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
01/04/1995
Recalls and Field Corrections: Foods -- Class I -- 01/04/1995
January 4, 1995 95-1
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Nutritional supplements: (a) Pneumo Complex Tablets, in 60
tablets per bottle, a nutritional supplement formulation
including lung and thymus tissue; (b) Thymus Complex
Tablets, a nutritional supplement formulation including
thymus, spleen, adrenal, lymph, placenta, parotid tissues,
in a base of synergistic herbs, in 60 tablet and 180 tablet
bottles. Recall #F-157/158-9.
CODE Lot numbers: (a) 13244; (b) 07041.
MANUFACTURER Impact Nutrition, Rocklin, California.
RECALLED BY Molecular Biologics, Inc., Benicia, California, by letter
August 17, 1994. Firm-initiated recall ongoing.
DISTRIBUTION California, Idaho, Colorado.
QUANTITY (a) 59 bottles; (b) 1,323 bottles of 60 and 370 bottles of
180 tablets were distributed.
REASON When taken according to the recommended dosage, the tablets
may cause irreversible injury to the developing fetuses in
some pregnant women due to the excessive levels of vitamin A
that would be ingested.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Keebler Toasteds Compliment Crackers:
(a) Buttercrisp Crackers, Item #32292;
(b) Onion Crackers, Item #32219;
(c) Wheat Crackers, Item #04911. Recall #F-150/152-5.
CODE Lot numbers: (a) 119U, 119W, 119Z, 126Z, 129U, 129W, 129Z,
131U, 136U, 136W, 137U, 146U, 146W, 151U, 151W, 152U, 161U,
161W, 161Z, 166U, 173U, 173W, 178U, 178W, 206U, 206W, 206Z,
208W;
(b) 122W, 122Z, 123Z, 139U, 139W, 140U, 146W, 146Z, 153U,
153W, 167U, 167W, 181U, 181W, 209U, 209W, 210U;
(c) 132U, 132Z, 140U, 140W, 143U, 147U, 147W, 147Z, 151U,
154U, 154W, 154Z, 164U, 164W, 168U, 168W, 171U, 182U, 182W,
182Z.
MANUFACTURER Keebler Company, Macon, Georgia.
RECALLED BY Keebler Company, Elmhurst, Illinois, by visit beginning
August 3, 1994, and by telephone August 5, 1994. The Food
Allergy Network was also notified. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 51,195 boxes; (b) 30,781 boxes; (c) 31,671 boxes were
distributed; firm estimated that 30 percent of product
remained on market at time of recall initiation.
REASON Product is mislabeled with a "K Pareve" kosher no dairy
legend on the container label which actually contains a
dairy product.
_______________
PRODUCT Dragon Seed brand Canned Sliced Mushrooms, in 2840 gm cans.
Recall #F-153-5.
CODE All can codes.
MANUFACTURER Unknown, possibly a Product of the People's Republic of
China.
RECALLED BY Tai Wing Hong, Brooklyn, New York, by letter September 26,
1994. Firm-initiated recall ongoing.
DISTRIBUTION New York, Massachusetts, Texas.
QUANTITY 3,000 cartons (6 cans per carton) were distributed.
REASON Product is contaminated with Staphylococcal enterotoxin.
_______________
PRODUCT Gunnoe's Farm brand (a) Potato Salad, in 12 ounce, 24 ounce,
and 10 pound containers; (b) Egg Salad, in 12 ounce, 3
pound, and 10 pound containers; (c) Pimento Spread, in 7
ounce, 12 ounce 3 pound, and 10 pound containers.
Recall #F-154/156-5.
CODE All product manufactured prior to 9/19/94. Firm uses a "USE
BY DATE" on their containers: (a) 10-19 or before (35 day
use by date); (b) 10-17 or before (32 day use by date);
(c) 12-16 or before (90 day use by date).
MANUFACTURER R.G. Gunnoe Farms, Inc., Salad Division, Charleston, West
Virginia.
-2- RECALLED BY Manufacturer, by verbal instructions to route men to remove
product as they make their routine weekly visits to store
accounts. This began on September 10, 1994. Firm-initiated
recall complete.
DISTRIBUTION West Virginia, Ohio, Kentucky, Virginia, North Carolina,
South Carolina.
QUANTITY Firm estimated that they manufactured the following amounts
of products which remain in date and are subject to this
recall:
(a) Potato Salad: 12 oz.- 300 cases (12 containers/case)
24 oz.- 1250 cases (6 containers/case)
10 lb.- 300 pails
(b) Egg Salad: 12 oz.- 225 cases
3 lb. - 90 pails
10 lb. - 20 pails
(c) Pimento Spread: 7 oz. - 480 cases (18 containers/case)
12 oz.- 3600 cases
3 lb. - 300 pails
10 lb. - 100 pails
REASON Product contains undeclared FD&C Yellow No. 5.
_______________
PRODUCT Vitamin Supplement Products: (a) Vit-A-Boost Tablets, 25
mcg selenium; (b) Little Super Vit-A-Boost Tablets, 50 mcg
selenium; (c) Super Vit-A-Boost Capsules, 50 mcg selenium;
(d) Super Vit-A-Boost Tablets, 50 mcg selenium.
Recall #F-168/171-5.
CODE Lot numbers: (a) 083020, 093034, 103029; (b) 083018,
083043, 093031, 123008, 123050; (c) 083022, 093028; (d)
063019, 093029, 093030, 103026, 123009.
MANUFACTURER Naturally Vitamin Supplements, Inc., Scottsdale, Arizona.
RECALLED BY Manufacturer, by letter June 7, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Arkansas, Arizona, California, Florida, Idaho, Indiana,
Louisiana, Michigan, Minnesota, Missouri, Montana, New
Jersey, New Mexico, North Dakota, Ohio, Oklahoma, Oregon,
Texas, Utah, Washington State, West Virginia, Wisconsin, and
international.
QUANTITY Undetermined.
REASON Products contain selenium in excess of the amount stated on
the label.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Source Plasma. Recall #B-109-5
CODE * 127 units
PW 03 358, PW 04 051, PW 04 196, PW 04 377, PW 04 508, PW 04
680, PW 05 689, PW 06 363, PW 07 026, PW 08 852, PW 09 011,
PW 09 212, PW 09 354, PW 09 576, PW 09 659, PW 09 734, PW 09
954, PW 10 115, PW 10 345, PW 10 510, PW 10 739, PW 10 931,
-3- PW 11 471, PW 11 909, PW 12 073, PW 12 298, PW 12 496, PW 14
115, PW 14 346, PW 14 489, PW 14 756, PW 14 920, PW 15 170,
PW 15 314, PW 15 341, PW 15 516, PW 15 518, PW 15 690, PW 15
905, PW 16 145, PW 16 313, PW 16 796, PW 16 975, PW 17 148,
PW 17 316, PW 18 345, PW 18 494, PW 18 753, PW 18 892, PW 19
114, PW 19 252, PW 19 495, PW 19 627, PW 19 901, PW 20 320,
PW 20 692, PW 21 158, PW 21 345, PW 21 690, PW 22 328, PW 22
516, PW 22 626, PW 22 836, PW 23 359, PW 23 617, PW 23 803,
PW 24 059, PW 24 292, PW 24 533, PW 26 593, PW 32 755, PW 32
896, PW 33 088, PW 33 206, PW 33 356, PW 33 473, PW 33 824,
PW 33 873, PW 34 460, PW 34 570, PW 34 699, PW 34 876, PW 35
199, PW 35 558, PW 35 939, PW 36 257, PW 36 381, PW 36 811,
PW 37 228, PW 37 362, PW 37 821, PW 37 930, PW 38 231, PW 38
702, PW 38 797, PW 42 982, PW 43 236, PW 43 619, PW 44 020,
PW 44 188, PW 44 741, PW 44 917, PW 45 393, PW 45 536, PW 45
966, PW 46 226, PW 46 620, PW 46 793, PW 47 178, PW 47 377,
PW 47 895, PW 47 988, PW 48 343, PW 48 427, PW 48 973, PW 49
283, PW 49 643, PW 49 906, PW 50 308, PW 50 561, PW 50 902,
PW 51 206, PW 51 621, PW 57 853, XW 06 448, XW 06 502,
XW 11 111.
** 584 units
PD 02 969, PD 64 117, PD 66 532, PD 69 267, PS 00 448, PS 12
558, PS 12 668, PS 12 840, PS 13 025, PS 13 254, PS 13 632,
PS 13 731, PS 13 950, PS 14 403, PS 14 629, PS 15 044, PS 15
307, PS 15 715, PS 15 991, PS 16 351, PS 16 658, PS 16 987,
PS 17 279, PS 17 912, PS 18 155, PS 18 917, PS 19 358, PS 19
704, PS 19 998, PS 20 309, PS 20 667, PS 21 080, PS 21 483,
PS 21 841, PS 22 266, PS 22 553, PS 22 737, PS 24 637, PS 24
844, PS 28 160, PS 28 671, PS 29 909, PS 30 481, PS 33 274,
PS 37 598, PS 40 179, PS 41 107, PS 41 736, PS 42 003, PS 42
435, PS 42 630, PS 45 458, PS 45 589, PS 46 149, PS 46 343,
PS 50 875, PS 51 181, PS 51 626, PS 54 477, PS 54 895, PS 55
057, PS 55 510, PS 55 735, PS 85 577, PS 86 129, PS 86 856,
PS 87 114, PS 87 745, PS 87 956, PS 88 483, PS 88 926, PS 89
125, PS 89 706, PS 89 890, PS 92 205, PS 96 285, PS 96 559,
PS 97 206, PS 97 451, PS 97 973, PS 98 325, PS 98 394, PS 98
546, PS 99 074, PS 99 121, PS 99 311, PW 44 956, PW 45 158,
PW 45 871, PW 46 004, PW 46 243, PW 46 329, PW 46 931, PW 47
838, PW 48 052, PW 48 201, PW 48 432, PW 48 666, PW 48 828,
PW 54 255, PW 54 416, PW 54 631, XD 56 210, XD 56 451, XD 56
760, XD 57 069, XD 60 159, XD 68 694, XD 68 976, XD 69 210,
XD 69 489, XD 69 742, XD 70 035, XD 70 431, XD 70 581, XD 70
965, XD 71 138, XD 71 509, XD 71 704, XD 72 091, XD 72 276,
XD 73 844, XD 74 235, XD 74 539, XD 74 812, XS 00 896, XS 02
251, XS 02 484, XS 02 787, XS 03 145, XS 03 698, XS 03 974,
XS 08 101, XS 08 637, XS 08 765, XS 09 264, XS 09 452, XS 09
945, XS 10 121, XS 10 176, XS 10 511, XS 10 838, XS 11 173,
XS 11 579, XS 11 846, XS 12 008, XS 12 159, XS 12 285, XS 12
656, XS 12 662, XS 12 915, XS 13 307, XS 13 568, XS 13 908,
XS 14 057, XS 14 202, XS 14 438, XS 14 611, XS 14 862, XS 15
099, XS 15 262, XS 15 575, XS 15 997, XS 16 004, XS 16 464,
XS 16 663, XS 16 887, XS 16 889, XS 17 177, XS 17 338, XS 17
-4- 530, XS 17 558, XS 17 862, XS 17 989, XS 18 211, XS 18 639,
XS 18 918, XS 19 332, XS 19 596, XS 20 065, XS 20 336, XS 20
815, XS 21 052, XS 21 554, XS 21 758, XS 22 427, XS 22 920,
XS 23 136, XS 23 201, XS 23 528, XS 23 598, XS 23 849, XS 24
123, XS 24 302, XS 24 516, XS 25 226, XS 25 385, XS 25 533,
XS 25 845, XS 25 911, XS 26 132, XS 26 238, XS 26 341, XS 26
485, XS 26 673, XS 27 123, XS 27 168, XS 27 328, XS 27 415,
XS 27 481, XS 28 478, XS 28 565, XS 28 689, XS 28 710, XS 28
813, XS 29 026, XS 29 237, XS 29 339, XS 29 520, XS 29 565,
XS 29 681, XS 29 919, XS 29 973, XS 30 036, XS 30 053, XS 30
262, XS 30 317, XS 30 320, XS 30 723, XS 30 908, XS 31 215,
XS 31 369, XS 31 758, XS 32 277, XS 32 545, XS 32 691, XS 32
749, XS 33 191, XS 33 359, XS 33 632, XS 33 641, XS 34 103,
XS 34 443, XS 34 465, XS 34 538, XS 35 271, XS 35 346, XS 35
516, XS 35 552, XS 35 869, XS 36 166, XS 36 276, XS 36 318,
XS 36 353, XS 36 666, XS 36 795, XS 37 145, XS 37 216, XS 37
263, XS 37 609, XS 37 686, XS 38 138, XS 38 559, XS 39 014,
XS 39 502, XS 39 552, XS 39 968, XS 39 998, XS 40 480, XS 40
493, XS 40 869, XS 40 922, XS 40 951, XS 41 186, XS 41 377,
XS 41 416, XS 41 546, XS 41 815, XS 41 866, XS 42 275, XS 42
287, XS 42 398, XS 42 716, XS 42 781, XS 42 856, XS 43 038,
XS 43 191, XS 43 331, XS 43 454, XS 43 660, XS 43 830, XS 44
097, XS 44 438, XS 44 547, XS 44 798, XS 45 001, XS 45 366,
XS 45 400, XS 45 582, XS 45 844, XS 46 121, XS 46 251, XS 46
526, XS 46 720, XS 47 056, XS 47 402, XS 47 867, XS 47 998,
XS 48 233, XS 48 300, XS 48 905, XS 49 011, XS 49 151, XS 49
309, XS 49 542, XS 49 795, XS 49 936, XS 50 096, XS 50 341,
XS 50 830, XS 50 864, XS 50 975, XS 51 383, XS 51 751, XS 51
821, XS 51 930, XS 52 338, XS 52 726, XS 52 779, XS 52 919,
XS 53 246, XS 53 636, XS 53 846, XS 54 133, XS 54 496, XS 54
582, XS 54 668, XS 55 054, XS 55 481, XS 55 769, XS 56 212,
XS 56 490, XS 56 509, XS 57 010, XS 60 185, XS 60 270, XS 60
602, XS 60 833, XS 61 005, XS 61 233, XS 61 286, XS 61 406,
XS 61 659, XS 61 770, XS 61 951, XS 62 178, XS 62 355, XS 62
715, XS 62 814, XS 63 084, XS 63 170, XS 63 591, XS 63 736,
XS 63 988, XS 64 347, XS 64 607, XS 64 963, XS 64 771, XS 64
931, XS 65 305, XS 65 628, XS 65 722, XS 66 036, XS 66 562,
XS 66 633, XS 66 779, XS 67 040, XS 67 728, XS 67 820, XS 67
877, XS 68 040, XS 68 503, XS 68 798, XS 68 872, XS 69 435,
XS 69 655, XS 70 284, XS 70 681, XS 70 811, XS 71 279, XS 71
456, XS 71 891, XS 72 382, XS 72 792, XS 72 895, XS 73 350,
XS 73 358, XS 73 724, XS 73 835, XS 74 257, XS 74 386, XS 74
607, XS 74 653, XS 75 151, XS 75 483, XS 76 097, XS 76 122,
XS 76 339, XS 76 411, XS 76 983, XS 77 082, XS 77 266, XS 77
320, XS 77 773, XS 77 842, XS 78 066, XS 78 358, XS 78 612,
XS 78 693, XS 78 872, XS 79 194, XS 79 508, XS 79 599, XS 79
772, XS 80 081, XS 80 494, XS 80 641, XS 80 686, XS 80 994,
XS 81 335, XS 81 567, XS 81 591, XS 81 811, XS 82 230, XS 82
445, XS 82 504, XS 82 628, XS 83 115, XS 83 212, XS 83 364,
XS 83 569, XS 84 043, XS 84 132, XS 84 450, XS 84 588, XS 84
868, XS 84 930, XS 85 352, XS 85 395, XS 85 907, XS 85 913,
XS 86 400, XS 86 442, XS 86 682, XS 86 882, XS 87 243, XS 87
-5- 801, XS 88 080, XS 88 550, XS 89 012, XS 89 100, XS 89 219,
XS 89 413, XS 89 807, XS 89 886, XS 89 999, XS 90 144, XS 90
521, XS 90 723, XS 91 013, XS 91 212, XS 91 285, XS 91 451,
XS 91 714, XS 91 957, XS 92 167, XS 92 481, XS 92 589, XS 92
760, XS 92 941, XS 93 246, XS 93 379, XS 93 389, XS 93 582,
XS 93 858, XS 93 927, XS 94 077, XS 94 196, XS 94 384, XS 94
812, XS 95 210, XS 95 322, XS 96 032, XS 96 170, XW 00 551,
XW 02 914, XW 03 193, XW 03 506, XW 03 819, XW 05 626, XW 07
284, XW 07 645, XW 07 746, XW 07 930, XW 08 417, XW 10 481,
XW 10 729, XW 11 812, XW 12 492, XW 12 689, XW 13 050, XW 15
067, XW 18 173, XW 18 237, XW 18 377, XW 18 486, XW 18 617,
XW 18 692, XW 18 781, XW 19 206, XW 50 895, XW 51 123, XW 51
307, XW 51 574, XW 59 275, XW 59 566, XW 59 721, XW 60 057,
XW 60 227, XW 60 558, XW 60 757, XW 73 892, XW 74 130, XW 74
353, XW 74 579, XW 74 599, XW 74 703, XW 74 802, XW 75 037,
XW 75 842, XW 76 029, XW 76 405, XW 76 592, XW 76 637, XW 77
160, XW 77 291, XW 77 636, XW 77 983, XW 78 649, XW 78 824,
XW 79 296, XW 79 612, XW 79 827, XW 80 602, XW 80 885, XW 82
722, XW 83 085, XW 83 431, XW 83 566, XW 83 938, XW 84 063,
XW 84 377, XW 84 556, XW 85 090, XW 85 462, XW 86 273, XW 86
598, XW 86 715, XW 86 948, XW 87 578, XW 87 772, XW 88 233,
XW 88 541, XW 88 733, XW 89 046, XW 89 309, XW 89 537, XW 89
746, XW 89 959, XW 90 208, XW 95 968, XW 97 890, XW 98 096,
XW 99 988.
MANUFACTURER Manufacturing Firm for units: *
Plasma Corporation of Clearwater, Clearwater, Florida.
Manufacturing Firm for units: **
Community Bio Resources, Inc., Birmingham, Alabama.
RECALLED BY Community Bio Resources, Inc, Birmingham, Alabama, by
letters dated from April 26, 1994 through June 14, 1994.
Firm-initiated recall complete.
REASON Blood products, which tested: (1) negative for the antibody
to human immunodeficiency virus type 1 (anti-HIV-1) but were
collected from donors who previously tested repeatedly
reactive for anti-HIV; or (2) non-reactive for hepatitis B
surface antigen (HBsAg), but were collected from donors who
previously tested repeatedly reactive for HBsAg, were
distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-111-5.
CODE Unit #5168146.
MANUFACTURER Department of the Navy, Naval Hospital, Camp LeJuene, North
Carolina.
RECALLED BY Manufacturer, by telephone May 25, 1994. Firm-initiated
recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit.
REASON Blood product, that tested repeatedly reactive for the
antibody to hepatitis C virus encoded antigen (anti-HCV),
was distributed.
-6- _______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Red Blood Cells,
Washed; (d) Platelets; (e) Platelets, Expired; (f) Fresh
Frozen Plasma; (g) Cryoprecipitated AHF; (h) Recovered
Plasma. Recall #B-114/121-5.
CODE Unit numbers: (a) 1330236, 1331477, 1341708, 1345875,
1347225, 1352049, 1353813, 1356518, 1363690, 1366416,
1441517;
(b) 1332793, 1335565, 1338550, 1340309, 1343111, 1350645,
1355180, 1359377, 1360505, 1362623, 1365056, 1367704,
1369083, 1370281, 1371338, 1372335, 1373304, 1375471,
1377013, 1377013, 1378650, 1380013, 1381156, 1382680,
1384580, 1386337, 1387601, 1389019, 1390443, 1391972,
1394296, 1396920, 1398784, 2205462, 3100495, 3102417,
3104133, 3105419, 3106855, 3108488, 3110054;
(c) 1357976, 1374385;
(d) 1343111, 1350645, 1355180, 1357976, 1360505, 1367704,
1370281, 1373304, 1374385, 1375471, 1377013, 1378650,
1381156, 1382680, 1387601, 1389019, 1391972, 1394296,
1398784, 3102417;
(e) 1396920, 3100495, 3104133, 3105419;
(f) 1367704, 1369083, 1370281, 1373304, 1377013, 1389019,
1390443;
(g) 1355108, 1371338, 1384580, 1387601;
(h) 1332793, 1335565, 1338550, 1340309, 1343111, 1350645,
1355180, 1357976, 1359377, 1360505, 1362623, 1365056,
1371338, 1372335, 1374385, 1375471, 1378650, 1381156,
1382680, 1384580, 1386337, 1387601, 1391972, 1394296,
1396920, 1398784, 2205462, 3100495, 3102417, 3104133,
3105419, 3106855, 3108488, 3110054.
MANUFACTURER Florida-Georgia Blood Alliance, Inc., Jacksonville, Florida.
RECALLED BY Manufacturer, by telephone January 24 and 31, 1994, followed
by letters sent February 2, 1994 and March 2, 1994. Firm-
initiated recall complete.
DISTRIBUTION Florida, Massachusetts, Georgia, New York, Illinois.
QUANTITY (a) 11 units; (b) 40 units; (c) 2 units; (d) 20 units; (e) 4
units; (f) 7 units; (g) 4 units; (h) 34 units.
REASON Blood products which were non-reactive for hepatitis B
surface antigen (HBsAg), but were collected from a donor who
previously tested repeatedly reactive for HBsAg, were
distributed.
_______________
PRODUCT Platelets. Recall #B-122-5.
CODE Unit numbers: 3164969, 3164971, 3164974, 3164976.
MANUFACTURER Central Texas Regional Blood Center, Austin, Texas.
RECALLED BY Manufacturer, by telephone October 17, 1993. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 4 units.
REASON Blood products labeled with incorrect expiration dates were
distributed.
-7- _______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-123/124-5.
CODE Unit #16FJ19011.
MANUFACTURER The American National Red Cross, Columbus, Ohio.
RECALLED BY Manufacturer, by letter May 24, 1994. Firm-initiated recall
complete.
DISTRIBUTION (a) Ohio; (b) California.
QUANTITY 1 unit of each component.
REASON Blood products, that tested negative for the antibody to the
human immunodeficiency virus type 1 (anti-HIV-1), but were
collected from a donor who previously tested repeatedly
reactive for anti-HIV-1, were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-133-5.
CODE Unit #60GS00768.
MANUFACTURER The American National Red Cross, Miami, Florida.
RECALLED BY Manufacturer, by telephone November 4, 1993. Firm-initiated
recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit.
REASON Blood product, collected from an ineligible donor due to
medication with human pituitary-derived growth hormone, was
distributed.
_______________
PRODUCT Platelets. Recall #B-134-5.
CODE Unit #12FJ75549.
MANUFACTURER The American National Red Cross, Charlotte, North Carolina.
RECALLED BY Manufacturer, by telephone July 15, 1994, followed by letter
July 18, 1994. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit.
REASON Blood product, containing unexpected antibodies to the red
blood cell antigen Kell (anti-K), but labeled as negative
for unexpected antibodies, was distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Reagent Red Blood Cells Surgiscreen (tm). Recall #B-112-5.
CODE Lot #3SS359.
MANUFACTURER Ortho Diagnostic Systems, Inc., Raritan, New Jersey.
RECALLED BY Manufacturer, by letter August 4, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 548 packages of 3 vials.
REASON Reagent Red Blood Cells, which incorrectly demonstrated
nonspecific reactivity, were distributed.
-8- _______________
PRODUCT Recovered Plasma. Recall #B-113-5.
CODE Unit 12LC19367.
MANUFACTURER The American National Red Cross, Charlotte, North Carolina.
RECALLED BY Manufacturer, by facsimile on April 22, 1994. Firm-
initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Recovered Plasma, corresponding to Red Blood Cells which
were contaminated with Staphylococcus (Staphylococcus
coagulase negative) was distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
======================
_______________
PRODUCT 22-Gauge Streamline Catheter. Recall #Z-007-5.
CODE Lot numbers: 307016M, 307225M, 309094M, 309232M, 309233M.
MANUFACTURER Menlo Care, Inc., Menlo Park, California.
RECALLED BY Manufacturer, by visit beginning November 22, 1993. Firm-
initiated recall complete.
DISTRIBUTION Nationwide, Italy.
QUANTITY Approximately 6,050 units were distributed.
REASON The streamline catheter has incomplete end seals.
_______________
PRODUCT Kirk Specialty Systems Pediatric, Infant and Adult CAPNO-FLO
Manual Resuscitators with Carbon Dioxide Level Monitors,
single-use, non-sterile prescription devices used for manual
ventilation and monitoring Co2 levels.
Recall # Z-127/142-5.
Model Number Description and Lot Numbers
(a) K-4130 Pediatric, swivel elbow with monitoring
port, no mask
K-4130EA Pediatric, swivel elbow with monitoring
port, no mask
(b) K-4133 Pediatric, swivel elbow with monitoring
port, pediatric mask
K-4133EA Pediatric, swivel elbow with monitoring
port, pediatric mask
(c) K-4143 Pediatric, adjustable popoff, pediatric
mask
K-4143EA Pediatric, adjustable popoff, pediatric
mask
(d) K-4230 Infant, swivel elbow with monitoring port,
no mask
K-4230EA Infant, swivel elbow with monitoring port,
no mask
(e) K-4235 Infant, swivel elbow with monitoring port,
infant mask
K-4235EA Infant, swivel elbow with monitoring port,
infant mask
-9- (f) K-4245 Infant, adjustable popoff, infant mask
K-4245EA Infant, adjustable popoff, infant mask
(g) K4000 Adult, standard elbow, no mask
K4000EA Adult, standard elbow, no mask
(h) K4001 Adult, standard elbow, adult mask
K4001EA Adult, standard elbow, adult mask
(i) K4002EA Standard elbow, SMA mask
(j) K4020 Adult, swivel elbow, no mask
K4020EA Adult, swivel elbow, no mask
(k) K4021 Adult, swivel elbow, adult mask
K4021EA Adult, swivel elbow, adult mask
(l) K4022 Adult, swivel elbow, SMA mask
K4022EA Adult, swivel elbow, SMA mask
(m) K4027 Adult, swivel elbow, adult and SMA Mask
K4027EA Adult, swivel elbow, adult and SMA Mask
(n) K4031 Adult, swivel elbow with monitoring port,
adult mask
K4031EA Adult, swivel elbow with monitoring port,
adult mask
(o) K4500 Adult cap, collapsed case
K4500EA Adult cap, collapsed case
(p) K4521 Adult cap, swivel elbow, adult mask,
collapsed case
K4521EA Adult cap, swivel elbow, adult mask,
collapsed case
CODE Model No. Lot numbers:
(a) K-4130 14058, 24032, 34078, 44038, 54028;
K-4130EA 14047, 14067, 24010, 44012, 44041, 54048;
(b) K-4133 24024, 34080, 44010, 44039, 54016;
K-4133EA 24030, 34073, 44021, 44040, 54030, 54046;
(c) K-4143 44011, 44067;
K-4143EA 44019;
(d) K4230 34033, 34054, 34079, 44035
K-4230EA 14048, 14049, 14066, 24013, 44042, 54047;
(e) K-4235 24025, 34076, 44006, 44036, 54018, 54019
K-4235EA 24031, 34072, 44031, 44070, 54017, 54029;
(f) K-4245 44009, 44073, 54027
K-4245EA 44018, 54050;
(g) K4000 14006, 14021, 14028, 14036, 24006, 34022,
344075, 44017, 44037, 54006, 54026, 123011,
123024
K4000EA 14022, 14025, 14035, 14049, 24001, 24028,
34003, 44060, 54007, 54044, 123012, 123020;
(h) K4001 14032, 14040, 14051, 24005, 24011, 34015,
34074, 44008, 44051, 54008, 54040
K4001EA 14029, 14042, 14053, 14068, 24007, 34026,
44029, 54043;
(i) K4002EA 34020;
(j) K4020 14020, 14065, 24029, 34012, 44001, 44043,
54022
K4020EA 24004, 24044, 34044, 34056, 44052, 54015;
-10- (k) K4021 44034, 54041, 24026, 34002, 34014, 44002,
44034, 54005, 54041
K4021EA 34071, 24020, 34004, 34064, 44007, 44020,
44044, 54004, 54024, 54049;
(l) K4022 14041, 34010, 54021
K4022EA 54042;
(m) K4027 24045, 54013
K4027EA 34009;
(n) K4031 44061, 54039
K4031EA 44050, 54025;
(o) K4500 44047
K4500EA 34005, 44062
(p) K4521 44046, 54023
K4521EA 34013, 34077
MANUFACTURER Kirk Specialty Systems (KSS), Carrollton, Texas.
RECALLED BY Manufacturer, by letters dated August 15, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,232 units were distributed between December 20, 1993 and
May 13, 1994.
REASON The plugs may fracture if resuscitators are exposed to
temperatures greater than 140 degrees F. Inserts that
accompany the resuscitators contain a warning not to store
the resuscitators in direct sunlight or expose to excessive
heat; however, the insert does not specify what temperature
is excessive.
_______________
PRODUCT Tanne Disposable Trephine Blades:
(a) Tanne Disposable Trephine Blades, Catalog No. E3050,
Sizes 6.0, 6.25, 6.50, 6.75, 7.0, 7.25, 7.50, 7.75,
8.0, 8.25, 8.50, 8.75, 9.0, 9.25, 9.50;
(b) Disposable Trephine Blades, Catalog No. E3096, Sizes
6.0, 6.2, 6.5, 6.7, 7.0, 7.2, 7.5, 7.7, 8.0, 8.2,
8.5, 8.7, 9.0, 9.2, 9.5, 6.0L, 6.2L, 6.5L, 6.7L,
7.0L, 7.2L, 7.5L, 7.7L, 8.0L, 8.2L, 8.5L, 8.7L,
9.0L, 9.2L, 9.5L;
(c) Castroviejo Corneal Transplant Trephine Blades (includes
2 disposable blades), Catalog No. E3094, Sizes 6.0, 6.5,
7.0, 7.2, 7.5, 7.7, 8.0, 8.2, 8.5, 9.0, 9.5;
(d) Paton See-Through Trephine Blades (includes 2 disposable
blades), Catalog No. E3086, Sizes 7.5, 8.0.
Recall #Z-171/174-5.
CODE (a) Tanne Disposable Trephine Blades
Product No. Lot No.
E3050 6.0 07727C 1532C 29102C 06411C 24712C
E3050 6.25 07725C 1502C 15021C 29201C 07113C
23913C
E3050 6.50 07224C 15321C 1552C 29202C 07114C
22413C
E3050 6.75 24713C 10423C 10421C 15522C 29203C
07912C
-11- E3050 7.0 26521C 0073C 07723C 083211C 29104C
08015C 1781C 23912C
E3050 7.25 09422C 15322C 15523C 29204C 07213C
23915C
E3050 7.50 26523C 09722C 09723C 10422C 15524C
29205C 07916C 1721C 2351C
E3050 7.75 28823C 1612C 3203C 04326C 07726C
10427C 10428C 29206C 06412C 23916C
E3050 8.0 26624C 15525C 1602C 00831C 36333C
36431C 083212C 09721C 15323C 29103C
07915C 17812C 2341C
E3050 8.2 2662C 00733C 36331C 36334C 00622C
0782C 07822C 08322C 29501C 07913C
E3050 8.5 15622C 00431C 32031C 3643C 0062C
07821C 07823C 29502C 08014C 23411C
E3050 8.75 07728C 15525C 29503C 08012C
E3050 9.0 17332C 08321C 15521C 15023C 29101C
07917C
E3050 9.25 083210C 08011C
E3050 9.50 3633C 0832C 09412C
(b) Disposable Trephine Blades
E3096 6.0 13713C 22117C 23211C 30914C 31611C
35016C 05725C 0972C 12122C 14221C
1572C
E3096 6.25 12712C 22114C 2591C 3091C 35017C
08327C 1562C 3432C 1463C 0594C
E3096 6.50 12713C 13712C 2331C 26111C 31612C
36411C 02024C 09421C 10426C 1352C
14322C 18421C 2013C 25731C
E3096 6.75 1351C 22412C 30911C 0422C 07722C
14222C 26823C 16123C
E3096 7.0 3641C 02124C 02125C 02222C 04221C
05128C 0702C 10425C 11921C 1202C
12523C 1412C 18422C 1892C 19721C
2752C 34321C 34322C 0043C 06831C
13831C 13832C 16631C 20033C 3213C
3623C 07212C 07214C 1281C 15414C
17512C 22118C 23212C 23214C 25911C
2741C 29418C
E3096 7.2 0292C 04325C 07729C 1262C 14123C
1922C 19626C 23922C 2692C 27521C
34323C 16223C 06935C 1383C 14031C
2443C 32131C 34731C 1121C 1291C
17213C 17814C 22119C 2391C 25913C
29417C 31711C 35019C 0693C
E3096 7.5 36412C 02223C 0282C 0502C 05121C
057210C 0692C 09921C 0992C 1002C
12521C 12522C 1422C 14321C 1902C
19021C 18424C 2402C 24021C 26921C
2722C 27221C 27222C 27522C 27523C
3442C 34421C 00531C 00632C 0732C
-12- 0083C 0703C 07031C 07531C 07532C
0763C 1653C 1663C 17232C 20231C
20331C 2173C 3223C 32331C 3263C
3273C 32731C 32732C 34031C 34032C
36231C 36232C 05942C 23213C 24711C
26114C 2751C 29419C 30916C 3161C
35111C 09411C 11514C 14112C 1481C
17212C 1771C 1921C 1961C 22416C
23213C 24711C 26114C 2751C 29419C
30916C 3161C 35111C
E3096 7.75 00621C 02921C 04327C 0442C 0572C
0762C 1212C 10021C 1972C 27223C
27224C 2732C 2762C 34422C 3452C
16124C 16221C 0053C 00631C 0623C
06331C 06332C 06731C 06934C 1883C
18831C 2023C 21731C 2463C 25031C
25032C 25231C 2583C 3473C 34832C
05941C 06311C 07311C 09212C 1301C
1561C 1571C 17912C 19211C 2101C
23914C 26112C 30915C 31713C 35012C
E3096 8.0 0222C 04328C 05127C 07021C 07621C
1252C 13422C 13423C 13424C 13521C
14021C 14121C 14223C 1432C 15721C
15722C 15723C 15724C 16021C 19022C
1912C 19121C 19023C 19024C 19627C
24023C 27321C 27322C 2742C 27421C
28722C 2882C 28821C 34521C 00532C
0063C 00633C 00832C 02731C 02733C
0633C 07533C 1173C 11731C 11732C
16531C 18231C 18232C 1963C 20032C
20232C 2033C 24631C 2523C 2563C
25931C 2603C 32231C 3403C 34033C
3413C 34131C 3483C 05943C 06312C
09213C 1091C 1271C 12912C 1341C
14113C 1421C 14313C 1751C 1931C
21011C 2201C 23312C 2521C 26113C
26115C 27512C 3101C 35015C 3511C
E3096 8.25 02123C 05021C 05023C 0512C 0772C
12021C 1222C 1342C 14122C 19625C
2392C 23921C 27621C 34522C 02732C
06333C 0673C 06733C 16632C 20031C
20131C 21732C 25631C 25633C 3283C
34831C 06313C 07914C 11212C 13714C
1411C 1791C 19611C 2241C 23911C
25912C 27513C 30917C 3171C 35018C
E3096 8.50 3651C 02221C 04223C 0942C 1192C
12121C 13421C 1842C 18423C 24022C
27422C 28822C 3462C 1622C 16222C
06231C 0643C 13931C 13833C 1673C
17234C 24531C 2513C 26031C 1261C
2071C 22411C 22414C 22415C 25914C
25915C 294110C 31712C
-13- E3096 8.75 05022C 09923C 34523C 0683C 19631C
2503C 2593C 1371C 15412C 2471C
30912C
E3096 9.0 04222C 07721C 12221C 16022C 18921C
0273C 06933C 32631C 11213C 1551C
30913C 35014C
E3096 9.25 05722C 03828C 16122C 14631C 11214C
21012C 23311C 27511C
E3096 9.50 02026C 08329C 1402C 16121C 17231C
2243C 2453C 24532C 0334C 17813C
20711C 2611C 35013C
E3096 6.0L 06931C 01722C 04321C 04323C 08326C
15024C 26524C 26621C 27622C 07911C
1131C 2311C 29414C 01722C 04321C
04323C 08326C 15024C 26524C 26621C
27622C
E3096 6.25L 17333C 09922C 27623C 11312C 13615C
2211C 09922C 27623C
E3096 6.5L 1723C 08325C 2622C 26622C 27624C
07111C 11313C 22111C
E3096 6.75L 05723C 08323C 26221C 11314C 22113C
31714C
E3096 7.0L 06732C 17334C 2003C 25632C 0172C
04324C 05727C 26222C 2682C 27625C
10212C 11315C 1361C 1541C 23112C
2941C
E3096 7.25L 02023C 0432C 05125C 08324C 26223C
26522C 27626C 13616C 29415C 0693C
24533C 36332C
E3096 7.5L 2573C 01721C 02122C 05721C 15621C
26821C 2872C 1191C 13617C 22115C
29416C 31718C 35011C
E3096 7.75L 1403C 2773C 02121C 05729C 1042C
26525C 26922C 28721C 00731C 07211C
1141C 14312C 1711C 22116C 31716C
E3096 8.0L 1393C 17233C 3193C 36432C 02025C
0212C 05728C 26526C 26822C 24621C
11412C 15413C 19712C 29412C 31715C
E3096 8.2L 06932C 25732C 02027C 05724C 10424C
26224C 26923C 27627C 07115C 11912C
13614C 2321C 29413C 31717C
E3096 8.5L 1453C 27731C 0202C 05726C 2652C
26924C 2792C 07112C 10213C 13612C
1431C 19711C 29411C 3501C
E3096 8.75L 0753C 02022C 05126C 15324C 27628C
11913C 13613C 23111C
E3096 9.0L 1733C 3233C 05124C 15025C 26527C
1151C 1971C 31719C
E3096 9.25L 02021C 05123C 15022C 26225C 26623C
11512C
E3096 9.5L 17331C 31931C 04322C 05122C 15526C
26925C 11513C 22112C
-14- (c) Castroviejo Corneal Transplant Trephine (includes 2
disposable blades)
E3094 6.0 All lot numbers listed under E3096 6.0
E3094 6.5 All lot numbers listed under E3096 6.5
E3094 7.0 All lot numbers listed under E3096 7.0
E3094 7.2 All lot numbers listed under E3096 7.2
E3094 7.5 All lot numbers listed under E3096 7.5
E3094 7.7 All lot numbers listed under E3096 7.7
E3094 8.0 All lot numbers listed under E3096 8.0
E3094 8.2 All lot numbers listed under E3096 8.2
E3094 8.5 All lot numbers listed under E3096 8.5
E3094 9.0 All lot numbers listed under E3096 9.0
E3094 9.5 All lot numbers listed under E3096 9.5
(d) Paton See-Through Transplant Trephine (includes 2
disposable blades)
E3086 6.0 All lot numbers listed under E3096 6.0
E3086 7.5 All lot numbers listed under E3096 7.5
E3086 8.0 All lot numbers listed under E3096 8.0
E3086 9.0 All lot numbers listed under E3096 9.0
MANUFACTURER Storz Instrument Company, St. Louis, Missouri.
RECALLED BY Manufacturer, by letter June 10, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 7,339 blades; (b) 56,415 blades; (c) 329 sets; (d) 72
sets were distributed.
REASON The outer sterile packaging/pouch containing the trephine
blade may have defects which could compromise the sterility
of the outer surface of the sealed blade pack contained in
the pouch.
_______________
PRODUCT Custom Sterile procedure packs which contain Ethicon Coated
Vicryl Sutures. Recall #Z-208-5.
CODE Catalog Numbers Lot Numbers
SAN12ANCWA 224764
SAN12PCYHC 224555
SAN12PCGWA 225516
SAN16PCVBC 226840
SAN41PCHCB 121841
SAN34PSSHB 128129
SAN63THGCC 120378
SBA21AN05F 120703
SBA56ANMVA 555233
SBA18HSHHC 122822, 123966, 124940
SBA45GSPHA 558538
SBA26KD05B 223178, 24933
SBA26KDTGB 224561, 226205
SBA49KDUM1 126919
SBA54LBJSC 556956, 557642, 558911
SBA04LCBMC 124267
SBA11LCPMC 121697
SBA21LCARB 122580
-15- SBA23LCGSE 223327
SBA23LCHHC 223789, 224310, 226355
SBA23LCWHD 225945
SBA24LCGMA 119468
SBA26LC4OB 226118
SBA35LCBLF 124452
SBA41LCPVE 123029
SBA43LCWFB 121456
SBA45LCCCB 559820
SBA51LCWKC 554231
SBA52LCRSG 558642
SBA55LCSFE 558589
SBA63LCGCB 119605
SBA63LCGCB 123183
SBA58LCSGD 555032, 558162
SBA16LPUVA 224485
SBA19LPSFF 120409
SBA43LPDJU 119556, 124753
SBA48LP74B 121741
SBA41LPCGX 118009, 119723
SBA41LPCGW 123399
SBA25LVUBF 223016
SBA11MNPMD 116964, 121532
SBA21MNUET 119517
SBA21MNEUO 120330
SBA47MNSWC 123317
SBA16THCHB 223720, 225235, 225647, 226116
SBA29VCSCC 120160
SCV48AAGSH 118974
SCV16AAMVE 224977
SCV25BAUBB 223882, 227790
SCV16BBNGA 224224, 226451
SVC12BSGTC 225132
SCV25BS04Q 222897
SCV25BS04R 226257
SCV25BS05I 225119
SCV25BSO60 225595
SCV41BSFWB 118514
SCV41BSFWC 123199
SCV56BSSME 557064
SCV48CAGSC 117093, 118513
SCV18CBEHD 117848
SCV69CBSVA 557245, 557932
SCV18CVYAE 120937
SCV26CVTGD 223799, 225509
SCV52CVEMF 556438
SCV23DKMMJ 224243
SCV25DRHH2 224113
SCV25DRHHJ 225698
SCV25DRHHK 226985
SCV63FPGCC 125356
SCV34FPHRA 119724, 125135
-16- SCV25HVUBB 224000, 225169
SCV12HVYHB 226331
SCV18LOHHC 121588
SVC18LOHHD 125431
SCV25MCUBB 225521, 227748
SCV42MNSMC 122442, 126476
SCV23MNRMH 220747, 222462
SCV23MNRMI 226283
SCV11OHNSM 119283
SCV21OHARE 117672
SCV21OHARF 122660
SCV26OH17H 227052
SCV26OH40K 222564
SCV48OHDGI 119896, 126911
SCV49OHUMB 127121
SCV57OHSGR 558223
SCV25OH15H 225054
SCV16OHDBG 222608, 226183
SCV16OHDKI 223263
SCV16OHDWK 224328
SCV16OHKDF 226633
SCV43OHHPA 119888
SCV42OHHHC 117797
SCV42OHWMK 119901
SCV34OHHRH 123046
SCV69OHSV1 115935, 116810
SCV51OHSQJ 120047
SCV63OHUHJ 118840
SCV22PCMSA 224534
SCV69PDSVF 557899
SCV18PRHHB 118210
SCV18PRHHC 127279
SCV25RC55B 224535
SCV21REARA 123657
SCV25REVAI 225037
SEN34EAPVE 118285
SEN63EAUKD 116400
SEN25LYUB1 226107
SER52DBLBB 555771
SER12TRFHD 223001
SER52SULBB 555043
SMA12CSSHE 227388
SMA18CSMFC 116718
SMA23CSDUE 224163, 225410
SMA23CSDUF 227324
SMA31CSSFI 120661
SMA32CSPLE 117861, 122398
SMA32CSSCA 117189
SMA38CSCMB 126865
SMA41CSTCH 123960
SMA44CSHMB 124617
SMA63CSUKF 123185
-17- SMA73CSGCF 120380
SMA34CS70C 121324
SMA18LATSC 119063, 121323
SMA51LCMZE 556310
SMA22LCJKC 223561
SMA14LSSMD 118907
SMA31LSLUC 119123
SMA45LSUCA 558462
SMA51LSKSB 557149
SMA53LSVOE 554946
SMA43LSDJH 120092
SMA47LSBPB 120236
SMA47LSBPC 125325
SMA63LSGCB 120503
SMA12PSJOC 226025
SMA47TLBPB 124443
SMA21VGPWE 121788
SNE11ACPMC 120233
SNE19ACSJF 120377
SNE42BSJCE 121434
SNE12BSSJF 226661
SNE34CRCHE 118453
SNE16DPVBB 226059
SNE11LMPMD 118477
SNE48LMGSQ 124200
SNE68LMSTD 119918, 127066
SOP30ARCED 116018, 124287
SOP54AR47C 555725
SOP41BKBHC 122037
SOP16BLHSA 225679
SOP21BSEBE 127916
SOP21BSEUM 120712, 126216
SOP56FMLDD 558537
SOP47FTASB 121473
SOP31GBEV2 123652
SOP11HPPY1 124790
SOP18HPHHC 122982
SOP19HPTCG 115571, 120663
SOP21HPEB1 125586
SOP25HPUBF 226062
SOP41HPAME 117201
SOP43HPMBF 125316
SOP11KNPY1 124627
SOP19KNTCG 117536
SOP21KNEBH 119575
SOP29KNMGD 118655
SOP36KNCCC 126933
SOP23KNWHC 226781
SOP31KNEVA 120888
SOP33KNDHF 124840
SOP38KNCNF 121453
SOP11LMPMB 121513
-18- SOP18PNHHC 125589
SOP13THNAA 119666, 121031
SOP29THMGG 121791
SOP29THSVB 122177
SOP30THTEA 116060
SOP18TJMFB 120510, 122307
SOP29TJMHC 115327, 123320
SOP46TJSPF 119779
SOP29TKSVA 115748
SOP29TKSVB 120184
SOP30TKTEA 116059
MANUFACTURER Ethicon, Inc., San Antonio, Texas (sutures).
RECALLED BY Baxter Healthcare Corporation, Convertors/Custom Sterile
Division, McGaw Park, Illinois, by letter October 3, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 12,221 packs were distributed; firm estimated that 40% of
the product remained on the market at time of recall.
REASON The sterility of the Ethicon Coated Vicryl Absorbable
Sterile Sutures could not be assured due to possible
microorganism contamination during aseptic processing.
_______________
PRODUCT Diascan Blood Glucose Monitoring Strips and Ultra brand
Glucose Monitoring Strips, used for measuring the blood
sugar level in diabetics: (a) Product codes 150500, 15200,
107500 Diascan Starter Kit and 151000 Accessory Kit;
(b) Product codes 707600, 708000, 70900, 750600.
Recall #Z-216/217-5.
CODE Lot numbers: (a) Lots with prefixes of 633 or M633;
(b) Lots PD210A and PD210B.
MANUFACTURER Behrngwerke Diagnostics, Germany
RECALLED BY Home Diagnostics, Inc., Fort Lauderdale, Florida, by letter
January 18, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 227,000 strips were distributed.
REASON Test results indicate some Diascan results are 18-36% low
while Ultra Plus test results are typically 22% low.
_______________
PRODUCT Cards O.S. Strep-A Kits and Concise Plus Strep-A kits, an
in-vitro diagnostic test kit used for the detection of group
A streptococcal antigen from throat swabs:
(a) Cards O.S. Strep-A, Part #CR7740;
(b) Cards O.S. Strep-A, Part #CR7741;
(c) Cards O.S. Strep-A, Part #CR7742;
(d) Concise Plus Strep-A, Part #4515;
(e) Concise Plus Strep-A, part #4516;
(f) Concise Strep-A, Part #4512;
(g) Concise Strep-A, Part #4513. Recall #Z-222/228-5.
CODE Lot numbers: (a) 710455.2 through 820215.1;
(b) 710155.1 through 820211.1;
-19- (c) 710328.1 through 740146.1;
(d) 780377.1 through 810105.1;
(e) 790287.1 through 810063.1;
(f) 760045.2 through 780312.1
(g) 760113.1 through 770441.1.
MANUFACTURER Pacific Biotech, Inc., San Diego, California.
RECALLED BY Manufacturer, by letter October 26, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 63,499 kits were distributed, FDA estimated that 5,000 kits
remained on the market at time of recall initiation.
REASON The product gives a false positive test result for group A
streptococcal antigen used as an aid in the diagnosis of
group A streptococcal pharyngitis.
_______________
UPDATE Recall #Z-032/033-5, which appeared in the November 2, 1994
Enforcement Report has been amended:
PRODUCT Angiographic contrast media injectors, used to inject
contrast media directly into the circulatory system:
(a) Medrad Mark IV; (b) Mark IV CT Injectors.
Recall #Z-032/033-5.
CODE All serial numbers.
MANUFACTURER Medrad, Inc., Indianola, Pennsylvania.
RECALLED BY Manufacturer, by instructions issued to Medrad Service
representatives on October 24, 1991. Firm-initiated recall
- accomplished by ongoing field upgrade.
DISTRIBUTION Nationwide and international.
QUANTITY Product is no longer being manufactured. Approximately
3,700 injectors, of the possibly 7,300 in commerce, have
been upgraded.
REASON Grease in the push button switches congealed causing the
devices to deliver contrast media at higher rates or volumes
than desired.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Modular Hip Stem/DRG Option, Sizes 2, 4, 6, and 8, used in
orthopedic surgery for implantation in the hip area.
Recall #Z-212/215-5.
CODE Cat No. Serial Number Lot Numbers
1179-5052 0001-2/0002-2 92-0323
0003-2/0011-2 92-0417
0012-2, 0014-2/0022-2 92-0543
0013-2 92-5052
0023-2/0033-2 92-0923
0034-2/0047-2 92-0924
0048-2/0083-2 93-0195
1179-5054 0001-4/0002-4 92-0324
0003-4/0005-4 92-0450
-20- 0006-4/0007-4 92-0046
0008-4/0021-4 92-0453
0022-4/0038-4 92-0925
0039-4/0063-4 92-0136
0064-4/0087-4 93-0137
1179-5056 0001-6/0003-6 92-0451
0004-6/0005-6 93-0676
0006-6/0021-6 92-0454
0022-6/0035-6 92-0926
0036-6/0048-6 92-0927
0049-6/0081-6 93-0194
1179-5058 0001-8/0005-8 92-0452
0006-8/0022-8 92-0545
0023-8/0024-8 92-0455
0025-8/0031-8 92-0928
0032-8 92-1150
0033-8/0035-8 93-0651
0036-8 92-1150
0037-8 93-0651
0038-8/0043-8 92-0929
0044-8 92-1150
0045-8/0049-8 92-0929.
MANUFACTURER BioPro, Port Huron, Michigan.
RECALLED BY Manufacturer, by letter November 24, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 135 units were distributed.
REASON The device labeling does not contain 510(k) labeling
stipulations. The stem must be labeled "for use only with
the cobalt-chromium modular heads, with BioPro 28 mm
zirconia Ceramic Heads." The labeling must include the
following preoperative warning: "Because of the limited
clinical and preclinical experience with Zirconia Ceramic
Heads, the biological effect of Zirconia wear particulates
is unknown."
_______________
PRODUCT Stratus CK-MB Fluorometric Enzyme Immunoassay, an automated
procedure for quantitative determination of CK-BM levels in
serum and plasma samples. Recall #Z-219-5.
CODE Catalog #B5700-60, Lot numbers: KXMB-1528 through 1630
except 1538, 1542, 1548, 1549, 1624, 1627.
EXP date: January 1994 to March 1994.
MANUFACTURER Baxter Diagnostic of PR, Inc., Aguada, Puerto Rico.
RECALLED BY Baxter Diagnostic, Inc., Miami, Florida, by telephone
December 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 12,027 kits were distributed from August 1993
to December 1993.
REASON Elevated calibrator A rates with high control recovery at
the low end leading to erroneous readings.
-21- _______________
PRODUCT Stratus Ultra-Sensitive hTSH Fluorometric Enzyme
Immunoassay, an automated procedure for the quantitative
determination of hTSH levels in serum and plasma samples.
Recall #Z-220-5.
CODE Catalog #B5700-44, Lot numbers: All kits containing
conjugate lots CXTS-29M through CXTS-40M, EXP date 8/23/93 -
4/22/94. Kit lot numbers: KXTS-224M through KXTS-322M.
MANUFACTURER Baxter Diagnostic of PR, Inc., Aguada, Puerto Rico.
RECALLED BY Baxter Diagnostics, Inc., Miami, Florida, by letter dated
October 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 31,000 kits were distributed from June 1993 to December
1993.
REASON Elevated calibrator A rates with high control recovery at
the low end leading to erroneous readings.
_______________
PRODUCT Stratus Total Thyroxine (T4) Fluorometric Enzyme Immunoassay
which is automated procedure for the Quantitative
determination of total Thyroxine (T4) levels in serum or
plasma samples. Recall #Z-221-5.
CODE Catalog #B5700-45, Lot numbers: KXTH-1197M EXP 7/4/94,
KXTH-1198M EXP 7/4/94, KXTH-1212M EXP 7/26/94, KXTH-1223M
EXP 7/26/94, KXTH-1176M EXP 7/4/94, KXTH-1177M EXP 7/4/94.
MANUFACTURER Baxter Diagnostic of PR, Inc., Aguada, Puerto Rico.
RECALLED BY Baxter Diagnostic, Inc., Miami, Florida, by telephone in May
1994 and June 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international
QUANTITY 1,626 kits were distributed from February 1994 to June 1994.
REASON Low control recovery.
_______________
PRODUCT Stratus Digoxin Fluorometric Enzyme Immunoassay
(Calibrator), an automated procedure for the quantitative
determination of therapeutic drug levels in serum or plasma.
Recall #Z-229-5.
CODE Catalog #B5700-10, lot numbers: XDK-2131 through 2133, 2135
through 2138, 2141, and 21421.
MANUFACTURER Baxter Diagnostic of PR, Inc., Aguada, Puerto Rico.
RECALLED BY Baxter Diagnostic, Inc., Miami, Florida, by letter November
1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,784 kits were distributed from June 1994 to November 1994.
REASON Defective calibrators caused high control recovery values.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT Bactoderm brand of Mupirocin Ointment 2%, in 15 gram tubes,
for dermotologic use on dogs only. Recall #V-008-5.
-22- CODE Lot numbers AM23 EXP 1/95, AM24 EXP 1/95, and BK11 EXP 12/95
(representing all lots in distribution).
MANUFACTURER SmithKline Beecham Animal Health, Lincoln, Nebraska.
RECALLED BY Manufacturer, by letter December 1, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Puerto Rico, Virgin Islands, West Indies.
QUANTITY 102,835 tubes were distributed; firm estimated that 20,000
to 25,000 tubes remained on the market at time of recall.
REASON Failure to meet potency and/or total degradation
specification through the labeled expiration date.
-23-
END OF ENFORCEMENT REPORT FOR JANUARY 4, 1995. BLANK PAGES MAY
FOLLOW.
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