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
03/20/1996
ENFORCEMENT REPORT FOR 03/20/96
March 20, 1996 96-12
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Various flavored bouillon:
(a) Bouillon, Chicken, 12/5/2 shells
(b) Bouillon, Chicken, 6/24/10 shells
(c) Bouillon, Beef, 4/24/10 shells
(d) Bouillon, Beef, 10/24/6 shells
(e) Bouillon, Chicken & Tomato, 4/24/6 shells
(f) Bouillon, Ham, 10/24/6, shells
(g) Bouillon, Chicken, 6/24/6 shells
(h) Bouillon, Beef, 6/24/6 shells
(i) Bouillon, Fish, 6/24/6 shells.
Recall #F-327/335-6.
CODE Puerto Rico:
Lot # Exp Date Lot # Exp Date
B507 12/7/96 B578 12/8/96
B510 12/10/96 B511 12/11/96
B512 12/12/96 B513 12/13/96
B514 12/14/96 B515 12/15/96
0525 10/25/96 0526 10/26/96
0529 10/29/96 A526 11/26/96
A527 11/27/96 A528 11/28/96
A529 11/29/96 A530 11/30/96
B501 12/1/96 B503 12/3/96
B504 12/4/96 B505 12/5/96
0526 10/26/96 A516 11/16/96
A513 11/13/96 A514 11/14/96
A515 11/15/96 A516 11/16/96
A526 11/26/96 A527 11/27/96
United States:
A513 11/13/96 A514 11/14/96
A515 11/15/96 A517 11/17/96
A521 11/21/96 A522 11/22/96
A527 11/27/96 B510 12/10/96
5B12 12/12/96 B517 12/17/96
B518 12/18/96 B519 12/18/96
B520 12/20/96 B521 12/21/96
0526 10/26/96 0523 10/23/96
0524 10/24/96 0525 10/25/96
B503 12/3/96 B504 12/4/96
B505 12/5/96 B506 12/6/96
B507 12/7/96.
MANUFACTURER Best Foods Caribbean Inc., Arecibo, Puerto
Rico.
RECALLED BY CPC International, Inc., Englewood Cliff, New
Jersey, by letter dated December 26, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 2,681 cases were distributed; firm estimates
none remains on the market.
REASON Products contain small pieces of metal wire.
_______________
PRODUCT Raw Sunflower Seeds, in 50 pound bags: (a)
Sunflower Seeds in Shell; (b) Sunflower
Kernals. Recall #F-338/339-6.
CODE Lot numbers: (a) 0I5F11; (b) 8I5F11.
MANUFACTURER Dahlgren & Company, Inc., Fargo, North Dakota.
RECALLED BY Dahlgren & Company, Inc., Crookston,
Minnesota, by telephone on September 13, 1995,
followed by letter on September 14, 1995.
Firm-initiated recall complete.
DISTRIBUTION Minnesota, North Dakota, Ohio.
QUANTITY (a) 10 bags; (b) 282 bags were distributed.
REASON Products contain illegal residues of
chloropicrin.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Balsams Spring Baby Water with fluoride, in
clear gallon PVC containers. Recall #F-324-6.
CODE All codes.
MANUFACTURER Balsams Spring Water Company, Berlin, New
Hampshire.
-2- RECALLED BY Veryfine Products, Inc., Westford,
Massachusetts, by issuing press release on
January 12, 1996, and by letter followed by
verbal notification. Firm-initiated recall
ongoing.
DISTRIBUTION Massachusetts, Maine, Rhode Island, New York,
New Jersey, Vermont, Virginia.
QUANTITY 5,121 cases (6 gallons per case) were
distributed.
REASON Product is unfit for food due to seal micro
leakage and contamination with extraneous
material.
_______________
PRODUCT Garlic & Pepper Seasoning in 8 ounce jars,
labeled to contain "Salt, Garlic, and Pepper".
Recall #F-326-6.
CODE Product code 50573, UPC code 8093325700 - All
Lots.
MANUFACTURER Texas Spice Company (TSP), Houston, Texas.
RECALLED BY Manufacturer, by letter dated October 19,
1995. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 287 cases (24 jars per case) were distributed.
REASON Product fails to bear an appropriate identity.
The product should be identified as "Garlic &
Pepper Flavored Salt."
_______________
PRODUCT Canned Anchovies with Capers, in 2 ounce cans.
Recall #F-336-6.
CODE TS253J and TS246J.
MANUFACTURER Conserver La Girond, Morocco.
RECALLED BY World Finer Foods, Inc., Bloomfield, New
Jersey, by letter June 9, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 1,425 cases were distributed.
REASON Product is unfit for food due to swollen cans.
_______________
PRODUCT Cream of Potato Condensed Soup, in 10.5 ounce
cans. Recall #F-337-6.
CODE 02434 VM 3990 and 02444 VM 3990.
MANUFACTURER Venice Maid Company, Inc., Vineland, New
Jersey.
RECALLED BY Manufacturer, by telephone March 10, 1994.
Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1,451 cases were distributed.
REASON Product is unfit for food due to swollen and
exploding cans.
-3- _______________
PRODUCT Fruit flavored cereal:
(a) Malt-O-meal Tootie Fruities Sweetened
Fruit Flavored Cereal, in 15 ounce plastic
bags; (b) Kroger Fruit & Frosted O's Pre-
Sweetened Cereal, in 15 ounce boxes.
Recall #F-340/341-6.
CODE (a) IJAN2697 and KJAN2597; (b) IJAN2697.
MANUFACTURER Malt-O-Meal Company, Northfield, Minnesota.
RECALLED BY Manufacturer, by telephone on February 21,
1996, followed by letter on February 28, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Idaho, Michigan, Minnesota, New Jersey, Ohio,
Texas, Washington state, Wisconsin.
QUANTITY 742 cases (12 bags/boxes per case) were
distributed.
REASON Product contains small metal shavings.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Akne-Mycin 2% Ointment (2% erythromycin), in
7.5 gram tubes, Rx for topical use for the
treatment of acne. Recall #D-094-6.
CODE Lot #44462/1 EXP 10/96.
MANUFACTURER Hermal Kurt Herrmann, Federal Republic of
Germany.
RECALLED BY Center Laboratories, Hermal Dermatology Group,
Delmar, New York, by letter issued on or about
March 1, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 53,200 units were distributed.
REASON Superpotency.
HUMAN TISSUE MANDATORY RECALLS ==============================
_______________
PRODUCT Human Tissues for Transplant.
Recall #B-321-6.
CODE Cornea Human Tissue Donor Numbers: 93-685,
94-001, 94-002, 94-005, 94-013, 94-014,
95-006; Sclera Human Tissue, Donor Numbers:
94-005, 94-006, 94-013, 94-014.
MANUFACTURER Lions Organ and Eye Bank, Fort Worth, Texas.
RECALLED BY Manufacturer, by letter dated August 23, 1995,
and sent on September 4, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION New Mexico, Texas.
QUANTITY 11 donors.
REASON Human tissues, not tested for HIV-2, was
distributed.
-4- RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Red Blood Cells. Recall #B-255-6.
CODE Unit #3189319.
MANUFACTURER Central Texas Regional Blood Center, Austin,
Texas.
RECALLED BY Manufacturer, by telephone and by letter dated
October 25, 1994. Firm-initiated recall
complete.
DISTRIBUTION Tennessee.
QUANTITY 1 unit.
REASON Blood product, which was collected from a
donor who had unprotected promiscuous sex, was
distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-256-6.
CODE Unit #M78288.
MANUFACTURER Topeka Blood Bank, Inc., Topeka, Kansas.
RECALLED BY Manufacturer, by telephone on April 25, 1995,
followed by letter dated May 1, 1995. Firm-
initiated recall complete.
DISTRIBUTION Kansas.
QUANTITY 1 unit.
REASON Blood product, which was collected from a
donor who had a history of malaria, was
distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Platelets, Pooled; (d) Fresh Frozen Plasma;
(e) Recovered Plasma. Recall #B-269/273-6.
CODE Unit numbers: (a) 1188429, 1188476, 1208137,
1209663, 3120980, 7162124; (b) 1188429,
1208137; (c) P38470, P40681, P42464, P50575,
P51896; (d) 1209663; (e) 1188429, 1185002,
1188476, 1208137, 3120980, 7162124.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, by letters dated December 8 and
11, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Texas, California.
QUANTITY (a) 6 units; (b) 2 units; (c) 5 units; (d) 1
unit; (e) 6 units.
REASON Blood products, collected from donors who were
exposed to blood through skin punctures or
mucous membranes, were distributed.
_______________
PRODUCT (a) Platelets, Pheresis; (b) Fresh Frozen
Plasma. Recall #B-281/282-6.
CODE Unit #9510532.
MANUFACTURER Lorain County Blood Bank, Elyria, Ohio.
-5- RECALLED BY Manufacturer, by letter and by telephone on
February 6, 1995. Firm-initiated recall
complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit.
REASON Blood products, labeled with an extended
expiration date, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-299/300-6.
CODE Unit numbers: 18207-7073 and 18209-0615.
MANUFACTURER Blood Systems, Inc., doing business as United
Blood Services, Cheyenne, Wyoming.
RECALLED BY Manufacturer, by telephone followed by letter
dated December 8, 1995. Firm-initiated recall
complete.
DISTRIBUTION Illinois and Switzerland.
QUANTITY 2 units of each component.
REASON Blood products, which were collected from a
donor with a history of body piercing within
twelve months of donation, was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-301-6.
CODE Unit #39KG37011.
MANUFACTURER American Red Cross Blood Services, Huntington,
West Virginia.
RECALLED BY Manufacturer, by telephone on December 13,
1994. Firm-initiated recall complete.
DISTRIBUTION West virginia.
QUANTITY 1 unit.
REASON Blood product, corresponding to a unit of
Fresh Frozen Plasma which was positive for
Enterobacter cloacae, was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-302/303-6.
CODE Unit #29CG40022.
MANUFACTURER American Red Cross Blood Services, Norfolk,
Virginia.
RECALLED BY Manufacturer, by letter dated February 16,
1994, and March 4, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Virginia, North Carolina.
QUANTITY 1 unit of each component.
REASON Blood products, collected from a donor with a
history of cancer, were distributed.
-6- _______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c)
Platelets; (d) Single Donor Plasma.
Recall #B-311/314-6.
CODE Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance (301) 594-
1070 for individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, Norfolk,
Virginia.
RECALLED BY Manufacturer, by telephone and fax on or about
December 2, 1994, followed by letter dated
December 9, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Virginia, North Carolina, Missouri, Illinois,
California, Puerto Rico, Switzerland.
QUANTITY 920 blood products.
REASON Blood products, collected from donors whose
health history screening was inadequately
performed, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Recovered Plasma.
Recall #B-317/320-6.
CODE Unit numbers: (a & b) 8415607, 8451393; (c)
8415607; (d) 8451393.
MANUFACTURER The Blood Center for Southeast Louisiana, New
Orleans, Louisiana.
RECALLED BY Manufacturer, by letter dated November 9,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Louisiana, Florida, California.
QUANTITY (a) 2 units; (b) 2 units; (c) 1 unit; (d) 1
unit.
REASON Blood products, which were collected from a
donor whose spouse tested positive for HCV-Ab,
were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Cryoprecipitated AHF; (e)
Recovered Plasma. Recall #B-322/326-6.
CODE Unit numbers: (a) 1380982, 1425743, 1433142,
1443902, 1460000, 1469368, 1462103, 1480505;
(b) 1462103, 1480505; (c) 1462103; (d)
1443902; (e) 1443902, 1469368, 1480505.
MANUFACTURER Mississippi Blood Services, Inc., Jackson,
Mississippi.
RECALLED BY Manufacturer, by letter between October 2,
1995 and January 25, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Mississippi, California, New York.
QUANTITY (a) 8 units; (b) 2 units; (c) 1 unit; (d) 1
unit; (e) 3 units.
-7- REASON Blood products, collected from donors who
tested positive for syphilis within 12 months
of donation were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT (a) Red Blood Cells, Expired; (b) Recovered
Plasma. Recall #B-315/316-6.
CODE Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance (301) 594-
1070 for individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, Norfolk,
Virginia.
RECALLED BY Manufacturer, by telephone and fax on or about
December 2, 1994, followed by letter dated
December 9, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Virginia, North Carolina, Missouri, Illinois,
California, Puerto Rico, Switzerland.
QUANTITY 920 blood products
REASON Blood products, collected from donors whose
health history screening was inadequately
performed, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Platelets, Pheresis; (d) Fresh Frozen Plasma;
(e) Cryoprecipitated AHF; (f) Recovered
Plasma. Recall #B-304/309-6.
CODE Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance (301) 594-
1070 for individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by telephone on August 30 and
31, 1994. Firm-initiated recall complete.
DISTRIBUTION North Carolina, South Carolina, Georgia,
Tennessee, Virginia, Florida, California.
QUANTITY Approximately 4,500 units.
REASON Blood products, which were incorrectly tested
for antibodies to the human immunodeficiency
virus types 1 and 2 (anti-HIV-1/2) were
distributed.
_______________
PRODUCT Cryoprecipitated AHF. Recall #B-310-6.
CODE Unit numbers: 102233-7126, 102233-7127,
102233-7128.
MANUFACTURER Blood Systems, Inc., Scottsdale, Arizona.
RECALLED BY Manufacturer, by letters dated September 11,
1995. Firm-initiated recall complete.
-8- DISTRIBUTION Arizona.
QUANTITY 3 units.
REASON Cryoprecipitated AHF, prepared from plasma
which was not frozen within eight hours of
phlebotomy, was distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Laser Targeting Systems:
(a) Model AM 5000 Advanced Miles Transmitter,
used to test Miles transmitters and target
vests; (b) Model Miles ATS-101 Aerial Target
System, used to target fighter aircraft in
air-to-ground and ground-to-ground combat.
Recall #Z-377/378-6.
CODE None.
MANUFACTURER Schwartz Electro-Optics, Inc., Orlando,
Florida.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan (a) August 11, 1995;
(b) December 1, 1995. Firm-initiated filed
correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 4 units; (b) 29 units.
REASON The laser products failed to comply with the
Federal laser product performance standard
protective housing requirements, 21 CFR
1040.10(f)(1).
_______________
PRODUCT Niks Night Vision Monocular with Laser
Illuminator, night vision scope with laser
illuminator. Recall #Z-331-6.
CODE None.
MANUFACTURER International Sourcing, Inc., Fort Wayne,
Indiana.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan January 5, 1996. Firm-
initiated field corrections ongoing.
DISTRIBUTION Nationwide.
QUANTITY Nationwide.
REASON The laser product failed to comply with the
Federal laser product performance standard, 21
CFR 1010.2, 21 CFR 1010.3, 21 CFR
1040.10(f)(3), 21 1040.10(f)(4), 21 CFR
1040.10(f)(5)ii, 21 CFR 1040.10(f)(6), 21 CFR
1040.10(g)(2)(iii), 21 CFR 1040.10(g)(5), 21
CFR 1040.10(h)(1)(iii). These are violations
of the labeling and performance requirements
of the laser standard. Also the Niks Nights
-9- Vision Monocular is defective under 21 CFR
1003.2, in that it emits 13-20 kev x-rays at a
rate of 3.5 mR/hr, which are not required to
accomplish its intended purpose.
_______________
PRODUCT Medi-Trace 200, Medi-Trace 200-30 ECG
Conductive Adhesive Electrodes.
Recall #Z-426/427-6.
CODE All lots.
MANUFACTURER Graphic Controls Corporation, Gananoque,
Ontario.
RECALLED BY Graphic Controls Corporation, Buffalo, New
York, by letters dated February 6, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimated that 1,121,000 electrodes
remained on the market at time of recall
initiation.
REASON The product lacks a 510(k). The labeling does
not provide adequate directions for use and
does not include all necessary precaution
statements.
_______________
PRODUCT AbTox Plazlyte Sterilization System, a low
temperature gas plasma sterilization system
used to sterilize surgical steel devices.
Recall #Z-472-6.
CODE All lots distributed between January and June
1995.
MANUFACTURER AbTox, Inc., Mundelein, Illinois.
RECALLED BY Manufacturer, via letter of August 17, 1995,
which provided revised instructions for use.
Firm-initiated field correction has been
completed.
DISTRIBUTION North Carolina, Washington, D.C., Kentucky,
Michigan, Texas, Wisconsin, California,
Georgia, Arkansas, Illinois, Minnesota, Ohio,
New York, Rhode Island, South Dakota.
QUANTITY 23 units were distributed.
REASON Labeling for the device promoted uses
unapproved in the United States.
_______________
PRODUCT Clinipad Sterile CV Pack 29028B.
Recall #Z-492-6.
CODE Kit #29028B, Lot #515823N.
MANUFACTURER Johnson & Johnson Medical, Inc., Arlington
Texas.
RECALLED BY Clinipad Corporation, Guilford, Connecticut
(kit assembler), by telephone on February 7,
1996. Firm-initiated recall ongoing.
-10- DISTRIBUTION New Jersey.
QUANTITY 80 kits were distributed.
REASON The clipping tabs on each side of the sheet
used to secure instrument lines tear when
weight is placed on them.
_______________
PRODUCT USCI Probe III Balloon-On-Wire Dilation
Catheter System, sterile.
Recall #Z-502/504-6.
CODE Catalog numbers: 004859, 004860, 004861, 196
Lots packaged from January 1994 to February
1996.
MANUFACTURER USCI Division, C. R. Bard, Inc., Billerica,
Massachusetts.
RECALLED BY Manufacturer, by letter dated February 16,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 8,897 units packaged from February 1994
through February 1996.
REASON Small holes were found in the sterile barrier
of Probe III test samples. USCI states that
testing was initiated to provide packaging
performance data after exposure to worst case
radiation sterilization. Holes could
compromise the sterility of the device.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Alko 6.8 pH/Electrolyte Calibrator for Corning
200 Series Blood Gas Analyzers.
Recall #Z-192-6.
CODE Catalog #A478-856, Lot #30719 EXP 7/97.
MANUFACTURER Alko Diagnostic Corporation, Holliston,
Massachusetts.
RECALLED BY Manufacturer, by letter mailed November 2,
1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 159 units were distributed.
REASON Bacterial contamination caused the pH value of
the lot to be outside the label-declared
value, which may cause measured pH values to
be falsely depressed.
_______________
PRODUCT IL Test ReferrIL B Calibrator for the Monarch
Chemistry and for the calibration of TCO 2 in
the ILab Chemistry Systems. Recall #Z-477-6.
CODE Catalog No. 35262, Lot numbers N1041015 and
N0153605.
-11- MANUFACTURER Instrumentation Laboratory Company,
Orangeburg, New York.
RECALLED BY Instrumentation Laboratory Company (ILC),
Lexington, Massachusetts, by letter dated
August 7, 1995. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 3,285 packages were distributed.
REASON The Monarch chloride values were reassigned
due to a -3MMOL bias found when using the
Monarch analyzer.
_______________
PRODUCT Stryker Sterile, Disposable Excel Medium Cone
Shield, designed for use with the Excel Pulsed
Irrigation/Suction System. Recall #Z-495-6.
CODE Lot #95091452.
MANUFACTURER Stryker Puerto Rico, Arroyo, Puerto Rico.
RECALLED BY Stryker Instruments, Division of Stryker
Corporation, Kalamazoo, Michigan, by letter
January 10, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Virginia, Illinois, Pennsylvania, Hong Kong.
QUANTITY 8 boxes (12 units per box) were distributed.
REASON The device package actually contains Stryker
Part Number 200-8, Disc Splash Guard, instead
of Part Number 207-210, the Excel Medium Cone
Shield. The Excel Cone Shield is designed for
use with the Excel Pulsed Irrigation/Suction
System. The Disc Splash Guard cannot be used
with this system.
MEDICAL DEVICE SAFETY ALERTS: ==============================
_______________
PRODUCT 3M Fletcher-Suit-Delclos (FSD) Applicators
(brachytherapy afterloading applicators for
radioactive cesium-137 sources used in
intracavity treatment of cervical and/or
uterine cancer) and Tandems:
(a) - Catalog No. 6586, 3M FSD with Standard
Tandems;
(b) Catalog No. 6587, 3M FSD with
Mini-Tandems;
(c) Catalog No. 6588, 3M FSD only.
Safety Alert #N-007/009-6.
CODE All serial numbers.
MANUFACTURER Basic Industries, New Brighton, Minnesota.
ALERTED BY Manufacturer, by letter dated January 8, 1996.
DISTRIBUTION Nationwide.
QUANTITY 1,023 units were distributed.
-12- REASON Possible failures resulting from long term
exposure to cleaning and sterilizing
solutions. The possible failures include
tungsten shielding jamming and preventing
after loading of the sources, the loss of the
internal tungsten shielding from the top
ovoid, and the possible detachment of the tip
of the tandem inside of a patient.
-13-
END OF ENFORCEMENT REPORT FOR MARCH 20, 1996. BLANK PAGES MAY
FOLLOW.
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