FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration,
U.S. Public Health Service, Department of Health and Human Services. It contains
information
on actions taken in connection with agency regulatory activities.
ENFORCE
12/02/1992
RECALLS AND FIELD CORRECTIONS: December 2, 1992
FOODS -- CLASS II
92-49
PRODUCT Refined Cane Sugar packed 9/14-17/92, in 1/8 ounce individual
paper packets, 2,000 per box, 1/10 ounce individual paper
packets, 2,000 per box, 24/10 canisters (20 ounces), and 1
pound cartons. The sugar is labeled under the following labels:
7 Eleven Sugar, catalog #15-515-01006, 200 1/8 ounce packets
per case;
Dixie Crystals Pure Sugar, catalog #15-515-00883, 2000 1/10
ounce packets per case, Savannah Food Service;
Kraft Sugar Packets, catalog #12-515-00582, 2000 1/10 ounce
packets per case, distributed by Sysco Corporation;
Sysco Classic Sugar, Catalog #15-515-00013, 2000 1/10 ounce
packets per case, distributed by Sysco Corporation;
Dixie Crystals Pure Sugar, ink stamped with "Hyatt" or "Bombay
Bicycle", catalog #15-515-00538 (generic code), 200 1/10 ounce
packets per case, Savannah Food service;
Bakers & Chefs Pure Cane Sugar Extra Fine Granulated, 2000 1/10
ounce packets per case;
Dixie Crystals Coffee Service Sugar, Catalog #15-510-00697, 24
1-pound cartons, Savannah Foodservice;
Coffee Service Sugar, ink stamped with Neighbors, catalog
#15-505-00 268 (generic case), 24 20-ounce canisters;
Coffee Service Sugar, ink stamped with Showboat, catalog
#15-505-00 268 (generic case), 24 20-ounce canisters;
Coffee Service Sugar, ink stamped with Flavorite, catalog
#15-505-00 268 (generic case), 24 20-ounce canisters;
Dixie Crystals Extra Fine Granulated Sugar for Institutional
Use Only, 40 pound boxes, Savannah Foods & Industries, Inc.,
Dixie Crystals Sugar Bowl Extra Fine Sugar in Envelopes,
catalog #15-509-00973, 12 cartons, 100 count envelopes,
manufactured by Savannah Foods & Industries, Inc.
Recall #F-116-3.
CODE Production codes: G258C, G259C, G260C, G261C.
MANUFACTURER Savannah Foodservice, Inc., Savannah, Georgia.
RECALLED BY Manufacturer, by letter September 18, 1992, or by telephone.
Firm-initiated recall complete.
DISTRIBUTION Louisiana, Florida, Alabama, Mississippi, Oklahoma,
Pennsylvania, Missouri, Texas.
QUANTITY 80,342 pounds were distributed; firm estimates none remains on
the market.
REASON Product is contaminated with glass particles.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT Rx vitamin oral liquids as follows:
(a) Triple-Vita-Flor Drops 0.25 mg, a Rx alcohol-free vitamin
packaged in 50 ml plastic bottles with droppers, sold under the
following labels:
PBI Triple-Vita-Flor Drops 0.25 mg dietary vitamin A,D,C
& fluoride supplement infants' drops, Manufactured by:
Pharmaceutical Basics, Inc.,
GG Triplevite with Fluoride dietary vitamin A,D,C &
fluoride supplement infants' drops 0.25 mg, Dist. by Geneva
Pharmaceuticals, Inc., Pharmacist's Choice Triple-Vita-Flor
Infants' Drops, dietary vitamin A,D,C & Fluoride supplement,
fluoride 0.25 mg, Pharmacist's Choice, Manufactured by
Pharmaceutical Basics, Inc.,
(b) Triple-Vita-Flor Drops 0.5 mg, a Rx sugar-free,
alcohol-free vitamin packaged in 50 ml plastic bottles with
droppers, sold under the following labels:
PBI Triple-Vita-Flor Drops 0.5 mg dietary vitamin A, D, C &
fluoride supplement infants' drops, Manufactured by:
Pharmaceutical Basics, Inc.,
GG Triplevite with Fluoride dietary vitamin A,D,C & fluoride
supplement infants' drops 0.5 mg, Dist. by Geneva
Pharmaceuticals, Inc. Recall #D-071/072-3.
CODE Lot numbers: (a) 18756, 18836, 19055, 19247, 19252;
(b) 19035, 19138, 19212, 19329, 19382.
MANUFACTURER Pharmaceutical Basics, Inc., Morton Grove, Illinois.
RECALLED BY Manufacturer, by letter November 13, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 355,849 bottles; (b) 31,039 bottles were distributed; firm
estimates 33 percent of product remains on the market.
REASON Preservative system not effective through expiration date.
-2-
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT Literature promoting Pro Med's capability to compound unit dose
bronchodilator medications, Rx new drugs without approved drug
applications. Recall #D-068-3.
CODES All literature distributed.
MANUFACTURER Pro Med Pharmacies, Amarillo, Texas.
RRECALLED BY Manufacturer, by telephone May 15, 1992. Firm-initiated field
correction complete.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates none of the literature remains on the market.
REASON Literature promoted firm's capability to compound drugs
regarded by FDA as unapproved new drugs.
PRODUCT Rx multivitamin oral liquids:
(a) Multi-Vita Drops w/Fluoride 0.25 mg, a Rx sugar-free,
alcohol-free vitamin packaged in 50 ml plastic bottles with
droppers, sold under the following labels:
PBI Multi-Vita Drops with Fluoride 0.25 mg multivitamin
& fluoride supplement infants' drops, Manufactured by
Pharmaceutical Basics, Inc.,
GG Polyvite with Fluoride multivitamin & fluoride supplement
infants' drops 0.25 mg, Dist. by Geneva Pharmaceuticals, Inc.,
(b) Multi-Vita Drops w/Fluoride 0.5 mg, a Rx sugar-free,
alcohol-free vitamin packaged in 50 ml plastic bottles with
droppers, sold under the following labels:
PBI Multi-Vita Drops with Fluoride 0.5 mg multivitamin &
fluoride supplement infants' drops, Manufactured by
Pharmaceutical Basics, Inc.,
GG Polyvite with Fluoride multivitamin & fluoride
supplement infants' drops 0.5 mg, Dist. by Geneva
Pharmaceuticals, Inc. Recall #D-069/070-3.
CODE Lot numbers: (a) 19090, 19159, 19264, 19390, 19421
(b) 18904, 19070, 19320, 19392.
MANUFACTURER Pharmaceutical Basics, Inc., Morton Grove, Illinois.
RECALLED BY Manufacturer, by letter November 13, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 75,916 bottles; (b) 33,225 bottles were distributed.
REASON Subpotency of Vitamin C ingredient prior to expiration date.
UPDATE "Excel" 0.9% Sodium Chloride Injection U.S.P. in 500 ml plastic
containers, Recall #D-469-2, manufactured by McGaw, Inc.,
Irvine, California, which appeared in the September 2, 1992
Enforcement Report has been extended to include all lots (422
lots) of the product manufactured from 2/14/90 through 6/8/92.
Lot numbers J0B718 through J2H462.
-3-
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT Platelets, Pheresis. Recall #B-071-3.
CODE Unit #24FL11265.
MANUFACTURER American Red Cross Blood Services, Louisville, Kentucky.
RECALLED BY Manufacturer, by letter August 5, 1991. Firm-initiated recall
complete.
DISTRIBUTION Kentucky.
QUANTITY 1 unit.
REASON Blood product from a donor who was immunized with Measles,
Mumps and Rubella (MMR) vaccine seven days prior to donation,
was distributed.
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-072/073-3.
CODE Unit #1403763.
MANUFACTURER Hunter Blood Center, Inc., Clearwater, Florida.
RECALLED BY Manufacturer, by letter March 9, 1992. Firm-initiated recall
complete.
DISTRIBUTION Florida.
QUANTITY 1 unit of each component.
REASON Blood products, which tested negative for the antibody to the
human immunodeficiency virus type 1 (anti-HIV-1), but were
collected from a donor who previously tested repeatedly
reactive for anti-HIV-1, were distributed.
PRODUCT Single Donor Plasma Liquid, Expired. Recall #B-074-3.
CODE Unit numbers: 101913251, 101919388, 101913237, 101942041,
101922943.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Scottsdale Memorial Hospital, Scottsdale, Arizona, by letter
September 25, 1991. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania.
QUANTITY 5 units.
REASON Blood components for further manufacture were distributed
labeled for transfusion.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
PRODUCT (a) Fresh Frozen Plasma, Expired; (b) Platelets, Expired;
(c) Platelets Pheresis, Expired. Recall #B-059/061-3.
CODE (a) 2213436, 2274141, 2283612, 2311449, 2311473, 2494452,
2497035, 2500364, 2503359, 2505087, 2508922, 2513701, 2596095,
2609009, H04931, H06901, J00972, J01222, J01398, J01606,
J01608, J01613, J03667, J03896, J04069, J04500, J04556, J04738,
J05467, J05636, J05977, J05981, J05995, J07471, J07475, J09191,
J09532, J09636;
(b) 226256, 226719, 249863, 250456, 2216352, 2216362, 2216364,
2244464, 2244482, 2253960, 2256505, 2256644, 2256687, 2256918,
2257335, 2257343, 2257540, 2257555, 2257593, 2257749, 2257760,
-4-
2257850, 2257860, 2260082, 2260136, 2260462, 2260500, 2260789,
2261440, 2262647, 2264568, 2264802, 2265724, 2265983, 2265999,
2266570, 2266966, 2267722, 2267724, 2267825, 2268292, 2268751,
2269464, 2269977, 2272648, 2274026, 2274876, 2274892, 2275050,
2275083, 2275094, 2275097, 2275116, 2276166, 2276293, 2276529,
2276654, 2277317, 2278504, 2278526, 2279390, 2279392, 2279565,
2279571, 2279572, 2280042, 2280056, 2280058, 2280196, 2280535,
2280544, 2280556, 2280591, 2280718, 2280719, 2281764, 2281948,
2281962, 2283698, 2284681, 2287327, 2287406, 2287730, 2287739,
2287743, 2287746, 2287918, 2287919, 2288149, 2288157, 2288163,
2288560, 2288996, 2290016, 2290408, 2290441, 2290658, 2290680,
2290881, 2290883, 2291004, 2291224, 2291274, 2292445, 2292472,
2294980, 2295954, 2295981, 2296533, 2296722, 2296724, 2297298,
2298045, 2298165, 2300171, 2300636, 2301460, 2302988, 2304995,
2304996, 2307735, 2307854, 2308442, 2308684, 2489607, 2489634,
2489680, 2489710, 2489746, 2491211, 2491218, 2493222, 2493228,
2493246, 2493254, 2493913, 2493965, 2493975, 2494392, 2494673,
2494674, 2494776, 2494844, 2494863, 2494871, 2495428, 2495567,
2495569, 2495611, 2495666, 2495670, 2495859, 2495869, 2495882,
2496534, 2497825, 2497838, 2498459, 2499377, 2499473, 2500519,
2501626, 2502333, 2502346, 2502501, 2503569, 2503953, 2504008,
2504034, 2504047, 2504087, 2504100, 2504113, 2504513, 2504522,
2504524, 2505883, 2505986, 2506228, 2506248, 2506729, 2507161,
2507165, 2507167, 2508184, 2508242, 2508254, 2508286, 2508296,
2508302, 2508319, 2508503, 2509769, 2509774, 2509775, 2509776,
2509790, 2510018, 2510033, 2510546, 2510577, 2510579, 2510586,
2510827, 2510831, 2510848, 2510863, 2511193, 2511201, 2511411,
2511412, 2511413, 2511424, 2511833, 2511883, 2511888, 2511967,
2511980, 2512735, 2513550, 2514473, 2514602, 2514872, 2514873,
2514894, 2514913, 2515611, 2516370, 2521730, 2521861, 2522051,
2522112, 2522140, 2522447, 2522459, 2522598, 2522950, 2525638,
2525644, 2525736, 2526442, 2526461, 2526479, 2526487, 2526730,
2526733, 2526735, 2526747, 2527114, 2527595, 2527623, 2528004,
2528011, 2528032, 2528180, 2530154, 2532625, 2533230, 2533231,
2533234, 2533235, 2533302, 2533529, 2533570, 2533580, 2533588,
2533593, 2535075, 2535077, 2355351, 2535365, 2535385, 2535386,
2535406, 2535407, 2535413, 2535416, 2535427, 2535556, 2535587,
2535597, 2535611, 2591639, 2591644, 2591648, 2591780, 2593009,
2593030, 2593034, 2593101, 2593141, 2593702, 2593703, 2593750,
2593763, 2593790, 2595875, 2596680, 2596706, 2596868, 2597016,
2598647, 2598648, 2598658, 2598823, 2600120, 2600190, 2600192,
2601156, 2601170, 2606744, 2606811, 2611189, 2901982, H08516,
J00972, J04162, J04383, J04387, J04391, J04394, J04397, J04455,
J04456, J04500, J04501, J04691, J04809, J04821, J04998, J05000,
J05038, J05044, J05115, J05139, J05140, J05141, J05142, J05146,
J05152, J05269, J05467, J05631, J05636, J05647, J06200, J06201,
J06202, J06204, J06219, J06246, J06248, J06255, J06256, J06318,
J06597, J06600, J06676, J06685, J06686, J06688, J06690, J06694,
J06695, J06698, J06795, J06798, J06799, J06800, J06801, J06827,
J06828, J06878, J06972, J06976, J07003, J07004, J07005, J07006,
J07044, J07046, J07047, J07051, J07054, J07232, J07254, J07274,
J07470, J07471, J07474, J07511, J07512, J07522, J07523, J07524,
-5-
J07628, J07638, J07657, J07658, J07659, J07661, J07662, J07666,
J07667, J07668, J07674, J07721, J07753, J07754, J07755, J07756,
J07758, J07804, J07817, J07821, J07919, J08035, J08125, J08126,
J08200, J08203, J08204, J08206, J08207, J08268, J08279, J08386,
J08389, J08390, J08409, J08416, J08419, J08420, J08430, J08518,
J08571, J08573, J08583, J08893, J08956, J08959, J08961, J08983,
J08984, J09022, J09023, J09098, J09105, J09140, J09163, J09165,
J09166, J09217, J09220, J09449, J09451, J09455, J09456, J09460,
J09461, J09462, J09466, J09470, J09475, J09479, J09530, J09635,
J09636, J09651, J09653, J09654, J09655, J09685, J09690, J09697,
J09712, J09713, J09714, J09741, J09794, J09795, J09874, J09876,
J09879, J09882, J09885, J09941 J09945, J09949, J09950, J09951,
J09953, J09956;
(c) 249915, 2228084, 2261901, 2261915, 2267674, 2267789,
2267838, 2267846, 2267982, 2286142, 2286147, 2286151, 2286154,
2289613, 2289730, 2421300, 2421442, 2445458, 2458251, 2458254,
2476573, 2490022, 2490038, 2490277, 2490328, 2490367, 2490370,
2490384, 2490397, 2490418, 2490495, 2494878, 2499129, 2499261,
2499264, 2499319, 2499329, 2499337, 2499344, 2499349, 2499392,
2499393, 2499473, 2499474, 2499478, 2499480, 2513176, 2513194,
2513244, 2513246, 2513259, 2513281, 2513304, 2513350, 2513360,
2513393, 2513395, 2513396, 2513398, 2513410, 2513411, 2530522,
2530531, 2530617, 2530651, 2530658, 2530674, 2530681, 2530728,
2530816, 2530821, 2530831, 2530869, 2530875, 2350882, 2530883,
2530895, 2534557, 2534560, 2534566, 2534570, 2534571, 2534572,
2534580, 2600540, 2600674, 2600803, 2600834, 2600854, 2600898,
2600915, 2600947, 2605581, 2609503, 2609653, 2609671, 2609858,
J04076, J04424, J06131, J06796, J06804, J07256, J08045, J09649.
MANUFACTURER Long Island Jewish Medical Center, New Hyde Park, New York.
RECALLED BY Manufacturer, by letter August 16, 1992. Firm-initiated recall
complete.
DISTRIBUTION Pennsylvania.
QUANTITY (a) 38 units; (b) 494 units; (c) 106 units.
REASON Blood components for further manufacture were distributed
labeled for transfusion.
PRODUCT (a) Single Donor Plasma Liquid, Expired; (b) Platelets,
Expired; (c) Pooled Platelet Concentrates, Expired; (d) Fresh
Frozen Plasma, Expired. Recall #B-075/078-3.
CODE Unit numbers: (a) 101895383, 101895390, 101907354, 101907385,
101917149;
(b) 101900288, 101902149, 101902170, 101903037, 101903476,
101903523, 101903524, 101903672, 101903673, 101903674,
101903675, 101904090, 101904096, 101904100, 101904102,
101904214, 101904215, 101905561, 101905562, 101905563,
101905566, 101905579, 101905581, 101905587, 101905590,
101905628, 101905635, 101905636, 101907287, 101907444,
101908962, 101908983, 101908986, 101908994, 101910366,
101910377, 101913552, 101914269, 101914272, 101915515,
101915516, 101915556, 101916747, 101917394, 101918203,
101918207, 101918700, 101918931, 101918952, 101918959,
101918969, 101919310, 101919585, 101921771, 101921779,
-6-
101922183, 101923076, 101923206, 101924182, 101924700,
101925130, 101926504, 101926515, 101926530, 101926536,
101932474, 101932638, 101933530, 101935823, 101936019,
101939666, 101941776, 101944286, 101946014, 101946034,
101946055, 101946056, 101946058, 101952742, 101960652,
101962251, 101963093, 101963097, 101964168, 101966752,
101966754, 101966755, 101966760, 101966777, 101966779,
101967576, 101969047, 101969207, 101969209, 101969481,
101971664, 101971674, 101971676, 101971694, 101971705,
101971914, 101972229, 101972246, 101972734, 101972743,
101972745, 101972750, 101972753, 101972769, 101972777,
101974301, 101974459, 101974688, 101976461, 101977575,
101977939, 101978991, 101980416, 101980419, 101983117,
101983120, 101983132, 101985752, 101987639, 101987642,
101987776, 101987777, 101988199, 101988930, 101988933,
101989072, 101989085, 101989087, 101989351, 101989690,
101989697, 101989767, 101990245, 101990410, 101990454,
101990678, 101991912, 101991917, 101991918, 101992725,
120771724, 120772390, 197-7119, 197-7121, 198-1286, 198-3398,
198-4109, 198-4114, 198-6812, 1983397, 523498.
(c) 68782 (consisting of Platelets, Expired; units 101889591,
101894577, 101894578, 101898839, 101899552, 101900097,
101900516, 101901316, 190296770, 190296771) and 68995
(consisting of Platelets, Expired; units 101937985, 101937987,
101939303, 101941408, 101941427, 101941461, 101942035,
101942039);
(d) 101877887, 101884392, 101890716, 101901350, 101915013,
101917795, 101922536.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Scottsdale Memorial Hospital, Scottsdale, Arizona, by letter
September 25, 1991. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY (a) 5 units; (b) 156 units; (c) 2 pools; (d) 7 units.
REASON Blood components for further manufacture were distributed
labeled for transfusion.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Ultramark 9 High Definition Imaging (UM 9 HDI) Diagnostic
Ultrasound System, an integrated ultrasound system that
provides anatomic, dynamic flow, and color flow information for
the hospital and clinic. Recall #Z-041-3.
CODE All units.
MANUFACTURER Advanced Technology Laboratory (ATL), Bothell, Washington.
RECALLED BY Manufacturer, by voice mail March 4, 1992. Firm-initiated
field correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 741 units were distributed.
REASON Incorrect software configuration codes, may have resulted in
10% measurement error.
-7-
PRODUCT Nitroglycerin-Lipid Set under the Smith & Nephew Sigma label,
used in conjunction with infusion pumps:
(a) Part #96115; (b) 86101; (c) 86941. Recall #Z-059/061-3.
CODE Lot numbers: (a) 029218162, 039218456, 059218959, 079219145
(McGaw); (b) 029218160, 049218801 (Travenol); (c) 029218161,
039218161, 069218939 (Abbott).
MANUFACTURER AVI, Inc., 3M Healthcare, St. Paul, Minnesota.
RECALLED BY Sigma International, (formerly known as Smith & Nephew (SIGMA),
Medina, New York, by telephone August 20 and 21, 1992, followed
by letter August 24, 1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 5,095 sets were distributed.
REASON Roller clamp has potential for failure to stop fluid flow.
PRODUCT Dinamp Vital Sign Monitors:
(a) Model 1846SX, Catalog numbers 8260 through 8264;
(b) Model 1846SX/P, Catalog numbers 8270 through 8276;
(c) Model 1846SX/OXYTRAK Oximeter, Catalog numbers 8280 through
8286. Recall #Z-092/094-3.
CODE Catalog No. Serial Nos.
8260 K7200 - K9999, L1000 - L1135
8270 J2170 - J3442
8280 H1500 - H2664
8261 H1860 - H2033
8262 H2760 - H2978
8263 H1725 - H1949
8264 H1275 - H1433
8271 H1540 - H1731
8272 H1700 - H1988
8273 H1550 - H1576
8274 H1640 - H1940
8276 H1500 - H1511
8281 H1095 - H1138
8282 H1100 - H1199
8283 H1110 - H1330
8284 H1080 - H1196
8286 H1019 - H1046.
MANUFACTURER Circuit Assembly Corporation, Irvine, California (component).
RECALLED BY Critikon, Inc., Tampa, Florida, by letter on or about January
17, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 8,508 units were distributed.
REASON The display segments and indicators, and push buttons have the
potential to malfunction, due to a defective connector material
utilized in the front panel display connector assembly.
PRODUCT Branemark System Drill/Countersink, Model SDIB 180, 3.15 x 10
mm, used with special drilling equipment to prepare the jawbone
to receive a self-tapping fixture. Recall #Z-108-3.
CODE Batch #507783 EXP 6/97.
-8-
MANUFACTURER Les Fils d'Auguste Maillefer SA, Ballaigues, Switzerland.
RECALLED BY Noblepharma USA, Inc., Chicago, Illinois, by telephone October
2, 1992, followed by letter October 13, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 436 units were distributed; firm estimates 50 percent of the
product remains on the market.
REASON The glass ampule labeled as 10 mm long drill/countersink may
contain a 13 mm long drill/countersink.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
PRODUCT MDT Biologic Spor-Test Biological Indicator, for monitoring
chemical and steam sterilization. Recall #Z-091-3.
CODE All lots of catalog numbers 30-2040-01, 30-2020-01, 30-2010-01,
260566, 260567, 260055, 30-2050-01, 30-2000-01, 230231001,
230231511.
MANUFACTURER MDT Biologic Company, Rancho Dominguez, California.
RECALLED BY Manufacturer, by letter March 30, 1992. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide, Switzerland, Canada.
QUANTITY Approximately 15,162 kits were distributed.
REASON The device contains inadequate storage instructions on some
packaging and instruction cards, in that it does not contain
instructions to allow the strips to come to room temperature
for two weeks before using if frozen.
MEDICAL DEVICE SAFETY ALERTS:
PRODUCT Theraplan and TP-11 Treatment Planning Systems, computerized
workstations used to calculate and determine appropriate
radiation treatment programs for doctors to administer to
cancer patients. Safety Alert #M-004/005-3.
CODE Theraplan Treatment Planning System -
Serial Numbers TH-01, TH-04, 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,
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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,
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-545,
THL-3100, THL-3102, THL-3103
TP-11 Treatment Planning System -
Serial Numbers TP-07, TP-08, TP-17, TP-20, TP-22,
TP-27, TP-30, TP-31, TP-41, TP-42, TP-47, TP-53,
TP-58, TP-63, TP-64, TP-67, TP-72, TP-74, TP-78,
TP-82, TP-83, TP-88, TP-89, TP-91, TP-92, TP-93,
TP-96, TP-100, TP-103, TP-109, TP-115, TP-125,
TP-127, TP-136, TP-139, TP-142, TP-149, TPL-200,
TPL-220, 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. (AECL Medical)], Carrollton, Texas (assembler of
device/importer of components).
Theratronics International, Ltd., [formerly Atomic Energy of
Canada, Ltd. (AECL Medical)], Kanata, Ontario, Canada.
ALERTED BY Manufacturer, by letter September 4, 1992.
DISTRIBUTION Nationwide.
QUANTITY 245 units.
REASON Systems must be used with caution with all simulations
performed and be checked for accuracy by independent means.
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END OF ENFORCEMENT REPORT FOR DECEMBER 2, 1992. BLANK PAGES MAY
FOLLOW.
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