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 1, 1998 98-13

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I =============
_______________
PRODUCT Hy-Top White Grape Juice from Concentrate, 64
fluid ounce bottles. Recall #F-188-8.
CODE 08068 CT133 xxxx, 01199 CT133 xxxx, 02189 CT133
xxxx, and 02198 CT133 xxxx (where xxxx = military
time).
MANUFACTURER Cliffstar Corporation, Joplin, Missouri.
RECALLED BY Federated Group, Inc., Arlington Heights,
Illinois, by letter and press release dated
February 4, 1998. Firm-initiated recall ongoing.
DISTRIBUTION Texas.
QUANTITY 480 cases (8 bottles per case) were distributed.
REASON Product contains undeclared sulfites.

_______________
PRODUCT Fisherman's Wharf Wild Alaskan Smoked Salmon
Sliced Nova, 3 ounce units. Recall #F-190-8.
CODE 717643.
MANUFACTURER Port Chatham Smoked Seafood, Everett, Washington.
RECALLED BY Manufacturer, by telephone on February 27, 1998,
followed by fax and press release. Firm-initiated
recall complete.
DISTRIBUTION Florida, North Carolina, South Carolina,
Tennessee, Georgia.
QUANTITY 2,769 pieces (519 pounds) of product were
distributed.
REASON Product is contaminated with Listeria
monocytogenes.

_______________
PRODUCT Alfalfa Sprouts, in 4 ounce plastic containers
packed by Krisp-Pak Co., Inc., and in unlabeled 5
pound flats. Recall #F-191-8.
CODE All lots distributed prior to August 1, 1997.
MANUFACTURER Krisp-Pak Company, Inc., Norfolk, Virginia.
RECALLED BY Manufacturer, by letter on August 1, 1997, and by
telephone on August 4 and 8, 1997. Virginia
Department of Agriculture issued press releases on
August 1, 4, and 5, 1997. Firm-initiated recall
complete.
DISTRIBUTION North Carolina, Maryland, Virginia, District of
Columbia.
QUANTITY Undetermined.
REASON Product may be contaminated with E.coli 0157:H7.

_______________
PRODUCT a) Corydalis & Argemone 11 Formula, 8 oz. glass
bottle
b) Corydalis & Argemone 15 Formula, 8 oz. glass
bottle
c) Corydalis & Argemone 16 Formula, 8 oz. glass
bottle
d) Hydratis & Baptisia 12 Formula, 8 oz. glass
bottle
e) Eriodyction & Grindelia 9 Formula/Lotion,4 oz.
glass bottle
f) Mahonia & Viola 10 Formula, 8 oz. glass bottle
g) Serrenoa & Pygeum 17 Formula, 4 oz. glass
bottle
h) Serrenoa & Pygeum 23 Formula, 4 oz. glass
bottle. Recall #F-315/322-8.
CODE a) 12/6/96, 3/14/97, 5/16/97, and 6/19/97
b) 12/6/96, 3/14/97, 5/16/97, and 6/19/97
c) 12/6/96, 3/14/97, 5/16/97, and 6/19/97
d) 1/28/97 and prior lots without lot code dates
e) 4/1/97 and prior lots without lot code dates
f) 12/6/96, 3/14/97, 5/16/97, and 6/19/97
g) 12/11/96 and 2/18/97
h) 12/11/96 and 2/18/97.
MANUFACTURER KW Botanicals, San Anselmo, California.
RECALLED BY Manufacturer, by letter dated July 28, 1997.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 243 8-ounce bottles and 130 4-ounce bottles were
distributed.
REASON Products were contaminated with Digitalis
glycosides.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ============
_______________
PRODUCT Hy-Top White Grape Juice from Concentrate, in 64
fluid ounce bottles. Recall #F-189-8.
CODE A7K09, B7K07, B7K26, C7K07, C7K14, C7K17, D7K17,
D7K25, E7K01, E7K09, F7K04, F7K27, G7K21, H7K14,
J7K01, J7K05, J7K11, K7K01, K7K21, K7K30, L7K05,
L7K19, M7K31, A8K22, A8K29, 3507255 CT390, 3507290
CT390, 3507377 CT390, 3507344 CT390, and 3507356
CT390.
MANUFACTURER Speaco Foods, Inc., Kansas City, Missouri; Ozark
Valley Products, Springdale, Arkansas.
RECALLED BY Federated Group, Inc., Arlington Heights,
Illinois, by letter and press release dated
February 4, 1998. Firm-initiated recall ongoing.
DISTRIBUTION Texas, Oklahoma, Nevada.
QUANTITY 4,705 cases (8 bottles per case) were distributed.
REASON product is misbranded in that it lists potassium
sulfate as an ingredient when potassium
metabisulfite was actually added.

_______________
PRODUCT Price Chopper brand Children's Chewable Vitamins
with Minerals in bottles of 60 tablets. Recall
#F-314-8.
CODE 38088-06, 38088-05, 38088-04, 38088-03, 38088-02,
38088-01, 37346.
MANUFACTURER NBTY, Inc., Bohemia, New York.
RECALLED BY Manufacturer, by telephone on or about March 5,
1998, and by electronic mail and voice mail dated
March 6, 1998. Firm-initiated recall ongoing.
DISTRIBUTION New York, Massachusetts, Pennsylvania, Vermont,
Connecticut.
QUANTITY Lot Quantity
38088-06: 434 units
38088-05: 372 units
38088-04: 462 units
38088-03: 864 units
38088-02: 1296 units
38088-01: 3600 units
37346 : 982 units were distributed.
REASON Product contains undeclared FD&C Yellow No. 6, Red
No. 40 and Blue No. 2.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ===========
_______________
PRODUCT Vitamin D, 3.25%, Homogenized Milk, Grade A,
Pasteurized, in one-gallon cartons under the
Meijer, Smith's, IGA, and Buehler's labels; one-half gallon (plastic) cartons under the Meijer,
Smith's, and Hawkins labels; one-quart cartons
under the Smith and Meijer labels; one-pint, half
pint, and 5-gallon cartons under the Smith label.
Recall #F-313-8.
CODE Use by date: MAR 13.
MANUFACTURER Smith Dairy Products, Orrville, Ohio.
RECALLED BY Manufacturer, by letters on March 6 and 9, 1998.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 15,119 gallons were distributed.
REASON Product is labeled as "Vitamin D Milk" but
consists in part of Chocolate milk.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
============
_______________
UPDATE Propranolol HCL, Recall #D-100/103-8, which
appeared in the March 25, 1998 Enforcement Report
should read: Product was distributed under the
following labels: Inwood, TEVA, URL, Schein,
Parmed, Qualitest, Rugby, Geneva, Moore, Major,
and Zenith Goldline.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ========
_______________
PRODUCT Red Blood Cells. Recall #B-649-8.
CODE Unit Numbers: 18207-6302, 18208-1466,
18209-2846, 18210-3888, 18207-1756.
MANUFACTURER United Blood Services, Cheyenne, Wyoming.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, letters
dated July 30, 1996, and November 12, 1996, and
telephone in March 1998.
DISTRIBUTION Illinois, Texas, Wyoming.
QUANTITY 5 units were distributed.
REASON Blood products were collected from a donor who
reported living an area designated as endemic for
malaria.

_______________
PRODUCT Source Plasma. Recall #B-723-8.
CODE 6020055489, 6020055739, 6020056046, 6020056301,
6020056620, 6020056914, 6020057250, 6020057518,
6020058104, 6020058345, 6020058951, 6020059581,
6020059812, 6020061175, 6020061462, 6020061707,
6020062066, 6020062316, 6020062626.
MANUFACTURER Premier BioResources, Inc., San Antonio, Texas.
RECALLED BY North American Biologicals, Inc., Boca Raton,
Florida, by letter dated November 16, 1997 and
January 21, 1998. Firm-initiated recall complete.
DISTRIBUTION California and Canada.
QUANTITY 19 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, Western blot indeterminate.

_______________
PRODUCT Platelets, Pheresis. Recall #B-729-8.
CODE Unit #12T16851.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by telephone on March 22, 1997, and
by letter on March 25, 1997. Firm-initiated
recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was mislabeled as CMV antibody
negative.

_______________
PRODUCT Red Blood Cells. Recall #B-742-8.
CODE Unit numbers: 03GY06816, 03GY06818.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by telephone February 9, 1998, and
by letter dated February 11, 1998. Firm-initiated
recall complete.
DISTRIBUTION Georgia.
QUANTITY 2 units were distributed.
REASON Blood products were prepared from a unit of Whole
Blood designated as overweight.

_______________
PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF;
c) Platelets; d) Recovered Plasma.
Recall #B-744/747-8.
CODE Unit #12Y66788.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by letter dated January 26, 1998.
Firm-initiated recall complete.
DISTRIBUTION North Carolina, Tennessee, Georgia, Switzerland.
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-748-8.
CODE Unit numbers: 18927R, 58002T, 58662T.
MANUFACTURER Ohio Blood Plasma, Inc., Cincinnati, Ohio.
RECALLED BY Manufacturer, by telephone on June 21, 1997.
Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 3 units were distributed.
REASON Blood products were drawn from an unsuitable
donor.

_______________
PRODUCT Platelets, Pheresis. Recall #B-749-8.
CODE Unit #16KF12861.
MANUFACTURER American Red Cross, Central Ohio Region, Columbus,
Ohio.
RECALLED BY Manufacturer, by letter dated December 24, 1997.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product tested negative for Cytomegalovirus
(CMV), but collected from a donor who previously
tested repeat reactive for CMV.

_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma; c)
Cryoprecipitated AHF; d) Plasma.
Recall #B-750/753-8.
CODE Red Blood Cells, Fresh Frozen Plasma, unit
KC47440; Red Blood Cells,
Cryoprecipitated AHF, Plasma, unit KN34421.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by letter dated November 4 and 5,
1996. Firm-initiated recall complete.
DISTRIBUTION Virginia and Tennessee.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
reported body piercing within 12 months of
donation.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma. Recall #B-754/756-8.
CODE Unit #KH82588.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by letter dated January 27, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Virginia.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor whose
high risk screening was inadequately performed.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma. Recall #B-757/759-8.
CODE Unit #KH44373.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by letter dated January 28, 1998.
Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit of each component was 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, Western blot indeterminate.

_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-760/761-8.
CODE Unit #KH81021.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by letter dated January 2, 1998.
Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a
history of sarcoidosis.

_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-762/763-8.
CODE Unit #39J73116.
MANUFACTURER American Red Cross Blood Services, Huntington,
West Virginia.
RECALLED BY Manufacturer, by letter dated April 3, 1996, and
May 7, 1996. Firm-initiated recall complete.
DISTRIBUTION West Virginia and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor taking
the drug Methotrexate.

______________
PRODUCT Red Blood Cells. Recall #B-764-8.
CODE Unit #29GT88345.
MANUFACTURER American Red Cross Blood Services, Norfolk,
Virginia.
RECALLED BY Manufacturer, by letter dated December 22, 1997.
Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who may
have traveled to an area considered endemic for
malaria.

_______________
PRODUCT Platelets, Pheresis. Recall #B-768-8.
CODE Unit #58411P.
MANUFACTURER Lane Memorial Blood Bank, Eugene, Oregon.
RECALLED BY Manufacturer, by letter dated December 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product with a platelet count below the
acceptable yield was distributed, not labeled as a
low yield product.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma. Recall #B-770/772-8.
CODE Unit #42W65412.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letter dated November 11, 1996.
Firm-initiated recall complete.
DISTRIBUTION Ohio and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for HBsAg, but were
collected from a donor who previously tested
repeat reactive with a "nonspecific" confirmatory
test for HBsAg.

_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-773/774-8.
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, San Jose,
California.
RECALLED BY Manufacturer, by letters dated January 26, 1998,
and February 23, 1998. Firm-initiated recall
complete.
DISTRIBUTION California, Switzerland.
QUANTITY a) 32 units; b) 29 units were distributed.
REASON Blood products were incorrectly tested for
syphilis.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma. Recall #B-776/778-8.
CODE Unit numbers: a) 42R47816, 42G39047, 42G42983; b)
42G42983; c) 42R47816, 42G39047, 42G42983.
MANUFACTURER American Red Cross, Cleveland, Ohio.
RECALLED BY Manufacturer, by letters dated June 7, 1996 and
June 5, 1996. Firm-initiated recall complete.
DISTRIBUTION Ohio, California, Switzerland.
QUANTITY a) 3 units; b) 1 unit; c) 3 units were
distributed.
REASON Blood products tested negative for antibody to the
human immunodeficiency virus type 1 (anti-HIV-1),
but collected from a donor who previously tested
repeat reactive for anti-HIV-1, and was
incorrectly reentered.

_______________
PRODUCT a) Red Blood Cells; b) Platelets;
c) Cryoprecipitated AHF. Recall #B-779/781-8.
CODE Unit #42T43472.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letter dated November 10, 1995.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested repeatedly reactive for the
antibody to the Hepatitis B core antigen (anti-HBc), and were subject to additional testing.

_______________
PRODUCT a) Red Blood Cells; b) Platelets, Pheresis; c)
Platelets; d) Recovered Plasma.
Recall #B-786/789-8.
CODE Unit numbers: a) 42FT20586, 42FX14692, 42FQ25904,
42J47644; b) 42FR01336, 42FR01524, 42FR01949,
42FR02156; c) 42J47644;
d) 42FT20586, 42FX14692, 42FQ25904, 42J47644.
MANUFACTURER American Red Cross, Cleveland, Ohio.
RECALLED BY Manufacturer, by letters dated December 4 and 14,
1995, and January 2, 1996. Firm-initiated recall
complete.
DISTRIBUTION Ohio and California.
QUANTITY a) 4 units; b) 4 units; c) 1 unit; d) 4 units were
distributed.
REASON Blood products tested negative for antibody to the
human immunodeficiency virus type 1 (anti-HIV-1),
but collected from donors who previously tested
repeat reactive for anti-HIV-1, with units tested
into compliance, and both donors incorrectly
reentered.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma; d) Recovered Plasma.
Recall #B-790/793-8.
CODE Unit numbers: a) 42L56442, 42Y68097, 42Y72211,
42L76564, 42L82687, 42G65958, 42W35017, 42FP02051,
42FP26945
b) 42L56442, 42Y68097, 42Y72211, 42L76564,
42W35017, 42FP02051; c) 42L56442, 42L76564
d) 42Y68097, 42Y72211, 42L82687, 42G65958,
42W35017, 42FP02051, 42FP26945.
MANUFACTURER American Red Cross, Cleveland, Ohio.
RECALLED BY Manufacturer, by letter dated June 24, 1996.
Firm-initiated recall complete.
DISTRIBUTION Ohio and California.
QUANTITY a) 9 units; b) 6 units; c) 2 units; d) 7 units
were distributed.
REASON Blood products tested negative for antibody to the
human immunodeficiency virus type 1 (anti-HIV-1),
but collected from a donor who previously tested
repeat reactive for anti-HIV-1, Western Blot
indeterminate and WB negative, and was incorrectly
reentered.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c)
Cryoprecipitated AHF; d) Platelets for further
manufacturing; e) Recovered Plasma.
Recall #B-799/803-8.
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, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letters dated June 10 and 26,
1996. Firm-initiated recall complete.
DISTRIBUTION Ohio, Florida, California, Switzerland.
QUANTITY a) 26 units; b) 12 units; c) 1 unit; d) 1 unit; e)
26 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 initially reactive for
anti-HIV-1 with no repeat testing performed.

_______________
PRODUCT a) Whole Blood; b) Red Blood Cells
c) Platelets; d) Fresh Frozen Plasma
e) Cryoprecipitated AHF; f) Recovered Plasma.
Recall #B-804/809-8.
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, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letters dated June 28, 1996, and
July 10, 1996. Firm-initiated recall complete.
DISTRIBUTION Ohio and California.
QUANTITY a) 1 unit; b) 10 units; c) 5 units; d) 2 units; 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 donors who
previously tested repeatedly reactive for
anti-HIV-1, Western blot negative.

_______________
PRODUCT a) Whole Blood; b) Red Blood Cells; c) Platelets;
d) Fresh Frozen Plasma; e) Recovered Plasma.
Recall #B-810/814-8.
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, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letters dated June 26, 1996, and
July 10, 1996. Firm-initiated recall complete.
DISTRIBUTION Ohio, California, New York, Switzerland.
QUANTITY a) 1 unit; b) 44 units; c) 33 units; d) 10 units;
e) 33 units were distributed.
REASON Blood products, which tested negative for the
antibody to the human immunodeficiency virus type
1 (anti-HIV-1), but were collected from donors
who previously tested repeatedly reactive for
anti-HIV-1, Western blot negative.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III =======
_______________
PRODUCT Fresh Frozen Plasma Pheresis.
Recall #B-446-8.
CODE Contact FDA, Center for Biologics Evaluation and
Research, Office of Compliance (301) 827-6220 for
individual unit numbers recalled.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by letter dated March 12, 1997.
Firm-initiated recall complete.
DISTRIBUTION Virginia, Maryland, Illinois.
QUANTITY 248 units were distributed.
REASON Fresh Frozen Plasma Pheresis was not frozen within
six hours of collection.

_______________
PRODUCT a) Plasma, Cryoreduced, Frozen; b) Plasma,
Pheresis. Recall #B-652/653-8.
CODE Contact FDA, Center for Biologics Evaluation and
Research, Office of Compliance (301) 827-6220 for
individual unit numbers recalled.
MANUFACTURER American Red Cross Great Lakes Region, Fort Wayne,
Indiana.
RECALLED BY Manufacturer, by letter dated October 14, 1997.
Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY a) 59 units; b) 33 units were distributed.
REASON Blood products' shipping temperature was not
recorded upon receipt.

_______________
PRODUCT Red Blood Cells, Irradiated. Recall #B-701-8.
CODE Units 21GC20191, 21GC20198, 21GC20224, 21GC20233,
and 21GC20689.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by telephone on December 4, 1997.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 5 units were distributed.
REASON Blood products may have remained at room temperature for an unacceptable length of time.

_______________
PRODUCT Red Blood Cells. Recall #B-736-8.
CODE Unit #03GX06510.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by telephone on January 28, 1998,
and letter dated February 11, 1998. Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.

_______________
PRODUCT Platelets, Pheresis, Irradiated.
Recall #B-737-8.
CODE Unit numbers: 03P09241, 03P09242, 03P09243,
03P09245, 03P09248.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by letter dated December 31, 1997.
Firm-initiated recall complete.
DISTRIBUTION Georgia and Oklahoma.
QUANTITY 5 units were distributed.
REASON Platelets were not stored under continuous agitation.

_______________
PRODUCT Platelets, Pheresis. Recall #B-743-8.
CODE Unit #03FG12703.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by telephone on September 29, 1997.
Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON A unit of Platelets Pheresis, which was
incompatible by crossmatch, was labeled as
compatible and distributed for transfusion.

_______________
PRODUCT Red Blood Cells. Recall #B-766-8.
CODE Unit #40GE26285.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on February 3, 1998.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.

_______________
PRODUCT Platelets, Pheresis. Recall #B-769-8.
CODE Unit #16KF10466.
MANUFACTURER American Red Cross, Columbus, Ohio.
RECALLED BY Manufacturer, by letter dated December 17, 1997.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON A unit of Platelets, Pheresis was labeled with the
incorrect expiration date.

_______________
PRODUCT Platelets, Pheresis. Recall #B-794-8.
CODE Double Collection Unit #49FP05175.
MANUFACTURER American Red Cross, Waco, Texas.
RECALLED BY American Red Cross, Tulsa, Oklahoma, by letter
dated February 3, 1998. Firm-initiated recall
complete.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit was distributed.
REASON Unlicensed blood products were distributed labeled
with the firm's license number.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
==========
_______________
PRODUCT Rehabilitation Beds, full electric:
a) BCW XL1000 Rehabilitation Bed, full electric,
1,000-lb. capacity, Twin - 39 x 80", 3/4 size 48"
x 80"
B) BCW XL1000 Rehabilitation Bed, full electric,
1,000-lb. capacity, Double - 54" x 80
c) BCW XL1000 Rehabilitation Bed, full electric,
1,000-lb. capacity, Queen - 60" x 80".
Recall #Z-412/414-8.
CODE The following serial numbers are affected by this
recall:
105148 105661 105798 105905
105170 105662 105799 105908
105171 105663 105816 105909
105637 105664 105817 105933
105648 105698 105820 106021
105651 105712 105833 106022
105652 105713 105834 106023
105653 105715 105866 106024
105654 105717 105877 106031
105655 105740 105878 106032
105656 105741 105881 106039
105657 105742 105882 106040
105658 105744 105891
105659 105750 105896
105660 105794 105899.
MANUFACTURER Raye's Inc., doing business as Wheelchairs of
Kansas, Ellis, Kansas.
RECALLED BY Manufacturer, by letter on March 19, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 58 beds were distributed.
REASON The devices have ground fault problems which could
cause shock to the user.

_______________
PRODUCT Laser Rangefinders, used to determine distance
between two points using reflected invisible
light: a) Superbove 600LRF;
b) Superbove 800 LRF. Recall #Z-416/417-8.
CODE None.
MANUFACTURER Asia Optical Company, Inc., Taiwan, Republic of
China.
RECALLED BY Tasco Sales, Inc., Miramar, Florida (importer).
FDA approved the firm's corrective action plan
November 10, 1997. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,205 units were distributed.
REASON The laser product failed to comply with the
following requirements of the Federal laser
product performance standard: 21 CFR 1040.10(c)
Classification of laser products, 1040.10(f)
Performance requirement, 1040.10(g) Labeling
requirements, 1040.10(h) Information requirements,
1005.25 Designation of a resident agent.

_______________
PRODUCT Nurses Heart Tubing Pack and Open Heart Pack,
custom surgical kits. Recall #Z-419/421-8.
CODE Nurses heart tubing pack, Catalog # 10-VAEHJH03HI,
LOT NUMBER JUN1397, OPEN HEART PACK, CATALOG #
04-IMH03HI, LOT NUMBER SEP0597, OPEN HEART PACK,
CATALOG # 05-IMH03HI, LOT NUMBER OCT2897 which
contain Bard Vascular Systems recalled Bard
William Harvey H-130 Over Pressure Safety Valve
(OPS).
MANUFACTURER C.R. Bard, Inc., Haverhill, Massachusetts
(component).
RECALLED BY Maxxim Medical, doing business as Sterile Design,
Clearwater, Florida, by telephone on October 29,
1997, followed by letter on November 4, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 68 trays were distributed; firm estimates none
remains on the market.
REASON Sterile Custom Kits contain recalled (Z-212-8)
component Bard William Harvey H-130 Over pressure
Safety Valve which is occluded preventing blood
flow through it.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Incon Therapy, Recon Rx version 3.01 software for
the portable Rx component, a component of a
neurological biofeedback monitoring system for the
treatment of incontinence.
Recall #Z-418-8.
CODE Serial numbers 1600 to 3326.
MANUFACTURER KWM Electronics Corporation, West Jordan, Utah.
RECALLED BY NextEra Medical, L.L.C., Columbus, Ohio, by recall
field correction August 1997 and by letter on
March 17, 1998. Firm-initiated field correction
ongoing.
DISTRIBUTION Indiana, West Virginia, Tennessee, Ohio, North
Carolina, New York, Nevada, Kentucky, Illinois,
Arizona, Florida.
QUANTITY 1,762 units were distributed.
REASON Rx units were not functioning correctly. Obsolete
version 3.01 software had been installed in the
units.

_______________
PRODUCT TI-CHRON Surgical Sutures, Size 2-0 with
Cardiopoint Needle, for use in general soft tissue
approximation and/or ligation.
Recall #Z-422-8.
CODE Product Code 28850-51, Lot 951222.
MANUFACTURER Sherwood-Davis & Geck, Manati, Puerto Rico.
RECALLED BY Sherwood-Davis & Geck, Hazelwood, Missouri, by
letter dated February 18, 1998, followed by visit.
Firm-initiated recall ongoing.
DISTRIBUTION Massachusetts, Connecticut, Florida, Kentucky,
Ohio, Wisconsin, Missouri, Nebraska, California.
QUANTITY 21 boxes (3 dozen units per box) were distributed.
REASON The device was labeled as containing a "TFE
polymer pledget", which is incorrect.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II ============
_______________
PRODUCT Levothyroxine Sodium Tablets indicated for
hypothyroidism in dogs. Recall #V-020-8.
BRAND NAME: LABELED FOR STRENGTH (mg/TAB) # TABS/BTL
THYROZINE ANPRO 0.1, 0.2, 0.3, 0.4, 1000'S
PHARMACEUTICAL 0.5, 0.6, 0.7, 0.8
THYROZINE PHOENIX 0.1, 0.2, 0.3, 0.4, 1000'S
PHARMACEUTICAL 0.5, 0.6, 0.8
THYROZINE PHOENIX 0.1, 0.2, 0.3, 0.5, 180'S
PHARMACEUTICAL 0.8
THYROZINE WESTERN 0.1, 0.2, 0.3, 0.4, 1000'S
VET SUPPLY 0.5, 0.6, 0.7, 0.8
THYROSYN VEDCO 0.1, 0.2, 0.3, 0,4 1000'S
0.5, 0.6, 0.7, 0.8
LEVOTABS BURNS VET 0.7 1000'S
SUPPLY
THYROXINE-L THE BUTLER 0.1, 0.2, 0.3, 0.4, 1000'S
COMPANY 0.5, 0.6, 0.7, 0.8
THYROXINE-L THE BUTLER 0.1, 0.2, 0.3, 0.6, 180'S
COMPANY 0.8
CODE All lots with expiration date of February
1998 through March 1999.
MANUFACTURER Anthony Products Company, Arcadia, California.
RECALLED BY Manufacturer, by telephone on February 23,
1998, and by letter dated March 9, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Arizona, California, Florida, Indiana, Iowa,
Missouri, Mississippi, New York, Ohio, Texas
and Wisconsin.
QUANTITY 62,018 bottles were distributed.
REASON Product was 64.3% to 85.7% subpotent.

END OF ENFORCEMENT REPORT FOR APRIL 1, 1998. BLANK PAGES MAY FOLLOW.

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End of Enforcement Report for