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
08/20/1991
Enforcement Report for Week of August 21, 1991
August 21, 1991
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.
Product: Uneviscerated Salted Yellow Croaker Fish (from Macao).
Recall #F-510-1.
Code: Uncoded.
anufacturer: New York Frozen Food Inc., Astoria, New York.
Recalled by: Manufacturer, by telephone on or about July 2, 1991, and
by letter July 8, 1991. Firm-initiated recall ongoing.
Distribution: New Jersey, New York.
Quantity: Approximately 500 pounds were distributed.
Reason: Potential Clostridium botulinum toxin hazard.
----
-1-
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.
Product: Dry Roasted Peanut Granules, packaged in 30 pound brown
cardboard boxes. Recall F-423-1.
Code: Uncoded.
anufacturer: John B. Sanfilippo and Son, Inc., Elk Grove Village,
Illinois (processor/shipper).
Recalled by: Sunshine Nut Company, Inc., San Antonio, Texas, by
telephone January 8-10, 1991. Firm-initiated recall
ongoing.
Distribution: Arkansas, Texas, Florida, Washington state, Alabama.
Quantity: 393 cartons were distributed; firm estimates none
remains on the market.
Reason: Product contains aflatoxin in excess of tolerance level.
----
Product: (a) Vernell's Black Jelly Bird Eggs, in 12 ounce packages;
(b) Vernell's Fruitti Bears Candy, in 30 pound cartons;
Recall #F-439/440-1.
Code: Lot numbers: (a) 021216; (b) 109210.
anufacturer: Vernell's Fine Candies, Inc., Bellevue, Washington.
Recalled by: Manufacturer, by letter April 26, 1991. Firm-initiated
recall ongoing.
Distribution: (a) Oregon, California, Washington state;
(b) Utah, Oklahoma, Oregon, Idaho, Washington state.
Quantity: (a) 1,053 cases (24 packages/case); (b) 1,056 cartons
were distributed.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
NONE
-2-
COSMETICS
Class I
NONE
Class II -
NONE
Class III -
Product: Baby Shampoo under Pennex and 25 private labels in
2 oz. & 4 oz. bottles in cases of 24; 16 oz. & 32 oz.
bottles in cases of 12; THE FOLLOWING LABELS ARE INVOLVED:
GOOD HEALTH, 16 FL. OZ., DISTRIBUTED BY PENNEX PRODUCTS CO.,
INC. VERONA, PA.
PIC N' SAVE DRUGS, 16 FL. OZ., DISTRIBUTED BY NATIONAL
MERCHANDISE CO. , JACKSONVILLE, FL.
DRUG GUILD, 32 FL. OZ., DISTRIBUTED BY DRUG GUILD
DISTRIBUTORS, INC., SECAUCUS, NJ.
NYSCO, 16 FL. OZ., DISTRIBUTED BY NYSCO INTERNATIONAL CO.,
MASS.
VONS, 16 FL. OZ., DISTRIBUTED BY VONS COMPANIES INC.,
GENERAL OFFICE, LOS ANGELES, CA.
SEAWAY, 16 FL. OZ., DISTRIBUTED BY SEAWAY FOODS, INC., DIV.
OF AMERICAN SEAWAY FOODS, INC., CLEVELAND, OHIO.
SUPER TRU, 16 FL. OZ., DISTRIBUTED BY SCRIVNER, INC.,
OKLAHOMA CITY, OK.
SHOP N' SAVE, 16 FL. OZ., DISTRIBUTED BY HANNAFORD BROS.
CO., SCARBOROUGH, ME.
SWEET LIFE, 16 FL. OZ., DISTRIBUTED BY SWEET LIFE PRODUCTS
CORP., SUFFIELD, CONN.
SHUR FINE, 16 FL. OZ., DISTRIBUTED BY 1986 SHURFINE-CENTRAL
CORP., NORTHLAKE, IL.
BI LO, 16 FL OZ, DISTRIBUTED BY BI-LO, INC., DRAWER 99,
MAULDIN, SC.
PHARMACIST PREFERRED, 16 FL OZ., DISTRIBUTED BY PHARMACY
PROVIDER SERVICES CORP., TALLAHASSEE, FL.
FEDCO, 16 FL. OZ., DISTRIBUTED BY FEDCO, INC., SANTA FE
SPRINGS, CA.
RELIABLE DRUGS, 16 FL. OZ., DISTRIBUTED BY RELIABLE DRUG
STORES, INC., INDIANAPOLIS, IN.
WELLBY SUPER DRUG, 16 FL. OZ., DISTRIBUTED BY HANNAFORD
BROS. CO., SCARBOROUGH, ME.
HAPPY HARRY, 16 FL. OZ., DISTRIBUTED BY MERCHANDISERS, INC.,
NEWARK, DEL.
SHOP N BAG, 16 FL. OZ., DISTRIBUTED BY SHOP' N BAG
MARKETING, PHILADELPHIA, PA.
LEGEND, 16 FL. OZ., DISTRIBUTED BY LEGEND PHARMACEUTICALS,
INC., SYRACUSE, NY.
HEALTH BRANDS, 4 FL. OZ., DISTRIBUTED BY HEALTH BRANDS,
BUFFALO, NY. 14207
KEY SELECTION, 16 FL. OZ., DISTRIBUTED BY BEN FRANKLIN,
DES PLAINES, IL.
-3-
MARSH, 16 FL. OZ., DISTRIBUTED BY MARSH SUPERMARKETS, INC.,
YORKTOWN, IN.
MEDI-GUARD, 16 FL. OZ., DISTRIBUTED BY LKS PRODUCTS, INC.,
GEN OFFICE, DUBLIN CA.
PMW PACE MEMBERSHIP WAREHOUSE, 32 FL. OZ., DISTRIBUTED BY
PACE MEMBERSHIP WAREHOUSE, INC., ENGLEWOOD, CO.
FINAST, 2 & 16 FL. OZ., DISTRIBUTED BY FIRST NATIONAL
SUPERMARKETS, INC., WINDSOR LOCKS, CT.
YANKEE PRIDE, 16 FL. OZ., DISTRIBUTED BY YANKEE PRIDE (DIV.
OF CHANDI, INC. ), FT. LEE, NJ.
BILL'S DRUGS 2 & 16 FL. OZ., DISTRIBUTED BY BILL'S DRUGS,
LAFAYETTE, CA.
Code: GOOD HEALTH -- E1368E, E1300E, D1492E, D1039E, C1394E,
C1055E, B1215E,
A1476E, A1170E, A1169E, A1168E, A1167E, M1305D, M1304D,
M1303D, M1025D, L1597D, L1596D, L1595D, L1594D, L1460D,
K1575D, H1807D, H1420D, H1419D, G1593D, G1592D, G1586D,
G1585D, G1589D, G1588D, G1587D, G1584D, G1583D, G1047D,
G1046D, F1031D, E1403D, D1292D, D1116D, D1115D, C1502D,
C1191D, B1595D, B1436D, B1161D, B1160D, B1159D, A1629D,
A1306D, M1400C, K1091C, K1085C, J1506C, J1199C, J1081C,
H1536C, G1300C, G1299C, G1178C, F1403C, E1172C, E1037C,
D1333C, D1028C, C1265C, A1166E, A1165E, A1164E, A1163E,
A1162E, M1307D, M1306D
(LOT E1490E WAS INCLUDED IN THE RECALL NOTICE, HOWEVER, IT
WAS NEVER DISTRIBUTED)
PIC N' SAVE DRUGS -- E1490E, D1492E, C1394E, K1418D, G1591D,
D1548D, C1078D, A1629D, M1400C, C1055C, B1387C, A1528C
DRUG GUILD -- E1368E, D1039E, K1418D, H1807D, F1031D,
D1292D, L1458C, L1133C, E1106C, B1387C
NYSCO -- E1490E,
VONS -- D1492E, A1163E, A1162E, G1046D, D1292D, D1114D,
C1191D, B1436D, A1306D, L1458C, L1133C, J1506C, F1106C,
E1038C, D1028C, C1265C, A1528C
SEAWAY -- E1368E, M1400C, M1249C, L1133C, J1081C, E1038C,
D1028C
SUPER TRU -- A1164E, L1594D, K1575D, K1418D, H1807D, H1419D,
G1591D, F1031D, E1403D, D1548D, D1292D, C1078D, B1436D,
A1306D, M1400C, M1249C, L1458C, L1133C, K1085C, J1506C,
F1106C, E1038L, D1333C, B1387C
SHOP N' SAVE -- C1394C, A1164E, M1307D, M1305D, L1594D,
H1807D, H1419D, G1047D, G1197D, D1292D, C1078D, M1400C,
M1249C, J1506C, H1486C, C1265C, C1055C, A1528C, F1271E
SWEET LIFE -- D1492E, G1591D, B1159D, L1458C, J1081C,
H1486C, G1178C, C1055C, A1528C
SHUR FINE -- D1492E, M1025D, K1575D
BI LO -- C1394E, H1419D, G1590D, G1046D, E1403D, J1506C,
J1199C, F1403C
PHARMACIST PREFERRED -- M1303D, L1594D, C1055C
FEDCO -- L1460D, E1197D, D1548D, D1114D, A1629D, M1249C,
L1458C
RELIABLE DRUGS -- L1460D, K1418D, G1047D
WELLBY SUPER DRUG -- G1046D, B1595D, J1199C
-4-
HAPPY HARRY -- E1038C
SHOP N BAG -- H1419D, M1400C
LEGEND -- L1458C, C1055C
HEALTH BRANDS -- C1620C
KEY SELECTION -- E1038C, E1085C, A1629D
MARSH -- A1528C
MEDI-GUARD -- D1333C, B1387C
PMW PACE MEMBERSHIP WAREHOUSE -- H1421D, G1594D, G1348D,
E1312D, D1118D, D1117D, C1498D, C1078D, A1630D, A1306D,
M1150C, K1086C, J1310C, H1233C, C1266C, C1054C, B1388C,
A1343C
(K1092C WAS INCLUDED IN THE PACE NOTIFICATION AS BEING
FILLED, HOWEVER, IT WAS NOT DISTRIBUTED)
FINAST -- A1528C
YANKEE PRIDE -- G1590D
BILL'S DRUGS -- G1590D.
anufacturer: Pennex Products Company, Inc., Verona, Pennsylvania.
Recalled by: Manufacturer, by telephone on or about June 25, 1991,
followed by letter. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Firm estimates that 3,500 dozen remain on market.
Reason: Formaldehyde not declared on label.
----
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product & Various unit-dose, strip packed Rx and OTC drugs, in
Codes: tablet form. Recall #D-520/605-1:
Product/Strength/Size Lot Number
1. Allopurinol, 300 mg., 1/2's 71733, 15061, 15425
2. Anturane, 100 mg., 1/2's 1T131499
(Sulfinpyrazone)
3. Armour Thyroid, 60 mg., 1/2's 05187
4. Bumex, 0.5 mg., 1/2's 0100
(Bumetanide)
5. Calan, 80 mg., 1/2's 0191386
(Verapamil HCl)
6. Calan SR, 240 mg., 1/2's 1090368
(Verapamil HCl) 1090369, 1190450
1190451, 1290010R
7. Capoten, 12.5 mg., 1/2's 0G31862
(Captopril) OG31873, 0H31895
0H31906, 0J31686
0K31697, 0K31708
0L31620, 0L31626
0L31638, 0L31638R
0L31678, 0M31578
-5-
8. Carafate, 1 g., 1/2's K03949
(Sucralfate)
9. Cardizem, 30 mg., 1/2's K05782
(Diltiazem HCl)
10. Cardizem, 90 mg., 1/2's K04543
(Diltiazem HCl)
11. Catapres, 0.1 mg., 1/2's 060011A
(Clonidine HCl)
12. Chlorpheniramine Maleate, 4 mg., 0B045
1/2's
13. Chlorpropamide, 250 mg., 1/2's 72368
14. Cipro, 500 mg., 1/2's OJEL, OKFD, OKFZ
(Ciprofloxacin HCl)
15. Clonidine HCl, 0.1 mg., 1/2's 106891
16. Constant-T, 300 mg., 1/2's 171461
(Theophylline)
17. Corgard, 20 mg., 1/2's 0G51918
(Nadolol)
18. Coumadin, 2 mg., 1/2's CH170A
(Warfarin Sodium)
19. Coumadin, 2 mg., 1 1/2's CF145A, CJ182A
(Warfarin Sodium)
20. Cyclobenzaprine HCl, 10 mg., 1/2's 396120
21. Cyproheptadine HCl, 4 mg., 1/2's 292952, 292955
292958, 292958R
22. Cytotec, 200 mcg., 1/2's 1290244
(Misoprostol)
23. Decadron, 0.5 mg., 1/2's 50404, 50809
(Dexamethasone)
24. Diazepam, 2 mg., 1/2's 3925727
25. Diazepam, 5 mg., 1/2's & 3925728R, 3926829
1 1/2's 3926845
26. Didronel, 200 mg., 1/2's 203847R
(Etidronate Disodium)
27. Florinef Acetate, 0.1 mg., 1/2's 1E4725
(Fludrocortisone Acetate)
28. Furosemide, 20 mg., 1/2's 292143, V012D, W065A
29. Furosemide, 40 mg., 1/2's V093L
30. Furosemide, 40 mg., 1 1/2's 900883
31. Glucotrol, 5 mg., 1/2's 0842A, 0852A, 0857A
(Glipizide) 0857A, 0872A, A041A
A690E, D530AR, D540A
32. Halcion, 0.25 mg., 1/2's 223YB
(Triazolam)
33. Haloperidol, 0.5 mg., 1/2's 71541, 72038
34. Haloperidol, 1 mg., 1/2's 039H0
35. Haloperidol, 2 mg., 1/2's 01479DA
36. Haloperidol, 5 mg., 1/2's 335490
37. Hydrochlorothiazide, 25 mg., 0L019AI, 71724
1/2's
38. Isosorbide Dinitrate, 5 mg., 116689
1/2's 513189
-6-
39. Klonopin, 0.5 mg, 1/2's 0501
(Clonazepam)
40. Lanoxin, 0.125 mg., 1/2's 0T3140
(Digoxin) 0Z1442
41. Lanoxin, 0.125 mg., 1 1/2's 0R1448, OT3140
(Digoxin) 0X2529, 0Z1442
42. Levatol, 20 mg., 1/2's 4NK79A
(Penbutolol Sulphate)
43. Lioresal, 10 mg., 1 1/2's 1T127251
(Baclofen)
44. Lopid, 600 mg., 1/2's 06111VA
(Gemfibrozil)
45. Lopressor, 50 mg., 1/2's 0T0081
(Metoprolol Tartrate) 1T002357, 1T135719
46. Lorazepam, 0.5 mg., 1/2's W029A, W030A
47. Magonate, 500 mg., 1/2's 1031252
(Magnesium Gluconate Dihydrate)
48. Maxzide, 37.5 mg./25 mg., 1/2's 304317P
(Triamterene/Hydrochlorothiazide)
49. Maxzide, 75 mg./50 mg., 1/2's 292305P
(Triamterene/Hydrochlorothiazide) 294312P, 296312P
50. Medrol, 4 mg., 3/4's 459DP
(Methylprednisolone)
51. Mestinon, 60 mg., 1/2's 1157
(Pyridostigmine Bromide)
52. Metoclopramide, 5 mg., 1/2's 0M03
53. Metoclopramide, 10 mg., 1/2's 14634, 007PR026
009PR007, 011PR001
012PR009, 012PR009R
103PR001, 104PR007
104PR007R, 71739, 0A40
0A45, 0J08, 0J08R
1A36, H48602, 023A13
0300699, 90B045,
90C058, 91C082, 91C107
54. Metoclopramide, 10 mg., 2 1/2's 14634, 0A40, 0A45
55. Moduretic, 5 mg./50 mg., 1/2's 50862
(Amiloride/Hydrochlorothiazide)
56. Orap, 2 mg., 1/2's 9193
(Pimozide) 9193R
57. Oxybutynin Chloride, 5 mg., 1/2's H35303, H50801,
0210507, 0210509
0410874, 0411040R
1001727
58. Parlodel, 2.5 mg., 1/2's 775P1496
(Bromocriptine Mesylate) 790P1502, 791P1504
80051777
59. Pepcid, 20 mg., 1/2's T0244
(Famotidine) T0413, T0527R
60. Prednisone, 5 mg., 1/2's 15660
61. Primidone, 250 mg., 1/2's 04042C, 04486CR
62. Proloid, 32 mg., 1/2's 06420VA
(Thyroglobulin)
-7-
63. Reglan, 5 mg. 1/2's 90339
(Metoclopramide) 91552, 91593, 91694R
64. Regroton, 50 mg./0.25 mg., 1/2's 01402
(Chlorthalidone/Reserpine)
65. Sinemet, 10 mg./100 mg., 1/2's 51082
(Carbidopa/Levodopa) T0381, T0381R
66. Sinemet, 25 mg./100 mg., 1/2's T0220
(Carbidopa/Levodopa) T0498
67. Sinemet, 25 mg./250 mg., 1/2's 51152
(Carbidopa/Levodopa) 51153, T0006, T0468
T0565, T0653, T0712R
68. Sulfamethoxazole/Trimethoprim, 102NC030R
400 mg./80 mg., 1/2's
69. Sulindac, 200 mg., 1/2's 39176D
70. Tegretol, 100 mg., 1/2's 1T001955
(Carbamazepine)
71. Tenormin, 50 mg., 1/2's AD801
(Atenolol) AD891, AD941, AE221
AE231, AE271, AE371
AE511R
72. Theo-Dur, 100 mg., 1 1/2's 90284
(Theophylline)
73. Trazadone HCl, 50 mg., 1/2's 110207, 0110032
0110055, 0310706
0310710, 0901739
1102181
74. Trazadone HCl, 50 mg., 1 1/2's 0110056
75. Trazadone HCl, 150 mg., 1/2's 0310727, 0310729R
0310818, 1002032
1102190
76. Triamterene/Hydrochlorothiazide, 01444DJ
75 mg./50 mg., 1/2's 34802X0, 34807G0
34807M0, 92641W
77. Trihexyphenidyl HCl, 2 mg., 1/2's 39057D, 39386D
39936DR, 40295D
78. Vasotec, 2.5 mg., 1/2's 58728
(Enalapril Maleate) 58809R
79. Vasotec, 5 mg., 1/2's 58682
(Enalapril Maleate) T8506, T8514, T9701
80. Verapamil HCl, 80 mg., 1/2's 03686C, 34302E0
34303B0, 34303J0
81. Verapamil HCl, 120 mg., 1/2's T085K
82. Vitamin B6, 50 mg. 1/2's 0EF0014
83. Xanax, 0.25 mg., 1/2's 383YD
(Alprazolam) 414YD, 437YD, 438YD
438YDR, 452YDR
84. Zestril, 5 mg., 1/2's 4497L
(Lisinopril)
85. Zestril, 10 mg., 1/2's 0438L
(Lisinopril)
86. Zinc, Chelated, 50 mg., 1/2's 14898
anufacturer: Various.
Recalled by: Pharmaceutical Services of Middle Tennessee, Inc.,
Nashville, Tennessee (repacker/responsible firm),
-8-
by telephone August 6, 1991 and letter August 7, 1991.
Firm-initiated recall ongoing.
Distribution: Tennessee.
Quantity: 71,389 unit dose packets were distributed; firm
estimates none remains on the market.
Reason: Cutting of tablets and unit-dose repacking of partial
tablets.
----
Product: (a) Whole Blood; (b) Red Blood Cells; (c) Recovered
Plasma. Recall #B-361/363-1.
Code: Unit numbers: (a) NA18707; (b) NA18617, NA18697;
(c) NA18617, NA18697.
anufacturer: East Texas Blood Center, Inc., Nacogdoches, Texas.
Recalled by: Manufacturer, by visit February 6, 1991, and by letter
dated February 8, 1991. Firm-initiated recall ongong.
Distribution: Texas.
Quantity: (a) 1 unit; (b) 2 units; (c) 2 units.
Reason: Blood products, incorrectly tested for the antibody
to the human immunodeficiency virus type 1 (anti-HIV-1),
and for the antibody to the hepatitis C virus (anti-HCV),
were distributed.
----
NOTE: Code section for Recall #B-338/342-1, blood products
distributed by the American Red Cross, Wichita, Kansas,
which appeared in the July 31, 1991 Enforcement Report has
been amended:
Granulocytes, Pheresis, Recall #B-341-1 - delete units
02P09833 and 02P09834.
----
Class III -
Product: (a) Whole Blood; (b) Red Blood Cells; (c) Platelets;
(d) Fresh Frozen Plasma; (e) Recovered Plasma.
Recall #B-364/368-1.
Code: Unit numbers: (a) NA18607, NA18655, NA18661, NA18709,
NA18711, NA18724, NA18752, NA18789, NA18791, NA18796:
(b) NA18602, NA18603 NA18604, NA18605, NA18606, NA18608,
NA18609, NA18610, NA18611, NA18612, NA18613, NA18614, NA18615, NA18616,
NA18618, NA18619, NA18620, NA18621, NA18622, NA18623, NA18624, NA18625,
NA18626, NA18627, NA18628, NA18629, NA18630, NA18631, NA18632, NA18633,
NA18634, NA18635, NA18636, NA18637, NA18638, NA18639, NA18640, NA18641,
NA18642, NA18643, NA18644, NA18645, NA18646, NA18647, NA18648, NA18649,
NA18650, NA18651, NA18652, NA18653, NA18654, NA18656, NA18658, NA18659,
NA18660, NA18662, NA18663, NA18664, NA18665, NA18666, NA18667, NA18668,
NA18669, NA18670, NA18671, NA18673, NA18674, NA18675, NA18676, NA18677,
NA18678, NA18679, NA18680, NA18682, NA18683, NA18684, NA18685, NA18686,
-9-
NA18687, NA18688, NA18689, NA18690, NA18691, NA18692, NA18693, NA18696,
NA18698, NA18700, NA18701, NA18702, NA18704, NA18705, NA18706, NA18708,
NA18710, NA18714, NA18715, NA18716, NA18717, NA18718, NA18719, NA18720,
NA18721, NA18722, NA18723, NA18725, NA18726, NA18727, NA18728, NA18729,
NA18730, NA18731, NA18732, NA18733, NA18734, NA18735, NA18736, NA18737,
NA18738, NA18739, NA18740, NA18741, NA18742, NA18743, NA18744, NA18745,
NA18750, NA18753, NA18754, NA18755, NA18756, NA18757, NA18758, NA18759,
NA18760, NA18762, NA18763, NA18764, NA18765, NA18766, NA18767, NA18768,
NA18769, NA18770, NA18771, NA18772, NA18773, NA18774, NA18775, NA18776,
NA18777, NA18778, NA18779, NA18780, NA18781, NA18782, NA18783, NA18784,
NA18785, NA18786, NA18787, NA18788, NA18790, NA18792, NA18793, NA18794,
NA18797, NA18798, NA18799, NA18800, NA18801, NA18802, NA18803, NA18804,
NA18805, NA18806, NA18808, NA18809, NA18810, NA18811, NA18812, NA18813,
NA18814, NA18815, NA18816, MU27217, MU27218, MU27220, MU27221, MU27222,
U27223, MU27224, MU27225, MU27226, MU27228, MU27229, MU27230, MU27231,
U27232, MU27233, MU27234, MU27235, MU27236, MU27258, MU27259, MU27260,
U27261, MU27262, MU27263, MU27264, MU27265, MU27266, MU27267, MU27269,
U27270, MU27271, MU27273, MU27274, MU27275, MU27276, MU27277, MU27278,
U27279, MU27280, MU27281, MU27282, MU27283, MU27284, MU27285, MU27286,
U27287, MU27288, MU27289, MU27290, MU27291, MU27292, MU27293, MU27294,
U27295, MU27296, MU27297, MU27298, MU27299, MU27300, MU27301, MU27302,
U27303, MU27304, MU27305, MU27306, MU27307, MU27308, MU27309, MU27310,
U27312, MU27313, MU27314, MU27315, MU27316, MU27317, MU27319, MU27320,
U27321, MU27322, MU27323, MU27324, MU27325, MU27326, MU27328, MU27329,
U27330, MU27331, MU27332, MU27334, MU27337, MU27338, MU27339, MU27340,
U27341, MU27342, MU27343, MU27344, MU27345, MU27347, MU27348, MU27349,
U27350, MU27351, MU27352, MU27353, MU27354, MU27355, MU27356, MU27358,
U27359, MU27360, MU27362, MU27363, MU27366, MU27367.
(c) NA18602, NA18651, NA18652, NA18653, NA18654, NA18655, NA18656, NA18659,
NA18660, NA18662, NA18663, NA18664, NA18665, NA18666, NA18667, NA18668,
NA18669, NA18670, NA18671, NA18672, NA18673, NA18674, NA18675, NA18708,
NA18710, NA18714, NA18715, NA18716, NA18717, NA18718, NA18719, NA18720,
NA18721, NA18722, NA18723, NA18725, NA18726, NA18727, NA18728, NA18729,
NA18730, NA18731, NA18732, NA18733, NA18734, NA18735, NA18736, NA18737,
NA18738, NA18739, NA18740, NA18742, NA18743, NA18744, NA18763, NA18775,
NA18776, NA18777, NA18778, NA18779, NA18780, NA18781, NA18782, NA18783,
NA18784, NA18785, NA18790, NA18792, NA18793, NA18794, NA18797, NA18798,
NA18799, NA18800, NA18801, NA18802, NA18803, NA18804, NA18809, NA18810,
NA18811, NA18812, NA18813, NA18814, NA18815, NA18816, MU27217, MU27218,
U27220, MU27221, MU27222, MU27223, MU27224, MU27225, MU27226, MU27228,
U27229, MU27230, MU27231, MU27232, MU27233, MU27234, MU27235, MU27236,
U27258, MU27259, MU27260, MU27261, MU27262, MU27263, MU27264, MU27265,
U27267, MU27269, MU27270, MU27271, MU27273, MU27274, MU27275, MU27276,
U27277, MU27278, MU27279, MU27280, MU27281, MU27282, MU27298, MU27299,
U27300, MU27301, MU27302, MU27303, MU27304, MU27305, MU27306, MU27307,
U27308, MU27309, MU27310, MU27312, MU27313, MU27315, MU27316, MU27319,
U27320, MU27321, MU27358, MU27359, MU27360, MU27362, MU27363, MU27366,
U27367.
(d) NA18621, NA18736, NA18802, NA18803, NA18804, NA18805, MU18806,
U27218, MU27259, MU27360.
(e) NA18602, NA18603, NA18604, NA18605, NA18606, NA18608, NA18609, NA18610,
NA18611, NA18612, NA18613, NA18614, NA18615, NA18616, NA18618, NA18619,
NA18620, NA18622, NA18623, NA18624, NA18625, NA18626, NA18627, NA18628,
-10-
NA18629, NA18630, NA18631, NA18632, NA18633, NA18634, NA18635, NA18637,
NA18638, NA18639, NA18640, NA18641, NA18642, NA18643, NA18644, NA18645,
NA18646, NA18647, NA18648, NA18649, NA18650, NA18651, NA18652, NA18653,
NA18654, NA18656, NA18658, NA18659, NA18660, NA18662, NA18663, NA18664,
NA18665, NA18666, NA18667, NA18668, NA18669, NA18670, NA18671, NA18673,
NA18674, NA18675, NA18676, NA18677, NA18678, NA18679, NA18680, NA18682,
NA18683, NA18684, NA18685, NA18686, NA18687, NA18688, NA18689, NA18690,
NA18691, NA18692, NA18693, NA18696, NA18698, NA18700, NA18701, NA18702,
NA18704, NA18705, NA18706, NA18708, NA18710, NA18714, NA18715, NA18716,
NA18717, NA18718, NA18719, NA18720, NA18721, NA18722, NA18723, NA18725,
NA18726, NA18727, NA18728, NA18729, NA18730, NA18731, NA18732, NA18733,
NA18734, NA18735, NA18736, NA18737, NA18738, NA18739, NA18740, NA18741,
NA18742, NA18743, NA18744, NA18745, NA18750, NA18753, NA18754, NA18755,
NA18756, NA18757, NA18758, NA18759, NA18760, NA18762, NA18763, NA18764,
NA18765, NA18766, NA18767, NA18768, NA18769, NA18770, NA18771, NA18772,
NA18773, NA18774, NA18775, NA18776, NA18777, NA18778, NA18779, NA18780,
NA18781, NA18782, NA18783, NA18784, NA18785, NA18786, NA18787, NA18788,
NA18790, NA18792, NA18793, NA18794, NA18797, NA18798, NA18799, NA18800,
NA18801, NA18808, NA18809, NA18810, NA18811, NA18812, NA18813, NA18814,
NA18815, NA18816, MU27217, MU27220, MU27221, MU27222, MU27223, MU27224,
U27225, MU27226, MU27228, MU27229, MU27230, MU27231, MU27232, MU27233,
U27234, MU27235, MU27236, MU27258, MU27260, MU27261, MU27262, MU27263,
U27264, MU27265, MU27266, MU27267, MU27269, MU27270, MU27271, MU27273,
U27274, MU27275, MU27276, MU27277, MU27278, MU27279, MU27280, MU27281,
U27282, MU27283, MU27284, MU27285, MU27286, MU27287, MU27288, MU27289,
U27290, MU27291, MU27292, MU27293, MU27294, MU27295, MU27296, MU27297,
U27298, MU27299, MU27300, MU27301, MU27302, MU27303, MU27304, MU27305,
U27306, MU27307, MU27308, MU27309, MU27310, MU27312, MU27313, MU27314,
U27315, MU27316, MU27317, MU27319, MU27320, MU27321, MU27322, MU27323,
U27324, MU27325, MU27326, MU27328, MU27329, MU27330, MU27331, MU27332,
U27334, MU27337, MU27338, MU27339, MU27340, MU27341, MU27342, MU27343,
U27344, MU27345, MU27347, MU27348, MU27349, MU27350, MU27351, MU27352,
U27353, MU27354, MU27355, MU27356, MU27358, MU27359, MU27362, MU27363,
U27366, MU27367.
anufacturer: East Texas Blood Center, Inc., Nacogdoches, Texas.
Recalled by: Manufacturer, by visit February 6, 1991 and by
letter February 8, 1991. Firm-initiated recall complete.
Distribution: Texas.
Quantity: (a) 10 units; (b) 300 units; (c) 153 units;
(d) 10 units; (e) 290 units.
Reason: Blood products, incorrectly tested for the antibody
to the human immunodeficiency virus type 1 (anti-HIV-1),
and for the antibody to the hepatitis C virus (anti-HCV),
were distributed.
----
NOTE: Code section for Recall #B-343/345-1, blood products
distributed by the American Red Cross, Wichita, Kansas,
which appeared in the July 31, 1991 has been amended:
Granulocytes, Recall #B-341-1 Pheresis - add units 02P09833
and 02P09834;
Platelets, Recall #B-345-1 - delete units 02P09833 and
02P09834.
----
-11-
DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
NONE
Class II -
Product: Dilapan Hygroscopic Cervical Dilator.
Recall #Z-891-1.
Code: Batch #D040490D.
anufacturer: Gynotech, Inc., Middlesex, New Jersey.
Recalled by: Manufacturer, by telephone January 18, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 1,825 units were distributed.
Reason: The device may break and fragments could be retained
in the patient. Premarket approval supplement for
manufacturing this device at Middlesex, N.J. location
has also not been approved.
----
Product: ConFirm Biological Sterilization Indicator System Test
Strips, indicated for use in determining efficiency of
steam, dry heat, or EO sterilization:
(a) Reorder No. CST010 (1 test set);
(b) Reorder No. CST060 (6 test sets). Recall #Z-895/896-1.
Code: All lots of product distributed in 1989 and 1990.
Product has 2 year expiration.
anufacturer: Cottrell, Ltd., Englewood, Colorado.
Recalled by: Manufacturer, by letter July 24, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 3,348 units were distributed.
Reason: The affected test strips are indicated for use as a
biological indicator in monitoring the unsaturated chemical
vapor (chemiclave) sterilization process, without
510(k) approval for this specific application.
----
Product: Beckman Synchron Control, Multi-Level Assayed Kit, an
in-vitro control kit intended for use with "Synchron"
Analyzer Systems, to monitor changes in calibration and
linearity along with analytical error and imprecision.
Recall #Z-897-1.
Code: Part #657365, Lot #M007190, Control Lot numbers:
M003011 (Level 1), M003012 (Level 2), M003013 (Level 3)
EXP 11/30/91.
anufacturer: Beckman Instruments, Inc., Carlsbad, California.
Recalled by: Beckman Instruments, Inc., Brea, California, by
-12-
letter February 5, 1991. Firm-initiated field
correction ongoing.
Distribution: Nationwide and international.
Quantity: 1,660 units were distributed; firm estimates that
little product remains on the market.
Reason: The AST and total bilirubin analytes in this lot of
product are recovering below the published insert
range on level 3 assayed control in the kit on some
SYNCHRON AS, CX4, and CX5 systems. Additionally, the
level 3 control may be decaying and form a precipitate
before the published expiration date which may cause
the magnesium recovery.
----
Product: Beckman Vigil PRX Multi-Level Protein Control,
an in-vitro control kit used to monitor the reliability and
overall performance of specific protein and therapeutic
drug test systems. Recall #Z-898-1.
Code: Part #442621, Lot #M002118 EXP 11/30/91.
anufacturer: Beckman Instruments, Carlsbad, California.
Recalled by: Beckman Instruments, Brea, California, by letter
February 28, 1991. Firm-initiated field correction ongoing.
Distribution: California, Connecticut, Indiana, Kentucky, Missouri,
North Carolina, New York, Oklahoma, Pennsylvania,
Wisconsin, Wyoming, Hawaii.
Quantity: 21 units were distributed.
Reason: The IA, IG, IM, Albumin and Transferrin analytes may
recover above the published insert range for the control
material when it is used for nephelometric assays in
conjunction with the "Array" Protein System Analyzers.
----
Product: Beckman Dri-Stat Reagent, an in-vitro reagent for use
in in-vitro diagnostic determinations of C02 levels.
Recall #Z-899-1.
Code: Lot #M909197 EXP 9/30/91.
anufacturer: Beckman Instruments, Inc., Carlsbad, California.
Recalled by: Beckman Instruments, Brea, California, by letter March 11,
1991. Firm-initiated field correction ongoing.
Distribution: California, Colorado, Georgia, Michigan, Minnesota,
New Jersey, Texas, Puerto Rico.
Quantity: 629 units were distributed; FDA estimates that very
little remains on the market.
Reason: Product does not maintain reconstituted eight hour
stability as specified in the published insert.
----
Product: 3M Maxi-Driver II (TM) Oscillating Saws:
(a) Model No. L120B;
(b) Model No. L220;
(c) Model No. L120A/B. Recall #Z-901/903-1.
-13-
Code: All serial numbers.
anufacturer: 3M Orthopedic Products Division, Irvine, California.
Recalled by: 3M Orthopedic Products Division, St. Paul, Minnesota, by
telephone April 10, 1991 followed by letter. Firm-initiated
recall complete.
Distribution: (a) Nationwide; (b & c) Nationwide, Canada, The
Netherlands.
Quantity: (a) 137 units; (b) 93 units; (c) 6 units were distributed.
Reason: Longer, heavier knee blades may disengage from the
device during use.
----
Product: Acetabular Shell Liner, Model 3820, an ultra-high
molecular weight polyethylene (UHMWPE) liner used in
combination with a metal acetabular shell.
Recall #Z-904-1.
Code: All production lots prior to and including P90L0229.
anufacturer: Orthomet, Inc., Minneapolis, Minnesota.
Recalled by: Manufacturer, by telephone January 1991. Firm-initiated
recall complete.
Distribution: Nationwide, Sweden, Germany, Austria, Belgium, Spain,
Italy, France.
Quantity: 2,068 liners were distributed.
Reason: When the fit between the liner and shell are poor the
shell liner can toggle and/or rotate within the metal
acetabular shell.
----
Product: Tecnomed TEC 1405 Generator, used for medical diagnostic
x-ray examination, Recall #Z-905-1.
Code: All serial numbers.
anufacturer: Tecnomed USA, Bay Shore, New York.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan July 26, 1991. Firm-initiated field correction
ongoing.
Distribution: Alabama.
Quantity: 1 unit was distributed.
Reason: Noncompliance with performance standard for x-ray
products in that there is no visible signal to
indicate that back-up time has been reached, nor is there
a means to prevent another exposure from being made before
the back-up timer has been reset.
----
Class III -
Product: Adjustable Wishbone Assembly, a component of a Set-Up
Module 5000 Adjustable Wishbone Retraction System,
used for retraction during surgery, Recall #Z-881-1.
Code: Serial numbers 3460.
-14-
anufacturer: Omni-Tract Surgical, Division of Minnesota Scientific
Inc., St. Paul, Minnesota.
Recalled by: Manufacturer, by letter May 28, 1991. Firm initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 99 units were distributed.
Reason: User misalignment during set-up may possibly cause the
retaining ring to loosen and not allow the device
assembly (clamp) to be properly tightened.
----
Product: Auto ICS Flow Cell/Stirrer Kit, Part #663495, an in-vitro
diagnostic product used for quantitation components of
biological fluids, Recall #Z-892-1.
Code: Lot numbers: PO-10-25, PO-09-27.
anufacturer: Beckman Instruments, Inc., Fullerton, California.
Recalled by: Beckman Instruments, Inc., Brea, California, by letter
December 21, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide and international
Quantity: 489 kits were distributed.
Reason: A portion of the stirrers were not magnetized, which if
used, would result in a nonhomogenous reagent mixture
that would be out of range values for the controls.
----
Product: Beckman Synchron CX Systems T-Uptake Reagent, an in-vitro
diagnostic kit for use with Synchron CX System Analyzers
for the quantitative determination of the unoccupied
thyroxine-binding capacity in serum and plasma.
Recall #Z-900-1.
Code: Part #445999, Lot numbers: 5258A, L5258A EXP 10/31/91.
anufacturer: Microgenics Corporation, Concord, California.
Recalled by: Beckman Instruments, Inc., Brea, California, by
telephone December 3, 1990. Firm-initiated recall ongoing.
Distribution: Washington D.C., California, Connecticut, Georgia, Hawaii,
Illinois, Kansas, Kentucky, Louisiana, New York, Oregon,
South Carolina, Tennessee, Virginia, West Virginia, Oklahoma.
Quantity: 26 units were distributed; firm estimates none remains
on the market.
Reason: The calibrator components are not performing to labeling
specifications due to a loss in reconstituted stability.
The stability loss can be attributed to the effect of
lyophilization on the human serum raw materials used in
the product.
----
VETERINARY PRODUCTS
NONE
-15-