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.

ENFORCE
04/27/1994

Recalls and Field Corrections: Foods -- Class I -- 04/27/1994

April 27, 1994 94-17

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
UPDATE Elsa Peretti Ceramicware, Recall #F-330/368-4 which appeared
in the April 13, 1994 Enforcement Report should be corrected
as follows:
QUANTITY: SKU 10336821 should be Blue/White Teapots
SKU 10464935 should be Blue/White Bowl
SKU 10351782 should be 183 pieces.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Fresh Shellstock Oysters (actually shucked oysters), packaged
into plastic containers. Recall #F-371-4.
CODE Shipper packer #1147SP.
MANUFACTURER Lionel's Seafood, Hopedale, Louisiana (distributor).
RECALLED BY Distributor. Oysters were destroyed November 12, 1993. Firm-
initiated recall complete.
DISTRIBUTION Louisiana, Alabama.
QUANTITY 623 gallons were distributed; firm estimates none remains on
the market.
REASON The oysters harvested at Cabbage Reef and Grand Pass have been
associated with at least 16 discrete outbreaks of
gastroenteritis.
_______________
PRODUCT Fresh Shellstock Oysters packaged in sacks. Recall #F-372-4.
CODE Oyster's sacks are identified by a tag showing the harvester
license number and waters from which harvested.
MANUFACTURER Cyril's Ice House Supplies, St. Bernard, Louisiana
(distributor).
RECALLED BY Distributor, telephone on or about November 23, 1993. Firm-
initiated recall complete.
DISTRIBUTION Louisiana, Alabama, Mississippi.
QUANTITY 539 sacks were distributed; firm estimates none remains on the
market.
REASON The oysters harvested at Cabbage Reef and Grand Pass have been
associated with at least 16 discrete outbreaks of
gastroenteritis.

_______________
PRODUCT Shellstock Oysters. Recall #F-373-4.
CODE None.
MANUFACTURER Collins Oyster Company, Golden Meadow, Louisiana.
RECALLED BY Manufacturer, by visit on or about Novemer 23, 1993. Firm-
initiated recall complete.
DISTRIBUTION Louisiana.
QUANTITY Approximately 1,846 sacks (approximately 80 pounds per sack)
were distributed; firm estimates none remains on the market.
REASON The oysters harvested at Cabbage Reef and Grand Pass have been
associated with at least 16 discreet outbreaks of
gastroenteritis.

_______________
PRODUCT Shellstock Oysters packed in burlap sacks. Recall #F-374-4.
CODE All product dated from 9-9-93 through 11-16-93.
MANUFACTURER B&S Seafood, Pass Christian, Mississippi (shipper).
RECALLED BY Shipper, by telephone November 16, 1993, and by letter
November 29, 1993. Firm-initiated recall complete.
DISTRIBUTION Mississippi, Alabama.
QUANTITY 2,079 sacks were distributed; firm estimates none remains on
the market.
REASON The oysters harvested at Cabbage Reef and Grand Pass have been
associated with at least 16 discreet outbreaks of
gastroenteritis.

_______________
PRODUCT Raw In-Shell Oysters in unlabeled burlap sacks.
Recall #F-375-4.
CODE None.
MANUFACTURER Eddies Quality Oysters, Port Sulphur, Louisiana.
RECALLED BY Manufacturer, by telephone November 17, 18, 19, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Alabama, Virginia, Maryland, Florida, Texas, Louisiana,
Mississippi.
QUANTITY Firm estimates none remains on the market.

-2-REASON The oysters harvested at Cabbage Reef and Grand Pass have been
associated with at least 16 discreet outbreaks of
gastroenteritis.

_______________
PRODUCT (a) Shellstock Oysters; (b) Shucked Oysters, harvested from
Grand Pass growing area in Louisiana. Recall #F-376/377-4.
CODE None.
MANUFACTURER King Cajun Quality Seafoods, New Iberia, Louisiana.
RECALLED BY Manufacturer, by telephone November 22, 1993. Firm-initiated
recall complete.
DISTRIBUTION Tennessee, Florida, Illinois, Louisiana, Missouri.
QUANTITY Firm estimates none remains on the market.
REASON The oysters harvested at Cabbage Reef and Grand Pass have been
associated with at least 16 discreet outbreaks of
gastroenteritis.

_______________
PRODUCT Fresh Shellstock Oysters packaged in sacks. Recall #F-378-4.
CODE Sacks are identified by a tag which identifies the harvester
license number and waters from which harvested.
MANUFACTURER Molero Seafood Products, Inc., St. Bernard, Louisiana
(distributor).
RECALLED BY Distributor, by visit. Firm-initiated recall complete.
DISTRIBUTION Louisiana, Alabama.
QUANTITY Firm estimates none remains on the market.
REASON The oysters harvested at Cabbage Reef and Grand Pass have been
associated with at least 16 discreet outbreaks of
gastroenteritis.

_______________
PRODUCT Del Monte Hamburger Relish, in 12 ounce jars.
Recall #F-379-4.
CODE 3014V1H08.
MANUFACTURER Vlasic Foods, Inc., City of Industry, California. (This plant
is no linger in operation).
RECALLED BY Del Monte Research Center, Walnut Cree, California, by letter
dated December 3, 1993. Firm-initiated recall complete.
DISTRIBUTION Texas, Louisiana, Nevada, California.
QUANTITY 258 cases (12 jars per case) were distributed.
REASON Product is contaminated with glass.

_______________
PRODUCT Tuna Loins in individual unlabeled plastic sleeves.
Recall #F-382-4.
CODE Lot #93.09.20.
MANUFACTURER Ban Chang Frozen Ind. Co., Ltd., Taiwan, Republic of China.
RECALLED BY Seven Seas Seafoods, Alhambra, California, by telephone
February 11, 1994. Firm-initiated recall complete.
DISTRIBUTION Washington state, Florida.
QUANTITY 42,013 pounds were distributed; firm estimates none remains on
the market.
REASON Product was decomposed and contained histamine.
-3-RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Tree Top Apple Juice in 1 gallon plastic containers.
Recall #F-381-4.
CODE C033H0900, C033H0901.
MANUFACTURER Hi Country Foods Corporation, Selah, Washington.
RECALLED BY Tree Top, Inc., Selah, Washington, by letter March 2, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Washington state.
QUANTITY Approximately 20 cases (6 units per case) were distributed.
REASON Product is contaminated with yeast.

_______________
PRODUCT Grand Union brand "no sugar added" Ice Pops, 1.75 fluid ounce
pops, cherry, orange, or grape flavored pops on a wooden
stick. Recall #F-384-4.
CODE All date codes.
MANUFACTURER Dunkirk Ice Cream Company, Inc., Dunkirk, New York.
RECALLED BY Manufacturer, by telephone March 4, 1994, followed by letter.
Firm-initiated recall ongoing.
DISTRIBUTION New Jersey, New York.
QUANTITY Approximately 1,320 cases (12 cartons per case, 12 pops per
carton).
REASON The label shows inconsistencies regarding contents, calories
and is misleading since it claims "no sugar" but declares
dextrose as an ingredient.

_______________
PRODUCT Minute Maid Apple Juice in 8.45 fluid ounce tetra paks.
Recall #F-386-4.
CODE 3-pack and 9-pack: XX:XXA"Y" OCT2794 AXXXXXZ;
XX:XXA"Y" OCT2894 AXXXXXZ; XX:XXA"Y" OCT2994 AXXXXXZ.
("X" is a number between 1-9, "Y" is the letter C or D, "Z" is
a letter between A and G).
MANUFACTURER Coca-Cola Foods, Anaheim, California.
RECALLED BY Coca-Cola Foods, A Division of the Coca-Cola Company, Houston,
Texas, by visits beginning February 14, 1994, firm-initiated
recall complete.
DISTRIBUTION Alaska, Arizona, California, Hawaii, Nevada, Utah.
QUANTITY 27,985 cases (27 paks per case) were distributed.
REASON Product is contaminated with yeast.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
========================
_______________
PRODUCT (a) Family Medic First Aid Treatment, 4 ounce pump spray, OTC
for topical administration; (b) AHHH Sunburn Therapy, in 6
ounce and 1 ounce gel; 4 ounce and 5 ounce spray.
Recall #D-254/255-4.
CODE All lots.
MANUFACTURER Tender Corporation, Littleton, New Hampshire (repacker).
RECALLED BY Repacker, by telephone March 17, 1994, followed by letter
March 25, 1994. Firm-initiated recall ongoing.
-4-DISTRIBUTION Nationwide.
QUANTITY Approximately 59,000 units were distributed.
REASON Presence of Pseudomonas cepacia.

_______________
PRODUCT Cephradine Capsules, USP, 250 mg capsules and 500 mg capsules,
Rx oral antibiotic, under the following labels: Biocraft,
Aligen, Biocraft, Darby (Rugby), Drug Guild (Harber label),
Geneva Generics, Geneva Pharmaceutical, Goldline, Lederle,
Major, H.L. Moore, Qualitest, Schein, UDL, UHL, Warner-
Chilcott. Recall #D-256/257-4.
CODE LOT NO. POTENCY SIZE EXP DATE
51372 250 mg 100's 10/1/93
51374 500 mg 100's 10/1/93
51451 500 mg 100's 12/1/93
51503 250 mg 100's 10/1/93
500's 10/1/93
51519 500 mg 100's 1/1/94
51520 500 mg 24's 2/1/94
100's 2/1/94
51554 250 mg 100's 4/1/94
51645 250 mg Unit Dose 7/1/94
51645 250 mg 24's 9/1/94
100's 9/1/94
500's 9/1/94
51693 500 mg 100's 8/1/94
51702 500 mg 100's 10/1/94
51371 250 mg 100's 10/1/93
500's 10/1/93
51373 500 mg 24's 10/1/93
100's 10/1/93
51402 500 mg 100's 11/1/93
51570 500 mg 100's 4/1/94
51646 250 mg 100's 9/1/94
51694 250 mg 100's 10/1/94
51701 500 mg 100's 10/1/94
52174 500 mg 100's 7/1/94
MANUFACTURER Biocraft Laboratories, Inc., Elmwood Park, New Jersey.
RECALLED BY Biocraft Laboratories, Inc., Fair Lawn, New Jersey, by letter
dated October 8, 11-14, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates there may have been 2,000 bottles for each
recalled lot on the market at time of recall initiation.
REASON Potency not assured through expiration date.

_______________
PRODUCT Triamcinolone Acetonide Cream, USP 0.1%, in 1 pound jars, Rx,
for relief of the inflammatory manifestations of
corticosteroid-responsive dermatoses. Recall #D-259-4.

-5-CODE Lot numbers: 1361 (EXP 4/94); 1679 (6/94); 1882 (8/94); 2163
(10/94); 2316 (12/94); 2373 (1/95); 2649 (3/95); 2807 (4/95);
2851 (5/95); 2899 (7/95); 3152 (8/95); 3401 (9/95), 3472
(8/95); 3740 (12/95); 3793 (1/96); 3941 3/96); 3980 (3/96);
4336 (5/96); 4373 (5/96); 4617 (7/96), 4671 (8/96); 4944
(9/95); 5203 (11/96) and 5250 (12/96).
MANUFACTURER Fougera, Division of Altana, Inc., Melville, New York.
RECALLED BY Manufacturer, by letters mailed March 29, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 100,504 jars were distributed.
REASON Superpotency.

_______________
PRODUCT I.V. solutions contained in a plastic "Mini-Bag Plus"
containers with vial adaptor ports for admixture of single
dose powdered drugs; Baxter Healthcare Corporation, Deerfield,
IL 60015 The following products are subject to the recall:
(a) 5% Dextrose Injection USP, packaged in Mini-Bag Plus 50 ml
and 100 ml Viaflex Single Dose Plastic Containers;
(b) 0.9% Sodium Chloride Injection USP, packaged in Mini-Bag
Plus 50 ml and 100 ml Viaflex Single Dose Plastic Containers.
Recall #D-260/261-4.
CODE Lot numbers: (a) PS026807, PS026930, PS026989, PS027466,
PS027847, PS027193, PS027193A, PS027193B, PS027557;
(b) PS027037, PS027086, PS027367, PS027912, PS027219,
PS027698, PS027698A, PS027698B.
MANUFACTURER (a) Baxter Healthcare Corp., North Cleveland, Mississippi.
(manufacturer of vial adaptor, foil cover sub-assembly)
(b) Baxter Healthcare Corp., Jayuya, Puerto Rico (manufacturer
of solutions.
RECALLED BY Baxter Healthcare Corp., I.V. Systems Division, Round Lake,
Illinois, by letter April 12, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 257,133 units were distributed; firm estimates that 15% of the
product remains on the market.
REASON Delamination of the foil seal located on the vial adaptor cap
which may result in difficulty removing the blue support disc.

_______________
PRODUCT Percogesic, aspirin-free analgesic, for enhanced relief of
pain, 325 mg, in bottles of 90, 50 and 24 tablets.
Recall #D-262-4.
CODE Lot numbers: 3021H or higher 90 tablet bottles; 3018H or
higher for bottles of 50; 3025H for bottles of 24.
MANUFACTURER The Procter & Gamble Company, Cayey, Puerto Rico.
RECALLED BY The Procter & Gamble Company, Cincinnati, Ohio, by letter on
or about April 11, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 14,646 cases (36 24-tablet bottles per case); 15,682 cases
(36 50-tablet bottles per case); 20,176 cases (24 90-tablet
bottles per case) were distributed.
-6-REASON Incomplete warning statement regarding antihistamine
ingredient.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Ibuprofen USP, 200 mg film coated tablets, in bottles of 50
and 100, non-prescription pain reliever. Recall #D-258-4.
CODE Lot #6816.
MANUFACTURER H.N. Norton Company, Shreveport, Louisiana.
RECALLED BY Manufacturer, by telephone and letter March 1, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Alabama, Arizona, California, Florida, Georgia, Indiana,
Kentucky, Louisiana, Maryland, Michigan, New York, Oklahoma,
Texas, Virginia.
QUANTITY 2,381 50-tablet bottles and 2,001 100-tablet bottles were
distributed.
REASON Bottles of 50 tablets were packaged in containers labeled 100
tablets.

HUMAN TISSUE MANDATORY RECALLS:
_______________
PRODUCT Allograft Human Banked Tissue, Dehydrated and Frozen Human
Bone. Recall #B-202-4.
CODE Approximately 400 pieces from the following 24 donors:
937001, 937003, 937005, 937007, 937008, 937009, 937010,
937011, 937012, 937013, 937014, 937015, 937016, 937017,
937018, 937020, 937026, 937033, 937034, 937035, 937036,
937037, 937041, 937067.
SUPPLIER Skilosovsky Research Institute, Moscow, Russia.
RECALLED BY Transplant Technology, Inc., San Antonio, Texas, by letter
dated March 10, 1994. FDA ordered recall ongoing.
DISTRIBUTION Alabama, Arizona, California, Florida, Georgia, Oklahoma,
Ohio, Oregon, Massachusetts, Maryland, Michigan, Minnesota,
North Carolina, South Carolina, Texas, West Virginia.
QUANTITY Approximately 400 pieces.
REASON This is a FDA ordered recall under 21 CFR 1270. Human bone
tissue was distributed which: 1) lacked adequate
documentation about the donors' relevant medical history
related to risk factors for, or clinical evidence of,
hepatitis B, hepatitis C, or human immunodeficiency virus
(HIV) infection; and 2) lacked the required documentation of
the donors' medical histories in English as the original
record, or as a verified translation into English, accompanied
by the original record.

_______________
PRODUCT Allograft Human Banked Tissue, Dehydrated and Frozen Human
Bone. Recall #B-203-4.

-7-CODE Approximately 2277 pieces from the following 36 donors:
93K01, 93K02, 93K03, 005-93, 007-93, 008-93, 009-93, 010-93,
93A011, 93A012, 93A015, 93A017, 93A018, 93A019, 93A022,
93A025, 93A026, 93A027, 93A029, 93A032, 93A036, 93A037,
93A038, 93A040, 93A043, 93A042, 93A045, 93A046, 93A047,
93A049, 93A050, 93A052, 93A053, 93A054, 93A057, 93A059.
SUPPLIER Skilosovsky Research Institute, Moscow, Russia.
RECALLED BY International Tissue Service, Ltd., San Antonio, Texas, by
letter dated March 9, 1994. FDA ordered recall ongoing.
DISTRIBUTION Texas.
QUANTITY Approximately 2,277 pieces.
REASON This is a FDA ordered recall under 21 CFR 1270. Human bone
tissue was distributed which: 1) lacked adequate
documentation about the donors' relevant medical history
related to risk factors for, or clinical evidence of,
hepatitis B, hepatitis C, or human immunodeficiency virus
(HIV) infection; and 2) lacked the required documentation of
the donors' medical histories in English as the original
record, or as a verified translation into English, accompanied
by the original record.

_______________
PRODUCT Allograft Human Banked Tissue, Dehydrated and Frozen Human
Bone. Recall #B-204-4.
CODE Approximately 3000 pieces from the following donors:
72592, 72992, 73092, 73292, 73492, 73792, 73892, 73992,
74092, 74192, 74292, 74492, 74592, 74892, 74992, 75392,
75492, 75592, 76192, 76292, 76492, 76592, 76792, 76892,
77092, 77192, 77392, 77592, 78192, 78292, 78392, 79092,
79192, 79292, 79392, 79492, 79892, 79992, 80092, 80192,
80292, 80392, 80492, 80592, 80692, 80792, 81192, 81292,
81392, 81492, 81892, 81992, 82092, 82192, 82292, 82392,
82492, 82692, 82892, 82992, 83092, 83292, 83392, 10393,
10493, 10693, 10793, 11093, 11193, 11393, 11493, 11593,
11693, 11793, 11893, 12093, 12193, 12293, 12393, 12493,
12593, 12893, 12993, 13393, 13593, 13893, 14093, 14193,
14393, 14493, 14593, 14793, 14993, 15193, 15293, 15393,
15593, 15793, 15893, 15993, 16093, 16193, 16393, 16493,
16693, 16993, 17293, 17593, 17693, 17793, 17893, 18193,
18693, 18993, 19093, 19293, 19393, 19493, 19593, 19893,
19993, 20093, 20293, 20493, 20693, 20893, 21193, 21393,
21493, 21693, 21793, 22193, 22293, 22493, 22593, 22693,
23193, 23293, 23393, 23593, 23693, 24093, 24193, 24393,
24493, 25193, 25293, 25993, 26693, 26793, 26993, 27093,
27193, 27593, 27793, 27993, 28193, 28493, 29293, 29393,
29493, 29593, 31493, 31593, 32193, 33193, 33693, 34093,
34193, 34793, 34893, 34993.
Last two digits of donor number indicate the calendar year,
i.e., "92" for 1992 and "93" for 1993.
SUPPLIER Moscow City Emergency Institute, Moscow, Russia.
RECALLED BY AlloTech, Inc., El Paso, Texas, by letters dated February 22,
1994. FDA ordered recall ongoing. See also FDA talk paper
T94-13, February 15, 1994.
-8-DISTRIBUTION Connecticut, Florida, Georgia, Kentucky, Mississippi, New
Mexico, Ohio, Oklahoma, Texas, Wyoming, Mexico.
QUANTITY Approximately 3,000 pieces were distributed between December
23, 1992 and February 16, 1994.
REASON This is a FDA ordered recall under 21 CFR 1270. Human bone
tissue was distributed which: 1) lacked adequate
documentation about the donors' relevant medical history
related to risk factors for, or clinical evidence of,
hepatitis B, hepatitis C, or human immunodeficiency virus
(HIV) infection; and 2) lacked the required documentation of
the donors' medical histories in English as the original
record, or as a verified translation into English, accompanied
by the original record.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Red Blood Cells. Recall #B-183-4.
CODE Unit #42W57586.
MANUFACTURER American Red Cross Services, Cleveland, Ohio.
RECALLED BY Manufacturer, by telephone April 19, 1993. Firm-initiated
recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit.
REASON Autologous Red Blood Cells, which tested repeatedly reactive
for the antibody to hepatitis B core antigen (anti-HBc), was
distributed without biohazard labeling.

_______________
PRODUCT Source Plasma. Recall #B-194-4.
CODE Unit numbers: FT06026602, FT06026754, FT06026876, FT06026926,
FT06026998, FT06025197, FT06025226, FT06025362, FT06025412,
FT06025609, FT06025697, FT06026032, FT06028186, FT06028805,
FT06028910, FT06029102, FT06027191, FT06027295, FT06027885.
MANUFACTURER Serologicals, Inc., Charlotte, North Carolina.
RECALLED BY Manufacturer, by facsimile September 27, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION North Carolina
QUANTITY 19 units.
REASON Blood products, which were collected from a donor who had a
history of intravenous drug (IV) use, were distributed.

_______________
PRODUCT Recovered Plasma. Recall #B-201-4.
CODE Unit #SW109987.
MANUFACTURER Scott and White Memorial Hospital and Scott, Sherwood, and
Brindley Foundation, Temple, Texas.
RECALLED BY Manufacturer, by notifying firm January 7, 1993, by letter
erroneously dated January 7, 1992. Firm-initiated recall
complete.
DISTRIBUTION Florida.
QUANTITY 1 unit.

-9-REASON Blood product, that tested negative for the antibody to the
human immunodeficiency virus type 1 (anti-HIV-1), but was
collected from a donor who previously tested repeatedly
reactive for anti-HIV-1, was distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-205-4.
CODE Unit numbers: 04LF12206, 04LF12207, 04LF12208, 04LF12211,
04LF12213, 04LF12214, 04LF12215, 04LF12216, 04LF12220,
04LG86671, 04LG86674, O4LG86675, 04LG86677, 04LG86678,
04LG86679, 04LG86680, 04LG86681, O4LG86684, 04LG86685,
O4LG86686.
MANUFACTURER American National Red Cross, Dedham, Massachusetts.
RECALLED BY Manufacturer, by telephone January 19, 1993, followed by
letter January 22, 1993. Firm-initiated recall complete.
DISTRIBUTION Massachusetts, Maine.
QUANTITY 20 units.
REASON Red blood cells, stored under improper temperatures, were
distributed.

_______________
PRODUCT Source Plasma. Recall#B-206-4.
CODE Unit #0970175399.
MANUFACTURER American Biomedical Systems, Boise, Idaho.
RECALLED BY Manufacturer, by letter dated August 4, 1993. Firm-initiated
recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit.
REASON Blood product, collected from an ineligible donor due to the
application of a tattoo less than 12 months prior to donation,
was distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-207/208-4.
CODE Unit #24LM98936.
MANUFACTURER The American National Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, (a) by telephone in April 1993, followed by
letter dated April 13, 1993; (b) by letter April 7, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION (a) Kentucky; (b) California.
QUANTITY 1 unit of each component.
REASON Blood products, collected from an ineligible donor due to the
application of a tattoo less than 12 months prior to
donation, were distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-209/210-4.
CODE Unit #T61178.
MANUFACTURER Topeka Blood Bank, Inc., Topeka, Kansas.

-10-RECALLED BY Manufacturer, by (a) letter March 23, 1993; (b) by telephone
March 22, 1993, followed by letter dated March 24, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION (a) Kansas; (b) Florida, New York.
QUANTITY 1 unit of each component.
REASON Blood products, collected from a donor who reported a history
of intravenous (IV) drug use, were distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-211/212-4.
CODE Unit #1463013.
MANUFACTURER Mississippi Blood Services, Jackson, Mississippi.
RECALLED BY Manufacturer, by telephone on February 2, 1993, and by letter
on April 19, 1993. Firm-initiated recall complete.
DISTRIBUTION New York, Mississippi.
QUANTITY 1 unit of each component.
REASON Blood products which tested reactive for syphilis by Rapid
Plasma Reagin (RPR) and confirmed positive by Fluorescent
Treponemal Antibody (FTA), were distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-227/228-4.
CODE Unit numbers: 4206274, 5725611, 7668560; (b) 7668560.
MANUFACTURER BloodCare, Dallas, Texas.
RECALLED BY Manufacturer, by letter March 25, 1993. Firm-initiated recall
complete.
DISTRIBUTION Texas, Maryland.
QUANTITY (a) 3 units; (b) 1 unit.
REASON Blood products, collected from ineligible donors due to travel
in areas endemic for malaria, were distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Platelets. Recall #B-184-4.
CODE Unit numbers: 42FZ18303, 42FZ18317, 42Y31312, 42Y31327,
42Y31353, 42Y31356, 42Y31358.
MANUFACTURER American Red Cross Services, Cleveland, Ohio.
RECALLED BY Manufacturer, by telephone August 10, 1992. Firm-initiated
recall complete.
DISTRIBUTION Ohio.
QUANTITY 7 units.
REASON Blood products which tested initially reactive for the
antibody to hepatitis B core antigen (anti-HBc) were not
retested in duplicate and were distributed for transfusion.

_______________
PRODUCT Source Plasma. Recall #B-200-4.
CODE Unit numbers: EO50001-003, EO50002-003, EO50003-003,
EO50004-003, EO50005-003, EO50006-003, EO50007-003,
EO50008-003, EO50009-003, EO50010-003, EO50011-003,

-11- EO50012-003, EO50013-003, EO50014-003, EO50015-003,
EO50016-003, EO50017-003, EO50018-003, EO50019-003,
EO50021-003, EO50022-003, EO50023-003, EO50024-003,
EO50025-003, EO50026-003, EO50027-003, EO50028-003,
EO50029-003, EO50030-003, EO50031-003, EO50032-003,
EO50033-003, EO50034-003, EO50035-003, NO85531-003,
NO85532-003, NO85533-003, NO85534-003, NO85535-003,
NO85536-003, NO85537-003, NO85538-003, NO85539-003,
NO85540-003, NO85541-003, NO85543-003, NO85544-003,
NO85547-003, NO85548-003, NO85549-003, NO85550-003,
NO85551-003, NO85552-003, NO85553-003, NO85554-003,
NO85555-003, NO85556-003, NO85558-003, NO85559-003,
NO85560-003, NO85561-003, NO85562-003, NO85563-003,
NO85564-003, NO85565-003, NO85566-003, NO85567-003,
NO85569-003, NO85570-003, NO85573-003, NO85574-003,
NO85575-003, NO85577-003, NO85578-003, NO85579-003,
NO85580-003, NO85581-003, NO85582-003, NO85583-003,
NO85584-003, NO85585-003, NO85586-003, NO85587-003,
NO85588-003, NO85589-003, NO85591-003, NO85592-003,
NO85593-003, NO85594-003, NO85596-003, NO85597-003,
NO85598-003, NO85599-003, NO85600-003, NO85601-003,
NO85602-003, NO85603-003, NO85605-003, NO85606-003,
NO85607-003, NO85608-003, NO85609-003, NO85610-003,
NO85611-003, NO85613-003, NO85614-003, NO85615-003,
NO85616-003, NO85617-003, NO85618-003, NO85620-003,
NO85621-003, NO85622-003, NO85623-003, NO85624-003,
NO85625-003, NO85626-003, NO85627-003, NO85628-003,
NO85629-003, NO85630-003, NO85631-003, NO85632-003,
NO85633-003, NO85634-003, NO85635-003, NO85636-003,
NO85637-003, NO85638-003, NO85639-003, NO85640-003,
NO85641-003, NO85642-003, NO85644-003, NO85645-003,
NO85646-003, NO85647-003, NO85648-003, NO85649-003,
NO85650-003, NO85651-003, NO85653-003, NO85654-003,
NO85655-003, NO85657-003, NO85658-003, NO85659-003,
NO85660-003, NO85661-003, NO85662-003, NO85663-003,
NO85664-003, NO85665-003, NO85666-003, NO85667-003,
NO85668-003, NO85669-003, NO85670-003, NO85671-003,
NO85672-003, NO85673-003, NO85674-003, NO85675-003,
NO85676-003, NO85677-003, NO85678-003, NO85679-003,
NO85680-003, NO85681-003, NO85682-003, NO85683-003,
NO85684-003, NO85686-003, NO85687-003, NO85688-003,
NO85689-003, NO85690-003, NO85691-003, NO85692-003,
NO85693-003, NO85694-003, NO85695-003, NO85696-003,
NO85697-003, NO85698-003, NO85699-003, NO85700-003,
NO85701-003, NO85702-003, NO85703-003, NO85704-003,
NO85705-003, NO85706-003, NO85707-003, NO85708-003,
NO85709-003, NO85710-003, NO85712-003, NO85713-003,
NO85714-003, NO85715-003, NO85717-003, NO85718-003,
NO85719-003, NO85720-003, NO85721-003, NO85722-003,
NO85724-003, NO85725-003, NO85726-003, NO85727-003,
NO85728-003, NO85729-003, NO85730-003, NO85731-003,
NO85732-003, NO85733-003, NO85734-003, NO85735-003,

-12- NO85736-003, NO85737-003, NO85738-003, NO85739-003,
NO85740-003, NO85741-003, NO85742-003, NO85743-003,
NO85744-003, NO85745-003, NO85747-003, NO85748-003,
NO85749-003, NO85750-003, NO85751-003, NO85752-003,
NO85753-003, NO85754-003, NO85755-003, NO85756-003,
NO85757-003, NO85759-003, NO85760-003, NO85761-003,
NO85762-003, NO85763-003, NO85764-003, NO85765-003,
NO85766-003, NO85767-003, NO85768-003, NO85769-003,
NO85770-003, NO85771-003, NO85772-003, NO85773-003,
NO85775-003, NO85776-003, NO85777-003, NO85778-003,
NO85779-003, NO85780-003, NO85781-003, NO85782-003,
NO85783-003, NO85784-003, NO85785-003, NO85787-003,
NO85788-003, NO85789-003, NO85790-003, NO85791-003,
NO85792-003, NO85793-003, NO85794-003, NO85795-003,
NO85796-003, NO85797-003, NO85798-003, NO85799-003,
NO85800-003, NO85801-003, NO85802-003, NO85803-003,
NO85804-003, NO85805-003, NO85806-003, NO85807-003,
NO85808-003, NO85809-003, NO85810-003, NO85811-003,
NO85812-003, NO85813-003, NO85814-003, NO85815-003,
NO85817-003, NO85818-003, NO85819-003, NO85820-003,
NO85821-003, NO85823-003, NO85824-003, NO85825-003,
NO85826-003, NO85827-003, NO85828-003, NO85829-003,
NO85830-003, NO85831-003, NO85832-003, NO85833-003,
NO85834-003, NO85835-003, NO85836-003, NO85837-003,
NO85838-003, NO85839-003, NO85840-003, NO85841-003,
NO85842-003, NO85843-003, NO85844-003, NO85845-003,
NO85846-003, NO85847-003, NO85848-003, NO85849-003,
NO85850-003, NO85852-003, NO85854-003, NO85855-003,
NO85856-003, NO85857-003, NO85858-003, NO85859-003,
NO85860-003, NO85861-003, NO85862-003, NO85863-003,
NO85864-003, NO85865-003, NO85866-003, NO85867-003,
NO85868-003, NO85869-003, NO85870-003, NO85871-003,
NO85872-003, NO85873-003, NO85874-003, NO85875-003,
NO85876-003, NO85877-003, NO85878-003, NO85879-003,
NO85880-003, NO85881-003, NO85882-003, NO85883-003,
NO85884-003, NO85885-003, NO85886-003, NO85887-003,
NO85888-003, NO85889-003, NO85891-003, NO85892-003,
NO85893-003, NO85894-003, NO85895-003, NO85896-003,
NO85897-003, NO85898-003, NO85899-003, NO85900-003,
NO85901-003, NO85902-003, NO85903-003, NO85904-003,
NO85905-003, NO85906-003, NO85907-003, NO85908-003,
NO85909-003, NO85910-003, NO85911-003, NO85912-003,
NO85913-003, NO85914-003, NO85915-003, NO85916-003,
NO85917-003, NO85918-003, NO85919-003, NO85920-003,
NO85921-003, NO85922-003, NO85923-003, NO85924-003,
NO85925-003, NO85926-003, NO85927-003, NO85928-003,
NO85929-003, NO85930-003, NO85931-003, NO85932-003,
NO85933-003, NO85934-003, NO85935-003, NO85936-003,
NO85937-003, NO85938-003, NO85939-003, NO85941-003,
NO85943-003, NO85944-003, NO85945-003, NO85946-003,
NO85947-003, NO85948-003, NO85949-003, NO85950-003,
NO85952-003, NO85953-003, NO85954-003, NO85955-003,

-13- NO85956-003, NO85957-003, NO85958-003, NO85959-003,
NO85960-003, NO85961-003, NO85962-003, NO85963-003,
NO85964-003, NO85965-003, NO85966-003, NO85967-003,
NO85968-003, NO85969-003, NO85970-003, NO85971-003,
NO85972-003, NO85974-003, NO85976-003, NO85977-003,
NO85978-003, NO85981-003, NO85982-003, NO85983-003,
NO85984-003, NO85985-003, NO85986-003, NO85987-003,
NO85988-003, NO85989-003, NO85990-003, NO85991-003,
NO85992-003, NO85993-003, NO85994-003, NO85995-003,
NO85996-003, NO85997-003, NO85998-003, NO85999-003, and
NO86000-003.
MANUFACTURER Premier BioResources, (Plasmapheresis Center), Gulfport,
Mississippi.
RECALLED BY Premier BioResources, Inc., Fort Worth, Texas, by letter
October 21, 1993. Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 468 units.
REASON Source Plasma exposed to unacceptable temperatures was
distributed.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Mouth-to-Mask Personal Resuscitator, a non-sterile, single-
use device. Recall #Z-535-4.
CODE Product #3052, lot #075042.
MANUFACTURER King Systems Corporation, Noblesville, Indiana.
RECALLED BY Manufacturer, by telephone August 14 and 18, 1992, followed
by letter August 18, 1992. Firm-initiated recall complete.
DISTRIBUTION Utah, California.
QUANTITY 10 cases (20 units per case) were distributed.
REASON The isolation valve was installed backwards.

_______________
PRODUCT Electrode lead wires and patient cables, multiple models,
used for used with ECG monitors and other similar devices:
(a) All Models of Unprotected cables; (b) All Models of
Unprotected Electrode Lead Wires. Recall #Z-539/540-4.
CODE All models with unprotected exposed metal pins.
MANUFACTURER 3M Healthcare, St. Paul, Minnesota.
RECALLED BY Manufacturer, by letter March 2, 1994. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Product labeling fails to provide adequate directions for
use and the devices pose an unwarranted risk of injury to
patients, because the products are not labeled to
contraindicate use with apnea monitors.

_______________
PRODUCT Aequitron Apnea Monitors with unprotected (exposed pin
style) lead wires and unprotected patient cables:
Models 8200 9200, 9216, 9500, and 9550. Recall #Z-541-4.
-14-CODE Any non-safety cable lead wire system which the firm
distributed and all serial numbers of the apnea monitors.
MANUFACTURER Aequitron Medical, inc., Minneapolis, Minnesota.
RECALLED BY Manufacturer, by Urgent-Medical Device Notification sent
November 10, 1993. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 65,000 monitors were distributed; firm
estimates 25,000 units are still in use.
REASON Devices lacked labels warning against the use of unprotected
lead wires.

_______________
PRODUCT All unprotected Patient Cables and Leadwires, including
Monitoring Electrodes with Pre-attached Unprotected
Leadwires under the Conmed, Medtronic/Andover and
Conmed/Andover labels:
(a) Patinet Cables - 345 model numbers with the following
item numbers or item number series:
BLH42-05; all "M" series (Andover products)
"CM" series; "FS" series; "HT" series; S218P and S219P-36
(Conmed products);
(b) Leadwires, 191 model numbers identified with the
following item number or item number series:
"FA" series; "FP" series, "LA" series; "LP" series; and item
#VS-2MM, #VS-3MM and VS-4MM (Conmed products).
"S" series - (Andover products);
Leadwire attached electrodes - 3 model numbers:
Item #s 1730-003 and 1740-003 - (Andover products)
Item #178-3333 - (Conmed product)
Leadwire attached electrodes are for use with neonatal and
pediatric children in monitoring heart activity. These are
packaged individually in heat-sealed peelable pouches and
have an expiration date of one year from manufacturer.
Leadwire Sets (contain multiple, color coded leadwires) --
Andover products as follows:
G24-02, G24-03 and G24-04;
"MA" series; "MB" series; "MCA" series; "MCL" series; "ML"
series, "MP" series;
"MT" series; NSM-002; "P" series; "RTG" series; "SL"
series; "T" series; and TA24-002II, TA24-03II
Conmed product: PP3-04. Recall #Z-542/543-4.
CODE All models of unprotected electrode lead wires marketed
since April 1991.
MANUFACTURER ConMed Corporatioan, Utica, New York and Andover Medical,
Haverhill, Massachusetts.
RECALLED BY ConMed Corporation, Utica, New York, by letters dated
November 15, 1993, and April 11, 1994. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,550,374 leadwires were distributed from April 1991 to
November 1993; firm estimates 250,268 remain on the market.
368,984 leadwires attached electrodes were distributed from
-15- September 1992 through November 1993; firm estimates 50
percent remains on the markte. Approximately 11,715 patient
cables were distributed from April 1991 to November; firm
estimates 50 percent remain on the market.
REASON Labeling fails to provide adequate directions for use and
the devices pose an unwarranted risk of injury to patients,
because the products are not labeled to contraindicate use
with apnea monitors.

_______________
PRODUCT Apnea monitors with unprotected leads: Model 2000W Option H
Heart/Respiration Monitors and Assurance 2000
Heart/Respiration Monitors. Recall #Z-545-4.
CODE All serial numbers.
MANUFACTURER EdenTec, A Nellcor Company, Eden Prairie, Minnesota.
RECALLED BY Manufacturer, by Urgent Medical Device Notification sent
September 20, 1993. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 3,000 monitors were distributed.
REASON Device labeling fails to provide adequate directions for use
and the devices pose an unwarranted risk of injury to
patients, because the product is not labeled to warn
connected to electrical power sources.

_______________
PRODUCT Hewlett-Packard Apnea Monitors (multiple models).
Recall #Z-549-4.
CODE All units with unprotected (exposed pin style) lead wires
and unprotected patient cables.
MANUFACTURER Hewlett-Packard Company, Andover, Massachusetts.
RECALLED BY Manufacturer, by letter April 11, 1994. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Device labeling fails to provide adequate directions for use
and the devices pose an unwarranted risk of injury to
patients, because the product is not labeled to warn against
the hazards of unprotected electrode lead wires being
connected to electrical power sources.

_______________
PRODUCT Maguire Enterprises ECG Electrode Lead Wires, Model K2150
and K2356, used by emergency medical service squads.
Recall #Z-550-4.
CODE All marketed in the past 5 years.
MANUFACTURER Maguire Enterprises, Inc., Fort Lauderdale, Florida.
RECALLED BY Manufacturer, by letter February 28, 1994. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.

-16-REASON Their labeling fails to provide adequate directions for use
and the devices pose an unwarranted risk of injury to
patients, because the products are not labeled to
contraindicate use with apnea monitors.

_______________
PRODUCT New Dimensions in Medicine Electrode Lead Wires and Patient
Cables (multiple models), used with ECG monitors and other
similar devices. Recall #Z-551/552-4.
CODE All models with unprotected exposed metal pins.
MANUFACTURER New Dimensions in Medicine, Dayton, Ohio.
RECALLED BY Manufacturer, by letter January 28, 1994. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Device labeling fails to provide adequate directions for use
and the devices pose an unwarranted risk of injury to
patients, because the products are not labeled to
contraindicate use with apnea monitors.

_______________
PRODUCT Novametrix Medical Systems Apnea Monitors, Models 902, 903,
and 910, used to monitor respiration. Recall #Z-553-4.
CODE All units.
MANUFACTURER Novametrix Medical Systems, Wallingford, Connecticut.
RECALLED BY Manufacturer, by letter February 24, 1994. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Device labeling fails to provide adequate directions for use
and the devices pose an unwarranted risk of injury to
patients, because the product is not labeled to warn against
the hazards of unprotected electrode lead wires being
connected to electrical power sources.

_______________
PRODUCT Rochester Electro-Medical Electrode Lead Wires, used with
electroencephalograph, electromyograph and electrophysiology
monitors, and other similar devices. Recall #Z-554-4.
CODE All marketed in the past 3 years.
MANUFACTURER Rochester Electro-Medical, Tampa, Florida.
RECALLED BY Manufacturer, by letter November 15, 1993. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Device labeling fails to provide adequate directions for use
and the devices pose a unwarranted risk of injury to
patients, because the products are not labeled to
contraindicate use with apnea monitors.

_______________
PRODUCT SpaceLabs Medical Apnea Monitors (multiple models), used to
monitor respiration. Recall #Z-555-4.
-17-CODE All models with unprotected (exposed pin style) lead wires
and unprotected patient cables.
MANUFACTURER SpaceLabs Medical, Redmond, Washington.
RECALLED BY Manufacturer, by letters of October 20-27, 1993, and
December 13, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Device labeling fails to provide adequate directions for use
and the devices pose an unwarranted risk of injury to
patients, because the product is not labeled to warn against
the hazards of unprotected electrode lead wires being
connected to electrical power sources.

_______________
PRODUCT Tronomed Medical Interconnect Systems, consisting of more
than 2,000 different cable, wire, and connector devices,
which have unprotected, exposed leads, intended for use in
conjunction with various medical electronic monitoring
devices, and in custom applications. Recall #Z-556/557-4.
CODE All units with unprotected exposed pin wire leads and
cables. This includes all standard and all custom
application products with exposed pins.
MANUFACTURER Tronomed, Inc., San Juan Capistrano, California.
RECALLED BY Manufacturer, by letter mailed early January 1994. Firm-
initialed field correction ongoing.
DISTRIBUTION Nationwide, Puerto Rico, Canada, Mexico.
QUANTITY Undetermined.
REASON Device labeling fails to provide adequate directions for use
and the devices pose an unwarranted risk of injury to
patients, because the products are not labeled to
contraindicate use with apnea monitors.

_______________
PRODUCT Vital Connections Electrode Lead Wires and patient Cables,
multiple models with unprotected exposed metal pins, used
with ECG monitors. Recall #Z-558/559-4.
CODE All marketed in the past 3 years.
MANUFACTURER Vital Connections, Tipp City, Ohio.
RECALLED BY Manufacturer, by letter February 28, 1994. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Device labeling fails to provide adequate directions for use
and the devices pose an unwarranted risk of injury to
patients, because the products are not labeled to
contraindicate use with apnea monitors.

_______________
PRODUCT Night Vision Image Intensifiers, Model T3C-3, used for
viewing objects and persons in subdued lighting.
Recall #Z-565-4.
CODE Model T3C-3.
MANUFACTURER Manufacturing Networks, Inc., San Francisco, California.
-18-RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan March 25, 1994. Firm-initialed field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 125 units.
REASON Products emitted x-radiation that is unnecessary to the
accomplishment of the purpose of the product, and creates a
risk of injury to users.

_______________
PRODUCT Ultramark 9 High Definition Imaging (HDI) Diagnostic
Ultrasound System with software versions 12.06 and 12.06A,
transmits ultrasound waves, receives the echoes, and
generates images based on information contained in the
echos. Recall #Z-571/572-4.
CODE All units with system software version 12.06 and 12.06A.
Serial numbers:
105442A 105647A 105661A 105703A 105714A
105726 105729 105734 105736 105742
105743 105747 105749 105752 105761
105762 105765 105770 105773 105778
105780 105784 105787 105791 105792
105793 105794 105795 105798 105806
105812 105829 105830 105831 105833
105838 105842 105843 105849 HD327
HD330 HD340 HD341 HD342 HD345
HD345A HD348 HD349 HD351 HD352
HD358 HD359 M02156 M105807 U105591B
U105753 U105754 U105788 V105384 V105835
W105442A W105642 WHD320.
MANUFACTURER Advanced Technology Laboratories (ATL), Bothell, Washington.
RECALLED BY Manufacturer, by letter September 1, 1993. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 124 units.
REASON The M-mode time markers may be incorrect resulting in
subsequent errors by off-line analysis of data recorded with
the incorrect time markers.

_______________
PRODUCT Ultramark 9 High Definition Imaging (HDI) Diagnostic
Ultrasound System with frame grabber, transmits ultrasound
waves, receives the echoes, and generates images based on
information contained in the echoes. Recall #Z-573-4.
CODE All units with the frame grabber option.
MANUFACTURER Advanced Technology Laboratories, Bothell, Washington.
RECALLED BY Manufacturer, by letter starting July 22, 1993 and was
completed on July 28, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 519 units.
REASON The 5 Mhz equivalent calculation can be in error when
performed on previously recorded data under certain
conditions.
-19-_______________
PRODUCT Fluid aspiration/irrigation peristaltic pump and
accompanying tubing, Rx for use in fluid irrigation or
aspiration during laparoscopic and endoscopic procedures:
(a) Fluid Irrigation and Aspiration Pump under the following
labels: Nortech Hydropump 150, part #4-150-00; Olympus
Model SP-2, Part #8104041;
(b) Aspiration Tubing Kit under the Northgate Catalog #7-
510-22, and Olympus Catalog #8313035 labels.
Recall #Z-594/595-4.
CODE All serial numbers for pumps, and all lot numbers for the
tubing kits.
MANUFACTURER Northgate Technologies, Inc., Arlington Heights, Illinois.
RECALLED BY Northgate sent letters dated February 24, 1994, and Olympus
America, Inc., Lake Success, New York, sent letters dated
February 28, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Mexico, France.
QUANTITY 5 Nortech Hydropump 150 pumps, 58 Olympus SP-2 pumps, and
130 cases of tubing were distributed; firm estimates that
all 63 pumps and 75 cases of tubing remain on the market.
REASON The aspiration tubing may be accidentally installed upside
down which may result in patient injury. In addition, the
collet may come loose and allow the pump to slip.

_______________
PRODUCT Baxter 15 gauge A.V. Fistula Set; 10 cartons of 50 sets each
per case, Rx single use sterile fluid pathway device used in
hemodialysis; Distributed by Baxter Healthcare Corporation,
Deerfield, IL 60015, Made in Japan; the following products
are subject to the recall:
(a) Product code 5M0561: 15 G x 2.5 cm (1") fixed hub
stainless steel needle with wings and 30 cm (12") of PVC
tubing to a female luer fitting
(b) Product code 5M0563: 15 G x 2.5 cm (1") back-eye, fixed
hub stainless steel needle with wings and 30 cm (12")
of PVC tubing to a female luer fitting;
(c) Product code 5M0497: 14 G x 2.5 cm (1") fixed hub
stainless steel needle with wings and 30 cm (12") of PVC
tubing to a female luer fitting;
(d) Product code 5M0562: 16 G x 2.5 cm (1") fixed hub
stainless steel needle with wings and 30 cm (12") of PVC
tubing to a female luer fitting;
(e) product code 5M0564: 16 G x 2.5 cm (1") back-eye, fixed
hub stainless steel needle with wings and 30 cm (12") of PVC
tubing to a female luer fitting;
(f) Product code 5M0565: 17 G x 2.5 cm (1") back-eye, fixed
hub stainless steel needle with wings and 30 cm (12") of PVC
tubing to a female luer fitting;
(g) Product code 5M0568: 15 G x 2.5 cm (1") back-eye,
rotating hub stainless steel needle with wings and 30 cm
(12") of PVC tubing to a female luer fitting;
(h) Product code 5M0569: 16 G x 2.5 cm (1") back-eye,
rotating hub stainless steel needle with wings and 30 cm
-20- (12") of PVC tubing to a female luer fitting;
(i) Product code 5M0570: 15 G x 3.2 cm (1.25") fixed hub
stainless steel needle with wings and 30 cm (12") of PVC
tubing to a female luer fitting;
(j) Product code 5M0571: 16 G x 3.2 cm (1.25") fixed hub
stainless steel needle with wings and 30 cm (12") of PVC
tubing to a female luer fitting
(k) Product code 5M0573: 16 G x 3.2 cm (1.25") back-eye,
fixed hub stainless steel needle with wings and 30 cm (12")
of PVC tubing to a female luer fitting;
(l) Product code 5M0574: 15 G x 3.2 cm (1.25") back-eye,
rotating hub stainless steel needle with wings and 30 cm
(12") of PVC tubing to a female luer fitting.
Recall #Z-596/607-4.
CODE Product code 5M0561, lot #93I13, 93I14, 93I22, 93H10
product code 5M0563, lot #93I06, 93I09, 93I22, 93I03
product code 5M0497, lot #93I13
product code 5M0562, lot #93H09, 93I24
product code 5M0564, lot #93H23, 93I29, 93J01, 93J05
product code 5M0565, lot #93I27, 93I29
product code 5M0568, lot #93H10, 93H19, 93H21, 93I13, 93I14,
93I20, 93I29
product code 5M0569, lot #93E28, 93H26
product code 5M0570, lot #93I27, 93J15
product code 5M0571, lot #93I14
product code 5M0573, lot #93I27
product code 5M0574, lot #93H21
MANUFACTURER Nissho Corporation, Osaka, Japan.
RECALLED BY Baxter Healthcare Corporation, Renal Division, McGaw Park,
Illinois, by letters of December 10, 1993 and January 6,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Mexico, Colombia, Australia, Venezuela, New
Zealand, Canada.
QUANTITY 740,518 units were distributed; firm estimates very little,
if any product remains on the market.
REASON The needle may accidentally separate from the hub assembly.

_______________
PRODUCT Night Vision Image Intensifiers, Model T3C2, used for
viewing objects and persons in subdued lighting.
Recall #Z-621-4.
CODE Model T3C-2.
MANUFACTURER Market Resourcing International, Dallas, Texas.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan April 8, 1994. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 11 units.
REASON Products emitted x-radiation that is unnecessary to the
accomplishment of the purpose of the product, and creates a
risk of injury to users.

-21-_______________
PRODUCT Latex Examination Gloves, sizes Small, Medium, Large, and
Unisize, packaged 10 dispenser boxes per case, 50 gloves
(Augmentin brand) or 100 gloves (Protectro brand), per
dispenser box. Recall #Z-622/625-4.
CODE All lots of both brands.
MANUFACTURER Alpha Healthcare Products, Inc., Akron, Ohio.
RECALLED BY Manufacturer, by telephone May 17 and 26, 1993. Firm-
initiated recall complete.
DISTRIBUTION Undetermined
QUANTITY Firm estimates none remains on the market.
REASON Gloves were manufactured using a production process in which
the manufacturing and testing procedures had not been
validated; the sampling and testing procedures were
inadequate, and only 23% of the firm's production met the
firm's criteria for acceptance. Also, the Augmentin glove
boxes were not labeled as containing patient examination
gloves, but as an advertisement for an antibiotic
(Augmentin), which was promoted to doctors.

_______________
PRODUCT Investigational software and User Manual Inserts Chapters 6
and 7, for the Model 330 Otacoustic Emissions Test
Instrument. This information relates to the Input/Output
Test and Spontaneous Otacoustic Emissions (SOAE).
Recall #Z-626/627-4.
CODE Various serial numbers for instruments distributed since
October 1991.
52006 52040 52065 63100
51012 52041 52067 73100
51014 52042 52071 53101
51015 52043 52072 63101
51016 52044 52073 83101
51017 52045 52074 53102
51018 52046 52075 63102
53103 52047 52076 83102
51019 52051 52077 53104
51020 52052 52081 63104
51021 52053 53085 83104
83103 52054 53086 53105
51022 52055 83087 63105
51024 52056 83089 83105
51025 52057 83090 53106
51029 52058 53091 63106
51030 52059 83095 83106
52034 52062 53097 53107
52036 52063 53098 63107
52039 52064 53099 63108
63109 63110.
MANUFACTURER Virtual Corporation, Portland, Oregon.
RECALLED BY Manufacturer, by letter dated October 29, 1993. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide.
-22-QUANTITY Investigational software was distributed with 82 instruments
nationally.
REASON Product was distributed without an approved 510(k) for the
intended use.

_______________
PRODUCT 3CC Medallion Syringe (Piston Syringe). Recall #Z-628-4.
CODE Catalog #MSS031-R, lot #081562.
MANUFACTURER Merit Medical Systems, Inc., Salt Lake City, Utah.
RECALLED BY Manufacturer, by telephone May 24 and 25, 1993. Firm-
initiated recall complete.
DISTRIBUTION Tennessee, Minnesota.
QUANTITY 50 units were distributed; firm estimates none remains on
the market.
REASON A manufacturing package defect. At least one of the product
units arrived at a hospital with the pouch (primary sterile
barrier) unsealed. The pouch had been sealed during
manufacture, but the seal was insufficient to hold the
rigors of sterilization and shipping.

_______________
PRODUCT Pam Pacific Enterprises/Skincare Gloves Co. Latex
examination gloves, 100 gloves in a paperboard box:
(a) Small; (b) Medium); (c) Large. Recall #Z-629/631-4.
CODE None. All units of gloves which Skincare purchased from L&T
Enterprises, Chino, California, on January 24, 1992 and
March 23, 1992.
MANUFACTURER Product of Taiwan.
RECALLED BY Skin Gloves Corporation, Alhambra, California, by letter
September 24, 1993. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 2,200 boxes were distributed; firm estimates none remains on
the market.
REASON Gloves contain foreign matter, pinholes, holes up to 1/4" in
length, and various fungi including three known human
pathogens (Aspergillus Nidulans, A. Flavus, and Chaetomium
Globosum) revealed in FDA test results.

_______________
PRODUCT Hewlett Packard Codemaster Switchless Internal Paddles
(electrodes), intended for use with Codemaster family of
defibrillators:
(a) Model M1741A (option C15, 7.5cm paddles)
(b) Model M1742A (option C16, 6.0cm paddles)
(c) Model M1743A (option C17, 4.5cm paddles)
(d) Model M1744A (option C18, 2.8cm paddles).
Recall #Z-633/636-4.
CODES All switchless internal paddle sets shipped prior to
September 30, 1993.
MANUFACTURER Hewlett Packard Co., Diagnostic Cardiology Business Unit,
McMinnville, Oregon.
RECALLED BY Manufacturer, by letter dated October 1993. Firm-initiated
recall ongoing.
-23-DISTRIBUTION Nationwide and international.
QUANTITY Approximately 1,850 paddle sets of various sizes were
available for distribution.
REASON Handling immediately after steam sterilization could result
in cracking of the cable insulation near the strain relief
of the paddle connection.

_______________
PRODUCT USCI Hemaquet Introducer Sheath Kit, used to facilitate
placing a catheter through the skin into a vein or artery:
(a) 6F Hemaquet Excel Sheath Kit, Item #010256;
(b) 7F Hemaquet Excel Sheath Kit, Item #010257;
(c) 7F Hemaquet Excel Sheath Kit, Item #009037;
(d) 7F Hemaquet Excel Sheath Kit With Obturator,
Item #010087;
(e) 8F Hemaquet Excel Sheath Kit, Item #010258;
(f) 10F Hemaquet Excel Sheath Kit, Item #006333.
Recall #Z-637/642-4.
Lot numbers: (a) 09GD0918, 09GD0919, 09GD1639, 09GD1640,
09GD1641, 09HD0466, 09HD0633; (b) 09GD0920, 09GD1643,
09GD1644, 09HD0467, 09HD0634, 09HD0468; (c) 09HD0974; (d)
09GD1650; (e) 09GD1647; (f) 09HD1603.
MANUFACTURER USCI Division C.R. Bard, Inc., Fitzwilliam, New Hampshire.
RECALLED BY USCI Division C.R. Bard, Inc., Billerica, Massachusetts, by
letter September 22, 1993, followed by telephone. Firm-
initiated recall complete.
DISTRIBUTION Nationwide, Ireland.
QUANTITY 9,040 units were distributed.
REASON Deformities in the stopcock component may allow blood and/or
gas leakage from the valve section, with the possible result
being the development of thromboses and/or emboli.

_______________
PRODUCT Teflon Coated Guide Wires - 15mm "J" Fixed Core, for
percutaneous entry into vessel using the Seldinger
Technique:
(a) USCI Teflon Coated Guidewires 0.035" 15mm "J" Fixed
Core, Catalog #007471;
(b) USCI Teflon Coated Guidewires 0.038" 15mm "J" Fixed
Core, Catalog #007472;
(c) Soft Tip 6F Pro-FLO XT EZ-PAK, Catalog #388421;
(d) Soft Tip 6F Pro-FLO XT EZ-PAK, Catalog #388422;
(e) Soft Tip 7F Pro-FLO XT EZ-PAK, Catalog #388423;
(f) Soft Tip 7F Pro-FLO XT EZ-PAK, Catalog #388424.
Recall #Z-644/649-4.
CODE Lot numbers: (a) 07GC0102, 07JC0493, 07GC1174, 07HC0777,
07BD0499, 07IC0274, 07JC0028, 07DD0835, 07CD0504, 07LC0489;
(b) 07HC0778, 07LC0490, 07CD0427, 07BD0500, 07IC0689,
07IC0306, 07KC0695, 07DD0175; (c) 09ED0665;
(d) 09ED0666; (e) 09ED0663 and 09ED0681;
(f) 09ED0664.
MANUFACTURER USCI Division C.R. Bard, Inc., Glen Falls, New York.
-24-RECALLED BY USCI Division, C.R. Bard, Inc., Billerica, Massachusetts, by
telephone June 18, 1993, followed by letter June 21, 1993.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 8,776 units were distributed.
REASON Teflon particles flaking off the guide wire could possibly
embolize and cause tissue necrosis and/or require surgical
removal.

_______________
PRODUCT Snare Wire Products:
(a) Wire Snare Cut Bent, Size 4 (nasal snare wire), Catalog
#N2398 4;
(b) Cut Wires Size 7 (sage cut wire), Catalog #N6305 7;
(c) Cut Wires Size 8 (sage cut wire), Catalog #N6305 8;
(d) Wire Snare Neivert-Eve No. 7 (Neivert-Eve tonsil
wire), Catalog #N6372 7;
(e) Wire Snare Neivert-Eve No. 8 (Neivert-Eve tonsil wire),
Catalog #N6372 8;
(f) Tonsil snare wire labeled as "WR SNR SPCL DBL BENT
ENDS SZ-7", Catalog #N6394 7;
(g) Tonsil snare wire labeled as "WR SNR SPCL DBL BENT ENDS
SZ-8", Catalog #N6394 8. Recall #Z-650/656-4.
CODE Packaging code dates 93126 through 94004.
MANUFACTURER Storz Instrument Company, Manchester, Missouri.
RECALLED BY Storz Instrument Company, St. Louis, Missouri, by letter
January 26, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 1,042 dozen; (b) 86 dozen; (c) 1,309 dozen; (d) 569
dozen; (e) 630 dozen; (f) 393 dozen; (g) 2,547 dozen.
REASON Wires may break during use.

_______________
PRODUCT Anamed Heated and Humidified Anesthesia Breathing Circuits,
indicated for the delivery of heated and humidified gases
from the anesthesia machine to the patient.
Recall #Z-657-4.
CODE All lots with the letters ANA followed by a 4-digit code.
MANUFACTURER Anamed Corporation/Laser Circuits, Riverside, California.
RECALLED BYManufacturer, by letters of February 10, 1994, and March 11,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 7,840 cases (18 per case) were distributed.
REASON The heater wire assembly was found to contain clusters of
resistance wire coils, instead of a regular series of coils
wound around the wire core. This defect may cause
overheating resulting in the tube melt down or fire.

_______________
PRODUCT Omnipulse Holmium Laser System, Model 1210, for use in
surgery. Recall #Z-688-4.
CODE Model 1210.
MANUFACTURER Trimedyne, Inc., Irvine, California.
-25-RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan February 9, 1994. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 108 units.
REASON The device fails to comply with calibration procedures;
warning logotype label lacked HeNe output parameters, and
there was a lack of adequate warning in the user manual
regarding catheters.

_______________
UPDATE Fonar Ultimate 3000 and B-3000/B0300/B0300M Magnetic
Resonance Imaging (MRI) Scanners, Recall #Z-450-4, which
appeared in the April 13, 1994, Enforcement Report should
have included in the CODE section reference to 125 active
sites that still need corrections.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Surgical Irrigator. Recall #Z-451-4.
CODE Serial numbers 1-2170 through 2-2360.
MANUFACTURER Alto Dean Medical, Inc., Woods Cross, Utah.
RECALLED BY Manufacturer, by letters on or about October 21, 1993.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 190 units were distributed.
REASON Excessive pressure could develop in the irrigator.

_______________
PRODUCT 5.6 Aggressive Meniscus Arthroscopic Cutters, preamendment
device, intended for the excision of soft and osseous
tissue: (a) Part #270-764-000; (b) Part #275-764-000.
Recall #Z-454/455-4.
CODE Lot numbers: 93055552 through 93075972; (b) 93075952
through 93116552.
MANUFACTURER Stryker Endoscopy, San Jose, California.
RECALLED BY Manufacturer, by letters mailed November 29, 1993, February
4, 1994, and April 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 986 boxes (5 cutters per box) were distributed.
REASON The cutter tips may break under some conditions of use
necessitating additional procedures to retrieve fragments.

_______________
PRODUCT Transcend Standard Edgewise Central/Lateral Ceramic Bracket,
Catalog #2001-901, used in orthodontic treatment of malposed
teeth. Recall #Z-567-4.
CODE Lot #M193350.
MANUFACTURER Unitek Corporation/3M, Monrovia, California.
RECALLED BY Manufacturer, by telephone and letter dated September 23,
1992. Firm-initiated recall complete.

-26-DISTRIBUTION Arizona, California, Florida, Iowa, Illinois, Massachusetts,
Michigan, Missouri, Mississippi, New Jersey, New York,
Pennsylvania, Tennessee, Texas, Germany, Italy, Japan, the
Netherlands.
QUANTITY 1,421 units were distributed; firm estimates none remains
ont the market.
REASON The packages actually contain the Cuspid/Bicuspid Ceramic
Brackets.

_______________
PRODUCT Series 5 Facebow, Catalog #328-222, an orthodontic product
used to provide extra oral force in the orthodontic
treatment of malposed teeth. Recall #Z-568-4.
CODE Lot #133 affixed to the back, lower right hand side of the
product pouch. There is no lot number marked on the facebow
itself.
MANUFACTURER Unitek Corporation/3M, 3M Dental Products Division Monrovia,
California.
RECALLED BY Manufacturer contacted all customers during March 1993, and
by telephone April 9, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Canada, Italy, Nicaragua, Venezuela.
QUANTITY Approximately 324 units were distributed; firm estimates
none remains on the market.
REASON Labeling mix-up. The series 5 Facebows, Catalog #328-222
were labeled as Series 5 Facebow, Catalog #328-242.

_______________
PRODUCT Medmetric KT1000/S Knee Ligament Arthrometer, developed to
provide objective intraoperative measurement of sagittal
plane measurement of the tibia relative to the femur at the
joint line. Recall #Z-577-4.
CODE Serial numbers: 101 to 120 and 122.
MANUFACTURER Medmetric Corporation, San Diego, California.
RECALLED BY Manufacturer, by letter December 6, 1993, followed by
telephone December 27, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Alaska, California, Connecticut, Idaho, Illinois, Louisiana,
Michigan, Minnesota, Oklahoma, Pennsylvania, South Carolina,
Utah, Virginia, Switzerland.
QUANTITY 25 units were distributed.
REASON Autoclaving the instrument causes the nylon gears to warp
and the iodized plate (cover) to haze, with the possibility
of chemical leaching.

_______________
PRODUCT Abbott X Systems (TDxFLx/TDx/ADx) REA Ethanol Calibrators,
for calibration of the REA Ethanol Assay on the TDxFLx, TDx
or ADx Analyzer, list #9545-01, in 2.5 ml vials.
Recall #Z-587-4.
CODE Lot numbers: 67213M300 EXP 5/93, 67213M301 EXP 5/93.
MANUFACTURER Abbott Laboratories, Diagnostics Division, Abbott Park,
Illinois.
RECALLED BY Manufacturer, by letter dated December 1992, sent on
December 14, 1992. Firm-initiated recall complete.
-27-DISTRIBUTION Nationwide and international.
QUANTITY 2,091 units were distributed.
REASON Some A calibrators were labeled as B calibrators.

_______________
PRODUCT Stryker Model 965 Spinal Surgibeds/Wedge Turning Frames
equipped with integrated storage tray. Recall #Z-588-4.
CODE All model 965's with optional integrated storage tray.
Serial numbers begin with 91.
MANUFACTURER Stryker Corporation, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by telephone beginning March 18, 1992, and by
letter beginning April 6, 1992. Firm-initiated recall
complete.
DISTRIBUTION Alabama, California, Iowa, Indiana, Kansas, Massachusetts,
North Dakota, Oklahoma, Pennsylvania, Tennessee, Texas,
Washington state, Wisconsin, Saudi Arabia, Australia,
France, United Kingdom, Venezuela, Bermuda.
QUANTITY 116 units were distributed.
REASON The traction weights hang low enough to be under the edge of
the storage tray, and they could catch under the edge of the
tray if the bed is subsequently raised.

_______________
PRODUCT Abbott AFP-EIA Diagnostic Kit, an enzyme immunoassay in-
vitro diagnostic for the quantitative measurement of alpha-
fetoprotein in human serum. Recall #Z-608-4.
CODE Lot numbers: 57059M300 EXP 3/10/92; 57059M301 EXP 3/10/92;
57060M300 EXP 4/21/92; 58343M100 EXP 3/10/94.
MANUFACTURER Abbott Laboratories, Diagnostics Division, Abbott Park,
Illinois.
RECALLED BY Manufacturer, by telephone between December 31, 1991 and
January 2, 1992. Firm-initiated recall complete.
DISTRIBUTION Alabama, California, Georgia, Missouri, New Jersey, North
Carolina, Pennsylvania, Texas.
QUANTITY 199 kits were distributed; firm estimates none remains on
the market.
REASON Confirmed microbial growth in the O standard vials.

_______________
PRODUCT Abbott CEA-EIA One Step Immunological Test System, an in-
vitro diagnostic for the quantitative measurement of
Carcinoembryonic Antigen in serum or plasma.
Recall #Z-609-4.
CODE Lot #56757M200 EXP 1/8/92.
MANUFACTURER Abbott Laboratories, Diagnostics Division, Abbott Park,
Illinois.
RECALLED BY Manufacturer, by telephone November 12-14, 1991, followed by
letter. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 357 kits were distributed; firm estimates none remains on
the market.
REASON The "low" control may fall below the specified range.

-28-_______________
PRODUCT Model 5345 Technical Manuals distributed with Medtronic
Model 5346 Temporary Pulse Generators. Recall #Z-675-4.
CODE Technical manuals distributed with Temporary Pulse
Generators, having the following serial numbers:
PAL006030P, PAL006037P, PAL006041P, PAL006042P, PAL006064P,
PAL006069P.
MANUFACTURER Medtronic Milaca, Inc., Milaca, Minnesota.
RECALLED BY Medtronic Inc., Minneapolis, Minnesota, by memorandum
January 21, 1994. Firm-initiated field correction complete.
DISTRIBUTION Arizona, Connecticut, Illinois, Kansas, Ohio, Oklahoma.
QUANTITY 7 units.
REASON Product was distributed with the wrong technical manual.

_______________
PRODUCT Breakaway Introducer Needles, which may be either sold
individually or as a component of a complete tray: (a) 2FR
V-Cath Introducer Needle, Product #350-20; (b) 2FR V-Cath
Complete Tray, Product #350-00. Recall #Z-683/684-4.
CODE Lot numbers: (a) 1003; (b) 040.
MANUFACTURER HDC Corporation, San Jose, California.
RECALLED BY Manufacturer, by telephone February 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY (a) 200 needles; (b) 401 trays were distributed; firm
estimates 64 percent of the trays and 72 percent of the
needles remain on the market.
REASON The silicone gasket dislodges from the flashback chamber,
thus preventing the insertion of the catheter.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS I
============
_______________
PRODUCT Dairy Heifer Ration Medicated containing monensin, in 50
pound bags, for increased rate of weight gain for slaughter,
stocker, feeder, dairy and beef replacement heifers weighing
more than 400 pounds on pasture. Recall #V-033-4.
CODE Lot #097932.
MANUFACTURER MFA, Inc., Columbia, Missouri.
RECALLED BY Manufacturer, January 11, 1994. Firm-initiated recall
complete.
DISTRIBUTION Missouri.
QUANTITY 115 bags were distributed on December 7, 1993.
REASON Product contaminated with excessive level of monensin.

SEIZURES:
=================================================================
_______________
PRODUCT Ultratronic Electrical Muscle Stimulators and component
circuit boards (electrical devices used to introduce
electrical current into the body to produce involuntary
muscle contractions) (93-696-477/9).

-29-CHARGES Adulterated - The articles are class III devices for which
no approved premarket approval applications are in effect.
Further, the methods used in, and the facilities and
controls used for the articles' manufacture do not conform
with good manufacturing practice requirements. Misbranded -
The articles' labeling represents and suggests that the
devices are adequate and effective treatment for, among
other things: strengthening and building chest, back, arms
and legs; tightening abdominals; etc., which representations
and suggestions are false and misleading or otherwise
contrary to fact because the devices are not adequate and
effective for such purposes. The articles' labels lack the
name and place of business of the manufacturer, packer, or
distributor. Adequate directions for use for the purposes
for which they are intended are also lacking from the
articles' labels since adequate directions cannot be written
for use of the devices by laymen. The labels inadequately
warn against their use in those pathological conditions or
by children where their use may be dangerous to health, nor
do the labels warn against unsafe dosage or methods of
administration or application, in such manner and form, as
are necessary for the protection of users. The articles are
dangerous to health when used in the manner or with the
frequency or duration prescribed, recommended, or suggested
in their labeling. The articles were not manufactured in a
duly registered establishment, nor were they included in a
required list.
LOCATION National Medical Fitness, trading and doing business as
Executive Fitness Products, Atlanta, Georgia.
FILED March 22, 1993; U.S. District Court for the Northern
District of Georgia, Atlanta Division; Civil #1:94-CV-
0774-JOF; FDC #66680.
SEIZED April 14, 1994; goods valued at approximately $214,145.
_______________
PRODUCT Aidex antimicrobial liquid soap, Aidex antimicrobial cream,
Aidex antimicrobial aqueous lotion; and Aidex spray cleaner
(92-516-235, et al.).
CHARGES New Drug - The articles of drug are new drugs that are
unapproved. Adulterated Drugs and Device - The quality of
some of the articles of drug falls below that which they
purport or are represented to possess; and, the class III
device fails to have an approved premarket approval
application in effect. Misbranded Drugs and Device - The
articles of drug bear labeling which is false and misleading
because it represents and suggests that the liquid soap
contains Resorcinol and the aqueous lotion contains
Resorcinol and PCMX, which representations and suggestions
are false, since they do not contain these ingredients. The
drugs also fail to bear labeling containing adequate
directions for use for the purposes for which they are
intended. The required 90-day notice or other information
with respect to the article of device has not been provided.

-30-LOCATION Medicine and Applied Sciences, Inc., also known as Panbaxy
Laboratories, Inc., Jessup, Maryland.
FILED March 18, 1994; U.S. District Court for the District
of Maryland; Civil #WN 94-685; FDC #66791.
SEIZED March 21, 1994 - goods valued at approximately $20,000.

-31-

END OF ENFORCEMENT REPORT FOR APRIL 27, 1994. BLANK PAGES MAY
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