FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration,
U.S. Public Health Service, Department of Health and Human Services. It contains
information
on actions taken in connection with agency regulatory activities.
ENFORCE
04/07/1994
Recalls and Field Corrections: Drugs -- Class I -- 04/07/1994
April 7, 1993 93-14
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
_______________
PRODUCT Magna-Bon brand (a) Antiseptic Cream; (b) Facial Cream;
(c) Burn Spray; (d) Magnum Strength; (e) Medium Strength;
(f) Mild Strength, all sizes. Recall #D-192/197-3.
CODE All lots.
MANUFACTURER Magna-Bon Corporation, Okeechobee, Florida.
RECALLED BY Manufacturer, by letter March 15 & 16, 1993. FDA requested
recall ongoing.
DISTRIBUTION Florida, California, Connecticut, Michigan, Tennessee,
Texas, Virginia.
QUANTITY Undetermined.
REASON The products were marketed without new drug approval and
very low pH.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________
PRODUCT Dilantin (Extended Phenytoin Sodium Capsules, USP)
Kapseals, 100 mg, in bottles of 1000, for control of
seizures. Recall #D-191-3.
CODE Lot numbers: 01021 FA, 03691 FA, 03891 FA.
MANUFACTURER Warner Lambert, Inc., Fajardo, Puerto Rico.
RECALLED BY Parke Davis, Division of Warner Lambert Company, Morris
Plains, New Jersey, by letter February 12, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 12,105 units were distributed.
REASON Product does not met dissolution specifications.
_______________
PRODUCT Furosemide Tablets USP, 80 mg, packaged in 10 tablet
blister packs, a diuretic. Recall #D-200-3.
CODE Lot #911394 EXP 11/1/93.
MANUFACTURER Roxane Laboratories, Inc., Columbus, Ohio.
RECALLED BY Manufacturer, by letter March 24, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 9,640 cartons of 10 blister packs were distributed.
REASON Product does not meet dissolution specifications.
_______________
PRODUCT Urocit-K Potassium Citrate, in bottles of 100, a Rx drug
for the prevention of nephrolithiasis (kidney stone
formation). Recall #-201-3.
CODE Lot #230795 EXP0795.
MANUFACTURER Mission Pharmacal Company, San Antonio, Texas.
RECALLED BY Manufacturer, by telephone February 22, 1993, followed by
visit, and by letter March 19, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,867 bottles were distributed; firm estimates none remains
on the market.
REASON Product does not meet dissolution specifications.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________
PRODUCT Sinubid Extended Release Tablets, in bottles of 100, a Rx
analgesic/decongestant/antihistamine. Recall #D-190-3.
CODE Lot numbers: 236DOD EXP 12/93, 27821D EXP 3/94,
40471D EXP 7/94.
MANUFACTURER Parke-Davis Division, Warner Lambert Company, Morris
Plains, New Jersey.
RECALLED BY Manufacturer, by letter November 6, 1992. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 8,616 bottles of lot 236DOD, 8,997 bottles of lot 27821D,
and 8,935 bottles of lot 40471D were distributed.
REASON Product does not meet dissolution specifications through
expiration date.
_______________
PRODUCT Rx oral cough/cold liquids: ( a) Promethazine VC Plain
Syrup (Promethazine Hydrochloride 6.25 mg/5 ml &
Phenylephrine Hydrochloride 5 mg/5 ml), for the temporary
relief of upper respiratory symptoms including nasal
-2- congestion associated with allergy or the common cold,
packaged under the following labels:
(i) PBI, Manufactured by Pharmaceutical Basics, Inc., in 4
fluid ounce bottles, in 1 pint bottles, and in 1 gallon
bottles;
(ii) GG, distributed by Geneva Pharmaceuticals, Inc.,
manufactured by Pharmaceutical Basics, Inc., in 4 fluid
ounce bottles and 1 pint bottles;
(iii) Major, manufactured by: Pharmaceutical Basics, Inc.,
for Major Pharmaceuticals Corp., (distributor), in 4 fluid
ounce bottles, 1 pint bottles, and in 1 gallon bottles;
(iv) Rugby, manufactured for Rugby Laboratories, Inc.,
manufactured by Pharmaceutical Basics, Inc., in 4 fluid
ounce bottles, 1 pint bottles and in 1 gallon bottles;
(b) Promethazine with Dextromethorphan Cough Syrup
(Promethazine Hydrochloride 6.25 mg/5 ml & Dextromethorphan
Hydrobromide 15 mg/5 ml), for the temporary relief of
coughs and upper respiratory symptoms associated with
allergy or the common cold, packaged in 1 pint bottles
under the following labels:
(i) PBI, manufactured by Pharmaceutical Basics, Inc.,
(ii) GG Promethazine DM Cough Syrup, disttributed by Geneva
Pharmaceuticals, Inc., manufactured by Pharmaceutical
Basics, Inc.
(iii) Major, manufactured by: Pharmaceutical Basics, Inc.,
for Major Pharmaceuticals Corp. (distributor);
(iv) Rugby Promethazine DM Cough Syrup, manufactured for
Rugby Laboratories, Inc., manufactured by Pharmaceutical
Basics, Inc. Recall #D-198/199-3.
CODE (a) Lot #19275, EXP 07/93; (b) lot #19265, EXP 07/93.
MANUFACTURER Pharmaceutical Basics, Inc., Morton Grove, Illinois.
RECALLED BY Manufacturer, by letter March 23, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 8,640 4-ounce, 20,712 16-ounce, and 384 1-gallon
bottles; (b) 15,295 16-ounce bottles were distributed.
REASON Products are subpotent for the promethazine ingredient.
_______________
PRODUCT Oxygen USP, in sizes D, Dey, E, F, GP45, J, K, and or MVE
cylinders. Recall #D-202-3.
CODE Lot numbers: 2309, 3032, 3033, 3034, 3035, 3036, 3039,
3041.
MANUFACTURER Capital Medical Supply, Division of Capital Welding Supply
Company, Inc., Little Rock, Arkansas.
RECALLED BY Manufacturer, by letter February 18, 1993 for lot 2309 and
a separate letter for the remainder of the lots. Firm-
initiated recall ongoing.
DISTRIBUTION Arkansas, Mississippi.
QUANTITY 361 cylinders were distributed.
REASON Current good manufacturing practice deficiencies.
-3- RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Platelets;
(d) Cryoprecipitated AHF; (e) Fresh Frozen Plasma;
(f) Red Blood Cells for Further Manufacture;
(g) Platelets for Further Manufacture;
(h) Source Leukocytes;
(i) Recovered Plasma, Pooled;
(j) Recovered Serum, Pooled;
(k) Recovered Plasma. Recall #B-166/176-3.
CODE (a) Whole Blood, units 31C65027, 31E24927, 31E50698,
31E78349, 31T09375, 31T81854, 31W21093, 31W22185, 31W23129,
31W24876;
(b) Red Blood Cells, units 31C00668, 31C02225, 31C06012,
31C11964, 31C15276, 31C22821, 31C29942, 31C50888, 31C52859,
31C54850, 31C55342, 31C57798, 31C59199, 31C59455, 31C67073,
31C68888, 31C70397, 31C71701, 31C76429, 31C77011, 31C79816,
31C83817, 31C88802, 31C90095, 31C91206, 31C92831, 31E00874,
31E02065, 31E02068, 31E02756, 31E03413, 31E06101, 31E07538,
31E09594, 31E16750, 31E16779, 31E18674, 31E21092, 31E22365,
31E32295, 31E33326, 31E35234, 31E41470, 31E44405, 31E47495,
31E62457, 31E64560, 31E66530, 31E71428, 31E91227, 31F75427,
31F90533, 31G00384, 31G01388, 31G04015, 31G07826, 31G08986,
31G29391, 31G98774, 31GC00533, 31GC07151, 31GC14813,
31GC92102, 31GE07253, 31H19250, 31H43092, 31H60311,
31H81223, 31H85711, 31H89532, 31K04082, 31K06857, 31K09444,
31K34197, 31K38898, 31K41517, 31K46785, 31K86263, 31L41850,
31L42296, 31L47191, 31L47484, 31L50795, 31L69979, 31M50051,
31M52113, 31M53244, 31M53986, 31M55072, 31M59326, 31M63579,
31M79016, 31N00535, 31N03232, 31N04486, 31N08559, 31N15962,
31N21094, 31N22101, 31N22458, 31N24671, 31N30098, 31N32358,
31N41075, 31Q02515, 31Q03496, 31Q04429, 31Q05303, 31R00273,
31R40771, 31R40957, 31R44321, 31R49493, 31R55510, 31R57852,
31R66199, 31R68841, 31R77435, 31R87982, 31R94241, 31S06776,
31S08394, 31S17369, 31S26837, 31S60658, 31S62888, 31S65542,
31S67967, 31S78177, 31S80071, 31S82835, 31S84548, 31S90313,
31S92245, 31S94348, 31T00057, 31T02296, 31T07712, 31T11086,
31T23146, 31T27838, 31T29974, 31T34114, 31T39515, 31T42326,
31T51054, 31T52882, 31T56410, 31T60595, 31T63005, 31T64918,
31T71708, 31T72223, 31T75519, 31T75860, 31T83936, 31T86351,
31T87549, 31T88418, 31T91732, 31T97341, 31W17692, 31W18220,
31W18875, 31W20620, 31W24140, 31W25906, 31W27589, 31W34979,
31W38761, 31W40313, 31W50104, 31W56981, 31W59756, 31W60862,
31W62065, 31W62926, 31W63623, 31W66710, 31W66958, 31W68256,
31W69968, 31X09228, 31X10261, 31Y12132, 31Y17476, 31Y31953,
31Y41861, 31Y44208, 31Y48493;
(c) Platelets, units 31C00668, 31C02225, 31C06012,
31C11964, 31C15276, 31C22821, 31C29942, 31C70397, 31C71701,
31C76429, 31C77011, 31C79816, 31C83817, 31C88802, 31C90095,
31C91206, 31E03413, 31E07538, 31E16750, 31E18674, 31E22365,
-4- 31E32295, 31E33326, 31E41470, 31E44405, 31E47495, 31E62457,
31E66530, 31E86522, 31E91227, 31F90533, 31GC00533,
31GC07151, 31GC92102, 31GE07253, 31K06857, 31K34197,
31L69979, 31L73724, 31M59326, 31M63579, 31M79016, 31N00535,
31N04486, 31N08559, 31N15962, 31N21094, 31N22101, 31N22458,
31N30098, 31N32358, 31N41075, 31Q02515, 31Q03496, 31Q05303,
31Q06494, 31R66199, 31R77435, 31R87982, 31R94241, 31S06776,
31S08394, 31S26837, 31S30658, 31S82835, 31S90313, 31S92245,
31S94348, 31T00057, 31T07712, 31T11086, 31T27838, 31T34114,
31T39515, 31T42326, 31T52882, 31T60595, 31T63005, 31T64918,
31T71708, 31T72223, 31T87549, 31T88418, 31T91732, 31W40313,
31W59756, 31W60862, 31W62065, 31W62926, 31W63623, 31W66710,
31W66958, 31W68256, 31W69968, 31X09228, 31X10261, 31Y31953,
31Y41861;
(d) Cryoprecipitated AHF, units 31C02225, 31C15276,
31C22821, 31C29942, 31C52859, 31C59455, 31C67073, 31C68888,
31C91206, 31C92831, 31E00874, 31E02065, 31E02756, 31E06101,
31E16779, 31E32295, 31E35234, 31E62457, 31E64560, 31F75427,
31GC14813, 31GE07253, 31H19250, 31H60311, 31K04082,
31K34197, 31M52113, 31M53244, 31M55072, 31M79016, 31N21094,
31N22458, 31N41075, 31Q02515, 31Q03496, 31R00273, 31R41493,
31R55510, 31R77435, 31S06776, 31S26837, 31S65542, 31S67967,
31S78177, 31T00057, 31T02296, 31T11086, 31T29974, 31T72223,
31T75519, 31T97341, 31W18220, 31W18875, 31W24140, 31W25906,
31W27589, 31W62065, 31W66710, 31W68256, 31Y17476, 31Y31953;
(e) Fresh Frozen Plasma, units 31C57798, 31C59199,
31C79816, 31E09594, 31E33326, 31E66530, 31G04015, 31L42296,
31L47484, 31M59326, 31N22101, 31N24671, 31Q05303, 31S62888,
31T07712, 31T42326, 31T86351, 31T91732, 31W40313, 31W56981,
31W59756, 31W60862, 31W69968;
(f) Red Blood Cells for Further Manufacture, units
31R41493, 31E82094, 31E86522, 31T25353;
(g)Platelets for Further Manufacture, units 31H60311,
31T51054, 31T56410, 31T83936, 31T86351, 31E71428, 31S17369,
31W38761, 31Y12132;
(h) Source Leukocytes, units 31C55342, 31E21092, 31E33326,
31GC14813, 31L47191, 31N03232, 31T25353;
(i) Recovered Plasma, Pooled, pools 89RB0505-1, 89RB1505-1,
91RB1401-1;
(j) Recovered Serum, Pooled, pools 85RB0912-2, 85RB2211-1,
85RB2911-1, 86RB0112-1, 86RB0206-1, 86RB0209-1, 86RB0310-1,
86RB0312-1, 86RB0512-1, 86RB0602-1, 86RB0605-1, 86RB0705-1,
86RB0804-1, 86RB0906-2, 86RB0907-1, 86RB1011-1, 86RB1205-2,
86RB1301-1, 86RB1310-1, 86RB1403-1, 86RB1507-1, 86RB1606-1,
86RB1808-1, 86RB2003-1, 86RB2105-1, 86RB2107-1, 86RB2107-2,
86RB2209-1, 86RB2305-1, 86RB2603-1, 86RB2703-1, 86RB2706-1,
86RB2808-1, 86RB3001-1, 87RB0201-1, 87RB0202-1, 87RB0207-1,
87RB0306-1, 87RB1008-1, 87RB1105-1, 87RB1210-1, 87RB1301-1,
87RB1307-2, 87RB1409-1, 87RB1512-1, 87RB1601-1, 87RB1809-2,
87RB2311-1, 87RB2412-1, 87RB2703-1, 87RB2801-1, 87RB2807-2,
87RB2809-1, 87RB2906-1, 87RB3010-1, 87RB3011-1, 87RB3011-2,
-5- 87RB3103-1, 87RB3103-1, 88RB0102-1, 88RB0104-1, 88RB0202-1,
88RB0212-1, 88RB0411-1, 88RB0505-1, 88RB0808-1, 88RB1008-1,
88RB1104-1, 88RB1110-1, 88RB1504-1, 88RB1506-1, 88RB1606-1,
88RB2012-1, 88RB2111-1, 88RB2204-1, 88RB2403-1, 88RB2508-1,
88RB2602-1, 88RB2706-1, 88RB2706-1, 88RB2708-1, 88RB2803-2,
88RB2908-1, 88RB2912-1, 88RB3012-1, 89RB0411-1, 89RB0411-1,
89RB0505-1, 89RB0602-2, 89RB0607-1, 89RB0607-1, 89RB0812-1,
89RB1003-1, 89RB1305-1, 89RB1407-1, 89RB2206-1, 89RB2606-1,
90RB03005 , 90RB03017 , 90RB0401-1, 90RB0607-1, 90RB1110-1,
90RB1301-1, 90RB1508-1, 90RB1606-1, 90RB1607-1, 90RB1710-1,
90RB1901-1, 90RB2108-1, 90RB2301-1, 90RB2306-1, 90RB2306-1,
91RB03006, 91RB03012, 91RB03035, 91RB03036, 91RB03058,
91RB03065, 91RB03079, 91RB03085, 91RB03087, 91RB03103,
91RB03116, 91RB03117, 91RB03120, 91RB03138, 91RB03146,
91RB03153, 91RB03161, 91RB03161, 91RB03167, 91RB03183,
91RB03187, 91RB03188, 92RB3035, 92RB3040, 92RB3050,
92RB3051, 92RB3077, 92RB3417, 92RB3424;
(k) Recovered Plasma, units 31C00668, 31C02225, 31C06012,
31C11964, 31C15276, 31C22821, 31C29942, 31C50888, 31C52859,
31C54850, 31C55342, 31C59455, 31C67073, 31C68888, 31C70397,
31C71701, 31C76429, 31C77011, 31C83817, 31C88802, 31C90095,
31C91206, 31C92831, 31E00874, 31E02065, 31E02068, 31E02756,
31E03413, 31E06101, 31E07538, 31E16750, 31E16779, 31E18674,
31E21092, 31E22365, 31E32295, 31E35234, 31E41470, 31E44405,
31E47495, 31E62457, 31E64560, 31E71428, 31E82094, 31E91227,
31F75427, 31F90533, 31G00384, 31G01388, 31G07826, 31G08986,
31G29391, 31G98741, 31G98774, 31GC00533, 31GC07151,
31GC14813, 31GC92102, 31GE07253, 31H19250, 31H43092,
31H60311, 31H81223, 31H85711, 31H89532, 31K04082, 31K06857,
31K09444, 31K34197, 31K38898, 31K41517, 31K46785, 31K86263,
31L41850, 31L47191, 31L69979, 31L73724, 31M50051, 31M52113,
31M53244, 31M53986, 31M55072, 31M63579, 31M79016, 31N00535,
31N03232, 31N04486, 31N08559, 31N15962, 31N21094, 31N22458,
31N30098, 31N32358, 31N41075, 31Q02515, 31Q03496, 31R00273,
31R41493, 31R44321, 31R49493, 31R55510, 31R57852, 31R66199,
31R68841, 31R77435, 31R87982, 31R94241, 31S06776, 31S08394,
31S17369, 31S26837, 31S30658, 31S65542, 31S67967, 31S78177,
31S84548, 31S90313, 31S92245, 31S94348, 31T00057, 31T02296,
31T11086, 31T23146, 31T25353, 31T27838, 31T29974, 31T34114,
31T39515, 31T51054, 31T52882, 31T56410, 31T60595, 31T63005,
31T64918, 31T71708, 31T72223, 31T75519, 31T75860, 31T83936,
31T87549, 31T97341, 31W17692, 31W18220, 31W18875, 31W20620,
31W24140, 31W25906, 31W27589, 31W34979, 31W38761, 31W50104,
31W62065, 31W62926, 31W63623, 31W66710, 31W66958, 31W68256,
31X09228, 31X10261, 31Y12132, 31Y17476, 31Y31953, 31Y41861,
31Y44208, 31Y48493.
MANUFACTURER American Red Cross Blood Services, Buffalo, New York.
RECALLED BY Manufacturer, by telephone between August 19 and 21, 1992,
and by letters between August 12, 1992 and September 25,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Alabama, California, Connecticut, Georgia, Kentucky,
Maryland, Massachusetts, Minnesota, New Jersey, New York,
-6- North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania,
Puerto Rico, Rhode Island, South Carolina, Tennessee,
Texas, and the District of Columbia, Illinois, Switzerland.
QUANTITY (a) 10; (b) 190; (c) 98; (d) 61; (e) 23; (f) 4; (g) 9;
(h) 7; (i) 3; (j) 141; (k) 165 units.
REASON Blood products, which either tested repeatedly reactive for
the 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) Platelets; (c) Platelets,
Pheresis; (d) Cryoprecipitated AHF; (e) Fresh Frozen
Plasma; (f) Red Blood Cells for Further Manufacture; (g)
Platelets for Further Manufacture; (h) Recovered Plasma.
Recall #B-185/192-3.
CODES (a) Red Blood Cells: 31E02532, 31G01166, 31H66963,
31H69439, 31H73930, 31T25660, 31T28216, 31T31484, 31T33879,
31T41724, 31T50613, 31T52089, 31T53993, 31T55867, 31T59473,
31T61789, 31T67216, 31T72539, 31T83620, 31Y00082;
(b) Platelets: 31T33879, 31T50613, 31T52089, 31T53993,
31T55867, 31T61789, 31T67216, 31T72539;
(c) Platelets Pheresis: 31P24506, 31P24661, 31P24729,
31P25380, 31P25664, 31P25855, 31P25989, 31P26135, 31P26345,
31P26575, 31P26790, 31P27033, 31P27280;
(d) Cryoprecipitated AHF: 31H73930, 31T31484, 31T72539;
(e) Fresh Frozen Plasma: 31H66963, 31T25660, 31T28216,
31T33879, 31T61789, 31T67216;
(f) Red Blood Cells for Further Manufacture: 31H66707,
31R38495;
(g) Platelets for Further Manufacture: 31T59473;
(h) Recovered Plasma: 31H69439, 31H73930, 31R38495,
31T31484, 31T41724, 31T50613, 31T52089, 31T53993, 31T55867,
31T59473, 31T72539, 31T83620, 31Y00082.
MANUFACTURER American Red Cross Blood Services, Buffalo, New York.
RECALLED BY Manufacturer, by letters dated January 14, 15, 18 and 20,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, California, Kansas, Montana, Maryland,
Massachusetts, Illinois, New York, Switzerland.
QUANTITY (a) 20 units; (b) 8 units; (c) 13 units; (d) 3 units;
(e) 6 units; (f) 2 units; (g) 1 unit; (h) 13 units.
REASON Blood products, which either: 1) tested repeatedly reactive
for the antibody to the human immunodeficiency virus type 1
(anti-HIV-1); 2) tested initially reactive for anti-HIV-1;
or 3) tested negative for anti-HIV-1, but were collected
from donors who previously tested initially reactive for
anti-HIV-1, were distributed.
-7-
_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma; (c) Recovered
Plasma. Recall #B-198/200-3.
CODE Unit numbers: (a) 58F28564, 58F63355; (b) 58F63355; (c)
58F28564.
MANUFACTURER American National Red Cross, North Charleston, South
Carolina.
RECALLED BY Manufacturer, by letters dated February 10, 1992 to April
13, 1992. Firm-initiated recall ongoing.
DISTRIBUTION South Carolina, California.
QUANTITY (a) 2 units; (b) 1 unit; (c) 1 unit.
REASON Blood products, which tested negative 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) Red Blood Cells; (b) Red Blood Cells, Expired;
(c) Platelets; (d) Fresh Frozen Plasma;
(e) Recovered Plasma. Recall #B-202/205-3.
CODE Unit numbers: 58F67130, 58H72400, 58K21236, 58K23277,
58L03834; (b) 58L00105, (c) 58F67130, 58K21236, 58K23277,
58L00105; (d) 58F67130, 58H72400; (e) 58L00105.
MANUFACTURER American National Red Cross, North Charleston, South
Carolina.
RECALLED BY Manufacturer, by letters dated from February 10, 1992, to
April 13, 1992. Firm-initiated recall ongoing.
DISTRIBUTION California.
QUANTITY (a) 5 units; (b) 1 unit; (c) 4 units; (d) 2 units (e) 1
unit.
REASON Blood products, collected from donors who previously tested
repeatedly reactive for anti-HIV-1, were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________
PRODUCT HiMark 400 and W624C Trimming System, used for industrial
marking and trimming of circuit components.
Recall #Z-317-3.
CODE Serial numbers: Undetermined.
MANUFACTURER General Scanning, TLSI Division, Somerville, Massachusetts.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan February 9, 1993. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 87 HiMark and 4 Trimming units were distributed.
-8- REASON Noncompliance with the performance standards for laser
products in that indication of emission at the laser head
was not provided and disruption of emission via the remote
interlock connector failed to engage the logic of the
manual reset feature.
_______________
PRODUCT Internal Defibrillator Paddles for use with the CodeMaster
family of Defibrillators: (a) Part #M1741A (option C15);
(b) Part #M1742A (option C16); (c) Part #M1743A (option
C17); (d) Part M1744A (option C18). Recall #Z-399/402-3.
CODE All code numbers 8/92 and earlier.
MANUFACTURER Hewlett Packard Company, McMinnville, Oregon.
RECALLED BY Manufacturer, by letter December 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 212 sets; (b) 225 sets; (c) 126 sets; (d) 122 sets were
distributed.
REASON Black enamel coating on the paddle spoon and stem may
blister and flake off during use.
_______________
PRODUCT Ceiling Suspension Systems used to support three or four
monitors for fluoroscopic x-ray systems, Models 9807 607
50009, 9807 607 4009. Recall #Z-403/404-3.
CODE Serial numbers: Undetermined.
MANUFACTURER Philips Medical Systems, North America Company, Nederland
B.V., Best, Netherlands.
RECALLED BY Philips Medical Systems, North America Company, Shelton,
Connecticut by visit. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 175 units subject to field correction.
REASON The nut making the connection between the central column
and the yoke may become loose and allow part of the ceiling
suspension, including the monitors to fall.
_______________
PRODUCT Ultramark 9 High Definition Imaging (UM 9HDI) Diagnostic
Ultrasound System, an integrated ultrasound system for
cardiac, obstetric, and vascular imaging. Recall #Z-407-3.
CODE All units with software versions 8.75 and 8.79.
MANUFACTURER Advanced Technology Laboratories, Inc., Bothell,
Washington.
RECALLED BY Manufacturer, by letter November 12, 1992. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 904 units were distributed.
REASON The Doppler velocity scale may not automatically reset to
the correct level when a new application preset from the
application specific menu is selected.
-9- _______________
PRODUCT Jay Active Back Wheelchair Cushion. Recall #Z-408-3.
CODE 12/15/90 (date of manufacture).
MANUFACTURER Jay Medical Ltd., Boulder, Colorado.
RECALLED BY Manufacturer, by letter January 29, 1990. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 227 units were distributed; firm estimates none remains on
the market.
REASON The plastic wings that fasten the back support to the frame
of the wheelchair can fracture, causing the back to
separate from the chair.
_______________
PRODUCT Baylor Rapid Autologous Transfusion (BRAT) System and Lid
Latch Spare Parts Kit, for use in autologous blood
salvaging, red cell concentration, and for washing of
salvaged blood for transfusion:
(a) Brat 150, Catalog Nos. 007100-000, 007100-010, 007100-
900; (b) BRAT 250, Catalog Nos. 007000-000, 007000-007,
007000-900; (c) BRAT 251, Catalog Nos. 007000-002, 007000-
003, 007000-004; (d) Lid Latch Spare Parts Kits, Catalog
No. 600845-000. Recall #Z-410/413-3.
CODE All 150, 250 and 251 machines manufactured prior to 1/21/93
and Lid Latch Spare Parts Kits, part #600845-000.
MANUFACTURER Cobe Cardiovascular, Inc., Arvada, Colorado.
RECALLED BY Manufacturer, by letter January 22, 1993. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 798 units were distributed.
REASON The centrifuge lid latch may fail to function, resulting in
the lid being forced open during use, causing broken bowl
parts and blood to be expelled from the centrifuge well.
_______________
PRODUCT Electrosurgical Pencils, used in surgery as a cutting and
coagulation device intended to remove tissue and control
bleeding by use of high frequency electrical current:
(a) Tech-Switch Catalog No. 9142N, Single-Use, Disposable.
Rockerswitch Electrosurgical Pencil with Flat Blade
Electrode;
(b) Tech-Switch Catalog No. 9144N, Single-Use, Disposable.
Rockerswitch Electrosurgical Pencil with Flat Blade
Electrode and Holder;
(c) Tech-Switch Catalog No. 9144NB,bulk, non-sterile;
(d) Tech-Switch Catalog No. 9162N, single-use, disposable,
buttonswitch electrosurgical pencil with flat blade
electrode;
(e) Tech-Switch Catalog No. 9164N, single-use, disposable.
Buttonswitch Electrosurgical Pencil with Flat Blade
Electrode and Holder;
-10- (f) Tech-Switch Catalog No. 9164NB, bulk, non-sterile;
(g) Tech-Switch Catalog No. 9165N; Single-Use, Disposable.
Buttonswitch Electrosurgical Pencil with Flat Blade
Electrode and Holder;
(h) Tech-Switch Catalog No. 9165NB, bulk, non-sterile;
(i) Tech-Switch Catalog No. 9174N, single-use, disposable.
Buttonswitch Electrosurgical Pencil with Needle Electrode
and Holder.
(j) Tech-Switch Catalog No. 9184, single-use, Disposable.
Buttonswitch Electrosurgical Pencil with Flat Blade
Electrode with Holder and Tip Cleaner;
(k) Tech-Switch Catalog No. 9189N, single-use, disposable.
Buttonswitch Electrosurgical Pencil with Flat Blade
Electrode. Fifteen-foot cord.
(l) Tech-Switch Catalog No. 9190N, single-use, disposable.
Buttonswitch Electrosurgical Pencil with Teflon coated Flat
Blade Electrode with Holster.
(m) BOVIE Model 514491, hand switching electrosurgical
pencil with blade and holster.
(n) BOVIE Model 514492, hand switching electrosurgical
pencil with blade and holster. Recall Z-414/427-3.
CODE All Pencils manufactured before September 1992, with an "H"
as the first letter of the lot code. All other codes
without an "H" as the first letter in the lot code. (The
exception is Catalog #9164NB where the following lot
numbers are excluded: 5367, 5369, 6628, 6670, 6671, 6672,
6673, 6731, 6732.
MANUFACTURER ConMed Corporation, Utica, New York.
RECALLED BY Manufacturer, by telephone February 24, 1993, followed by
letters March 3, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Catalog # #Distributed
9142N 25,834
9144N 94,900
9162N 22,956
9164NB 263,261
9165N 44,168
9174N 5,341
9184 19,262
9164N 860,280
9144NB 35,750
9165NB 8,700
9190N 6,150
9189N 7,457
514491 9,750
514492 9,750 .
REASON Products are subject to intermittent cutting and/or
coagulation, self-activation, and complete failure to
function as intended.
-11-
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________
PRODUCT Murex Suds Rubella Reagent Kit for in-vitro diagnostic use.
Recall #Z-165-3.
CODE Catalog #3013, lot #2078 EXP 2/93.
MANUFACTURER Murex Corporation, Norcross, Georgia.
RECALLED BY Manufacturer, by letter on or about June 1, 1992. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY 63 kits were distributed.
REASON Product does not meet its performance specification since
it does not detect weakly positive samples.
_______________
PRODUCT Large Tantalum Hemoclips, permanently implantable ligation
clamps used for low clip use procedures like
cholecystectomy or vasectomy. Recall #Z-379-3.
CODE Catalog #523370, lot numbers: 2E1510, 2F1247.
MANUFACTURER Weck, Research Triangle Park, North Carolina.
RECALLED BY Manufacturer, by letter October 1, 1992. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 2,106 boxes (10 units per box) were distributed; firm
estimates none remains on the market.
REASON Outer labeling may indicate the incorrect metal and catalog
number.
_______________
PRODUCT Life Trace Fetal Monitoring Spiral Electrode, Single Helix,
Catalog #FSE 1000, used to monitor fetal heart rate during
labor. Recall #Z-398-3.
CODE Lot numbers: F96442 EXP 4/95.
MANUFACTURER Graphic Controls Canada Ltd., Ganaoque, Ontario, Canada.
RECALLED BY Graphic Controls, Medical Products Division, Buffalo, New
York, by telephone and visits on or about March 19, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Mid-west and eastern United States.
QUANTITY 7,963 units were distributed.
REASON The inner pouch may incorrectly identify the product as
Life Trace Fetal End, Reorder #FSE 2000.
_______________
PRODUCT Ortho Fibrinogen Degradation Products (FDP) Assay, for the
semiquantitive determination of fibrinogen degradation
products in serum or urine by latex particle agglutination.
Recall #Z-406-3.
-12-
CODE Product #738580, lot numbers: FDK111, FDK202.
MANUFACTURER Diagnostica Stago, Franconville, France.
RECALLED BY Ortho Diagnostics, Inc., Raritan, New Jersey, by telephone
November 11 and 12, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 146 units were distributed; firm estimates none remains on
the market.
REASON The cap on the blood collection tube may become loose
during use, which may result in accidental spillage of
blood.
RECALLS AND FIELD CORRECTIONS: VETERINARY -- CLASS II
_______________
PRODUCT Autoclaved Erythromycin Diluent, in 250 ml and 500 ml glass
bottles. Recall #V-020-3.
CODE Lot numbers: 9322, 9325, 9329, 9330.
MANUFACTURER Central Arizona Veterinary Labs, Inc., (CAVL), Casa Grande,
Arizona.
RECALLED BY Manufacturer, by telephone and visit. Firm-initiated
recall completed March 15, 1993.
DISTRIBUTION California, Texas.
QUANTITY 98 bottles were distributed.
REASON Product is an unapproved new animal drug and was not
manufactured in conformance with current good manufacturing
practice regulations.
_______________
PRODUCT Autoclaved, Distilled Sterile Water. Recall #V-021-3.
CODE None.
MANUFACTURER Central Arizona Vet Labs, Inc., (CAVL)/J/J Sheldon &
Associates, Casa Grande, Arizona.
RECALLED BY Manufacturer, by telephone December 4, 1992. Firm-
initiated recall complete.
DISTRIBUTION Arizona, California, Idaho.
QUANTITY 93 bottles.
REASON Product was not manufactured in conformance with current
good manufacturing practice regulations.
_______________
PRODUCT Injectable Spectinomycin Antibiotic, in 1 gallon plastic
containers, used for calf scour in cattle.
Recall #V-022-3.
CODE Batches: 9313, 9316. 9317, 9321, 9326, 9327, 9338, 9343.
MANUFACTURER Central Arizona Vet Labs, Inc., (CAVL)/J.J. Sheldon &
Associates, Casa Grande, Arizona.
RECALLED BY Manufacturer, by telephone and by visit on or about January
15, 1993. Firm-initiated recall complete.
DISTRIBUTION Arizona, Texas.
QUANTITY 186 gallons were distributed.
-13-
REASON Product is an unapproved new animal drug and was not
manufactured in conformance with current good manufacturing
practice regulations.
_______________
PRODUCT Combined Injectable Spectinomycin and Neomycin Antibiotics
in 1 gallon plastic containers. Recall #V-023-3.
CODE 9332, 9340.
MANUFACTURER Central Arizona Veterinary Labs, Inc., (CAVL), Casa Grande,
Arizona.
RECALLED BY Manufacturer, by telephone and by visit beginning December
4, 1992. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 36 gallons were distributed.
REASON Product is an unapproved new animal drug and was not
manufactured in accordance with current good manufacturing
practice regulations.
_______________
PRODUCT Febantel-Trichlorfon Paste, in 1.4 ounce syringe, OTC broad
spectrum equine anthelmintic (wormer) and boticide, under
the following labels: Negabot-Plus Paste (Cutter label),
Combotel Paste (Haver label), and Paratrol Paste (Purina
Mills label). Recall #V-024-3.
CODE Kits 369149 through 360183.
MANUFACTURER Miles, Inc., Shawnee Mission, Kansas.
RECALLED BY Manufacturer, by letter February 1 and 12, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 538,772 units were distributed.
REASON Firm's stability studies show that product exhibits
stability failure prior to the end of the expiration period
of 24 months.
SEIZURES:
_______________
PRODUCT "Kickers" and "Efedrin" Tablets/Caplets (92-648-086).
CHARGE New drug - The articles are unapproved new drugs.
Misbranded - The articles' labels fail to bear adequate
directions for use and they are not exempt from that re-
quirement since they are unapproved new drugs.
FIRM The Hammer Corporation, Atlanta, Georgia.
FILED February 26, 1993; U.S. District Court for the Northern
District of Georgia, Atlanta Division; Civil #1:93-CV-445-
MHS; FDC #66640.
SEIZED March 9, 1993 - goods valued at approximately $96,643.
-14-
_______________
PRODUCT Oxygen, USP (93-672-387).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the articles' manufacture, processing,
packing, and holding do not conform to and are not operated
and administered in conformity with current good
manufacturing practice regulations.
FIRM Rochester Therapy Service Company, Rochester, New York.
FILED March 11, 1993; U.S. District Court for the Western
District of New York; Civil #93-672-387; FDC #66665.
SEIZED March 22, 1993 - goods valued at approximately $3,101.
END OF ENFORCEMENT REPORT FOR APRIL 7, 1992. BLANK PAGES MAY FOLLOW.
-15-
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