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.
September 17, 1997
97-38
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Surimi (Imitation Crab) Spread. The 8 oz.
containers are labeled as "Surimi Crab Spread"
and the 4 lb. containers are labeled as
"Imitation Crab Spread". Recall #F-819-7.
CODE 8 oz. containers with "Use by" date "8/31/97";
4 lb. containers
are uncoded and thus are all under recall.
MANUFACTURER Silver Creek Farms, Twin Falls, Idaho.
RECALLED BY Manufacturer, on or about August 12, 1997,
and by press release on August 13, 1997.
Firm-initiated recall complete.
DISTRIBUTION Oregon, Utah, Idaho, Wyoming, Nevada.
QUANTITY 558 pounds distributed. This is broken down
into 53 cases (12-8 ounce cups per case) and 20
cases (3-4 pound tubs per case).
REASON The product is contaminated with Listeria
monocytogenes.
_______________
PRODUCT Strawberry Frozen Yogurt, in 3 gallon tubs, 1/2
gallon, quart, and pint containers, under the following
labels: Our Own, Licks, and Muhlenberg Foods.
Recall #F-820-7.
CODE 161.
MANUFACTURER Muhlenberg Foods, Reading,
Pennsylvania.RECALLED BY Manufacturer, by telephone
on July 31, 1997, and by press release
on August 1, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania.
QUANTITY 12 pint, 40 quart, 38 half gallon, and 11 3-gallon
containers.
REASON Product is contaminated with Listeria
monocytogenes.
_______________
UPDATE Refrigerated potato salad products, which appeared
in the September 3, 1997 Enforcement Report is being
updated as follows:
PRODUCT Refrigerated Potato Salad Products produced by
Orval Kent Food Products in 1 lb., 2 lb. and 3 lb.
plastic retail containers under the Orval Kent,
Pathmark, Demoulas, Giant of Landover Maryland,
Acme Markets and Marsh Supermarkets labels and
five and ten lb. bulk containers under the
Orval Kent (also 30 lb.), Salad Plus, Signature Salads,
Signature Delights, Sysco Classic, Sysco Block
& Barrel, Alliant, PYA Monarch, Matthew's Salad
House and Metromedia labels as follows:
a) Orval Kent Deluxe Potato Salad, 3/10 lb., UPC
79453-13005
b) Alliant Prestige Mustard Potato Salad with
Salad Dressing,
Alliant Foodservice Inc., Dist., Deerfield, IL
60015, 3/10 lb.,
UPC 08077-84131
c) Alliant Prestige American Potato Salad with
Salad Dressing,
3/10 lb., UPC 08077-84132
d) Alliant Prestige American Potato Salad with
Mayonnaise, 3/10 lb., UPC 08077-84138
e) Sliced Mustard Potato Salad
i) PYA Monarch, Dist. by P.Y.A./Monarch,
Virginia Beach, VA 23455-3701, 1/10
lb., UPC 86270-01457
ii) Orval Kent, 3/10 lb., UPC 79453-40204
f) Diced Potato Salad with Egg
i) Super G, Distributed by Super G, Inc.,
Landover, MD 20785 12/1 lb.
ii) Orval Kent, 3/10 lb., UPC 79453-40304
g) Orval Kent Classic Potato Salad, 2/5 lb., UPC
79453-40756
h) Sliced Potato Salad with Egg
i) Acme Corner Deli Cuisine, Distributed by
Acme Markets, Inc., Malvern, PA 19355,
12/1 lb., UPC 79453-04453
ii) Sysco, Distributed by Sysco Corporation,
Houston, TX 77077-2099, 3/10 lb., UPC
74865-10108
iii) Orval Kent, 3/10 lb., UPC 79453-41004
1/10 lb., UPC 79453-44106
i) Baked Style Potato Salad
i) Orval Kent, 2/5 lb., UPC 79453-41756
ii) Alliant Prestige, 2/5 lb., UPC
08077-70502
j) Orval Kent Amish Potato Salad, 1/10 lb.,
UPC 79453-41804
k) Metromedia Steakhouses Company, L.P. Southern
Style Potato
Salad, Mfg. by Orval Kent Food Company, Inc.,
Wheeling, IL
60090 for Exclusive Use in the Metromedia
Steakhouses Company,
LP, 3/10 lb.
l) German Potato Salad
i) Sysco, 1/10 lb., UPC 74865-07978
ii) Pathmark, Packed for Pathmark Stores,
Inc., Woodbridge, NJ 07086, 12/1 lb.,
UPC 020670
iii) Orval Kent, 2/5 lb., UPC 79453-45200
1/10 lb., UPC 79453-45204
m) Diced Potato Salad
I) Orval Kent, 6/5 lb., UPC 79453-01313
6/3 lb., UPC 79453-42815
3/10 lb., UPC 79453-42883
6/2 lb., UPC 79453-42885
1/10 lb., UPC 79453-42886
12/1 lb., UPC 79453-42888
ii) Sysco, 3/10 lb., UPC 74865-18777
iii) Orval Kent Canadian label, 1/10 lb., UPC
79453-20842 6/3 lb., UPC 79453-28526
n) Orval Kent 100% Fat Free Potato Salad, 1/10
lb., UPC 79453-43004
o) Fat Free Roasted Garlic Red Potato Salad
i) Orval Kent Signature Delights, 2/5 lb.,
UPC 79453-43387
ii) Sysco Imperial, 2/5 lb., UPC 74865-40707
p) Sliced White Potato Salad
i) Demoulas, Distributed by Demoulas
Supermarket, Tewksbury, MA 01876, 12/1
lb., UPC 70226-65006
ii) Sysco, 3/10 lb.
iii) Orval Kent, 3/10 lb., UPC 79453-44001
and 1/10 lb.
q) Sysco Reduced Fat Country Style Potato
Salad with Egg, 3/10 lb., UPC 74865-31311
r) Red Skinned Potato Salad
i) Orval Kent Signature Delights, 2/5 lb.,
UPC 79453-44787
ii) Alliant Prestige, 2/5 lb., UPC
08077-70503
s) Country Style Potato Salad with Egg
i) PYA Monarch, 1/10 lb., UPC 86270-07179
ii) Sysco, 3/10 lb., UPC 74865-18775
iii) Orval Kent, 1/10 lb., UPC 79453-45904
1/30 lb., UPC 79453-45949
iv) Orval Kent Homestyle Egg & Potato
Salad, 2/5 lb., UPC 79453-45000
t) Southern Style Mustard Potato Salad
i) PYA Monarch, 1/10 lb., UPC 86270-01456
ii) Orval Kent, 1/10 lb. and 1/10 lb., UPC
79453-43104
u) Orval Kent Low Country Potato Salad, 1/10
lb., UPC 79453-45704
v) Sliced Potato Salad with Vegetables
i) Chilled Salad, Distributed by G.D.
Matthews & Sons, Charlestown, MA 02129,
3/10 lb.
ii) Pathmark, 12/1 lb. 6/2 lb. 6/3 lb.
iii) Orval Kent, 6/3 lb., UPC 79453-45815
12/1 lb., UPC 79453-45888
3/10 lb., UPC 79453-45849
w) Diced Mustard Potato Salad
i) Acme Corner Deli Cuisine, 12/1 lb., UPC
79453-05653 6/2 lb., UPC 79453-05953
ii) Orval Kent, 3/10 lb., UPC 79453-46301
6/3 lb., UPC 79453-46315
x) Homestyle Potato Salad
i) Deli Fresh at Marsh, Dist. by Marsh
Supermarkets, Inc., Indianapolis, IND
46256-3350, 12/1 lb., UPC 79453-46425
ii) Orval Kent, 1/10 lb., UPC 79453-46404
y) Orval Kent Red Royale Potato Salad, 2/5
lb., UPC 79453-41456
z) Sysco Southern Style Mustard Potato Salad,
3/10 lb., UPC 74865-33830
aa) Super G Diced Potato Salad with
Vegetables, 6/2 lb., 3/10 lb., UPC
79453-14001, 12/1 lb.
bb) Alliant Prestige Gourmet Potato Salad, 2/5
lb., UPC 08077-70504
cc) Orval Kent Signature Specialties Natural
Potato & Herb Salad 2/5 lb., UPC
79453-80056
dd) Orval Kent Signature Specialties Red
Potato & Egg Salad Supreme, 2/5 lb., UPC
79453-80656
ee) Sour Cream & Dill Potato Salad
i) Salads Plus, Dist by Orval Kent, 3/10
lb. and 1/10 lb., UPC 79453-88005
ii) Block & Barrel Deluxe Potato Salad,
Dist. by Sysco Corp., 2/5 lb., UPC
74865-40685. Recall# F-684/F-713-7.
CODE All potato salad products with expiration dates
prior to September 15, marked with the code "W7",
i.e. SEP15W7.
MANUFACTURER Orval Kent Food Company, Inc., Wheeling,
Illinois.
RECALLED BY Manufacturer beginning on August 4, 1997.
Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Puerto Rico, and Canada.
QUANTITY 5,644,170 pounds were distributed.
REASON Potato salads may be contaminated with Listeria
monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Pepperidge Farm Frozen Assorted Mini & Large
Danish Pastries:
a) Pepperidge Farm Frozen Assorted Mini Danish
Pastries UPC# 510006747;
b) Pepperidge Farm Frozen Assorted Large Danish
Pastries UPC# 510007812. Recall #F-809/810-7.
CODE All product with "use by" dates between April 21,
1997 and August 14, 1997.
MANUFACTURER Campbell Soup National HQ, Camden, New Jersey.
RECALLED BY Pepperidge Farms, Inc., Norwalk, Connecticut, by
letter dated February 20, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY a) 37,064 cases (96 pastries per case); b) 14,730
cases (48 pastries per case) were distributed.
REASON The pastries contain excessive levels of sulfites.
_______________
PRODUCT Cock brand Tapioca Pearl. Recall #F-811-7.
CODE All including EMB 75113N (Best Before 1996).
MANUFACTURER Unknown in Thailand.
RECALLED BY Hong Thai Foods Corporation, Brooklyn, New York,
by letter dated
April 7, 1997. Firm-initiated recall complete.
DISTRIBUTION New York, New Jersey, Pennsylvania, Connecticut,
Massachusetts, Illinois, Virginia, Florida.
QUANTITY 49 cases were distributed.
REASON Product contains the following undeclared colors:
FD&C Yellow, No. 5, FD&C Blue No. 1, and FD&C Red No. 3.
_______________
UPDATE Brown Sugar, in 1, 2, 4, 25, 50 and 100 lb
packages. Recall #F-806-7, which appeared in the
September 10, 1997 Enforcement Report should read:
CODE Lot #46092/46106.
RECALLED BY Manufacturer, on or about May 5, 1996.
QUANTITY Approximately 2 million pounds.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Ensure Plus, vanilla flavored, high-calorie
nutritional drink, packed in 8 fluid ounce plastic cans. Recall #F-808-7.
CODE Cans are identified with lot code: 28778L5 EXP1
MAY 98.
MANUFACTURER Ross Products Division, Columbus, Ohio.
RECALLED BY Manufacturer, by telephone on June 24, 1997,
followed by fax.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,208 cases were distributed.
REASON Product bears the label of another food and
contains erroneous label information regarding identity and nutrient
content.
RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II =======
_______________
PRODUCT Nectar Watermist a non alcohol body spray made
from natural distilled water extracted from blossoms of
orange trees packaged into .5 ounce, 4 ounce, 8 ounce
and 16 ounce glass bottles. Recall #F-807-7.
CODE The codes under recall consists of all product
codes shipped prior to July 28, 1997 and includes the
following items:
4 oz. Nectar WaterMist Item #FG-8120D-00
Packaging Lot #s 71611, 71621, 71631;
8 oz. Nectar WaterMist, Item #FG-8123D-00,
Packaging Lot #s 71641, 71651;
8 oz. Nectar WaterMist (tester), Item #
PG-7427D-00, Packaging
Lot #s 71641, 71651;
Bulk lot #s
.5 oz Nectar (tester) sample, Item # PG-7421D-00,
Packaging lot #7F09A (only given to sales reps);
Dramming/Nectar bulk (3 X 16 oz.), Item #PG-7740D-00,
Packaging Lot# 7F09A.
MANUFACTURER Allure Cosmetics, San Leandro, California Herba
Aromatica, Hayward, California (importer of scented
floral water).
RECALLED BY The Donna Karan Beauty Company (DKBC) New York,
New York, by telephone visit and fax beginning on
July 28, 1997, followed by letter on August 1, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION California, New York, Washington state, Oregon,
Virginia, Pennsylvania, Maryland, New Jersey,
Massachusetts, Connecticut, Florida, Minnesota,
Illinois, Wisconsin, Indiana, Michigan, Texas.
QUANTITY Item #FG-8120D-00 - 3,606 units - 4 oz Nectar
Item #FG-8123D-00 - 1,967 units - 8 oz Nectar
Item #PG-7427D-00 - 713 units - 8 oz Watermist
Item #PG-7426D-00 - 4,028 units - 5 oz Nectar
Item #PG-7440D-00 - 65 units - Dramming bulk
(3 x16 oz) were distributed.
REASON Product is contaminated with Burkholderia cepacia,
a pathogen.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
===========
_______________
PRODUCT Thiopental Sodium for Injection, USP, 5 gram/vial,
in 200 ml vials, in 10 packs of vials of Thiopental
Sodium without kits under the Gensia label, kits and
vial ten packs) and the Ohmeda label (kits), for
preparation of intravenous stock solution only.
Recall #D-265-7.
CODE Lot numbers: P6P825,P7A817, P7A818 (Ohmeda Kit
label),
P6A317P1, P6P312, (Gensia label/10 pak) and
P6S815 (Gensia Kit label).
MANUFACTURER Gensia Laboratories, Ltd., Irvine, California.
RECALLED BY Manufacturer, by letter on April 21, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY Approximately 7,900 kits and 9,000 vials in ten
packs were distributed.
REASON Vials were found to contain glass particles.
_______________
PRODUCT Captopril (Capoten) 25 mg Tablets, individually (1
tablet) labeled, single blister packed tablets with
labeled single unit plastic overwrap, Rx, used in the
treatment of hypertension.
Recall #D-266-7.
CODE Lot #J5J65A EXP 8/99.
MANUFACTURER ER Squibb & Sons, Inc., Division of Bristol Myers
Squibb, Medical Department, Princeton, New Jersey.
RECALLED BY AmeriSource Health Services, doing business as
American Health Packaging (AHP), Columbus, Ohio,
by telephone on or about October 22, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Ohio, Tennessee, Massachusetts.
QUANTITY 130 amber bags (13,000 tablets) were distributed.
Firm estimates none remains on the market.
REASON Labeling error: Incorrect product identification
- Plastic overwrap declares the product as Warfarin
Sodium (Coumadin) 2 mg Tablets. Each individual
blister label is correctly labeled.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Ciprofloxacin HCl (Cipro), 500 mg tablets,
individually (1 tablet) labeled single blister packed
tablets with a plastic overwrap, an antibiotic.
Recall #D-264-7.
CODE Lot #6BCJ EXP 2/99.
MANUFACTURER Bayer Corporation Pharmaceutical Division, West
Haven, Connecticut..
RECALLED BY AmeriSource Health Services, Columbus, Ohio, doing
business as American Health Packaging (AHP), by
telephone on or about March 11, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Ohio, Tennessee, Massachusetts.
QUANTITY 90 amber bags (9,000 tablets) were distributed;
firm estimates none remains on the market.
REASON Labeling: error on declared strength. Plastic
overwrap declares the product as 250 mg.
_______________
UPDATE Recall #D-171-7, Regular Strength Enteric Coated
Aspirin Tablets, 325 mg, packaged in 100, 250, and
500 count bottles of various lots, which appeared in
the May 14, 1997 Enforcement Report as a Class II
recall has been reclassified to a Class III recall.
_______________
UPDATE Recall #D-259/260-7, Baclofen Tablets which
appeared in the September 10, 1997 Enforcement Report
should read: MANUFACTURER: Biocraft Laboratories,
Elmwood Park, New Jersey.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Red Blood Cells. Recall #B-1193-7.
CODE Unit #M46536.
MANUFACTURER Lane Memorial Blood Bank, Eugene, Oregon.
RECALLED BY Manufacturer, by visit on October 8, 1996.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
engaged in high risk behavior.
_______________
PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes
Reduced; c) Platelets; d) Fresh Frozen Plasma.
Recall #B-1344/1347-7.
CODE Unit numbers: a) 29123-1232, 29092-0971,
29128-0189, 29093-9146, 29119-4436, 29125-8658,
29122-3879, 29082-2745, 29081-2570; b) 29131-8807;
c) 29123-1232, 29092-0971, 29093-9146, 29125-8658,
29122-3879, 29131-8807; d) 29123-1232, 29092-0971,
29128-0189, 29122-3879, 29082-2745, 29081-2570.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by letter on either May 30, 1996,
June 5, 1996, or July 5, 1996. Firm-initiated recall
complete.
DISTRIBUTION Illinois, Florida, Switzerland.
QUANTITY a) 9 units; b) 1 unit; c) 6 units; d) 6 units were
distributed.
REASON Blood products tested negative for the antibody to
the human T-lymphotropic virus I (anti-HTLV-1) but
were collected from donors who previously tested
repeatedly reactive for anti-HTLV-1, Western blot
negative or indeterminate.
_______________
PRODUCT Platelets, Pheresis. Recall #B-1350-7.
CODE Unit #21P69503.
MANUFACTURER American Red Cross, Portland, Oregon.
RECALLED BY Manufacturer, by telephone on June 12, 1997, and
by letter dated June 17, 1997.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product had an unacceptable platelet count.
_______________
PRODUCT Platelets. Recall #B-1368-7.
CODE Unit #25FR70821.
MANUFACTURER American Red Cross Blood Services, Syracuse, New
York.
RECALLED BY Manufacturer, by letter dated November 3, 1995.
Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 1 unit was distributed.
REASON Platelets were prepared from a unit of whole blood
designated as "difficult" phlebotomy.
_______________
PRODUCT Red Blood Cells, Washed. Recall #B-1378-7.
CODE Unit numbers: 16337-4457, 16337-4456,
16337-4474, 16337-7805.
MANUFACTURER Blood Systems, Inc., Hattiesburg, Mississippi.
RECALLED BY Manufacturer, by letter dated March 21, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Mississippi.
QUANTITY 4 units were distributed.
REASON Blood products were labeled with extended
expiration dates.
_______________
PRODUCT a) Cryoprecipitate; b) Fresh Frozen Plasma.
Recall #B-1387/1388-7.
CODE Unit numbers: a) 8580139 and 8551475;
b) 8574398 and 8526946.
MANUFACTURER The Blood Center, New Orleans, Louisiana.
RECALLED BY Manufacturer, by letter and or telephone between
September 8, 1995 and October 9, 1995.
Firm-initiated recall complete.
DISTRIBUTION Louisiana.
QUANTITY 2 units of each component were distributed.
REASON Blood products contained anti-D antibodies, but
were labeled as negative for unexpected antibodies.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-1402/1403-7.
CODE Unit numbers: a) 16339-7346, 16339-7344,
16339-7341; b) 16339-7347, 16339-7346, 16339-7344,
16339-7343, 16339-7342, 16339-7341, 16339-7340,
16339-7000.
MANUFACTURER Blood Systems, Inc., Meridian, Mississippi.
RECALLED BY Manufacturer, by telephone on June 3, 1997.
Firm-initiated recall
complete.
DISTRIBUTION Mississippi.
QUANTITY a) 3 units; b) 8 units were distributed.
REASON Blood products were tested using samples that were
stored at an unacceptable temperature.
_______________
PRODUCT Red Blood Cells. Recall #B-1404-7.
CODE Unit numbers: 16339-8033, 16339-8036, 16339-8037,
16339-8039, 16339-8041, 16339-8042, 16339-8044,
16339-8045, 16339-8046, 16339-8047, 16339-8048,
16339-8050, 16339-8051, 16339-8052.
MANUFACTURER Blood Systems, Inc., Meridian, Mississippi.
RECALLED BY Manufacturer, by telephone on June 9, 1997.
Firm-initiated recall complete.
DISTRIBUTION Mississippi.
QUANTITY 14 units were distributed.
REASON Blood products were tested using samples that were
stored at an unacceptable temperature.
_______________
PRODUCT Red Blood Cells. Recall #B-1408-7.
CODE Unit #8637621.
MANUFACTURER The Blood Center, New Orleans, Louisiana.
RECALLED BY Manufacturer, by telephone June 7, 1996.
Firm-initiated recall complete.
DISTRIBUTION Louisiana.
QUANTITY 1 unit was distributed.
REASON Blood product was not properly tested for HIV-Ag.
_______________
UPDATE United Blood Services, Scottsdale, Arizona recall
which appeared in the September 3, 1997 Enforcement
Report should read:
PRODUCT: a) Red Blood Cells; b) Fresh Frozen
Plasma; c) Recovered Plasma.
Recall #B-1281/1283-7.
CODE: Unit numbers: 10230-8872, 10175-4045.
QUANTITY: 4 units were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Recovered Plasma. Recall #B-1348-7.
CODE 29093-9146, 29119-4436, 29125-8658,
29131-8807.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by letter on either May 30, 1996,
June 5, 1996 or July 5, 1996. Firm-initiated recall
complete.
DISTRIBUTION Illinois, Florida, Switzerland.
QUANTITY 4 units were distributed.
REASON Blood products tested negative for the antibody to
the human T-lymphotropic virus (anti-HTLV-1), but
were collected from donors who previously tested
repeatedly reactive for anti-HTLV-1, Western blot
negative or indeterminate.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-1385-7.
CODE Unit #16335-3005 and 16335-3007.
MANUFACTURER Blood System, Inc., doing business as United Blood
Services,
Hattiesburg, Mississippi.
RECALLED BY Manufacturer, by telephone on October 19, 1996 and
by letter on November 22, 1996. Firm-initiated recall
complete.
DISTRIBUTION Mississippi.
QUANTITY 2 units were distributed.
REASON Fresh Frozen Plasma was not frozen within eight
hours of phlebotomy.
_______________
PRODUCT Red Blood Cells, Deglycerolized.
Recall #B-1386-7.
CODE Unit numbers: 29444-5147, 29444-5055.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on June 23, 1996, and
by letter on July
30, 1996. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 2 units were distributed.
REASON Deglycerolized Red Blood Cells were not treated
with rejuvenating solution prior to freezing.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS
II
=========
_______________
PRODUCT Lead Protective Aprons used to shield patients
during x-ray procedures. Recall #Z-904-7.
CODE Serial numbers: 6502-6523, 6532-6537, 6551,
6555-6559, 6567-6569, 6578-6579, 6585-6642,
6648-6668, 6670-6678, 6681-6686, 1237-1238, 3896-3909,
3911-1912, 3914-3919, 3966-3968, 3975-3976, 3993,
3998, 4040-4042, 1237-1238.
MANUFACTURER Pulse Medical, Inc., Davie, Florida.
RECALLED BY Manufacturer, by letter on June 10 and 16, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 153 aprons were distributed.
REASON Radiation protection devices contain lead contaminated
with small amounts of radioactive substances.
_______________
PRODUCT Abiomed BVS 5000 Bi-Ventricular Support System
Transistor on Compressor Driver. The device
(PMA #900023) provides ventricular assist and
restores hemodynamics in patients suffering
severe cardiac dysfunction. It consists of
three major components: the BVS Console,
the BVS pumps and the BVS Cannulae.
Recall #Z-909-7.
CODE Console Catalog No. 0005-000, Console serial
numbers: 1314,1336, 1339, 1341-1352, 1352, 1355.
MANUFACTURER Abiomed, Inc., Danvers, Massachusetts.
RECALLED BY Manufacturer, by letter dated June 30, 1997.
Firm-initiated recall complete.
DISTRIBUTION Arkansas, California, Florida, Illinois, Louisiana,
Michigan, Missouri, New Jersey, Oklahoma, Texas.
QUANTITY 17 consoles were distributed.
REASON The console can stop during use and go into
continuous alarm.
END OF ENFORCEMENT REPORT FOR SEPTEMBER 17, 1993. BLANK PAGES
MAY FOLLOW.
####
End of Enforcement Report for
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