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
12/08/1993
Recalls and Field Corrections: Cosmetics -- Class III -- 12/08/1993
December 8, 1993 93-49
RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS III
====================
_______________
PRODUCT Longs Vitamin E Creme, in 4-ounce plastic jars, a
moisturizing supplement for the skin. Recall #F-106-4.
CODE Lot numbers: 3174EC1 and 3236EC1.
MANUFACTURER HPC Laboratories, Inc., doing business as Hunt Products,
Dallas, Texas.
RECALLED BY Manufacturer, by telephone October 1, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION California.
QUANTITY 11,184 jars were distributed; firm estimates that 50 percent
of the product distributed remained on the market when
recall was initiated.
REASON Product is mislabeled. Label states the product contains
aloe vera, collagen, and Vitamin A & D, but product does not
contain these ingredients.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
========================
_______________
PRODUCT USP Oxygen in Size E Cylinders. Recall #D-039-4.
CODE Batch numbers C570 through C610.
MANUFACTURER HealthCor, Inc. (formerly Permian Medical, Inc.) Midland,
Texas.
RECALLED BY Manufacturer, by visits between May 8, 1993, and July 23,
1993. Firm-initiated recall complete. DISTRIBUTION Texas.
QUANTITY 206 cylinders were distributed; firm estimates none remains
on the market.
REASON Current good manufacturing practice deficiencies.
---------------
PRODUCT Hydrocodone Bitartrate and Acetaminophen, 5 mg/500 mg
Tablets, in bottles of 100, 500 and 1,000, for the relief of
pain, under the following labels: Blue Cross, Schein
Pharmaceuticals, Aligen Independent Laboratories, Goldline,
Qualitest, Mason, Moore, IDE Star, URL, Par-Med, Major
Pharmaceuticals, and Halsey Drug. Recall #D-046-4.
CODE All lots, sizes and labels.
MANUFACTURER Halsey Drug Company, Inc., Brooklyn, New York.
RECALLED BY Manufacturer, by letter November 10, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 450 batches of 1,000,000 tablets each, were
distributed in the last 3 years.
REASON Abbreviated New Drug Application discrepancies.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT SPS Suspension (Sodium Polystyrene Sulfonate Suspension
USP), 473 ml 120 ml and 60 ml. Recall #D-036-4.
CODE Lot numbers: 473 ML - lots - 192271, 292241, 492101,
692111, 792311, 1092081, 1292011, 193221, 293151, 393161,
593061, 693171, 893191, 993031
120 ML - LOTS 492031, 1092271, 993271
60 ML - LOTS 192081, 192151, 292123, 392131, 592081, 792141,
892133, 992171, 1092291, 1292031, 193112, 293191, 393101,
493291, 693031, 793291, 893301
MANUFACTURER Carolina Medical Products Company, Farmville, North
Carolina.
RECALLED BY Manufacturer, by letters sent the week of November 8, 1993,
followed by telephone. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,500 473-ml bottles; 200 120-ml bottles; 21,000 60-ml units
were distributed.
REASON Use of non-approved formulation.
_______________
PRODUCT Guaifenesin and Codeine Phosphate Syrup cough preparations:
Tusscidin AC Expectorant Cough Suppressant, 4-fluid ounces,
and 8-fluid ounces;
Tusscidin AC Expectorant Cough Suppressant, 128-fluid
ounces;
Guiatuss AC Syrup, cough suppressant expectorant, 4-fluid
ounces, 1 pint and 1 gallon, manufactured for Goldline
Laboratories;
Guaifenesin A.C. Syrup, 1 pint (473 ml), manufactured for
United Research Laboratories, Inc. Recall #D-037-4.
-2- CODE All lots and codes manufactured between September 25, 1993
and October 13, 1993.
MANUFACTURER H.R. Cenci Laboratories, Inc., Fresno, California.
RECALLED BY Manufacturer, by letter October 1993. Firm-initiated field
correction complete.
DISTRIBUTION California, Hawaii, Florida, New Jersey, Ohio, Oregon,
Pennsylvania, Texas.
QUANTITY Firm estimates that about 10,000 units covering all sizes
remain on the market.
REASON Product does not meet USP specifications for pH.
_______________
PRODUCT Trifluoperazine Hydrochloride Concentrate 10 mg/ml, in 2-
fluid ounce containers, indicated for the management of
manifestations of psychotic disorders as well s the short
term treatment of non-psychotic anxiety, where it is
considered second-line therapy. Recall #D-038-4.
CODE Lot #73416.
MANUFACTURER Geneva Pharmaceuticals, Inc., Broomfield, Colorado.
RECALLED BY Manufacturer, by letter November 22, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 10,023 units were distributed.
REASON Product does not meet stability specifications.
_______________
PRODUCT Norwich brand Enteric Safety Coated Aspirin, 325 mg, in
bottles of 150. Recall #D-040-4.
CODE Lot numbers 92G5 and 92G6 EXP 7/94.
MANUFACTURER Granutec, Inc., Wilson, North Carolina.
RECALLED BY Chattem, Inc., Chattanooga, Tennessee, by memorandum and
letter November 16, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 71,370 bottles were distributed.
REASON Product does not meet dissolution specifications though
expiration date.
_______________
UPDATE Percodan Tablets, Recall #D-029-4, which appeared in the
November 24, 1993 Enforcement Report should read:
CODE: Lot #EEA-001A.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Red Blood Cells,
for further manufacture; (d) Platelets; (e) Platelets,
Expired; (f) Cryoprecipitated AHF; (g) Fresh Frozen Plasma;
(h) Plasma; (i) Recovered Plasma. Recall #B-050/058-4.
CODE Unit numbers:
(a) 05C02839, 05C91259, 05F23060, 05F25709, 05F25837,
05F27321, 05F27490 , 05F29420, 05F30368, 05F30521, 05F32902,
-3- 05F33684, 05F34063, 05F34287, 05F35859, 05F37175, 05F50071,
05F52001, 05G31808, 05G34412, 05G37333, 05H47770, 05LF02960,
05LV00781, 05LV01372, 05LW03622, 05Q25823, 05Q25857,
05Q28177, 05Q28333, 05R56848, 05S58395, 05V27450, 05Y54751,
53GV05302, 53GV05557, 53KF12035, 53KF18633, 53KF27180,
53KQ15486, 53KQ19692, 53KQ25435, 53KT08056, 53KT08259,
53KT22346, 53KW19575, 53KY20266, 53KY29351, and 53KZ09958;
(b) 05C01620, 05C01950, 05C21184, 05C60533, 05C61484,
05C63014, 05C63982, 05C64567, 05C71402, 05C76831, 05C86166,
05C92410, 05C95331, 05C99426, 05E03574, 05E07302, 05F25302,
05F43185, 05F44510, 05F44751, 05F45487, 05F47946, 05F48616,
05F54478, 05F55636, 05F55919, 05F57464, 05F58043, 05G29214,
05G36558, 05G41680, 05G42366, 05G43383, 05G48602, 05G61517,
05G70464, 05G70789, 05G71346, 05GL03236, 05GN01946,
05GN04280, 05GV00316, 05GZ00419, 05H47741, 05H54893,
05H61216, 05H63092, 05H63168, 05H64277, 05H66448, 05J41473,
05J42050, 05J46275, 05J55798, 05J60078, 05J60224, 05J68091,
05J76009, 05K27339, 05K28013, 05K30890, 05K31571, 05K35579,
05K35767, 05K50032, 05K68133, 05K71777, 05KY10412, 05L17166,
05L19941, 05L30379, 05L33799, 05L49578, 05L52178, 05L53343,
05L54550, 05L54865, 05LF00274, 05LF01535, 05LH01084,
05LH03324, 05LH04834, 05LL02896, 05LL04439, 05LR02483,
05LR02931, 05LR04245, 05LS00604, 05LT00319, 05LT00361,
05LT01697, 05LT02070, 05LV00092, 05LV00259, 05LV00731,
05LV00793, 05LV01271, 05LW00032, 05LW02471, 05LX00184,
05LX01436, 05LX03815, 05M30393, 05M42835, 05N07314,
05N08879, 05N11529, 05N11718, 05N13072, 05N25618, 05N26143,
05N27866, 05N28517, 05N88613, 05N94709, 05N95017, 05N96718,
05R21326, 05R36435, 05R40421, 05R43857, 05R43927, 05S60977,
05S72512, 05S83268, 05V19281, 05V19464, 05V19819, 05V20574,
05V20594, 05V21334, 05V21759, 05V22096, 05V22647, 05V23017,
05V23308, 05V23813, 05V24701, 05V25239, 05V25773, 05V26283,
05V26845, 05V27206, 05V27995, 05V28310, 05V28533, 05V29132,
05V29280, 05V29372, 05V29651, 05V29728, 05W51496, 05W52608,
05W60300, 05W76956, 05W93940, 05X54405, 05X56806, 05X60686,
05X63207, 05X69237, 05X75816, 05X78296, 05X80589, 05X82358,
05Y25119, 05Y27607, 05Y29591, 05Y30603, 05Y32349, 05Y32459,
05Z08109, 05Z16766, 27FC00853, 27FC06001, 27FC16339,
27Y00431, 27Y01117, 27Y03078, 27Y05795, 27Y09032, 27Y11957,
27Y15104, 29FN11543, 53FC04124, 53FE01112, 53GH17789,
53GH19871, 53GJ11635, 53GJ20021, 53GJ21289, 53GJ24047,
53GJ27765, 53GJ29990, 53GJ30447, 53GJ31279, 53GL14388,
53GL17842, 53GL18002, 53GL18691, 53GL21034, 53GL24593,
53GL26132, 53GL28057, 53GL29634, 53GL31099, 53GL32036,
53GL32264, 53GN12287, 53GN14688, 53GN15434, 53GN18792,
53GN20986, 53GN27751, 53GN28676, 53GN29672, 53GN36183,
53GN38050, 53GN39659, 53GN43053, 53GQ08243, 53GV03346,
53GV03373, 53GV03443, 53GV03861, 53GV03950, 53GV03966,
53GV04492, 53GV04541, 53GV05044, 53GV06029, 53GV06587,
53GZ24130, 53GZ25905, 53GZ29053, 53GZ33609, 53GZ34028,
53KE11494, 53KE15226, 53KE15480, 53KF06791, 53KF07463,
53KF07704, 53KF08936, 53KF09967, 53KF10066, 53KF10862,
-4- 53KF11896, 53KF13047, 53KF20217, 53KF22258, 53KF22789,
53KF24110, 53KF25103, 53KF25980, 53KF30395, 53KF30480,
53KF32600, 53KF32938, 53KF34040, 53KL18146, 53KL24550,
53KL32559, 53KL35236, 53KL35886, 53KL37429, 53KM18023,
53KM21021, 53KM24308, 53KM27356, 53KN15345, 53KN18418,
53KN19804, 53KN26687, 53KN27362, 53KQ12636, 53KQ15192,
53KQ16965, 53KQ18439, 53KQ19616, 53KQ20715, 53KQ21265,
53KQ24648, 53KQ25290, 53KQ25413, 53KQ26950, 53KQ37007,
53KQ40595, 53KQ41018, 53KR13854, 53KR17498, 53KR19467,
53KR24954, 53KR28813, 53KR29114, 53KR29880, 53KS14230,
53KS16609, 53KS21622, 53KT13471, 53KT14595, 53KT18217,
53KT18243, 53KT21270, 53KT22554, 53KT22638, 53KT28823,
53KT29710, 53KT32694, 53KT34036, 53KT35410, 53KW16876,
53KW20639, 53KW23085, 53KW23962, 53KW25878, 53KX13649,
53KX21835, 53KY08743, 53KY34806, 53KY37735, 53KY39213,
53KY43255, 53KY43890, 53KZ06978, 53KZ07935, 53KZ10594,
53KZ14195, 53KZ17499, 53KZ19603, 53KZ21068, 53KZ25373,
53KZ32649, 53KZ32689, 53L86085, and 53LK02324;
(c) 05H45752, 05H55532, 05J62146, 05LH04133, 05N16977,
05N26675, 05W58402, 05X63191, 05X78408, 05Y27135, 05Z15894,
53G31121, 53GN24437, 53GN25450, 53GV07082, 53KN29550, and
53KZ32970;
(d) 05C00385, 05C60533, 05C76831, 05C86166, 05C92410,
05C99426, 05F25302, 05F54478, 05F55636, 05G29214, 05G36558,
05G41680, 05G42366, 05G43383, 05G61517, 05G64168, 05H45752,
05H47741, 05H54893, 05H63092, 05J55798, 05J60078, 05J60224,
05J62146, 05K27339, 05K30890, 05K31571, 05K35579, 05L17166,
05L30379, 05L33799, 05L49578, 05L52178, 05LV00731,
05LV00793, 05M21268, 05M30393, 05N07314, 05N08879, 05N11529,
05N13072, 05N25618, 05N26143, 05N26675, 05N88613, 05N94709,
05N95017, 05R40421, 05R43857, 05S60977, 05S72512, 05V28310,
05X73644, 05Y27607, 05Y29591, 05Y30603, 27Y07602, 29FN11543,
53FC04124, 53GL18002, 53GL18691, 53GL21034, 53GL28057,
53GN15434, 53GN38050, 53GN39659, 53GV03861, 53GV04492,
53GV04541, 53GV05044, 53GV06029, 53GV06587, 53GZ34028,
53KE11494, 53KE15226, 53KE15480, 53KF06791, 53KF07704,
53KF08936, 53KF10862, 53KF11887, 53KF13047, 53KF20217,
53KF30395, 53KF32600, 53KF32938, 53KF34040, 53KL35886,
53KL37429, 53KN27362, 53KQ18439, 53KQ19616, 53KQ21265,
53KQ24648, 53KQ37007, 53KQ40595, 53KR13854, 53KR29880,
53KT13471, 53KT14595, 53KT22554, 53KT35410, 53KX13649,
53KY39213, 53KZ19603, 53KZ21068, 53LF13184
(e) 05C63014, 05C63982, 05N11718;
(f) 05J68091, 05L17166, 05R43927, 05S69396, 53KN26687,
53KR19467, 53KT18217, 53KY35424, 53KY43255, and 53KZ32970
(g) 05C64567, 05F25302, 05F43185, 05F45487, 05F47946,
05F54478, 05J41473, 05K30890, 05L49578, 05L52178, 05M30393,
05N13072, 05N94709, 05R43857, 05S60977, 05Z08109, 27Y07602,
53GL32036;
(h) 05C60533, 05H63092, 05K31571, 53KF07704, 05LV00793,
05P19690, 05P20672A, 05P20672B, 05P21054A, 05P21684A,
05P21684B, 05P24228A, 05P24228B, 05P24841, 05P26264B,
-5- 05P30263A, 05P30263B, 05P30263C, 53GJ21289, 53GJ24047,
53GJ31279, 53GL26132, 53GL29634, 53GL32264, 53GN27751,
53GN28676, 53GN29672, 53GN43053, 53GV03373, 53GV03861,
53GV04492, 53KF06791, 53KF07463, 53KF30480, 53KL35236,
53KM21021, 53KM27356, 53KN18418, 53KQ16965, 53KQ18439,
53KQ21265, 53KQ37007, 53KQ41018, 53KR13854, 53KR24954,
53KR28813, 53KR29114, 53KS21622, 53KS27832, 53KT13471,
53KT21270, 53KT22554, 53KT32694, 53KW23085, 53KW23962,
53KX21835, 53KY34806, 53KZ32649, 53KZ32689;
(i) 05C01620, 05C01950, 05C61484, 05C63014, 05C63982,
05C71402, 05C76831, 05C86166, 05C92592, 05C95331, 05C97134,
05C99426, 05E03574, 05E07302, 05F42804, 05F44510, 05F44751,
05F55636, 05F55919, 05F57464, 05F58043, 05G36558, 05G41680,
05G42366, 05G43383, 05G61517, 05G64168, 05G70464, 05G70789,
05G71346, 05GL03236, 05GN01946, 05GN04280, 05GV00316,
05GZ00419, 05GZ02980, 05H45752, 05H47741, 05H54893,
05H55532, 05H59335, 05H63168, 05H64277, 05H66448, 05J42050,
05J43563, 05J46275, 05J55798, 05J60078, 05J60224, 05J62146,
05J68091, 05J76009, 05K27339, 05K28013, 05K35579, 05K35767,
05K50032, 05K68133, 05K71777, 05KY10412, 05L17166, 05L19941,
05L30379, 05L33799, 05L47842, 05L53343, 05L54550, 05L54865,
05LF00274, 05LF01535, 05LH01084, 05LH03324, 05LH04133,
05LH04834, 05LL02896, 05LL04439, 05LR02483, 05LR02931,
05LR04245, 05LS00604, 05LT00319, 05LT00361, 05LT01697,
05LV00092, 05LV00259, 05LV01271, 05LW00032, 05LW02471,
05LX00184, 05LX01436, 05LX03815, 05M31502, 05M42835,
05N07314, 05N08879, 05N11529, 05N11718, 05N16977, 05N18639,
05N25618, 05N26143, 05N27866, 05N28517, 05N88613, 05N95017,
05N96718, 05P28141, 05R21326, 05R36435, 05R40421, 05R43507,
05R43927, 05S69396, 05S72512, 05S80233, 05S83268, 05V19281,
05V19464, 05V19819, 05V20574, 05V20594, 05V21334, 05V21759,
05V22096, 05V22647, 05V23017, 05V23308, 05V23813, 05V24701,
05V25239, 05V25773, 05V26283, 05V26845, 05V27206, 05V27995,
05V28310, 05V28533, 05V29132, 05V29280, 05V29372, 05V29651,
05V29728, 05W51496, 05W52608, 05W58402, 05W60300, 05W76956,
05W91071, 05W91328, 05W93940, 05W97663, 05X54405, 05X56806,
05X60686, 05X63191, 05X63207, 05X69237, 05X73644, 05X75816,
05X78296, 05X78408, 05X80589, 05X82358, 05Y25119, 05Y27135,
05Y27607, 05Y29591, 05Y32349, 05Y46355, 05Y48311, 05Y56015,
05Y56361, 05Z16766, 27FC00853, 27FC05503, 27FC06001,
27FC11818, 27FC16339, 27Y00431, 27Y00698, 27Y01117,
27Y02481, 27Y03078, 27Y04897, 27Y05795, 27Y09032, 27Y11706,
27Y11957, 27Y15104, 29FN11543, 53FC04124, 53FE01112,
53G31121, 53GH17789, 53GH19871, 53GJ11635, 53GJ30447,
53GL11221, 53GL14388, 53GL17842, 53GL18002, 53GL18691,
53GL21034, 53GL24593, 53GL28057, 53GN12287, 53GN14688,
53GN15434, 53GN18792, 53GN20986, 53GN25450, 53GN36183,
53GN38050, 53GN39659, 53GQ08243, 53GV03346, 53GV03443,
53GV03950, 53GV03966, 53GV04541, 53GV05044, 53GV06029,
53GV06587, 53GV07082, 53GZ24259, 53GZ34028, 53KE11494,
53KE15226, 53KE15480, 53KF09967, 53KF10066, 53KF10862,
53KF11887, 53KF11896, 53KF13047, 53KF20217, 53KF20221,
-6- 53KF22258, 53KF22789, 53KF24110, 53KF25103, 53KF25980,
53KF30395, 53KF32600, 53KF32938, 53KF34040, 53KL18146,
53KL24550, 53KL32559, 53KL35886, 53KL37429, 53KM18023,
53KM24308, 53KN15345, 53KN19804, 53KN26687, 53KN27362,
53KN29550, 53KQ12636, 53KQ15192, 53KQ19616, 53KQ20715,
53KQ24648, 53KQ25290, 53KQ25413, 53KQ26950, 53KQ40595,
53KR17498, 53KR19467, 53KS14230, 53KS16521, 53KS16609,
53KS27986, 53KS28415, 53KT07079, 53KT09143, 53KT14595,
53KT18217, 53KT18243, 53KT22638, 53KT26851, 53KT29710,
53KT32946, 53KT34036, 53KT35410, 53KW16876, 53KW20639,
53KW22315, 53KW24362, 53KW25878, 53KY35424, 53KY37735,
53KY39213, 53KY43890, 53KZ06978, 53KZ07935, 53KZ08996,
53KZ10594, 53KZ14195, 53KZ17499, 53KZ19603, 53KZ21068,
53KZ32970, 53L15571, 53L80673, 53L86085, 53LK02324,
53T63863;
MANUFACTURER American Red Cross Blood Services, Washington, D.C.
RECALLED BY American Red Cross, Baltimore, Maryland, by letters dated
from August 15, 1991 through September 13, 1992. Firm-
initiated recall ongoing.
DISTRIBUTION California, New York, Pennsylvania, Florida, Switzerland.
QUANTITY (a) 49 units; (b) 336 units; (c) 17 units; (c) 17 units; (d)
107 units; (e) 3 units; (f) 10 units; (g) 18 units; (h) 60
units; (i) 309 units.
REASON Blood products which tested non-reactive for the antibody to
the human immunodeficiency virus type 1 (anti-HIV-1) but
were collected from donors, who previously tested either
initially reactive for anti-HIV-1 and were not retested in
duplicate or repeatedly reactive for anti-HIV-1, were
distributed.
_______________
PRODUCT Platelets. Recall #B-071-4.
CODE Unit #1195202.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, by telephone August 3, 1993, followed by
letter August 23, 1993. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product labeled with the incorrect expiration date was
distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-072-4.
CODE Unit #FX70212.
MANUFACTURER Fairfax Hospital System, Inc., doing business as Fairfax
Hospital Blood Donor Center.
RECALLED BY Manufacturer, by letter September 22, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION New Jersey.
QUANTITY 1 unit.
-7- REASON Blood product which tested nonreactive for the antibody to
the human immunodeficiency virus type 1 (anti-HIV-1), but
was collected from a donor who previously tested repeatedly
reactive for anti-HIV-1, with multiple Western Blot test
results ranging from negative to positive, was distributed.
_______________
PRODUCT Platelets. Recall #B-073-4.
CODE Unit #11044-6388.
MANUFACTURER United Blood Services, Inc., El Paso, Texas.
RECALLED BY Manufacturer, by telephone October 31, 1992, followed by
letter November 1, 1992. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product containing anti-Kell antibodies, but labeled
as negative for unexpected antibodies, was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-076-4.
CODE Unit #12FC58196.
MANUFACTURER American Red Cross, Charlotte, North Carolina.
RECALLED BY Manufacturer, by letter July 16, 1993. Firm-initiated
recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit.
REASON Blood product was collected from a donor who had visited an
area designated as endemic for malaria and had taken
prophylactic anti-malarial medications two years prior to
donation.
_______________
PRODUCT Source Plasma. Recall #B-077-4.
CODE Unit #049000475.
MANUFACTURER North American Biologicals, Inc., Dallas, Texas.
RECALLED BY North American Biologicals, Inc., Miami, Florida, by
telephone on or about March 22, 1993. Firm-initiated recall
complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product tested repeatedly reactive for hepatitis B
surface antigen (HBsAg).
_______________
PRODUCT Source Leukocytes. Recall #B-080-4.
CODE Unit #9325273.
MANUFACTURER Hoxworth Blood Center, Cincinnati, Ohio.
RECALLED BY Manufacturer, by letters dated April 20 and 22, 1993. Firm-
initiated recall complete.
DISTRIBUTION Florida, New York.
QUANTITY 1 unit.
REASON Source Leukocytes tested repeatedly reactive for anti-HIV-1.
-8- RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
===================
_______________
PRODUCT (a) Whole Blood; (b) Whole Blood, For Further Manufacture;
(c) Red Blood Cells; (d) Red blood Cells, For Further
Manufacture; (e) Platelets; (f) Platelets, Pheresis; (g)
Platelets, Expired; (h) Granulocyte, Pheresis; (i)
Cryoprecipitated AHF; (j) Fresh Frozen Plasma; (k) Plasma;
(l) Recovered Plasma. Recall #B-059/070-4.
CODE (a) 05C95279, 05C95570, 05F25471, 05F29812, 05F32162,
05F33913, 05G45114, 05G68500, 05G71594, 05G72188, 05G73193,
05GL01659, 05J55174, 05J56869, 05J59675, 05J61400,
05KF11696, 05L53509, 05LF01728, 05LL04828, 05N01062,
05Y49374, 53GV05360, 53KF13849, 53KF15882, 53KF19732,
53KF21716, 53KQ11593, and 53KQ23658;
(b) 05Z28883;
(c) 05C00623, 05C00971, 05C01717, 05C01833, 05C67312,
05C73192, 05C73922, 05C81156, 05C83657, 05C92485, 05C98878,
05C98924, 05C99854, 05E03550, 05E10324, 05E10442, 05F25407,
05F25676, 05F27583, 05F30301, 05F36178, 05F38545, 05F54623,
05FC02842, 05FC05116, 05FC08026, 05FG01774, 05G31838,
05G32166, 05G34423, 05G37347, 05G38481, 05G39391, 05G50726,
05G52400, 05G58817, 05G59818, 05G61766, 05G64764, 05G68187,
05G68728, 05G70645, 05G71101, 05G73194, 05G73439, 05GH00867,
05GH01170, 05GJ00235, 05GL00430, 05GL00787, 05GL01122,
05GL02192, 05GZ04764, 05H31057, 05H31409, 05H32679,
05H48652, 05H51835, 05H56676, 05H61211, 05J46512, 05J57178,
05J59169, 05J59866, 05J68914, 05J71083, 05J74126, 05K29247,
05K30532, 05K31907, 05K36233, 05K37913, 05K57126, 05K69901,
05K71899, 05K74033, 05KY07461, 05KY09402, 05KY09859,
05KY10459, 05KY10460, 05L17931, 05L17950, 05L26250,
05L29135, 05L32206, 05L33309, 05L38262, 05L42505, 05L42932,
05L43561, 05L44433, 05L47406, 05L48173, 05L50758, 05L51668,
05L55665, 05LE00740, 05LF03384, 05LH01001, 05LL01845,
05LL02709, 05LL03651, 05LL04370, 05LL04502, 05LL05395,
05LR04838, 05LS00965, 05LT02304, 05LT02739, 05LT03245,
05LT03929, 05LT04094, 05LV00785, 05LV01225, 05LW00707,
05LW03543, 05LW06116, 05LX01116, 05N09375, 05N23422,
05N27227, 05N28369, 05R21061, 05R25426, 05R53533, 05R53769,
05R55963, 05R58924, 05S66857, 05S69962, 05S72058, 05S79206,
05S82502, 05V19211, 05V19697, 05V20194, 05V20993, 05V21210,
05V22001, 05V22418, 05V22533, 05V23157, 05V23582, 05V23811,
05V24490, 05V24579, 05V25190, 05V25706, 05V26731, 05V27934,
05V28257, 05V28534, 05V29093, 05V29130, 05V29895, 05W49501,
05W52337, 05W52479, 05W55264, 05W57323, 05W57633, 05W58064,
05W65584, 05W67999, 05W70798, 05W74856, 05W75208, 05W77725,
05W78335, 05W80552, 05W89110, 05W93425, 05W96107, 05X48848,
05X53164, 05X55363, 05X61161, 05X66636, 05X74249, 05X74858,
05X79360, 05X82087, 05X82177, 05X82204, 05X83134, 05Y18544,
05Y28905, 05Y34564, 05Y35298, 05Y47736, 05Y52631, 05Y55974,
05Z14695, 05Z17376, 05Z18118, 05Z22961, 05Z25473, 05Z26505,
05Z27949, 05Z29263, 05Z30130, 27FC01550, 27FC04439,
27FC09074, 27Y01602, 27Y02028, 27Y04176, 27Y04479, 27Y13829,
-9- 27Y14839, 27Y17202, 27Y18984, 29KC00278, 29KC04482,
29KC09138, 29KC09940, 29KC10319, 29KH01971, 29KH05383,
29KH07832, 29KH08765, 29KH11091, 53G53646, 53GH13254,
53GH14129, 53GH22582, 53GJ00177, 53GJ11056, 53GJ16370,
53GJ19691, 53GJ21164, 53GJ22406, 53GJ22608, 53GJ25376,
53GJ26066, 53GJ27637, 53GJ29034, 53GJ30354, 53GJ31121,
53GJ31164, 53GJ31838, 53GL12754, 53GL13539, 53GL15708,
53GL16740, 53GL22160, 53GL23716, 53GL29173, 53GN11596,
53GN12081, 53GN15122, 53GN18421, 53GN23171, 53GN30678,
53GV03508, 53GV04831, 53GV05839, 53GV07141, 53GZ14870,
53GZ16796, 53GZ20590, 53GZ22840, 53GZ24958, 53GZ26707,
53GZ28957, 53GZ29590, 53GZ35179, 53GZ35372, 53KE12968,
53KE13227, 53KE13471, 53KF22337, 53KF22356, 53KF24326,
53KF26135, 53KF28164, 53KF31131, 53KF31740, 53KL24037,
53KL25059, 53KL27447, 53KL31286, 53KL33017, 53KL33115,
53KL34080, 53KL35491, 53KL35547, 53KL36007, 53KL37519,
53KL37810, 53KL38211, 53KL39132, 53KL39383, 53KM17621,
53KM19332, 53KM22519, 53KN14826, 53KN17115, 53KN21142,
53KN21524, 53KN21879, 53KN25884, 53KN26449, 53KN27360,
53KN27385, 53KN27478, 53KN30328, 53KN30371, 53KQ13901,
53KQ14081, 53KQ14447, 53KQ16593, 53KQ17606, 53KQ17632,
53KQ18265, 53KQ19784, 53KQ20406, 53KQ20555, 53KQ21144,
53KQ22409, 53KQ23493, 53KQ24672, 53KQ27936, 53KQ28242,
53KQ29856, 53KQ32020, 53KQ34703, 53KQ35449, 53KQ36119,
53KQ41633, 53KR10492, 53KR14139, 53KR22124, 53KR24478,
53KR27568, 53KR28068, 53KS12227, 53KS13891, 53KS16839,
53KS17394, 53KS18970, 53KS20523, 53KS20884, 53KS22161,
53KS22231, 53KS26795, 53KS27778, 53KS28094, 53KT06964,
53KT07480, 53KT08197, 53KT08910, 53KT10408, 53KT11391,
53KT11875, 53KT11926, 53KT14404, 53KT16717, 53KT18087,
53KT18601, 53KT19023, 53KT20965, 53KT22479, 53KT23435,
53KT23498, 53KT24435, 53KT25909, 53KT27630, 53KT28331,
53KT29531, 53KT31047, 53KT31103, 53KT32203, 53KT33442,
53KT35290, 53KW11833, 53KW14079, 53KW17900, 53KW18025,
53KW20407, 53KW23058, 53KX09794, 53KX18044, 53KX19874,
53KY17222, 53KY18148, 53KY19765, 53KY21315, 53KY23330,
53KY24916, 53KY27376, 53KY28711, 53KY29940, 53KY30297,
53KY35964, 53KY39090, 53KY42281, 53KY43296, 53KZ07378,
53KZ11725, 53KZ15122, 53KZ19105, 53KZ19809, 53KZ20519,
53KZ21915, 53KZ29125, 53KZ31727, 53M95755, and 53R41547
(d) 05C68202, 05K50729, 05L45943, 05N26019, 05Y53536,
05Z29383, 53GN36269, 53KR12822, and 53KR16808
(e) 05C00971, 05C73192, 05C83657, 05C92485, 05C99854,
05F25676, 05G31838, 05G32166, 05G34423, 05G37347, 05G38481,
05G50726, 05G52400, 05G58817, 05G61766, 05G68187, 05G70645,
05G71101, 05H31057, 05H48652, 05H51835, 05H56676, 05H61211,
05J57178, 05J59169, 05J59866, 05J68914, 05K57126, 05K69901,
05L17950, 05L25684, 05L26250, 05L29135, 05L33309, 05L38262,
05L41931, 05L42505, 05L42932, 05L44433, 05L45943, 05L48173,
05L50758, 05L51668, 05LE00740, 05LV01225, 05LW03543,
05N09375, 05N27227, 05R21061, 05R25426, 05R53533, 05R53769,
05R55963, 05S66857, 05V26731, 05X79360, 05Y18544, 05Y34564,
-10- 05Y35298, 05Y47736, 05Y52631, 05Y53536, 05Z17376, 05Z17759,
05Z26505, 29KC00278, 29KC04482, 29KC09940, 29KH01971,
29KH05383, 29KH07832, 29KH08765, 53G53646, 53GJ27637,
53GL15708, 53GL16740, 53GL22160, 53GL23062, 53GN18421,
53GV04831, 53GV05839, 53GV07141, 53GZ28957, 53KE13227,
53KE13471, 53KF14343, 53KF16426, 53KF20552, 53KF28651,
53KF33524, 53KL24037, 53KL39132, 53KL39383, 53KN27360,
53KN27385, 53KQ13901, 53KQ17606, 53KQ19784, 53KQ20406,
53KQ20555, 53KQ23493, 53KQ24672, 53KT11926, 53KT16717,
53KT18087, 53KT20965, 53KT22479, 53KT27630, 53KT29531,
53KT31103, 53KT32748, 53KT35290, 53KW11833, 53KW14079,
53KX09794, 53KX18044, 53KX19874, 53KY21315, 53KY23330,
53KY24916, 53KY27376, 53KY29940, 53KY30297, 53KY35964,
53KZ21915, 53LT13150, 53LT15212, 53LT15805, 53LT16602,
53LT22153, 53LT22678, 53LT23325, 53M95755, and 53R41547
(f) 05P26222, 05P27129, 05P28663, 05P30350;
(g) 05F25407, 53KY19765;
(h) 05P31328;
(i) 05H31409, 05K31907, 05Y28905, 53GJ31838, 53KF26135,
53KF26864, 53KT18601, 53KY42281;
(j) 05C83657, 05C92485, 05C98878, 05F25676, 05F38545,
05F38890, 05G52400, 05G58817, 05J68914, 05K37913, 05L38262,
05L43561, 05L44433, 05L45943, 05L50758, 05L51668, 05LW06116,
05N26019, 05R25426, 05R53533, 05Y34564, 05Y35298, 05Y52631,
05Y53536, 05Z17376, 05Z26505, 53GL15708;
(k) 05C00623, 05C67312, 05F27583, 05F30301, 05F52002,
05G39391, 05G68187, 05G71101, 05J59169, 05J59866, 05S82502,
05Z22961, 29KH11091, 53GJ22406, 53GJ22608, 53GL23716,
53GN30678, 53GV03508, 53GZ26707, 53GZ29590, 53KF22337,
53KF28164, 53KF30334, 53KL33017, 53KL33115, 53KL35491,
53KL36007, 53KL37810, 53KL38211, 53KN21879, 53KN30328,
53KQ13901, 53KQ21144, 53KQ27936, 53KQ32020, 53KQ41633,
53KR28068, 53KS22161, 53KS23126, 53KS26795, 53KS27778,
53KT22479, 53KT23435, 53KT23498, 53KT25909, 53KT33442,
53KW14079, 53KX18044, 53KY21315, 53KY30297, 53KY39090,
53KZ07378, 53KZ19809, 53KZ21915, 53KZ31727, 53R41547;
(l) 05C00971, 05C01717, 05C01833, 05C73192, 05C73922,
05C81156, 05C94038, 05C98924, 05C99854, 05E03550, 05E05705,
05E10324, 05E10442, 05F25407, 05F33670, 05F35649, 05F36178,
05F53218, 05F53460, 05F54623, 05FC02842, 05FC04135,
05FC05116, 05FC08026, 05FG01774, 05G31838, 05G32166,
05G38481, 05G48096, 05G50726, 05G61766, 05G64764, 05G70645,
05G73194, 05G73439, 05GH00867, 05GH01170, 05GJ00235,
05GL00430, 05GL00787, 05GL01122, 05GL02192, 53GL16740,
05GZ04764, 05H31057, 05H31409, 05H32679, 05H48652, 05H51835,
05H56676, 05H61211, 05J46512, 05J57178, 05J66936, 05J71083,
05J74126, 05J76095, 05K29247, 05K30532, 05K31907, 05K36233,
05K57126, 05K69901, 05K71899, 05KY06986, 05KY07461,
05KY09402, 05KY09859, 05KY10459, 05KY10460, 05L17931,
05L17950, 05L19581, 05L26250, 05L29135, 05L33309, 05L41931,
05L42505, 05L47406, 05L48173, 05L51261, 05L55665, 05LF03384,
05LH01001, 05LL01845, 05LL03651, 05LL04370, 05LL04502,
-11- 05LL05395, 05LR04838, 05LS00965, 05LT00158, 05LT02304,
05LT02739, 05LT03245, 05LT03929, 05LV00785, 05LV01225,
05LW00707, 05LW04926, 05LX01116, 05N00899, 05N07383,
05N09375, 05N17014, 05N23422, 05N27227, 05N28369, 05R25409,
05R53769, 05R55963, 05R58924, 05S66857, 05S69962, 05S79206,
05V19211, 05V19697, 05V20194, 05V20993, 05V21210, 05V22001,
05V22418, 05V22533, 05V23157, 05V23582, 05V23811, 05V24490,
05V24579, 05V25190, 05V25706, 05V26731, 05V27934, 05V28257,
05V28534, 05V29093, 05V29895, 05W49501, 05W52337, 05W52479,
05W52692, 05W55264, 05W57323, 05W65584, 05W67999, 05W70798,
05W74856, 05W75208, 05W78335, 05W80552, 05W81069, 05W88634,
05W88867, 05W88901, 05W89110, 05W93425, 05W96107, 05X48848,
05X55363, 05X61161, 05X66636, 05X72800, 05X73863, 05X74249,
05X79360, 05X82087, 05X82177, 05X82204, 05X83134, 05Y18544,
05Y28905, 05Y54991, 05Y55974, 05Z14695, 05Z17759, 05Z25060,
05Z25473, 05Z27949, 05Z29263, 05Z29383, 05Z30130, 27FC01550,
27FC04439, 27FC09074, 27Y01602, 27Y02028, 27Y04176,
27Y04479, 27Y06247, 27Y13829, 27Y14839, 27Y17202, 27Y18984,
29KC00278, 29KC04482, 29KC09138, 29KC09940, 29KC10319,
29KC11113, 29KH01971, 29KH05383, 29KH07832, 29KH08765,
53G53646, 53GH13254, 53GH14129, 53GH22582, 53GJ00177,
53GJ11056, 53GJ16370, 53GJ19691, 53GJ20002, 53GJ21164,
53GJ26066, 53GJ27637, 53GJ30354, 53GJ31164, 53GJ31838,
53GL12754, 53GL13539, 53GL22160, 53GL23062, 53GL29173,
53GN11596, 53GN12081, 53GN15122, 53GN18421, 53GN23171,
53GN36269, 53GV04831, 53GV05839, 53GV07141, 53GZ14870,
53GZ16796, 53GZ20590, 53GZ22840, 53GZ24958, 53GZ28957,
53KE12968, 53KE13227, 53KE13471, 53KF14343, 53KF16426,
53KF18280, 53KF20552, 53KF22356, 53KF26864, 53KF28651,
53KF28822, 53KF31131, 53KF33524, 53KL24037, 53KL25059,
53KL27447, 53KL31286, 53KL33405, 53KL34080, 53KL35547,
53KL35973, 53KL37519, 53KL39132, 53KL39383, 53KM17621,
53KM19332, 53KM22519, 53KN14826, 53KN17115, 53KN21142,
53KN21524, 53KN25884, 53KN27360, 53KN27385, 53KN27478,
53KQ14081, 53KQ16593, 53KQ17606, 53KQ17632, 53KQ18265,
53KQ19784, 53KQ20406, 53KQ20555, 53KQ22409, 53KQ23493,
53KQ24672, 53KQ26603, 53KQ28242, 53KQ29856, 53KQ34703,
53KQ36119, 53KR12822, 53KR14139, 53KR16808, 53KR22124,
53KR27568, 53KS12227, 53KS13891, 53KS16839, 53KS17394,
53KS18970, 53KS20523, 53KS20884, 53KS28094, 53KT06964,
53KT07480, 53KT08910, 53KT10408, 53KT11391, 53KT11875,
53KT11926, 53KT14404, 53KT16717, 53KT18087, 53KT18601,
53KT19023, 53KT19175, 53KT20965, 53KT24435, 53KT27630,
53KT28331, 53KT29531, 53KT31103, 53KT32203, 53KT32748,
53KT35290, 53KW11833, 53KW17900, 53KW18025, 53KW20294,
53KW20407, 53KW20566, 53KW22932, 53KW23058, 53KW23658,
53KX09794, 53KX14678, 53KX17025, 53KX19874, 53KY18148,
53KY19765, 53KY23330, 53KY24916, 53KY27376, 53KY28711,
53KY29940, 53KY35964, 53KY42281, 53KY43296, 53KZ11725,
53KZ15122, 53KZ19105, 53KZ20519, 53KZ26560, 53KZ29125,
53M95755.
MANUFACTURER American Red Cross Blood Services, Washington, D.C.
-12- RECALLED BY American Red Cross, Baltimore, Maryland, by letters dated
from August 15, 1991 through September 13, 1992. Firm-
initiated recall complete.
DISTRIBUTION California, New York, Pennsylvania, Florida, Switzerland.
QUANTITY (a) 29 units; (b) 1 unit; (c) 410 units; (d) 9 units;
(e) 134 units; (f) 4 units; (g) 2 units; (h) 1 unit;
(i) 8 units; (j) 27 units; (k) 56 units; (l) 354 units.
REASON Blood products which tested non-reactive for the antibody to
the human immunodeficiency virus type 1 (anti-HIV-1), but
were collected from donors, who previously tested either
initially reactive for anti-HIV-1 and were not retested in
duplicate, or repeatedly reactive for anti-HIV-1, were
distributed.
_______________
PRODUCT Resolve Panel A Reagent Red Blood Cells. Recall #B-074-4.
CODE Lot #RA757 EXP 7/20/93.
MANUFACTURER Ortho Diagnostic Systems, Inc., Raritan, New Jersey.
RECALLED BY Manufacturer, by letter June 30, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 949 panels.
REASON Xga positive cells were incorrectly labeled as Xga negative.
_______________
PRODUCT Resolve Panel A Reagent Red Blood Cells. Recall #B-075-4.
CODE Lot #RA742 EXP 4/6/93.
MANUFACTURER Ortho Diagnostic Systems, Inc., Raritan, New Jersey.
RECALLED BY Manufacturer, by letter March 22, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 623 panels.
REASON Ytb negative reagent cells incorrectly labeled as Ytb
positive.
_______________
PRODUCT (a) Platelets; (b) Fresh Frozen Plasma.
Recall #B-078/079-4.
CODE Unit numbers: (a) BUI 15036-7241; (b) BUI 15036-7243.
MANUFACTURER United Blood Services Blood System, Inc., Scottsdale,
Arizona.
RECALLED BY United Blood Services Blood Systems, Inc., Lubbock, Arizona,
by telephone between September 2 and 11, 1991. Firm-
initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit of each component.
REASON Blood products, prepared more than eight hours after
phlebotomy, were distributed.
_______________
PRODUCT Source Leukocytes. Recall #B-081-4.
CODE 9306102, 9306103, 9039643, 9311736, 9311737, 9317886,
9322507, 9325544, 9346626.
-13- MANUFACTURER Hoxworth Blood Center, Cincinnati, Ohio.
RECALLED BY Manufacturer, by letters dated April 20 and 22, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Florida, New York.
QUANTITY 9 units.
REASON Source Leukocytes, which either: tested repeatedly reactive
for the antibody to human immunodeficiency virus type 1
(anti-HIV-1); tested repeatedly reactive for the antibody to
hepatitis B core antigen (anti-HBc); tested reactive for
syphilis; or were untested for the hepatitis B surface
antigen (HBsAg), the antibody to human T-lymphotropic virus
type I (anti-HTLV-I), anti-HBc, and anti-HIV-1, were
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
UPDATE The Enforcement Report of November 17, 1993 reported Recall
#Z-089/093-4 (Inflatable penile prosthesis preparation
packages) as ongoing. Please note that the recall is
completed. Also, the reason for recall should read: The
Tyvek lids of the sterile packaging in a small number of the
above products were found to have an incidence of seal
separation which could compromise package integrity.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
UPDATE Recall #Z-117-4 which appeared in the November 24, 1993
Enforcement Report should read:
PRODUCT Promotional literature for Miracle Ear Hearing Aids. These
brochures have the following numbers and titles:
1-550161-334 Miracle-Ear Canal Hearing Systems;
1-550161-335 Miracle-Ear Clarifier Technology;
1-550161-301 El Clarificador (Spanish brochure);
1-550161-300 Sistemas Auditivos Intracanal (Spanish
brochure);
1-550161-338 Miracle-Ear/Straight Talk about Hearing Loss;
1-550158-030 What Everyone Should Know About Hearing
Loss...America's Quiet Health Problem.
CODE All versions of the promotional literature featuring the
Clarifier Circuit.
MANUFACTURER Dahlberg, Inc., Golden Valley, Minnesota (hearing aids)
RECALLED BY Manufacturer, by letter dated April 29, 1993, requesting
that franchisees destroy the promotional literature. Firm-
initiated field correction complete. See also FDA press
release P93-14, April 26, 1993.
QUANTITY The number of the promotional literature still at
franchisees, when the recall began, is unknown.
REASON Mislabeling -- Unsubstantiated claims in labeling
promotional literature caused the hearing aids to be
misbranded.
-14- _______________
UPDATE Recall #Z-114/116-4 which appeared in the November 24, 1993
Enforcement Report should read:
PRODUCT Promotional literature for Starkey CE7 and CE8 in-the-ear
Hearing Aids, SA S7 and SA S8 Custom Canal/SecretEar Mini
in-the-ear hearing Aids and Trilogy Programmable Hearing
Aids. The promotional literature is identified below:
(a) Brochures Titled:
Let Our Secret be your secret
Introducing an Egg Cellent Sales Opportunity
So I'm not getting any younger-Discovery
Your Reasons For Not Hearing Well Have Virtually
Disappeared-Intra IV
Your Hearing is a Priceless Gift
Discover the Pleasure and Value of Better Hearing-CE8
Now, Fine-Tuning Your Hearing is As Easy As 123-Trilogy
Peace and Quite are Sometimes The Best Reasons for SecretEar
Finally a tiny, feather-light, attractive solution to your
hearing loss
Call us and find out how building your patient's peace of
mind can build your bottom line-worry free protection
plan
If you haven't seen our hearing aids yet, we're not
surprised
A Hearing Loss is More Noticeable...Than a Hearing Aid
How's your Hearing? -- EGG chair
Understanding life's Most Important, Most Intimate, Most
Cherished, Most Anticipated sounds and Conversations
Discovery Series Nine - Discovery I, Discovery II - Applica.
Spec. Tech.
Intra IV-The New Revolution
(b) Counter Cards Titled:
Peace and Quiet are Sometimes the Best Reasons...-Secret Ear
People Buy Our Hearing Aids For A Lot Of Little Reasons-
SecretEar
(c) Printed Material for Mailing Titled:
People Buy Our Hearing Aids For A lot Of Little Reasons
Peace and Quiet Are Sometimes the Best Reasons For SecretEar
If You Haven't Seen Our Hearing Aids Yet, We're Not
Surprised
How's Your Hearing - EGG Chair
Why keep doing this, this, and this...when you can push
1,2,3
Hearing Health Quiz/Better Living thru Better Hearing
Special Consultation/Special Invitation
Tomorrow's Technology is Hear Today
Now You Can See How You Hear/Better Hearing Is now made
easier
(d) Printed In Touch Technology Updates:
Automatic Signal Processing
Circuit Selection
Glossary
-15- (e) Printed Technology Updates for the Following Hearing Aid
Options:
CRR II ISP/OSP
FRC HDP/PPF
ISP/OSP CRRII
Series 9, Discovery I IFC
CODE All copies of these pieces of promotional literature
distributed prior to May 7, 1993.
MANUFACTURER Starkey Laboratories, Inc., Eden Prairie, Minnesota (hearing
aids)
RECALLED BY Manufacturer by memorandum dated May 7, 1993, requesting
that the dealers destroy the promotional literature. Firm-
initiated field correction complete. See also FDA press
release P93-14, April 26, 1993.
QUANTITY The number of pieces of promotional literature still at
dealers when the recall began is unknown.
REASON Mislabeling -- Unsubstantiated claims in labeling
promotional literature caused the hearing aids to be
misbranded.
-16-
END OF ENFORCEMENT REPORT FOR DECEMBER 8, 1993. BLANK PAGES MAY
FOLLOW.
####