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
08/05/1992
RECALLS AND FIELD CORRECTIONS: August 5, 1992
FOODS - CLASS I
92-32
PRODUCT Fresh picked crabmeat processed on 8/14/91, in 16 ounce
containers:
(a) Jumbo Crabmeat; (b) Backfin Crabmeat;
(c) Claw Crabmeat; (d) Special Crabmeat. Recall #F-455/458-2.
CODE None.
MANUFACTURER Gloucester Seafood, Inc., Gloucester, Virginia.
RECALLED BY Manufacturer, by telephone October 25, 1991. Firm-initiated
recall complete.
DISTRIBUTION Maryland, Virginia.
QUANTITY Approximately 1,605 pounds were distributed; firm estimates
none remains on the market.
REASON Product was contaminated with Listeria monocytogenes.
PRODUCT Fresh picked crabmeat processed on 10/29/91, in 16 ounce
containers: (a) Clawmeat; (b) Special Crabmeat;
(c) Jumbo Lump Crabmeat. Recall #F-459/461-2.
CODE None.
MANUFACTURER Gloucester Seafood, Gloucester, Virginia.
RECALLED BY Manufacturer, by telephone February 20, 1992. Firm-initiated
recall complete.
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DISTRIBUTION Maryland.
QUANTITY 341 pounds were distributed; firm estimates none remains on the
market.
REASON Product was contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT Cephradine Capsules, 250 mg, a semi-synthetic cephalosporin, in
100 capsule bottles, under Barr and Major labels.
Recall #D-438-2.
CODE Lot #OI55OCZ EXP 9/92 (or 10/92 on some Barr labels).
MANUFACTURER Barr Laboratories, Inc., Pomona, New York.
RECALLED BY Manufacturer, by letter July 17, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 11,457 bottles were distributed.
REASON Subpotency.
PRODUCT Various Rx injectable drug products:
(a) Atropine Sulfate Injection, USP, 1 ml, in multiple dose
vials, (i) 1 mg/ml, (ii) 0.3 mg/ml;
(b) Heparin Sodium Injection, 1,000 USP units/ml, in 1 ml
single dose vials;
(c) Magnesium Sulfate Injection, USP, 50%, 500 mg/ml; in 2 ml
single dose vials. Recall #D-440/443-2.
CODE Lot numbers: (a) 1 mg/ml: lot #311331 EXP 12/94,
320144 EXP 2/95; 0.3 mg/ml: lot #320154 EXP 2/94;
(b) 320282 EXP 3/94;
(c) 320141 EXP 7/93, 320219 EXP 8/93, 320086 EXP 7/93.
MANUFACTURER Lyphomed, Division of Fujisawa USA, Inc., Grand Island,
New York.
RECALLED BY Lyphomed, Division of Fujisawa USA, Inc., Melrose Park,
Illinois, by letter July 16, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION (a & b) Nationwide; (c) Nationwide and Hong Kong.
QUANTITY (a) 309,375 vials (1 mg/ml) and 2,925 vials (0.3 mg/ml) of
Atropine Sulfate were distributed, with the firm estimating
that 87,000 vials of 1 mg and 1,000 vials of 0.3 mg product
remain on the market;
(b) 123,975 vials were distributed, with the firm estimating
that 31,000 vials remain on the market;
(c) 492,600 vials were distributed, with the firm estimating
that 96,000 vials remain on the market.
REASON The vials have a low fill volume.
UPDATE Recall #D-435-2, Disopyramide Phosphate Capsules, 100 mg, which
appeared in the July 29, 1992 Enforcement Report should read:
Recalled by Barr Pharmaceuticals, Inc., Pomona, New York by
letter July 9, 1992.
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RECALLS AND FIELD CORRECTIONS: DRUGS -- Class III
PRODUCT Technetium Tc 99m Generator, sterile, non-pyrogenic, a
diagnostic agent for intravenous injection. Recall #D-436-2.
CODE Lot #9221-4F-071.
MANUFACTURER The Dupont Merck Pharmaceutical Company, No. Billerica,
Massachusetts.
RECALLED BY Firm notified of the problem by the consignee on June 1, 1992.
Unit was returned to the firm on the same date. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed and was destroyed 7/15/92.
REASON Unit received less than intended fill.
PRODUCT Valpin 50, anisotropine methylbromide, 50 mg oral tablets, in
100 tablet bottles, a Rx anticholinergic. Recall #D-437-2.
CODE Lot #DN236A 12/94.
MANUFACTURER Du Pont Pharmaceuticals, Garden City, New York.
RECALLED BY Manufacturer, by letter June 9, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Puerto Rico.
QUANTITY 6,003 bottles were distributed; firm estimates 2,500 bottles
remain on the market.
REASON Product does not meet content uniformity specifications.
PRODUCT Naturlax, sugar free orange flavored psyllium hydrophilic
mucelloid, a natural fiber laxative. Recall #D-439-2.
CODE Lot #910936.
MANUFACTURER Cenci Powder Products, Inc., Fresno, California.
RECALLED BY Manufacturer, by telephone and by letters of January 8 and 27,
1992. Firm-initiated recall ongoing.
DISTRIBUTION California, Florida, Minnesota, New Jersey, Tennessee.
QUANTITY 1,224 bottles distributed.
REASON Sugar free product packed in bottles labeled as containing
sugar.
PRODUCT MMI Opti-UP brand Barium Sulfate for suspension for use in air
contrast examination of the upper gastrointestinal tract, in
312 gram cups. Recall #D-444-2.
CODE Lot #904920.
MANUFACTURER Century Pharmaceutical, Inc., Indianapolis, Indiana.
RECALLED BY MMI, Inc., Southfield, Michigan, by letter April 7, 1992.
Firm-initiated recall complete.
DISTRIBUTION New Jersey, Michigan, Missouri, Texas, South Carolina, Abu
Dhabi UAE, Switzerland.
QUANTITY 1,536 cups were distributed; firm estimates none remains on the
market.
REASON Incorrect expiration date on product.
-3-
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
PRODUCT (a) Red Blood Cells, Washed; (b) Platelets, Pooled;
(c) Cryoprecipitated AHF, Pooled. Recall #B-361/363-2.
CODE Unit numbers: (a) 3117813; (b) 32424, 33158, 32472; (c) 32891.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, (a & b) by telephone December 5, 1991, July 16,
1991 and September 4, 1991; (c) by telephone July 19, 1991 and
August 16, 1991. Firm-initiated recall ongoing.
DISTRIBUTION Texas.
QUANTITY (a) 1 Unit; (b) 3 units; (c) 1 unit.
REASON Blood products, which were either 1) labeled with the incorrect
expiration date; or 2) pooled products which contained expired
single donor units, were distributed.
PRODUCT Platelets. Recall #B-364-2.
CODE Unit #KX31592.
MANUFACTURER Central Blood Bank, Pittsburgh, Pennsylvania.
RECALLED BY Manufacturer, by telephone November 30, 1990. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit.
REASON Blood product, which tested repeatedly reactive for the
antibody to human T-lymphotropic virus type I (anti-HTLV-I),
was distributed.
PRODUCT Red Blood Cells. Recall #B-372-2.
CODE Unit numbers: 11E57097 and 11F74348.
MANUFACTURER American Red Cross, St. Louis, Missouri.
RECALLED BY Manufacturer, by telephone January 3, 1992, followed by letter
January 8, 1992 for unit 11E57097; by telephone, followed by
letter November 7, 1991 for unit 11F74348. Firm-initiated
recall complete.
DISTRIBUTION Missouri.
QUANTITY 2 units.
REASON Blood products which 1) tested repeatedly reactive for the
hepatitis B surface antigen (HBsAg), or 2) tested non-reactive
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 Source Plasma. Recall #B-370-2.
CODE Unit numbers: N-59719-024 and N-59725-024.
MANUFACTURER Pine Bluff Plasma Center, Inc., Pine Bluff, Arkansas.
RECALLED BY Manufacturer, by telephone January 30, 1992. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 2 units were distributed.
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REASON Blood products which tested repeatedly reactive for hepatitis B
surface antigen (HBsAg), were distributed.
PRODUCT Source Plasma. Recall #B-386-2.
CODE Unit #10917F.
MANUFACTURER Allegheny Biologicals, Inc., Jacksonville, Florida.
RECALLED BY Manufacturer, by letter May 26, 1992. Firm-initiated recall
complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit.
REASON Source Plasma, which tested negative for hepatitis B surface
antigen (HBsAg), but was collected from a donor who previously
tested repeatedly reactive for HBsAg, was distributed.
RECALLS AND FIELD CORRECTION: BIOLOGICS - CLASS III
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma;
(d) Recovered Plasma. Recall #B-349/352-2.
CODE Unit numbers: (a) 16F52348, 16L41036; (b) 16L41036;
(c) 16L41036; (d) 16F52348.
MANUFACTURER American Red Cross, Columbus, Ohio.
RECALLED BY Manufacturer, by telephone February 7, 1992 followed by letters
of February 14, 1992 and March 13, 1992. Firm-initiated recall
complete.
DISTRIBUTION Ohio, California.
QUANTITY (a) 2 units; (b) 1 unit; (c) 1 unit; (d) 1 unit.
REASON Blood products which tested repeatedly reactive for hepatitis B
surface antigen (HBsAg), were distributed.
PRODUCT Source Plasma. Recall #B-359-2.
CODE Unit #PF10388.
MANUFACTURER Community Bio-Resources, Inc., New Orleans, Louisiana.
RECALLED BY Manufacturer, by telephone March 25, 1992, followed by letter
March 26, 1992. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood component not tested for the antibody to the human
immunodeficiency virus, type 1/2 (anti-HIV-1/2) was distributed.
PRODUCT Recovered Plasma. Recall #B-360-2.
CODE M4162.
MANUFACTURER Montrose Memorial Hospital, Montrose, Colorado.
RECALLED BY Manufacturer, by telephone June 12, 1992 and by letter June 13,
1992. Firm-initiated recall complete.
DISTRIBUTION Colorado, Florida.
QUANTITY 1 unit.
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REASON Blood product, which tested initially reactive for hepatitis B
surface antigen (HBsAg) was incorrectly interpreted as
nonreactive and was distributed.
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-375/376-2.
CODE Unit #8158931.
MANUFACTURER J.K. and Susie L. Wadley Research Institute and Blood Bank,
Dallas, Texas.
RECALLED BY Consignee of Red Blood Cells notified firm by telephone May 15,
1992. Recalling firm notified firm of Recovered Plasma by
letter July 6, 1992. Firm-initiated recall complete.
DISTRIBUTION Texas, California.
QUANTITY 1 unit of each component.
REASON Blood products labeled with two unit numbers were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
PRODUCT Treatment Table Models 73 and 73M used with the Theratron Model
T1000 Cobalt 60 Radiation Therapy Devices. Recall #Z-905-2.
CODE Serial numbers: 001, 002, 007, 010, 012.
MANUFACTURER Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd. (AECL Medical), Carrollton, Texas;
Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd. (AECL Medical), Ontario, Canada.
RECALLED BY Manufacturer, by implementing a design change (DC 16167) on
March 20, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION California, Florida, Illinois, Kansas.
QUANTITY All units were modified.
REASON The table(s) continue to rise for 2-3 seconds after the
operator released the "deadman" enabling switch.
PRODUCT Cobalt 60 Radiation Therapy Units:
(a) Model T780; (b) Model 780C; (c) T1000. Recall #Z-907/909-2.
CODE Serial number range (a) 003 through 433; (b) 002 through 103;
(c) 001 through 012.
MANUFACTURER Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd. (AECL Medical), Carrollton, Texas;
Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd. (AECL Medical), Ontario, Canada.
RECALLED BY Manufacturer, by bulletin issued September 24, 1991.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 142 units; (b) 19 units; (c) 9 units were distributed.
REASON The collimator rotation drive system on the units may not be
able to hold the position the operator chooses during a
treatment if an unbalanced configuration of accessories is used.
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PRODUCT Cobalt 60 Radiation Therapy Units:
(a) Theratron Model T780; (b) Theratron Model T780C;
(c) Eldorado Model E76; (d) Eldorado Model E78.
Recall #Z-910/913-2.
CODE Serial number range: (a) 003 through 433; (b) 002 through 103;
(c) 003, 005, 1X; (d) 002 through 903.
MANUFACTURER Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd. (AECL Medical), Carrollton, Texas;
Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd. (AECL Medical), Ontario, Canada.
RECALLED BY Manufacturer, by User Bulletin CUB-92-10 sent on or before June
1, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 142 units; (b) 19 units; (c) 3 units; (d) 15 units were
distributed.
REASON Some of these units were shipped with grade 5 bolts instead of
grade 8 bolts, which are used to secure the head, beamstopper
and counterweight to the arm, and also to secure the arm to the
tube shaft for rotational units. These bolts are also used to
secure the head/neck assembly to the carriage assembly of
vertical units. Use of incorrect bolt grade may compromise
safety to due to fatigue failure.
PRODUCT Cobalt Radiation Therapy Units, Theratron and ELdorado Models:
(a) T80; (b) T765; (c) T780; (d) E6; (e) E8;
(f) E76; (g) E78; (h) EG; (i) ESG. Recall #Z-914/922-2.
CODE (a) Serial number range 012 though 156;
(b) Serial number 007;
(c) Serial number range 003 through 433;
(d) Serial number range 008 through 097;
(e) Serial number range 005 through 102;
(f) Serial numbers 003, 005, 1X;
(g) Serial number range 002 through 903;
(h) Serial numbers 021, 034, 027;
(i) Serial number XXX (unknown) and 004.
MANUFACTURER Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd. (AECL Medical), Carrollton, Texas;
Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd. (AECL Medical), Ontario, Canada.
RECALLED BY Manufacturer, by User Bulletin CUB-92-03 dated May 11, 1992.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 156 units; (b) 1 unit; (c) 142 units; (d) 18 units;
(e) 24 units; (f) 3 units; (g) 15 units; (h) 3 units;
(i) 2 units were distributed.
REASON The firm's User Bulletin CUB-92-03 dated 11 May 1992, provided
maintenance instructions to reduce a mechanical timer problem
that could result in radiation overdose due to timing error.
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PRODUCT Cobalt Radiation Therapy Units, Theratron, ELdorado, and
Phoenix Models:
(a) T80; (b) T765; (c) T780; (d) T780C; (e) T1000;
(f) E6; (g) E8; (h) E76; (i) E78; (j) Phoenix;
Recall #Z-923/932-2.
CODE (a) Serial number range 012 though 156;
(b) Serial number 007;
(c) Serial number range 003 through 433;
(d) Serial number range 002 through 103;
(e) Serial number range 001 through 012;
(f) Serial number range 008 through 097;
(g) Serial number range 005 through 102;
(h) Serial numbers 003, 005, 1X;
(i) Serial number range 002 through 903;
(j) Serial number range 001 through 036;
MANUFACTURER Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd. (AECL Medical), Carrollton, Texas;
Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd. (AECL Medical), Ontario, Canada.
RECALLED BY Manufacturer, by User Bulletin CUB-92-04 dated May 11, 1992.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 156 units; (b) 1 unit; (c) 142 units; (d) 19 units; (e) 9
units; (f) 18 units; (g) 24 units; (h) 3 units; (i) 15 units
(j) 15 units were distributed.
REASON Use of Molykote lubricants in air cylinders may lead to a stuck
or slow moving source which may result in a radiation overdose.
PRODUCT Cobalt 60 and Linear Accelerator Radiation Therapy Units, and
Simulators:
(a) T80; (b) T780; (c) T780C;
Linear Accelerator, Theratron Models;
(d) T6; (e) T20; (f) T25;
Simulators, Therasim Models:
(g) T720; (h) T750. Recall #Z-933/940-2.
CODE (a) Serial number range 012 through 156;
(b) Serial number range 003 through 433;
(c) Serial number range 002 through 103;
Linear Accelerator, Theratron Models;
(d) Serial number range 010 through 563;
(e) Serial number range 031 through 813;
(f) Serial number range 022 through 033;
Simulators, Therasim Models:
(g) Serial number range 038 through 601;
(h) serial number range 007 through 135.
MANUFACTURER Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd. (AECL Medical), Carrollton, Texas;
Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd. (AECL Medical), Ontario, Canada.
-8-
RECALLED BY Manufacturer, by User Bulletin CUB-92-09 sent on or before June
1, 1992, User Bulletin AUB-92-02 sent to all accelerator users
on or before June 1, 1992, and by User Bulletin SUB-92-01 sent
to all Simulator users on or before June 1, 1992.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY (1) 56 units; (2) 142 units; (3) 19 units; (4) 16 units;
(5) 16 units; (6) 4 units; (7) 14 units; (8) 84 units were
distributed.
REASON The key in the pulley bushing attached to the gantry gear drive
reducer may become loose and fall out with extended use and
cause the pulley to slip, resulting in unwanted gantry motion
and possible incorrect radiation dose administration.
PRODUCT Cobalt 60 Radiation Therapy Units, Theratron and Phoenix Models:
(a) T780C; (b) T1000; (c) Phoenix. Recall #Z-941/943-2.
CODE (a) Serial number range 002 through 103;
(b) Serial number range 001 through 012;
(C) Serial number range 001 through 036.
MANUFACTURER Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd. (AECL Medical), Carrollton, Texas;
Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd. (AECL Medical), Ontario, Canada.
RECALLED BY Manufacturer, by User Bulletin CUB-92-07 dated April 3, 1992.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 19 units; (b) 9 units; (c) 15 units were distributed.
REASON Fuses can blow during beam treatment causing misadministration
of radiation dosage.
PRODUCT (a) Peripheral Rotablator, designed for use in arms and legs;
(b) Coronary Rotablator, designed to remove plaque and
calcified deposits from arteries leading to the heart.
Recall #Z-944/945-2.
CODE All lots.
MANUFACTURER Heart Technology, Bellevue, Washington.
RECALLED BY Manufacturer, by letter June 24 & 25, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 13,000 units were distributed; firm estimates 2,000 to 3,000
units remain on the market.
REASON The device may contain a small protruding loop of one of the
three wires that make up the drive shaft, which can cause the
device to fail.
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
PRODUCT Phoenix Model Cobalt 60 Radiation Therapy Unit with Console
A112709-113. Recall #Z-906-2.
-9-
CODE Serial numbers: 001, 003, 005, 006, 008, 010, 012, 014, 017,
018, 020, 023, 032, 036, one unknown serial number.
MANUFACTURER Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd. (AECL), Carrollton, Texas; Theratronics
International, Ltd, formerly Atomic Energy of Canada, Ltd.,
(AECL Medical), Ontario, Canada.
RECALLED BY Manufacturer, by User Bulletin CUB-91-08EX sent September 26,
1991. Firm-initiated field correction complete.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates all units have been modified in accordance with
the user bulletin.
REASON A wide-component-to-component variation in the characteristic
of a chip in the timer control console circuit could result in
the circuit triggering improperly.
PRODUCT Seldinger Needles, 18 gauge TW, angiographic needles designed
for the percutaneous puncture of the anterior wall of a vessel
in order to provide a suitable entry site for intravascular
guide wire, vessel dilator (when necessary) and catheter
introduction. Recall #Z-946-2.
CODE Lot #44198.
MANUFACTURER Mallinckrodt Medical, Inc., Angelton, Texas.
RECALLED BY Manufacturer, by telephone January 1, 1989. Firm-initiated
recall completed on March 1, 1989.
DISTRIBUTION Virginia, Illinois, Missouri, Florida.
QUANTITY Firm estimates none remains on the market.
REASON The device was mislabeled as a Seldinger needle, when it
actually contained a Potts-Cournand needle.
UPDATE Schneider Teflon Fixed Core .025 inches, 145 cm Straight Tip
Guidewires, Recall #Z-866-2, which appeared in the July 22,
1992 Enforcement Report is a completed recall.
MEDICAL DEVICE SAFETY ALERTS
PRODUCT Cobalt 60 Radiation Therapy Units, Linear Accelerators and
Simulators:
Theratron Models: (a) T780; (b) T780C; (c) T1000; (d) T80;
Eldorado Models: (e) E6; (f) E8; (g) E76; (h) E78;
(i) Phoenix;
Linear Accelerator Models (j) T6; (k) T20; (l) T25;
Therasim Simulator Models: (m) T720; (n) T750.
Safety Alert #M-063/076-2.
CODE (a) Serial number range 003 through 433;
(b) Serial number range 002 through 103;
(c) Serial number range 001 through 012;
(d) Serial number range 012 through 156;
(e) Serial number range 008 through 097;
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(f) Serial number range 005 through 102;
(g) Serial numbers 003, 005, 1X;
(h) Serial number range 002 through 903;
(i) Serial number range 001 through 036;
Linear Accelerator, Theratron Models:
(j) Serial range 010 through 563;
(k) Serial number range 031 through 813;
(l) Serial range 022 through 033:
Simulators, Therasim Models:
(m) Serial number range 038 through 601;
(n) Serial number range 006 through 142.
MANUFACTURER Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd. (AECL), Carrollton, Texas; Theratronics
International, Ltd, formerly Atomic Energy of Canada, Ltd.,
(AECL Medical), Ontario, Canada.
ALERTED BY Manufacturer, by User Bulletin CUB-91-05, dated 9/16/91 and
User Bulletins CUB-92-06, AUB-92-03 and SUB-92-02, all dated
5/11/92.
DISTRIBUTION Nationwide.
QUANTITY (a) 142 units; (b) 19 units; (c) 9 units; (d) 156 units; (e) 18
units; (f) 24 units; (g) 3 units; (h) 15 units; (i) 15 units;
(j) 16 units; (k) 16 units; (l) 4 units; (m) 14 units; (n) 84
units were distributed.
REASON The firm issued User Bulletin CUB-91-05, dated 9/16/91, to
T780, T780C, T1000 and Phoenix users warning them that the
hardware securing the lead wedges to the wedge filter tray may
become loose and allow the lead wedge to fall. The firm also
issued User Bulletins CUB-92-06, AUB-92-03 and SUB-92-02, all
dated 5/11/92, to all users of the above listed units and
refurbishers of the older models T80, T780, E6, E8, E76 and E78
units to warn them that accessories such as rails, beam shaping
trays, wedge filters, and other collimator mounted hardware may
become loose, disengage, and fall, possibly striking a
patient. All bulletins asked the users to examine all screws
for accessories and rails to verify they are secure, and served
as a reminder to perform proper routine checks.
PRODUCT Cobalt 60 Radiation Therapy Devices Eldorado Models:
(a) E6; (b) E8; (c) E76; (d) E78; (e) EG; (f) ESG.
Safety Alert #M-077/082-2.
CODE (a) Serial number range 008 through 097;
(b) Serial number range 005 through 102;
(c) Serial numbers 003, 005, 1X;
(d) Serial number range 002 through 903;
(e) Serial numbers 021, 034, 027;
(f) Serial numbers XXX (unknown) and 004.
MANUFACTURER Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd. (AECL), Carrollton, Texas; Theratronics
International, Ltd, formerly Atomic Energy of Canada, Ltd.,
(AECL Medical), Ontario, Canada.
ALERTED BY Manufacturer, by telephone June 12 and 19, 1992 followed by
memorandums dated June 16, 1992.
-11-
DISTRIBUTION Nationwide and international.
QUANTITY (a) 18 units; (b) 24 units; (c) 3 units; (d) 15 units;
(e) 3 units; (f) 2 units were distributed.
REASON The treatment head of an Eldorado unit fell suddenly. Users
were requested to discontinue use of the units until the firm
could determine the possible cause of the incident and identify
preventive measures to follow. Users were then advised of the
results of the firm's investigation and provided with
inspection procedures to follow before returning units to
service.
PRODUCT Cobalt 60 Radiation Therapy Units, Eldorado Models:
(a) E6; (b) E8; (c) E76; (d) E78. Safety Alert #M-083/086-2.
CODE (a) Serial number range 007 through 080;
(b) Serial number range 005 through 102;
(c) Serial numbers 003, 005, 1X;
(d) Serial number range 002 through 903.
MANUFACTURER Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd. (AECL), Carrollton, Texas; Theratronics
International, Ltd, formerly Atomic Energy of Canada, Ltd.,
(AECL Medical), Ontario, Canada.
ALERTED BY Manufacturer, by User Bulletin CUB-92-11NA sent to users on or
about June 1, 1992.
DISTRIBUTION Nationwide.
QUANTITY (a) 18 units; (b) 24 units; (c) 3 units; (d) 15 units.
REASON An incident occurred in China in which a treatment table
attached to an Eldorado unit raised suddenly possibly due to
improper installation. The bulletin stated that precautions
should be taken when installing a table to an Eldorado unit to
help prevent collisions and/or injury should unwanted motion
occur and provided instructions for installing a table.
MASS SEIZURE
PRODUCT Frozen shrimp (92-658-730).
CHARGE Adulterated - The products contain saccharin, a food
additive which is unsafe because its use is not in
conformity with the regulation which prescribes the
conditions under which it may be safely used.
FIRM New England Shrimp Company, Inc., Ayer, Massachusetts.
FILED July 13, 1992; U.S. District Court for the District
of Massachusetts; Civil #92-11715MA, FDC #66479.
SEIZED July 16, 1992 - goods valued at approximately $2.75 million.
SEIZURES
PRODUCT Latex patient examination gloves (92-646-766/76).
CHARGE Adulterated - The quality of the gloves falls below that
which they purport or are represented to possess since they
exceed the defect rate established by regulation.
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FIRM American International Medical Equipment Sales, Inc., Bronx,
New York.
FILED May 22, 1992 - U.S. District Court for the Southern
District of New York; Civil #92CV3606, FDC #66419.
SEIZED June 1, 1992 - goods valued at approximately $21,000.
PRODUCT Canned sliced peaches (92-643-805).
CHARGE Adulterated - The products consist in part of a filthy
substance, Geotrichum mold.
Misbranded - The products purport to be and are represented
as canned peaches, a food for which a standard of identity
has been prescribed, and their quality falls below such
standard because they contain pit fragments in excess of the
amount allowed by the standard, and their labels fail to
bear a statement that they fall below such standard.
FIRM Apollo Warehouse, Newark, New Jersey.
FILED May 5, 1992 - U.S. District Court for the District
of New Jersey; Civil #92-1866; FDC #66412.
SEIZED May 19, 1992 - goods valued at approximately $6,456.
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