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.
August 27, 1997 97-35
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT The Sandwich Makers Sandwiches: a) Steak &
Cheese Sub, 7 ounces; b) Ham & Cheese Sub, 7.5
ounces; c) Submarine, 8 ounces.
Recall #F-681/683-7.
CODE 7161. All products have a 7 day self life.
MANUFACTURER Americas Foods, Inc., Norfolk, Virginia.
RECALLED BY Manufacturer, by fax on June 24, 1997.
Firm-initiated recall complete.
DISTRIBUTION a) Arizona, Texas, South Carolina, Illinois,
Mississippi, Kentucky, Florida
b&c) Virginia, North Carolina, South Carolina.
QUANTITY a) 1,230 sandwiches; b) 332 sandwiches; c) 260
sandwiches were distributed.
REASON Products are contaminated with Listeria
monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Bluebird Pineapple Juice from concentrate, in
6 ounce tin cans. Recall #F-680-7.
CODE EHEAT.
MANUFACTURER Citrus World, Inc., Lake Wales, Florida.
RECALLED BY Manufacturer, by telephone beginning on April
17, 1997, followed by press release on April
23, 1997, and letter dated April 22, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 35,924 cases
REASON Product contains high levels of tin.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS
II ==========
_______________
PRODUCT Sea-Clens Wound Cleanser, (Sodium Chloride),
in 6 fluid ounce bottles. (Note: The product
is labeled with the company name of Sween
Corporation, N. Mankato, Minnesota.)
Recall #D-249-7.
CODE Lot #1G6AB EXP 7/98.
MANUFACTURER Coloplast Corporation, North Mankato,
Minnesota.
RECALLED BY Manufacturer, by letter on August 12, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 740 cases (6 bottles per case) were
distributed; firm estimated that 10 percent of
product remained on market at time of recall
initiated.
REASON Pseudomonas Aeruginosa contamination.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT ACTH (Corticotropin for Injection, USP), 40
units, in 10 ml vials. Rx, a preparation of
pituitary adrenocorticotropin hormone derived
from the anterior lob of hog pituitary.
Recall #D-248-7.
CODE Lot numbers: 01156P, EXP 8/97; 01256P, EXP
9/97; and 01356P, EXP 9/97.
MANUFACTURER Warner-Lambert Company, Parke-Davis Sterile
Products Division, Rochester, Michigan.
RECALLED BY The Parke-Davis Division of Warner-Lambert
Co., Morris Plains, New Jersey, by letter on
July 28, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY The amount of product shipped was as follows:
34,176 units of lot 01156P between 9/04/96 and
08/01/96. 800 units of lot 01256P between
7/31/96 and 5/07/97. 10,323 units of lot
01356P between 10/31/96 and 5/07/97.
REASON Variability in assay results (stability).
_______________
PRODUCT Fluocinolone Acetonide Cream, USP 0.01%, Rx
sold in tubes of 15 g, used as an anti-
inflammatory and anti-pruritic agent.
Recall #D-250-7.
CODE Lot #5143-1 EXP 6/97.
MANUFACTURER G & W Laboratories, South Plainfield, New
Jersey.
RECALLED BY Manufacturer, by letter on May 2, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 1,930 tubes were distributed.
REASON Inconsistent assays during stability testing.
_______________
PRODUCT Vasosulf Ophthalmic Solution (Sulfacetamide
Sodium 15% phenylephrine Hydrochloride
0.125%), 5 ml and 15 ml sizes.
Recall #D-251-7.
CODE Lot numbers: VE3433 and VE3459.
MANUFACTURER OMJ Pharmaceuticals, San German, Puerto Rico.
RECALLED BY CIBA Vision Ophthalmics, Duluth, Georgia, by
letter August 8, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide
QUANTITY 12,552 units for lot VE3433; 6,588 fo lot
VE3459 were distributed.
REASON Labeling error -- Phenylephrine HCL content on
insert reads 25 mg/ml and carton reads 125
mg/ml. The correct amount is 1.25 mg/ml,
which is correctly listed on the container and
carton display panel.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Red Blood Cells. Recall #B-1141-7.
CODE Unit #49FF26362.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.
RECALLED BY Manufacturer, by telephone on April 9, 1997,
and by letter on April 17, 1997.
Firm-initiated recall complete.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose
body temperature had not been documented.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c)
Platelets, Pheresis; d) Platelets, for further
manufacture; e) Fresh Frozen Plasma.
Recall #B-1158/1162-7.
CODE Unit numbers: a) 2004852, 2004853, 2004855,
2004871, 2004872, 2004875, 2025381, 5044803,
5044805, 5044816, 5044827, 5044839, 5050383,
5050386, 5050387, 5050394, 5050414
b) 2004853, 2004855, 5050383, 5050386,
5050387, 5050390, 5050414
c) 5043389, 5043395, 5043396, 5043400,
5043401, 5043404
d) 2004852, 5043399, 5043403, 5050394
e) 2004852, 2004853, 2004872, 2004875,
2025381, 5044810, 5044816, 5044825,
5044827, 5044839, 5050414.
MANUFACTURER LifeShare, Inc., also known as Lorain County
Blood Bank, Inc., Elyria, Ohio.
RECALLED BY Manufacturer, by telephone on May 28, 1996,
followed by letters dated June 10, 1996.
Firm-initiated recall complete.
DISTRIBUTION Ohio and Florida.
QUANTITY a) 17 units; b) 7 units; c) 6 units; d) 4
units; e) 11 units were distributed.
REASON Blood products were incorrectly tested for
the antibody to the hepatitis B core antigen
(anti-HBc).
_______________
PRODUCT Source Plasma. Recall #B-1192-7.
CODE Unit numbers: 79350334, 79028837, 79027199,
79025263.
MANUFACTURER Bio-Blood Components, Inc., Gary, Indiana.
RECALLED BY Manufacturer, by fax on April 9, 1997.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 4 units were distributed.
REASON Blood product were collected from a donor who
received a tattoo within twelve months of
donation.
_______________
PRODUCT Abbott HCV EIA 2.0 Diagnostic Kit, Hepatitis C
Virus Encoded Antigen. Recall #B-1208-7.
CODE Lot Number: 29807M100 EXP 29 Oct 97.
MANUFACTURER Abbott Laboratories, Diagnostics Division,
Abbott Park, Illinois.
RECALLED BY Manufacturer, by telephone on July 25 and 28,
1997, followed by letter dated July 30, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Florida, Illinois, Michigan, Tennessee, Texas,
Washington state.
QUANTITY 69 - 5000 test kits of HCV EIA were
distributed; firm estimated that 20% of the
HCV EIA kits remained on the market at time of
recall initiation.
REASON HCV EIA kits may contain a small number of
ungrounded coated beads.
_______________
PRODUCT Abbott HIVAG-1 Monoclonal EIA Diagnostic Kit
Antibody to Human Immunodeficiency Virus Type
1 (HIV-1). Recall #B-1210-7.
CODE Lot Number: 28087M201, EXP 17 Sep 97.
MANUFACTURER Abbott Laboratories, Diagnostics Division,
Abbott Park, Illinois.
RECALLED BY Manufacturer, by telephone on July 25 and 28,
1997, followed by letter dated July 30, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION California, Florida, Illinois, Iowa,
Louisiana, Massachusetts, Michigan, South
Carolina, Tennessee, Texas.
QUANTITY 269 - 1000 test kits were distributed, with
the firm estimating that 3% of the kits
remain on the market.
REASON HIVAG-1 EIA kits may contain a small number of
ungrounded coated beads.
_______________
PRODUCT a) Red Blood Cells; b) Red Blood Cells,
Leukocytes Removed; c) Platelets; d)
Cryoprecipitate; e) Fresh Frozen Plasma; f)
Recovered Plasma. Recall #B-1212/1217-7.
CODE a) 19037-1569 19034-6451 19039-2788
19035-9984 19033-9393 19033-1129
19032-5963 19038-5359 19029-0570
19027-4568 19029-5428 19026-8142
b) 19031-7300
c) 19029-0570 19028-5359
d) 19026-8142 19031-7300 19039-2788
19035-9984
e) 19037-1569
f) 19026-8142 19031-7300 19035-9984
19039-2788 19034-6451 19029-0570
19027-4568 19029-5428 19033-1129
19032-5963 19028-5359.
MANUFACTURER United Blood Services, Reno, Nevada.
RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by
letter on February 18, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Alabama, California, Florida, Louisiana, North
Carolina, Nevada, South Dakota, Tennessee,
Texas, Switzerland.
QUANTITY a) 12 units; b) 1 unit; c) 2 units; d) 4
units; e) 1 unit; f) 11 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
negative.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1219/1220-7
CODE Unit 12060-0552.
MANUFACTURER United Blood Services, Albuquerque, New
Mexico.
RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by
letter on February 4, 1997. Firm-initiated
recall complete.
DISTRIBUTION Nevada and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were drawn from an unsuitable
donor.
_______________
PRODUCT a) Platelets; b) Recovered Plasma.
Recall #B-1221/1222-7.
CODE Unit #20037-7281.
MANUFACTURER United Blood Services, Lafayette, Louisiana.
RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by
letters on March 19, 1997, April 9, 1997, and
July 7, 1997. Firm-initiated recall complete.
DISTRIBUTION Louisiana and North Carolina.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were drawn from an unsuitable
donor.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1223/1224-7.
CODE Unit #20019-5651.
MANUFACTURER United Blood Services, Lafayette, Louisiana.
RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by
letter on February 18, 1997, and April 9,
1997. Firm-initiated recall complete.
DISTRIBUTION Louisiana and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products, which tested negative for the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1), but were collected from a
donor who previously tested repeatedly
reactive for anti-HIV-1, Western blot
negative, were distributed.
_______________
PRODUCT Baxter Gammagard Solvent/Detergent Treated
Immunoglobulin G (Immune Globulin Intravenous
(Human): a) Baxter's Gammagard S/D 5G;
b) Baxter's Gammagard S/D 10G.
Recall #B-1225/1226-7.
CODE Lot # 2620M010AB, 2620M011AA, 2620M012AA.
MANUFACTURER Baxter Healthcare Corporation, Hyland
Division, Glendale, California.
RECALLED BY Manufacturer, by letter dated April 24, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 10,173 vials were distributed.
REASON Baxter's IGIV solvent/detergent vials are
misbranded in that they incorrectly list the
reconstitution volume as 10 ml.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma. Recall #B-1227/1229-7.
CODE Unit #12093-5239.
MANUFACTURER United Blood Services, Albuquerque, New
Mexico.
RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by
letter on March 19, 1997. Firm-initiated
recall complete.
DISTRIBUTION New Mexico and North Carolina.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
with a medical history of hepatitis.
______________
PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF;
c) Platelets; d) Recovered Plasma.
Recall #B-1230/1233-7.
CODE Unit numbers: a) 10499-7432, 10496-0963,
10490-4257; b) 10499-7432, 10496-0963; c)
10490-4257; d) 10499-7432, 10496-0963.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by
letter on May 24, 1997. Firm-initiated recall
complete.
DISTRIBUTION Alabama, Montana, Nevada, Switzerland.
QUANTITY a) 3 units; b) 2 units; c) 1 unit; d) 2 units
were distributed.
REASON Blood products were collected from a donor
with a history of cancer.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh
Frozen Plasma. Recall #B-1234/1236-7.
CODE Unit numbers: a) 29083-5722; b) 29083-5722,
29085-5309; c) 29083-5722.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by
letters on February 5, 1997, and May 2, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois and Mississippi.
QUANTITY a) 1 unit; b) 2 units; c) 1 unit 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
negative.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh
Frozen Plasma; d) Recovered Plasma.
Recall #B-1238/1241-7.
CODE Unit numbers: a) 12415-9782, 12414-7079,
12412-7323, 12409-7504, 12078-6408,
12408-2436, 12090-2683, 12088-9992,
12093-2339, 12080-5112
b) 12412-7323, 12088-9992, 12090-2683,
12409-7504
c) 12078-6408, 12415-9782, 2414-7079
d) 12093-2339, 12408-2436, 12409-7504,
12412-7323, 12090-2683, 12088-9992,
12080-5112.
MANUFACTURER United Blood Services, Albuquerque, New
Mexico.
RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by
letters on March 11, 1997, and July 7, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Colorado, North Carolina, New Mexico, Texas,
Switzerland.
QUANTITY a) 10 units; b) 4 units; c) 3 units; d) 7
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
negative.
_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma;
c) Recovered Plasma. Recall #B-1242/1244-7.
CODE Unit numbers: a) 22055-1442 and 22061-2904
b) 22061-2904; c) 22055-1442.
MANUFACTURER United Blood Service, Las Vegas, Nevada.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated March 11, 1997. Firm-initiated
recall complete.
DISTRIBUTION Nevada and North Carolina.
QUANTITY a) 2 units; b) 1 unit; c) 1 unit was
distributed.
REASON Blood products were collected from a donor who
was previously deferred for high risk
behavior.
_______________
PRODUCT Recovered Plasma. Recall #B-1245-7.
CODE Unit #14001-8286.
MANUFACTURER United Blood Services, Lafayette, Louisiana.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated March 19, 1997. Firm-initiated
recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
was previously deferred.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1246/1247-7.
CODE Unit #20035-3643.
MANUFACTURER United Blood Services, Lafayette, Louisiana.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letters dated March 19, 1997 and April 9,
1997. Firm-initiated recall complete.
DISTRIBUTION Louisiana and North Carolina.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
was previously deferred for a history of
intravenous (IV) drug use.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1248/1249-7.
CODE Unit numbers: 19224-1747 and 19038-9200.
MANUFACTURER United Blood Services, Reno, Nevada.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated February 18, 1997. Firm-initiated
recall complete.
DISTRIBUTION Nevada and Switzerland.
QUANTITY 2 units of each component was distributed.
REASON Blood products were collected from a donor who
previously made a therapeutic donation, were
distributed.
_______________
PRODUCT a) Red Blood Cells; b) Plasma.
Recall #B-1250/1251-7.
CODE Unit #29GY02968.
MANUFACTURER American Red Cross Blood Services, Norfolk,
Virginia.
RECALLED BY Manufacturer, by letters dated April 28, 1997,
and June 6, 1997. Firm-initiated recall
complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
with Amyopathic dermatomyositis.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1252/1253-7.
CODE Unit #24KE10855.
MANUFACTURER American Red Cross Blood Service, Louisville,
Kentucky.
RECALLED BY Manufacturer, by letters dated April 23 and
18, 19997. Firm-initiated recall complete.
DISTRIBUTION Puerto Rico and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
received a hepatitis B booster vaccine.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-1254/1255-7.
CODE Unit #22KQ07215.
MANUFACTURER American Red Cross, Philadelphia,
Pennsylvania.
RECALLED BY Manufacturer, by telephone and by letter dated
January 24, 1997. Firm-initiated recall
complete.
DISTRIBUTION Pennsylvania and New Jersey.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
reported travel to an area designated as
endemic for malaria.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-1256/1257-7.
CODE Unit #22GP69729.
MANUFACTURER American Red Cross, Philadelphia,
Pennsylvania.
RECALLED BY Manufacturer, by telephone and by letter dated
November 5, 1996. Firm-initiated recall
complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
reported travel to an area designated as
endemic for malaria.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c)
Cryoprecipitate; d) Recovered Plasma.
Recall #B-1259/1262-7.
CODE Unit numbers: a) 22052-0182; b) 22044-5302;
c) 22052-0182; d) 22052-0182, 22044-5302.
MANUFACTURER United Blood Services, Las Vegas, Nevada.
RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by
letter on July 7, 1997. Firm-initiated recall
complete.
DISTRIBUTION Nevada and Switzerland.
QUANTITY a) 1 unit; b) 1 unit; c) 1 unit; d) 2 units
were distributed.
REASON Blood products were collected from a donor
with a history of hepatitis.
_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma;
c) Recovered Plasma. Recall #B-1263/1265-7.
CODE a) 10211-4613, 10204-5931, 10154-3691; b)
10211-4613, 10204-5931; c) 10154-3691.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by
letter on July 7, 1997. Firm-initiated recall
complete.
DISTRIBUTION Arizona and Switzerland.
QUANTITY a) 3 units; b) 2 units; c) 1 unit was
distributed.
REASON Blood products were drawn from an unsuitable
donor.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c)
Platelets, Pheresis; d) Platelets, for further
manufacture; e) Fresh Frozen Plasma.
Recall #B-1163/1167-7.
CODE Unit numbers: a) 2004854, 2004856, 2004857,
2004858, 2004859, 2004861, 2004862, 2004864,
2004865, 2004866, 2004867, 2004868, 2004869,
2004870, 2004874, 2021800, 2021801, 2021802,
2021804, 2021805, 2021806, 2025371, 2025372,
2025373, 2025374, 2025375, 2025376, 2025377,
2025379, 2025383, 2025385, 2025386, 2025387,
2025388, 2025389, 2025390, 2025391, 2025392,
2025394, 2025395, 2025397, 2025398, 2025399,
2025979, 2025980, 2025981, 5044789, 5044790,
5044791, 5044793, 5044794, 5044795, 5044797,
5044798, 5044799, 5044800, 5044801, 5044802,
5044806, 5044807, 5044808, 5044809, 5044811,
5044812, 5044813, 5044815, 5044817, 5044818,
5044819, 5044820, 5044821, 5044822, 5044824,
5044828, 5044829, 5044830, 5044831, 5044832,
5044833, 5044834, 5044836, 5044837, 5044838,
5050385, 5050389, 5050391, 5050392, 5050393,
5050395, 5050396, 5050397, 5050399, 5050400,
5050401, 5050402, 5050403, 5050404, 5050405,
5050406, 5050407, 5050408, 5050409, 5050410,
5050411, 5050415
b) 2004856, 2004857, 2004858, 2004859,
2025371, 2025372, 2025373, 2025374, 2025375,
2025377, 5044791, 5044792, 5044793, 5044798,
5044799, 5050389, 5050391, 5050392, 5050395,
5050397, 5050398, 5050399, 5050400, 5050401,
5050403, 5050404, 5050405, 5050406, 5050408,
5050410, 5050412, 5050415
c) 5043390, 5043391, 5043392, 5043393, 5043394
d) 2004854, 2025376, 5044789, 5044795,
5050385, 5050402, 5050407, 5050409, 5050411,
5050412
e) 2004858, 2004868, 2004874, 2025376,
2025981, 5044789, 5044792, 5044820, 5044829,
5044830, 5050398, 5050403, 5050404, 5050411.
MANUFACTURER LifeShare, Inc., also known as Lorain County
Blood Bank, Inc., Elyria, Ohio.
RECALLED BY Manufacturer, by telephone on May 28, 1996,
followed by letter dated June 10, 1996.
Firm-initiated recall complete.
DISTRIBUTION Ohio and Florida.
QUANTITY a) 105 units; b) 32 units; c) 5 units; d) 10
units; e) 14 units were distributed.
REASON Blood products were incorrectly tested for the
antibody to the hepatitis B core antigen
(anti-HBc).
________________
PRODUCT Platelets, Pheresis. Recall #B-1168-7.
CODE Unit numbers: 1207386, 1207412, 1207427,
1207432.
MANUFACTURER Houchin Community Blood Bank,
Bakersfield, California.
RECALLED BY Manufacturer, by telephone on August 14, 1996.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 4 units were distributed.
REASON Blood products were not tested for the HIV-1
p24 antigen.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS
II =========
_______________
PRODUCT SURGIKOS Latex Surgical Gloves, Sterile.
Recall #Z-754/761-7.
CODE Model Numbers Lot Numbers
6455 95100001 through 97020001
6460 95100011 through 97030103
6465 95100103 through 97030209
6470 95080726 through 97020508
6475 95081504 through 97031002
6480 95082296 through 97021603
6485 95071653 through 97021805
6490 95071695 through 97021901.
MANUFACTURER Fime-Darby Latex Products Seramban,Malaysia
RECALLED BY Johnson & Johnson Medical, Inc., Arlington,
Texas, by letter, July 1, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 417,000 pairs were distributed.
REASON Open seals were found, thereby compromising
the sterility of the medical devices.
_______________
PRODUCT Kilit Ampules, are used to monitor
steam-under-pressure sterilization cycles,
labeled under the brand names Cotrell Limited
and SPS Medical:
a) Kilit Ampules, Catalog Number 4312018
b) Kilit Ampules, Catalog Number 4312019
c) Kilit Ampules, Catalog Number 4399511
(manufactured for Cottrell, Ltd.);
d) Kilit Ampules, Catalog Number 4399155
(manufactured for SPS Medical).
Recall #Z-764/767-7.
CODE All lots of the above Catalog Numbers are
subject to recall.
MANUFACTURER Becton Dickinson Microbiology Systems,
Cockeysville, Maryland.
RECALLED BY Becton Dickinson Microbiology Systems, Sparks,
Maryland, by letter in May 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimates none remains on the market.
REASON Devices do not meet labeled D-values and some
are outside the label claim for spore count.
This could produce incorrect result when
applied to the standard microbiological
sterilization cycle.
_______________
PRODUCT Electric Powered Moist Heating Pad with
momentary switch:
a) Roberts Hydro Thero Pad Model 1327-1,
Pro-Temp MHP Model 1327-1
b) Roberts Hydro Thero pad Model 1313-1.
Recall #Z-796/797-7.
CODE a) Control numbers 971247, 971260 through
971324, 971349 through 971362, 971397 through
971431, 971482 through 971561, 970541 through
970660
b) control numbers 970889 through 970911,
970924 through 971025, 971081 through 971200,
971212, 971144 through 971147.
MANUFACTURER Roberts Manufacturing Company, Inc.,
Baltimore, Maryland.
RECALLED BY Manufacturer, by telephone on May 23, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY a) 315 units; b) 246 units were distributed.
REASON During assembly of the product it was
discovered that splitting the electric power
cord caused copper wires to become exposed.
_______________
PRODUCT Heartstart Battery Charger, Catalog #902850,
intended to charge the following batteries:
90 11 00 Heartstart Battery
90 43 00 Heartstart Battery
90 11-90 Heartstart 3000 Training Battery
90 41 00 Heartstart 1000 Training Battery.
Recall #Z-802-7.
CODE Lot Nos. 97182A, 97212A.
MANUFACTURER Ault, Inc., Minneapolis, Minnesota (battery
supplier/responsible firm).
RECALLED BY Laerdal Medical Corp., Wappingers Falls, New
York, by letter dated June 27, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 301 battery charges are affected.
REASON The two lots of battery chargers were missing
a resistor that controls the lights and
charging activity in the battery charger.
_______________
PRODUCT Contour Mammography System, Model M-CTR-1 and
M-CTR-2 dedicated for mammographic imaging
using X-ray. Recall #Z-859/860-7.
CODE Units with Serial Numbers in 29000 series are
Contour 2 models and all others are Contour 1
(425 Serial #s):
BMC-27503, BMC-27504, BMC-27505, BMC-27506,
BMC-27509, BMC-27510, BMC-27512, BMC-27513,
BMC-27514, BMC-27516, BMC-27520, BMC-27522,
BMC-27523, BMC-27524, BMC-27526, BMC-27527,
BMC-27528, BMC-27578, BMC-27579, BMC-27580,
BMC-27581, BMC-27582, BMC-27583, BMC-27584,
BMC-27586, BMC-27587, BMC-27596, BMC-27597,
BMC-27598, BMC-27599, BMC-27600, BMC-27602,
BMC-27603, BMC-27604, BMC-27605, BMC-27606,
BMC-27607, BMC-27608, BMC-27609, BMC-27610,
BMC-27611, BMC-27612, BMC-27613, BMC-27614,
BMC-27615, BMC-27634, BMC-27635, BMC-27636,
BMC-27637, BMC-27638, BMC-27639, BMC-27641,
BMC-27642, BMC-27643, BMC-27644, BMC-27646,
BMC-27647, BMC-27648, BMC-27649, BMC-27650,
BMC-27652, BMC-27654, BMC-27655, BMC-27656,
BMC-27658, BMC-27701, BMC-27702, BMC-27703,
BMC-27705, BMC-27706, BMC-27707, BMC-27708,
BMC-27710, BMC-27711, BMC-27712, BMC-27713,
BMC-27714, BMC-27715, BMC-27716, BMC-27717,
BMC-27718, BMC-27719, BMC-27720, BMC-27721,
BMC-27722, BMC-27723, BMC-27724, BMC-27725,
BMC-27726, BMC-27727, BMC-27729, BMC-27730,
BMC-27731, BMC-27732, BMC-27733, BMC-27734,
BMC-27735, BMC-27737, BMC-27738, BMC-27739,
BMC-27740, BMC-27741, BMC-27742, BMC-27743,
BMC-27745, BMC-27746, BMC-27753, BMC-27754,
BMC-27755, BMC-27756, BMC-27757, BMC-27758,
BMC-27759, BMC-27760, BMC-27761, BMC-27762,
BMC-27763, BMC-27764, BMC-27765, BMC-27766,
BMC-27767, BMC-27768, BMC-27770, BMC-27771,
BMC-27772, BMC-27773, BMC-27774, BMC-27775,
BMC-27777, BMC-27778, BMC-27779, BMC-27780,
BMC-27780, BMC-27781, BMC-27783, BMC-27784,
BMC-27801, BMC-27802, BMC-27803, BMC-27804,
BMC-27805, BMC-27806, BMC-27807, BMC-27808,
BMC-27809, BMC-27812, BMC-27813, BMC-27814,
BMC-27815, BMC-27816, BMC-27817, BMC-27818,
BMC-27820, BMC-27821, BMC-27822, BMC-27823,
BMC-27824, BMC-27828, BMC-27829, BMC-27831,
BMC-27832, BMC-27833, BMC-27834, BMC-27835,
BMC-27836, BMC-27837, BMC-27838, BMC-27840,
BMC-7841, BMC-27842, BMC-27844, BMC-27845,
BMC-27846, BMC-27848, BMC-27849, BMC-27850,
BMC-27851, BMC-27852, BMC-27853, BMC-27855,
BMC-27858, BMC-27859, BMC-27860, BMC-27861,
BMC-27865, BMC-27866, BMC-27867, BMC-27868,
BMC-27869, BMC-27870, BMC-27871, BMC-27872,
BMC-27873, BMC-27874, BMC-27875, BMC-27876,
BMC-27877, BMC-27888, BMC-27889, BMC-27890,
BMC-27891, BMC-27892, BMC-27893, BMC-27895,
BMC-27896, BMC-27897, BMC-27898, BMC-27900,
BMC-27901, BMC-27902, BMC-27903, BMC-27904,
BMC-27905, BMC-27906, BMC-27907, BMC-27908,
BMC-27909, BMC-27910, BMC-27911, BMC-27912,
BMC-27913, BMC-27914, BMC-27915, BMC-27916,
BMC-27919, BMC-27920, BMC-27922, BMC-27923,
BMC-27924, BMC-27925, BMC-27926, BMC-27927,
BMC-27928, BMC-27929, BMC-27930, BMC-27931,
BMC-27932, BMC-27935, BMC-27936, BMC-27938,
BMC-27939, BMC-27940, BMC-27942, BMC-27943,
BMC-27945, BMC-27946, BMC-27956, BMC-27957,
BMC-27959, BMC-27960, BMC-27961, BMC-27962,
BMC-27965, BMC-27966, BMC-27968, BMC-27969,
BMC-27971, BMC-27972, BMC-27973, BMC-27974,
BMC-27975, BMC-27976, BMC-27979, BMC-27981,
BMC-27982, BMC-27985, BMC-27986, BMC-27989,
BMC-27990, BMC-27993, BMC-27994, BMC-27995,
BMC-27997, BMC-27998, BMC-27999, BMC-28001,
BMC-28002, BMC-28003, BMC-28004, BMC-28005,
BMC-28015, BMC-28016, BMC-28017, BMC-28018,
BMC-28019, BMC-28020, BMC-28021, BMC-28022,
BMC-28024, BMC-28025, BMC-28026, BMC-28027,
BMC-28032, BMC-28043, BMC-28044, BMC-28045,
BMC-28047, BMC-28048, BMC-28050, BMC-28052,
BMC-28053, BMC-28054, BMC-28056, BMC-28057,
BMC-28059, BMC-28061, BMC-28062, BMC-28063,
BMC-28064, BMC-28065, BMC-28066, BMC-28067,
BMC-28069, BMC-28071, BMC-28072, BMC-28074,
BMC-28075, BMC-28076, BMC-28096, BMC-28097,
BMC-28098, BMC-28099, BMC-28103, BMC-28104,
BMC-28105, BMC-28109, BMC-28110, BMC-28111,
BMC-28112, BMC-28113, BMC-28114, BMC-28116,
BMC-28117, BMC-28118, BMC-28119, BMC-28120,
BMC-28122, BMC-28125, BMC-28126, BMC-28127,
BMC-28128, BMC-28129, BMC-28130, BMC-28133,
BMC-28134, BMC-28135, BMC-28136, BMC-28139,
BMC-28140, BMC-28141, BMC-28142, BMC-28143,
BMC-28144, BMC-28151, BMC-28152, BMC-28154,
BMC-28155, BMC-28157, BMC-28158, BMC-28167,
BMC-28168, BMC-28171, BMC-28174, BMC-28175,
BMC-28176, BMC-28182, BMC-28183, BMC-28185,
BMC-28186, BMC-28187, BMC-28188, BMC-28195,
BMC-28217, BMC-28219, BMC-28223, BMC-28224,
BMC-28225, BMC-28230, BMC-28252, BMC-28253,
BMC-28257, BMC-29000, BMC-29001, BMC-29002,
BMC-29003, BMC-29004, BMC-29005, BMC-29006,
BMC-29007, BMC-29008, BMC-29009, BMC-29010,
BMC-29014, BMC-29015, BMC-29016, BMC-29017,
BMC-29022, BMC-29023, BMC-29024, BMC-29026,
BMC-29027, BMC-29028, BMC-29045, BMC-29046,
BMC-29047, BMC-29048, BMC-29049, BMC-29051,
BMC-29052, BMC-29053, BMC-29054, BMC-29055,
BMC-29056, BMC-29057, BMC-29059, BMC-29060,
BMC-29061, BMC-29062, BMC-29063, BMC-29066,
BMC-29068, BMC-29069, BMC-29072, BMC-29073 &
BMC-29076.
The following serial numbers are for the 58
units which the firm had shipped retrofit kits
between 9/95 and 2/97: (Bennett still needs to
verify that these retrofits were performed by
dealers' servicemen):
BMC-27830, BMC-29129, BMC-29196, BMC-29081,
BMC-28042, BMC-29021, BMC-27941, BMC-29019,
BMC-27856, BMC-29177, BMC-28051, BMC-27616,
BMC-27610, BMC-27944, BMC-27987, BMC-27996,
BMC-27517, BMC-29168, BMC-29067, BMC-27970,
BMC-27967, BMC-27769, BMC-28023, BMC-27937,
BMC-27525, BMC-27507, BMC-28172, BMC-27508,
BMC-29011, BMC-29013, BMC-29020, BMC-27827,
BMC-27988, BMC-29287, BMC-29018, BMC-28026,
BMC-27847, BMC-29025, BMC-29139, BMC-27843,
BMC-29112, BMC-27826, BMC-27958, BMC-28046,
BMC-28156, BMC-29249, BMC-29121, BMC-29003,
BMC-28058, BMC-27744, BMC-27501, BMC-27653,
BMC-29012, BMC-27857, BMC-28121, BMC-27640,
BMC-29074 and BMC-27977.
MANUFACTURER Bennett X-Ray Technologies, subsidiary of Trex
Medical Corporation, Copiague, New York.
RECALLED BY Manufacturer, by letter dated March 5, 1997.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 483 units subject to retrofit.
REASON This diagnostic x-ray device was found to be
in non-compliance with the Federal Performance
Standard for Diagnostic X-ray Systems and
their Major Components. The 150 watt bulb may
cause overheating in the collimator gears.
_______________
PRODUCT Multigas Analyzer, simultaneously monitors gas
concentrations and alerts clinical personnel
when the concentration of anesthetic agents,
oxygen, carbon dioxide or nitrous oxide falls
outside the defined limits. Recall #Z-862-7.
CODE Serial Number Range 518-000001 through
518-000551 (non inclusive), Software Versions
less than 1.00.26
MANUFACTURER Spacelabs Medical, Inc., Redmond, Washington.
RECALLED BY Manufacturer, by letter on May 15, 1997.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 303 devices were distributed.
REASON The multigas analyzer may display an incorrect
agent identification.
_______________
PRODUCT Narkomed Anesthesia Machines, intended to
deliver anesthetic gases and oxygen and may be
used to ventilate patients. Recall #Z-863-7.
CODE Product Manufactured Between December 5, 1996,
and March 21, 1997.
MANUFACTURER North American Drager, Telford, Pennsylvania.
RECALLED BY Manufacturer, by letter dated June 6, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 281 units were distributed.
REASON The oxygen flush button on some of these
machines may stick in the open position.
_______________
PRODUCT 3100A Flexible Patient Circuit Body, Part
#769960, Used With Model 3100 HFOV, for
ventilatory support and treatment of
respiratory failure. Recall #Z-864-7.
CODE Lot #042297.
MANUFACTURER Sensormedics, Inc., Yorba Linda, California.
RECALLED BY Surgical Technologies, Inc., Brea, California,
by telephone on July 2, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Illinois, Pennsylvania, The Netherlands,
Canada, Argentina.
QUANTITY 54 boxes were distributed.
REASON The dump valve and temperature port
subassembly near the patient end of the
circuit body was reversed due to an assembly
error.
_______________
PRODUCT Epstein-Barr Virus-Viral Capsid Antigen IgG
Enzyme-linked Immunosorbent Assay, Product No.
2325700 (International), 425700 (Domestic),
Lot No. 2325700-120 (International),
425700-120 (Domestic), for in-vitro diagnostic
use. Recall #Z-865-7.
CODE Lot #120 EXP 11/97.
MANUFACTURER Trinity Biotech (formerly Clark Laboratories),
Jamestown, New York.
RECALLED BY Manufacturer, by letter dated July 25, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION New Jersey and international.
QUANTITY 960 kits were distributed.
REASON The absorbance of the kit calibrator has
dropped below the acceptable optical density
range of 0.250.
_______________
PRODUCT Oxygen Pressure Regulator with Constant Flow:
a) Regulator Model No. L270-020 for the
following kits: L151JD, L175-010, L175-010D,
L175-010JD, L175-011D, L175-011JD, L175-014,
L175-01R, L175-030, L175-030D, L175-030JD,
L175-03R, L175-140, L444, L444-010, L515,
L515-010, L515D, L515JD, L520, L520-010, L521,
L523, L523-100, L524, L525, L526, L541-020,
L541-040, L542-020, L542-040, L561, L561-010,
L561-020, L567, L574, L594, L902001, L902002,
L902003, L520-100
b) Regulator Model No. L270-050 for the
following kits: L228 and L228-030.
Recall #Z-866/867-7.
CODE All regulators distributed prior to 4/11/97.
MANUFACTURER Allied Healthcare Products, Inc., St. Louis,
Missouri.
RECALLED BY Manufacturer, by letter dated May 20, 1997,
and by telephone on May 23, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 150,000 regulators were
distributed.
REASON The device was involved in fires which
occurred as a result of contamination
introduced into the oxygen regulators during
maintenance or use.
_______________
PRODUCT Consensus Knee Femoral Component, Nonporous
CoCr, Size 5 Right, for joint replacement.
Recall #Z-868-7.
CODE Lot No. 230224A.
MANUFACTURER US Medical Products, Inc., Austin, Texas.
RECALLED BY Manufacturer, by telephone on May 22, 1997.
Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 2 units were distributed.
REASON The labeling stated product was a right knee
component, but the component in the package
was a left knee component.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Dual Lumen 7Fr. Catheter (DLC-7D), Urodynamics
Catheterization Trays (TCL-7) that include
DLC-7D Catheters. Recall #Z-762/763-7.
CODE Lot numbers: a) 4617701; b) 2617802.
MANUFACTURER Life-Tech, Inc., Houston, Texas.
RECALLED BY Manufacturer, by letter,on or about dated June
30, 1997
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide
QUANTITY 360/30 cartons were distributed.
REASON The catheters were shipped with a partially
occluded pressure lumen.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS
III ===
_______________
PRODUCT OptiCare Opti-Pak containing Aureo SP-250
(medicated swine feed premix containing
chlortetracycline, sulfamethazine and
penicillin. Recall #V-041-7.
CODE Lots 611055D, 611056D, 6120312D, 6120313D,
7040666D, 7040667D.
MANUFACTURER Hubbard Milling Company, Mankato, Minnesota.
RECALLED BY Manufacturer, by telephone on June 19, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois, Indiana, Iowa, North Dakota,
Ohio, and South Dakota.
QUANTITY 1284 20-pound bags were distributed.
REASON Incorrect withdrawal time of 7 days printed on
the labeling instead of the required 15 days
and misidentification of sulfamethazine as
sulfathiazine.
END OF ENFORCEMENT REPORT FOR AUGUST 27, 1997. BLANK PAGES MAY
FOLLOW.
End of Enforcement Report for
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