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
05/21/1991
FDA Enforcement for the week of 5/22/91
FDA ENFORCEMENT REPORT
FOR MAY 22, 1991
May 22, 1991
Recalls and Field Corrections:
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
NONE
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
Product: Fresh, raw potatoes under the following brand names and
sizes:
(a) Wada Farms brand, U.S. No. 1, in 100 pound
and 50 pound burlap sacks, in 50 pound cardboard boxes,
10 pound paper net bags, 10 pound poly bags, and 5 pound
poly bags;
-1-
(b) Sharp brand, U.S. No. 2, in 50 pound burlap sacks;
(c) Golden Crown brand, U.S. No. 1, in 10 pound paper
net bags;
(d) Burbank Potato Company brand, U.S. No. 1, in 5
pound paper net bags;
(e) Burbank Potato Company brand, U.S. No. 1, in 20 pound
cardboard boxes;
(f) Big Wheel brand, U.S. No. 1, in 50 pound cardboard
boxes;
(g) Snoboy brand, U.S. No. 1, in 50 pound cardboard
boxes, and in 10 pound poly bags. Recall #F-382-1.
Code: Not coded.
Manufacturer: Wada Farms Potatoes, Inc., Blackfoot, Idaho.
Recalled by: Manufacturer, by letter March 5, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide and Canada.
Quantity: 10,000,000 pounds were distributed.
Reason: The product is contaminated with the pesticide
chlorothalonil in excess of prescribed tolerance.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Sugar Free Eskimo Pie, 3.2 fluid ounces each.
Recall #F-381-1.
Code: 0181A.
Manufacturer: Ice Cream Specialties, St. Louis, Missouri.
Recalled by: Manufacturer, by telephone April 24, 1991.
Firm-initiated recall ongoing.
Distribution: Illinois.
Quantity: 57 cases (12 boxes per case) were distributed; firm
estimates none remains on the market.
Reason: The outer box lists the product as being "sugar free"
and containing fat. The individual packages are
labeled as "Fat Freedom" and indicate sugar as one of
the ingredients. The product was analyzed and found
to contain no sucrose but did contain 4.5% fat.
----
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
-2-
Class II -
Product: Platelets. Recall #B-217-1.
Code: Unit #29KV01052.
Manufacturer: American Red Cross Blood Services, Norfolk, Virginia.
Recalled by: Manufacturer, by letter October 10, 1990. Firm-initiated
recall complete.
Distribution: Virginia.
Quantity: 1 unit.
Reason: Blood product which tested non-reactive for the antibody
to the Human Immunodeficiency Virus Type 1 (anti-HIV-1),
but was collected from a donor who previously tested
repeatably reactive for anti-HIV-1, was distributed.
----
Product: Platelets. Recall #B-233-1.
Code: Unit #1422457.
Manufacturer: LifeSource, Glenview, Illinois.
Recalled by: Manufacturer, by letter March 1, 1991. Firm-initiated
recall complete.
Distribution: Illinois.
Quantity: One unit.
Reason: Blood product collected from a donor who reported an
exposure to hepatits, was distributed.
-----
Product: Recovered Plasma. Recall #B-239-1.
Code: Unit collected in 1989: 0035, 0038, 0062, 0083, 0087, 0092,
0090, 0118, 0156, 0163, 0187, 0188, 0216, 0304, 0306, 0341,
0349, 0359, 0631;
Units collected in 1990: 0105, 0108, 0160, 0161, 0212,
0213, 0214, 0217, 0642, 0676, 0682, 0688, 0697, 0770, 0779,
0782, 0836, 0902, 0939, 0947, 0948, 1040, 1072, 1073, 1118,
1119, 1124, 1150, 1153, 1159, 1185, 1252, 1359, 1381, 1540,
1541, 1545, 1552, 1557, 1560, 1562, 1564, 1566, 1575, 1578,
1704, 1707, 1720, 1814, 1817, 1821, 1926, 1939;
Units collected in 1991: 0256, 0319, 0337, 0341, 0370, 0411,
0451, 0472.
Manufacturer: Mountain View Hospital, Payson, Utah.
Recalled by: Manufacturer, by letters dated March 27, 1991 and
April 18, 1991. Firm-initiated recall ongoing.
Distribution: New York.
Quantity: 80 units.
Reason: Recovered Plasma collected from improperly screened
donors was distributed.
----
-3-
Class III -
Product: Recovered Plasma. Recall #B-240-1.
Code: Unit #0111.
Manufacturer: Mountain View Hospital, Payson, Utah.
Recalled by: Manufacturer, by letters dated March 27, 1991 and
April 18, 1991. Firm-initiated recall ongoing.
Distribution: New York.
Quantity: 1 unit.
Reason: Recovered Plasma which tested repeatably reactive for
the antibody to the Human T-lymphotropic Virus Type I
(HTLV-I) was distributed.
----
Product: Tencell Panel Reagent Red Blood Cells - Cell #3.
Recall #B-241-1.
Code: Lot # 91105 EXP 4/19/91.
Manufacturer: Organon Teknika Corporation, West Chester, Pennsylvania.
Recalled by: Manufacturer, by letter April 1, 1991. Firm-initiated
recall complete.
Distribution: Nationwide and international.
Quantity: 546 kits.
Reason: N (positive) Reagent Red Blood Cells labeled as N (negative)
were distributed.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: Volumetric infusion pumps for delivery of all IV fluids
and blood products into the body:
(a) Sigma 6000 Volumetric Infusion Pump;
(b) Avon Medical A760 Volumetric Infusion Pump.
Recall #Z-652/653-1.
Code: Approximately 4,700 units are affected, each unit has
a unique serial number. Not all serial numbers are
affected since some units had been corrected previously
as follow-up to Recall #Z-119/121-0 which appeared in
the December 6, 1989 Enforcement Report.
Manufacturer: Smith & Nephew SIGMA Inc., Medina, New York.
Recalled by: Manufacturer, by letter on or about May 1, 1991.
Firm-initiated field correction ongoing.
Distribution: (a) Nationwide, Canada; (b) England, The Netherlands,
Ireland, Italy.
Quantity: Approximately 4,700 units subject to field correction.
-4-
Reason: A Flex cable failure can cause erratic (gibberish)
display problems, or a programming error that could
result in a volume limit or rate entry chance at set up.
----
Product: Saline-Filled Oval Mammary Prosthesis with Posterior
Mentor Leaf Valve Fill Tube, used for routine cosmetic
augmentation and for tissue replacement following
mastectomy. Recall #Z-654-1.
Code: Catalog #350-1930MT, lot #37952.
Manufacturer: Mentor Corporation, Goleta, California.
Recalled by: Manufacturer, by telephone on or about August 24, 1990.
Firm-initiated field correction complete.
Distribution: Alabama, Indiana, Pennsylvania, Tennessee, Virginia,
West Virginia.
Quantity: 54 units were distributed; firm estimates none remains
on the market.
Reason: The device did not contain the fill tube stylet
accessory for the leaf valve. Also some containers were
labeled as diaphragm valve instead of leaf valve.
----
Product: Telemed Systems Disposable Gastroenterology and Cytology
Devices/Kits, sterile, manufactured prior to 4/18/91, used
to collect cell samples from patients' lungs and
digestive system:
1. Occlusion Balloons;
2. Disposable Polypectomy Snares;
3. Guidewires;
4. Gastrointestinal Brushes;
5. Bronchial Brushes;
6. Sclerotherapy Needles;
7. Transbronchial Needle;
8. E.R.C.P. Cannulas;
9. Papillotomes/Sphincterotomes;
10. Pigtail Stents;
11. Amsterdam Stents;
12. Stent Kits. Recall #Z-655/666-1.
Code: Catalog numbers: 1. 1560, 1562, 1702;
2. 4002, 4004, 4006, 4008, 4010, 4012, 4014;
3. 6002, 6004;
4. 3002, 3004, 3006, 3008, 3010, 3012;
5. 3102, 3104;
6. 2002, 2004, 2006, 2008;
7. 2102;
8. 5002, 5004, 5006;
9. 5102, 5104, 5106, 5108, 5110;
10. 5802, 5804, 5806, 5808, 5810, 5812;
11. 5602, 5604, 5606, 5608, 5610, 5612, 5614, 5616, 5618,
5620, 5622, 5624, 5626, 5628, 5630;
-5-
12. 5702, 5704, 5706, 5708, 5710, 5712, 5502, 5504, 5506,
5508, 5510, 5512, 5514, 5516, 5518, 5520, 5522, 5524, 5526,
5528, 5530.
Manufacturer: Telmed Systems, Inc., Marlborough, Massachusetts.
Recalled by: Manufacturer, by letter April 18, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: Unknown.
Reason: The sterility of the devices has been compromised by
loss of package integrity.
----
Product: Scimed Triguide Coronary Guiding Catheters, 8 French
shaft size:
(a) Anterior, Model numbers: FL3.5A, FL4A, FL4.5A,
FL5A, FL4A Side Holes, FK4.5A Side Holes, FL5A
Side Holes;
(b) Posterior, Model numbers: FL4P, FL5P, FL4P Side
Holes. Recall #Z-667/668-1.
Code: All lots.
Manufacturer: SCIMED Life Systems, Inc., Maple Grove, Minnesota.
Recalled by: Manufacturer, by telephone starting April 4, 1990 and
by FAX April 5, 1991 for foreign accounts except Canada,
which was telephoned. Firm-initiated recall ongoing.
Distribution: Nationwide, France, Germany, Belgium, Canada, Denmark.
Quantity: 370 units were distributed.
Reason: The "Anterior" coronary guiding catheters are labeled as
"Posterior" catheters and the "Posterior" catheters are
labeled as "Anterior."
----
Product: Model PRS 800 LH Point Range Sensor (Low Powered
Class III Laser). Recall #Z-669-1.
Code: Serial numbers: Undetermined.
Manufacturer: CyberOptics Corporation, Minneapolis, Minnesota.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan April 24, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 36 units were distributed.
Reason: Noncompliance with the performance standard for laser
products in that the product failed to incorporate a
remote interlock connector.
----
Product: Proof Flash Biological Indicators, for monitoring 270 F
steam gravity sterilization cycles. Recall #Z-672-1.
Code: Lot numbers: 059002PF, 059003PF, 079001PF.
Manufacturer: AMSCO Scientific, Apex, North Carolina.
Recalled by: Manufacturer, by letter on or about September 4, 1990.
Firm-initiated recall complete.
-6-
Distribution: Nationwide, Canada, Australia.
Quantity: 1,285 boxes (50 units/box) were distributed; firm estimates
none remains on the market.
Reason: The positive controls may not show growth within 24-48
hours as stated on the product labeling.
----
Extension Note: Recall #Z-030-1 which appeared in the November 7, 1990
Enforcement Report has been extended.
The firm's action in the removal of the reworked Unibody
Regulator, Product No. 13100 with adjustable flowmeter
rate specified by the customer, and storing them in
quarantine until an appropriate method of reconditioning
is established, constitutes an extension of the subject
recall.
----
Class III -
NONE
VETERINARY PRODUCTS
Class I -
NONE
Class II -
NONE
Class III -
Product: Bismusal Suspension, oral liquid, in 1 gallon containers,
an OTC product used as an aid in control of non-specific
diarrhea. Recall #V-072-1.
Code: Lot numbers: 890841, 890922, 890966, 890967, 900522,
900521-1.
Manufacturer: Veterinary Laboratories, Inc., Lenexa, Kansas.
Recalled by: Manufacturer, by letter August 7, 1990. Firm-initiated
recall complete.
Distribution: Nationwide.
Quantity: 7,943 containers were distributed.
Reason: Possible failure to meet manufacturer's potency
specifications due to lack of homogeneity.
----
Medical Device Safety Alerts:
Product: Theratron Teletherapy Units (a) T60 (b) T80 and T80R,
used to treat cancer patients. Safety Alert #M-020/021-1.
Code: All serial numbers.
Manufacturer: Theratronic International, Ltd. (formerly Atomic Energy of
Canada, Ltd.) Ontario, Canada.
-7-
Alerted by: Manufacturer, by issuing user bulletins: TP-I-85 in
January 1985, CUB-87-3 dated June 22, 1987 and CUB 90-7
dated October 24, 1990.
Distribution: Nationwide and international.
Quantity: 159 units were distributed.
Reason: Cracks found on cast iron arms.