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
02/24/1993
Recalls and Field Corrections: Foods -- Class I -- 02/24/1993
FEBRUARY 24, 1993 93-8
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
PRODUCT (a) Lotta Hotta Espinaca Dip, hot pepper cheese/spinach dip, in
17 ounce glass jar; (b) Chile Con Queso, 17 ounce glass jars.
Recall #F-222/223-3.
CODE None.
MANUFACTURER Nina, Ltd., Trenton, Missouri.
RECALLED BY Lotta Hotta, Inc., Overland Park, Kansas, by visit (a) December
22, 1992; (b) January 7, 1993. Firm-initiated recall complete.
DISTRIBUTION Kansas, Missouri.
QUANTITY (a) 814 units were distributed; (b) Approximately 1,900 units
were distributed.
REASON Product has the potential to support the outgrowth of
Clostridium botulinum toxin.
PRODUCT Fisher/Rex Fresh and Fast Chicken Cor Don Bleu Sandwich, 5.7
ounces. Recall #F-224-3.
CODE 33692 and 32292.
MANUFACTURER Fisher's Bakery and Sandwich Company, Raleigh, North Carolina.
RECALLED BY Manufacturer, by visit December 7 & 15, 1992. Firm-initiated
recall ongoing. State of North Carolina issued press releases
on December 10 & 15, 1992. Firm-initiated recall complete.
DISTRIBUTION North Carolina, South Carolina, Virginia.
QUANTITY Approximately 400 sandwiches were distributed.
REASON Product was found to be contaminated with Listeria
monocytogenes by the North Carolina Department of Agriculture.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT Oridol-DM Liquid, Rx liquid oral
antitussive/mucolytic-expectorant, 10 mg, packaged in 16 ounce
brown plastic bottles with white plastic caps, under the
following labels: LuChem, Qualitest, and Major.
Recall #D-138-3.
CODE Lot 6292 EXP 9 94.
MANUFACTURER H.N. Norton & Company (formerly LuChem Pharmaceuticals, Inc.),
Shreveport, Louisiana.
RECALLED BY Manufacturer, by letter on or about December 28, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,794 units under the LuChem label, 10,000 units under the
Qualitest label, and 744 units under the Major label were
distributed.
REASON One or more bottles of Oridol-C was mislabeled as Oridol-D.M.
PRODUCT Redi-Script Cephalexin Capsules USP, a Rx antibiotic, in
bottles labeled to contain 100 500-mg capsules.
Recall #D-139-3.
CODE Labels do not bear a lot number or expiration date.
MANUFACTURER Prepackage Specialists, Division of PDRx Pharmaceuticals, Inc.,
Oklahoma City, Oklahoma (repacker/own label distributor).
RECALLED BY Repacker, by telephone February 1, 1993, followed by letter
dated February 2, 1993. Firm-initiated recall ongoing.
DISTRIBUTION New Jersey, California, Illinois.
QUANTITY 9,504 bottles were distributed; firm estimates that little, if
any, of the lot remains on the market.
REASON Some bottles labeled as 500 mg strength contain 250 mg capsules.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT Cotatate DH Syrup, under the Major label, a liquid oral
antitussive/expectorant Rx drug consisting of hydrocodone
Bitartrate, 5 mg, and Guaifenesin, 100 mg, packaged in 16 ounce
brown plastic bottles. Recall #D-137-3.
CODE Lot #5871 EXP 3/94.
MANUFACTURER H.N. Norton & Company (formerly LuChem Pharmaceuticals, Inc.),
Shreveport, Louisiana.
RECALLED BY Manufacturer, by letter on or about December 28, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,428 units were distributed.
REASON Product does not meet stability specifications.
PRODUCT Rx drugs for injection in partial additive plastic I.V. bag,
called PAB bag:
(a) 5% Dextrose USP, 100 ml, 50 ml, and 25 ml;
(b) 0.9% Sodium Chloride USP, 100 ml, 50 ml;
(c) 0.4% Theophylline and 5% Dextrose, 100 ml, 50 ml;
(d) Metronidazole USP, 100 ml. Recall #D-140/143-3.
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CODE Lot numbers: (a) J2N931, J2N932, J2N938, J2N941, J2N942 (100
ml); J2N924, J2N925, J2N926, N2N927, J2N936, J2N937 (50 ml);
J2N923 (25 ml);
(b) J2N929, J2N930, J2N934, J2N935, J2N943 (100 ml); J2N939,
J2N951 (50 ml);
(c) J2N933 (100 ml); J2N928 (50 ml); (d) J2N944.
MANUFACTURER McGaw, Inc., Irvine, California.
RECALLED BY Manufacturer, by letter December 21, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY (a) 239,552 units (100 ml), 71,568 units (50 ml), 19,952 units
(25 ml); (b) 316,736 units (100 ml), 341,040 units (50 ml); (c)
5,424 units (100 ml), 2,184 units (50 ml); (d) 74,616 units
were distributed.
REASON Some units may contain rubber particulate matter.
PRODUCT Chem-Tuss Elixir, a liquid antihistaminic, nasal
vasoconstrictor Rx drug, packaged in 16 ounce brown plastic
bottles. Recall #D-144-3.
CODE Lot #5915 EXP 4/95.
MANUFACTURER H.N. Norton & Company (formerly LuChem Pharmaceuticals, Inc.),
Shreveport, Louisiana.
RECALLED BY Manufacturer, by letter on or about November 3, 1992.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 104 units were distributed.
REASON Product contains excess FD&C Blue #1 color.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Kendall Curity Disposable Non-Sterile, Latex Exam Gloves, large
ambidextrous, a disposable device intended for a variety of
uses in hospitals and other health areas. Recall #Z-712-2.
CODE Reorder No. 1810, Lot Nos. 03JAN92, 00001 thru 00085, 04JAN92,
00086 thru 00241, 06JAN92, 00361 thru 00368.
MANUFACTURER Lovytex BDN BHD, Panglima Garang, Malaysia.
RECALLED BY Kendall Healthcare Products Company, Mansfield, Massachusetts,
by letter on or about May 21 & 22, 1992, and January 25, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Cartons had visible mold contamination and culture tests were
positive for mold and aerobic bacteria.
PRODUCT Porter: MXR Flowmeter/Nitrous Oxide - Oxygen Flowmeter used
for nitrous sedation during dental procedures:
MXR Model numbers: (a) 2000; (b) 2000-OS; (c) 2050; (d) 2055;
(e) 2056; (f) 2060. Recall #Z-823/828-2.
CODE Serial numbers: (a) 62,602 through 68,040; (b) 58,826 through
58,951; (c) 179 through 659; (d) 158 through 769; (e) 004; (f)
146 through 868.
MANUFACTURER Porter Instrument Company, Inc., Hatfield, Pennsylvania.
RECALLED BY Manufacturer, by mailing new instruction manual to include all
present owners of MXR-2000 units. Firm-initiated field
correction ongoing.
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DISTRIBUTION Nationwide, Canada, Denmark.
QUANTITY Approximately 6,500 units were distributed between 1/86 and
3/13/90.
REASON Malfunctions may allow for 100% nitrous oxide with 0% 0xygen
flow.
PRODUCT Safedge Oscillating Blade (17.0 mm Cut Edge), Part #1117, a
cutting accessory for orthopedic bone saw. Recall #Z-162-3.
CODE Lot #91120501.
MANUFACTURER Stryker Corporation, Instruments Division, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter September 28, 1992. Firm-initiated
recall complete.
Distribution Florida, Michigan, Tennessee, Texas, Vermont, Virginia,
California, Turkey.
QUANTITY 12 units were distributed.
REASON Wrong product, Part #1100, Section Blade, may be found in
package, instead of Part #1117, Safedge Oscillating Blade.
PRODUCT (a) White Irrigating Sleeve, single-use, for cataract surgery,
Catalog #OPO-WS;
(b) Collared Phaco I/A Tubing Set, Catalog #OPO-30WC. The
Sleeve is contained in the AMO OPO-30WC Collared Phaco I/A
Tubing Set with white irrigation set and is also sold
separately as OPO-WS White Irrigation Sleeve.
Recall #Z-265/266-3.
CODE All lots.
MANUFACTURER Allergan Medical Optics (AMO), Irvine, California.
RECALLED BY Manufacturer, by telephone November 24, 1992, followed by
letter December 1, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Argentina, South Africa, Japan, Canada, Hong Kong,
Spain.
QUANTITY Approximately 28,800 units were distributed.
REASON Sleeve may tear or become deformed due to heat being generated
during use.
PRODUCT Therac Model 20 (T20) Cobalt 60 Linear Accelerator Radiation
Therapy Devices, used to treat cancer patients.
Recall #Z-267-3.
CODE Serial numbers: 031, 041, 043, 046, 058, 064, 065, 067, 073,
077, 412, 512, 612, 711, 813.
MANUFACTURER Theratronics International, Ltd., Carrollton, Texas.
RECALLED BY Theratronics International, Ltd., (formerly Atomic Energy of
Canada Ltd.), Kanata, Ontario, Canada, by User Bulletin AUB
92-05 US dated December 3, 1992. Firm-initiated field
correction ongoing.
DISTRIBUTION Alaska, Alabama, California, Florida, Illinois, Kansas,
Kentucky, Michigan, New York, Pennsylvania, Texas.
QUANTITY 15 units were distributed.
REASON Improper dose distribution may occur in electron mode if hand
control pushbuttons are operated quickly in a particular
sequence.
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PRODUCT Therac Model 6(T6) Cobalt 60 Linear Accelerator, radiation
therapy devices used to treat cancer patients. Recall #Z-268-3.
CODE Serial numbers: 010, 015, 018, 020, 021, 024, 025, 027, 030,
031, 035, 036, 037, 038, 039, 563.
MANUFACTURER Theratronics International, Ltd., Carrollton, Texas.
RECALLED BY Theratronics International, Ltd., (formerly Atomic Energy of
Canada, Ltd.) Kanata, Ontario, Canada, by User Bulletin AUB
92-04 US dated December 3, 1992. Firm-initiated field
correction ongoing.
DISTRIBUTION Alabama, California, Illinois, Kentucky, Oklahoma, Minnesota,
Michigan, Montana, New Jersey, New York, Pennsylvania, Texas,
Tennessee.
QUANTITY 14 units were distributed.
REASON Unwanted gentry motion may occur with the treatment room door
closed.
PRODUCT Eldorado, Theratron, and Phoenix Model Cobalt 60 Radiation
Therapy Devices:
(a) Eldorado 76 (E76); (b) Eldorado 78 (E78); (c) Theratron 765
(T765); (d) Theratron 780 (T780); (e) Theratron 780C (T780C);
(f) Theratron 1000 (T000); (g) Phoenix. Recall #Z-269/275-3.
CODE Serial numbers: (a) 003 and 005; (b) 002, 003, 008, 010, 013,
027, 028. 050, 051, 058, 061, 063, 064, 902, 903; (c) 007 and
008; (d) 003, 004, 005, 007, 008, 010, 011, 016, 017, 019, 021,
024, 026, 027, 028, 033, 037, 040, 042, 049, 051, 052, 055,
056, 057, 058, 059, 060, 064, 067, 068, 073, 074, 075, 082,
083, 086, 089, 097, 101, 113, 114, 116, 121, 127, 128, 129,
133, 136, 137, 143, 149, 150, 151, 160, 161, 177, 178, 179,
182, 210, 215, 221, 226, 230, 232, 233, 234, 235, 236, 241,
249, 251, 252, 253, 262, 266, 275, 278, 280, 284, 288, 293,
296, 298, 299, 302, 306, 307, 308, 311, 314, 315, 318, 322,
323, 326, 333, 334, 335, 336, 341, 343, 351, 359, 360, 366,
367, 369, 381, 386, 388, 395, 398, 399, 401, 402, 415, 417,
426, 428, 431, 433, R20, and one unit with serial number
unknown; (d) 002, 009, 014, 016, 020, 022, 024, 030, 032, 035,
036, 038, 043, 058 R/V, 072, 073, 078, 082, 103; (e) 001, 004,
005, 007, 008, 010, 011, 012; (f) 001, 003, 005, 008, 010, 012,
014, 017, 018, 020, 023, 032, 036.
MANUFACTURER Theratronics International, Ltd., Carrollton, Texas.
RECALLED BY Theratronics International, Ltd. (formerly Atomic Energy of
Canada, Ltd), Kanata, Ontario, Canada, by User Bulletin
CUB-92-13 US dated December 3, 1992. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 187 units.
REASON Potential problems involving control system pneumatics, mode
push button, electrons, emergency stop switch, hand control
cable, hand control support, and dual timer on these devices
can affect treatment timing and gentry operation.
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PRODUCT Ultraviolet (UV) Lamps. Recall #Z-281-3.
CODE Serial numbers: Unknown.
MANUFACTURER Quality Lamp, Inc., Canton, Ohio.
RECALLED BY Manufacturer. FDA approved the firm's corrective action plan
October 19, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 7,721 units were distributed.
REASON Noncompliance with performance standards for light emitting
products since the lamps are relabeled and are unreported to
CDRH, and since they were manufactured in an unregistered
medical establishment without a quality control testing and
certification program in effect, they remain adulterated and
misbranded.
PRODUCT Bud Ultraviolet Device, intended for surface cleaning and
surface energizing of endosseous implants. Recall #Z-282-3.
CODE All serial numbers.
MANUFACTURER BUD Industries, Inc., East Aurora, New York.
RECALLED BY Manufacturer, by telephone and letter January 6, 1993.
Firm-initiated field correction complete.
DISTRIBUTON New York.
QUANTITY 5 units were distributed. All units has been returned as of
1/26/93.
REASON Product was distributed without an approved 510(k), PMA or IDE.
PRODUCT Allergan Mini Contact Lens. Recall #Z-290-3.
CODE TC010.
MANUFACTURER Allergan Hydron, Farnborough, Hampshire, United Kingdom.
RECALLED BY Allergan Pharmaceuticals, Irvine, California, by telephone
December 23-24, 1992, followed by letter December 24, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 10 units were distributed.
REASON Product may be contaminated with Pseudomonas cepacia.
PRODUCT Burkhart Roentgen brand Ceiling-Mounted Support Column, which
can hold two maneuverable arms capable of holding a surgical
light, an x-ray shield or CT injector. Recall #Z-292-3.
CODE Catalog #C-100.
MANUFACTURER Burkhart Roentgen, Inc., Pinellas Park, Florida.
RECALLED BY Manufacturer, by visit January 1993. Firm-initiated field
correction ongoing.
DISTRIBUTION Pennsylvania, Tennessee, Texas, Florida, Illinois, Minnesota,
Missouri.
QUANTITY 27 units were distributed.
REASON The support column may fail causing the arm to fall.
PRODUCT HyperFormer Pump Dispensing Set, Catalog #V9900-01, used to
prepare total parenteral nutrition solutions in hospital
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pharmacies. Recall #Z-293-3.
CODE All lots beginning with F1 or F2 except Lots beginning with F2P
or F2S, F2N499, F2N672, F2N673.
MANUFACTURER McGaw of Puerto Rico, Inc., Sabana Grande, Puerto Rico.
RECALLED BY McGaw, Inc., Irvine, California, by letter November 6, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY Approximately 32,720 units were distributed; firm estimates
2,000 units remain on the market.
REASON Some tubing sets are improperly color-coded, which can result
in incorrect compounding of solution.
PRODUCT Endopath Disposable Surgical Trocar, used to establish a path
of entry for endoscopic instruments during gynecologic
laparoscopy and other abdominal procedures:
(a) Model LR005; (b) Model R1011; (c) Model B1011.
Recall #Z-294/296-3.
CODE Lot numbers: (a) DG3347, DG3348, DG3349, DG3350, DG3351,
DG3352, DG3368, DG10K1, DG15K1, DG16K1;
(b) DG3358, DG3359, DG3360, DG3361, DG33369, DG3370, DG3371,
DG3372, DG3383, DG3384, DG3390, DG3393, DG3444, DG3445, DG16KE,
DG18KE, DG24KE, DG25KE, DG29KE;
(c) DG3434, DG3435, DG3436, DG3437, DG3438.
MANUFACTURER Ethicon, Inc., Juarez, Mexico.
RECALLED BY Ethicon, Inc., Cincinnati, Ohio, by Fax July 25, 1992, and
August 5, 1992 to international distributors and by verbal
instructions to domestic sales representatives on July 27,
1992, followed by letter dates July 27, 1992. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 78,428 units were distributed.
REASON The devices were leaking air due to excessive sealant which
interferes with the closure on the flapper valve on the sleeve
component.
PRODUCT (a) Tracheal Tubes with Flexibend Adapters, Catalog #5-10817,
8.5 mm, Catalog #5-10818, 9 mm, and Catalog #5-10820, 10 mm,
and Catalog #5-19112, 6 mm size, sterile devices sold in units
of 10;
(b) Flexibend Adapters, Catalog #5-14018, 9 mm, and Catalog
#5-14020, 10 mm size, non-sterile, sold in bulk, in units of
100. The adapter is an interim connection between the tracheal
tube and the 15 mm adapter that hooks to the respirator
circuit. Recall #Z-336/337-3.
CODE Catalog # Lot #
(a) 5-10818 008221
5-10817 009038
5-10820 005491, 007503, 009041, 9109G003749
5-191112 559421
(b) 5-14018 009341
5-14020 006138.
MANUFACTURER Sheridan Catheter Corporation, Argyle, New York.
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RECALLED BY Manufacturer, by letter September 14, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION (a) Louisiana, Virginia, Pennsylvania, Oklahoma, Hawaii,
Finland, Japan, Brazil, Italy, Holland, Australia;
(b) United Kingdom and Norway.
QUANTITY (a) 4,120 units; (b) 400 units were distributed.
REASON Devices may crack which may cause them to be non-functional.
PRODUCT ECAT Scanner, positron emission tomography system, model #953.
Recall #Z-306-3.
CODE Serial numbers: 3600035-03 0001001 and 9011EA01AJ.
MANUFACTURER CTI Pet Systems, Knoxville, Tennessee.
RECALLED BY Siemens Gammasonics, Knoxville, Tennessee, by undated Field
Modification Instruction No. 19. Firm-initiated field
correction ongoing.
DISTRIBUTION Germany.
QUANTITY 2 units were distributed.
REASON A problem in the software on the sorter printed circuit board
could cause the sorter to cease functioning.
PRODUCT ECAT Scanner, positron emission tomography system, Model #951.
Recall #Z-307-3.
CODE Serial numbers: 9011DB01CW, 9012DB03CW.
MANUFACTURER CTI PET Systems, Knoxville, Tennessee.
RECALLED BY Siemens Gammasonics, Knoxville, Tennessee, by field
modification instruction #17, dated August 20, 1991.
Firm-initiated field correction ongoing.
DISTRIBUTION Illinois, Arizona.
QUANTITY 2 units were distributed.
REASON The ring source functions to normalize the device prior to
scanning a patient. In some cases the ring source does not
extend as designed and, in such cases, the devices will lock-up
and cannot be used.
PRODUCT High pressure extension tubes, used to connect the angiographic
injector syringe to a catheter which is inserted into the
patient's vascular system:
(a) 10" tube with fixed adapter;
(b) 10" tube with rotating adapter;
(c) 20" tube with rotating adapter;
(d) 30" tube with rotating adapter;
(e) 30" tube with rotating adapter. Recall #Z-309/313-3.
CODE Lot numbers: (a) 022691; (b) 060591; (c) 090992;
(d) 021092; (e) 063592.
MANUFACTURER Critical Specialties, Inc., West Chester, Pennsylvania.
RECALLED BY Liebel-Flarsheim Company, Cincinnati, Ohio, by letter November
10 & 16, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 375 units; (b) 25 units; (c) 575 units; (d) 1,000 units;
(e) 850 units were distributed.
REASON The 10" and 30" tubes have a defect in the seal between the
-8-
luer lock end fitting and the tube which could lead to leakage
or air entering the tubing system. Also the 20" tubes have a
defective roter adapter at the male luer which could cause the
tubes to separate from the catheter during an injection.
UPDATES Recall #Z-172-3, Wavicide-01, which appeared in the January 6,
1993 Enforcement Report should read:
CODE: All lots distributed before 8-12-92.
Recall #Z-119/120-3, Technomed USA, Bay Shore, New York,
TEC1410 Anatomical Programming Generator which appeared in the
January 20, 1993, Enforcement Report has been withdrawn because
it was determined that the products were never distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
PRODUCT ECAT Scanner, positron emission tomography system, Model Nos.
713, 831, 931, 933, 951, 951R, 953, and 953B. Not all units of
these model numbers are subject to recall.
(a) ECAT Scanner, Model No. 713;
(b) ECAT Scanner, Model No. 831;
(c) ECAT Scanner, Model No. 931;
(d) ECAT Scanner, Model No. 951;
(e) ECAT Scanner, Model No. 951R;
(f) ECAT Scanner, Model No. 953;
(g) ECAT Scanner, Model No. 953B;
(h) ECAT Scanner, Model No. 933. Recall #Z-298/305-3.
CODES (a) Serial No. 9008GG01CW.
(b) Serial No. 8711AD02CW.
(c) Serial Nos. 8702AD01AF, 8708AD01CW, 8711AD01CW, 8801AD01CW,
8802AD01CW, 8802AD02CW, 8804AA01A0, 8807AD02AB, 8811AD01CW,
8906AD01CW, & 8908AE01CW.
(d) Serial Nos. 8807BD01AB & 8904BE01CW.
(e) Serial Nos. 3600026-00 0001001, 3600031-00 0001001,
3600036-01 0001001*, 8911DB01AJ, 9011DB01CW, 9012DB01AR,
9102DB01CW, & 9102DB03CW.
(f) Serial Nos. 3600036-00 0001001, 3600036-01 0001001*,
3600036-01 0001003, 3600036-01 0001004, 3600036-01 0001005 &
9106DB01CW.
(g) Serial Nos. 3600034-00 0001001, 3600034-01 0001001,
3600035-03 0001001, 3600036-01 0001002, 8912EA01AJ, 8912EB02CD
& 9011EA01AJ.
(h) Serial Nos. 3600039-00 0001001, 3600041-00 0001001,
8912EC01AF & 9006EC01A1.
* Through an error at the manufacturer, two different models
were assigned identical serial numbers.
MANUFACTURER CTI PET Systems, Knoxville, Tennessee.
RECALLED BY Siemens Gammasonics, Inc., Knoxville, Tennessee, by field
modification instruction #25, dated April 30, 1992.
Firm-initiated field correction ongoing.
DISTRIBUTION Arizona, California, Illinois, Michigan, Minnesota, Missouri,
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Nebraska, New York, North Carolina, Tennessee, Australia,
Belgium, Canada, England, Germany, France, The Netherlands,
Italy.
QUANTITY 40 units were distributed.
REASON Bed failed to return to zero position. Also the computer
failed to clear previous bed settings when emergency stop
button was depressed.
PRODUCT DuPont ACA(R) Digoxin Antibody Conjugate Reagent (DGN-ABC
Reagent), an accessory of the DuPont ACA(R) Discrete clinical
analyzer system, used to treat a patient specimen of blood
serum in preparation for the measurement of its digoxin
concentration. Recall #Z-288-3.
CODE Lot numbers: 18BD694 EXP 11/1/91, 1DD635 EXP 1/1/92.
MANUFACTURER E.I. DuPont De Nemours & Company, Wilmington, Delaware.
RECALLED BY Manufacturer, by letter August 16, 1991. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 10,851 kits of lot 1BD694 and 3,549 kits of lot 1DD635 were
distributed; firm estimates none remains on the market.
REASON Inaccurate Digoxin (DGN) concentration levels and the device's
inability to calibrate the ACA(R) Discrete Clinical Analyzer
for the DGN Test Method at the 0.4 mg/ml level due to low
recovery of the 0.4 mg/ml calibrator.
MEDICAL DEVICE SAFETY ALERTS: (NOTE: M changed to N number)
PRODUCTS (a) Theraplan Treatment Planning Systems with Software Versions
V05 and V04B-C;
(b) TP-11 Treatment Planning Systems with, Software Versions
V09 and V08B-C, computerized workstations used to calculate and
determine appropriate radiation treatment programs for doctors
to administer to cancer patients. Safety Alert #N-023/024-3.
CODES Theraplan Treatment Planning System - 190 units
Serial Numbers TH-01, TH-07, TH-09, TH-23, TH-24, TH-35, TH-37,
TH-49, TH-53, TH-56, TH-64, THL-201, THL-203, THL-204, THL-209,
THL-216, THL-217, THL-218, THL-219, THL-227, THL-228, THL-229,
THL-230, THL-233, THL-234, THL-235, THL-238, THL-244, THL-245,
THL-254, THL-258, THL-259, THL-262, THL-264, THL-266, THL-269,
THL-272, THL-276, THL-277, THL-278, THL-279, THL-284, THL-286,
THL-287, THL-290, THL-291, THL-300, THL-301, THL-302, THL-304,
THL-305, THL-306, THL-307, THL-310, THL-311 THL-314, THL-318,
THL-319, THL-320, THL-321, THL-322, THL-323, THL-324, THL-325,
THL-328, THL-330, THL-332, THL-333, THL-334, THL-335, THL-337,
THL-340, THL-341, THL-342, THL-343, THL-345, THL-346, THL-347,
THL-348, THL-349, THL-351, THL-353, THL-358, THL-360, THL-361,
THL-365, THL-366, THL-368, THL-370, THL-373, THL-374, THL-375,
THL-377, THL-379, THL-383, THL-384, THL-385, THL-386, THL-387,
THL-390, THL-391, THL-392, THL-393, THL-394, THL-395, THL-396,
THL-397, THL-398, THL-399, THL-400, THL-401, THL-402, THL-403,
THL-404, THL-405, THL-406, THL-407, THL-408, THL-411, THL-413,
THL-414, THL-415, THL-416, THL-417, THL-420, THL-422, THL-425,
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THL-426, THL-427, THL-428, THL-429, THL-430, THL-431, THL-433,
THL-434, THL-435, THL-436, THL-437, THL-438, THL-441, THL-443,
THL-445, THL-446, THL-448, THL-449, THL-450, THL-451, THL-452,
THL-453, THL-454, THL-456, THL-457, THL-458, THL-459, THL-460,
THL-461, THL-462, THL-463, THL-464, THL-468, THL-469, THL-470,
THL-471, THL-472, THL-473, THL-475, THL-476, THL-500, THL-501,
THL-503, THL-404, THL-505, THL-510, THL-512, THL-513, THL-514,
THL-515, THL-517, THL-528, THL-529, THL-530, THL-531, THL-533,
THL-535, THL-536, THL-539, THL-3100, THL-3102, THL-3103
TP-11 Treatment Planning System - 41 units
Serial Numbers TP-07, TP-08, TP-20, TP-27, TP-30, TP-31, TP-41,
TP-42, TP-63, TP-67, TP-72, TP-74, TP-78, TP-83, TP-88, TP-89,
TP-92, TP-93, TP-96, TP-103, TP-109, TP-115, TP-125, TP-127,
TP-139, TP-149, TPL-221, TPL-251, TPL-255, TPL-267, TPL-268,
TPL-285, TPL-292, TPL-294, TPL-309, TPL-316, TPL-338, TPL-364,
TPL-367, TPL-371, TPL-543,
MANUFACTURER Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd., Kanata, Ontario, Canada;
Theratronics International, Ltd., 2833 Trinity Mills Road,
Suite 149, Carrollton, Texas.
ALERTED BY Manufacturer, by User Bulletin TH UB 92-006, dated December 3,
1992.
DISTRIBUTION Nationwide.
QUANTITY (a) 190 units; (b) 41 units.
REASON Potential for mix-up of patient data during transfer from one
data disk to another.
PRODUCT: Vena Tech Vena Cava Filter Systems, sterile Rx implantable
stainless steel cone shaped filter for placement in the
inferior vena cava to preclude emboli ascending from any
inferior vein in patients with thromboembolic disease who
cannot receive anticoagulants, and patients with chronic
recurrent pulmonary embolism. The following kits all contain
the same vena cava filter, with VJ and VF models having less
than full length struts, while the 30CJ, 30CF and 30D models
have full length struts: Safety Alert #N-027/031-3.
(a) Catalog No. 31324: Vena Tech LGM Vena Cava Filter System
for Jugular Access, Type LGM-VJ-U, Distributed by Vena Tech
Corporation;
(b) Catalog No. 31325: Vena Tech LGM Vena Cava Filter System
for Femoral Access, Type LGM-VF-U, Distributed by: Vena Tech
Corporation;
(c) Catalog No. 31326: B. Braun Vena Tech 30CJ Vena Cava Filter
System for Jugular Approach, Type LGM-30-CJ/U, Distributed by:
B. Braun Vena Tech;
(d) Catalog No. 31327: B. Braun Vena Tech 30CF Vena Cava Filter
System for Femoral Approach, Type LGM-30-CF/U, Distributed by:
B. Braun Vena Tech;
(e) Catalog No. 31328: B. Braun Vena Tech 30D Vena Cava Filter
System for Jugular or Femoral Approach, Type LGM-30-D/U,
Distributed by: B. Braun Vena Tech;
CODE All serial numbers of all five catalog numbers.
MANUFACTURER: Celsa LG Medical, Chassenueil, France
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ALERTED BY B. Braun Vena Tech, B. Braun of America, Evanston, Illinois, by
undated letter.
DISTRIBUTION Nationwide.
QUANTITY 13,213 filters were distributed; firm estimates 70 units remain
on the market.
REASON Inadequate instructions for use, i.e. insertion information,
result in the filters posing a high risk of serious adverse
health consequences, including vessel or cardiovascular trauma,
bleeding, or death.
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END OF ENFORCEMENT REPORT FOR FEBRUARY 26, 1993. BLANK PAGES MAY
FOLLOW.