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
07/06/1995
ENFORCEMENT REPORT FOR 07 05 95
July 5, 1995 95-27
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Tenex Tablets, 1 mg, in bottles of 100, an anti-
hypertensive. Recall #D-201-5.
CODE Lot #0941345 EXP 12/96.
MANUFACTURER A.H. Robins Company, Richmond, Virginia.
RECALLED BY Manufacturer, by letter June 19, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 12, 398 bottles were distributed.
REASON A bottle labeled Tenex Tablets was found to contain Donnatal
Tablets.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Ponstel 250 mg Capsules, (mefenamic acid), an anti-
inflammatory, in bottles of 100. Recall #D-199-5.
CODE Lot numbers and EXP dates: 08170FA 7/95, 01082FA 7/95,
03492FA 7/95, 00280FA 8/95, 12890FA 8/95, 14792FA 8/95,
12990FA 9/95, 012N0FA 11/95, 02913FA 12/95, 00311FA 1/96,
03013FA 1/96, 01921FA 2/96, 06743FA 3/96, 06843FA 3/96,
00941FA 4/96, 05151FA 4/96, 05251FA 4/96, 00361FA 5/96,
07363FA 6/96, 07363FB 6/96, 00561FA 7/96, 05491FA 9/96,
05591FA 9/96, 031N1FA 10/96, 032D1FA 12/96, 08212FA 2/97.
MANUFACTURER Warner Lambert Company, Fajardo, Puerto Rico.
RECALLED BY Parke Davis, Division of Warner Lambert Company, Morris
Plain, New Jersey, by letter June 12, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 225,822 units were distributed.
REASON Withdrawal of NDA Site Supplement for the product.
_______________
PRODUCT Norlestrin FE, 1/50 Tablets, one dispenser of 28 tablets
each, professional sample, not to be sold, oral
contraceptive. Recall #D-200-5.
CODE Lot numbers: 02001FB EXP 1/96, 02001FH EXP 1/96.
MANUFACTURER Warner Lambert Company, Fajardo, Puerto Rico.
RECALLED BY Parke-Davis, Division of Warner Lambert Company, Morris
Plain, New Jersey, by letter June 12, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 7,770 units were distributed.
REASON Withdrawal of NDA.
_______________
PRODUCT Various drug products: (a) Norlestrin FE, 1/50 Tablets, 5
dispenser of 28 tablets and Norlestrin FE, 1/50 Tablets, 3
dispensers of 28 tablets each, for institutional use only;
(b) Norlestrin 21, 1/50 Tablets, 5 dispensers of 21 tablets
each; (c) Norlutin 5 mg Tablets, indicated in amenorrhea;
(d) Uticort 0.025% Gel, in 15 g tube, topical corticosteroid
and Uticort 0.025% Gel, in 60 g tubes; (e) Norlutate 5 mg
Tablets, in bottles of 50, indicated in amenorrhea.
Recall #D-202/206-5.
CODE Lot numbers and EXP dates: (a) 08392FA 8/95, 08392FC 8/95,
08392FG 8/95, 02001FD 1/96, 02001FE 1/96 (5-dispenser pack),
08392FD 8/95, 08392FF 8/95, 02001FA 1/96, 02001FF 1/96 (3-
dispenser pack); (b) 08392FE 8/95, 02001FC 1/96; (c) 03280FA
10/95, 10951FA 5/96; (d) 00963B 8/96, 01594B 9/97 (15 G
tube); 029N2B 11/95, 01323B 2/96, 03343B 7/96, 00193B 9/96,
01624B 2/97, 07064B 6/97 (60 G tube); (e) 00182FA 7/95,
00282FA 7/95, 00492FA 8/95, 00592FA 8/95, 03080FA 8/95,
03180FA 9/95, 09590FA 10/95, 09690FA 10/95, 08000FA 11/95,
08100FA 11/95, 133DOFA 12/95, 08621FA 2/96, 08721FA 2/96,
02731FA 3/96, 00541FA 4/96, 00641FA 4/96, 04151FA 5/96,
04251FA 5/96, 07261FA 6/96, 07361FA 6/96, 06971FA 7/96,
07071FA 7/96, 01191FA 10/96, 01291FA 11/96, 01391FA 12/96,
14091FA 12/96, 00422FA 1/97, 00522FA 1/97, 06412FA 1/97,
06512FA 1/97.
MANUFACTURER Warner Lambert Company, Fajardo, Puerto Rico.
RECALLED BY Parke Davis, Division of Warner lambert Company, Morris
Plain, New Jersey, by letter June 9, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 411,592 units were distributed.
REASON Withdrawal of NDAs for each of the products.
-2-
_______________
PRODUCT Mytussin AC Cough Syrup, a schedule V narcotic OTC
expectorant and cough suppressant, under the following
labels: Pennex Mytussin AC Cough Syrup, in 1 pint and 1
gallon bottles; Robafen AC Cough Syrup (Major), in 1 pint, 4
fluid ounce, and in 1 gallon bottles, and GG Glydeine Cough
Syrup (Geneva), in 1 pint bottles. Recall #D-207-5.
CODE Lot numbers: 20003 EXP 10/95, 20079 EXP 12/95.
MANUFACTURER Pennex Pharmaceuticals, Inc., Morton Grove, Illinois.
RECALLED BY Morton Grove Pharmaceuticals, Inc., Morton Grove, Illinois,
by letter June 14, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Illinois, Pennsylvania, Kentucky, Indiana, New Jersey,
California, Ohio, Georgia, Louisiana, Texas, Colorado, New
York, Arkansas, Puerto Rico.
QUANTITY 31,894 4-ounce bottles; 24,410 pint bottles, and 1,667
gallon size bottles were distributed.
REASON Subpotency of codeine ingredient.
_______________
PRODUCT Children's Allerest, 24 chewable tablets (unit dose) per
box, an OTC antihistamine and nasal decongestant.
Recall #D-208-5.
CODE Lot #36399 EXP 9/95.
MANUFACTURER Fisons Corporation, Rochester, New York.
RECALLED BY Manufacturer, by letter June 27, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 18,816 boxes (24 tablets per box) were distributed; firm
estimated that little, if any, product remained on market at
time of recall initiation.
REASOn Subpotency of the chlorpheniramine ingredient.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Whole Blood CPDA-1; (b) Red Blood Cells (c) Platelets;
(d) Recovered Plasma. Recall #B-390/393-5.
CODE Unit numbers: (a) 03FN01265, 03FY00053, 03F89744; (b)
03FW02304, 03F89752; (c) 03F89752; (d) 03FW02304, 03F89748,
03F89752.
MANUFACTURER American National Red Cross, Atlanta, Georgia.
RECALLED BY Manufacturer, by telephone on or about March 8, 1993, or by
letters dated March 16, 1993, April 28, 1993, or May 3,
1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY None of the units are in commerce.
REASON Blood products which tested initially negative for anti-HCV
on an invalidated test run but tested repeatedly reactive
for anti-HCV upon retesting or on a subsequent donation, or
were untested for anti-HCV, were distributed for transfusion
or for further manufacture.
-3-
_______________
PRODUCT Source Plasma. Recall #B-415-5.
CODE Unit numbers:
152937 153216 153888 192127 198806 199093
199674 200044 200501 200507 202044 202329
202852 203132 203658 203930 204470 204726
205299 205550 206108 206386 206950 207292
208030 208220 208638 2160706 292150 292620
293193 293684 294171 294656 295663 296079
296200 296672 297142 297625 298138 298162
298569 298592 298809 299021 299443 3088102
3088363 3088376 3092202 3092427 3098383 3098915
3099162 3107300 3107913 3108199 3108826 3109108
3109730 3110021 3110607 3110934 3111496 3111811
3112451 3112741 3113335 3113731 3114240 3114619
3115205 3115644 3116111 3116604 3117007 3117417
3117885 3118302 3118944 3119341 3119823 3120243
3120682 3121100 3121467 3121785 3122379 3122782
3123379 3123709 3124246 3124600 3125158 3125508
3126026 3126429 3126939 3127278 3127906 3128277
3128860 3129285 3129888 3130254 3130809 3131186
3131552 3131848 3132246 3133200 3134168 3134529
3135080 3135415 3136103 3136483 3137038 3137462
3138017 3138374 3139029 3139323 3140075 3140608
3141141 3141696 3142130 3142682 PD05348 PD05498
PS00294 PS27515 PS27777 PS28190 PS28451 PS28919
PS29181 PS29409 PS29744 PS30126 PS30275 PS30734
PS30944 PS31683 PS32410 PS32662 PS33088 PS33242
PS34187 PS34248 PS64701 PS64762 PS77333 PS86954
PS89718 PS95379 PS95555 PS96201 PS96442 PS96980
PS97096 PS97373 PS97844 PS97916 PS98382 PS98604
PS99067 PS99662 PS99888 PW11238 PW11884 PW12268
PW52193 PW52510 PW52674 PW52901 PW53119 PW53336
XD00150 XD00480 XD00571 XD00668 XD07644 XD07755
XD11681 XD28033 XD28090 XD28243 XD28326 XD29627
XD29827 XD30032 XD30373 XD30575 XD30754 XD31135
XD31344 XD32378 XD33151 XD33914 XD34944 XD40743
XD40824 XD40969 XD41097 XD41199 XD41434 XD41507
XD41913 XD41976 XD42137 XD42194 XD42323 XD42402
XD42557 XD42617 XD42742 XD42829 XD42949 XD43002
XD43142 XD43196 XD43331 XD43402 XD43519 XD43586
XD43753 XD43822 XD43933 XD52224 XD68694 XD68976
XD69210 XD69489 XD69742 XD70035 XD70431 XD70581
XD70965 XD71138 XD71509 XD71704 XD72091 XD72276
XD73844 XD74235 XD74539 XD74812 XS23146 XS23618
XS25597 XS26232 XS30493 XS30847 XS31422 XS35964
XS36323 XS37160 XS37270 XS43741 XS58646 XS69882
XS73546 XS76310 XS76755 XS77811 XS79752 XS79787
XS86282 XS89187 XS91481 XW54184 XW60310 XW60610
XW60831 XW61132 XW72457.
MANUFACTURER Community Bio-Resources, Inc., Orlando, Florida; Community
Bio-Resources, Inc., Clearwater, Florida; Community Bio-
Resources, Inc., Tampa, Florida.
-4-
RECALLED BY Community Bio-Resources, Inc., Birmingham, Alabama, by
letters mailed between June 14, 1994 and August 8, 1994.
Firm-initiated recall complete.
DISTRIBUTION Michigan, New Jersey, Austria.
QUANTITY 279 units.
REASON Blood products which tested negative for antibody to the
human immunodeficiency virus type 1 (anti-HIV-1(, but were
collected from donors who previously tested repeatedly
reactive for anti-HIV-1; tested negative for hepatitis B
surface antigen (HBsAg), but were collected from donors who
previously tested repeatedly reactive for HBsAg or had a
history of hepatitis; or were collected from donors with a
history of intravenous (IV) drug use/high risk behavior.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitated
AHF; (d) Recovered Plasma. Recall #B-419/422-5.
CODE Unit numbers: (a) 1104370, 1114691, 1138887; (b) 1114691,
1138887; (c) 1114691; (d) 1104370, 1114691, 1138887.
MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City,
Missouri.
RECALLED BY Manufacturer, by letters dated May 12 or 13, 1994, and by
letters of February 1 and 16, 1995. Firm-initiated recall
complete.
DISTRIBUTION Kansas, Missouri, Tennessee, Arizona.
QUANTITY (a) 3 units; (b) 2 units; (c) 1 unit; (d) 3 units.
REASON Blood products, which tested negative for antibody to the
human immunodeficiency virus type 1 (anti-HIV-1), but were
collected from donors who previously tested repeatedly
reactive for anti-HIV-1, were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-423-5.
CODE Unit #4513392.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by letters dated February 15 or 16, 1995.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON Blood product, which tested negative for syphilis but was
collected from a donor who previously tested repeatedly
reactive for syphilis, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-426/428-5.
CODE Unit numbers: 0059315, 2032309, 1083165, 1109426 0119003.
MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City,
Missouri.
RECALLED BY Manufacturer, by letters dated May 12, 1994, and February 3,
1995. Firm-initiated recall complete.
DISTRIBUTION Missouri, Kansas.
-5-
QUANTITY 5 units of each component.
REASON Blood products, which tested negative for antibody to human
immunodeficiency virus type 1 (anti-HIV-1), but were
collected from a donor who previously tested Western blot
indeterminate, were distributed.
_______________
PRODUCT Cryoprecipitated AHF. Recall #B-429-5.
CODE Unit #50G64276.
MANUFACTURER American National Red Cross, Toledo, Ohio.
RECALLED BY Manufacturer, by letter or facsimile on or about July 13,
1994. Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit.
REASON Blood products, corresponding to Red Blood Cells
contaminated with Staphlyococcus epidermidis, were
distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT (a) Whole Blood CPDA-1; (b) Red Blood Cells; (c) Platelets;
(d) Fresh Frozen Plasma; (f) Platelets, Pheresis; (g)
Recovered Plasma; (h) Platelets, Expired.
Recall #B-394/400-5.
CODE Unit numbers: (a) 03F89745, 03FN01262, 03FN01263,
03FN01264, 03FY00056, 03LG02470, 03LG02471, 03LG02473,
03LG02474, 03LG02475, 03LG02476, 03LJ02815, 03LJ02816,
03LN04359, 03LN04362, 03LS02093, 03LS02094, 03LS02096,
03LS02098, 03LW03576, 03T93369;
(b) 03F89743, 03F89746, 03F89747, 03F89749, 03F89750,
03F89751, 03F89753, 03F89754, 03F89755, 03F89756, 03F89758,
03F89759, 03F89760, 03F89761, 03FJ20439, 03FJ20440,
03FJ20441, 03FJ20442, 03FJ20443, 03FJ20444, 03FJ20445,
03FJ20446, 03FJ20447, 03FJ20448, 03FJ20451, 03FJ20452,
03FN01261, 03FN01266, 03FN01267, 03FQ00611, 03FQ00612,
03FQ00614, 03FV01575, 03FV01576, 03FV01577, 03FV01578,
03FV01579, 03FV01580, 03FV01581, 03FV01582, 03FV01583,
03FV01584, 03FV01585, 03FV01587, 03FV01588, 03FV01589,
03FV01590, 03FV01591, 03FV01592, 03FV01593, 03FV01594,
03FV01595, 03FV01596, 03FV01597, 03FV01598, 03FV01599,
03FV01600, 03FV01601, 03FV01602, 03FV01603, 03FV01604,
03FV01606, 03FV01607, 03FV01608, 03FV01609, 03FV01612,
03FV01614, 03FV01615, 03FV01616, 03FV01617, 03FV01618,
03FV01620, 03FV01621, 03FV01622, 03FV01623, 03FV01624,
03FV01625, 03FV01626, 03FV01627, 03FV01628, 03FV01629,
03FV01630, 03FV01631, 03FV01632, 03FV01633, 03FV01634,
03FV01636, 03FV01637, 03FV01638, 03FV01640, 03FV01641,
03FV01642, 03FV01644, 03FV01645, 03FV01647, 03FV01648,
03FV01649, 03FV01650, 03FV01651, 03FV01652, 03FV01654,
03FW02297, 03FW02298, 03FW02299, 03FW02300, 03FW02301,
03FW02302, 03FW02303, 03FW02305, 03FW02306, 03FW02307,
-6-
03FW02308, 03FW02309, 03FW02310, 03FW02311, 03FW02312,
03FW02314, 03FW02315, 03FW02316, 03FW02318, 03FW02319,
03FW02320, 03FW02321, 03FW02322, 03FW02323, 03FW02324,
03FW02325, 03FW02326, 03FW02327, 03FW02330, 03FW02331,
03FW02332, 03FW02335, 03FW02336, 03FW02337, 03FW02338,
03FW02339, 03FW02340, 03FW02342, 03FW02343, 03FW02344,
03FE02345, 03FW02346, 03FW02347, 03FW02348, 03FW02349,
03FW02350, 03FW02351, 03FW02352, 03FW02353, 03FW02355,
03FW02356, 03FW02357, 03FW02358, 03FW02359, 03FW02360
03FW02361, 03FW02362, 03FW02363, 03FW02364, 03FW02365,
03FW02366, 03FW02367, 03FW02368, 03FW02369, 03FW02370,
03FW02371, 03FW02372, 03FW02374, 03FW02375, 03FW02376,
03FW02377, 03FW02379, 03FW02381, 03FW02382, 03FW02383,
03FW02384, 03FW02386, 03FW02387, 03FW02388, 03FW02389,
03FW02390, 03FW02391, 03FW02392, 03FW02393, 03FW02394,
03FW02395, 03FW02396, 03FW02397, 03FW02398, 03FW02400,
03FW02402, 03FW02403, 03FW02404, 03FW02405, 03FW2354,
03FY00054, 03FY00055, 03K03634, 03K03635, 03K03636,
03K03637, 03K03638, 03K03639, 03K03640, 03K03641, 03K03643,
03K03644, 03K03645, 03K03646, 03LG02472, 03LN04360,
03LN04361, 03LS02095, 03LT10348, 03LT10349, 03LT10350,
03LT10354, 03LT10355, 03LT10356, 03LT10359, 03LT10360,
03LT10361, 03LT10362, 03LT10363, 03LW03575, 03LW03577,
03S78041, 03S78043, 03S78045, 03S78046, 03S78047, 03S78048,
03S78049, 03S78051, 03S78052, 03S78053, 03S78054, 03T93358,
03T93359, 03T93360, 03T93361, 03T93362, 03T93363, 03T93364,
03T93365, 03T93367, 03T93368, 03T93370, 03W36245, 03W36247,
03W36248, 03W36249, 03W26250, 03W36251, 03W36253, 03W36254,
03W36255, 03W36256, 03W26357, 03W36257, 03W36258, 03W36261,
03W36263;
(c) 03F89751, 03F89753, 03F89760, 03FJ20441, 03FJ20444,
03FJ20445, 03FJ20446, 03FJ20447, 03FJ20449, 03FJ20451,
03FJ20452, 03FJ20453, 03FV01575, 03FV01576, 03FV01577,
03FV01579, 03FV01580, 03FV01585, 03FV01590, 03FV01592,
03FV01593, 03FV01594, 03FV01596, 03FV01598, 03FV01599,
03FV01601, 03FV01602, 03FV01603, 03FV01604, 03FV01605,
03FV01606, 03FV016091634, 03FV01611, 03FV01615, 03FV01616,
03FV01617, 03FV01618, 03FV01620, 03FV01636, 03FV01643,
03K03634, 03K03636, 03K03637, 03K03639, 03K03640, 03K03641,
03K03644, 03K03645, 03K03646, 03LT10351, 03LT10359,
03S78041, 03S78051, 03S78052, 03S78053, 03S78054, 03T93358,
03T93361, 03T93362, 03W36263;
(d) 03FJ20442, 03S78044, 03K03636, 03K03638, 03K03645,
03FJ20439, 03FJ20440, 03FJ20441, 03FJ20443, 03T93368,
03W36259, 03W36253;
(e) 03FG02811, 03FG02813, 03FG02814, 03FG02815, 03FG02816,
03FG02817, 03FK00991-1, 03FK00991-2, 03FK00992, 03FK00993,
03FX00504, 03FZ00175, 03LL02358, 03LL02359, 03LL02360,
03LL02361, 03LQ03843, 03LQ03845, 03P59596, 03P59598;
(f) 03F89749, 03F89750, 03F89751, 03F89753, 03F89754,
03F89755, 03F89756, 03F89757, 03F89758, 03F89759, 03F89760,
03FJ20444, 03FJ20445, 03FJ20446, 03FJ20447, 03FJ20448,
-7-
03FJ20449, 03FJ20451, 03FJ20452, 03FJ20453, 03FN01267,
03FQ00611, 03FQ00612, 03FQ00613, 03FQ00614, 03FV015605,
03FV01575, 03FV01576, 03FV01577, 03FV01578, 03FV01579,
03FV01580, 03FV01581, 03FV01582, 03FV01583, 03FV01584,
03FV01585, 03FV01587, 03FV01588, 03FV01589, 03FV01590,
03FV01591, 03FV01592, 03FV01593, 03FV01594, 03FV01595,
03FV01596, 03FV01597, 03FV01598, 03FV01599, 03FV01600,
03FV01601, 03FV01602, 03FV01603, 03FV01604, 03FV01606,
03FV01607, 03FV01608, 03FV01609, 03FV01611, 03FV01612,
03FV01614, 03FV01615, 03FV01616, 03FV01617, 03FV01618,
03FV01620, 03FV01621, 03FV01622, 03FV01623, 03FV01624,
03FV01625, 03FV01626, 03FV01627, 03FV01629, 03FV01630,
03FV01631, 03FV01632, 03FV01633, 03FV01634, 03FV01635,
03FV01636, 03FV01637, 03FV01638, 03FV01639, 03FV01640,
03FV01641, 03FV01642, 03FV01643, 03FV01644, 03FV01645,
03FV01646, 03FV01647, 03FV01648, 03FV01649, 03FV01650,
03FV01651, 03FV01652, 03FV01653, 03FV01654, 03FW02297,
03FW02298, 03FW02299, 03FW02300, 03FW02301, 03FW02302,
03FW02303, 03FW02305, 03FW02306, 03FW02307, 03FW02308,
03FW02309, 03FW02310, 03FW02311, 03FW02312, 03FW02314,
03FW02315, 03FW02316, 03FW02318, 03FW02319, 03FW02320,
03FW02321, 03FW02322, 03FW02323, 03FW02324, 03FW02325,
03FW02326, 03FW02327, 03FW02330, 03FW02331, 03FW02332,
03FW02335, 03FW02336, 03FW02337, 03FW02338, 03FW02339,
03FW02340, 03FW02342, 03FW02343, 03FW02344, 03FW02345,
03FW02346, 03FW02347, 03FW02348, 03FW02349, 03FW02350,
03FW02351, 03FW02352, 03FW02353, 03FW02354, 03FW02355,
03FW02356, 03FW02357, 03FW02358, 03FW02359, 03FW02360,
03FW02361, 03FW02362, 03FW02363, 03FW02364, 03FW02365,
03FW02366, 03FW02367, 03FW02368, 03FW02369, 03FW02370,
03FW02371, 03FW02372, 03FW02374, 03FW02375, 03FW02376,
03FW02377, 03FW02379, 03FW02381, 03FW02382, 03FW02383,
03FW02384, 03FW02386, 03FW02387, 03FW02388, 03FW02389,
03FW02390, 03FW02391, 03FW02392, 03FW02393, 03FW02394,
03FW02395, 03FW02396, 03FW02397, 03FW02398, 03FW02400,
03FW02402, 03FW02403, 03FW02404, 03FW02405, 03K03635,
03K03639, 03K03640, 03K03641, 03K03643, 03LS02095,
03LS02097, 03LT10348, 03LT10349, 03LT10350, 03LT10351,
03LT10352, 01LT10353, 03LT10354, 03LT10356, 03LT10357,
03LT10358, 03LT10359, 03LT10360, 03LT10361, 03LT10362,
03LT10363, 03S78045, 03S78046, 03S78047, 03S78048, 03S78049,
03S78051, 03S78052, 03S78054, 03T93358, 03T93359, 03T93360,
03T93361, 03T93362, 03T93363, 03T93364, 03T93365, 03T93366,
03T93367, 03T93370, 03T93371, 03W36245, 03W36246, 03W36247,
03W36248, 03W36249, 03W36250, 03W36251, 03W36252, 03W36254,
03W36255, 03W36256, 03W36257, 03W26258, 03W36261, 03W36263;
(g) 03F89754, 03F89759, 03FJ20440, 03FJ20442, 03FJ20448,
03FV01614, 03FV01632, 03FV01645, 03T93359, 03T93360.
MANUFACTURER American National Red Cross, Atlanta, Georgia.
RECALLED BY Manufacturer, by telephone on or about March 8, 1993 or by
letters dated March 16, 1993, April 28, 1993, or May 3,
1993. Firm-initiated recall complete.
-8-
DISTRIBUTION Nationwide.
QUANTITY None of the units are in commerce.
REASON Blood products which tested initially negative for the
antibody to the hepatitis C virus encoded antigen (anti-HCV)
on an invalidated test run but tested repeatedly reactive
for anti-HCV upon retesting or on a subsequent donation;
were untested for anti-HCV; or tested negative for anti-HCV
on an invalidated test run but tested negative for anti-HCV
upon retesting on or on a subsequent donation were
distributed.
_______________
PRODUCT Platelets. Recall #B-407-5.
CODE Unit #16FJ31423.
MANUFACTURER American National Red Cross, Columbus, Ohio.
RECALLED BY Manufacturer, by letter September 21, 1994. Firm-initiated
recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit.
REASON Blood product corresponding to Red Blood Cells which were
possibly contaminated with gram positive rods, were
distributed.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-416-5.
CODE Unit numbers: 5041054, 5041055, 5041056, 5041057, 5041058,
5041059, 5041060, 5041061, 5041062, 5041063, 5041064,
5041065, 5041066, 5041067, 5041068.
MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City,
Missouri.
RECALLED BY Manufacturer, by telephone January 10, 1995, for unit
5041063, and the remaining units by letter February 3, 1995.
Firm--initiated recall complete.
DISTRIBUTION Missouri, Kansas.
QUANTITY 15 units.
REASON Fresh Frozen Plasma which was not frozen within eight hours
of phlebotomy was distributed.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-418-5.
CODE Unit #09H67225.
MANUFACTURER American Red Cross Blood Services, Omaha, Nebraska.
RECALLED BY Manufacturer, by telephone July 15, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nebraska.
QUANTITY 1 unit.
REASON Fresh Frozen Plasma which was not frozen within eight hours
of phlebotomy was distributed.
-9-
_______________
PRODUCT Recovered Plasma. Recall #B-424-5.
CODE Unit #4513392.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY manufacturer, by letters dated February 15 or 16, 1995.
Firm-initiated recall complete.
DISTRIBUTION Switzerland.
QUANTITY 1 unit.
REASON Blood product, which tested negative for syphilis but was
collected from a donor who previously tested repeatedly
reactive for syphilis, were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-425-5.
CODE Unit #R26132.
MANUFACTURER Heartland Blood Center, Aurora, Illinois.
RECALLED BY Manufacturer, by telephone March 4, 1995. Firm-initiated
recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit.
REASON A unit of Red Blood Cells, labeled with the incorrect
expiration date, was distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-430-5.
CODE Unit #50G64276.
MANUFACTURER American National Red Cross, Toledo, Ohio.
RECALLED BY Manufacturer, by letter or facsimile on or about July 13,
1994. Firm-initiated recall complete.
DISTRIBUTION Switzerland.
QUANTITY 1 unit.
REASON Blood product, corresponding to Red Blood Cells contaminated
with Staphlyococcus epidermidis, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-446/447-5.
CODE Unit #6004139.
MANUFACTURER Northwest Florida Blood Center, Inc., Pensacola, Florida.
RECALLED BY Manufacturer, by letter August 10, 1994. Firm-initiated
recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit of each component.
REASON Blood products, which were untested for the antibody to the
human immunodeficiency virus type 1 (anti-HIV-1), the
hepatitis B surface antigen (HBsAg), the antibody to the
hepatitis B core antigen (anti-HBc), the antibody to the
hepatitis C virus encoded antigen (anti-HCV), the antibody
to the human T-lymphotropic virus type I (anti-HTLV-I), and
syphilis, were distributed.
-10-
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Stryker Quick Pressure Monitor and Tissue Expander Monitor
Sets: (a) Stryker Quick Monitor, Part #295-2; (b) Stryker
Tissue Expander Monitor Set (also called Patient Kit for
Pressure Monitor), Part #295-20. Products are parts for a
hand held, portable pressure monitor system specifically
designed for measuring tissue pressure.
Recall #Z-749/750-5.
CODE All lot numbers beginning with 91, 92, and 93.
MANUFACTURER Stryker Instruments, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letters of January 13, 1994, February 17,
1994, and March 17, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 6,561 units were distributed.
REASON An air leak may be present which would result in lower,
inaccurate readings on the Pressure Monitor Hardware.
_______________
PRODUCT Validator 10 Plus Autoclaves - units and circuit boards,
used for sterilization:
CODE (a) Driver board assemblies, catalog # 3339954 or 1528392;
(b) Validator 10 Plus ETL/CSA 100 volt units, catalog #
1525299 or # 1531883, serial # AD7471 through AD10485;
(c) Validator 10 Plus units repaired by dealer service
technicians with the referenced driver boards after 01
December 1992;
(d) Repaired or reconditioned (catalog # 9446451 or #
9446535) Validator 10 Plus 110 volts units, shipped between
01 December 1992 and 31 January 1994. Recall #Z-849/852-5.
MANUFACTURER Pelton & Crane, Division of Siemens Medical Systems,
Charlotte, North Carolina.
RECALLED BY Manufacturer, by letter March 31, 1995. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimates that over 3,000 sterilizers and over 1,500
repair circuit boards are subject to field correction.
REASON Defective printed driver circuit boards have caused smoking
and fires within the affected units.
_______________
PRODUCT 2100 EC Childbearing Bed, Part #2100-06-00.
Recall #Z-873-5.
CODE Serial number range: 88052, A880664, 91010093, 91060188,
91070092, 91070094-91070098, 91080091, 90180093-91080096,
91080098-91080100, 91080102-91080105, 91090091-93020107
(excluding part #2100-00-000).
MANUFACTURER Arnold Chup, doing business as Maplewood Industries,
Tualatin, Oregon (component).
RECALLED BY Stryker Adel Medical, Ltd., Clackamas, Oregon, by letters of
May 21 and 26, 1993, and June 10, 1993. Firm-initiated
recall complete.
-11-
QUANTITY 451 parts were distributed.
REASON A defective weld may have caused the foot pan mount to
separate from the bracket.
_______________
PRODUCT Single-use Insulin Syringes, Product #321-4106.
Recall #Z-919-5.
CODE Lot #940829.
MANUFACTURER Shina Medical Corporation, Kongju-Kun, Chang Nam Do, Korea.
RECALLED BY Medi-Hut Company, Inc., Lakewood, New Jersey, by letter
dated 16, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 353 cases were distributed.
REASON Multiple product and packaging defects.
_______________
PRODUCT MH-11 Mediheat disposable, air activated crib warmer, Part
#4995126, long lasting 110 F for 12 hours.
Recall #Z-928-5.
CODE All lot numbers.
MANUFACTURER Maramunji Sangyo Company,, Ltd., Osaka, Japan.
RECALLED BY Heatmax, Inc., Dalton, Georgia, by letters of January 24 and
27, 1995, and February 1, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 66,298 warmers were distributed.
REASON There are reported burns associated with the use of this
product.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Power Cables for the Quantum 2000, QAD1 and QAD PV
Ultrasound Systems, used to connect the ultrasound unit to
the wall outlet. Recall #Z-924/925-5.
CODE All power cables for the Quantum 2000, QAD1, and QAD PV
Ultrasound Systems are involved.
Serial number range for the QAD 1 ultrasound unit - SSN0053
through SSN0590 (non-inclusive).
Serial number range for the QAD PV ultrasound unit -
SSN0298 through SNN0584 (non-inclusive).
Serial number range for the Q2000 Ultrasound unit -
SSN1000 through SSN1521 (non-inclusive).
MANUFACTURER Siemens Medical Systems, Inc., Issaquah, Washington.
RECALLED BY Manufacturer, by letter January 28, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, Japan.
QUANTITY 247 QAD1 systems and 86 QAD PV systems were distributed.
REASON Cable connectors catch on fire or there is a burning smell
associated with the cable connectors.
-12-
_______________
PRODUCT Vidas Chlamydia Assay Kits (CHL), Catalog #30101, for the
quantative detection of Chlamydia antigen in endocervical,
male urethral, or male urine specimen. Recall #Z-930-5.
CODE Lot #951030-0 EXP 10/30/95.
MANUFACTURER bioMerieux Vitek, Inc., Rockland, Massachusetts.
RECALLED BY Manufacturer, by telephone January 11 and 12, 1995, followed
by letter. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 954 kits were distributed.
REASON The kit may contain Solid Phase Receptacles (SPR) without
lid holes, in which any sample using a SPR without a lid
hole would produce a negative CHL result.
-13-
####
END OF ENFORCEMENT REPORT FOR JULY 5, 1995. BLANK PAGES MAY FOLLOW.