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
04/13/1994
Recalls and Field Corrections: Foods -- Class I -- 04/13/1994
April 13, 1994 94-15
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Elsa Peretti ceramicware:
(1) Blue/white teapot; (2) Powder blue tea cup/saucer;
(3) Blue teapot; (4) Blue sugar bowl;
(5) Blue creamer; (6) Blue dessert plate;
(7) Black bowl, 7 inch; (8) Black bowl, 9 inch;
(9) Black carafe; (10) Black pitcher;
(11) Black mug; (12) Tan sugar bowl;
(13) Tan creamer; (14) Tan cup/saucer;
(15) Small tan sugar bowl; (16) Small tan creamer;
(17) Powder blue small mug; (18) Powder blue small creamer;
(19) Blue/white bowl, 2 inch; (20) Blue/white bowl, 4 inch;
(21) Black dinner plate; (22) Extra large black bowl;
(23) Black tray, 15 inch; (24) Blue/white bowl, 9 inch;
(25) Powder blue small sugar bowl; (26) Tan dessert plate;
(27) Tan small sugar bowl; (28) Black tray, 20 inch;
(29) Glossy black tureen; (30) Tan mug;
(31) Powder blue mug; (32) Glossy black dinner plate;
(33) Black indent dish; (34) Glossy black cup/saucer;
(35) Tan indent dish; (36) Tan indent bowl;
(37) Tan indent bowl; (38) Black small creamer;
(39) Black pumpkin dish. Recall #F-330/368-4.
CODE All lots.
MANUFACTURER Arrigo Bianchini, Firenze, Italy.
RECALLED BY Tiffany and Co., New York, New York, by letter December 8,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Number of pieces sold to customers from retail stores:
10336821 - white teapot - 149 pieces
10336848 - powder blue tea cup/saucer - 589 pieces
10336856 - powder blue teapot - 245 pieces
10336864 - powder blue sugar bowl - 4 pieces
10336872 - powder blue creamer - 45 pieces
10337321 - powder blue dessert plate - 190 pieces
10351804 - black bowl 7 inches - 738 pieces
10351812 - black bowl 9 inches - 884 pieces
10351855 - black carafe - 825 pieces
10351863 - black pitcher - 543 pieces
10364868 - black mug - 450 pieces
10373271 - tan sugar bowl - 4 pieces
10373298 - tan creamer - 84 pieces
10373301 - tan cup/saucer - 250 pieces
10378427 - small tan sugar bowl - 73 pieces
10378435 - small tan creamer - 180 pieces
10378443 - powder blue small sugar bowl - 26 pieces
10378451 - powder blue small creamer - 309 pieces
10382734 - blue/white bowl 2 inches - 58 pieces
10382742 - blue/white bowl 4 inches - 80 pieces
10442869 - black dinner plate - 531 pieces
10443121 - extra large black bowl - 153 pieces
10443148 - black tray 15 inches - 145 pieces
10464935 - white bowl 9 inches - 0 pieces
10478723 - powder blue small sugar bowl - 282 pieces
10479436 - tan dessert plate - 107 pieces
10507936 - tan small sugar bowl - 77 pieces
10628156 - black tray 20 inches - 37 pieces
11452744 - glossy black tureen - 25 pieces
11452752 - tan mug - 39 pieces
11452779 - powder blue mug - 51 pieces
11452787 - glossy black dinner plate - 43 pieces
11452795 - black indent dish - 295 pieces
11452809 - glossy black cup/saucer - 76 pieces
11452817 - tan indent dish - 72 pieces
11452825 - tan indent bowl - 31 pieces
11452833 - tan indent bowl - 36 pieces
11721451 - black small creamer - 0 pieces.
10351782 - black pumpkin dishes - 0 pieces.
REASON The products contain excessive levels of leachable lead.
_______________
PRODUCT Marque Escuminac brand Frozen Minced Lobster meat, in 5
pound boxes, packed 10 boxes per carton. Recall #F-370-4.
CODE 5380 on master carton. The only known manufacturing code is
A2372.
-2- MANUFACTURER Raymond O'Neill & Son Fisheries, Baie Ste. Anne, N.B.,
Canada.
RECALLED BY Northeast Consulting & Marketing Corporation, North Reading,
Massachusetts, by telephone, followed by letter February 3,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Massachusetts, Indiana, New Hampshire, Florida, Connecticut,
Maine.
QUANTITY 144 cases were distributed.
REASON Product is contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Crystallized Young Ginger Slices. Recall #F-329-4.
CODE None.
MANUFACTURER Haddon House Food Products, Inc., Medford, New Jersey.
RECALLED BY Manufacturer, by visit not later than December 6, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 8,832 packages.
REASON Product contains undeclared sulfites.
_______________
PRODUCT Dominick's Thick and Chunky Salsa, medium, and mild, made
from tomatoes, water onion, peppers, tomato paste, vinegar,
salt, jalepenos, onion powder and garlic powder, in 16 ounce
glass jars. Recall #F-369-4.
CODE All lots.
MANUFACTURER Torbitt & Castelman Company, Buckner, Kentucky.
RECALLED BY Dominick's Finer Foods, Northlake, Illinois, by electronic
mail message February 26, 1994. Firm-initiated recall
complete.
DISTRIBUTION Illinois.
QUANTITY 1,696 cases of mild and 1,853 cases of medium salsa were
distributed; firm estimates less than 20 percent of product
remain on the market.
REASON Product is contaminated with glass.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Taco Bell Reconstituted Lemon Juice, in 4 ml packets.
Recall #F-326-4.
CODE All lots.
MANUFACTURER Borden, Inc., Grocer Products Division, Columbus, Ohio.
RECALLED BY Manufacturer, by letter February 2, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 16,603 cases were distributed.
REASON Product contained undeclared sulfites.
-3- _______________
PRODUCT Kroger Apple & Cinnamon Toasted Oats, 31.5 ounces per box.
Recall #F-327-4.
CODE All lots distributed by Kroger Company in Kentucky, Ohio,
Tennessee, Texas, Virginia, West Virginia.
MANUFACTURER Malt-O-Meal Company, Northfield, Minnesota.
RECALLED BY Manufacturer, by letter February 24, 1994. Firm-initiated
recall complete.
DISTRIBUTION Kentucky, Ohio, Tennessee, Texas, Virginia, West Virginia.
QUANTITY 6,251 cases (6 boxes per case) were distributed.
REASON Product contained undeclared sulfites.
_______________
PRODUCT Balsamic Vinegar, in 17 fluid ounce brown glass bottles.
Recall #F-328-4.
CODE None. All product is subject to recall.
MANUFACTURER East Coast Olive Oil Corporation, Utica, New York.
RECALLED BY Manufacturer, by telephone February 22, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION New York, Pennsylvania, Massachusetts, Connecticut, Florida.
QUANTITY 247 cases (12 bottles per case) were distributed; firm
estimates 200 cases remain on the market.
REASON Product contains undeclared sulfites.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Nasacort Inhaler (Triamcinolone Acetonide), metered dose
aerosol inhalers in two sizes, 10 g and 6.7 g, indicated for
the nasal treatment of seasonal and perennial allergic
rhinitis symptoms. Recall D-134-4.
CODE Lot numbers: CN92495 EXP 3/95, CN95023 EXP 10/95, CN92340
EXP 6/94, CN95524 EXP 11/94, CN95558 EXP 7/95, CN95568 EXP
8/95.
MANUFACTURER Armstrong Laboratories, West Roxbury, Massachusetts.
RECALLED BY Rhone-Poulenc Rorer Pharmaceutical, Inc., Collegeville,
Pennsylvania, by letters of January 13, 1994, and March 9,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 42,444 units of lot CN92495; 47,520 units of lot CN95023;
40,131 units of lot CN92340; 46,564 units of lot CN95524;
40,942 units of lot CN95558; and 42,184 units of lot CN95568
were distributed.
REASON Product may have variable unit spray content which may
result in subpotency.
_______________
PRODUCT Abbott Fentanyl Citrate Injection, USP, 50 mcg/ml, in 10 ml
and 20 ml Abboject Unit-of-Use syringes, a schedule II
narcotic analgesic for intravenous use. Recall #D-234-4.
CODE Lot numbers: 76-471-R1 EXP 5/94 (10 ml); 76-472-R1 (20 ml).
MANUFACTURER Abbott Laboratories, Rocky Mount, North Carolina.
-4- RECALLED BY Abbott Laboratories, Abbott Park, Illinois, by letters dated
March 21, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Wisconsin, Massachusetts, North Carolina, Georgia, Kentucky,
Ohio, Illinois, Missouri, Oregon, New York, Indiana,
California, South Carolina.
QUANTITY 240 10-ml syringes and 1,900 20-ml syringes were
distributed; firm estimates that 10 percent of the product
remains on the market.
REASON Potency not assured through expiration date.
_______________
PRODUCT Clemastine Fumarate, 1.34 mg tablets, packaged in 16 tablet
cartons under the K-Mart "K-Hist 1" label, an antihistamine.
Recall #D-235-4.
CODE Lot numbers: 3C49E, 3C50E, 3C51E.
MANUFACTURER Perrigo Company, Allegan, Michigan.
RECALLED BY Manufacturer, by telephone beginning April 9, 1993. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 9,792 dozen were distributed.
REASON Incomplete warning statement regarding antihistamine
ingredient.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT BDI multi-product display labels (counter display signs).
No specific product is being recalled. Recall #D-236-4.
CODE None.
MANUFACTURER BDI Pharmaceuticals, Division Body Dynamics, Inc.,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by letter March 10, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Material promoted ephedrine products for stimulant and/or
weight loss claims.
_______________
PRODUCT Tanoral Suspension (Chlorpheneramine Tannate, Phenylephrine
Tannate, Pyrilamine Tannate), Pediatric Suspension, in 4
ounce and 16 ounce bottles. Recall #D-237-4.
CODE Lot numbers: 53-124, 53-125, 53-126, 53-127, 53-128, 53-
179. Each lot carries an expiration date of 4/94.
MANUFACTURER Ferndale Laboratories, Inc., Ferndale, Michigan.
RECALLED BY Manufacturer, by letter May 18, 1993. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY Lot 53-124: 1716 16-fl oz., Lot 53-124C: 2445 4-fl oz
Lot 53-125: 2372 16 fl oz., Lot 53-126: 2342 16-fl oz
Lot 53-127: 2341 16-fl oz., Lot 53-128: 2331 16-fl oz
Lot 53-179: 2345 16-fl oz. were distributed.
REASON Presence of yeast formation.
-5- RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Red Blood Cells, Recovered Plasma. Recall #B-161/162-4.
CODE Unit numbers: (a) GJ36391; (b) Units FS15001, FS15002,
FS15003, FS15005, FS15006, FS15007, FS15009, FS15010,
FS15011, FS15013, FS15017, FS15018, FS15019, FS15020,
FS15024, FS15025, FS15026, FS15028, FS15029, FS15030,
FS15034, FS15036, FS15037, FS15038, FS15041, FS15042,
FS15043, FS15044, FS15045, FS15047, FS15050, FS15051,
FS15054, FS15057, FS15059, FS15060, FS15061, FS15063,
FS15064, FS15065, FS15068, FS15069, FS15070, FS15072,
FS15075, FS15076, FS15081, FS15082, FS15085, FS15091,
FS15093, FS15370, FS15372, FS15374, FS16014, FS16018,
FS16026, FS16041, FS16042, FS16047, FS16060, FS16070,
FS16072, FS16083, FS16087, FS16094, FS16103, FS16107,
FS16112, FS16115, FS16127, FS16129, FS16130, FS16135,
FS16138, FS16142, FS16143, FS16151, FS16155, FS16157,
FS16158, FS16159, FS16170, FS16171, FS16172, FS16182,
FS16189, FS16191, FS16196, FS16197, FS16204, FS16205,
FS16216, FS16225, FS16226, FS16231, FS16232, FS16234,
FS16238, FS17124, FS17126, FS17128, FS17129, FS17133,
FS17134, FS17135, FS17139, FS17141, FS17143, FS17144,
FS17146, FS17147, FS17151, FS17152, FS17153, FS17155,
FS17156, FS17157, FS17158, FS17159, FS17160, FS17166,
FS17167, FS17169, FS17172, FS17174, FS17175, FS17177,
FS17179, FS17181, FS17182, FS17185, FS17187, FS17188,
FS17190, FS17191, FS17192, FS17193, FS17195, FS17198,
FS17202, FS17203, FS17206, FS17207, FS17209, FS17210,
FS17213, FS17215, FS17216, FS17217, FS17218, FS17235,
FS17236, FS17237, FS17242, FS17243, FS17246, FS17249,
FS17252, FS17253, FS17255, FS17256, FS17257, FS17259,
FS17260, FS17263, FS17265, FS17269, FS17270, FS17271,
FS17272, FS17273, FS17278, FS17281, FS17284, FS17287,
FS17291, FS17294, FS17296, FS17297, FS17298, FS17301,
FS17302, FS17304, FS17307, FS17308, FS17309, FS17310,
FS17312, FS17314, FS17317, FS17320, FS17321, FS17323,
FS17325, FS17326, FS17327, FS17328, FS17329, FS17330,
FS17332, FS17333, FS17334, FS17335, FS17336, FS17337,
FS17339, FS17340, FS17341, FS17342, FS17343, FS17345,
FS17346, FS17347, FS17348, FS17349, FS17352, FS17353,
FS17355, FS17358, FS17359, FS17360, FS17366, FS17370,
FS17372, FS17374, FS17375, FS17377, FS17382, FS17384,
FS17386, FS17387, FS17388, FS17389, FS17390, FS17391,
FS17392, FS17394, FS17395, FS17397, FS17398, FS17400,
FS17620, FS17621, FS17627, FS17630, FS17631, FS17634,
FS17636, FS17637, FS17638, FS17639, FS17641, FS17642,
FS17643, FS17645, FS17646, FS17650, FS17651, FS17652,
FS17653, FS17655, FS17657, FS17658, FS17664, FS17665,
FS17670, FS17673, FS17677, FS17678, FS17680, FS17681,
FS17682, FS17683, FS17688, FS17689, FS17693, FS17694,
FS17696, FS17700, FS17701, FS17706, FS17707, FS17709,
FS17710, FS17711, FS17712, FS17713, FS17715, FS17716,
FS17723, FS17724, FS17725, FS17726, FS17727, FS17728,
-6- FS17732, FS17734, FS17736, FS17740, FS17742, FS17744,
FS17745, FS17746, FS17747, FS17748, FS17750, FS17880,
FS17883, FS17884, FS17888, FS17889, FS17891, FS17893,
FS17894, FS17901, FS17903, FS17907, FS17908, FS17910,
FS17912, FS17913, FS17915, FS17916, FS17918, FS17919,
FS17920, FS17922, FS17923, FS17928, FS17929, FS17931,
FS17933, FS17934, FS17936, FS17944, FS17946, FS17948,
FS17950, FS17952, FS17953, FS17954, FS17958, FS17959,
FS17960, FS17961, FS17963, FS17965, FS17968, FS17969,
FS17970, FS17971, FS17972, FS17973, FS17977, FS17979,
FS17980, FS17984, FS17988, FS17989, FS17991, FS17993,
FS17994, FS17995, FS17996, FS17997, FS17999, FS18001,
FS18002, FS18005, FS18006, FS18009, FS18016, FS18017,
FS18018, FS18020, FS18021, FS18022, FS18029, FS18031,
FS18033, FS18038, FS18039, FS18043, FS18044, FS18045,
FS18046, FS18048, FS18049, FS18051, FS18054, FS18056,
FS18057, FS18058, FS18059, FS18061, FS18062, FS18066,
FS18067, FS18072, FS18074, FS18075, FS18077, FS18081,
FS18082, FS18083, FS18086, FS18087, FS18088, FS18089,
FS18090, FS18091, FS18092, FS18093, FS18094, FS18099,
FS18106, FS18111, FS18113, FS18114, FS18115, FS18116,
FS18117, FS18121, FS18122, FS18126, FS18128, FS18129,
FS18134, FS18135, FS18138, FS18140, FS18141, FS18143,
FS18144, FS18146, FS18148, FS18150, FS18152, FS18154,
FS18155, FS18156, FS18158, FS18160, FS18161, FS18162,
FS18165, FS18166, FS18167, FS18168, FS18172, FS18173,
FS18174, FS18175, FS18176, FS18177, FS18180, FS18185,
FS18187, FS18191, FS18192, FS18193, FS18194, FS18195,
FS18196, FS18197, FS18198, FS18201, FS18204, FS18205,
FS18206, FS18207, FS18209, FS18213, FS18216, FS18217,
FS18218, FS18219, FS18220, FS18221, FS18222, FS18223,
FS18224, FS18227, FS18228, FS18229, FS18233, FS18236,
FS18237, FS18239, FS18240, FS18244, FS18247, FS18248,
FS18250, FS18253, FS18254, FS18256, FS18259, FS18260,
FS18261, FS18263, FS18264, FS18265, FS18266, FS18270,
FS18275, FS18276, FS18279, FS18281, FS18284, FS18286,
FS18289, FS18291, FS18293, FS18294, FS18302, FS18304,
FS18305, FS18308, FS18310, FS18311, FS18312, FS18316,
FS18318, FS18322, FS18325, FS18326, FS18327, FS18328,
FS18332, FS18333, FS18334, FS18340, FS18341, FS18344,
FS18345, FS18347, FS18348, FS18351, FS18352, FS18355,
FS18356, FS18358, FS18359, FS18363, FS18365, FS18367,
FS18370, FS18373, FS18374, FS18376, FS18377, FS18378,
FS18380, FS18384, FS18385, FS18386, FS18388, FS18389,
FS18398, FS18401, FS18403, FS18404, FS18407, FS18408,
FS18410, FS18421, FS18422, FS18424, FS18425, FS18427,
FS18428, FS18429, FS18440, FS18442, FS18444, FS18445,
FS18446, FS18447, FS18452, FS18453, FS18454, FS18456,
FS18458, FS18461, FS18462, FS18469, FS18472, FS18474,
FS18475, FS18478, FS18483, FS18484, FS18485, FS18487,
FS18488, FS18489, FS18490, FS18491, FS18498, FS18500,
FS18751, FS18752, FS18756, FS18757, FS18758, FS18759,
FS18761, FS18763, FS18766, FS18771, FS18772, FS18774,
-7- FS18776, FS18779, FS18781, FS18782, FS18784, FS18785,
FS18788, FS18789, FS18790, FS18792, FS18793, FS18795,
FS18798, FS18799, FS18800, FS18804, FS18807, FS18808,
FS18809, FS18811, FS18813, FS18814, FS18815, FS18819,
FS18820, FS18822, FS18827, FS18828, FS18829, FS18831,
FS18832, FS18833, FS18835, FS18840, FS18842, FS18843,
FS18845, FS18846, FS18848, FS18849, FS18850, FS18852,
FS18853, FS18854, FS18855, FS18856, FS18858, FS18866,
FS18867, FS18868, FS18869, FS18871, FS18872, FS18878,
FS18879, FS18880, FS18881, FS18882, FS18883, FS18886,
FS18888, FS18889, FS18891, FS18893, FS18894, FS18895,
FS18896, FS18897, FS18902, FS18903, FS18904, FS18907,
FS18912, FS18914, FS18916, FS18918, FS18920, FS18922,
FS18923, FS18925, FS18926, FS18928, FS18929, FS18930,
FS18931, FS18934, FS18935, FS18936, FS18938, FS18941,
FS18942, FS18943, FS18945, FS18946, FS18949, FS18950,
FS18953, FS18954, FS18955, FS18956, FS18957, FS18958,
FS18960, FS18962, FS18964, FS18965, FS18968, FS18970,
FS18971, FS18972, FS18973, FS18976, FS18978, FS18979,
FS18980, FS18983, FS18985, FS18988, FS18992, FS18993,
FS18994, FS18995, FS18996, FS18998, FS18999, FS19001,
FS19009, FS19010, FS19012, FS19023, FS19024, FS19025,
FS19035, FS19047, FS19052, FS19066, FS19071, FS19072,
FS19080, FS19084, FS19085, FS19086, FS19099, FS19103,
FS19106, FS19120, FS19122, FS19124, FS19129, FS19134,
FS19251, FS19252, FS19253, FS19256, FS19257, FS19258,
FS19264, FS19266, FS19267, FS19269, FS19270, FS19271,
FS19272, FS19275, FS19278, FS19279, FS19281, FS19283,
FS19288, FS19289, FS19290, FS19292, FS19293, FS19295,
FS19299, FS19300, FS19302, FS19303, FS19307, FS19309,
FS19310, FS19312, FS19313, FS19314, FS19316, FS19317,
FS19322, FS19323, FS19325, FS19327, FS19330, FS19332,
FS19333, FS19337, FS19338, FS19339, FS19340, FS19347,
FS19351, FS19354, FS19355, FS19356, FS19357, FS19360,
FS19367, FS19370, FS19373, FS19374, FS19376, FS19378,
FS19379, FS19380, FS19382, FS19385, FS19386, FS19389,
FS20755, FS20756, FS20759, FS20761, FS20763, FS20764,
FS20765, FS20766, FS20767, FS20768, FS20769, FS20770,
FS20775, FS20778, FS20779, FS20781, FS20784, FS20790,
FS20791, FS20792, FS20795, FS20796, FS20800, FS20802,
FS20805, FS20806, FS20808, FS20815, FS20816, FS20817,
FS20818, FS20822, FS20823, FS20824, FS20828, FS20831,
FS20832, FS20833, FS20834, FS20835, FS20836, FS20839,
FS20841, FS20844, FS20845, FS20848, FS20849, FS20850,
FS20852, FS20853, FS20854, FS20859, FS20862, FS20863,
FS20864, FS20865, FS20874, FS20875, FS20877, FS20886,
FS20887, FS20890, FS20891, FS20892, FS20893, FS20894,
FS20900, FS20902, FS20904, FS20908, FS20910, FS20913,
FS20924, FS20929, FS20932, FS20933, FS20934, FS20936,
FS20938, FS20939, FS20941, FS20942, FS20944, FS20946,
FS20948, FS20949, FS20957, FS20958, FS20960, FS20961,
FS20963, FS20964, FS20965, FS20966, FS20968, FS20971,
-8- FS20973, FS20974, FS20979, GJ36391, LS01212, LS01213,
LS01215, LS01216, LS01219, LS01220, LS01221, LS01222,
LS01224, LS01225, LS01227, LS01230, LS01231, LS01234,
LS01238, LS01239, LS01240, LS01241, LS01244, LS01245,
LS01246, LS01247, LS01248, LS01249, LS01250, LS01538,
LS01539, LS01540, LS01547, LS01549, LS01557, LS01575,
LS01586, LS01587, LS01592, LS01593, LS01595, LS01596,
LS01601, LS01603, LS01604, LS01608, LS01611, LS01612,
LS01613, LS01614, LS01617, LS01618, LS01619, LS01621,
LS01622, LS01624, LS01629, LS01631, LS01632, LS01635,
LS01636, LS01637, LS01642, LS01643, LS01644, LS01645,
LS01647, LS01648, LS01652, LS01654, LS01655, LS01657,
LS01662, LS01663, LS01664, LS01665, LS01670, LS01677,
LS01679, LS01680, LS01687, LS01692, LS01696, LS01697,
LS01700, LS01706, LS01707, LS01711, LS01714, LS01715,
LS01716, LS01720, LS01725, LS01726, LS01727, LS01728,
LS01734, LS01735, LS01737, LS01740, LS01741, LS01742,
LS01743, LS01745, LS01746, LS01750, LS01751, LS01755,
LS01759, LS01760, LS01761, LS01768, LS01772, LS01778,
LS01779, LS01780, LS01791, LS02501, LS02502, LS02504,
LS02507, LS02512, LS02515, LS02517, LS02522, LS02531,
LS02532, LS02533, LS02535, LS02536, LS02538, LS02539,
LS02541, LS02544, LS02548, LS02550, LS02552, LS02553,
LS02555, LS02556, LS02559, LS02562, LS02564, LS02568,
LS02570, LS02571, LS02572, LS02574, LS02577, LS02578,
LS02579, LS02585, LS02588, LS02589, LS02591, LS02594,
LS02596, LS02600, LS02603, LS02606, LS02612, LS02616,
LS02617, LS02619, LS02620, LS02622, LS02623, LS02624,
LS02628, LS02629, LS02630, LS02635, LS02637, LS02640,
LS02641, LS02642, LS02646, LS02649, LS02652, LS02654,
LS02657, LS02658, LS02659, LS02660, LS02662, LS02663,
LS02664, LS02666, LS02667, LS02671, LS02672, LS02673,
LS02674, LS02676, LS02678, LS02680, LS02681, LS02683,
LS02688, LS02689, LS02690, LS02692, LS02694, LS02697,
LS02700, LS02701, LS02703, LS02705, LS02706, LS02708,
LS02709, LS02710, LS02711, LS02712, LS02713, LS02714,
LS02715, LS02716, LS02718, LS02719, LS02720, LS02721,
LS02723, LS02724, LS02726, LS02728, LS02732, LS02735,
LS02738, LS02747, LS02749, LS02750, LS02751, LS02759,
LS03002, LS03005, LS03008, LS03012, LS03014, LS03016,
LS03019, LS03020, LS03025, LS03026, LS03029, LS03031,
LS03033, LS03034, LS03036, LS03038, LS03046, LS03047,
LS03049, LS03051, LS03052, LS03053, LS03610, LS03632,
LS03634, LS03636, LS03639, LS03640, LS03642, LS03643,
LS03648, LS03650, LS03651, LS03652, LS03653, LS03656,
LS03658, LS03659, LS03661, LS03662, LS03665, LS03667,
LS03669, LS03670, LS03671, LS03672, LS03673, LS03674,
LS03675, LS03676, LS03678, LS03679, LS03680, LS03683,
LS03684, LS03685, LS03686, LS03687, LS03690, LS03691,
LS03693, LS03694, LS03695, LS03698, LS03699, LS03700,
LS03701, LS03702, LS03703, LS03704, LS03706, LS03709,
LS03711, LS03712, LS03713, LS03714, LS03717, LS03718,
-9- LS03719, LS03722, LS03723, LS03725, LS03732, LS03735,
LS03736, LS03737, LS03739, LS03740, LS03743, LS03744,
LS03746, LS03747, LS03749, LS03772, LS03774, LS03776,
LS03780, LS03783, LS03785, LS03786, LS03790, LS03792,
LS03793, LS03794, LS03795, LS03796, LS03797, LS03799,
LS03801, LS03802, LS03805, LS03807, LS03812, LS03816,
LS03817, LS03818, LS03819, LS03822, LS03823, LS03827,
LS03828, LS03829, LS03830, LS03836, LS03837, LS03838,
LS03839, LS03843, LS03848, LS03850, LS03851, LS03853,
LS03854, LS03856, LS03859, LS03862, LS03863, LS03871,
LS03872, LS03876, LS03877, LS03878, LS03880, LS03881,
LS03882, LS03887, LS03888, LS03889, LS03891, LS03893,
LS03894, LS03895, LS03897, LS03898, LS03903, LS03905,
LS03907, LS03908, LS03913, LS03915, LS03917, LS03921,
LS03922, LS03925, LS03926, LS03927, LS03934, LS03935,
LS03937, LS03938, LS03939, LS03943, LS03948, LS03949,
LS03952, LS03954, LS03962, LS03964, LS03966, LS03967,
LS03968, LS03971, LS03974, LS03976, LS03978, LS03981,
LS03982, LS03983, LS03984, LS03986, LS03987, LS03989,
LS03990, LS03991, LS03998, LS04000, LS04001, LS04005,
LS04008, LS04009, LS04010, LS04013, LS04015, LS04016,
LS04017, LS04018, LS04020, LS04022, LS04023, LS04024,
LS04027, LS04028, LS04029, LS04031, LS04032, LS04035,
LS04036, LS04038, LS04040, LS04041, LS04043, LS04045,
LS04046, LS04048, LS04049, LS04051, LS04052, LS04053,
LS04054, LS04057, LS04058, LS04059, LS04060, LS04061,
LS04063, LS04064, LS04066, LS04067, LS04069, LS04070,
LS04072, LS04073, LS04074, LS04077, LS04078, LS04083,
LS04084, LS04085, LS04086, LS04087, LS04088, LS04089,
LS04090, LS04092, LS04095, LS04096, LS04097, LS04098,
LS04101, LS04102, LS04103, LS04105, LS04112, LS04115,
LS04116, LS04117, LS04118, LS04120, LS04122, LS04124,
LS04125, LS04126, LS04127, LS04128, LS04129, LS04133,
LS04134, LS04136, LS04137, LS04138, LS04139, LS04140,
LS04141, LS04142, LS04145, LS04147, LS04148, LS04150,
LS04152, LS04153, LS04154, LS04159, LS04162, LS04166,
LS04169, LS04170, LS04171, LS04172, LS04173, LS04251,
LS04253, LS04254, LS04255, LS04256, LS04257, LS04259,
LS04261, LS04262, LS04264, LS04266, LS04267, LS04272,
LS04274, LS04277, LS04280, LS04281, LS04284, LS04287,
LS04288, LS04290, LS04291, LS04292, LS04293, LS04294,
LS04296, LS04298, LS04304, LS04305, LS04308, LS04309,
LS04310, LS04311, LS04315, LS04317, LS04318, LS04320,
LS04322, LS04323, LS04324, LS04325, LS04326, LS04328,
LS04329, LS04332, LS04339, LS04340, LS04341, LS04343,
LS04344, LS04347, LS04348, LS04349, LS04351, LS04353,
LS04359, LS04364, LS04370, LS04371, LS04373, LS04374,
LS04377, LS04378, LS04381, LS04383, LS04384, LS04386,
LS04387, LS04392, LS04399, LS04403, LS04405, LS04406,
LS04407, LS04408, LS04409, LS04414, LS04416, LS04417,
LS04419, LS04421, LS04424, LS04425, LS04426, LS04428,
LS04435, LS04441, LS04442, LS04443, LS04447, LS04448,
LS04451, LS04454, LS04458, LS04462, LS04464, LS04465,
-10- LS04467, LS04476, LS04477, LS04480, LS04484, LS04485,
LS04486, LS04488, LS04489, LS04490, LS04491, LS04493,
LS04495, S 36713, S 36714, S 36715, S 36716, S 36717,
S 36718, S 36719, S 36720, S 36721, S 36724, S 36725,
S 36729, S 36732, S 36733, S 36740, S 36741, S 36742,
S 36746, S 36748, S 36749, S 37017, S 37022, S 37029,
S 37030, S 37034, S 37035, S 37042, S 37044, S 37048,
S 37049, S 37054, S 37059, S 37065, S 37074, S 37075,
S 37090, S 37093, S 37115, S 37128, S 37134, S 37159,
S 37162, S 37165, S 37176, S 37179, S 37186, S 37187,
S 37190, S 37194, S 37202, S 37206, S 37213, S 37218,
S 37220, S 37245, S 37248, S 38222, S 38223, S 38230,
S 38231, S 38240, S 38241, S 38243, S 38249, S 38250,
S 40754, S 40758, S 40763, S 40765, S 40769, S 41491,
S 41492, S 41498, S 41501, S 41502, S 41509, S 41511,
S 41522, S 41523, S 41524, S 41525, S 41526, S 41527,
S 41529, S 41530, S 41534, S 41535, S 41536, S 41549,
S 41555, S 41559, S 41560, S 41561, S 41567, S 41576,
S 41580, S 41582, S 41591, S 41604, S 41606, S 41607,
S 41608, S 41610, S 41619, S 41620, S 41621, S 41625,
S 41638, S 41639, S 41647, S 41652, S 41660, S 41665,
S 41666, S 41668, S 41670, S 41688, S 41699, S 41704,
S 41707, S 41710, S 41712, S 41713, S 41715, S 41716,
S 41717, S 41719, S 41720, S 41721, S 41723, S 41730,
S 41740, S 41741, S 42501, S 42507, S 42508, S 42511,
S 42512, S 42521, S 42530, S 42532, S 42545, S 42548,
S 42550, S 42551, S 42564, S 42571, S 42572, S 42579,
S 42588, S 42591, S 42592, S 42603, S 42606, S 42607,
S 42612, S 42619, S 42620, S 42627, S 42633, S 42634,
S 42637, S 42644, S 42647, S 42649, S 42660, S 42665,
S 42667, S 42671, S 42684, S 42694, S 42698, S 42707,
S 42710, S 42717, S 42718, S 42723, S 42724, S 42725,
S 42744, S 42745, S 42747, S 42749, S 42752, S 42761,
S 42776, S 42778, S 42779, S 42783, S 42785, S 42788,
S 42798, S 42800, S 42819, S 42820, S 42825, S 42826,
S 42831, S 42833, S 42836, S 42839, S 42844, S 42847,
S 42848, S 42853, S 42855, S 42859, S 42860, S 42867,
S 42870, S 42872, S 42875, S 42876, S 42879, S 42889,
S 42891, S 42903, S 42905, S 42906, S 42915, S 42918,
S 42921, S 42922, S 42926, S 42934, S 42935, S 42936,
S 42946, S 42954, S 42962, S 42963, S 42965, S 42979,
S 42981, S 42984, S 42985, S 42989, S 42992, S 43000,
S 43081, S 43109, S 43113, S 43139, S 43144, S 43150,
S 43152, S 43158, S 43163, S 43164, S 43185, S 43188,
S 43233, S 43234, S 43245, S 43247, S 43248, S 43278,
S 43299, S 43302, S 43304, S 43312, S 43316, S 43323,
S 43350, S 43357, S 43362, S 43385, S 43391, S 43434,
S 43444, S 43456, S 43504, S 43527, S 43544, S 43545,
S 43549, S 43573, S 43583, S 43592, S 43593, S 43600,
S 43604, S 43612, S 43613, S 43641, S 43648, S 43650,
S 43653, S 43662, S 43667, S 43669, S 43687, S 43692,
S 43697, S 43700, S 43704, S 43706, S 43733, S 43746,
-11- S 43755, S 43756, S 43779, S 43780, S 43794, S 43798,
S 43810, S 43814, S 43832, S 43833, S 43846, S 43855,
S 43856, S 43874, S 43883, S 43885, S 43900, S 43904,
S 43905, S 43942, S 43959, S 43965, S 43975, S 43977,
S 43994, S 43999, S 44000, S 44001, S 44006, S 44008,
S 44019, S 44021, S 44023, S 44024, S 44026, S 44028,
S 44263, S 44271, S 44275, S 44285, S 44294, S 44303,
S 44304, S 44306, S 44330, S 44331, S 44342, S 44343,
S 44344, S 44352, S 44353, S 44359, S 44364, S 44386,
S 44387, S 44391, S 44401, S 44407, S 44410, S 44422,
S 44424, S 44425, S 44426, S 44430, S 44437, S 44457,
S 44463, S 44469, S 44484, S 44486, S 44497, S 44499,
S 44500, S 44531, S 44555, S 44557, S 44560, S 44567,
S 44569, S 44573, S 44574, S 44578, S 44590, S 44600,
S 44607, S 44610, S 44614, S 44624, S 44625, S 44630,
S 44637, S 44651, S 44659, S 44676, S 44677, S 44688,
S 44707, S 44718, S 44720, S 44726, S 44740, S 44743,
S 44753, S 44759, S 44760, S 44761, S 44764, S 44765,
S 44766, S 44767, S 44770, S 44778, S 44791, S 44800,
S 44801, S 44804, S 44821, S 44826, S 44827, S 44841,
S 44847, S 44848, S 44849, S 44850, S 44851, S 44858,
S 44859, S 44860, S 44861, S 44868, S 44874, S 44883,
S 44884, S 44885, S 44887, S 44896, S 44900, S 44904,
S 44905, S 44906, S 44908, S 44916, S 44920, S 44921,
S 44932, S 44933, S 44938, S 44939, S 44942, S 44945,
S 44952, S 44955, S 44959, S 44968, S 44970, S 44971,
S 44976, S 44978, S 44979, S 44981, S 44983, S 44986,
S 44987, S 44995, S 45000, S 45002, S 45006, S 45009,
S 45010, S 45013, S 45018, S 45019, S 45022, S 45025,
S 45044, S 45048, S 45049, S 45050, S 45054, S 45057,
S 45058, S 45066, S 45068, S 45074, S 45075, S 45076,
S 45077, S 45078, S 45080, S 45086, S 45088, S 45091,
S 45095, S 45101, S 45102, S 45103, S 45104, S 45111,
S 45112, S 45113, S 45114, S 45115, S 45116, S 45121,
S 45122, S 45127, S 45128, S 45132, S 45135, S 45138,
S 45139, S 45144, S 45145, S 45156, S 45162, S 45163,
S 45164, S 45165, S 45171, S 45182, S 45183, S 45185,
S 45189, S 45202, S 45204, S 45207, S 45212, S 45214,
S 45225, S 45227, S 45255, S 45257, S 45267, S 45268,
S 45275, S 45291, S 45298, S 45299, S 45300, S 45301,
S 45302, S 45303, S 45307, S 45310, S 45311, S 45320,
S 45329, S 45338, S 45339, S 45341, S 45342, S 45343,
S 45344, S 45350, S 45352, S 45357, S 45358, S 45376,
S 45380, S 45391, S 45395, S 45412, S 45414, S 45416,
S 45424, S 45430, S 45433, S 45436, S 45438, S 45442,
S 45443, S 45447, S 45449, S 45464, S 45467, S 45468,
S 45469, S 45471, S 45474, S 45475, S 45477, S 45480,
S 45490, S 45498, S 45500, S 45559, S 45560, S 45561,
S 45562, S 45597, S 45606, S 45613, S 45654, S 45655,
S 45668, S 45685, S 45711, S 45712, S 45715, S 45731,
S 45738, S 45753, S 45754, S 45768, S 45773, S 45785,
S 45789, S 45795, S 45802, S 45808, S 45811, S 45822,
S 45827, S 45848, S 45853, S 45872, S 45896, S 45913,
-12- S 45916, S 45917, S 45918, S 45924, S 45930, S 45931,
S 45939, S 45957, S 45989, S 45993, S 46000, S 46002,
S 46003, S 46005, S 46016, S 46030, S 46036, S 46038,
S 46041, S 46042, S 46049, S 46050, S 46051, S 46052,
S 46057, S 46059, S 46060, S 46078, S 46251, S 46252,
S 46258, S 46260, S 46261, S 46262, S 46269, S 46270,
S 46271, S 46272, S 46273, S 46282, S 46283, S 46284,
S 46292, S 46293, S 46298, S 46300, S 46305, S 46306,
S 46315, S 46318, S 46323, S 46324, S 46327, S 46330,
S 46331, S 46334, S 46340, S 46341, S 46347, S 46354,
S 46356, S 46359, S 46363, S 46366, S 46370, S 46371,
S 46374, S 46380, S 46381, S 46410, S 46415, S 46440,
S 46447, S 46449, S 46450, S 46457, S 46458, S 46461,
S 46464, S 46471, S 46476, S 46483, S 46485, S 46489,
S 46518, S 46522, S 46527, S 46528, S 46536, S 46539,
S 46551, S 46553, S 46556, S 46560, S 46574, S 47009,
S 47024, S 47030, S 47039, S 47047, S 47061, S 47074,
S 47081, S 47093, and S 47094.
MANUFACTURER Blood Bank of San Bernardino and Riverside Counties, San
Bernardino, California.
RECALLED BY Manufacturer, (a) by letter May 12, 1993; (b) by fax of
April 14, 1993, and by letter November 24, 1993. Firm-
initiated recall complete.
DISTRIBUTION (a) California; (b) New York.
QUANTITY (a) 1 unit; (b) 2,290 units.
REASON Blood products collected from donors who:
1) admitted to IV drug use, or 2) were not asked medical
history questions for behaviors placing the donor at risk
for transmission of the human immunodeficiency virus type 1
(anti-HIV-1), were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Rusch Encapsulon Epidural Catheter 19 gauge, 36 inches, open
end, rounded tip, sterile Rx device for continuous epidural
anesthesia. Recall #Z-298-4.
CODE Catalog #1210, lot numbers: 20204A, 20204B.
MANUFACTURER TFX Medical, Inc., Jeffrey, New Hampshire.
RECALLED BY Rusch, Inc., Duluth, Georgia, by telephone December 20,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, California, Rhode Island, Texas, Ohio,
Georgia, Arizona, Mississippi, Illinois.
QUANTITY Firm estimates 143 boxes (10 units per box) remain on the
market.
REASON A catheter package was open upon receipt at a hospital, thus
compromising the sterility of the device.
_______________
PRODUCT Fonar Ultimate 3000 and B-3000/B03000M Magnetic Resonance
Imaging (MRI) Scanners. Recall #Z-450-4.
-13- CODE Site numbers: 003, 006, 007, 009, 011, 012, 026, 028, 035,
037, 040, 041, 042, 045, 046, 052, 053, 061, 067, 073, 080,
090, 094, 102, 116, 120, 122, 124, 135, 159, 161
(decommissioned); 077, 179, 191, 194 (undergoing
installation and testing).
MANUFACTURER Fonar Corporation, Melville, New York.
RECALLED BY Manufacturer, by visit between January 7 and 21, 1994.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 160 units.
REASON The anatomical phantom, used by technicians during quality
assurance evaluation will malfunction with respect to
evaluating left-right image reversal.
_______________
PRODUCT Stryker Critical Care Beds: (a) Model 2020; (b) Model 2010;
(c) Model 2021. Recall #Z-536/538-4.
CODE All units with serial numbers from 9201-0802 through
9205-0608. This represents beds manufactured January
through May 1992.
MANUFACTURER Stryker Corporation, Patient Handling Division, Kalamazoo,
Michigan.
RECALLED BY Manufacturer, by letters sent over a period of June-July
1992. Firm-initiated field correction complete.
DISTRIBUTION Nationwide, Australia, Brazil, Canada, Japan, The
Netherlands.
QUANTITY 437 beds were distributed.
REASON The beds had bolts (cap screws) breaking off which held load
cells to the crossbars at the foot end of the bed.
_______________
PRODUCT 20/20 Indeflator, a dilatation catheter inflation device,
used for inflating/deflating angioplasty catheter balloons
positioned at a site of an arterial lesion during a PTCA or
PTA procedure, sold individually under ACS label Catalog
#24310, and the Peripheral Systems Group Label Catalog
#50700. Sold in kits under the ACS label Catalog #22297.
Recall #Z-569-4.
CODE All lot numbers.
MANUFACTURER Advanced Cardiovascular Systems, Inc (ACS), Temecula,
California.
RECALLED BY Advanced Cardiovascular Systems, Inc., Santa, Clara,
California, by letter January 5, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 126,843 units were distributed.
REASON Sterility may be compromised due to small holes in the outer
pouch which contains the plastic tray holding the device.
_______________
PRODUCT Handbooks for Mini Speech Processor-MSP Issue 4.
Recall #Z-561-4.
-14- CODE All MSPs shipped from Cochlear PTY in Sidney, Australia
between May 8, 1993, and January 14, 1994.
MANUFACTURER Cochlear Proprietary (Pty) Limited, Cove, Australia.
RECALLED BY Cochlear Corporation, Englewood, Colorado, by letter on or
about February 18, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Argentina, Canada, Colombia, Ecuador, Israel,
Mexico, Uruguay, Venezuela.
QUANTITY 729 issues.
REASON The handbooks lack adequate warning and precautions which
guide the users in the proper use and operation. These
warnings and precautions have either been omitted or
deemphasized.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Sani Sleeve Equipment Drape, 50 mm x 1,650 mm, sterile,
packaged 1 sleeve per pouch, barrier protection for
handpieces and hoses. Recall #Z-209-4.
CODE Product #9340, lot #STR-1 880725.
MANUFACTURER Pesco Corporation, Kwangju, S. Korea.
RECALLED BY Nieusma R & D, Inc., Lincoln, Nebraska, by October 13, 1992.
Firm-initiated recall complete.
DISTRIBUTION Washington state, California.
QUANTITY 154 boxes (12 units per box) were distributed.
REASON Sealing tape ineffective after being over-sterilized.
_______________
PRODUCT A-Gent Magnesium Clinical Chemistry Reagent, in 125 ml
bottles, an in-vitro diagnostic for the qualitative
determination of magnesium in human serum. Recall #Z-566-4.
CODE Lot #78-012HW, 78-014HW, 81-229HW, 81-231HW, 84-486HW.
MANUFACTURER Abbott Laboratories, Diagnostics Division, South Pasadena,
California.
RECALLED BY Abbott Laboratories, Diagnostics Division, Abbott Park,
Illinois, by telephone February 7, 1994, followed by letter
February 11, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 3,125 kits were distributed; firm estimates 946 kits remain
on the market.
REASON Device does not meet on-board stability claims. Tests
performed confirmed a downward drift of as much as 60
percent for controls and patient samples over the 24 hour
calibration interval.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT Veta-K1, Vitamin K1 Injection, 10 mg/ml, in 100 ml bottles,
also under the Veda-K injection label for Vedco.
Recall #V-040-4.
CODE Lot #50467.
MANUFACTURER Sanofi Animal Health, Inc., Overland Park, Kansas.
-15- RECALLED BY Sanofi Animal Health, Ft. Dodge, Iowa, by letter December
20, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Missouri, Texas, Nebraska, Mississippi, Minnesota, New
Mexico, California, Canada.
QUANTITY 3,012 bottles were distributed.
REASON Glass particles found in some of the bottles.
MEDICAL DEVICE SAFETY ALERTS:
=============================================
_______________
PRODUCT Capsure Steroid Eluting, Polyurethane, Bipolar, Implantable,
Tined, Ventricular, Transvenous Pacemaker Leads:
(a) Model 4004/4004M; (b) Model 4082.
Safety Alert #N-029/030-4.
CODE All serial numbers.
MANUFACTURER Medtronic Puerto Rico, Inc., Villalba, Puerto Rico.
ALERTED BY Medtronic, Inc., Minneapolis, Minnesota, by letter October
8, 1993.
DISTRIBUTION Nationwide and international.
QUANTITY 74,484 leads were implanted.
REASON The leads fail at a rate greater than anticipated and over
time the failure mechanisms can progress to complete loss of
capture.
-16-
END OF ENFORCEMENT REPORT FOR APRIL 13, 1994. BLANK PAGES MAY
FOLLOW.
####