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
12/13/1995
ENFORCEMENT REPORT FOR 12/13/95
December 13, 1995 95-50
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCTS All ice cream novelties manufactured prior to October 20,
1995, and packaged under various labels as follows:
CONES: Ice Cream Cones, 2½ ounce, 6 cones per box
packaged under the Smith label.
Ice Cream Cones, 3 ounce, 6 cones or 24 cones per box
packaged under the Nutty Buddy and Broughton labels.
Nutty Buddy Cones, 2½ ounce, 6 cones per box packaged under
the Northwest and Shurfresh labels.
Ice Cream Crunchy Cones, 2½ ounce, 6 or 24 cones per box
packaged under the Broughton label.
CUPS: Chocolate Flavored Ice Cream Cup, 3 ounces, 108 cup
per box packaged under the Northwest and Pierre labels.
Chocolate Flavored Ice Cream Cup, 4 ounces, 48 cups per box
packaged under the Northwest and Pierre labels.
Sugar Free-Fat Free Cups, 4 ounce, 48 cups per box
packaged under the Northwest label.
Strawberry Flavored Ice Cream Cups, 4 ounce, 48 cups per box
packaged under the Northwest and Pierre labels.
Strawberry Flavored Ice Cream Cups, 3 ounce, 108 cups per
box packaged under the Northwest label.
Chocolate Sundae Cup, 4 ounce, 108 per box packaged under
the Holland label.
Chocolate Sundae Cup, 5 ounce, 36 per box packaged under the
Northwest label.
Strawberry Sundae Cup, 4 ounces packaged under the Holland
label.
Strawberry Sundae Cup, 5 ounces, 36 cups per box packaged
under the Northwest label.
Strawberry & Chocolate Sundae Cup, 3 ounces, 108 cups per
box packaged under the Broughton and Pierre labels.
Vanilla Ice Cream Cup, 3 ounces, 108 cups per box packaged
under the Northwest, Broughton, and Pierre labels.
Vanilla Ice Cream Cup, 4 ounces, 48 cups per box packaged
under the Northwest, Holland, and Pierre labels.
Orange Sherbet Cup, 4 ounce, 48 cups per box Packaged under
the Northwest and Pierre labels.
Orange Sherbet Cup, 3 ounce, 108 cups per box Packaged under
the Northwest and Pierre labels.
Raspberry Sherbet Cup, 4 ounces, 48 cups per box packaged
under the Northwest and Pierre labels.
Lemon Sherbet Cups, 4 ounce packaged under the Northwest
label.
Lime Sherbet Cups, 4 ounce packaged under the Pierre and
Northwest labels.
Strawberry Sherbet Cups, 4 ounce packaged under the
Northwest and Pierre labels.
BARS: Chocolate Covered Vanilla Bars, 2½ ounce bar, 6, 12
or 24 per box packaged under the Smith, Maplehurst,
Goldenrod, Northwest, and Broughton, Velvet Olde Mill, and
Shurfresh labels.
Orange Cream Bars, 2½ ounces, 12 bars or 24 bars per box
packaged under the Holland, Goldenrod, Shurfresh,
Northwest, Broughton, Maplehurst, and Smith labels.
Chocolate Covered Low Fat Ice Milk Bars, 2½ ounce, 12 per
box packaged under the Holland label.
Chocolate Scooter Crunch Bars, 2½ ounce, 6 or 24 per box
packaged under the Scooter label.
Strawberry Scooter Crunch Bars, 2½ ounce, 6 or 24 per box
packaged under the Scooter label.
Chocolate Covered Toffee Bars, 2½ ounce, 24 bars per box
packaged under the Northwest and Pierre labels.
Chocolate Covered Toffee Bars, 2½ ounce, 6 bars per box
packaged under the Pierre and Smith labels.
Chocolate Crunch Bars, 3 ounce, 24 bars per box packaged
under the Maola and East Coast labels.
Strawberry Crunch Bars, 3 ounce, 24 bars per box packaged
under the Maola and East Coast labels.
Chocolate Covered Deluxe Vanilla Bars, 3 ounce, 6 or 24 per
box packaged under the Pierre label.
Fudge Bars, 6, 12, or 24 pack packaged under the Broughton,
Goldenrod, Holland, Maplehurst, Pierre, Shurfresh, and
Northwest labels.
Combo Cream bars, 24 pack packaged under the Goldmine label.
Chocolate Eclair Bars, 24 pack packaged under the East Coast
and Maola labels.
Sugar-free Bars, 6 pack packaged under the Velvet Olde Mill
label.
-2- SANDWICHES: Vanilla Ice Cream Sandwiches, 2½ ounce, 6, 12,
or 24 per box packaged under the Northwest, Pierre, Smith,
Maplehurst, Shurfresh, and Goldenrod labels.
Vanilla Ice Cream Sandwiches, 3 ounce, 24 per box packaged
under the Holland and Pierre labels.
SLICES: Vanilla Slices, 4 ounce, 8 slices per box packaged
under the Northwest and Jack & Jill labels.
Neapolitan Slices, 4 ounce, 8 slices per box packaged under
the Jack & Jill and Northwest labels.
Neapolitan Slices, 4½ ounce, 8 or 12 slices per box packaged
under the Acme and Giant labels.
Vanilla Ice Cream Santa Slices, 2 1/4 ounce, 6 per box
packaged under the Northwest label.
Vanilla Ice Cream Tree Slices, 2 1/4 ounce, 6 per box
packaged under the Northwest label.
Chocolate & Vanilla Checkerboard Slices, 24 pack packaged
under the Northwest label. Recall #F-060/094-6.
CODES The retail boxes can be identified with the dates: "Oct 19
96" or "10 19 96" and before. Shipping master cases are
identified with the Julian date of manufacture: "292" and
before.
MANUFACTURER Frecker's Ice Cream Company, Columbus, Ohio.
RECALLED BY Manufacturer, initially by press release and telephone on
October 20, 1995, followed by recall letters and/or press
releases on/about October 26, 1995, November 2 and 21, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Ohio, Kentucky, Indiana, Maryland, North Carolina, Michigan,
Pennsylvania, Iowa, Illinois.
QUANTITY Undetermined.
REASON Products were manufactured using an ice cream base that was
contaminated with Listeria monocytogenes.
_______________
PRODUCT Cooked Frozen Ready-To-Eat Shrimp, bulk. Recall #F-103-6.
CODE Lot #FJ0601.
MANUFACTURER King and Prince Seafood Corporation, Brunswick, Georgia.
RECALLED BY Manufacturer, by letter and telephone on October 5, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Georgia, Tennessee, West Virginia, Kansas.
QUANTITY 545 20-pound cases were distributed.
REASON Product is contaminated with Listeria Monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Quinlan brand Mini Pretzels, in 3 ounce plastic bags.
Recall #F-095-6.
CODE JAN 16-LGE.
MANUFACTURER Quinlan Pretzel Company, Denver, Pennsylvania.
RECALLED BY Manufacturer, by letter on October 19, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Connecticut, New York, Massachusetts, Pennsylvania, New
Hampshire, Vermont.
-3- QUANTITY Approximately 4,800 bags were produced; firm estimated that
25 percent of the product remained on market at time of
recall initiation.
REASON Excess sodium hydroxide.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Various Vavel brand food products:
(a) "Vavel" brand eggplant appetizer, packed in metal cans,
net weight 15 ounces
(b) "Vavel" brand sun dried tomatoes in oil, packed in glass
jars, net weight 11.6 ounces
(c) "Vavel" brand pimento style peppers, packed in glass
jars, net weight 24 fluid ounces
(d) "Vavel" brand roasted peppers, packed in glass jars, net
weight 12 ounces and 24 ounces
(e) "Vavel" brand capricorn peppers, packed in glass jars,
net weight 24 fluid ounces Recall #F-096/100-6.
CODE None.
MANUFACTURER Plovdivska Konserva Ltd., Plovdiv, Bulgaria.
RECALLED BY Adamba Imports, Brooklyn, New York, by telephone and letters
on November 2, 1995. FDA-initiated recall ongoing.
DISTRIBUTION New York, New Jersey, Illinois, Maryland, Connecticut,
Texas.
QUANTITY (a) 385 cases (24 cans per case); (b) 300 cases (12 jars per
case); (c) 224 cases (12 jars per case); (d) 539 cases (12
jars per case); (e) 359 cases (12 jars per case).
REASON The products are low acid canned food (LACF) or acidified
foods, but no process has been filed with the FDA. The
products also are in violation of the LACF or acidified food
good manufacturing practices.
_______________
PRODUCT Rice in 50 pound plastic woven bags. Recall F-101-6.
CODE None.
MANUFACTURER Cormier Rice Milling Company, Inc., Dewitt, Arkansas.
RECALLED BY Berghorst Foods, Inc., Grandville, Michigan, by recovering
and destroying product. Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 12 bags were distributed; firm estimates none remains on the
market.
REASON Product is adulterated due to rodent filth.
_______________
PRODUCT Geisha brand Tiny Shrimp, packed in water in 4-1/4 ounce
cans. Recall #F-102-6.
CODE Can lid embossed 0106CP/030195, carton labeled Lot:
R5653-05 / can lid embossed 0106CP/300994, carton labeled
lot: R5634-06.
MANUFACTURER Continental Pacific Corp., Ltd., Bangkok Thailand.
-4- RECALLED BY Nozaki America, Inc., New York, New York, by telephone the
week of October 30, 1995, followed by fax dated November 7,
1995. Firm-initiated recall ongoing.
DISTRIBUTION New Jersey, Florida, Ohio, Pennsylvania, Michigan,
Minnesota, Illinois.
QUANTITY 2,461 cartons were distributed; firm estimated that a small
amount of product remained on market at time of recall
initiation.
REASON Product is adulterated due to decomposition.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Piroxicam Capsules USP 20 mg, in bottles of 100, Rx anti-
inflammatory. Recall #D-035-6.
CODE Lot #31384 EXP 6/97.
MANUFACTURER Mutual Pharmaceutical Company, Inc., Philadelphia,
Pennsylvania.
RECALLED BY Manufacturer, by letter on October 31, 1995. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 4,785 bottles were distributed; firm estimates none remains
on the market.
REASON Product does not meet dissolution specifications.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Triamcinolone, a synthetic adrenocorticosteroid:
(a) Triamcinolone USP; (b) Triamcinolone Diacetate USP
Micronized. Recall #D-033/034-6.
CODE (a) Bulk drug lot 189KW; (b) Bulk drug lot 772YP.
MANUFACTURER The Upjohn Company, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter on October 27, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide, Korea, Brazil.
QUANTITY Two bulk lots.
REASON Products contain trace quantities of decabromodiphenylether
resulting from synthesis reagent.
_______________
PRODUCT SoloPak Sodium Chloride Injection USP, 0.9%, preservative
free, in 10 ml single use vials, used to flush intravascular
catheters or used as a sterile, isotonic single dose
vehicle, solvent or diluent for substances to be
administered intravenously. Recall #D-036-6.
CODE Lot numbers: 950327, 950108, 950441, 950579, 950614.
MANUFACTURER SoloPak Laboratories, Inc., Elk Grove Village, Illinois.
RECALLED BY Manufacturer, by letter dated November 29, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
-5- QUANTITY 523,725 vials were distributed; firm estimated that 4
percent of product remained on market at time of recall
initiation.
REASON Product does not meet pH specifications.
_______________
PRODUCT Rhinocort (budesonide) Nasal Inhaler 2 mg/ml metered 200
doses, Rx drug for the management of allergic rhinitis.
Recall #D-037-6.
CODE Lot numbers and EXP Dates: UFll 6/96, UG12 7/96, UH13 8/96,
UH14 8/96, UH15 8/96, UI16 9/96, UK17 10/96.
MANUFACTURER 3M Health Care, Loughborough, UK.
RECALLED BY Astra USA., Inc., Westborough, Massachusetts, by letter on
or about November 30, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 626,602 units were distributed.
REASON Product does not meet specification for degradation.
_______________
UPDATE Recall #D-030-6 which appeared in the December 6, 1995
Enforcement Report should read:
PRODUCT: Mephyton (Phytonadione) 5 mg Tablets, Rx Systemic
coagulant.
HUMAN TISSUE MANDATORY RECALL
=============================================
_______________
PRODUCT Human Tissue for Transplant: Demineralized Cortical Bone
Corneas, left and right; Skin, Gryopreserved; Patellar
tendon; Femoral head; Femur segment; Bone dowel w/cortical;
Fibula segment, whole; and Crushed cancellous.
Recall #B-125-6.
CODE Unit numbers: 162-93-1 through 162-93-140.
MANUFACTURER Michigan Tissue Bank, Lansing, Michigan.
RECALLED BY Manufacturer, by letters dated April 25, 1995 and May 9,
1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY Tissues from one donor.
REASON Human tissues, with a change in donor's status from HBsAg
negative to confirmed positive, was distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT (a) Fresh Frozen Plasma; (b) Cryoprecipitated AHF.
Recall #B-114\115-6.
CODE Unit numbers: (a) 0214617, 0214643, 0214656, 0214657,
0214658, 0214662, 0214663, 0214664, 0214665, 0214666,
0214667, 0214669, 0214671, 0214673, 0214677, 0214679,
0214680, 0214681, 0214682, 0214684, 0214685, 0214686,
0214688, 0214689, 0214690, 0214693, 0214696, 0214697,
0214698, 0214831, 0214847, 0214849, 0214850, 0214851,
-6- 0214854, 0214856, 0214859, 0214863, 0214868, 0214872,
0214873, 0214877, 0214890, 0214891, 0214894, 0214911,
0214913, 0214914, 0214915, 0214916, 0214922, 0214923,
0214924, 0214925, 0214927, 0214928, 0214929, 0214930,
0214931, 0214933, 0214936, 0214938, 0214939, 0214940,
0214941, 0214944, 0214946, 0214952, 0214954, 0214955,
0214958, 0214960, 0214963, 0214964, 0214966, 0214973,
0214976, 0215003, 0215004, 0215005, 0215006, 0215007,
0215008, 0215009, 0215010, 0215011, 0215012, 0215014,
0215015, 0215016, 0215017, 0215018, 0215019, 0215020,
0215021, 0215023, 0215024, 0215025, 0215026, 0215108,
0215109, 0215111, 0215112, 0215113, 0215116, 0215119,
0215121, 0215122, 0215123, 0215124, 0215127, 0215128,
0215132, 0215133, 0215134, 0215135, 0215136, 0215137,
0215138, 0215141, 0215142, 0215143, 0215144, 0215145,
0215146, 0215147, 0215148, 0215150, 0215151, 0215152,
0215153, 0215155, 0215265, 0215273, 0215274, 0215279,
0215280, 0215290, 0215300, 0215309, 0215311, 0215313,
0215314, 0215315, 0215461, 0215462, 0215468, 0215474,
0215476, 0215479, 0215480, 0215481, 0215482, 0215483,
0215532, 0215871, 0215873, 0215904, 1205823, 1205824,
1205825, 1205826, 1205828, 1205830, 1205832, 1205833,
1205834, 1205835, 1205836, 1205838, 1205839, 1205842,
1205843, 1205844, 1205845, 1205846, 1205847, 1205848,
1205849, 1205850, 1205851, 1205853, 1205854, 1205855,
1205856, 1205857, 1205858, 1205859, 1205860, 1205861,
1205862, 1205863, 1205864, 1205865, 1205866, 1205867,
1205868, 1205869, 1205870, 1205872, 1205874, 1205875,
1205876, 1205879, 1205880, 1205883, 1205884, 1205885,
1205886, 1205887, 1205889, 1205891, 1205892, 1205893,
1205895, 1205897, 1205898, 1205899, 1206023, 1206025,
1206026, 1206031, 1206032, 1206033, 1206034, 1206038,
1206039, 1206042, 1206043, 1206047, 1206051, 1206053,
1206054, 1206057, 1206060, 1206061, 1206062, 1206068,
1206122, 1206123, 1206124, 1206125, 1206126, 1206128,
1206129, 1206133, 1206134, 1206136, 1206137, 1206138,
1206139, 1206141, 1206142, 1206143, 1206144, 1206145,
1206147, 1206148, 1206150, 1206152, 1206153, 1206154,
1206155, 1206156, 1206157, 1206158, 1206161, 1206162,
1206163, 1206165, 1206166, 1206167, 1206168, 1206170,
1206171, 1206172, 1206174, 1206175, 1206176, 1206177,
1206178, 1206181, 1206182, 1206183, 1206184, 1206185,
1206186, 1206188, 1206189, 1206190, 1206191, 1206192,
1206193, 1206194, 1206196, 1206197, 1206199, 1206200,
1206201, 1206202, 1206204, 1206205, 1206206, 1206207,
1206208, 1206209, 1206210, 1206211, 1206212, 1206213,
1206214, 1206215, 1206216, 1206218, 1206221, 1206222,
1206223, 1206224, 1206225, 1206226, 1206227, 1206228,
1206229, 1206230, 1206231, 1206236, 1206313, 1206314,
1206315, 1206316, 1206318, 1206319, 1206320, 1206321,
1206322, 1206324, 1206325, 1206326, 1206329, 1206331,
1206332, 1206336, 1206337, 1206339, 1206343, 1206344,
1206345, 1206347, 1206348, 1206349, 1206350, 1206352,
-7- 1206353, 1206354, 1206355, 1206356, 1206357, 1206359,
1206360, 1206361, 1206362, 1206363, 1206364, 1206365,
1206366, 1206367, 1206368, 1206369, 1206370, 1206371,
1206372, 1206373, 1206374, 1206375, 1206377, 1206378,
1206602, 1206605, 1206609, 1206610, 1206611, 1206612,
1206613, 1206614, 1206620, 1206623, 1206631, 1206636,
1206643, 1206732, 1206776, 2122541, 2122542, 2122544,
2122545, 2122546, 2122547, 2122549, 2122550, 2122551,
2122552, 2122553, 2122554, 2122556, 2122558, 2122559,
2122560, 2122561, 2122563, 2122564, 2122565, 2122567,
2122568, 2122570, 2122571, 2122576, 2122577, 2122578,
2122579, 2122581, 2122726, 2122727, 2122731, 2122732,
2122734, 2122735, 2122736, 2122737, 2122738, 2122741,
2122743, 2122744, 2122749, 2122752, 2122753, 2122755,
2122761, 2122763, 2122790, 2122791, 2122794, 2122795,
2122796, 2122797, 2122798, 2122799, 2122801, 2122802,
2122804, 2122805, 2122806, 2122807, 2122808, 2122810,
2122811, 2122812, 2122813, 2122815, 2122817, 2122818,
2122819, 2122820, 2122821, 2122822, 2122823, 2122824,
2122825, 2122826, 2122828, 2122829, 2122830, 2122832,
2122834, 2122835, 2122837, 2122838, 2122839, 2122840,
2122841, 2122842, 2122843, 2122844, 2122846, 2122847,
2122848, 2122851, 2122852, 2122853, 2122854, 2122855,
2122856, 2122857, 2122863, 2122864, 2122866, 2122868,
2122869, 2122870, 2122873, 2122874, 2122875, 2122876,
2122879, 2122880, 2122882, 2122884, 2122885, 2122886,
2122887, 2122888, 2122889, 2122890, 2123160, 2123190,
2123577, 2123578, 2123583, 2123589, 3109301, 3109302,
3109303, 3109304, 3109306, 3109307, 3109309, 3109312,
3109316, 3109318, 3109321, 3109322, 3109323, 3109324,
3109326, 3109327, 3109329, 3109330, 3109331, 3109334,
3109335, 3109336, 3109337, 3109338, 3109339, 3109340,
3109342, 3109361, 3109363, 3109364, 3109368, 3109369,
3109371, 3109376, 3109377, 3109467, 3109469, 3109470,
3109471, 3109473, 3109478, 3109480, 3109481, 3109482,
3109487, 3109494, 3109497, 3109502, 3109504, 3109507,
3109508, 3109509, 3109510, 3109513, 3109514, 3109516,
3109517, 3109518, 3109520, 3109521, 3109522, 3109523,
3109524, 3109525, 3109527, 3109528, 3109529, 3109531,
3109532, 3109533, 3109534, 3109535, 3109536, 3109538,
3109539, 3109543, 3109544, 3109545, 3109547, 3109548,
3109549, 3109550, 3109551, 3109553, 3109554, 3109555,
3109556, 3109560, 3109561, 3109563, 3109564, 3109565,
3109566, 3109567, 3109568, 3109569, 3109570, 3109571,
3109573, 3109574, 3109575, 3109576, 3109580, 3109581,
3109586, 3109590, 3109591, 3109592, 3109593, 3109596,
3109597, 3109600, 3109601, 3109604, 3109606, 3109607,
3109609, 4085165, 4085166, 4085167, 4085168, 4085169,
4085170, 4085171, 4085172, 4085173, 4085174, 4085175,
4085176, 4085177, 4085178, 4085179, 4085180, 4085181,
4085182, 4085184, 4085185, 4085186, 4085187, 4085188,
4085189, 4085190, 4085191, 4085193, 4085194, 4085196,
-8- 4085197, 4085198, 4085199, 4085201, 4085203, 4085204,
4085205, 4085206, 4085207, 4085208, 4085209, 4085210,
4085211, 4085212, 4085213, 4085214, 4085215, 4085216,
4085217, 4085219, 4085225, 4085233, 4085237, 4085241,
4085245, 4085249, 5045064, 6001837, 6001838, 6001839,
6001841, 6001842, 6001843, 6001844, 6001846, 6001847,
6001849, 6001850, 6001852, 6001885, 6001889, 6001890,
6001891, 6001894, 6001895, 6001904, 6001905, 6001907,
6001909, 6001910, 6001911, 6001924, 6001925, 6001926,
6001927, 6001928, 6001929, 6001930, 6001932, 6001931,
6001933, 6001934, 6001939, 6001944, and 6001974;
(b) 0214312, 0214313, 0214315, 0214316, 0214317, 0214320,
0214322, 0214323, 0214324, 0214325, 0214326, 0214327,
0214328, 0214331, 0214332, 0214333, 0214524, 0214525,
0214526, 0214527, 0214528, 0214529, 0214530, 0214531,
0214534, 0214535, 0214536, 0214537, 0214538, 0214539,
0214540, 0214542, 0214543, 0214544, 0214545, 0214546,
0214548, 0214549, 0214550, 0214551, 0214552, 0214553,
0214555, 0214558, 0214559, 0214560, 0214561, 0214562,
0214563, 0214564, 0214565, 0214566, 0214569, 0214570,
0214571, 0214573, 0214575, 0214584, 0214585, 0214586,
0214587, 0214588, 0214589, 0214591, 0214592, 0214593,
0214594, 0214595, 0214597, 0214598, 0214599, 0214601,
0214602, 0214603, 0214606, 0214607, 0214608, 0214611,
0214612, 0214613, 0214614, 0214615, 0214619, 0214620,
0214621, 0214625, 0214628, 0214630, 0214699, 0214700,
0214702, 0214703, 0214705, 0214706, 0214709, 0214711,
0214713, 0214714, 0214717, 0214719, 0214722, 0214723,
0214724, 0214725, 0214727, 0214730, 0214947, 0214949,
0214984, 0214999, 0215180, 0215187, 0215195, 0215200,
0215207, 0215213, 0215518, 0215529, 0215533, 0215544,
0215552, 0215557, 0215559, 0215565, 0215567, 0215576,
0215596, 0215598, 0215606, 0215608, 0215609, 0215610,
0215611, 0215622, 0215625, 0215627, 0215628, 4085116.
MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City,
Missouri.
RECALLED BY Manufacturer, by telephone on August 25 and 29, 1995,
followed by letter dated September 7, 1995. Firm-initiated
recall complete.
DISTRIBUTION Missouri, Kansas.
QUANTITY (a) 729 units; (b) 138 units.
REASON Blood products, which were exposed to unacceptable storage
temperatures, were distributed.
_______________
PRODUCT Red Blood Cells, Deglycerolized. Recall #B-122-6.
CODE Unit numbers 03Z04899 and 03R85935.
MANUFACTURER American Red Cross Blood Services, Lansing, Michigan.
RECALLED BY Manufacturer, by letter dated May 17, 1994. Firm-initiated
recall complete.
DISTRIBUTION Michigan and Puerto Rico.
QUANTITY 2 units.
-9- REASON Frozen Red Blood Cells, which were deglycerolized using
outdated 12% Sodium Chloride (NaCl), were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Platelets. Recall #B-098-6.
CODE Unit #8120848.
MANUFACTURER Permian Basin Regional Blood Center, Midland, Texas.
RECALLED BY Manufacturer, by letter dated April 15, 1995. Firm-
initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product, collected from a donor who provided
incomplete medical history, was distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-117-6.
CODE Unit #2639193.
MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis,
Indiana.
RECALLED BY Manufacturer, by telephone on September 7, 1994, followed by
letter dated October 12, 1994. Firm-initiated recall
complete.
DISTRIBUTION New Jersey.
QUANTITY 1 unit.
REASON Blood product, found to be repeat reactive for anti-HBc, was
distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-120/121-6.
CODE Unit numbers: (a) 3802615, 3802616, 3802619, 3802620,
3802621, 3802622, 3802623, 3802624, 3802625, 3802626,
3802628, 3802629, 3802630, 3802631, 3802632; (b) 3802628.
MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis,
Indiana.
RECALLED BY Manufacturer, by telephone on October 24, 1994, followed by
letter dated November 10, 1994. Firm-initiated recall
complete.
DISTRIBUTION Indiana.
QUANTITY (a) 15 units; (b) 1 unit.
REASON Blood products, collected from paid donors, were labeled as
volunteer donations, and distributed.
_______________
PRODUCT Red Blood Cells for Further Manufacture. Recall #B-123-6.
CODE Unit #01KS09864.
MANUFACTURER American National Red Cross, Rochester, New York.
RECALLED BY Manufacturer, by letter dated June 9, 1994. Firm-initiated
recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
-10- REASON Blood product, which was collected from a donor who had
visited an area designated as endemic for malaria, was
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Puncture Attachment UA0876 to Sector Transducer Types 8534,
8535, 8536. The puncture attachment enables biopsies and
punctures to be performed using the B&K Ultrasound
Transducers types 8534/8535/8536. Recall #Z-078-6.
CODE All lot numbers.
MANUFACTURER B&K Medical A/S, Gentofte, Denmark.
RECALLED BY B&K Medical Systems, North Billerica, Massachusetts, by
letter dated September 7, 1995. FDA-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 431 units were distributed.
REASON The puncture attachment becomes cracked and delaminated
after users expose the puncture attachments to multiple
autoclave sterilization cycles.
_______________
PRODUCT Multi-Purpose Lens Cleaning Solution, a soft contact lens
chemical disinfectant, in 4 ounce or 8 ounce bottles under
the following labels: Allergan "Complete", Wall-Mart
"Equate", Target, K-Mart "Vision Pride", Longs, Payless,
Fred Meyer.
Recall #Z-188-6.
CODE 4 ounce bottles in kits: solution lot no. 07A33 in kit lot
#27A41; 8 ounce (240 mL) bottles in kits: solution lot
#07A51 in kit lot #27A07. Also kit lot no. EA0886 (made in
Ireland); 12 ounce bottles: lot numbers: 06A59, 06A93,
06A96, 07A00, 07A03, 07A04, 07A19, 07A32, 07A34, 07A35,
07A36, 07A39, 07A41, 07A42, 07A46, 07A47, 07A66.
MANUFACTURER Allergan, Inc., Waco, Texas.
RECALLED BY Allergan, Inc., Irvine, California, by telephone on April
10, 1995, followed by letter dated April 11, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 1,118 4-ounce bottles in kits; 34,210 8-ounce bottles in
kits; 215,514 12-ounce bottles in kits were distributed. On
August 4, 1995 firm estimated 36% of the product remained on
market.
REASON Product sterility may be compromised, due to a defective
filter.
_______________
PRODUCT Olympus AU800 Bicarbonate Reagent, used for the quantitative
determination of bicarbonate (co2) in human serum used in
the diagnosis and treatment of numerous potentially serious
disorders associated with changes in body acid-base balance.
Recall #Z-202-6.
-11- CODE Catalog #ODR2009, Lot numbers: ODR9408, ODR9411, ODR9502,
ODR9505.
MANUFACTURER Medical Analysts Systems, Camarillo, California.
RECALLED BY Olympus America, Inc., Clinical Instrument Division,
Melville, New York, by letter August 29, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY Approximately 3,200 bottles were manufactured during a
period from 8/94 to 5/95; firm estimated that less than 200
bottles remained on market at time of recall initiation.
REASON The bicarbonate reagent failed shelf life stability and
expiration dating.
_______________
PRODUCT Kendall Curity Abdominal Pads, 8 x 10 inches, sterile.
Recall #Z-204-6.
CODE Catalog #7198, lot #KG9412AS.
MANUFACTURER Kendall Healthcare Products Company, Augusta, Georgia.
RECALLED BY Kendall Healthcare Products Company, Mansfield,
Massachusetts, by letter dated November 3, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 320 pads were distributed.
REASON The sterility of the device has been compromised due to loss
of package integrity.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Alko 102-0, Alko Standard A Calibrator for DuPont Dimension
ISE Module, used for calibrating Na+ K+, Ci, and TCO2
Electrode on the DuPont ISE Subsystem Dimension Chemistry.
Recall #Z-194-6.
CODE Catalog #A102-0, Lot #20203.
MANUFACTURER Alko Diagnostic Corporation, Holliston, Massachusetts.
RECALLED BY Manufacturer, by letter dated December 2, 1993. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 1,440 units were distributed; firm estimates none remains on
the market.
REASON The Calibrator concentration of NA+, K+, and LI+ was above
the specification.
_______________
PRODUCT Alko Fluid Pack Calibrator for Corning 654 Analyzers, serves
as a calibrator for the Corning 654 Analyzer.
Recall #Z-195-6.
CODE Catalog No. A473-605, Lot Nos. 30814, 30815, 31004, 31007.
MANUFACTURER Alko Diagnostic Corporation, Holliston, Massachusetts.
RECALLED BY Manufacturer, by letters dated October 28, 1994. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
-12- QUANTITY 61 units.
REASON The Calibrator concentration levels of NA+, K+, and LI+ were
inconsistent with the labeling.
_______________
PRODUCT Alko Fluid Pack Calibrator for Corning 634 Analyzers, used
to calibrate clean condition the calcium and pH electrodes
in the corning 634 Analyzer. Recall #Z-196-6.
CODE Catalog #A478-548, Lot numbers: 50212, 50332, 30722, 30723.
MANUFACTURER Alko Diagnostic Corporation, Holliston, Massachusetts.
RECALLED BY Manufacturer, by letter dated May 18, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 44 units were distributed.
REASON The pH value of the lot is outside the label declared value,
which may cause measured pH values to be raised.
_______________
PRODUCT Alko Fluid Pack Calibrator for Nova 3 Analyzers, serves as a
calibrator for C1 and TC02 parameters on the Nova 3.
Recall #Z-197-6.
CODE Catalog #A081-30, lot #20434 and 20435.
MANUFACTURER Alko Diagnostic Corporation, Holliston, Massachusetts.
RECALLED BY Manufacturer, by letter dated October 28, 1994. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 41 units were distributed.
REASON The calibrators have bacterial growth in the product, caused
by the omission of the preservative during the
manufacturing.
_______________
PRODUCT Alko Reference Housing for AVL, Beckman, and DuPont ISE
Analyzers, used to produce a constant reference potential
for ion selective electrodes. Recall #Z-198-6.
CODE Catalog #A084-4, lot numbers 0100 through 0287.
MANUFACTURER Alko Diagnostic Corporation, Holliston, Massachusetts.
RECALLED BY Manufacturer, by letter dated November 11, 1994. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 82 units were distributed; firm estimates none remains on
the market.
REASON The housing leaks around the inlet and exit fittings,
causing the electrodes to fail calibration.
_______________
PRODUCT Alko Fluid Pak Calibrator for Nova 8 Analyzers, serves as a
calibrator for pH and Ca++. Recall #Z-199-6.
CODE Catalog #A081-45, lot #41231.
MANUFACTURER Alko Diagnostic Corporation, Holliston, Massachusetts.
RECALLED BY Manufacturer, by letters dated August 31, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
-13- QUANTITY 48 units were distributed; firm estimates none remains on
the market.
REASON The pH value of the lot is outside the label declared value,
which may cause measured pH values to be raised.
_______________
PRODUCT Alko Standard A Calibrator for AVL 984, 987, and Beckman 820
Analyzers serve as a calibrator for Na, K, pH and Ca++.
Recall #Z-200-6.
CODE Catalog #A084-0, lot #41133.
MANUFACTURER Alko Diagnostic Corporation, Holliston, Massachusetts.
RECALLED BY Manufacturer, by letter dated July 20, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 11 units were distributed.
REASON The pH value of the lot is outside the label declared value,
which may cause measured pH values to be raised.
_______________
PRODUCT Cyclic AMP (cAMP) Adenosine 3',5' monophosphate
radioimmunoassay in vitro diagnostic kit, 200-tube kit.
Recall #Z-203-6.
CODE Catalog #NEK-033, Lot #E0209.
MANUFACTURER Dupont NEN Products, Boston, Massachusetts.
RECALLED BY Manufacturer, by telephone on or about March 2, 1994,
followed by E-Mail messages. Firm-initiated recall
complete.
DISTRIBUTION Kansas, Connecticut, New York, California, Canada.
QUANTITY 6 kits were distributed.
REASON Kits contained duplicate buffers and no antisera.
_______________
PRODUCT Arterial Embolectomy Catheter and Syringe, intended for use
in removing arterial emboli: (a) Product Design 3EMB80;
(b) Product Design 4EMB80. Recall #Z-209/210-6.
CODE Lot numbers: (a) 9580503271; (b) 9580502234.
MANUFACTURER Biosensors International, Singapore.
RECALLED BY Sorin Biomedical, inc., Irvine, California, by letter on
June 2, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Italy, Korea.
QUANTITY 518 units were distributed.
REASON The products were labeled "40 cm" when they should have been
labeled "80 cm".
-14-
END OF ENFORCEMENT REPORT FOR DECEMBER 13 1995. BLANK PAGES MAY
FOLLOW.
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