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
06/27/1995
ENFORCEMENT REPORT FOR 06/28/95
June 28, 1995 95-26
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Lorazepam Tablets, USP, 0.5 mg, in bottles of 100, 500, and
1,000; (b) Lorazepam Tablets, 1 mg, in bottles of 100 and
500 tablets, Rx drugs indicated for the management of
anxiety disorders, under the Danbury and Schein labels.
Recall #D-190/191-5.
CODE Lot numbers: (a) 44075D, 44076D, 44461D, 44462D, 44463D,
44464D, 44704D, 44705D, 44706D, 44707D, 44708D, 44709D,
44710D, 45007D, 45008D, 45165D, 45166D, 45196D, 45197D,
45198D, 45199D, 45348D, 45349D, 45350D, 45351D, 45352D,
DAL084, DAM084, DAN084, DAP084, DAR084, DCU094, DVC094,
DCX094, DDA094, DFA064, DFB064, DFC064, DFD064, DFE064,
DGL124, DGM124, DGN124, DGP124;
(b) 43728D, 43888D, 44264D, 44265D, 44286D, 44287D, 44288D,
44289D, 44290D, 44291D, 44292D, 44293D, 45226D, 45227D,
45289D, 45290D, 45291D, 45292D, DCP064, DCRO64, DCS064,
DCT064, DGB094, DGC094, DGD094, DGE094, DGF094, DGUO74,
DGV074, DGW074, DHA074, DJG114, DJH114. Expiration dates
range from June 1995 to September 1996.
MANUFACTURER Danbury Pharmacal, Inc., Danbury, Connecticut (responsible
firm).
RECALLED BY Danbury Pharmacal, Inc., Brewster, New York, by letter May
4, 1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY (a) 112,491 100-tablet bottles; 57,695 500-tablet bottles;
187 1000-bottles; (b) 120,359 100-tablet bottles; 35,633
500-tablet bottles were distributed; firm estimated that 10
percent of product remained on market at time of recall
initiation.
REASON Potency not assured through expiration date.
_______________
PRODUCT Procardia XL (nifedipine) Tablets, 30 mg, in bottles of 100,
an antianginal drug. Recall #D-198-5.
CODE Lot #01499 EXP 12/96.
MANUFACTURER Rrepackaging Company of America (RCA), Woodburn, Oregon
(repacker/responsible firm).
RECALLED BY Thrifty Payless, Inc., Wilsonville, Oregon, by store
bulletin June 8, 1995, and by fax to retail stores June 12,
1995. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 36 bottles were distributed.
REASON Approximately 40 repacked units were mislabeled.
RECALLS AND FIELD CORRECTIONS -- DRUGS -- CLASS III
=======================
_______________
PRODUCT Sulfacetamide Sodium 10% Sterile Ophthalmic Solution, USP,
15 ml, Antibacterial eye drops. Recall #D-189-5.
CODE Batch numbers: 84, 118, 249, 328, 380, 386, 9914, 10055,
10158, 10208 10239, 10257, 10321, 10453, 10517, 10655,
10694, 10748, 10796, 10843, 10940, 10945, 10984, 11090,
11124, 11249, 11255, 11354, 11459, 11507, 11552, 11607,
11651. (NOTE: only the lots with a Prescript
Pharmaceuticals, Inc. relabeling and lot number are under
recall).
MANUFACTURER Prescript Pharmaceuticals, Pleasanton, California
(relabeler/responsible firm).
RECALLED BY Relabeler, by letter May 24, 1995. Firm-initiated recall
complete.
DISTRIBUTION California, Illinois, Maine, Michigan, New York, New Jersey,
Ohio, Pennsylvania, Utah, Vermont.
QUANTITY Approximately 370 bottles were distributed.
REASON Product stored above temperature designated on label.
_______________
PRODUCT Clofibrate Capsules, USP, 500 mg, Rx oral antilipidemic
agent, in bottles of 100 capsules, under the following
labels: Rugby, Goldline, GG (Geneva). Recall #D-192-5.
CODE Lot #327340 EXP 01/97.
MANUFACTURER Banner Gelatin Products Ltd., Calgary, Alberta, Canada.
RECALLED BY Novopharm, Inc., Schaumburg, Illinois, by telephone June 6,
1996, followed by letter June 8, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Illinois, Ohio, Colorado, Tennessee, Nevada.
QUANTITY 2,383 bottles were distributed; firm estimated that 30
percent of the product remained on market at time of recall
initiation.
REASON Product does not meet dissolution specifications.
_______________
PRODUCT Promethazine, anti-tussive products, under the Cenci label
or any one of the following labels: Darby Drug, United
Research Labs, Goldline, Qualitest, Halsey: (a)
Promethazine VC Plain in 4 ounce, 8 ounce, 16 ounce, and 1
gallon sizes; (b) Promethazine VC with Codeine i 4 ounce, 8
ounce, 16 ounce and 1 gallon sizes; (c) Promethazine with
Codeine in 4 ounce, 8 ounce, and one gallon sizes.
Recall #D-193/195-5.
CODE Lot numbers: (a) 052480, 072506, 072537, 082555, 102655,
102710, 122796, 122797, 122798, 122799, 122800, 033408,
043495, 043496, 043497, 093665, 113231, 123715, 024322,
024324, 044352.
(b) 000000, 082548, 082559, 092123, 092629, 122786, 122788,
122789, 122790, 122791, 013330, 013332, 013333, 013334,
013335, 013340, 013341, 023373, 023393, 023394, 023395,
023396, 023397, 033403, 033417, 033418, 033419, 033420,
033421, 033422, 033423, 033453, 033454, 033455, 033456,
043493, 043494, 043516, 043517, 073558, 073575, 073576,
083597, 083628, 083629, 083630, 083631, 083632, 083633,
083634, 083635, 123716, 014300, 014310, 014315, 034335,
034336, 034337, 034338, 034339, 044349, 044350.
(c) 000000, 052461, 052485, 062505, 072532, 112714, 112718,
112726, 112734, 112735, 112736, 122754, 122755, 122756,
122758, 122762, 122763, 122765, 122766, 122767, 122775,
122805, 122814, 013302, 013303, 013304, 013305, 013306,
013307, 013308, 013309, 013310, 013311, 013312, 013325,
013327, 013349, 013350, 013351, 023356, 023357, 023359,
023360, 023361, 023370, 023371, 023372, 023385, 023386,
023387, 023388, 023389, 023391, 023392, 023398, 033427,
033428, 033429, 033430, 033431, 033432, 033433, 033434,
033442, 033443, 033444, 022445, 033446, 033447, 033448,
033449, 033450, 033451, 033452, 043447, 043482, 043483,
043484, 043485, 043486, 043487, 043488, 043489, 043490,
043491, 043492, 043508, 043518, 053522, 053528, 053530,
063531, 063532, 063533, 063534, 063535, 063552, 073566,
073567, 073578, 073579, 073580, 073581, 073582, 073588,
073592, 073593, 073594, 083595, 083596, 083610, 083613,
083614, 083615, 083616, 083619, 083620, 083621, 083622,
083623, 083624, 083638, 083639, 083640, 083641, 083646,
093658, 093661, 093673, 093674, 093675, 093676, 093677,
093683, 103713, 014301, 014302, 014305, 014306, 014307,
024325, 024327, 034330, 034331, 034332, 034333, 044342,
044343, 044344, 044345, 044348, 044353, 054354, 054355,
054356, 054359, 054361.
MANUFACTURER H.R. Cenci Laboratories, Inc., Fresno, California.
RECALLED BY Manufacturer, by letter June 16, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Number of individual bottles of each product:
(a) (b) (c)
4 oz. size = 23,668 100,588 278,138
8 oz. size = 41,385 71,342 256,474
16 oz. size = 26,995 128,814 345,730
1 gallon size = 494 4,448 11,781.
REASON Current good manufacturing practice deficiencies.
_______________
PRODUCT RU-TUSS Tablets, decongestant/antihistaminic, packed in
bottles of 100 tablets, and 500 tablets, samples, blister
cards of 20 tablets each. EXP dates 5/95 through 5/97.
Recall #D-196-5.
CODE Lot numbers: 07147, 08173, 08181, 08751, 09043, 09044,
09045, 09046, 09047, 09454, 09841, 09879, 09936, 10036,
10037, 10046, 10585, 10586, 10669, 10710, 10711, 10752,
10970, 10971, 10972, 10973, 10974, 10975, 10976, 10977,
10978, 12382 (100-tablet bottles);
09048, 09049, 09050, 09455, 09976, 09977, 09978, 10047,
10048, 10096, 10097, 10500, 10670, 10671, 10712, 10979,
10980, 10981, 10982, 10983 (500-tablet bottles);
08399, 09815, 09816, 09817, 09818,10604, 10803 (physician
samples).
MANUFACTURER EON Laboratories Manufacturing, Inc., Laurelton, New York.
RECALLED BY Knoll Pharmaceutical Company, Shreveport, Louisiana, by
letter June 16, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 27,393 500-tablet bottles and 339,331 100-tablet bottles
were distributed.
REASON Package insert incorrectly declares a different set of
inactive ingredients.
_______________
PRODUCT Bulk Potassium Chloride Extended-Release Capsules, 10 mEq
(750 mg) equivalent to 10 mEq (390 mg) potassium, and 10 mEq
(360 mg) of chloride, Rx for further manufacturing,
processing or repacking. Recall #D-197-5.
CODE V4126 repackage by 7/26/95.
MANUFACTURER KV Pharmaceutical Company, St. Louis, Missouri.
RECALLED BY Ethex Corporation, St. Louis, Missouri, by telephone June 13
and 14, 1995, followed by letter June 15, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Florida and Connecticut.
QUANTITY 76 10,000-capsule bulk containers were distributed.
REASON Product may not maintain dissolution specifications through
repackage date on bulk container.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-307/308-5.
CODE Unit #29121-9302.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone December 21, 1994, followed by
letter December 28, 1994. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit of each component.
REASON Blood products, which were collected from a donor who had a
history of cancer, were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-309-5.
CODE Unit #53 Y 32761.
MANUFACTURER The American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY Manufacturer, by letter July 20, 1994, and August 1, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Maryland.
QUANTITY 1 unit.
REASON Blood product collected from a donor living in a malarial
endemic area was distributed.
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Red Blood Cells,
for further manufacture; (d) Platelets; (e) Platelets,
expired; (f) Platelets, Pheresis; (g) Cryoprecipitated AHF;
(h) Fresh Frozen Plasma; (i) Recovered Plasma.
Recall #B-349/357-5.
CODE (a) 01S43224; (b) 01KE01423, 01KE01569, 01KT04520,
01KT04998, 01KT06990, O1KT08539, 01KT09654, 01KT11059,
01KV05925, 01S24369, 01S25115, 01S28486, 01S29133, 01S39864,
02S40552, 01S42082, 01S44767, 01S45618, 01S46880, 01S47889,
01S52561, 01S54276, 01S55153, 01S55763, 01S57139, 01T16109,
01T19962, 01T19969, 01T20032, 01T20725, 01T22723, 01T22765,
01T25089, 01T25009, 01T25451, 01T25551, 01T25567, 01T30013,
01T30125, 01T30159, 01T30281, 01T30288, 01T30375, 01T32227,
01T32295, 01T32379, 01T33759, 01T35712, 01T35790, 01T38033,
01T38117, 01T38390, 01T40928, 01T41421, 01T43487, 01T43503,
01T43666, 01T45456, 01T47214, 01T47344, 01T51356, 01T53167,
01T53914, 01T58147, 01T58631, 01T58825, 01T58827, 01T61073,
01T62595, 01T63253, 01T65121, 01T66060, 01T68056, 01T69604,
01T69681, 01T71018, 01T72848, 01T74137, 01T74822, 01T75669,
01T75685, 01T78556, 01T79106, 01T81132, 01T82109, 01T84704,
01T85643, 01T86561, 01T87710, 01T88392, 01T91476, 01T93006,
01T96204; (c) 01T38391; (d) 01KE01423, 01KL00160, 01L25953,
01L25988, 01L26011, 01L26043, 01L26138, 01L26389, 01L26481,
01S24369, 01S25115, 01S28486, 01S29133, 01S40552, 01S42082,
01S44767, 01S45618, 01S46880, 01S52561, 01S54276, 01S57139,
01T16109, 01T19962, 01T22723, 01T25089, 01T25099, 01T30281,
01T32295, 01T35712, 01T35790, 01T38033, 01T40928, 01T43666,
01T45456, 01T47344, 01T62595, 01T63253, 01T65121, 01T68056,
01T74822, 01T78556, 01T79106, 01T84704, 01T86561, 01T87710,
01T88392, 01T93006, 01T96204; (e) 01KE01569, 01S55763,
01T58147, 01T61073, 01T71018; (f) 01L25887; (g) 01S39864,
01T25451, 01T25551, 01T30159, 01T33759, 01T38177, 01T47214,
01T51356, 01T81132, 01T91476; (h) 01T19969, 01T22765,
01T25567, 01T32227, 01T38390, 01T53167, 01T53914, 01T58825,
01T58827, 01T74137; (i) 1KE01423, 01KE01569, 01KT04520,
01KT04998, 01KT08539, 01KT09654, 01KT11059, 01KV05925,
01S24369, 01S25115, 01S28486, 01S29133, 01S39864, 01S40552,
01S42082, 01S44767, 01S45618, 01S46880, 01S47889, 01S52561,
01S54276, 01S55153, 01S55763, 01S57139, 01T20032, 01T20388,
01T20725, 01T22723, 01T25411, 01T25451, 01T25551, 01T30013,
01T30125, 01T30159, 01T30281, 01T30375, 01T32295, 01T32379,
01T33759, 01T35712, 01T35790, 01T38033, 01T38177, 01T40928,
01T41421, 01T43487, 01T43503, 01T43666, 01T45456, 01T47214,
01T47344, 01T51356, 01T58147, 01T58631, 01T61073, 01T62595,
01T63253, 01T65121, 01T66060, 01T68056, 01T69604, 01T69681,
01T71018, 01T72848, 01T74822, 01T75669, 01T75685, 01T78556,
01T79106, 01T81132, 01T84704, 01T85643, 01T86561, 01T87710,
01T88392, 01T91476, 01T93006, 01T96204.
MANUFACTURER American Red Cross Blood Services, Rochester, New York.
RECALLED BY Manufacturer, by letters issued July 1994 to November 1994.
Firm-initiated recall ongoing.
DISTRIBUTION New York, Pennsylvania, California, Florida, Maryland,
Switzerland.
QUANTITY (a) 1 unit; (b) 93 units; (c) 1 unit; (d) 48 units; (e) 5
units; (f) 1 unit; (g) 10 units; (h) 10 units; (i) 78 units.
REASON Blood products which tested repeatedly reactive for antibody
to human immunodeficiency virus type 1 (anti-HIV-1); or
tested negative for anti-HIV-1, but were collected from
donors who previously tested repeatedly reactive for anti-
HIV-1, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-405/406-5.
CODE Unit #60FT01377.
MANUFACTURER American Red Cross Blood Services, Miami, Florida.
RECALLED BY Manufacturer, by letter June 29, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Florida and California.
QUANTITY 1 unit of each component.
REASON Blood products collected from a donor with a history of
hepatitis were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-413-5.
CODE Unit numbers: 26K47938, 26K47943.
MANUFACTURER American National Red Cross, Mobile, Alabama.
RECALLED BY Manufacturer, by telephone June 28, 1993, or by letters of
November 20, 1992 and June 28, 1993. Firm-initiated recall
complete.
DISTRIBUTION Alabama, Florida.
QUANTITY 2 units.
REASON Blood product which was prepared greater than eight hours
after the collection of the associated Whole Blood Units,
were distributed for transfusion.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-358/360-5.
CODE Unit numbers: (a) 01F18541, 01G32344; (b) 01G32344; (c)
01F18541, 01G32344.
MANUFACTURER American Red Cross Blood Services, Rochester, New York.
RECALLED BY Manufacturer, by letters issued July 1994, to November 1994.
Firm-initiated recall ongoing.
DISTRIBUTION New York, Pennsylvania, California, Florida, Maryland,
Switzerland.
QUANTITY (a) 2 units; (b) 1 unit; (c) 2 units.
REASON Blood products which tested repeatedly reactive for antibody
to human immunodeficiency virus type 1 (anti-HIV-1; or
tested negative for anti-HIV-1, but were collected form
donors who previously tested repeatedly reactive for anti-
HIV-1, were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-368-5.
CODE Unit #38FM68255.
MANUFACTURER American National Red Cross, Fort Wayne, Indiana.
RECALLED BY Manufacturer, by telephone February 27, 1993. Firm-
initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit.
REASON Blood product, which was untested for syphilis, was
distributed.
_______________
PRODUCT Platelets. Recall #B-407-5.
CODE Unit #16FJ31423.
MANUFACTURER American National Red Cross, Columbus, Ohio.
RECALLED BY Manufacturer, by letter September 21, 1994. Firm-initiated
recall compete.
DISTRIBUTION Ohio.
QUANTITY 1 unit.
REASON Blood product corresponding to Red Blood Cells which were
possibly contaminated with gram positive rods, were
distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-414-5.
CODE Unit numbers: 26F34759, 26F34769, 26G03966, 26K53008,
26K53021, 26M67066, 26N12012, 26N12029, 26N12063, 26N12065.
MANUFACTURER American National Red Cross, Mobile, Alabama.
RECALLED BY Manufacturer, by telephone June 28, 1993, or by letters of
November 20, 1992 and June 28, 1993. Firm-initiated recall
complete.
DISTRIBUTION Alabama, Florida.
QUANTITY 10 units.
REASON Blood product which was exposed to unacceptable shipping
temperatures was distributed.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-417-5.
CODE Unit numbers: 09T51481, 09T51483.
MANUFACTURER American Red Cross Blood Services, Omaha, Nebraska.
RECALLED BY Manufacturer, by telephone October 17, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nebraska.
QUANTITY 2 units.
REASON Fresh Frozen Plasma which was not frozen within eight hours
of phlebotomy was distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
========================
_______________
PRODUCT Hewlett-Packard Models M1722A and M1722B CodeMaster XL+
defibrillator/monitors with external pacing option.
Recall #Z-686/687-5.
CODE Serial numbers: 3241A10386, 3241A10514, 3241A10549,
3301A10628, 3301A0640, 3301A10690, 3301A10794, 3301A10796,
3303A01434, 3303A01549, 3303A10899, 3304A2204 through
3304A13364 (non-continuous).
MANUFACTURER Hewlett-Packard, McMinnville, Oregon.
RECALLED BY Manufacturer, by letter dated January 1995, mailed starting
on February 1, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 281 units.
REASON An intermittent pacer problem with the allowed margin
between the measure-Pacer-Current delivered and Pacer-
current-shutdown threshold being too narrow. This results
in a "PACER FAILURE" message on the monitor screen.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT & Labeling concerning Phaco-emulsification system handpieces
CODE with non-rotatable nosecones. The Stainless Premier
Phacoemulsification Handpiece, Part #DP8020 and the
Microseal Phaco-emulsification Handpiece, Part #DP8040, can
be used with either the Protege or Premiere Systems:
(a) Pages in Owner's Manual for Storz Protege Microsurgical
System; (b) Pages in Owner's Manual for Storz Premier
Microsurgical System. Recall #Z-739/740-5.
MANUFACTURER Storz Instrument Company, St. Louis, Missouri.
RECALLED BY Manufacturer, by letter dated January 23, 1995. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
REASON Device labeling did not reflect a design change which made
the nosecone non-rotatable.
_______________
PRODUCT Airway Pressure Monitor, Model CM5000SC, Part #900-50SC-001,
an electronic device used to monitor pressurized breathing
circuits. Recall #Z-778-5.
CODE Serial numbers: 8912, 8915, 8916, 8917, 8918, 8919, 8920,
8924, 8925, 8926, 8928, 8929, 8931.
MANUFACTURER Canadian Monaghan Ltd., London, Ontario, Canada.
RECALLED BY Monaghan Medical Corporation, Plattsburgh, New York, by
telephone on or about February 29, 1995. Firm-initiated
recall complete.
DISTRIBUTION Louisiana, New York, North Carolina.
QUANTITY 13 units were distributed; firm estimates none remains on
the market.
REASON There is a potential for failure of an electronic component
which provides the audible alarm from the monitor and remote
indicator.
_______________
PRODUCT Agee-Wristjack Multiplanar Ligamentotaxis Fracture Reduction
System, for treatment of distal radius fractures.
Recall #Z-798-5.
CODE Lot numbers HBL-094-083 through HBL-095-047.
MANUFACTURER Hand Biomechanics Lab, Inc., Sacramento, California.
RECALLED BY Manufacturer, by undated letter sent on or about April 14,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 540 units were distributed.
REASON Residual metal debris in system guide liner tube was found
in finished product.
_______________
PRODUCT Spordex Culture Media, Reorder #NA114, used for culturing
AMSCO's Sporden and Spordi Spore Strip Biological Indicators
which have been used to monitor either steam, dry heat or
ethylene oxide sterilization processes. Recall #Z-847-5.
CODE All lots within expiration date.
MANUFACTURER American Sterilizer Company, Erie, Pennsylvania.
RECALLED BY Manufacturer, by letter April 27, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,717 boxes (100 units per box) are subject to recall.
REASON The firm was not able to validate the 7-days incubation time
recommended on the labeling.
_______________
PRODUCT Rubella IgG Elisa Serology Test Kit, for the detection of
IgG antibodies to Rubella antigen in human serum by Enzyme-
Linked Immunosorbent Assay, 480 determinations, for in-vitro
diagnostic use. Recall #Z-856-5.
CODE Catalog #2305301, Lot #705-166 EXP 9/95.
MANUFACTURER Clark Laboratories, Inc., Jamestown, New York.
RECALLED BY Manufacturer, by telephone between June 2 and 13, 1994.
Firm-initiated recall complete.
DISTRIBUTION California, Texas, Washington state.
QUANTITY 62 kits were distributed. Units were reworked or destroyed.
REASON There is a problem with fluctuating performance of the
calibrator serum which could result in false negatives or
equivocal test results.
_______________
PRODUCT Infant Warmer Care Station 1131-00-00, used to provide a
constant flow of warm air around the infant. The firm is
also recalling the following items that use the same
casters: Bassinet -- 0033-96-00, 0033-69-00, 0033-85-00;
Infant Care Station - 0031-12-00, 0031-13-00; Delivery Cart
- 0031-04-00, 0031-08-00; Custom Furniture - 9999-97-65.
Recall #Z-886-5.
CODE Serial numbers: 109-322 non-continuous; 90010014-90120200
non-continuous; 91010263-91120189 non-continuous; A0000021
and A0000028; A176-A278 non-continuous.
MANUFACTURER Tenet Casters, Inc., Hebron, Kentucky (component).
RECALLED BY Stryker Adel Medical Ltd., Clackamas, Oregon, by telephone
beginning June 26, 1992, followed by letters dated June 24,
1992, and August 3, 1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Mexico, Canada, Australia, Hong Kong.
QUANTITY 605 units were distributed; firm estimates none remains on
the market.
REASON Potential for wheel casters to break.
_______________
PRODUCT FNA-21 Fine Needle Aspiration Device, sterile single use
syringe and 21 gauge needle for the fine needle aspiration
of abnormal palpable masses in the breast, trunk or neck.
Recall #Z-920-5.
CODE Catalog numbers: FNA-21-1 (one sample pack), FNA-21-3 (3
pack), FNA-21-12 (12 pack), FNA-21-24 (24 pack); Lot
numbers: 0107931175 EXP 7/98, 011293155 12/98, 2494000877
EXP 6/99, 4394001879 EXP 11/99, 4394001655 EXP 11/99,
0695007918 EXP 10/99.
MANUFACTURER Lettix, B.V., The Netherlands.
RECALLED BY Euro-Med, Division of Cooper-Surgical, Shelton, Connecticut,
by letter March 17, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 18,657 devices were distributed.
REASON The sterility of the device has been compromised due to loss
of package integrity.
_______________
PRODUCT Measles (Rubeola) IgG Elisa Test Kit, for the detection of
IgG antibody to measles virus in human sera, for in-vitro
diagnostic use. Recall #Z-922-5.
CODE Product #2306000, Lot #107 EXP 5/96.
MANUFACTURER Clark Laboratories, Inc., Jamestown, New York.
RECALLED BY Manufacturer, by letter May 17, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 240 kits were distributed.
REASON A problem with a drop in absorbance value of the calibrator
was found, which could result in false positive test
results.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Paramax CLiNaK Potassium Electrode, an in-vitro diagnostic
for the determination of potassium in serum, plasma, and
urine. Recall #Z-734-5.
CODE Product #B6110-202, Lot #PPPE63 EXP 12/95.
MANUFACTURER Dade Lytening Systems, Inc., (formerly Baxter Lytening
Systems, Inc.) Danvers, Massachusetts.
RECALLED BY Manufacturer, by telephone March 13, 1995. Firm-initiated
recall complete.
DISTRIBUTION Arkansas, Florida, Georgia, Massachusetts, Michigan,
Mississippi, New Jersey, New York, Ohio, Oklahoma,
Pennsylvania, South Carolina, Texas.
QUANTITY 30 kits were distributed.
REASON The Clinak Potassium Electrodes were shipped with a 10 ml
bottle of Lithium Fill Solution instead of a 10 ml bottle of
Potassium Fill solution.
_______________
PRODUCT Herpes Simplex Virus 1 IgG ELISA Serology Test Kits, for the
detection of IgG antibodies to Herpes Simplex virus 1
antigen in human serum by Enzyme-Linked Immunosorbent Assay,
for in-vitro diagnostic use. Recall #Z-830-5.
CODE Catalog #2305400, Lot #703-114 EXP 4/95.
MANUFACTURER Clark Laboratories, Inc., Jamestown, New York.
RECALLED BY Manufacturer, by letter March 17, 1995. Firm-initiated
recall complete.
DISTRIBUTION California, Florida, Louisiana, Maryland, Michigan, New
York, Texas, Australia, Germany, Israel, Italy, New Zealand,
Portugal, Spain, Turkey.
QUANTITY 307 kits were distributed.
REASON The absorbance values for controls and specimens are lower
than expected.
_______________
PRODUCT Teflon Patches, used in cardiovascular surgery:
(a) Teflon Felt Patch 4" x 4", Item #007836; (b) Teflon
Fabric Patch, 6" x 6", Item #000967. Recall #Z-840/841-5.
CODE Lot numbers: (a) 654120; (b) 391320, 391350.
MANUFACTURER Bard Vascular Systems Division, Haverhill, Massachusetts.
RECALLED BY Manufacturer, by letter October 19, 1993. Firm-initiated
recall complete.
DISTRIBUTION Illinois, Minnesota.
QUANTITY (a) 65 pieces; (b) 380 pieces were distributed.
REASON The products were contaminated with a mixture of polymerized
ethylene oxide formed during ETO sterilization.
_______________
PRODUCT Liquid Multi-Analyte Calibrator (MAC), an in-vitro
diagnostic product intended to be used as a calibrator and
as a daily quality control product for methods run on the
aca analyzer. Recall #Z-859-5.
CODE Lot #M9408.
MANUFACTURER Medical Analysis Systems (MAS), Camarillo, California.
RECALLED BY Du Pont Medical Products, Glascow, Delaware, by letter May
10, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 2,687 kits were distributed.
REASON Due to instability of magnesium (mg) and phosphate (phos)
analytes in the calibrator, which can result in incorrect mg
and phos values for the level 2 of MAC calibrator.
_______________
PRODUCT Abbott IMx and AxSYM Free T4 Calibrators and Controls, used
for the quantitative determination of Free Thyroxine in
human serum or plasma:
(a) IMx System Free T4 Calibrators, List #2222-01, 6 bottles
(4 ml each);
(b) IMx System Free T4 Controls, List #2222-10, 3 bottles (8
ml each);
(c) Abbott AxSYM System Free T4 Standard Calibrators, List
#7A54-01, 6 bottles (4 ml each);
(d) Abbott AxSYM System Free T4 Master Calibrators, List
#7A54-30, 2 bottles (4 ml each);
(e) Abbott AxSYM System Free T4 Controls, List #7A54-10, 3
bottles (8 ml each). Recall #Z-863/867-5.
CODE Lot numbers: (a) 88216Q100; (b) 89434Q100; (c) 88217Q100,
88217Q101; (d) 88994Q101; (e) 89184Q100.
MANUFACTURER Abbott Health Products, Inc., Barceloneta, Puerto Rico.
RECALLED BY Abbott Laboratories, Diagnostics Division, Abbott Park,
Illinois, by telephone and by letter June 5, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 5,189 packs were distributed; firm estimated that less than
5 percent of product remained on market at time of recall
initiation.
REASON Some of the Free T4 calibrators and controls may have
elevated Free T4 levels, which can result in patient samples
with depressed values when using the affected calibrators.
_______________
PRODUCT Ultra Urodynamic System, a urodynamic measurement system
that measures the flow/volume of urine:
(a) Ultra Model; (b) Ultra Lite Model; (c) Ultra Compact
Model. Recall #Z-870/872-5.
CODE (a) Model #5251700; (b) Model #5253200; (c) Model #5253300.
MANUFACTURER Surgitek, Racine, Wisconsin.
RECALLED BY Cabot Medical Corporation, Langhorne, Pennsylvania, by
telephone April 4 and 5, 1995, followed by letter dated
letter April 3, 1995. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 21 units were distributed.
REASON Leakage current through the EMG leads of the Endotek Ultra
System may exceed the Underwriters Laboratories (UL)
recommended safe levels.
_______________
PRODUCT Abbott IMx Free T3 Reagent Pack, an in-vitro diagnostic
microparticle enzyme immunoassay (MEIA) for the quantitative
measurement of free Triiodothyronine in human or serum or
plasma (EDTA and heparin), 100 tests. Recall #Z-887-5.
CODE List #2221; Lot numbers: 90805Q100, 93741Q100, 93961Q100,
94616Q100, 94533Q100, 95045Q100, 95247Q100, 95498Q100,
01347Q100, 01685Q100, 01686Q100, 02714Q100, 03005Q100,
03543Q100, 04597Q100.
MANUFACTURER Abbott Health Products, Inc., Barceloneta, Puerto Rico.
RECALLED BY Abbott Laboratories, Diagnostics Division, Abbott Park,
Illinois, by telephone May 26, 1995, followed by letters
dated May 23, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 16,822 packs were distributed; firm estimated that less than
5 percent remained on market at time of recall initiation.
REASON Some normal patients may show thyroid results above the
reference range when the affected kits are used.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
==========
_______________
PRODUCT Biomox (amoxicillin) Veterinary for oral suspension, 50/1
ml, in 15 ml bottles. Recall #V-031-5.
CODE Lot numbers and EXP dates: 31048 10/01/94, 31049
10/01/94, 31251 01/01/95, 31524 03/01/95, 31645 05/01/95,
31886 07/01/95, 33076 10/01/95, 33359 11/01/95, 33421
12/01/95, 33645 02/01/96, 33874 04/01/96.
MANUFACTURER Biocraft Laboratories, Elmwood Park, New Jersey.
RECALLED BY Biocraft Laboratories, Fair Lawn, New Jersey, by letter
October 6, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Virginia.
QUANTITY 833,760 bottles were distributed.
REASON Current good manufacturing practice deficiencies.
SEIZURES:
=================================================================
_______________
PRODUCT Compressed Oxygen, USP (95-662-365).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the article's manufacture, processing,
packing, and holding do not conform to and are not operated
and administered in conformity with current good
manufacturing practice requirements.
LOCATION Daley's Medical Rental, Inc., Dolton, Illinois.
FILED June 15, 1995; U.S. District Court for the Northern District
of Illinois, Eastern Division; Civ. #95C 3525; FDC #67094.
SEIZED June 16, 1995 - goods valued at approximately $13,092.
_______________
PRODUCT Ultrasonic tip for phaco-emulsification machine which is
used in eye cataract surgery (94-714-809).
CHARGE Adulterated - The article is a class III medical device for
which there is no approved premarket approval application in
effect; nor were the methods used in, and the facilities and
controls used for, the article's manufacture, packing, and
storage in conformity with current good manufacturing
practice requirements. Misbranded - The article was not
included in a list as required, nor was the required notice
or other information provided.
LOCATION Sherburne Manufacturing Co., Long Beach, California.
FILED January 11, 1995; U.S. District Court for the Central
District of California; Civ. #CV 95-0219MRP(JGx);
FDC #66722.
SEIZED February 23, 19953 - goods valued at approximately $800,000.
END OF ENFORCEMENT REPORT FOR JUNE 28, 1995. BLANK PAGES MAY FOLLOW.
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