FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

July 18, 2001 01-28

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I

______________________________
RECALL NUMBER,PRODUCT AND CODE:
D-263-1, Deltasone 10 mg. tablets [prednisone tablets, USP] in 500 tablet bottles. Rx. NDC 009-0193-02. CODE: Lot 29DRB. Exp. 9/2004.
REASON:
Tablet mix-up, bottles labeled to contain 10 mg tablets may contain 5 mg tablets.
MANUFACTURER/RECALLING FIRM:
Pharmacia Corporation, Kalamazoo, MI 49001
RECALLED BY:
The recall is being conducted through National Notification Center (NNC), Indianapolis, Indiana. A press release issued on June 18, 2001. NNC will contact the direct accounts via letter.
FIRM INITIATED RECALL:
Ongoing
DISTRIBUTION:
Nationwide
QUANTITY:
6,792 bottles

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

_______________________________

RECALL NUMBER, PRODUCT AND CODE:
D-249-1, AndroGel Testosterone Gel 1%, 5 gram unit does aluminum foil packets,
30 packets per carton; NDC #0051-8450-30
CODE: Lot 00207, exp.05/02
REASON:
SUBPOTENCY (AT RELEASE)
MANUFACTURER:
Laboratories Besins Iscovesco, Montrouge, France
RECALL BY:
Unimed Pharmaceuticals, Inc., Deerfield, IL, telephone and faxed wholesalers and
carriers on 6/15/01.
FIRM INITIATED RECALL:
Ongoing
DISTRIBUTION:
IL, ND, FL, PA, IN, TN AZ, NY MA, NJ, KY
QUANTITY:
1,512 cartons
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
D-261-1
Vira-A [Vidarabine Ophthalmic Ointment, USP] 3% sterile ophthalmic ointment; 3.5 gm tubes. Rx. NDC 61570-367-71
[1 tube cartons and 61570-367-72 [12 tube cartons.]
REASON:
Stability Failure (9 month assay)
MANUFACTURER
Warner Lambert Co., Rochester, MI
RECALL BY:
King Pharmaceuticals, Inc., Bristol TN, contacted NOL-DO by telephone and fax 4/20/01.
FIRM INITIATED RECALL:
Ongoing
DISTRIBUTION:
Nationwide
QUANTITY:
Lot.No.5550-1, 39,326 units and Lot No. 53D0-1, 12 units
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
D-262-1, Cortisporin TC, a topical antibiotic/steroid, 10mL, NDC 61570-090-10.
REASON:
SUBPOTENCY (Colistin Sulfate Ingredient at 9 month stability)
MANUFACTURER
Warner-Lambert Co, Rochester, MI 48407
RECALL BY:
King Pharmaceuticals, Bristol, TN, contacted NOL-DO by telephone on 4/20/01 and by fax.
FIRM INITIATED RECALL:
Ongoing
DISTRIBUTION:
Nationwide
QUANTITY:
23,316 units

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

_______________________________
RECALL NUMBER, PRODUCT AND CODE:
D-260-1, Extra strength enteric-coated aspirin tablets, 500 mg in 60 tablet bottles, packaged under three labels as follows:

Equate (Walmart)
Lot number: 0044685
Expiration: 3/01

Bi-Mart (Eugene, OR)
Lot number: 8E01222
Expiration: 3/01

Western Family (Portland, OR)
Lot number: 8E01222
Expiration: 3/01
REASON:
DISSOLUTION TEST FAILED
MANUFACTURER
INK International, Hauppauge, NY 11788
RECALL BY:
Leiner Health Products, Carson, CA (Lot 8E01222) and Leiner health products, Largo, Fl. (Lot 0044685)
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
AR and OR
QUANTITY:
Equate Label (lot 0044685) = 5,328 bottles
Bi-Mart Label (lot 8E01222) = 1,728 bottles
Western Family Label (lot 8E01222) = 8,136 bottles

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_______________________________
RECALL NUMBER, PRODUCT AND CODE:
B-1547-1, Red Blood Cells, Leukocytes Reduced, units 50LG42192, 50LG42209
REASON:
Blood products, collected from a donor whose arm had not been adequately prepared prior to venipuncture, were distributed.
MANUFACTURER/RECALLING FIRM:
American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH
RECALL BY:
The recalling firm notified consignees by telephone on March 5, 2001, and by letters dated March 12, 2001.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
OH
QUANTITY:
2 units
________
RECALL NUMBER, PRODUCT AND CODE:
B-1549-1, Red Blood Cells, unit G02018
B-1550-1, Platelets, units S30085, G02018, G01613, G01828
REASON:
Blood products, which were mislabeled as CMV antibody negative, were distributed.
MANUFACTURER/RECALLING FIRM:
Michigan Community Blood Center, Grand Valley Blood Program, Grand Rapids, MI
RECALL BY:
The recalling firm notified consignees, located in Michigan and New York, by facsimiles dated July 28, 2000.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
MI and NY
QUANTITY:
5 units
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
B-1563-1, Red Blood Cells, unit 13GX30166
B-1564-1, Platelets, unit 13GX30166
B-1565-1. Recovered Plasma, unit 13GX30166
REASON:
Blood products, collected from a donor who was at increased risk for new variant Creutzfeld Jakob Disease (nvCJD), were distributed
MANUFACTURER/RECALLING FIRM:
American Red Cross Blood Services, Southeastern Region, Detroit, MI
RECALL BY:
The recalling firm notified Michigan consignees by letters dated January 25, 2001.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
MI
QUANTITY:
3 units
________
RECALL NUMBER, PRODUCT AND CODE:
B-1572-1, Source Plasma, unit LP-32757
REASON:
Blood product, collected from a donor who had a tatto within twelve months of donation, was distributed
MANUFACTURER:
Pyramid Biological Corporation, Las Vegas, NV
RECALL BY:
Pyramid Biological Corporation, Van Nuys, CA, by facsimile dated June 19, 2000.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
Germany
QUANTITY:
1 unit

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

_______________________________
RECALL NUMBER, PRODUCT AND CODE:
Z-890-1, Ventriculostomy Kits, Catalog No. 46155, Lot No. T0749,
REASON:
Antiseptic products may be contaminated with bacteria.
MANUFACTURER/RECALLING FIRM:
Medtronic PS Medical, Goleta, CA
RECALL BY:
By letter, dated April 28, 2000.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
Nationwide, Latin America, Middle East
QUANTITY:
297
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
Z-978-0, Various custom Kits containing antiseptic products
REASON:
Antiseptic products may be contaminated with bacteria.
MANUFACTURER/RECALLING FIRM:
Life-Tech International, INC., Stafford, TX
RECALL BY:
By letters on March 15, 2000 and May 3, 2000.
FIRM INITIATED RECALL:
Complete.
DISTRIBUTION:
Nationwide
QUANTITY:
1452
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
Z-1021-0, Custom Epidural Anesthesia Tray, Custom Nerve Block Tray,Custom Spinal Block Tray containing Antiseptic Products
REASON:
Antiseptic products may be contaminated with bacteria.
MANUFACTURER/RECALLING FIRM:
I-Flow Corporation, Lake Forest, CA
RECALL BY:
By letter on June 7, 2000.
FIRM INITIATED RECALL:
Complete.
DISTRIBUTION:
Nationwide and Guam
QUANTITY:
165,000.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

________
RECALL NUMBER, PRODUCT AND CODE:
Inter-OP Rim Flare, Hemispherical, Revision, and Protrusio Acetabular Shells for Hip Implants.

Z-404-1
Inter-Op Rim Flare Acetabular Shells: Catalog Numbers: 4361-00- 039/071 Lot Numbers: 1398234, 1398235, 1398236, 1398964, 1398965, 1398966, 1402091, 1402092, 1402093, 1402094, 1402095, 1402106, 1402107, 1402108, 1402109, 1402110, 1402739, 1402739-A, 1402739-B, 1402740, 1402741, 1402742, 1402743, 1402744, 1402745, 1402746, 1402747, 1402745, 1403566, 1403567, 1403568, 1403569, 1403570, 1403571, 1403572, 1403573, 1403574, 1403575, 1404209, 1404210, 1404211, 1404212, 1404213, 1404214, 1404215, 1404216, 1404217, 1404218, 1405571, 1405572, 1405573, 1405574, 1405575, 1405576, 1405577, 1405578, 1406172, 1406173, 1406174, 1406175, 1406176, 1406177, 1406178, 1406179, 1406180, 1406181, 1406832, 1406833, 1406834, 1406835, 1406836, 1406836-B, 1406836-C, 1406836-A, 1406837, 1406838, 1406839, 1406840, 1406841, 1407611, 1407612, 1407613, 1407614, 1407615, 1407616, 1407617, 1407618, 1407619, 1407620, 1408217, 1408218, 1408219, 1408220, 1408221, 1408222, 1408223, 1408224, 1408225, 1408226, 1408937, 1408938, 1408939, 1408940, 1408941, 1408942, 1408943, 1408944, 1408945, 1408946, 1409726, 1409727, 1409728, 1409729, 1409730, 1409731, 1409732, 1409733, 1409734, 1409735, 1410359, 1410360, 1410361, 1410362, 1410363, 1410364, 1410365, 1410366, 1410367, 1410368, 1410369, 1410370, 1410371, 1410372, 1410373, 1410374, 1410375, 1410376, 1410488, 1410489, 1411621, 1411622, 1411623, 1411624, 1411625, 1411626, 1411627, 1411628, 1411629, 1411630, 1411631, 1411632, 1411633, 1411634, 1411635, 1411636, 1411637, 1411638, 1411639, 1411640, 1411640-A, 1411641, 1411642, 1411643, 1411644, 1411645, 1411646, 1411647, 1412401, 1412401-A, 1412402, 1412403, 1412404, 1412404-A, 1412405, 1412406, 1412407, 1412407-A, 1412408, 1413062, 1413063, 1413063-A, 1413064, 1413065, 1413066, 1413067, 1413068, 1413069, 1413070, 1414345, 1414471, 1414767, 1414817, 1414942, 1415123, 1415123-A, 1415331, 1415361, 1415361-A, 1416461, 1416474, 1415567, 1415568, 1415766, 1415861, 1415961, 1416348, 1416446, 1416457, 1416490, 1416657, 1416666, 1416685, 1416689, 1416693, 1416790, 1416802, 1416804, 1416973, 1416977, 1416997, 1417098, 1417113, 1417136, 1417228, 1417244, 1417264, 1417480, 1417517, 1417519, 1417626, 1417637, 1417856, 1417958, 1418012, 1418022, 1418035, 1418035-A, 1418079, 1418102, 1418174-A, 1418174, 1418222, 1418291, 1418343, 1418408, 1418432, 1416465, 1418545, 1418559, 1418607, 1418655, 1418707, 1418770, 1418790, 1418870, 1418949, 1419018, 1419027, 1419117, 1419125, 1419135, 1419220, 1419273, 1419365, 1419472, 1420225, 1420353, 1420997, 1421037, 1421496, 1421504, 1422296, 1422386, 1423064, 1423215, 1424148, 1424150, 1425177, 1425178, 1426324, 1425523, 1428455, 1428854, 1430073, 1430239, 1431435, 1431437, 1432624, 1432704, 1434015, 1434117, 1435456, 1435586, 1436608, 1436654, 1437490, 1437498, 1438213, 1436215, 1439040, 1439234, 1439689, 1439791, 1440856, 1441104, 1442051, 1442211, 1443615, 1443693, 1444683, 1444892, 1446417, 1446633, 1448031, 1448054, 1449276, 1449357, 1450891, 1450895, 1452080, 1452289, 1453613, 1453584, 1455031, 1455038, 1456455, 1456661, 1458031, 1458035, 1459223, 1459224, 1460548, 1460563, 1461992, 1462162, 1463151, 1463425, 1464826, 1465060, 1419465, 1420435, 1421059, 1421677, 1422406, 1423224, 1424355, 1426429, 1426804, 1428857, 1430241, 1431634, 1432743, 1434250, 1435659, 1439258, 1439804, 1441108, 1442451, 1443712, 1444915, 1446937, 1446234, 1449560, 1451088, 1462364, 1453701, 1453754, 1456671, 1458048, 1459228, 1460809, 1462194, 1463432, 1419565, 1419674, 1419699, 1419772, 1419821, 1419853, 1420017, 1420153, 1420220, 1420457, 1420548, 1420622, 1420666, 1420695, 1420765, 1420864, 1420899, 1420901, 1421073, 1421073-A, 1421227, 1421228, 1421249, 1421332, 1421334, 1421334-A, 1421335, 1421682, 1421748, 1421815, 1421827, 1422001, 1422006, 1422025, 1422210, 1422210-A, 1422406-A, 1422407, 1422628, 1422629, 1422631, 1422772, 1422773, 1422967, 1423063, 1423226, 1423226-A, 1423377, 1423663, 1423680, 1423733, 1423734, 1423970, 1423971, 1424356, 1424525, 1424527, 1424670, 1424685, 1424916, 1424917, 1425006, 1425007, 1425430, 1425556, 1425557, 1425826, 1425636, 1425922, 1425997, 1426220, 1426244, 1426836, 1426929, 1427088, 1427247, 1427588, 1427589, 1427796, 1427797, 1428464, 1429058, 1429061, 1429343, 1429344, 1429563, 1429565, 1429877, 1429879, 1430071, 1430445, 1430447, 1430891, 1430891-A, 1431000, 1431002, 1431152, 1431231, 1431234, 1431635, 1431844, 1431845, 1431646, 1432050, 1432058, 1432060, 1432333, 1432481, 1432638, 1432839, 1433238, 1433264, 1433516, 1433516-A, 1433543, 1433838, 1433912, 1434640, 1434540-A, 1434553, 1434681, 1434685, 1434743, 1434744, 1434822, 1434932, 1435909, 1435925, 1435938, 1436157, 1436185, 1436280, 1436400, 1436425, 1436452, 1436814, 1436814-A, 1436831, 1436847, 1436997, 1437046, 1467060, 1437258, 1437273, 1437287, 1437498-A, 1437592, 1437593, 1437599, 1437632, 1437679, 1437659, 1437933, 1437957, 1438153, 1438363, 1436392, 1436537, 1438545, 1438679, 1438686, 1438737, 1438866, 1438911, 1438931, 1439259, 1439365, 1439437, 1439455, 1439464, 1439474, 1439640, 1439667, 1439678, 1439657, 1439938, 1439993, 1440001, 1440104, 1440139, 1440198, 1440365, 1440846, 1441135, 1441451, 1441458, 1441648, 1441673, 1441874, 1441888, 1441911, 1442038, 1442481-A, 1442492, 1442649, 1442671, 1442869, 1442891, 1443108, 1443144, 1443165, 1443864, 1443880, 1444018, 1444027, 1444280, 1444288, 1444463, 1444509, 1444625, 1445179, 1445180, 1445639, 1445844, 1445866, 1446000, 1446164, 1446232, 1446363, 1447056, 1447119, 1447300, 1447310, 1447602, 1447620, 1447758, 1447812, 1447814, 1448249, 1448436, 1448465, 1448881, 1448882, 1448882-A, 1448909, 1449109, 1449124, 1449581, 1449787, 1449799, 1449975, 1450221, 1450421, 1450439, 1450707, 1450729, 1461188, 1451445, 1451450, 1451635, 1451641, 1451840, 1451840-A, 1452070, 1452075, 1452563, 1452602, 1452848, 1452648-A, 1452870, 1453143, 1453325, 1453338, 1453352, 1453764, 1454052, 1454061, 1454061-A, 1454374, 1454556, 1454566, 1454793, 1454801, 1455375, 1455568, 1455741, 1455746, 1455749, 1456026, 1456040, 1456236, 1456449, 1456671-A, 1456851, 1456854, 1457311, 1457328, 1457563, 1457778, 1458022, 1458022-A, 1458050, 1456311, 1456483, 1458495, 1456496, 1458706, 1458715, 1458972, 1459219, 1459532, 1459722, 1459738, 1459892, 1450123, 1450132, 1460286, 1460301, 1450315, 1450623, 1461021, 1461034, 1461319, 1461322, 1461641, 1461763, 1461793, 1461979, 1462343, 1462373, 1462638, 1462550, 1462794, 1462810, 1462978, 1463001. 1463119, 1463657, 1463719, 1463951, 1464190, 1464508, 1464522, 1464545, 1464581, 1464816, 1465247

Z-405-1
Inter-Op Hemispherical Acetabular Shells: Catalog Number 4360-00- 039/065 Lot Numbers: 1307848, 1307849, 1307850, 1308416, 1308417, 1308418, 1308419, 1308420, 1309239, 1309239-A, 1309240, 1309240-A, 1309241, 1309241- A, 1309242, 1309242-A, 1310552, 1310583, 1311021, 1311022, 1311023, 1311024, 1311024-A, 1311025, 1314535, 1314535-A, 1315832, 1315833, 1315834, 1315834-A, 1315835, 1315835-A, 1315836, 1315836-A, 1315837, 1315837-A, 1319884, 1332210, 1332211, 1332212, 1332213, 1332214, 1332215, 1332216, 1332217, 1332218, 1332219, 1332642, 1332843, 1332844, 1334099, 1338806, 1360757, 1360758, 1360759, 1360760, 1360761, 1360762, 1360763, 1360764, 1360765, 1361387, 1361388, 1361389, 1361390, 1361391, 1377891, 1377892, 1377893, 1377894, 1377895, 1384097, 1384098, 1384519, 1389344, 1389347, 1389925, 1389926, 1390399, 1390403, 1390407, 1390413, 1390418, 1390418-A, 1391307, 1391311, 1391315, 1391318, 1391323, 1392118, 1392122, 1392126, 1392130, 1392131, 1393097, 1393101, 1393105, 1393109, 1393113, 1394058, 1394083, 1394068, 1394072, 1394076, 1395032, 1398229-A, 1398230-A, 1398232, 1398233, 1396511, 1398970, 1398971, 1398972, 1398973, 1398974, 1399494, 1399495, 1399496, 1399497, 1399498, 1399499, 1399500, 1399501, 1399502, 1399503, 1399504, 1399505, 1399506, 1399507, 1399508, 1399509, 1400065, 1400077, 1400089, 1400683, 1400695, 1401036, 1401291, 1401578, 1401843, 1402148, 1402476, 1402806, 1402989, 1403232, 1403527, 1403814, 1404101, 1404386, 1404665, 1404897, 1405202, 1405612, 1405841, 1406156, 1406433, 1406741, 1407041, 1407291, 1407708, 1407992, 1408367, 1408688, 1409039, 1409289, 1409543, 1409969, 1410164, 1410526, 1410652, 1411082, 1411420, 1411752, 1412056, 1412327, 1412708, 1413702, 1414127, 1414481, 1399510, 1399511, 1399512, 1400066, 1400067, 1400056, 1400078, 1400079, 1400080, 1400090, 1400091, 1400674, 1400684, 14OO685, 1400566, 1400696, 1400697, 1400698, 1401046, 1401062, 1401063, 1401298, 1401311, 1401317, 1401564, 1401591, 1401597, 1401652, 1401862, 1401867, 1402155, 1402173, 1402271, 1402500, 1402511, 1402576, 1402807, 1402810, 1402822, 1403002, 1403031, 1403041, 1403243, 1403274, 1403281, 1403537, 1403559, 1403564, 1403823, 1403831, 1403860, 1404105, 1404116, 1404245, 1404396, 1404407, 1404509, 1404870, 1404708, 1404721, 1404907, 1405040, 1405041, 1405345, 1405355, 1405371, 1405618, 1405625, 1405630, 1405850, 1405976, 1405993, 1406236, 1406248, 1406250, 1406456, 1406519, 1406528, 1406894, 1406899, 1406904, 1407098, 1407102, 1407133, 1407376, 1407389, 1407392, 1407714, 1407732, 1407629, 1408024, 1408086, 1408109, 1408383, 1408398, 1408436, 1408701, 1408708, 1408798, 1409049, 1409120, 1409134, 1409295, 1409360, 1409375, 1409630, 1409637, 1409648, 1409978, 1409985, 1409990, 1410191, 1410261, 1410276, 1410530, 1410538, 1410608, 1410863, 1410873, 1410882, 1411180, 1411193, 1411202, 1411427, 1411434, 1411437, 1411756, 1411642, 1411866, 1412077, 1412065, 1412096, 1412334, 1412365, 1412498, 1413417, 1413455, 1413511, 1413764, 1413795, 1413799, 1414155, 1414250, 1414257, 1414496, 1414505, 1414511, 1399513, 1399514, 1399515, 1399516, 1399517, 1400062, 1400063, 1400064, 1400069, 1400070, 1400071, 1400072, 1400073, 1400074, 1400075, 1400076, 1400081, 1400082, 1400083, 1400084, 1400065, 1400086, 1400087, 1400065, 1400675, 1400676, 1400677, 1400678, 1400679, 1400680, 1400681, 1400682, 1400687, 1400688, 1400689, 1400690, 1400891, 1400692, 1400693, 1400694, 1400699, 1400700, 1400701, 1400702, 1400703, 1401003, 1401011, 1401014, 1401147, 1401157, 1401166, 1401178, 1401189, 1401190, 1401190-A, 1401283, 1401317-A, 1401352, 1401458, 1401459, 1401467, 1401476, 1401483, 1401491, 1401601, 1401611, 1401647, 1401729, 1401747, 1401752, 1401789, 1401797, 1401873, 1401980, 1401992, 1401999, 1402026, 1402036, 1402134, 1402145, 1402289, 1402294, 1402312, 1402358, 1402367, 1402450, 1402487, 1402471, 1402587, 1402835, 1402651, 1402674, 1402678, 1402703, 1402735, 1402764, 1402839, 1402649, 1402658, 1402892, 1402946, 1402955, 1402971, 1402987, 1403092, 1403102, 1403112, 1403152, 1403183, 1403188, 1403216, 1403229, 1403376, 1403390, 1403398, 1403416, 1403419, 1403438, 1403507, 1403522, 1403598, 1403691, 1403708, 1403708, 1403724, 1403756, 1403770, 1403804, 1403887, 1403959, 1403971, 1403981, 1403989, 1404072, 1404085, 1404096, 1404247, 1404252, 1404264, 1404269, 1404292, 1404380, 1404381, 1404364, 1404518, 1404520, 1404531, 1404536, 1404548, 1404638, 1404648, 1404659, 1404747, 1404764, 1404766, 1404770, 1404821, 1404854, 1404876, 1404890, 1405059, 1405062, 1405072, 1405112, 1405172, 1405179, 1405165, 1405197, 1405381, 1408392, 1405464, 1405484, 1405493, 1405503, 1405618, 1405599, 1405638, 1405700, 1405708, 1405715, 1405721, 1405808, 1405817, 1405833, 1406000, 1406015, 1406018, 1406116, 1406131, 1406137, 1406137-A, 1406142, 1406257, 1406271, 1406282, 1406370, 1406388, 1406407, 1406419, 1406426, 1406542, 1406548, 1406554, 1406704, 1406704-A, 1406714, 1406728, 1406737, 1406919, 1406924, 1407003, 1407004, 1407005, 1407014, 1407019, 1407030, 1407152, 1407160, 1407174, 1407247, 1407262, 1407271, 1407264, 1407289, 1407399, 1407408, 1407427, 1407510, 1407514, 1407523, 1407694, 1407695, 1407840, 1407850, 1407858, 1407870, 1407921, 1407957, 1407968, 1407977, 1408119, 1408127, 1408151, 1408239, 1406249, 1406257, 1408266, 1408361, 1408534, 1408547, 1408560, 1408569, 1406573, 1408582, 1408662, 1408684, 1408809, 1406514, 1408822, 1408834, 1409001, 1409015, 1409023, 1409032, 1409140, 1409150, 1409160, 1409176, 1409244, 1409264, 1409270, 1409265, 1409389, 1409400, 1409411, 1409416, 1409491, 1409509, 1409531, 1409536, 1409654, 1409797, 1409798, 1409816, 1409819, 1409624, 1409837, 1409956, 1410041, 1410054, 1410062, 1410070, 1410084, 1410149, 1410159, 1410173, 1410287, 1410295, 1410301, 1410327, 1410503, 1410504, 1410520, 1410522, 1410642, 1410649, 1410655, 1410739, 1410751, 1410759, 1410767, 1410773, 1410888, 1410943, 1410958, 1410965, 1410965, 1411059, 1411069, 1411077, 1411208, 1411211, 1411293, 1411308, 1411317, 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Z-406-1
Inter-Op Revision Acetabular Shells: Catalog Number 4362-00-043/081 Lots: 1416600, 1419910, 1421997, 1424530, 1429364, 1431233, 1432625, 1435287, 1437504, 1439465, 1444925, 1447803, 1451202, 1454363, 1457138, 1459884, 1462359, 1398237, 1399490, 1400670, 1402098, 1402752, 1403581, 1416961, 1417080-A, 1417080, 1417187, 1417328, 1418923, 1419181, 1419357, 1419358, 1419536, 1419756, 1420307, 1420547, 1420664, 1420861, 1421036, 1421645, 1421650, 1421805, 1421808, 1421809, 1421996, 1422209, 1422389, 1422627, 1422963, 1423216. 1427586, 1427587, 1427798, 1427799, 1428452, 1429562, 1429564, 1429876, 1429878, 1430070, 1431302, 1431311, 1431436, 1431438, 1431633. 1432723, 1433237, 1433839, 1433932, 1434019, 1435457, 1435660, 1436710, 1436724, 1436866, 1437506, 1437766, 1437773, 1437992, 1438009, 1439515, 1439522, 1439533, 1439535, 1439860, 1445154, 1445412, 1445422, 1445825, 1446032, 1448060, 1448253, 1448753, 1448988, 1449136, 1451459, 1451844, 1452081, 1452364, 1452608, 1454550, 1454572, 1454972, 1455277, 1455561, 1457547, 1457765, 1458017, 1458300, 1458679, 1460071, 1460238, 1460498, 1460740, 1460979, 1423376, 1423517, 1424020, 1424153, 1424357, 1424357-A, 1426453, 1428855, 1428856, 1429058, 1429059, 1429360, 1430072, 1430240, 1430243, 1430443, 1430446, 1431232, 1431536, 1431641, 1431843, 1432056, 1432059, 1432513, 1434264, 1434541, 1434654, 1434823, 1435004, 1435006, 1436596, 1437074, 1437080, 1437082, 1437296, 1437313, 1436226, 1438240, 1438405, 1439095, 1439103, 1439401, 1443720, 1443883, 1443896, 1444309, 1444315, 1444694, 1446256, 1446454, 1446648, 1446943, 1447123, 1447313, 1449372, 1449599, 1449979, 1450456, 1450900, 1450918, 1452875, 1453136, 1453364, 1453357, 1453760, 1453953, 1455736, 1456012, 1456228, 1456372, 1456672, 1456842, 1458962, 1458962-A, 1459193, 1459260, 1459526, 1459708, 1451270, 1461497, 1461542, 1461777, 1461910, 1462120, 1462560, 1462780, 1463167, 1463377, 1463587, 1463892, 1464435, 1464809, 1465056, 1465242, 1397531, 1398237-A, 1398238, 1398968, 1398968-A, 1398989, 1399467, 1399488, 1399488-A, 1399488-B, 1399489, 1398490-A, 1400092, 1400093, 1403094, 1400095, 1400095-A, 1400096, 1400096-A, 1400668, 1400669, 1400671, 1400672, 1401450, 1401451, 1401452, 1401453, 1401453-A, 1401453-B, 1401454, 1402096, 1402097, 1402099, 1402100, 1402101, 1402102, 1402103, 1402104, 1402105, 1402749, 1402750, 1402751, 1402751-A, 1402753, 1402764, 1402755, 1402788, 1402757, 1402758, 1403578, 1403578-A, 1403579, 1403580, 1403580-A, 1403582, 1403583, 1403584, 1403585, 1403586, 1403587, 1404303, 1404304, 1404304-A, 1404305, 1404306, 1404307, 1405260, 1407622, 1410378, 1410388, 1410400, 1411659, 1413053, 1413462, 1413995, 1414784, 1415739, 1416199, 1418660, 1419240, 1423832, 1425019, 1425724, 1426705, 1431526, 1443338, 1449465, 1450525, 1463348, 1404308, 1405261, 1408196, 1410379, 1410389, 1411648, 1411660, 1413054, 1413463, 1413996, 1414785, 1415740, 1416200, 1418661, 1420412, 1423833, 1425020, 1425725, 1426706, 1431527, 1445276, 1449466, 1450526, 1463349, 1404309, 1405262, 1408197, 1410380, 1410390, 1411549, 1412409, 1413065, 1413454, 1413997, 1414786, 1415741, 1416201, 1418662, 1420413, 1423834, 1425021, 1425726, 1426707, 1431528, 1445278, 1449467, 14,53356, 1463350, 1404309-A, 1404310, 1404311, 1404312, 1405255, 1405256, 1405257, 1405258, 1405259, 1405263, 1405254, 1406842, 1406843, 1406844, 1406844-A, 1406845, 1406846, 1407621, 1408198, 1408199, 1408200, 1408201, 1409110, 1409111, 1409736, 1409737, 1410377, 1410381, 1410381-A, 1410382, 1410382-A, 1410383, 1410384, 1410365, 1410386, 1410387, 1410391, 1410392, 1410393, 1410394, 1410395, 1410396, 1410397, 1410398, 1410399, 1411650, 1411651, 1411652, 1411653, 1411654, 1411655, 1411656, 1411657, 1411658, 1412410, 1412411, 1412412, 1412413, 1412414, 1412415, 1412416, 1412417, 1413052, 1413056, 1413057, 1413058, 1413059, 1413060, 1413061, 1413086, 1413087, 1413461, 1413465, 1413465, 1413467, 1413463, 1413469, 1413991, 1413992, 1413993, 1413994, 1413998, 1413999, 1414000, 1414779, 1414780, 1414781, 1414781-A, 1414782,1414783, 1414787, 1414788, 1415732, 1415733, 1415734, 1415735, 1415736, 1415737, 1415738, 1415742, 1415743, 1415744, 1416193, 1416194, 1416195, 1416196, 1416197, 1416198, 1416202, 1417818, 1417819, 1417820, 1417821, 1417822, 1417823, 1418658, 1418659, 1418663, 1418664, 1419233, 1419234, 1419235, 1419236, 1419237, 1419238, 1419239, 1420413-A, 1420414, 1420415, 1422505, 1422506, 1422507, 1422524, 1422525, 1422526, 1424846, 1424847, 1424848, 1425010, 1425011, 1425012, 1425013, 1425015, 1425017, 1425211, 1425212, 1425213, 1425214, 1425215, 1425216, 1425217, 1425218, 1425219, 1425727, 1425728, 1425729, 1425730, 1425731, 1425732, 1426702, 1426703, 1426704, 1426708, 1426709, 1431051, 1431052, 1431063, 1431054, 1431055, 1431524, 1431525, 1432429, 1432430, 1437909, 1443332, 1443333, 1443334, 1443335, 1443336, 1443337, 1445281, 1445263, 1446579, 1446580, 1446581, 1446582, 1446583, 1449463, 1449464, 1449468, 1449469, 1449470, 1449471, 1450520, 1450521, 1450522, 1450523, 1450524, 1453531, 1453534, 1453535, 1453537, 1454747, 1454748, 1454749, 1454750, 1454751, 146,3351, 1463352, 1463353.

Z-407-1
Inter-Op Protrusio Acetabular Shells: Catalog Number 4360-00-053/081 Lots: 1403576, 1403577, 1406182, 1406182-A, 1406182-B, 1406182-C, 1406183, 1406183-A, 1406184, 1406185, 1406185-A, 1406186, 1406187, 1406188, 1406189, 1406190, 1406847, 1406847-A, 1406848, 1406848-A, 1406849, 1406849-A, 1406849-B, 1407623, 1407624, 1407625, 1407626, 1407627, 1407628, 1407629, 1408212, 1406212-A, 1408213, 1408213A, 1406214, 1406214-A, 1408215, 1409738, 1409739, 1409739-A, 1409740, 1409741, 1410401, 1410402, 1410403, 1410404, 1410405, 1410406, 1410407-A, 1410407, 1410408, 1411661, 1411662, 1411663, 1411664, 1411665, 1411666, 1411667, 1411668, 1411669, 1411670, 1411671, 1413049, 1413050, 1413051, 1413473, 1413474, 1413475, 1413476, 1413477, 1413478, 1414002, 1414003, 1414004, 1414005, 1414006, 1414007, 1414789, 1414790, 1414791, 1414792, 1414793, 1416203, 1416789, 1418656, 1418657, 1419244, 1419245, 1419644, 1420416, 1420417, 1420418, 1420876, 1420877, 1420878, 1420879, 1424850, 1424851, 1424852, 1424853, 1424854, 1425220, 1425221, 1425222, 1425223, 1425224, 1425737, 1425738, 1425739, 1428228, 1429703, 1430484, 1430485, 1431048, 1431049, 1431050, 1431521, 1431522, 1431523, 1432428, 1434891, 1437901, 1437905, 1437908, 1440437, 1440438, 1440439, 1440440, 1440441, 1440442, 1441523, 1441524, 1441525, 1441526, 1441527, 1445284, 1446584, 1449472, 1449473, 1453538, 1453540.
REASON:
Product contains manufacturing oil residue
MANUFACTURER/RECALLING FIRM:
Sulzer Orthopedics, Inc., Austin, TX
RECALL BY:
The recalling firm notified all US sales agencies and distributors of this recall by faxed message on 12/5/00. International distributors and agents were notified by fax on 12/6/00. The faxes were followed by "Dear Doctor" letters of 12/19/00 which requested all patients be notified of the recall.
FIRM INITIATED RECALL:
Ongoing
DISTRIBUTION:
Nationwide, Australia, Canada, Japan, Korea, Switzerland and Italy
QUANTITY:
10,114

_______________________________________
RECALL NUMBER, PRODUCT, MODEL AND CODES:
Z-682-1, Welch Allyn Wall Plug-In Transformer included with otoscopes, episcopes, audioscopes, ophthalmoscopes, & retinoscopes, Model 71034, with date codes 0900c or 1200c;
REASON:
There is a design problem that could expose user to electric shock.
MANUFACTURER/RECALLING FIRM:
Welch Allyn, Inc., Skaneateles Falls, NY.
RECALL BY:
Manfacturer, by letter on May 8 and 18, 2001.
FIRM INITIATED RECALL:
Ongoing
DISTRIBUTION:
Worldwide
QUANTITY:
1755
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
Z-0690-1, Impax Technology Inc. DDS
Intended use is as Diagnostic Image Display Software
Model/catalog number: DS3000, CS5000, XA3000
REASON:
Wrong image presents to radiologist upon database query.
MANUFACTURER/RECALLING FIRM:
Toshiba America Medical Systems, Inc., Tustin, CA
RECALL BY:
TAMS reports that one unit located in PA is being returned and is not in service. TAMS has requested the software update in CDROM form and will update the second unit located at UCLA @ Oliveview.
FIRM INITIATED RECALL:
Ongoing
DISTRIBUTION:
CA and PA
QUANTITY:
2 units
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
Z-0683-1, Agilent Heartstream FR2 Automatic External Defibrillator, portable, Model 3860A, Serial No. 1000013120
REASON:
Battery insertion test may fail due to a tantalum capacitor with the incorrect voltage rating.
MANUFACTURER/RECALLING FIRM:
Agilent Technologies, Inc., Heartstream Operation, Seattle, WA
RECALL BY:
On 10/17/00 the firm left a voice mail with the customer contact requesting that the unit be pulled from service, if it had been placed in service, and to send it back to the firm.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
Fort Bragg, NC
QUANTITY:
1 unit
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
Z-0691-1 through Z-0693-1
Software used on the Computerized Tomography Fluoroscopy
CT Fluroscopy option, model numbers TSXF-003A; TSXF-003B; TSXF-003C for Aquilion (Model No. TSX-101A) and Asteion (Model No. TSX-021A) Computed Tomography Scanners
REASON:
X-ray generation without operator command using unusual program sequence.
MANUFACTURER/RECALLING FIRM:
Toshiba America Medical Systems, Inc. (TAMS), Tustin, CA
RECALL BY:
Toshiba customer notification will begin 5/10/2001 which describes precautions and preventative measures.
FIRM INITIATED RECALL:
Ongoing
DISTRIBUTION:
Nationwide.
QUANTITY:
44 units

END OF ENFORCEMENT REPORT FOR July 18, 2001.

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Hypertext uploaded by tg 2001-JUL-18.