.
_______________
PRODUCT a) Red Blood Cells; b) Platelets;
c) Fresh Frozen Plasma;
d) Cryoprecipitated AHF;
e) Recovered Plasma. Recall #B-202/206-8.
CODE Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance (301) 827-6220
for individual unit numbers recalled.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated March 12, 1996. Firm-initiated
recall complete.
DISTRIBUTION Arizona, Mississippi, Switzerland.
QUANTITY a) 21 units; b) 11 units; c) 3 units; d) 3
units; e) 8 units were distributed.
REASON Blood products were collected from donors
whose body temperatures at the time of
donation may have been greater than 99.6 F.
_______________
PRODUCT Platelets, Pheresis. Recall #B-209-8.
CODE Unit #LH37946.
MANUFACTURER American Red Cross Blood Services, Dedham,
Massachusetts.
-10-
RECALLED BY Manufacturer, by letter dated February 12,
1997. Firm-initiated recall complete.
DISTRIBUTION New Hampshire.
QUANTITY 1 unit was distributed.
REASON Blood product for which the date and time of
receipt was not documented.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-213/214-8.
CODE Unit #9590804.
MANUFACTURER Florida Blood Services, Inc., Tampa, Florida.
RECALLED BY Manufacturer, by telephone on April 5, 1996.
Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
with an elevated body temperature.
_______________
PRODUCT a) Red Blood Cells; b) Platelets;
c) Recovered Plasma. Recall #B-219/221-8.
CODE Unit #10502-9811.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated May 5, 1997. Firm-initiated
recall complete.
DISTRIBUTION Arizona and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products had an acceptable ALT but were
collected from a donor who previously had an
elevated ALT on two separate occasions.
_______________
PRODUCT Red Blood Cells. Recall #B-229-8.
CODE Unit #03FW55736.
MANUFACTURER American Red Cross, Atlanta, Georgia.
RECALLED BY Manufacturer, by telephone on September 2,
1997, and by letter dated September 10, 1997.
Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
reported cold and flu symptoms after donation.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-242-8.
CODE Unit numbers: 03H03993 and 03H03995.
MANUFACTURER American Red Cross Blood Services, Miami,
Florida.
RECALLED BY Manufacturer, by telephone on February 3,
1997. Firm-initiated recall complete.
-11-
DISTRIBUTION Florida.
QUANTITY 2 units were distributed.
REASON Blood products were not frozen within 8 hours
of whole blood collection.
_______________
PRODUCT Red Blood Cells. Recall #B-271-8.
CODE Unit #17182-2574.
MANUFACTURER United Blood Services, McAllen, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on September 17, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product may have remained at room
temperature for more than 30 minutes.
_______________
PRODUCT Whole Blood. Recall #B-272-8.
CODE Unit #21R45004.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by telephone on August 21 and
22, 1997. Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product may have remained at room
temperature more than 30 minutes.
_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-278/279-8.
CODE Unit #03KJ03020.
MANUFACTURER American Red Cross Blood Services, Miami,
Florida.
RECALLED BY Manufacturer, by telephone on June 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
took antibiotics within 48 hours of donation.
RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS II ========
_______________
PRODUCT Pediatric Flow Meter/Humidifier Holder,
Model #PV5LP-627. Recall #Z-198-8.
CODE All lot/code numbers.
MANUFACTURER Sunrise Medical HHG, Inc. (also known as
Devilbiss Respiratory Products Division),
Somerset, Pennsylvania.
RECALLED BY Manufacturer, by telephone and fax on October
23, 1997. Firm-initiated recall ongoing.
-12-
DISTRIBUTION Nationwide, Australia, Canada.
QUANTITY 424 units were distributed.
REASON The labeling failed to warn users that the
device is intended to be directly attached to
a DeVilbiss Model PV5L Oxygen Concentrator
only, and that when using with other models,
the device should be used only as a remote
holder and must be securely fastened to a
sturdy horizontal surface.
_______________
PRODUCT Fresenius Hemodialysis Delivery System with
Software Version 8.02, 3.91 and 2.50, used to
pump dialysate solution and blood through
hemodialyzer so that hemodialysis can take
place in patient and act as an artificial
kidney. Recall #Z-201/202-8
CODE All lot codes/serial numbers.
MANUFACTURER Fresenius Medical Care, Walnut Creek,
California.
RECALLED BY Manufacturer, by letter on November 5, 1997.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide, Canada, Mexico, Caribbean.
QUANTITY 21,083 units were distributed.
REASON In the unlikely event of a sudden massive
blood leak, the system may not give an alarm.
_______________
PRODUCT Ruby Laser System, Model #5000, used in
dermatology. Recall #Z-204-8.
CODE None.
MANUFACTURER Sharplan Lasers, Inc., Allendale, New Jersey.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan on November 26, 1997.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 121 units were distributed.
REASON The operator's manual lacked calibration
procedures.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Fisher Diagnostics brand LEUKO-STAT Stain Kit,
Catalog #CS430D, in-vitro diagnostic.
Recall #Z-199-8.
CODE Lot Nos. 97F17, 97F24, 97F26, 97H08.
MANUFACTURER Richard-Allan Scientific, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter on August 18, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 139 kits were distributed.
-13-
REASON One of the three kit components was mislabeled
so that two of the components bear the same
label.
_______________
PRODUCT INNOFLUOR AMIKACIN SYSTEM CALIBRATORS, Catalog
No. 41024, in-vitro diagnostic product.
Recall #Z-200-8.
CODE Lot No. 26215.
MANUFACTURER Oxis International, Inc., Portland, Oregon.
RECALLED BY Manufacturer, by letter on October 2, 1997.
Firm-initiated recall complete.
DISTRIBUTION Belgium, France, Germany, Greece, Spain, and
the United Kingdom.
QUANTITY 50 sets were distributed.
REASON The device may not perform according to
specifications during the labeled shelf life.
-14-
END OF ENFORCEMENT REPORT FOR DECEMBER 3, 1997. BLANK PAGES MAY FOLLOW.
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End of Enforcement Report for
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