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
09/25/1990
FDA Enforcement for the week of September 26, 1990
FDA ENFORCEMENT REPORT
FOR SEPTEMBER 26, 1990
September 26, 1990
Recalls and Field Corrections:
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
NONE
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
NONE
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
NONE
-1-
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Baxter Ergoloid Mesylate Oral Tablets, 1 mg, an Rx drug
used in the treatment of patients with an idiopathic decline
in mental capacity. Recall #D-366-0.
Code: All lots.
Manufacturer: Bolar Pharmaceutical Company, Inc., Copiague, New York.
Recalled by: Baxter Healthcare Corporation, Deerfield, Illinois, by
letter August 1, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 574 bottles of 100, 190 bottles of 500 and 1,417 boxes
of 100 unit dose tablets were distributed; firm estimates
that little, if any, of the product remains on market.
Reason: Product not manufactured in comformity with conditions
approved in the Abbreviated New Drug Application (ANDA).
----
Product: (a) Red Blood cells; (b) Fresh Frozen Plasma.
Recall #B-161/162-0.
Code: Unit numbers: (a) 0530017, 0530018; (b) 0529132.
Manufacturer: Bronx VA Medical Center, Bronx, New York.
Recalled by: Manufacturer, by telephone April 4, 1990. Firm-initiated
recall ongoing.
Distribution: New York, Puerto Rico.
Quantity: (a) 2 units; (b) 1 unit were distributed.
Reason: Blood products, which tested initially reactive
for the antibody to the human immunodeficiency virus
(anti-HIV-1) by EIA were distributed for transfusion.
----
Product: (a) Platelets; (b) Fresh Frozen Plasma. Recall #B-191/192-0.
Code: (a) 446707, 457024; (b) 446707, 457024.
Manufacturer: Belle Bonfils Medical Center, Denver, Colorado.
Recalled by: Manufacturer, by telephone April 27, 1990, followed by
letter April 30, 1990. Firm-initiated recall ongoing.
Distribution: Colorado.
Quantity: (a) 2 units; (b) 2 units were distributed.
-2-
Reason: Blood products, tested for the antibody to the
human immunodeficiency virus type 1 (anti-HIV-1) in
a manner not consistent with the manufacturer's test
kit instructions, were distributed.
----
Product: (a) Whole Blood; (b) Red Blood Cells;
(c) Platelets; (d) Fresh Frozen Plasma;
(e) Cryoprecipitated AHF; (f) Recovered Plasma.
Recall #B-200/205-0.
Code: Unit numbers: (a) FC07179, GF38378, GG39895, GG64446,
GH24723, GH26820, GK25545, GL11875, GL12931, GN92017,
GN92976, LN00447, LS88845, PH90515;
(b) FC06999, FC07795, FC08615,
FC12311, FC85394, FF14704, FF15556, FF99061, FG00429,
FG75839, FG79444, FG81752, FG89745, FG95274, FG95441,
FG97497, FG98720, FH01390, FH04346, FH05297, FH08654,
FH10608, FH11542, FH13160, FH13720, FH13801, FH14731,
FH16135, FH16343, FH16352, FH16725, FH18702, FH18849,
FH19012, FH20901, FH21018, FH21743, FH22214, FH22999,
FH23010, FH23939, FH25172, FH25527, FH25561, FH26408,
FH26514, FH97493, FH99737, FJ33314, FJ38373, FJ47056,
FJ51464, FJ56332, FK51862, FK53088, FK54227, FK55571,
FK58476, FK59781, FK61649, FK65890, FL33193, FL34414,
FL34836, FL36513, FL39073, FL40476, FL42550, FL44093,
FL44444, FL45978, FL47685, FL48746, FL49928, FL50673,
FL51223, FL52390, FL52459, FL53831, FN01684, FN03919,
FN04068, FN05101, FN06041, FN08609, FN08944, FN10947,
FN23370, FP37937, FP38165, FR18884, FR18910, FR22675,
FR28816, FR31083, FR32150, FR32745, FR33108, FR33577,
FR33684, FR34112, FR35415, FR36744, FR36875, FS02573,
GC47407, FC53915, GC76337, GE14663, GE14878, GE25056,
GE29729, GE35374, GE39384, GE39951, GE40405, GF18380,
GF28905, GF30020, GF30522, GF31954, GF35995, GF37029,
GG24997, GG29020, GG34968, GG42860, GG49210, GG55203,
GG59585, GG61978, GG64053, GG70085, GG72244, GG72486,
GG73904, GG73986, GG74948, GG78207, GG80632, GH31480,
GH38767, GH39530, GH45626, GH46469, GH49301, GH50499,
GH51228, GJ22211, GJ26783, GJ30378, GJ32622, GJ34324,
GJ40076, GK23631, GK37956, GK39609, GK46780, GK51741,
GK51874, GL13926, GL14393, GL25309, GL30221, GL31225,
GL33386, GN08061, GN08243, GN08746, GN14532, GN14978,
GN17415, GP02439, GP86081, GP87428, GQ60669, GQ64782,
GR64713, GR80052, GR81392, GR87958, GR94093, GS23913,
LC72905, LF47494, LF58156, LF65745, LF67360, LH30392,
LI79002, LK00102, LP64803, LP70065, LP73476, LP75890,
LQ07052, LQ07980, LQ10349, LQ11807, LQ91148, LQ92426,
LQ96629, LR88150, LR88810, LS77421, LS78121, LS80526,
LS85544, LS91793, LT69902, LV66806, LV70271, LV75646,
LV80324, LV83878, LW58629, LW60155, LW61094, LW62155,
LW63180, LW63335, LW63855, LW64991, LW66155, LW67339,
LX72781, LY79918, LY80832, LY81307, LY83639, LY88211.
-3-
(c) FC06999, FC12311, FF14704, FF15556,
FF99061, FH01390, FH04346, FH05297, FH08654, FH10608,
FH11542, FH13160, FH13801, FH14731, FH16343, FH16352,
FH18702, FH18849, FH19012, FH20901, FH21018, FH21743,
FH22214, FH22999, FH23010, FH23939, FH25527, FH26514,
FH97493, FJ47056, FK51862, FK55571, FK58476, FK59781,
FK61649, FK65890, FL34414, FL34836, FL36513, FL39073,
FL40476, FL42550, FL44093, FL44444, FL45978, FL47685,
FL49928, FL50673, FL51223, FL52390, FL52429, FL53831,
FN03919, FN08944, FN23370, FP37937, FP38165, FR22675,
FR28816, FR31083, FR32150, FR32745, FR33108, FR33577,
FR33684, FR34112, FR35415, FR36875, FS02573, GC47407,
GC53915, GE14878, GE25056, GE35374, GE39951, GE40405,
GF18380, GF28905, GF30020, GF30522, GF31954, GF35995,
GF37029, GG29020, GG34968, GG42860, GG59585, GG61978,
GG70085, GG72244, GG72486, GG74948, GG78207, GG80632,
GH31480, GH38767, GH39530, GH45626, GH46469, GH49301,
GH50499, GH51228, GJ22211, GJ26783, GJ30378, GJ32622,
GJ34324, GJ40076, GK23631, GK37956, GK39609, GK46780,
GK51741, GK51874, GL13926, GL14393, GL25309, GL31225,
GL33386, GN08061, GN08243, GN08746, GN14978, GN17415,
GP86801, GQ60669, GQ64782, GR64713, GR80052, GR94093,
GS23913, KL02222, KL02558, KL02929, KL03137, KL03372,
KL03919, KL04078, KL04336, KL04811, KL04971, KL05152,
LC72905, LF47494, LF58156, LF65146, LF67360, LH30392,
LP64803, LP70065, LQ07502, LQ07980, LQ10349, LQ91148,
LQ92426, LQ96629, LR88810, LS77421, LS78121, LS80526,
LS85544, LS91793, LV83878, LW60155, LW61094, LW62155,
LW63335, LW63855, LW64991, LW66155, LW67339, LX72781,
LY79918, LY81307, LY83639, LY88211.
(d) FC06999, FC12311, FC85394, FF15556, FH05297, FH11542,
FH18702, FH23939, FH25527, FL34414, FP30806, FP37937,
FR28816, FR32150, FR33577, FR34112, FR35415, GE35374,
GF30020, GG29020, GG42860, GG61978, GH31480, GH45626,
GH46469, GJ34324, GJ40076, GK37956, GK51741, GL13926,
GL14393, GN08061, GN08243, GN08746, GN17415, GR64713,
GS23913, LP70065, LQ07980, LQ10349, LS85544, LS91793,
LV93295, LW63335, LW66155;
(e) FH13720, FJ56332, FN04068, GG64053;
(f) FC07795, FC08615, FF14704, FF99061, FG00429, FG18380,
FG75839, FG79444, FG81752, FG89745, FG95274, FG95441,
FG97497, FG98720, FH01390, FH04346, FH08654, FH10608,
FH13160, FH13720, FH13801, FH14731, FH16135,
FH16343, FH16352, FH16725, FH18849, FH19012, FH20901,
FH21018, FH21743, FH22214, FH22999, FH23010, FH25172,
FH25561, FH26408, FH26514, FH97493, FH99737, FJ33314,
FJ38373, FJ47056, FJ51464, FJ56332, FK51862, FK53088,
FK54227, FK55571, FK58476, FK59781, FK61649, FK65890,
FL34836, FL36513, FL38193, FL39073, FL40476, FL42550,
FL44093, FL44444, FL45978, FL47685, FL48746, FL49928,
FL50673, FL51223, FL52390, FL52459, FL53831, FN01684,
FN03919, FN04068, FN05101, FN06041, FN08609, FN08944,
-4-
FN10947, FN23370, FP38165, FR18884, FR18910, FR22675,
FR31083, FR32745, FR33108, FR33684, FR36744, FR36875,
FS02573, GC47407, GC53915, GC76337, GE14663, GE14878,
GE25056, GE29729, GE30909, GE39951, GE40405, GF28905,
GF30522, GF31954, GF35995, GF37029, GG24997, GG34968,
GG49210, GG55203, GG59585, GG64053, GG68419, GG70085,
GG72244, GG72486, GG73904, GG73986, GG74948, GG78207,
GG80632, GH38767, GH39530, GH49301, GH50499, GH51228,
GJ22211, GJ26783, GJ30378, GJ32622, GK23631, GK39609,
GK46780, GK51874, GL25309, GL30221, GL31225, GL33386,
GN14532, GN14978, GP02439, GP86081, GP87428, GQ60669,
GQ64781, GR80052, GR81392, GR87958, GR94093, LC72905,
LF47494, LF65146, LF65745, LF67360, LH30392, LK00102,
LP64803, LP73476, LP75890, LQ07602, LQ11807, LQ91148,
LQ92426, LQ96629, LR88150, LR88810, LS77421, LS78121,
LS80526, LT69902, LV66806, LV70271, LV75646, LV80324,
LV83878, LW58629, LW62155, LW61094, LW62155, LW63180,
LW63855, LW64991, LW67339, LX72781, LX79002, LY79918,
LY80832, LY81307, LY83639, LY88211.
Manufacturer: American Red Cross, Los Angeles-Orange Counties
Region, Los Angeles, California.
Recalled by: Manufacturer, by telephone or visit starting
October 20, 1988, followed by letter October 20, 1988
and by press release October 20, 1988. Firm-initiated
recall ongoing.
Distribution: California, New York, Tennessee, Pennsylvania, Minnesota,
Switzerland.
Quantity: (a) 23; (b) 503; (c) 363; (d) 107; (e) 20; (d) 398
units were distributed.
Reason: Units which tested repeatably reactive for 1) the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1); 2) hepatitis b surface Antigen
HBsAg); or were drawn from ineligible donors based
on previous anti-HIV-1 or HBsAg test results, were
distributed.
----
Class III -
Product: Aminophylline Tablets, 100 mg and 200 mg, in 100 and
1,000 tablet bottles, an Rx product used for the
treatment of asthma and is distributed under the
Major Pharmaceuticals, Bioline, Goldline, URL, Parmed,
Qualitest, Purepac and Duramed labels. Recall #D-368/369-0.
Code: Lot numbers range from 8728 to 91221.
Manufacturer: Duramed Pharmaceuticals, Inc., Cincinnati, Ohio.
Recalled by: Manufacturer, by letter September 5, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 38 million tablets were distributed; firm
estimates a limited amount of the product remains on
market.
-5-
Reason: Certain lots fail USP limits for ethylenediamine content.
----
Product: Compressed Oxygen USP in size D and E aluminum
cylinders. Recall #D-367-0.
Code: All lots.
Manufacturer: Northshore Medical services, Inc., Mandeville, Louisiana.
Recalled by: Manufacturer. Firm-initiated recall ongoing.
Distribution: Louisiana.
Quantity: 15 cylinders were recovere; firm estimates 30 cylinders
remain in consumer channels.
Reason: Current good manufacturing practice deficiencies.
----
Product: (a) Whole Blood; (b) Red Blood Cells;
(c) Platelets; (d) Cryoprecipitated AHF;
(e) Fresh Frozen Plasma; (f) Recovered Plasma.
Recall #B-193/198-0.
Code: All blood components drawn from March 1, 1990
through April 18, 1990, except those units listed under
Recall #B-191/192-0, in sequential numbers:
317039 through 317499
328322 through 328499
374694 through 374912
380601 through 382527
392000 through 392184
397212 through 397748
403694 through 404231
407836 through 408169
409060 through 409103
413646 through 413705
415480 through 415672
422425 through 424886
445327 through 446829
453938 through 455346
456574 through 457085
461500 through 461510.
Manufacturer: Belle Bonfils Medical Center, Denver, Colorado.
Recalled by: Manufacturer, by telephone April 27, 1990, followed
by letter April 30, 1990. Firm-initiated recall ongoing.
Distribution: Whole Blood and all components, except Recovered Plasma,
were shipped to Colorado except Recovered Plasma which
was also shipped to Missouri and Pennsylvania.
Quantity: (a) 322 units; (b) 8396 units; (c) 2957;
(d) 379 units; (e) 2468 unitsl (f) 1392 units
were distributed.
-6-
Reason: Blood products, tested for the antibody to the
human immunodeficiency virus type 1 (anti-HIV-1) in
a manner not consistent with the manufacturer's test
kit instructions, were distributed.
----
Product: Thrombin, USP Thrombostat, 10,000 units/vial, an Rx
sterile topical liquid. Recall #B-199-0.
Code: Lot #05020P EXP 1/2/93.
Manufacturer: Parke-Davis, Division of Warner-Lambert Company, Rochester
Michigan.
Recalled by: Manufacturer, by letter April 30, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 14,800 vials were distributed.
Reason: Thrombin packaged with a 5 milliliter (ml) vial of
diluent instead of a 10 ml vial of diluent, was distributed.
----
Product: (a) Whole Blood; (b) Red Blood Cells; (c) Platelets;
(d) Fresh Frozen Plasma; (e) Cryoprecipitated AHF;
(f) Recovered Plasma. Recall #B-206/211-0.
Code: Unit numbers: (a) FC30676, GE26523, GF27370, GF36789,
GF40760, GK24893, GN91958, GR81993, LT67325, LV86286;
(b) FC03477, FC10068, FC24870
FC37259, FC42257, FC51373, FC54716, FC99514, FF04514,
FF06430, FF06622, FF08628, FF10030, FF12241, FF14666,
FF15045, FF16314, FF20123, FG66771, FG68252, FG71682,
FG74691, FG76577, FG79949, FG80160, FG82380, FG82679,
FG83887, FG85826, FG87343, FG87580, FG89946, FG90210,
FG91402, FG92641, FG93698, FG94505, FG95018, FG96383,
FG96421, FG97279, FG97301, FG98957, FG99395, FH23362,
FH24573, FH26696, FJ54642, FJ59539, FJ66633, FK52016,
FK52253, FK53418, FK54055, FK54816, FK58869, FK60170,
FK60819, FK62232, FK63520, FK63924, FK64733, FL45210,
FL45217, FL50755, FL53099, FN00137, FN00144, FN00147,
FN00148, FN12805, FN13579, FN13758, FN16304, FN16305,
FN16839, FN20867, FN23938, FN25374, FN25420, FN27249,
FN28050, FN29143, FN20961, FN31741, FP28158, FP29509,
FP30573, FP30806, FP31017, FP31625, FP31839, FP32160,
FP32947, FP33115, FP33328, FP33967, FP34456, FP35969,
FP36011, FP36363, FP36449, FP36780, FP37488, FP37825,
FP38269, FP38601, FP39534, FP40224, FR35799, FR35974,
FS02742, FS03387, GC76044, GE21240, GE30037, GE30072,
GE30909, GE39398, GE39563, GF19894, GF26813, GF31976,
GF33928, GF35166, GF38142, GF38701, GF39309, GF40177,
GF41067, GG34579, GG51568, GG52780, GG57340, GG61517,
GG62084, GG64392, GG65199, GG65761, GG68419, GG71310,
GG71313, GG71997, GG74046, GG77585, GG25197, GG27050,
GH31578, GH35636, GH39384, GH39452, GH41380, GH45663,
-7-
GJ29071, GJ31490, GJ32666, GJ37656, GJ38990, GK38862,
GK38869, GK41939, GK44353, GK50051, GK53912, GL10259,
GL24424, GL31526, GL32520, GL33378, GL34345, GM95284,
GM95489, GM96250, GN03810, GN08635, GN12173, GN13507,
GN16780, GN17336, GN17704, GN18683, GP02449, GP02451,
GP02458, GP84641, GP90964, GR75476, GR83292, GR83462,
GR87764, GR88650, GR91992, GR94520, LC79153, LC80875,
LC82314, LC89148, LF47901, LF51793, LF59141, LF65141,
LF65146, LF65148, LF65256, LG68464, LF68732, LF69494,
LF70680, LH28625, LH28890, LH34441, LH35817, LH35828,
LM35835, LP42428, LP62797, LP67578, LP71587, LP72583,
LP73484, LQ02746, LQ07972, LQ08425, LQ11189, LQ12635,
LQ14169, LQ15198,LQ96382, LQ99903, LR87900, LR90374,
LR91845, LR95208, LR95377, LR95487, LR97326, LR99537,
LS92517, LS95065, LS97018, LS98035, LS98822, LS99737,
LS99771, LS99775, LT61777, LT68950, LT69700, LT69769,
LV82039, LV82772, LV84036, LV85341, LV90498, LV90801,
LV93295, LW56954, LW66269, LW66680, LW66681, LX69628,
LX77165, LX77247, LX78490, LX81107, LY76007, LY78836,
LY81828, LY86895, LY87463.
(c) FC30676, FC37259, FC42257, FC51373,
FC99514, FF04514, FF06430, FF06622, FF08628, FF10030,
FF12241, FF14666, FF15045, FF16314, FF20123, FG66771,
FG71682, FG76577, FG79949, FG82380, FG82679, FG83887,
FG87343, FG89946, FG90210, FG91402, FG94698, FG94505,
FG95018, FG96383, FG96421, FG98957, FH24573, FJ59539,
FJ66633, FK54055, FK58869, FK60819, FK62232, FK63520,
FK63924, FK64733, FL45210, FL45217, FN23938, FN25374,
FN25420, FN27249, FN20850, FP23160, FP28158, FP29509,
FP30573, FP30806, FP31017, FP31839, FP32947, FP33115,
FP33328, FP33967, FP34456, FP35969, FP36011, FP36449,
FP36780, FP37488, FP37825, FP38269, FP38601, FP39534,
FP40224, FR35799, FR35974, FS02742, GC76044, GE21240,
GE30037, GE30909, GE39563, GF26813, GF31976, GF35166,
GF38701, GF39309, GF41067, GG51568, GG52780, GG57340,
GG62084, GG65199, GG65761, GG71997, GG74046, GG77585,
GH25197, GH27050, GH31578, GH35636, GH39384, GH39452,
GH41380, GJ29071, GJ31490, GJ32666, GJ38990, GK38862,
GK38869, GK44353, GK53912, GL10259, GL24424, GL31526,
GL32520, GL33378, GL34345, GN03810, GN08635, GN21273,
GN16780, GN17704, GN18683, GP90964, GR75476, GR83292,
GR83462, GR87764, GR88650, GR91992, KC00799, KC02195,
KC02705, KC03802, LF47901, LF51793, LF59141, LF65141,
LF65146, LF65148, LF65256, LF68464, LF69494, LF70680,
LH28890, LH35817, LP42428, LP62797, LP67578, LP71587,
LP72583, LQ02746, LQ07972, LQ08425, LQ11189, LQ14169,
LQ15198, LQ96382, LQ99903, LR87900, LR90374, LR95208,
LR95377, LR95487, LR97326, LR99537, LS95065, LS97018,
LS98035, LS98822, LS99737, LS99771, LS99775, LT61777,
LT68950, LT69700, LV82039, LV82772, LV84036, LV85341,
LV93295, LW66269, LW66680, LW66681, LX69628, LX77247,
LY76007, LY78836, LY81828, LY87463.
-8-
(d) FC03477, FC10068, FC30676,
FC42257, FF06622, FF08628, FF10030, FF15045, FF16314,
FF20123, FK60819, FK62232, FK63520, FK64733, FN28050,
FP29509, FP30573, FP30806, FP31839, FP34456, FP35969,
FP38269, FP38601, FP40224, FR35974, GF26813, GF39309,
GG51568, GG65761, GH35636, GH39452, GJ29071, GJ31490,
GJ38990, GK38869, GK44353, GL34345, GN03810, GN13507,
GN18683, GR83292, GR91992, LF58156, LF68464, LF69494,
LF70680, LQ02746, LQ08425, LQ14169, LQ96382, LR95377,
LS98822, LT61777, LT68950, LV85341, LV93295, LX69628,
LX77165, LY76007, LY81828, LY87463;
(e) FJ54642, FN12805, FN13579, FN13758, FN16304, FN16839,
FN20867, FN29143, FN30961, GE30072, LC79153, LC83214,
LH28625, LH24441, LH35828, LH35835;
(f) FC24870, FC37259, FC51373,
FC54716, FC99514, FF04514, FF06430, FF12241, FF14666,
FG66771, FG68252, FG71682, FG74691, FF76577, FF14666,
FG80160, FG82380, FG82679, FG83887, FG85826, FG87343,
FG87580, FG89946, FG90210, FG91402, FG92641, FG93698,
FG94505, FG95018, FG96383, FG96421, FG97279, FG97301,
FG98957, FG99395, FH23362, FH24573, FH26696, FJ54642,
FJ59539, FJ66633, FK52016, FK52253, FK53418, FK54055,
FK54816, FK58869, FK60170, FK63924, FL45210, FL45217,
FL50755, FL53099, FN00137, FN00144, FN00147, FN00148,
FN12805, FN13579, FN13758, FN16304, FN16305, FN16839,
FN20867, FN23938, FN25374, FN25430, FN27249, FN29143,
FN30961, FN31741, FP28158, FP31017, FP31625, FP32160,
FP32947, FP33115, FP33328, FP33967, FP36011, FP36363,
FP36449, FP36780, FP37488, FP37825, FP39534, FR35799,
FS02742, FS03387, GC76044, GE21240, GE30037, GE30072,
GE39398, GE39563, GF19894, GF31976, GF33928, GF35166,
GF38142, GF38701, GF40177, GF41067, GG34579, GG52780,
GG57340, GG61517, GG62084, GG64392, GG65199, GG71310,
GG71313, FF71997, GG74046, GG77585, GH25197, GH27050,
GH31578, GH39384, GH41380, GH45663, GJ32666, GJ37656,
GK38862, GK41939, GK50051, GK53912, GL24424, GL31526,
GL32520, GL33378, GM95284, GM95489, GM96250, GN08635,
GN12173, GN16780, GN17336, GN17704, GP02449, GP02451,
GP02458, GP84641, GP90964, GR75476, GR83462, GR87764,
GR88650, GR94520, LC79153, LC80875, LC82314, LC89148,
LF47901, LF51793, LF59141, LF65141, LF65148, LF65256,
LF68732, LH28625, LH28890, LH34441, LH35817, LH35828,
LH35835, LP42428, LP62797, LP67578, LP71587, LP72583,
LP73484, LQ07972, LQ11189, LQ12635, LQ15198, LQ99903,
LR87900, LR90374, LR91845, LR95208, LR95487, LR97326,
LR99537, LS92517,
LS95065, LS97018, LS98035, LS99737, LS99771, LS99775,
LT69700, LT69769, LV82039, LV82772, LV84036, LV90498,
LV90801, LW56954, LW66269, LW66680, LW66681, LX77247,
LX78490, LX81107, LY78836, LY86895.
Manufacturer: American Red Cross, Los angeles-Orange Counties
Region, Los Angeles, California.
-9-
Recalled by: Manufacturer, by telephone or visit starting October
20, 1988 followed by letter and by press release.
Firm-initiated recall ongoing.
Distribution: California, New York, Tennessee, Pennsylvania,
Minnesota, Switzerland.
Quantity: (a) 10; (b) 270; (c) 188; (d) 61; (e) 16; (f) 207
units were distributed.
Reason: Units which tested repeatably reactive for 1) the
antibody to the human immunodeficiency virus type 1
(anti-HIV-1); 2) hepatitis B surface antigen (HbsAg);
or were drawn from ineligible donors based on previous
anti-HIV-1 or HBsAg test results, were distributed.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: Bard Alfentanil Infuser, also known by the names BARD
Harvard Alfenta Pump and Bard Harvard Mini-Infuser,
Model 900. The pump is intended for intravenous delivery
of narcotic Alfentanil: (a) Catalog #6461900;
(b) Catalog #6461900R. Recall #Z-864/865-0.
Code: All serial numbers in production over the last three
years which include B35,000 series to the B44,000
series.
Manufacturer: Bard Med Systems, Division of C.R. Bard, Inc., North
Reading, Massachusetts.
Recalled by: Manufacturer, by telephone July 26, 1990 followed by
visit. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 2,760 units were distributed.
Reason: The pump did not alarm when an over-infused condition
occurred.
----
Product: Edwards disposable pressure transducer kits, indicated for
use with pressure monitoring catheters, on patients
requiring intravascular, intracranial, or intrauterine
blood pressure monitoring:
(a) 53 Series Disposable Pressure Transducers,
Models 53-600, 53-600F, 53-600F30, 53-200, 53-DTS-212,
53-DTS-260, 53-DTS272, 53-DTS-284, 53-1X2-260, 53-DTS-1X2-M,
53-2X2-260, 53-2X3-260, 53-3X3-260;
(b) 51 Series disposable Pressure Transducers,
custom made kits of the 53 series transducers;
(c) VAMP/DPT Disposable Pressure Transducers,
Model 48-VMP160T. Recall #Z-880/882-0.
-10-
Code: (a & b) All lot numbers beginning with OA, OB, OC,
OD, OE, OF followed by 4 numerical digits, and one lot
number 0G0814; (c) Lot #0F670.
Manufacturer: Baxter Healthcare Corporation, Edwards Critical-Care
Division, Irvine, California.
Recalled by: Edwards Critical-Care, Baxter Healthcare Corporation,
Irvine, California, by letter July 25, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide, Puerto Rico, South America, Canada,
United Kingdom, Greece, Australia.
Quantity: 800,000 kits were distributed.
Reason: The kits are subject to inaccurate blood pressure
readings due to transducer pressure drift.
----
Product: Enmet Oxygen Monitor used with GE Signa brand Magnetic
Resonance Imaging Systems. Recall #Z-895-0.
Code: Systems with magnetic enclosures with the following
model numbers: 46-255043G1, 46-258500G1, 46258734G1,
46-271558G1, 46-271560G1, 46-282341G1, 46-282343G1,
46-282345G1.
Manufacturer: General Electric Company - Medical Systems,
Waukesha, Wisconsin.
Recalled by: Manufacturer, by field modification and notification
December 19, 1989. Firm-initiated field correction ongoing.
Distribution: Nationwide and international.
Reason: The audible warning from the scan room oxygen monitor
may be manually overridden and therefore fail to provide
audible warning of low oxygen conditions.
----
Product: Toshiba TCT Computed tomography X-Ray Systems:
(a) Toshiba TCT-600 XT Computed Tomography X-Ray System;
(b) Toshiba TCT-600 HQ Computed Tomography X-Ray System.
Recall #Z-893/894-0.
Code: Serial numbers: (a) A9612056, A9622059, A0512066, 9612055,
A9552024, A9542020, A9512002, A9602050, A0532081, A9612057,
99362UNKN, A9532011, 9622062.
(b) 9532077, B9550299, OH01015, PH11245, 9612117, 9572080,
0542153, IL82118, 9612118, 9602148, 8622046, 9552055,
9552052, 9542048, 9532035, 0532146, IL80297, B9612158,
0542152, 9512015, 9512055, B9542087, 8612043, 9612162,
B9552097, B9612154, 9602149.
Manufacturer: Toshiba Corporation, Tokyo, Japan.
Recalled by: Toshiba America Medical Systems, Inc., Tustin,
California, by letter July 24, 1990. Firm-initiated
recall ongoing.
Distribution: Alabama, California, Colorado, Delaware, Georgia, Illinois,
Kansas, Louisiana, Massachusetts, Maryland, New Jersey,
New York, Ohio, Oregon, Pennsylvania, Texas, Virginia,
Wisconsin.
-11-
Quantity: (a) 13 units; (b) 27 units were distributed.
Reason: Erroneous diagnostic and anatomic information may be
provided to the user during certain modes of operation
due to defective software.
----
Class III -
NONE
VETERINARY PRODUCTS
NONE