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
05/24/1995
ENFORCEMENT REPORT FOR 05/24/95
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCTS Robaxisal Tablets pink and white laminated tablets that
contain Methocarbamol, USP 400 mg and Aspirin, USP 325 mg,
packaged in bottles containing 56 tablets. Recall #D-172-5.
CODE Lot Number EXP Date
S051LA 05/31/97
S165KI 04/95
S063LB 03/31/97
S201KL 05/31/97
S094KF 04/96.
MANUFACTURER Pharmaceutical Corporation of America, Carmel, Indiana
(repacker/responsible firm).
RECALLED BY Repacker, by letter March 17, 1995. Firm-initiated recall
complete.
DISTRIBUTION Indiana.
QUANTITY 53 bottles of lot S051LA; 53 bottles of lot S165KI;
107 bottles of lot S063LB; 62 bottles of lot S094KF;
14 bottles of lot S201KL were distributed.
REASON The repack label incorrectly declares acetaminophen as an
ingredient instead of aspirin. The correct brand name
Robaxisal is present on the label.
_______________
PRODUCT Dilantin (Extended Phenytoin Sodium Capsules, USP),
Kapseals, 100 mg, in bottles of 100 and 1000, indicated for
the control of seizures. Recall #D-174-5.
CODE Lot numbers: 05254FA EXP 4/96, 08354FA EXP 5/96 (100s);
05354FA EXP 4/96, 02364FA EXP 6/96 (1000s).
MANUFACTURER Warner Lambert Company, Fajardo, Puerto Rico.
RECALLED BY Parke-Davis, Division of Warner Lambert Company, Morris
Plains, New Jersey, by letters mailed between April 20 and
21, 1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 83,886 bottles were distributed.
REASON Product does not meet dissolution specifications through the
expiration date.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Acthar Lyophilized Corticotropin for Injection, 40 USP units
per vial, Rx injectable for diagnostic testing of
adrenocortical function. Recall #D-173-5.
CODE Lot #L29302 EXP 2/96.
MANUFACTURER Armour Pharmaceutical Company, Bradley, Illinois.
RECALLED BY Rhone-Poulenc Rorer Pharmaceuticals, Inc., Collegeville,
Pennsylvania, by letter April 28, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, Saudi Arabia.
QUANTITY 13,678 vials were distributed; firm estimated that 1,000
vials remained on market at time of recall initiation.
REASON Superpotency.
_______________
PRODUCT Bacitracin Ointment USP, in 1/2 ounce and 1 ounce tubes, OTC
first aid antibiotic ointment, under the following labels:
NMC, Geneva, Pathmark, Longs Drug Stores, Major Quality,
Walgreen, Schein, Drug Guild Distributors, McKesson, Mason
Distributors, Payless Drug Stores Northwest, HealthMart,
Snyder's Drug Stores, Medalist. Recall #D-175-5.
CODE Lot numbers: 2D578 EXP 4/95 (NMC, Geneva, Pathmark, Longs,
Snyder), 2D600 EXP 4/95 (NMC, Major), 2E650 EXP 5/95, 2E673
EXP 5/95 (NMC, Schein, Drug Guild, Major, Walgreen, Mason,
Medalist, Payless), 2F716 EXP 6/95 (NMC Schein, Drug Guild,
HealthMart), 2G765 EXP 7/95 (NMC, Major, Walgreen,
Pathmark), 2I776 EXP 9/95 (NMC, Payless, Major, HealthMart,
Drug Guild, Walgreen), 2G816 EXP 7/95 (NMC, Geneva,
Walgreen, Drug Guild, Snyder), 2J824 EXP 10/95 (NMC Geneva,
Pathmark, Major, Drug Guild, Schein, Longs), 2J879 EXP 10/95
(NMC, Walgreen, Drug Guild, Major), 2J093 EXP 10/95 (NMC,
Walgreen, Drug Guild, Mason), 2K940 EXP 11/95 (NMC Payless,
Snyder, Medalist, Geneva).
MANUFACTURER NMC Laboratories, Inc., Glendale, New York.
-2- RECALLED BY Manufacturer, by letter May 2, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 250,614 1/2 ounce tubes and 513,374 1-ounce tubes were
distributed.
REASON Subpotency.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Red Blood Cells,
Washed; (d) Platelets; (e) Platelets, Pheresis; (f)
Cryoprecipitated AHF; (g) Granulocytes, Pheresis; (h) Fresh
Frozen Plasma; (i) Plasma; (j) Leukocytes; (k) Whole Blood,
For Further Manufacture; (l) Red Blood Cells, For Further
Manufacture; (m) Platelets, Expired and Platelets, Pheresis;
(n) Recovered Plasma. Recall #B-253/266-5.
CODE (a) Whole Blood, 42 units: 05C84938, 05F43889, 05F48337,
05GL00811, 05J72321, 05K33219, 05K41453, 05K63476, 05K68477,
05K69706, 05KY10668, 05KY10804, 05L45464, 05LH03169,
05LL00892, 05LL00893, 05LL03728, 05LL05554, 05N26202,
05V29681, 05V29760, 05W91063, 05X78824, 05Y44682, 53GL18353,
53GQ12150, 53GQ12952, 53GV05200, 53GZ17757, 53KF06487,
53KF32393, 53KQ19084, 53KR20350, 53KS14304, 53KT10724,
53KT15516, 53KT19139, 53KY22029, 53KY23001, 53KY23056,
53KZ14201, and 53KZ19041
(b) Red Blood Cells, 548 units: 05C02951, 05C61484,
05C68316, 05C83766, 05C96215, 05C96711, 05C99986, 05E08848,
05F31858, 05F37966, 05F51035, 05F52373, 05F52514, 05F53436,
05F53444, 05F54498, 05F55938, 05F57024, 05FC06372,
05FC06651, 05FC07998, 05FG00496, 05FG00663, 05FG01869,
05G39349, 05G50692, 05G66250, 05G70844, 05G71756, 05G73549,
05G74086, 05GH02019, 05GL00158, 05GL01585, 05GL04110,
05GN02025, 05GN02775, 05GN05520, 05GV00287, 05GV00812,
05GV01007, 05GV01074, 05GV03078, 05GZ02375, 05GZ02823,
05GZ03155, 05GZ04120, 05H38646, 05H52716, 05H53644,
05H56909, 05H61995, 05H62533, 05H62650, 05H64329, 05H64634,
05J50000, 05J63838, 05J64472, 05J70990, 05J72837, 05J73909,
05J74465, 05J74952, 05J74978, 05K31686, 05K34768, 05K60220,
05K64299, 05K64550, 05K65395, 05K69278, 05K72087, 05K72658,
05K73077, 05K73307, 05K74345, 05KL09422, 05KL10325,
05KM06160, 05L24602, 05L45719, 05L47684, 05L48080, 05L52464,
05L53357, 05L55115, 05LF03464, 05LF05637, 05LH02355,
05LH02913, 05LH03760, 05LH04244, 05LH04553, 05LH04907,
05LJ00331, 05LJ00998, 05LJ10869, 05LL00086, 05LL03940,
05LL04104, 05LL04449, 05LL05506, 05LR00723, 05LR01994,
05LR04079, 05LR05069, 05LR05331, 05LS00619, 05LS01388,
05LV00441, 05LV00910, 05LW00772, 05LW04403, 05LX01814,
05LX02608, 05LX03789, 05M27676, 05M29242, 05M32538,
05M32545, 05M37931, 05M40698, 05M43002, 05N02338, 05N05806,
05N18416, 05N19199, 05N19543, 05N22371, 05N24922, 05N29031,
05R21161, 05R48233, 05R48284, 05R50389, 05R50615, 05R53148,
-3- 05R55335, 05R55772, 05S79332, 05S81470, 05S84064, 05S84216,
05S85924, 05V21132, 05V21730, 05V21985, 05V22538, 05V23396,
05V27155, 05V27736, 05V28008, 05V28398, 05V28584, 05V29008,
05V29165, 05V29530, 05V30077, 05W00205, 05W02083, 05W86994,
05W87030, 05W91127, 05W91490, 05W93445, 05W93988, 05X68275,
05X68505, 05X70644, 05X71915, 05X71984, 05X75272, 05X75608,
05X75627, 05X75697, 05X75901, 05X77119, 05X77123, 05X78582,
05X78869, 05X80514, 05X82991, 05Y29362, 05Y30396, 05Y32083,
05Y43014, 05Y45976, 05Y52186, 05Y52447, 05Y53089, 05Z26357,
05Z28251, 05Z32125, 05Z32153, 27FC01364, 27FC03232,
27FC06549, 27FC06830, 27FC09438, 27FC12192, 27FC14564,
27FC15872, 27FC16673, 27FC17528, 27FC17590, 27FC17808,
27FC19395, 27FC19527, 27FC25305, 27Y01200, 27Y02430,
27Y03331, 27Y04901, 27Y05614, 27Y07522, 27Y10278, 27Y18633,
29FN12275, 29FN13174, 29GW00975, 29KC00854, 29KC02364,
29KC07788, 29KC09485, 29KH06708, 29KV00656, 29KV01812,
29KV02655, 53FC01488, 53FC07095, 53FC09989, 53FC16552,
53FJ00306, 53FL05255, 53FR00628, 53FW00678, 53GH11273,
53GH12627, 53GH12727, 53GH16974, 53GH17082, 53GH18313,
53GH18470, 53GH20001, 53GH20614, 53GH21412, 53GJ11256,
53GJ15778, 53GJ18706, 53GJ18827, 53GJ18894, 53GJ18940,
53GJ19856, 53GJ21336, 53GJ24668, 53GJ24971, 53GJ27807,
53GJ29298, 53GJ29603, 53GJ29885, 53GJ30365, 53GJ30953,
53GJ31687, 53GJ32759, 53GJ35150, 53GJ36846, 53GL12197,
53GL14500, 53GL15084, 53GL15785, 53GL23005, 53GL24117,
53GL24625, 53GL24837, 53GL25267, 53GL26584, 53GL28026,
53GL28320, 53GL30630, 53GL31611, 53GL36058, 53GN12387,
53GN13773, 53GN14886, 53GN15149, 53GN17990, 53GN18523,
53GN20083, 53GN21819, 53GN23823, 53GN25099, 53GN25476,
53GN27778, 53GN29024, 53GN30324, 53GN30675, 53GN31051,
53GN31484, 53GN31696, 53GN33189, 53GN34721, 53GN35896,
53GN35975, 53GN37940, 53GN39633, 53GN40037, 53GN41242,
53GN42107, 53GN43107, 53GQ07181, 53GQ08219, 53GQ09269,
53GQ10244, 53GQ10703, 53GQ13558, 53GV03645, 53GV04178,
53GV04686, 53GV06201, 53GV06752, 53GV06863, 53GV07246,
53GZ11739, 53GZ14019, 53GZ15028, 53GZ15609, 53GZ17009,
53GZ18602, 53GZ20037, 53GZ21167, 53GZ21691, 53GZ22096,
53GZ25030, 53GZ26311, 53GZ26768, 53GZ28516, 53GZ30550,
53GZ30927, 53GZ30998, 53GZ34506, 53GZ34627, 53GZ38833,
53GZ40713, 53H72662, 53J04244, 53KE13476, 53KE13864,
53KE14057, 53KE18500, 53KF08981, 53KF21393, 53KF22201,
53KF22814, 53KF25794, 53KF25839, 53KF29550, 53KF30263,
53KF33851, 53KF34253, 53KF34286, 53KF35952, 53KF35992,
53KF36549, 53KF37091, 53KL18419, 53KL18655, 53KL21543,
53KL21911, 53KL22881, 53KL23672, 53KL24310, 53KL24921,
53KL26820, 53KL28868, 53KL29262, 53KL29765, 53KL30666,
53KL33209, 53KL34254, 53KL34919, 53KL35049, 53KL35116,
53KL36102, 53KL38816, 53KL39477, 53KL39552, 53KL40509,
53KL41920, 53KL44524, 53KL45224, 53KL46056, 53KL46601,
53KM21412, 53KM22329, 53KM25556, 53KM26103, 53KM27041,
53KM28132, 53KN11883, 53KN11947, 53KN14971, 53KN15252,
-4- 53KN16425, 53KN18667, 53KN19436, 53KN19872, 53KN20213,
53KN22843, 53KN25902, 53KN27063, 53KN27243, 53KN27291,
53KN28617, 53KN30064, 53KN34252, 53KQ14289, 53KQ14709,
53KQ15650, 53KQ16630, 53KQ21901, 53KQ26021, 53KQ28319,
53KQ29048, 53KQ34230, 53KQ34373, 53KQ39853, 53KQ44167,
53KQ44905, 53KR09635, 53KR09876, 53KR12662, 53KR13183,
53KR15462, 53KR25114, 53KR28904, 53KR29909, 53KS11056,
53KS13370, 53KS14435, 53KS18966, 53KS22109, 53KS23432,
53KS25076, 53KS25369, 53KS25913, 53KS26730, 53KS29388,
53KS30905, 53KT06079, 53KT10542, 53KT13549, 53KT13655,
53KT15258, 53KT15528, 53KT15685, 53KT16328, 53KT16612,
53KT18295, 53KT19038, 53KT19164, 53KT20668, 53KT21713,
53KT21937, 53KT22667, 53KT23881, 53KT24189, 53KT24355,
53KT26194, 53KT29735, 53KT30349, 53KT30581, 53KT31180,
53KT31215, 53KT31271, 53KT32050, 53KT33272, 53KT33616,
53KT35326, 53KT37673, 53KT38033, 53KT38860, 53KW09198,
53KW12252, 53KW12833, 53KW15327, 53KW19156, 53KW19906,
53KW20799, 53KW22792, 53KX09135, 53KX09210, 53KX10854,
53KX11067, 53KX12139, 53KX12996, 53KX14435, 53KX15367,
53KX16439, 53KX16698, 53KX17162, 53KX17625, 53KX17764,
53KX20497, 53KX21656, 53KY19686, 53KY20579, 53KY21000,
53KY21953, 53KY22182, 53KY24358, 53KY26713, 53KY28140,
53KY31651, 53KY32177, 53KY32534, 53KY33546, 53KY36420,
53KY37710, 53KY38841, 53KY38918, 53KY39625, 53KY39834,
53KZ06815, 53KZ12851, 53KZ13249, 53KZ15459, 53KZ15593,
53KZ15863, 53KZ17590, 53KZ21256, 53KZ22655, 53KZ25332,
53KZ26827, 53KZ28195, 53KZ29105, 53KZ30119, 53KZ33333,
53KZ34748, 53KZ34788, 53KZ36275, 53KZ36944, 53KZ39620,
53L18724, 53L34652, 53LE12170, 53LE12496, and 53R84924
(c) Red Blood Cells, Washed, Two units:
05E09750 and 05X82881
(d) Platelets, 138 units: 05C68316, 05C83766, 05C96215,
05C96711, 05C99986, 05E08848, 05F54498, 05G66250, 05G71756,
05GH02186, 05H38646, 05H52716, 05H62650, 05H64329, 05J50000,
05J73909, 05K27242, 05K34768, 05K63811, 05K68577, 05K69278,
05L45719, 05L47684, 05L48080, 05LW04403, 05M29242, 05M37931,
05N14121, 05N18416, 05N19199, 05N19543, 05N22371, 05P24231,
05P25598, 05P26633, 05P28079, 05P28570, 05R48233, 05R48284,
05R50389, 05R50615, 05R55772, 05S73591, 05S84064, 05V27736,
05V28398, 05V29165, 05X75608, 05X77119, 05X77123, 05X80514,
05X80829, 05Y43014, 05Y45976, 05Y50488, 05Y52186, 05Y52447,
05Z32125, 05Z32153, 29KC00854, 29KC02364, 29KC07788,
29KV00656, 29KV01812, 53FC07095, 53FC16552, 53FR00628,
53GJ15778, 53GJ22726, 53GJ24668, 53GJ30953, 53GJ32759,
53GJ36846, 53GL22746, 53GL28026, 53GL28320, 53GN12387,
53GN13773, 53GN17990, 53GN34721, 53GN39633, 53GN41242,
53GQ10703, 53GV04686, 53GV06752, 53GV06863, 53GZ38833,
53J04244, 53KE14057, 53KE18500, 53KF25794, 53KF25839,
53KF29263, 53KF33851, 53KF34286, 53KF36549, 53KF37091,
53KL41920, 53KN27063, 53KN27291, 53KQ21173, 53KQ26021,
53KQ31128, 53KQ39853, 53KQ44167, 53KQ44905, 53KS23432,
53KT10542, 53KT13549, 53KT13655, 53KT15258, 53KT15528,
-5- 53KT16328, 53KT20668, 53KT21713, 53KT30349, 53KT33616,
53KX16698, 53KX17764, 53KX20497, 53KX22237, 53KY20579,
53KY22182, 53KY24358, 53KY24985, 53KY28140, 53KY36420,
53KY37710, 53KY38918, 53KY39834, 53KZ13249, 53KZ20380,
53KZ23131, 53KZ26827, 53KZ29105, 53KZ34788, 53KZ39620, and
53R84924
(e) Platelets, Pheresis, 179 units: 05P20225, 05P20906,
05P21042, 05P21463, 05P21593, 05P21611, 05P21917, 05P21947,
05P24132, 05P24160, 05P24169, 05P24342, 05P24716, 05P24739,
05P24930, 05P25147, 05P25408, 05P25453, 05P25861, 05P26076,
05P26288, 05P26971, 05P27178, 05P27829, 05P27973, 05P27995,
05P28191, 05P28230, 05P28261, 05P28412, 05P28683, 05P28726,
05P28783, 05P28818, 05P28850, 05P29226, 05P29292, 05P29533,
05P29632, 05P29653, 05P30033, 05P30136, 05P30157, 05P30290,
05P30335, 05P30433, 05P30441, 05P30653, 05P30672, 05P30698,
05P30748, 05P30893, 05P30939, 05P31234, 05P31331, 05P31359,
05P31370, 05P31490, 05P31621, 05P31633, 05P31693, 05P31793,
05P31799, 05P31875, 05P32211, 05P32225, 05P32239, 53KT22104,
53LF11245, 53LF11325, 53LF12422, 53LF14399, 53LF15140,
53LF15958, 53LT11096, 53LT11206, 53LT11312, 53LT11344,
53LT11372, 53LT11600, 53LT11678, 53LT11793, 53LT11830,
53LT11903, 53LT12054, 53LT12372, 53LT12471, 53LT13032,
53LT13070, 53LT13087, 53LT13103, 53LT13110, 53LT13259,
53LT13352, 53LT13490, 53LT13569, 53LT13629, 53LT13941,
53LT13947, 53LT14094, 53LT14209, 53LT14259, 53LT14493,
53LT14554, 53LT14585, 53LT15025, 53LT15034, 53LT15065,
53LT15082, 53LT15131, 53LT15231, 53LT15478, 53LT15608,
53LT15686, 53LT15862, 53LT15882, 53LT15956, 53LT16066,
53LT16457, 53LT16498, 53LT16524, 53LT16634, 53LT17058,
53LT17072, 53LT17078, 53LT17228, 53LT17254, 53LT17392,
53LT17785, 53LT18089, 53LT18198, 53LT18314, 53LT18352,
53LT18356, 53LT18844, 53LT18950, 53LT18966, 53LT19261,
53LT19384, 53LT19500, 53LT19643, 53LT19713, 53LT19724,
53LT19831, 53LT19947, 53LT20091, 53LT20170, 53LT20433,
53LT20590, 53LT20752, 53LT20921, 53LT21113, 53LT21139,
53LT21333, 53LT21340, 53LT21679, 53LT21836, 53LT21875,
53LT22032, 53LT22178, 53LT22308, 53LT22669, 53LT23027,
53LT23274, 53LT23408, 53LT23714, 53LT23795, 53LT23864,
53LT24045, 53LT24563, 53LT24696, 53LT24940, 53LT25023,
53LT25330, 53LT25352, 53LT25645, 53LT25990, 53LT26375, and
53TL14304
(f) Cryoprecipitated AHF, 15 units: 05H53644, 05K27242,
05L24602, 05S81470, 05Z26357, 53GL30630, 53GN37940,
53H72662, 53KF22826, 53KL45224, 53KM27041, 53KT31271,
53KT32050, 53KT33272, and 53KT35326
(g) Granulocyte, Pheresis, Two units: 05P26712 and 53LT22818
(h) Fresh Frozen Plasma, 23 units: 05C83766, 05E08848,
05F35280, 05F37966, 05F53436, 05GN05520, 05H52716, 05H64634,
05J50000, 05K64299, 05K69278, 05LW04403, 05LX02608,
05M27676, 05N18416, 05N19199, 05N24922, 05R48233, 05R55772,
05Y52447, 05Y53630, 05Z32153, and 53KY19686
-6- (i) Plasma, 106 units: 05P24597A, 05P24597B, 05P25757A,
05P25757B, 05P25975A, 05P25975B, 05P26520A, 05P26520B,
05P26632A, 05P27761A, 05P27761B, 05P28521A, 05P28521B,
05P28564A, 05P28564B, 05P28564C, 05P28900A, 05P30281A,
05P30281B, 05P30281C, 05P30647A, 05P30647B, 05P31900A,
05P31900C, 53GJ18894, 53GJ21336, 53GJ27807, 53GJ29885,
53GJ30365, 53GJ31687, 53GJ35150, 53GJ36846, 53GL22746,
53GL24117, 53GL24837, 53GL31611, 53GL32928, 53GN12387,
53GN13802, 53GN17990, 53GN21819, 53GN29024, 53GN31051,
53GN31484, 53GN31696, 53GN34721, 53GQ13558, 53GV06863,
53GZ11739, 53GZ18602, 53GZ21167, 53GZ26311, 53GZ28516,
53GZ30704, 53GZ34506, 53GZ34627, 53H65687, 53J04244,
53J41834, 53KE13864, 53KF08981, 53KF22201, 53KF34286,
53KL28868, 53KL38816, 53KL39477, 53KL46056, 53KL46601,
53KM22329, 53KM25556, 53KM26103, 53KM28132, 53KN27243,
53KN30064, 53KN34252, 53KQ21173, 53KQ28319, 53KQ31128,
53KQ34230, 53KQ34373, 53KR25114, 53KR30106, 53KS25369,
53KS26730, 53KT15685, 53KT23881, 53KT24355, 53KT30581,
53KX21656, 53KY24358, 53KY31651, 53KY32177, 53KY33546,
53KY39625, 53KZ20380, 53KZ23131, 53KZ28413, 53KZ33333,
53KZ34506, 53KZ36275, 53L26850, 53LT11229A, 53LT11229B,
53LT11229C, 53LT12378A, 53LT12378B, and 53LT12378C
(j) Leukocytes, One unit: 05C00268
(k) Whole Blood, For Further Manufacture, Three units:
05R39311, 05W94220, and 53KF16575
(l) Red Blood Cells, For Further Manufacture, 30 units:
05C92608, 05F48364, 05K63811, 05K67800, 05R34467, 05R36970,
05W89960, 05W95461, 05X71128, 05X72024, 05X73444, 05Y50488,
05Z30984, 53FE00481, 53GJ16011, 53GL22746, 53GL32928,
53GN14912, 53GZ21582, 53GZ30351, 53GZ30704, 53KF28408,
53KF29263, 53KQ20752, 53KQ21173, 53KR26620, 53KR30106,
53KT22104, 53KY24985, and 53KZ20380
(m) Platelets, Expired, 27 units: 05H50487, 05H64634,
05K64299, 05K65395, 05K72087, 05L53357, 05M27676, 05Z19033,
53FJ00306, 53GH18470, 53GJ24971, 53GQ13558, 53GV06201,
53KE13476, 53KQ16630, 53KX10854, 53KX11067, 53KX12139,
53KX12996, 53KX15367, 53KX15447, 53KX16439, 53KX17162,
53KX17625, 53KX21656, 53KY21953, and 53KZ15459; Platelets,
Pheresis, For Further Manufacture, One unit: 05P31823
(n) Recovered Plasma, 546 units: 05C00268, 05C02951,
05C61484, 05C92608, 05C92846, 05C96215, 05C96711, 05C99986,
05E09750, 05F44170, 05F51404, 05F52373, 05F52514, 05F53444,
05F54498, 05F57024, 05FC06372, 05FC06651, 05FC07998,
05FG00496, 05FG00565, 05FG01869, 05G39349, 05G50692,
05G66250, 05G70844, 05G71756, 05G73549, 05G74086, 05GH02019,
05GH02186, 05GL00158, 05GL00925, 05GL01585, 05GL04110,
05GN02025, 05GN02775, 05GN04375, 05GV00812, 05GV01007,
05GZ02823, 05GZ03155, 05GZ04120, 05H44295, 05H50487,
05H52646, 05H53644, 05H55755, 05H56909, 05H61995, 05H62533,
05H62650, 05H64329, 05J63838, 05J70990, 05J72837, 05J73254,
05J73909, 05J74465, 05J74952, 05J74978, 05K27242, 05K34768,
-7- 05K60220, 05K63811, 05K64550, 05K65395, 05K67800, 05K68577,
05K69414, 05K72087, 05K72658, 05K73077, 05K73307, 05K74345,
05KL09422, 05KL10227, 05KL10325, 05KM06160, 05KM07218,
05L31413, 05L42615, 05L45719, 05L47684, 05L48080, 05L52464,
05L52772, 05L53357, 05L54429, 05L55115, 05LF03464,
05LF05637, 05LH02355, 05LH02913, 05LH03760, 05LH04244,
05LH04907, 05LJ00331, 05LJ00588, 05LJ00998, 05LJ10869,
05LL00086, 05LL03940, 05LL04104, 05LL04449, 05LL04878,
05LL05506, 05LL05809, 05LR00723, 05LR01994, 05LR04079,
05LR05069, 05LR05331, 05LS00619, 05LS01388, 05LT00365,
05LV00441, 05LV00910, 05LW00772, 05LX01814, 05LX03789,
05M29242, 05M37931, 05M43002, 05N02338, 05N14121, 05N19428,
05N19543, 05N22371, 05N24760, 05N29031, 05R21161, 05R34467,
05R36970, 05R48284, 05R50389, 05R53148, 05R55335, 05S73591,
05S79332, 05S81470, 05S84064, 05S84216, 05S85924, 05V21132,
05V21730, 05V21985, 05V22538, 05V27014, 05V27269, 05V27736,
05V28008, 05V28398, 05V28584, 05V29008, 05V29165, 05V29530,
05V30077, 05W00205, 05W02083, 05W72833, 05W86910, 05W86994,
05W87030, 05W89960, 05W91127, 05W91490, 05W93445, 05W93988,
05W95461, 05W99891, 05X68505, 05X70644, 05X71128, 05X71915,
05X71984, 05X72024, 05X73444, 05X75272, 05X75608, 05X75627,
05X75697, 05X75901, 05X77119, 05X77123, 05X78582, 05X78869,
05X80514, 05X82881, 05X82991, 05Y29362, 05Y30396, 05Y40494,
05Y43014, 05Y45976, 05Y50488, 05Y52186, 05Y53089, 05Z26318,
05Z26357, 05Z28251, 05Z30984, 05Z32125, 27FC01364,
27FC03232, 27FC06549, 27FC06830, 27FC09438, 27FC12192,
27FC14564, 27FC15872, 27FC17528, 27FC17590, 27FC17808,
27FC19395, 27FC19527, 27FC25305, 27Y01200, 27Y02430,
27Y03331, 27Y04901, 27Y05614, 27Y07522, 27Y10278, 27Y10674,
27Y18633, 27Y20674, 29FN13174, 29GL05961, 29GP03114,
29GW00417, 29GW00496, 29GW00918, 29GW00975, 29GW01486,
29GW01919, 29KC00854, 29KC02364, 29KC07788, 29KC09485,
29KH06708, 29KV00656, 29KV00821, 29KV01111, 29KV01549,
29KV01812, 29KV02104, 29KV02655, 29KV02825, 29KV03400,
29KV03855, 29KV04327, 29KV04744, 53FC01488, 53FC07095,
53FC09989, 53FC16552, 53FE00481, 53FJ00306, 53FL05255,
53FQ01473, 53FR00628, 53FW00678, 53GH11273, 53GH12727,
53GH16974, 53GH17082, 53GH18313, 53GH18470, 53GH20001,
53GH20614, 53GH21412, 53GH22121, 53GJ11256, 53GJ13149,
53GJ15778, 53GJ16011, 53GJ17976, 53GJ18827, 53GJ18940,
53GJ19856, 53GJ20612, 53GJ20751, 53GJ22634, 53GJ22726,
53GJ23436, 53GJ24668, 53GJ24971, 53GJ26118, 53GJ29298,
53GJ29603, 53GJ30953, 53GJ32759, 53GL12197, 53GL14500,
53GL15084, 53GL15785, 53GL20794, 53GL22108, 53GL23005,
53GL25267, 53GL26584, 53GL28026, 53GL28320, 53GL30630,
53GL36058, 53GN14886, 53GN14912, 53GN15149, 53GN18523,
53GN20083, 53GN23823, 53GN25099, 53GN25476, 53GN27778,
53GN30324, 53GN33189, 53GN35896, 53GN35975, 53GN37940,
53GN39633, 53GN40037, 53GN41242, 53GN42107, 53GN43107,
53GQ07181, 53GQ08219, 53GQ09269, 53GQ10244, 53GQ10703,
53GV03645, 53GV04178, 53GV04686, 53GV06201, 53GV06752,
53GV07246, 53GZ14019, 53GZ15028, 53GZ15609, 53GZ17009,
-8- 53GZ17087, 53GZ20037, 53GZ21582, 53GZ21691, 53GZ22096,
53GZ25030, 53GZ26768, 53GZ27011, 53GZ30351, 53GZ30550,
53GZ30927, 53GZ30998, 53GZ38371, 53GZ38833, 53GZ40713,
53H72662, 53KE13476, 53KE14057, 53KE17945, 53KE18500,
53KF07860, 53KF21393, 53KF22814, 53KF22826, 53KF25794,
53KF25839, 53KF28408, 53KF29263, 53KF29550, 53KF30263,
53KF33851, 53KF34253, 53KF35952, 53KF35992, 53KF36549,
53KF37091, 53KL18419, 53KL18655, 53KL21543, 53KL21911,
53KL22881, 53KL23672, 53KL24310, 53KL24921, 53KL26820,
53KL29262, 53KL29765, 53KL30666, 53KL33209, 53KL34254,
53KL34919, 53KL35049, 53KL35116, 53KL36102, 53KL39552,
53KL41920, 53KL45224, 53KM21412, 53KM22510, 53KM27041,
53KN11883, 53KN11947, 53KN14971, 53KN15252, 53KN16425,
53KN19436, 53KN19872, 53KN20213, 53KN22843, 53KN25902,
53KN27063, 53KN27291, 53KN28617, 53KN34768, 53KQ10752,
53KQ13302, 53KQ14289, 53KQ14709, 53KQ15458, 53KQ15650,
53KQ20752, 53KQ21901, 53KQ22401, 53KQ26021, 53KQ26773,
53KQ28310, 53KQ29048, 53KQ32083, 53KQ33643, 53KQ39853,
53KQ44167, 53KQ44905, 53KR09536, 53KR09635, 53KR09876,
53KR12662, 53KR13183, 53KR15462, 53KR25904, 53KR28904,
53KR29909, 53KS11056, 53KS13370, 53KS13732, 53KS14435,
53KS18966, 53KS22109, 53KS25076, 53KS25913, 53KS28232,
53KS29388, 53KS30905, 53KT06079, 53KT10542, 53KT13549,
53KT13655, 53KT14698, 53KT15258, 53KT15528, 53KT16328,
53KT16612, 53KT17734, 53KT19038, 53KT19164, 53KT20668,
53KT21713, 53KT21937, 53KT22104, 53KT22667, 53KT23325,
53KT24189, 53KT26194, 53KT26659, 53KT29735, 53KT30349,
53KT31180, 53KT31215, 53KT31271, 53KT31593, 53KT32050,
53KT32201, 53KT33272, 53KT33616, 53KT35326, 53KT37673,
53KT38033, 53KT38860, 53KW12252, 53KW12833, 53KW15327,
53KW19156, 53KW19906, 53KW20799, 53KW22792, 53KX09210,
53KX10854, 53KX11067, 53KX12139, 53KX12996, 53KX15367,
53KX15447, 53KX16439, 53KX16698, 53KX17162, 53KX17625,
53KX17764, 53KX19628, 53KX19810, 53KX20497, 53KX22237,
53KY20800, 53KY21000, 53KY21953, 53KY22182, 53KY24985,
53KY26210, 53KY26713, 53KY28140, 53KY32534, 53KY36420,
53KY37710, 53KY38841, 53KY38918, 53KY39834, 53KZ06815,
53KZ12851, 53KZ15459, 53KZ15593, 53KZ15620, 53KZ15863,
53KZ17590, 53KZ21256, 53KZ22655, 53KZ25153, 53KZ25332,
53KZ26827, 53KZ28195, 53KZ29105, 53KZ30119, 53KZ34788,
53KZ36944, 53KZ39620, 53LE12170, 53LE12496, and 53R84924.
MANUFACTURER The American National Red Cross, Washington, D.C.
RECALLED BY The American National Red Cross, Baltimore, Maryland, by
letters dated from August 5, 1991 through September 13,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 42 units; (b) 548 units; (c) 2 units; (d) 138 units; (e)
179 units; (f) 15 units; (g) 2 units; (h) 23 units; (i) 106
units; (j) 1 unit; (k) 3 units; (l) 30 units; (m) 28 units
(includes one platelets, Pheresis); (n) 546 units.
-9- 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 repeatedly
reactive for anti-HIV-1, were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
=====================
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Red Blood Cells,
Washed; (d) Platelets; (e) Platelets, Pheresis; (f)
Cryoprecipitated AHF; (g) Granulocytes, Pheresis; (h) Fresh
Frozen Plasma; (i) Plasma; (j) Leukocytes; (k) Whole Blood,
For Further Manufacture; (l) Red Blood Cells, For Further
Manufacture; (m) Platelets, Expired; (n) Recovered Plasma.
Recall #B-267/280-5.
CODE Unit numbers:
(a) Whole Blood, Six units:
05LF01825, 05LF02351, 05LF04217, 53KF14955, 53KF20026, and
53KF22164
(b) Red Blood Cells, 253 units: 05C00419, 05C02521,
05C92467, 05C96771, 05C98499, 05F53412, 05F54963, 05F56324,
05FC02071, 05FC03395, 05FC04367, 05FC05567, 05G45372,
05G67048, 05G73244, 05GH01920, 05GH02566, 05GH02853,
05GL00325, 05GL04424, 05GV00640, 05GV02114, 05H66730,
05J63348, 05J66158, 05J68451, 05J69077, 05J69137, 05J73830,
05J74573, 05K43573, 05KE06070, 05KL10575, 05KL10888,
05KY08111, 05KY09948, 05L38305, 05L45612, 05L55195,
05LF00931, 05LJ00407, 05LJ10002, 05LL00137, 05LL01566,
05LL02094, 05LR01187, 05LW00116, 05LX03933, 05M26468,
05M30507, 05M31934, 05M37665, 05N05084, 05R48801, 05R54579,
05R57265, 05S71698, 05V27826, 05W00006, 05W00732, 05W89379,
05W91230, 05W93282, 05W96202, 05W96561, 05W98611, 05W99579,
05X58997, 05Y47046, 05Y55013, 05Z27890, 05Z29621, 27FC00420,
27FC01497, 27FC02632, 27FC04949, 27FC07052, 27FC09269,
27FC10684, 27FC13367, 27FC17678, 27FC18294, 27FC19091,
27FC20262, 27S00903, 27S09181, 27S12659, 27Y00580, 27Y00724,
27Y07932, 27Y08198, 27Y08235, 27Y09026, 27Y10611, 27Y11357,
27Y14005, 27Y14364, 27Y14609, 27Y17509, 27Y23431, 29GP01729,
29KV01896, 29KV02726, 53FL06417, 53FQ01819, 53FR00127,
53FX06200, 53GH14908, 53GH21871, 53GJ11274, 53GJ11778,
53GJ12181, 53GJ18447, 53GJ19452, 53GJ19793, 53GJ21264,
53GJ22381, 53GJ23113, 53GJ23861, 53GJ24775, 53GL11054,
53GL11593, 53GL17737, 53GL19376, 53GL21140, 53GL29589,
53GL30799, 53GL36985, 53GL38037, 53GL40348, 53GL40369,
53GN11044, 53GN11983, 53GN17107, 53GN20188, 53GN26016,
53GN31203, 53GN36750, 53GN36916, 53GN37513, 53GN40557,
53GN43945, 53GV04924, 53GZ19491, 53GZ20593, 53GZ24345,
53GZ27320, 53GZ28034, 53GZ28386, 53GZ31024, 53GZ39061,
53K90081, 53KF16984, 53KF17086, 53KF19113, 53KF32164,
53KF32812, 53KF33047, 53KF34229, 53KF36682, 53KL32714,
53KL33659, 53KL35318, 53KL37854, 53KL39296, 53KL39618,
53KL45461, 53KN14119, 53KN14776, 53KN15073, 53KN15474,
-10- 53KN16547, 53KN18342, 53KN18806, 53KN20409, 53KN20560,
53KN21027, 53KN22183, 53KN24380, 53KN31071, 53KN34784,
53KQ12609, 53KQ16936, 53KQ23968, 53KQ27541, 53KQ29357,
53KQ32110, 53KQ35153, 53KQ35485, 53KQ37089, 53KQ38192,
53KQ39863, 53KQ41372, 53KQ43543, 53KQ45093, 53KR13098,
53KR19684, 53KR22013, 53KR30723, 53KS11595, 53KS14823,
53KS19115, 53KS28007, 53KT06253, 53KT09629, 53KT09907,
53KT11592, 53KT13219, 53KT14564, 53KT15969, 53KT18730,
53KT19995, 53KT24990, 53KT28336, 53KT29263, 53KT31324,
53KT33031, 53KT34826, 53KT35084, 53KT36048, 53KT37430,
53KT38251, 53KW11976, 53KW20399, 53KW20540, 53KW21107,
53KW24708, 53KX06216, 53KX08997, 53KX09479, 53KX21104,
53KY19707, 53KY20508, 53KY20645, 53KY22808, 53KY24984,
53KY31838, 53KY39810, 53KY45347, 53KZ08745, 53KZ18168,
53KZ19406, 53KZ19794, 53KZ25516, 53KZ28514, 53L18678,
53L78378, 53LE12098, 53LE12856, 53NQ29357, 53R65441,
53R87445, and 53Y10903
(c) Red Blood Cells, Washed, One unit: 53GN22233
(d) Platelets, 54 units: 05C00419, 05C96771, 05C98499,
05F54963, 05G45372, 05J52842, 05J66158, 05L42918, 05M30507,
05M31934, 05R54579, 05R57265, 05Y52441, 05Z14968, 29FN10671,
53FQ01819, 53GL11593, 53GL21140, 53GL38037, 53GL40348,
53GL40369, 53GN17107, 53GN37513, 53K90081, 53KF16984,
53KF19113, 53KF32812, 53KF34229, 53KF36682, 53KL39296,
53KQ18451, 53KQ20667, 53KQ23968, 53KQ37089, 53KQ39863,
53KQ41372, 53KQ43543, 53KT09629, 53KT14564, 53KT15969,
53KT19995, 53KT31324, 53KT33031, 53KT34826, 53KT35084,
53KT37430, 53KY39810, 53KZ28803, 53LE12856, 53LT23854,
53LT25203, 53R65441, 53R87445, and 53Y10903
(e) Platelets, Pheresis, 62 units: 05P20587, 05P24648,
05P24999, 05P25074, 05P25569, 05P25838, 05P26031, 05P26452,
05P27828, 05P28603, 05P28653, 05P29117, 05P29567, 05P29608,
05P30021, 05P30201, 05P30499, 05P30531, 05P30984, 05P31316,
05P31529, 05P31966, 53LT11288, 53LT11488, 53LT11739,
53LT11960, 53LT12337, 53LT13033, 53LT13068, 53LT13761,
53LT13851, 53LT13945, 53LT14767, 53LT15708, 53LT16176,
53LT16307, 53LT16859, 53LT17221, 53LT17917, 53LT18613,
53LT18938, 53LT18948, 53LT19198, 53LT19436, 53LT19873,
53LT20119, 53LT20948, 53LT21422, 53LT21641, 53LT22141,
53LT22892, 53LT22967, 53LT23052, 53LT23418, 53LT23956,
53LT24218, 53LT24845, 53LT25225, 53LT25444, 53LT25672,
53LT26325, and 53LT26443
(f) Cryoprecipitated AHF, Seven units: 05C92467, 05J63348,
05M37665, 05Z24482, 53GJ21264, 53GN36916, and 53KS30905
(g) Granulocyte, Pheresis, Five units: 05P20812, 05P21518,
05P29195, 05P32053, and 53LT14429
(h) Fresh Frozen Plasma, 10 units: 05F43059, 05F53412,
05G68195, 05J52842, 05J59165, 05J66158, 05L42918, 05M31934,
05R48801, and 27FC04949
(i) Plasma, 42 units: 53FL06417, 53GJ19113, 53GJ19793,
53GJ22381, 53GJ27721, 53GL11593, 53GL17737, 53GL30799,
53GL32175, 53GL40348, 53GL40369, 53GN17107, 53GN26016,
-11- 53GN40557, 53GZ19491, 53GZ27320, 53GZ28386, 53GZ33732,
53KF32812, 53KL32714, 53KL35318, 53KL35810, 53KL39618,
53KN18964, 53KN21027, 53KN22183, 53KN34784, 53KQ18451,
53KQ29357, 53KQ38192, 53KQ39520, 53KS19115, 53KS28007,
53KT24990, 53KT28336, 53KT34826, 53KT38251, 53KX08997,
53KY39810, 53KZ18168, 53KZ28514, and 53R87445
(j) Leukocytes, One unit: 05G72842
(k) Whole Blood, For Further Manufacture, Three units:
05C95267, 05J55545, and 53KQ13178
(l) Red Blood Cells, For Further Manufacture, 12 units:
05J52842, 05J59165, 05L42918, 05X79914, 53FQ01251,
53GJ27721, 53GL32175, 53GZ33732, 53KQ20211, 53KQ20667,
53KQ25323, and 53KQ36604
(m) Platelets, Expired, Eight units: 05L38305, 53FR00127,
53GL19376, 53KQ20211, 53KQ25323, 53KW24708, 53KX21104, and
53KY20508
(n) Recovered Plasma, 241 units: 05C00419, 05C02521,
05C78813, 05C92467, 05C96771, 05C98499, 05F51990, 05F54963,
05FC02071, 05FC03395, 05FC04367, 05G45372, 05G67048,
05G72842, 05G73244, 05GH01920, 05GH02566, 05GL00325,
05GL04424, 05GV00640, 05GV02114, 05GZ04738, 05H66730,
05J63348, 05J66922, 05J67435, 05J68451, 05J69077, 05J72600,
05J73830, 05J74573, 05K71859, 05KE06070, 05KL10575,
05KL10888, 05KY08111, 05KY09948, 05L38305, 05L43093,
05L45612, 05L55195, 05LF00931, 05LJ00407, 05LJ10002,
05LL00137, 05LL01566, 05LL02094, 05LR01187, 05LW00116,
05LX03933, 05M30507, 05M37665, 05N01343, 05N05084, 05R54579,
05R57265, 05V26674, 05V27260, 05V27826, 05W00006, 05W00732,
05W87837, 05W93282, 05W96202, 05W98611, 05W99579, 05X58997,
05X70253, 05X79914, 05Y47046, 05Y55013, 05Z14968, 05Z24482,
05Z29621, 27FC00420, 27FC01497, 27FC02632, 27FC07052,
27FC09269, 27FC10684, 27FC13367, 27FC17678, 27FC18294,
27FC19091, 27FC20262, 27S00903, 27S09181, 27S12659,
27Y00580, 27Y00724, 27Y07932, 27Y08198, 27Y08235, 27Y09026,
27Y10611, 27Y11357, 27Y14005, 27Y14364, 27Y14609, 27Y16219,
27Y17509, 27Y23431, 29FN10671, 29GP01729, 29GP03509,
29KV01896, 29KV02726, 53FQ01819, 53FR00127, 53FX06200,
53GH14908, 53GH20798, 53GH21871, 53GJ11274, 53GJ11778,
53GJ12181, 53GJ17047, 53GJ18447, 53GJ19452, 53GJ21264,
53GJ23113, 53GJ23861, 53GJ24215, 53GJ24775, 53GL11054,
53GL19376, 53GL21140, 53GL29589, 53GL36985, 53GL38037,
53GN11044, 53GN11983, 53GN20188, 53GN22233, 53GN26756,
53GN31203, 53GN36750, 53GN36916, 53GN37513, 53GN43945,
53GV04924, 53GV05970, 53GV06592, 53GZ17041, 53GZ20593,
53GZ24345, 53GZ28034, 53GZ31024, 53GZ39061, 53K90081,
53KF16984, 53KF17086, 53KF19113, 53KF32164, 53KF33047,
53KF34229, 53KF36682, 53KL33659, 53KL37854, 53KL39296,
53KL45461, 53KN14119, 53KN15073, 53KN15351, 53KN15474,
53KN16547, 53KN18342, 53KN18806, 53KN20409, 53KN20560,
53KN24380, 53KN31071, 53KQ12609, 53KQ16936, 53KQ20667,
53KQ23968, 53KQ25323, 53KQ27541, 53KQ32110, 53KQ35153,
53KQ35485, 53KQ36604, 53KQ37089, 53KQ39863, 53KQ41372,
-12- 53KQ45093, 53KR13098, 53KR19684, 53KR22013, 53KR30723,
53KS11595, 53KS14823, 53KT06253, 53KT09629, 53KT09907,
53KT11592, 53KT13219, 53KT14564, 53KT15969, 53KT18730,
53KT19995, 53KT29263, 53KT31324, 53KT33031, 53KT35084,
53KT36048, 53KT37430, 53KW11976, 53KW17146, 53KW17410,
53KW20251, 53KW20399, 53KW20540, 53KW21107, 53KW24708,
53KX06216, 53KX09479, 53KX21104, 53KY17022, 53KY19707,
53KY20508, 53KY20645, 53KY22808, 53KY24984, 53KY30637,
53KY31838, 53KY45347, 53KZ08745, 53KZ16745, 53KZ19406,
53KZ19794, 53KZ25516, 53KZ28803, 53L18678, 53L78378,
53LE12098, 53LE12856, 53LZ00250, 53LZ02901, 53R65441,
53Y10903.
MANUFACTURER The American National Red Cross, Washington, D.C.
RECALLED BY The American National Red Cross, Baltimore, Maryland, by
letters dated from August 5, 1991 through September 13,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 6 units; (b) 253 units; (c) 1 unit; (d) 54 units; (e) 62
units; (f) 7 units; (g) 5 units; (h) 10 units; (i) 42 units;
(j) 1 unit; (k) 3 units; (l) 12 units; (m) 8 units;
(n) 241 units.
REASON Blood products which tested non-reactive for the antibody to
the human immunodeficiency virus type 1 (anti-HIV-1), but
were collected rom donors who previously tested repeatedly
reactive for anti-HIV-1, were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Zephyr(tm) Flow Assisted Infusion Catheter, packed either as
a Catheter alone, or in a kit with a stylet:
Catheter w/8 cm distal Tip, Product #137103 (catheter only),
#537103 (kit w/stylet); Catheter w/12 cm distal tip, Product
#137101 (catheter only), #537101 (kit w/stylet); Catheter
w/18 cm distal tip, Product #137102 (catheter only), #537102
(kit w/stylet). Recall #Z-445/446-5.
CODE Lot numbers: Lot numbers: R1042, R1133, R1136, R1137,
R1144, R1147, R1150, R1157, R1158, R11644, R1166, R1171,
R1173, R1177, P8737, P8776, P8767, P8799.
MANUFACTURER Target Therapeutics, Inc., San Jose, California.
RECALLED BY Manufacturer, by letter October 1, 1991. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 388 units were distributed; firm estimates none remains on
the market.
REASON Possible design problem and a need for more detailed
physician training in handling.
_______________
PRODUCT Incstar Varicella IgG Zoster Clin-Elisa Test Kit, Product
#4620, an in-vitro diagnostic test kit for detecting
antibodies in human serum to Varicella zoster virus.
Recall #Z-743-5.
-13- CODE Lot numbers: 042565, 322024, 372344, 382254, 402124,
412304, 422584, 452264, 462404.
MANUFACTURER Incstar Corporation, Stillwater, Minnesota.
RECALLED BY Manufacturer, by telephone February 21 and 22, 1995,
followed by letter February 23, 1995. Firm-initiated recall
complete.
DISTRIBUTION California, Massachusetts, Maryland, Nevada, New York,
England, Netherlands, Spain.
QUANTITY 59 kits were distributed.
REASON The kit indicated that assay results have found a greater
than expected number of negative results among patients
samples and that low positive samples could result in a
negative assay response.
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PRODUCT Beckman "PRI" Primidone Reagent Kit, used for the
quantitative determination of Primidone in human serum.
Recall #Z-748-5.
CODE Catalog #446730, lot #M402038, EXP 3/31/96.
MANUFACTURER Beckman Instruments, Inc., Carlsbad, California.
RECALLED BY Beckman Instruments, Inc., Brea, California, by letter
December 14, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Arizona, Arkansas, California, Nevada.
QUANTITY 23 kits were distributed.
REASON Due to an incorrect conversion factor on the reagent card,
the test results are incorrect.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
________________
PRODUCT Oxacillin on Microscan Dried Gram Positive MIC and Dried
Positive Combo Panels, specifically, including catalog
numbers: Dried Gram Positive Combo Type 6, Catalog #B1017-
60; Dried Gram Positive Breakpoint Combo Type 6, Catalog
#B1017-61, Dried Gram Positive MIC Type 6, Catalog #B1017-
62; Dried Gram Positive MIC Type 8, Catalog #B1017-90;
International products and Catalog numbers:
Dried Gram Positive Combo Type 1C Catalog #J1016-39C; Dried
Gram Positive Breakpoint Combo Type 1J, Catalog #J1016-29A;
Dried Gram Positive Combo Type 2J, Catalog #J1016-30A; Dried
Gram Positive Combo Type 4I, Catalog #B1016-23A; Dried Gram
Positive Combo Type 3I, Catalog #B1016-27A; Dried Gram
Positive Breakpoint Combo Type 2I, Catalog #B1016-30A.
Recall #Z-744/747-5.
CODE (a) All Dried Positive MIC Dried Positive Combo, and Dried
Positive Breakpoint Combo, Lot numbers: 19NOV95 through
10MAR96; (b) Positive Combo Type 6, Lot numbers: 20OCT95B,
20OCT95C, 15JUL95B, 15JUL95C, 15JUL95D, 25JUL95B, 25JUL95C,
25JUL95D, 28OCT95B, 28OCT95C, 28OCT95D; (c) Positive MIC
Type 6, Lot numbers: 11AUG95B, 11AUG95C, 11AUG95D,
07DEC95B, 07DEC95C; (d) Positive Breakpoint Combo Type 6,
Lot numbers: 08AUG95B, 08AUG95C, 08AUG95D.
-14- MANUFACTURER Dade International MicroScan, Inc., West Sacramento,
California.
RECALLED BY Manufacturer, by letter March 21, 1995. Firm-initiated
field correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 1.6 million panels were distributed.
REASON The instructions to add a raw material (Cations) were
inadvertently deleted. As a result of this, the Oxacillin
broth in the affected lots contains an insufficient quantity
of cations resulting in lighter growth of the organism.
This deficiency resulted in an increased frequency of
out-of- range Quality Control with Enterococcus faecalis
ATCC 29212 and potentially lower MIC's with clinical
isolates of Staphylococci.
_______________
PRODUCT Custom packed NMC Diala Kits for use in Dialysis Treatments:
(a) Product Code, NMC-97-4952-00;
(b) Product Code, NMC-97-7831-00;
(c) Product Code, NMC-97-8020-00;
(d) Product Code, NMC-98-8006-00;
(e) Product Code, NMC-97-0370-00. Recall #Z-760\764-5.
CODE Lot Numbers: (a) 94085434; (b) 94095333; (c) 94100999,
94113427, 9480001; (d) 94116132; (e) 94085321.
MANUFACTURER Sterile Design SW, Division of Maxxim Medical, Stafford,
Texas.
RECALLED BY Sterile Design, Division of Maxxim Medical, Clearwater,
Florida, by letters of March 23, 1995, and April 19, 1995.
Firm-initiated recall complete.
DISTRIBUTION California, New Jersey, Ohio, Hawaii, New York, Indiana.
QUANTITY 150 cases of 12 kits and 679 cases of 24 kits were
distributed.
REASON An unknown number of cases of Diala Kits custom packed for
specific hospitals may have been sent to the wrong
hospitals.
-15-
END OF ENFORCEMENT REPORT FOR MAY 24, 1995. BLANK PAGES MAY FOLLOW.