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.
October 29, 1997 97-44
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Oriental Mascot brand Dried Sweet Potato, in
plastic bags (Heat Sealed), net weight 8
ounces, 100 bags per carton.
Recall #F-031-8.
CODE None. All product with undeclared sulfites.
MANUFACTURER Unknown.
RECALLED BY Summit Import Corporation, New York, New York
(importer), by letter on December 9, 1996,
followed by telephone on January 3, 1997.
Firm-initiated recall complete.
DISTRIBUTION New York, Ohio, Connecticut, Pennsylvania,
North Carolina, Maryland, Illinois.
QUANTITY 30 cartons (100 x 8 oz. bags) were
distributed.
REASON The product contains undeclared sulfites.
_______________
PRODUCT Silken Tofu under the Nasoya and Vitasoy
labels, in 19 ounce flexible plastic tubs.
Recall #F-032-8.
CODE "USE BY:JUN04_", where the blank may be "A",
"B", or "C".
MANUFACTURER Nasoya Foods, Inc., Leominster, Massachusetts.
RECALLED BY Manufacturer, by telephone June 13, 16, and
17, 1997. Firm-initiated recall complete.
DISTRIBUTION Massachusetts, Maine, Florida, New York,
New Jersey.
QUANTITY Firm estimates none remains on the market.
REASON Product was found to be contaminated with
Salmonella sp.Group E2.
_______________
PRODUCT A "Cleansing Herbal Dietary Supplement." The
"Chomper" product is promoted as an "herbal
laxative" and "cleansing" agent to be used as
part of a regimen of dietary products
distributed by this company:
a) Chomper 350; b) Chomper 100
c) Chomper with Cayenne 100
d) Chomper with Cayenne 270
e) Chomper, bulk, 8.8/9.0 oz
Recall #F-033/037-8.
CODE 350 COUNT (TABS): 703118, 703119, 703120,
703121, 703126, 703127, 703128, 703129,
100 COUNT (TABS): 703131
250 GRAM/8.8 OZ. (BULK-POWDER): 703238
350 COUNT (TABS) & 100 COUNT (TABS) & BULK
(9.00 OZ. POWDER): D6409, 027041, 027042.
All lots of Chompers produced by ABCO and JMI.
MANUFACTURER ABCO Inc., Concord, California, & JMI Phoenix
Laboratories, Inc., Tempe, Arizona.
RECALLED BY Arise & Shine, Mt. Shasta, California, by
telephone, followed by letters on May 9 and
30, 1997, and June 9, 1997. Firm-initiated
recall ongoing. See also FDA press release
P97-14, 1997, May 16, 1997, and FDA Statement
dated June 12, 1997.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimated that very little product
remained on market at time of recall
initiation.
REASON The product is contaminated with Digitalis.
_______________
PRODUCT Plantain Leaves both cut and powdered.
Recall #F-038/039-8.
CODE Lots 15-791, 16-121, and 16-338,
lots 15-791 consists of both cut plantain
leaves and powdered plantain, the other lots
are cut.
MANUFACTURER Herbarium, Inc., Kenosha, Wisconsin.
RECALLED BY Manufacturer, by letter dated June 20, 1997.
Firm-initiated recall complete. See also FDA
Statement dated June 12, 1997.
DISTRIBUTION California, Illinois, Iowa, Michigan, New
Jersey, New York, Pennsylvania.
-2-
QUANTITY 5735 pounds of cut plantain leaves and 950
pounds of powdered plantain leaves were
distributed.
REASON Product was contaminated with Digitalis
glycosides.
_______________
PRODUCT Plantain Leaves both cut and powdered.
Recall #F-040/041-8.
CODE All product distributed between 7/13/95 and
5/97.
MANUFACTURER Nature's Cathedral, Inc., Blairstown, Iowa.
RECALLED BY Manufacturer, by telephone on June 16, 1997,
followed by letter. Firm-initiated recall
complete. See also FDA statement dated June
12, 1997.
DISTRIBUTION Colorado, Iowa, Utah, California, Oregon,
Michigan, New York, Vermont, Massachusetts,
Arizona, Florida, Washington state, Canada.
QUANTITY 6,040.5 pounds plantain cut and sifted and 24
pounds of plantain powder were distributed
since 2/96.
REASON Product was contaminated with Digitalis
glycosides.
_______________
PRODUCT Plantain Leaves both cut and powdered, in 1
pound poly bags. Recall #F-042/043-8.
CODE All product distributed between 7/20/95 to
6/4/97.
MANUFACTURER Ameriherb, Inc., Ames, Iowa.
RECALLED BY Manufacturer, by telephone beginning June 7,
1997. Firm-initiated recall complete. See
also FDA statement dated June 12, 1997.
DISTRIBUTION Nationwide.
QUANTITY 166 pounds cut and 13 pounds powder were
distributed.
REASON Product was contaminated with Digitalis
glycosides.
_______________
PRODUCT Plantain Leaves, in 1 pound - 5 pound bags.
Recall #F-044-8.
CODE 0205B, 0404B, and 0526B.
MANUFACTURER Pacific Botanicals, Grant Pass, Oregon.
RECALLED BY Manufacturer, by telephone beginning June 25,
1997. Firm-initiated recall complete. See
also FDA statement dated June 12, 1997.
DISTRIBUTION Nationwide and Canada.
QUANTITY 93.66 pounds were distributed.
REASON Product was contaminated with Digitalis.
glycosides.
-3-
_______________
PRODUCT Uriseptic Tea. Recall #F-045-8.
CODE None.
MANUFACTURER Wise Woman Herbals, Creswell, Oregon.
RECALLED BY Manufacturer, by fax and telephone on June 10,
1997, and letter June 23, 1997.
Firm-initiated recall complete. See also FDA
statement dated June 12, 1997
DISTRIBUTION California, Hawaii, Massachusetts, Oregon,
Pennsylvania, Vermont, Washington state,
Canada.
QUANTITY 21.5 pounds were distributed.
REASON Product was contaminated with Digitalis
glycosides.
_______________
PRODUCT Plantain Leaves, cut and sifted, dry repacked
from bulk into 1-pound clear plastic bags.
Recall #F-046-8.
CODE All product received from supplier between
2/1/96 and 6/6/97.
MANUFACTURER Trinity Herb, A Division of Trinity
Enterprises, Inc., Sebastopol, California.
RECALLED BY Manufacturer, by letter on June 23, 1997.
Firm-initiated recall complete. See also FDA
statement dated June 12, 1997.
DISTRIBUTION Nationwide and Canada.
QUANTITY 245 pounds were distributed.
REASON Product was contaminated with Digitalis
glycosides.
_______________
PRODUCT Plantain and herbal extracts in 1 ounce and 4
ounce bottles:
(a) PURE HERBS Brand Plantain extract
(b) PURE HERBS Brand E.T.B.-M
(c) PURE HERBS M. & B.-A
(d) PURE HERBS G.F.-G.
(e) M.& B.-A (computer printed label)
(f) L.L. -F. (LNGV) (computer printed label).
Recall #F-047/052-8.
CODE Lot numbers: a) 072, 081, 082, 083, 091, 092.
(b-f) All lots.
MANUFACTURER Ameriherb, Inc., Ames, Iowa (supplier).
RECALLED BY Pure Herb, Ltd., Madison, Wisconsin, by letter
on August 4, 1997. Firm-initiated recall
ongoing. See also FDA statement dated June
12, 1997.
DISTRIBUTION Nationwide and Canada.
QUANTITY Approximately 1,100 bottles of plantain
extract and an unknown quantity of the other
products were distributed.
-4-
REASON Product were contaminated with Digitalis
glycosides.
_______________
PRODUCT Nature Cleanse Tablets (Nature's Plus &
BotaniCleanse brands). 90 tablets per bottle.
Recall #F-053-8.
CODE Lot numbers: 28437, 28800, 28857, 29641 and
product numbers 1138 & 1140.
MANUFACTURER National Nutritional Laboratories, Inc.,
Huntington Station, New York.
RECALLED BY Natural Organics, Inc., Melville,
New York, by letter on July 25, 1997.
Firm-initiated recall complete. See also FDA
statement dated June 12, 1997.
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
REASON Product was contaminated with Digitalis
glycosides.
_______________
PRODUCT Plantain Extract in 1 ounce, 4 ounce, and «
gallon containers. Recall #F-054-8.
CODE Lots 0000015 through 0000023.
MANUFACTURER Good Herbs, Inc., Troy, Michigan.
RECALLED BY Manufacturer, by telephone beginning July 10,
1997. Firm-initiated recall complete. See
also FDA statement dated June 12, 1997.
DISTRIBUTION Nationwide and Canada.
QUANTITY 128 1-ounce bottles, 113 4-ounce bottles and
3-half gallon bottles were distributed.
REASON Product was contaminated with Digitalis
glycosides.
_______________
PRODUCT Blessed Herbs Plantain Herb, Wildcrafted, 1
pound. Recall #F-055-8.
CODE Lot #L428C.
MANUFACTURER Blessed Herbs, Oakham, Massachusetts.
RECALLED BY Manufacturer, by letter on July 7, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY 153 1-pound packages were distributed.
REASON Product was contaminated with Digitalis
glycosides.
_______________
PRODUCT a) Plantain Leaf, cut/sifted, wildcrafted;
b) ABDO-MENDS Tea. Recall #F-056/057-8.
CODE None.
MANUFACTURER Jean's Greens, Newport, New York.
-5-
RECALLED BY Manufacturer, by telephone , followed by
letters dated June 16 and 26, 1997.
Firm-initiated recall complete. See also FDA
press release P97-14, May 14, 1997, and FDA
statement dated June 12, 1997.
DISTRIBUTION Nationwide, Japan, France.
QUANTITY a) 12 pounds; b) 50 cups (loose tea) - sold in
2-cup bags and 2,461 bags were distributed.
REASON Product was contaminated with Digitalis
glycosides.
_______________
PRODUCT Sprout products, with the exception of the
snow pea sprouts, the products are packaged in
12-packs containing 4-oz. plastic cups which
are labeled with the company name. All of the
sprout varieties are also packaged in 2-lb.
unlabeled plastic bags. With the exception of
the snow pea sprouts, all of the varieties are
packaged in 5-lb. unlabeled plastic bags
contained inside of a labeled case:
a) First Harvest Alfalfa Sprouts
b) First Harvest Mung Bean Sprouts
c) First Harvest Mixture (adzuki, lentils,
green pea)
d) First Harvest Radish Sprouts
e) First Harvest Spicy Sprouts (alfalfa and
radish)
f) First Harvest Crispy Sprout Mix (green
peas, Chinese red beans, lentils)
g) Snow Pea Sprouts. Recall #F-058/063-8.
CODE All product.
MANUFACTURER First Harvest, Kansas City, Kansas.
RECALLED BY Manufacturer, by telephone on June 2&3, 1997.
Firm-initiated recall complete.
DISTRIBUTION Kansas and Missouri.
QUANTITY Firm estimates none remains on the market.
REASON The sprouts were found contaminated with
Salmonella Anatum and/or Salmonella Infantis
and were associated with an outbreak of
salmonellosis.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
============
_______________
PRODUCT Amicar Syrup, 25%, in 16 ounce bottles, useful
in enhancing hemostasis when fibrinolysis
contributes to bleeding. Recall #D-017-8.
CODE Lot numbers: 445-578 EXP MAR00 and
446-877 EXP APR00.
MANUFACTURER Lederle/Wyeth Ayerst Pharmaceuticals,
Pearl River, New York.
-6-
RECALLED BY Immunex Corporation, Seattle, Washington, by
fax on September 17, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,215 bottles of lot 445-578 and 133 bottles
of lot 446-877 were distributed.
REASON Product is contaminated with Candida
parapsilosis (yeast).
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ==========
_______________
PRODUCT Belladonna Alkaloids with Phenobarbital
Tablets, (Phenobarbital USP 16.2
mg/Hyoscyamine Sulfate USP 0.1037 mg/Atropine
Sulfate USP 0.0194/Scopolamine Hydrochloride
USP 0.0065 mg), in bottles of 100 and 1,000.
Product is sold as Bellatal and Rexatal under
the Richwood label and as Hyosophen under the
Rugby label. The drug provides peripheral
anticholinergic/antispasmodic action and mild
sedation is prescribed for use in the
treatment of irritable bowel syndrome and
acute enterocolitis. Recall #D-020-8.
CODE Lot numbers: B3899 EXP 10/97, B3916 EXP 1/98,
B3917 EXP 1/98, 61008 EXP 10/98, 61009 EXP
10/98, 61204 EXP 12/98, 70107 EXP 1/99, 70301
EXP 3/99, 70302 EXP 4/99, 70407 EXP 4/99,
70616 EXP 7/99, 70702 EXP 7/99.
MANUFACTURER Richwood Pharmaceuticals Company, Inc., doing
business as Manufacturing Chemists Company,
Indianapolis, Indiana.
RECALLED BY Richwood Pharmaceuticals Company, Inc.,
Florence, Kentucky, by letter faxed on
October 8, 1997, followed by mail. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 29,123,000 tablets were distributed.
REASON Product failed content uniformity testing for
Belladonna Alkaloids.
_______________
PRODUCT Claforan Sterile (cefotaxime sodium) equiv. to
1 g cefotaxime IM/IV, in cartons of 25 vials,
a broad spectrum antibiotic. Recall #D-021-8.
CODE Lot #97H3W (cartons), 97H3W1 and 97H3W2
(vials).
MANUFACTURER Hoechst Marion Roussel, Frankfort, Germany
(bulk powder).
RECALLED BY Hoechst Marion Roussel, Kansas City, Missouri,
by letter dated September 2, 1997, followed by
telephone on September 3, 1997.
Firm-initiated recall ongoing.
-7-
DISTRIBUTION Nationwide.
QUANTITY 99,550 vials were distributed.
REASON Glass particles in vials.
RECALLS AND FILED CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Aredia (Pamidronate disodium for Injection),
lyophilized powder for reconstitution, 30
mg/vial, Rx indicated for the treatment of
patients with moderate to severe Paget's
disease. Recall #D-255-7.
CODE Lot numbers: 1005800 EXP MAY 98, 1006000
EXP JUN 99.
MANUFACTURER Product is labeled as manufactured by Ciba-Geigy Ltd.,
Basile, Switzerland and
Distributed by Ciba Pharmaceutical Co.,
Division of Ciba-Geigy Co., Summit,
New Jersey.
RECALLED BY Novartis Pharmaceutical Corporation, Summit,
New Jersey, by letter on December 10, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 46,760 vials were distributed.
REASON Labeling error -- Immediate vial label is
missing dosage strength statement.
_______________
PRODUCT Hytone (Hydrocortisone) 2-1/2% Cream, packaged
in tubes of 3.5 g (professional sample size),
Rx topical cream used for the treatment of
inflammatory and pruritic manifestations of
corticosteroid responsive dermatoses.
Recall #D-278-7.
CODE Lot #MN0969 EXP 6/30/98.
MANUFACTURER Rhone-Poulenc Rorer Puerto Rico, Inc., Manati,
Puerto Rico.
RECALLED BY Dermik Laboratories, Inc., (a Rhone Poulenc
Rorer Co.) Collegeville, Pennsylvania, by
letter July 14, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates little if any product remained
on market at time of recall initiation.
REASON Out of specification assay (high) and
incorrect expiration dating; product labeled
with 48 months in contrast to correct 24
months after manufacturing.
_______________
PRODUCT Barre brand Dihistine DH Elixir, Cough
Suppressant/Nasal Decongestant /Antihistamine
(Codeine Phosphate/Pseudoephrine
-8-
Hydrochloride/Chlorpheniramine maleate), in 4,
8, 16, and 164 (1 gallon) containers, Rx for
the temporary relief of cough.
Recall #D-014-8.
CODE Lot numbers: RD6219, RF6266, RF6305, RF6306,
RF6307, RJ6419, RJ6476, RJ6477, RJ6478,
RK6524, RK6525, RK6526, RK6527, RL6621,
RL6622, RN6710, VS5831, RL6817, RL6818.
MANUFACTURER Alpharma, U.S. Pharmaceuticals Division,
Baltimore, Maryland.
RECALLED BY Manufacturer, by letter dated September 9,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimated that 24,412 units remained in
commerce at time of recall initiation.
REASON Subpotent for codeine phosphate at 18 month
stability test point.
_______________
PRODUCT OTC vitamin/amino acids/mineral products: a)
Plex in 20 ounce containers; b) Kids Plex Jr,
in 16 ounce containers.
Recall #D-015/016-8.
CODE Lot numbers: a) 97144; b) 97419, 97148,
97128, 97077.
MANUFACTURER Natureade, Inc., Paramount, California.
RECALLED BY Performance Nutrition, Division of Naturade,
Inc., Dallas, Texas, by letter September 30,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY a) 2,205 units; b) 16,749 units were
distributed.
REASON Product insert makes unapproved drug claims
related to attention deficit hyperactivity
disorder.
_______________
PRODUCT Nitrostat Sublingual Tablets (Nitroglycerin,
USP), 0.3 mg, in bottles of 100, indicated for
the acute relief of an attack or prophylaxis
of angina pectoris due to coronary artery
disease. Recall #D-018-8.
CODE Lot #04446F EXP 3/98.
MANUFACTURER Warner Lambert Company, Fajardo, Puerto Rico.
RECALLED BY Parke-Davis, Division of Warner Lambert
Company, Morris Plains, New Jersey, by letter
on September 18, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 24,846 bottles were distributed.
REASON Assay failure at 15 month stability test.
-9-
_______________
PRODUCT Liquid Oxygen, USP, Cryogenic Dewar, Rx.
Recall #D-019-8.
CODE Lot #F10H1778.
MANUFACTURER Jimmie Jones Sooner Airgas, Tulsa, Oklahoma.
RECALLED BY Manufacturer, by telephone on July 10, 1997.
Firm-initiated recall complete.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit was distributed.
REASON Yellowish brown discharge from transfilling
hose.
_______________
PRODUCT Orudis KT Caplets (Ketoprofen), 12.5 mg in
bottles of 30 Caplets and Siderack/Floorstand
Displays containing 4 dozen 30's, OTC product,
indicated for the temporary relief of minor
aches and pains. Recall #D-022-8.
CODE Lot 6XG288 (bottles) and 2716, 3016 (case for
lot 6XG288).
MANUFACTURER Whitehall Robins Laboratories, Guayama, Puerto
Rico.
RECALLED BY Whitehall-Robins Healthcare, Madison, New
Jersey, by letter on September 19, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 43,740 bottles were distributed; firm
estimated that 4,000 bottles remained on
market at time of recall initiation.
REASON Content uniformity failure.
_______________
PRODUCT Oxygen USP, in aluminum "D" size high pressure
cylinders. Recall #D-023-8.
CODE All lots remaining in expiry date.
MANUFACTURER Valley Medical Equipment and Supply, Inc.,
Star City, West Virginia.
RECALLED BY Manufacturer, by visit. Firm-initiated recall
ongoing.
DISTRIBUTION West Virginia and Pennsylvania.
QUANTITY Approximately 20 cylinders were distributed.
REASON Current good manufacturing practice
deviations. Failure to document assay
results.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ========
_______________
PRODUCT Source Plasma. Recall #B-876-7.
CODE Unit numbers: HVM507, HVM537, HVM562, HVM592.
MANUFACTURER Plasma Services of Montana, Billings, Montana.
-10-
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated April 30, 1997. Firm-initiated
recall complete.
DISTRIBUTION Kentucky.
QUANTITY 4 units were distributed.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type I (anti-HIV-1), but were collected from a
donor who previously tested Western blot
indeterminate.
_______________
PRODUCT a) Platelets, Pheresis; b) Platelets Pheresis
Irradiated; c) Fresh Frozen Plasma.
Recall #B-1307/1309-7.
CODE Unit numbers: a) 21 P68820, 21 P68092;
b) 21 P68820, 21 P68092; c) 21 P68820.
MANUFACTURER American Red Cross Blood, Portland, Oregon.
RECALLED BY Manufacturer, by letter on May 28, 1997.
Firm-initiated recall complete.
DISTRIBUTION Oregon and Washington state.
QUANTITY a) 2 units; b) 2 units; c) 1 unit was
distributed.
REASON Blood products were collected from a donor who
received an accidental needle stick.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1340/1341-7.
CODE Unit #28LG00655.
MANUFACTURER American Red Cross Blood Services, Savannah,
Georgia.
RECALLED BY Manufacturer, by letter on April 18, 1997, and
telephone on April 22, 1997. Firm-initiated
recall complete.
DISTRIBUTION Georgia and California.
QUANTITY 1 unit was of each component was distributed.
REASON Blood products were collected from a donor
with a history of cancer.
_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-1342/1343-7.
CODE Unit #28LE17742.
MANUFACTURER American Red Cross Blood Services, Savannah,
Georgia.
RECALLED BY Manufacturer, by telephone on April 17, 1997,
and by letter on April 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION South Carolina and Georgia.
QUANTITY 1 unit of each component was distributed.
-11-
REASON Blood products were collected from a donor
with a history of cancer.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh
Frozen Plasma; d) Recovered Plasma.
Recall #B-1362/1365-7.
CODE Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance (301) 827-6220
for individual unit numbers recalled.
MANUFACTURER Topeka Blood Bank, Inc., doing business as
Kansas Blood Services, Topeka, Kansas.
RECALLED BY Manufacturer, by telephone and letter on June
23, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Arkansas, California, Florida, Georgia,
Kansas, Missouri.
QUANTITY a) 285 units; b) 41 units; c) 110 units; d)
159 units were distributed.
REASON Blood products were collected from donors in
which infectious disease testing (HIV antigen,
anti-HIV 1/2) was performed improperly.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1369/1370-7.
CODE Unit #16047-7379.
MANUFACTURER Blood Systems, Inc., Jackson, Mississippi.
RECALLED BY Manufacturer, by letter dated June 28, 1995.
Firm-initiated recall complete.
DISTRIBUTION Mississippi and Switzerland.
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), but were collected from a
donor who previously tested repeatedly
reactive for anti-HIV-1.
_______________
PRODUCT Red Blood Cells. Recall #B-1354-7.
CODE Unit #22GE38444.
MANUFACTURER American Red Cross Blood Services,
Philadelphia, Pennsylvania.
RECALLED BY Manufacturer, by telephone on January 15,
1997. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Blood product tested positive for the C
antigen was labeled as negative.
_______________
PRODUCT Red Blood Cells. Recall #B-1379-7.
CODE Unit #16LY27294.
-12-
MANUFACTURER American Red Cross Blood Services,
Columbus, Ohio.
RECALLED BY Manufacturer, by telephone on June 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product tested positive for anti-CMV was
labeled as CMV negative.
_______________
PRODUCT Red Blood Cells. Recall #B-055-8.
CODE Unit #4799158.
MANUFACTURER BloodCare, Dallas, Texas.
RECALLED BY Manufacturer, by telephone on April 10, 1997,
followed by letter dated May 12, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
traveled to an area considered endemic for
malaria.
_______________
PRODUCT Platelets. Recall #B-056-8.
CODE Unit 21364-6125.
MANUFACTURER United Blood Services, Fargo, North Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on February 19, 1997. Firm-
initiated recall complete.
DISTRIBUTION North Dakota.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
Whole Blood with an extended collection time.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III =======
_______________
PRODUCT Red Blood Cells. Recall #B-057-8.
CODE Unit #21360-6577.
MANUFACTURER United Blood Services, Fargo, North Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on March 25, 1996. Firm-initiated
recall complete.
DISTRIBUTION North Dakota.
QUANTITY 1 unit was distributed.
REASON Blood product remained at room temperature for
an unacceptable length of time.
_______________
PRODUCT Red Blood Cells. Recall #B-058-8.
CODE Unit numbers: 21364-7128, 21364-7134,
21364-6053, 21364-6054, 21364-6057,
21364-7124.
-13-
MANUFACTURER United Blood Services, Fargo, North
Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona,
by telephone on March 1 and 24, 1997.
Firm-initiated recall complete.
DISTRIBUTION North Dakota.
QUANTITY 6 units were distributed.
REASON Blood products were exposed to unacceptable
temperatures during shipment.
____________
PRODUCT Fresh Frozen Plasma. Recall #B-059-8.
CODE Unit numbers: 10515-0057 and 10515-0060
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona,
by telephone on August 15, 1996. Firm-
initiated recall complete.
DISTRIBUTION Arizona.
QUANTITY 2 units were distributed.
REASON Blood products were prepared from units of
Whole Blood with extended collection times.
______________
PRODUCT Red Blood Cells. Recall #B-060-8.
CODE Unit numbers: 10521-0414, 10521-1162.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on December 1, 1996, followed by
letter dated January 2, 1997. Firm-initiated
recall complete.
DISTRIBUTION Arizona.
QUANTITY 2 units were distributed.
REASON Blood products remained at room temperature
for an unacceptable length of time.
_______________
PRODUCT Red Blood Cells. Recall #B-061-8.
CODE Unit #29445-8892.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on July 30, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product remained at room temperature for
an unacceptable length of time.
_______________
PRODUCT Platelets. Recall #B-067-8.
CODE Unit #22KZ13545.
MANUFACTURER American Red Cross Blood Services,
Philadelphia, Pennsylvania.
RECALLED BY Manufacturer, by telephone on March 19, 1997.
Firm-initiated recall complete.
-14-
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Blood product which tested positive for anti-Lea,
was distributed labeled as negative for
unexpected antibodies.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
==========
_______________
PRODUCT AirCare Source Control Airator.
Recall #Z-910-7.
CODE Serial numbers 000085 through 000298.
MANUFACTURER Industrial Molding Corporation, Lubbock,
Texas.
RECALLED BY Apotheus Laboratories, Ltd., Lubbock, Texas,
by telephone on July 21, 1997, by fax on July
22, 1997, followed by letter dated July 23,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Florida, Illinois, Louisiana, Kentucky,
Kansas, Pennsylvania, Texas.
QUANTITY 213 units were distributed.
REASON seven units were found to have Primary
Inspiratory Relief (PIR) Valves that stuck;
two of the devices were also found to have
stuck Inspiratory Negative Pressure Relief
Valves.
_______________
PRODUCT Cell-Dyn 3500 Software, Revision G or H
used in Cell-Dyn 3500 CS Hematology Analyzer
and Cell-Dyn 3500SL Hematology Analyzer.
Recall #Z-021/022-8.
CODE List Nos: 03H69-01, 04H41-01,
91340-01, 91340-03, 91350-01, 91350-03.
MANUFACTURER Abbott Diagnostics Division, Santa Clara,
California.
RECALLED BY Manufacturer, by letter sent beginning
September 29, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 3,938 kits were distributed.
REASON When using the Cell-Dyn 3500 Software,
Revision G or H, specimens run in the
Auxiliary Mode can recover white blood cells
(WBC) results higher than expected.
_______________
PRODUCT Cardiolife Defibrillator, used to restore
normal heart rhythms:
a) Model TEC-8250A; b) Model TEC-8251A.
Recall #Z-023/024-8.
CODE a) Units shipped from 7/21/92 - 8/18/94;
b) Units shipped from 6/22/92 -3/13/96.
-15-
MANUFACTURER Nihon Kohden Corporation, Ohsato-Gun, Saitama-
Ken, Japan.
RECALLED BY Nihon Kohden American, Inc., Irvine,
California, by telephone followed by letter on
August 12, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 134 units were distributed.
REASON If the battery is used beyond the recommended
life cycle, the battery may develop an
internal short circuit, thereby creating an
excessive current flow in the charging circuit
of the defibrillator which could render the
defibrillator inoperable until appropriate
repairs can be made.
_______________
PRODUCT Vigilance brand Continuous Cardiac
Output/Oximetry (CCO/Sv02) Monitor, with drug
calculation mode to calculate infusion rates,
Product Code 74 DYG. Recall Z-031-8.
CODE Various serial numbers.
MANUFACTURER Baxter Healthcare Corporation, Cardio Vascular
Group (CVG), Irvine, California.
RECALLED BY Manufacturer, by letter dated September 5,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Japan.
QUANTITY 312 units were distributed.
REASON An inherent software coding error, when
combined with a data entry of the patients
weight in pounds, will result in an infusion
rate 2.2 times greater than the correct
calculation.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT AMS Sphincter 800/Securo-T Urinary Prosthesis
Accessory Kit, Part Number 72401685, used to
treat urinary incontinence caused by intrinsic
sphincter deficiency (ISD). Recall #Z-019-8.
CODE The lot number of the recalled accessory kits
begins with DE157, and is followed by three
additional digits which vary and indicate the
number of each unit.
MANUFACTURER American Medical Systems, Inc., Pfizer Medical
Technology Group, Minnetonka, Minnesota.
RECALLED BY Manufacturer, by letter on October 9, 1997.
Firm-initiated field correction ongoing.
DISTRIBUTION California, Massachusetts, Minnesota,
Missouri, North Carolina, Pennsylvania, Texas,
and Utah.
QUANTITY 18 units were distributed.
-16-
REASON A package insert for another product was put
in the product packages.
_______________
PRODUCT Various sterile devices for surgical use:
a) EYE SPEARS (Ophthalmic Sponges)- packed in
pouches of 2, 5 and 10. Sold in cases of
100/case and 200/case
b) NEUROLOGICAL SPONGES - various sizes,
packed in pouches of 10, sold in cases of
200/case
c) COTTON BALLS - various sizes, packed in
pouches of 5, sold in cases of 250/case.
Recall #Z-025/027-8.
CODE All lots, all catalog numbers.
MANUFACTURER AMD-RITMED, Inc., Buffalo, New York.
RECALLED BY Manufacturer, by letter dated September 12,
1997. Firm-initiated field correction
complete.
DISTRIBUTION Nationwide.
QUANTITY All sterile product currently in the
marketplace. The firm sells approximately 220
cases per month.
REASON The directions for use claim the devices are
ETO sterilized when in fact they are gamma
irradiated.
-17-
END OF ENFORCEMENT REPORT FOR OCTOBER 29, 1997. BLANK PAGES MAY FOLLOW.
####
End of Enforcement Report for
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