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
03/06/1990
FDA Enforcement for the week of March 7, 1990
FDA ENFORCEMENT REPORT
FOR MARCH 7, 1990
March 7, 1990
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: Enriched bakery products, multiple net weights and brands:
(a) White Bread, 16 ozs. Pull Date DEC10: Wonder Country
Style, Wonder Small, Wonder Thin, County Fair, County Fair
Pantry Pride, Pantry Pride, Big Star, County Market,
Hays, Hyde Park, IGA, Piggly Wiggly, Sally's, Shur Fresh
Super Valu;
-1-
White Bread, 20 ozs. Wonder Big, Pull Date DEC10: Wonder
Large Daffodil Farm Split Top, Home Pride Butter Top;
White Bread, 24 ozs. Wonder Buttermilk, Pull Date DEC10:
Wonder Country Style, Wonder Giant, Wonder Hotel &
Restaurant, Wonder Jumbo Wonder Thin, County Fair Thin,
Pantry Pride, Big Star, County Market, Food Rite, Hays, Hyde
Park, Hyde Park Certified, IGA, Metro Markets, Piggly
Wiggly, Sally's, Seessel's Golden Harvest, Shur Fresh, Super
Valu;
(b) Light White Bread, 16 ozs. Pull Date DEC10:
Wonder, Home Pride Butter Top;
(c) Wheat Bread, 20 ozs., Pull Date DEC10: Wonder Family,
Daffodil Farm Split Top, Home Pride Butter Top, Hyde Park,
Shur Fresh Butter Top;
(d) Light Wheat Bread, 16 ozs. Pull Date DEC10: Wonder,
Home Pride Butter Top;
(e) Seven Grain Bread, 20 ozs., Pull Date DEC10:
Daffodil Farm, Home Pride Butter Top;
(f) Light Oatmeal Bread, 16 ozs., Pull Date DEC10: Wonder;
(g) Hamburger/Sandwich Buns, 12 ozs. (8's), Pull Date DEC
10: Wonder, County Fair, Pantry Pride, Big Star,
County Market, Food Rite, Hays, Hyde Park, Hyde Park
Certified, IGA, Piggly Wiggly, Sally's, Seessel's Golden
Harvest, Shur Fresh, Super Valu;
14 ozs. (16's): Wonder Restaurant Variety;
17 ozs. (12's): Wonder Restaurant Variety;
18 ozs. (8's) Wonder Restaurant Variety;
21 ozs. (12's) Wonder, Wonder Seeded, Wonder Restaurant
Variety, (24's) Wonder Sheet Rolls;
23 ozs. (8's) Wonder Restaruant Variety;
(h) Light Hamburger Buns, 12 ozs. (8's), Pull Date DEC10:
Wonder;
(i) Hot Dog Buns, 12 ozs. (8's), Pull Date DEC10: Wonder,
County Fair, Pantry Pride, Big Star, County Market,
Food Rite, Hays, Hyde Park, Hyde Park Certified, IGA,
Piggly Wiggly, Sally's, Seessel's Golden Harvest Shur
Fresh, Super Valu;
(j) Light Hot Dog Buns, 11.5 ozs. (8's) Pull Date DEC10:
Wonder:
(k) Brown 'N Serve Rolls, 11 ozs (12's), Pull Date DEC10:
Foodland, Sally's, Shop 'N Save;
12 ozs. (12's) Wonder Original, Wonder Gem Style, County
Fair, Pantry Pride, Always Save, Big Star, County Market,
Food Rite, Harmon's, Hay's, Hyde Park, Hyde Park Certified,
Hy-Vee, IGA, Natural Harvest, Overland, Piggly Wiggly,
Price Chopper, Seessel's Golden Harvest, Shur Fresh,
Super Valu;
(l) Honey Buns, 3 ozs., Pull Date DEC11: Hostess Glazed,
3.75 ozs. Hostess Iced, Daffodil Farms;
(m) Hostess Apple Danish, 3.75 ozs., Pull Date DEC 11;
(n) Hostess Raspberry Danish, 3.75 ozs., Pull Date DEC11;
(o) Hostess Carmel Pecan Swirls, 4 ozs., Pull Date DEC11;
(p) Hostess Orange Swirls, 4 ozs., Pull Date DEC11.
Recall #F-411/426-0.
-2-
Code: Packages codes: M139-336, M139-337, or M139-338 and
Pull dates DEC10 and DEC11.
Manufacturer: Continental Baking Company, Memphis, Tennessee.
Recalled by: Continental Baking Company, St. Louis, Missouri, by
telephone December 4, 1989. Firm-initiated recall complete.
Distribution: Alabama, Arkansas, Kentucky, Mississippi, Missouri,
Tennessee.
Quantity: 192,837 packages of the various bread products;
61,886 packages of the various hamburger/sandwich and
hot dog buns, 14,703 packages of the brown 'n serve rolls,
and 110,994 packages of the honey buns, Danish and swirl
products were distributed; firm estimates none remains
on market.
Reason: Products possibly contained glass fragments.
----
Product: Jeannie Lou's fried pastries with fruit or fruit flavored
filing: Apple Pie; Peach Pie; Lemon Pie.
Recall #F-445/447-0.
Code: All products bearing pull date of FEB 05, 1990, FEB 06, 1990
or FEB 07, 1990.
Manufacturer: Old Timey Pies, Inc., Gadsden, Alabama.
Recalled by: Manufacturer, by telephone and by letter January 25, 1990.
Firm-initiated recall complete.
Distribution: Alabama, Georgia.
Quantity: 9,600 pies were distributed; firm estimates none remains on
market since products have now passed the labeled pull date.
Reason: Products contained undeclared FD&C Yellow No. 5 and lacked
net weight statements. The apple and peach pies also
contained undeclared sulfites.
----
Class III - A situation in which the use of, or exposure to
a violative product is not likely to cause adverse health
consequences.
NONE
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Schering's Etrafon, brand of perpherazine, USP, and
amitriptyline hydrochloride, USP, in 4 strengths, a
-3-
combination Rx drug used for its tranquilizing and
antidepressant action, in bottles of 100 and 500 and
in unit dose packages of 100:
(a) Etrafon 2-10 Tablets, 2 mg perherazine and 10mg
amitriptyline HCl;
(b) Etrafon Tablets (2-25), 2mg perherazine and 10mg
amitriptyline HCl;
(c) Etrafon-A Tablets (4-10), 4mg perherazine and 10mg
amitriptyline HCl;
(d) Etrafon-Forte Tablets (4-25), 4mg perherazine and 25mg
amitriptyline HCl. Recall #D-153/156-0.
Code: Lot numbers and EXP dates: (a) 5-ANA-1 12/89, 5-ANA-2
12/89, 5-ANA-101 4/90, 5-ANA-102 1/90, 6-ANA-1 3/91, 6-ANA-2
6/91, 6-ANA-3 6/91, 6-ANA-4 8/91, 7-ANA-1 12/91, 7-ANA-2
12/91 & 12/89;
(b) 4-ANC-104 12/89, 4-ANC-105 12/89, 5-ANC-1 12/89,
5-ANC-2 2/90, 5-ANC-3 2/90, 5-ANC-4 4/90, 5-ANC-5 1/90,
5-ANC-101 6/90, 5-ANC-102 6/90, 5-ANC-103 10/90,
5-ANC-500 1/90, 6-ANC-1 10/90, 6-ANC-2 3/91, 6-ANC-3 5/91,
6-ANC-4 5/91, 6-ANC-5 7/91, 6-ANC-6 10/91, 6-ANC-7 10/91,
6-ANC-8 11/91, 7-ANC-2 10/90;
(c) 6-ANB-1 3/91, 6-ANB-2 4/91
(d) Lots: 4-ANE-101 exp. 12/89, 4-ANE-102 exp. 12/89
5-ANE-1 2/90, 5-ANE-2 2/90, 5-ANE-101 2/90, 5-ANE-102
6/90, 5-ANE-501, 1/90 6-ANE-1 1/90, 6-ANE-2,1/90, 6-ANE-3
1/90, 6-ANE-4 6/9, 6-ANE-101, 10/91, 6-ANE-500 11/89.
Manufacturer: Schering Laboratories, Kenilworth, New Jersey.
Recalled by: Schering Laboratories, Union, New Jersey, by letter on or
about November 10, 1989. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 142,804,700 tablets were distributed; FDA estimates less
then 10 percent remains on market.
Reason: Product fails dissolution specifications.
----
Product: Polymox brand of Amoxicillin for oral suspension USP,
equivalent to 125 mg per 5 ml, an Rx antibiotic powder for
reconstitution. Recall #D-158-0.
Code: Lot numbers: F9201C EXP 7/92, J9203A EXP 10/93,
J9208A EXP 11/93, K9221C EXP 7/93, J9206A EXP 10/93,
J9214A EXP 11/93, J9202B EXP 10/93, J9207B 10/93.
Manufacturer: Bristol-Myers-Squibb, Evansville, Indiana.
Recalled by: Bristol-Myers-Squibb, Barceloneta, Puerto Rico, by
letter January 12, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 102,998 bottles were distributed; firm estimated
20,000 to 60,000 units remained on the market when
recall was initiated.
-4-
Reason: Some units have an incorrect potency declaration of
250 mg/5 ml on the tear-off top label.
----
Product: Triamterene 50 mg/Hydrochlorothiazide 25 mg, Capsules,
in bottles of 100, 500 and 1,000, an oral Rx drug for the
treatment of hypertension, under the following labels:
Bolar Pharmaceuticals, American Preferred Pharmaceutical,
Baxter Healthcare, Best Generics, Bioline Laboratories,
Dixon's Hane, Genetco, Geneva Generics, Glenlawn, Goldline
Laboratories, Harber Pharmaceutical, H & H Laboratories, IDE
Interstate, J.J. Balan, Lemmon, Major Pharmaceuticals, Martec
Pharmaceutical, H.L. Moore Drug Exchange, Parmed
Pharmaceuticals, Purepac Pharmaceutical, Qualitest Products,
Rugby Laboratories, Schein Pharmaceutical, Squibb,
United Research Labs, Warner Chilcott Labs, Vitarine
Pharmaceuticals;
(b) Phenytoin Sodium 100 mg Extended Release Capsules, in
bottles of 100 and 1,000, an Oral Rx for control of
tonic-clonic and psychomotor seizures, under the following
labels: Bolar Pharmaceutical, Best Generics, Bioline
Laboratories, Genetco, Geneva Generics, Glenlawn,
Goldline Laboratories, Harber Pharmaceutical, IDE
Interstate, Lederle Laboratories, Lemmon, Major
Pharmaceuticals, L.I. Moore Drug Exchange, Parmed
Pharmaceuticals, Purepac Pharmaceutical, Rugby Laboratories,
Schein Pharmaceutical, Squibb, (URL) United Research
Laboratories. Recall #D-160/161-0.
Code: All lots.
Manufacturer: Bolar Pharmaceutical Company, Inc., Copiague, New York.
Recalled by: Manufacturer, by letter January 31, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Puerto Rico.
Quantity: Approximately (a) 1 billion; (b) 287 million capsules
were distributed.
Reason: Lack of assurance of bioequivalency and Abbreviated New
Drug Application discrepancies.
----
Class III -
Product: Acetaminophen and Codeine Phosphate Tablets C-III 300 mg/
60 mg,, in bottles of 100, 500 and 1,000 tablets, an Rx
oral analgesic, under the Zenith and Major Pharmaceuticals
label. Recall #D-151-0.
Code: Lot #3916-54 EXP 5/91.
Manufacturer: Zenith Laboratories, Northvale, New Jersey.
Recalled by: Manufacturer, by letter November 16, 1989. Firm-initiated
recall ongoing.
Distribution: California, Florida, Kentucky, Michigan, Missouri,
Nebraska, South Carolina, Tennessee.
-5-
Quantity: Approximately 1,615,600 tablets were distributed.
Reason: Product does not meet dissolution specifications.
----
Product: Trilafon Aqueous Solution brand of perphenazine, USP
5 mg/ml injection, in bottles of 100's, an Rx drug used
in the management of psychotic disorders and for control
of nausea and vomiting in adults. Recall #D-152-0.
Code: Lot numbers: 5-AEC-1005 EXP 5/90, 7-AEC-1003 EXP 3/92,
9-AEC-1003 EXP 2/94.
Manufacturer: Schering Pharmaceuticals, Manati, Puerto Rico.
Recalled by: Schering Laboratories, Union, New Jersey, by letter
November 9, 1989. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 618 boxes were distributed.
Reason: Product is subpotent.
----
Product: Sidmak Laboratories brand Dipyridamole 25 mg sugar coated
tablets, in bottles of 1,000, an Rx product.
Recall #D-157-0.
Code: Lot #0190236.
Manufacturer: Sidmak Laboratories, East Hanover, New Jersey.
Recalled by: Manufacturer, by letter November 21, 1989. Firm-initiated
recall ongoing.
Distribution: Pennsylvania, Missouri, New York, New Jersey, Puerto Rico.
Quantity: 2,722 bottles were distributed.
Reason: Product does not meet dissolution specifications.
----
Product: Fay's Grape Flavor-Chewable Children's Pain Reliever
Non-Aspirin Tablets, an OTC product in bottles of 30.
Recall #D-159-0.
Code: Lot numbers: 9K02P EXP 10/91, 9L19R EXP 10/91.
Manufacturer: L. Perrigo Company, Allegan, Michigan.
Recalled by: Manufacturer, by telephone followed by letter January 17,
1990. Firm-initiated recall ongoing.
Distribution: New York, Pennsylvania.
Quantity: 16,728 packages were distributed.
Reason: Some unit cartons are misprinted with incorrect dosage
for children 4-5 years of age. The bottle labels are
correct.
----
Product: Thyroid Tablets, USP, 195 mg, in bottles of 100, 1,000 and
bulk units, an Rx used to promote a generalized increase
in the metabolic rate of body tissue, under the Richlyn
Laboratories and Major Pharmaceuticals labels.
Recall #D-162-0.
-6-
Code: Lot #41769 EXP 6/91.
Manufacturer: Richlyn Laboratories, Inc., Philadelphia, Pennsylvania.
Recalled by: Manufacturer, by telephone followed by letter February 2,
1990. Firm-initiated recall ongoing.
Distribution: California, Michigan, New Jersey, Pennsylvania.
Quantity: 1,156 bottles of 100 tablets; 78 bottles of 1,000 tablets and
110,000 tablets in bulk containers were distributed; firm
estimates 150,000 to 200,000 tablets remain on market.
Reason: Product is subpotent.
----
Product: BMI MC103 Protective Ointment with Vitamins A & D in
3 ounce tubes, an OTC ointment used for protection of
sensitive and/or healing skin areas subject to
irritation. Recall #D-163-0.
Code: No lot numbers -- Product code 705.
Manufacturer: White Cross Ven Tech, Mississauga, Ontario, Canada.
Recalled by: Foster Medical Supply, Yorkville, New York, by
telephone followed by letter February 1, 1990. Firm-
initiated recall ongoing.
Distribution: New York.
Quantity: 447 tubes were distributed.
Reason: Product is an imported drug which was distributed
after the issuance of a notice of refusal of admission.
----
CORRECTION: Merck Hydrodiuril, Hydrochlorothiazide Tablets, 25 mg.,
Recall #D-137-0, which appeared in the February 7, 1990
Enforcement Report should read: Codes for bottles of
1,000 -- L1528 APR90, M0636 FEB91. Lot #M0686 should not
have been included.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
Product The Life Design Systems (LDS) Pulmanex Infant Manual
Resuscitator with oxygen reservoir:
(a) Model No. LDS-9230;
(b) Model No. LDS-9250-1;
(c) Model No. LDS-9794-3477;
(d) Model No. LDS-9754;
(e) Model No. LDS-9230;
(f) Model No. LDS-9245;
(g) Model No. LDS-9284-7747;
Pulmanex Neonatal Manual Resuscitator with Oxygen Reservoir
& Swivel Flex:
(h) Model No. LDS-9390-34;
(i) Model No. LDS-9354-7747;
-7-
(j) Model No. LDS-9350. These are used to manually
resuscitate infants and neonatals in emergency
situations. Recall #Z-369/378-0.
Code: Lot numbers: (a) 9073-6; (b) 9074-6; (c) 9072-6;
(d) 9073-6; (e) 9068-1; (f) 9072; (g) 9073;
Pulmanex Neonatal Manual Resuscitator with Oxygen Reservoir
& Swivel Flex:
(h-j) 9073;
Manufacturer: Life Design Systems, Carrollton, Texas.
Recalled by: Manufacturer, by telephone on or about March 14, 1989.
Firm-initiated recall ongoing.
Distribution: Texas, California, Virginia, Kentucky, Wisconsin,
Washington state, Missouri, Iowa, Ohio, Minnesota.
Quantity: (a) 7 units; (b) 16 units; (c) 14 units; (d) 70 units;
(e) 7 units; (f) 7 units; (g) 7 units; (h) 7 units;
(i) 7 units; (j) 7 units were distributed.
Reason: Devices may contain a component (exhalation port) which was
mistakenly added to these models which may create too much
resistance for an infant to breath air out.
----
Product: (a) Pulmanex Adult Manual Resuscitator with Oxygen
Reservoir and Swivel Elbow Model No. LDS 9010-47;
(b) Swivel Flex Track Adapter with Monitoring Port,
Model No. LDS-8701. Recall #Z-379/380-0.
Code: Lot numbers: (a) 9160; (b) 9243.
Manufacturer: Life Design Systems, Carrollton, Texas.
Recalled by: Manufacturer, by letter on or about September 12, 1989.
Firm-initiated recall complete.
Distribution: Canada.
Quantity: (a) 20 cases (6 units/case); (b) 10 cases (50 units/case)
were distributed; firm estimates none remains on market.
Reason: The swivel elbow was manufactured with a diameter of
the elbow and dimensions of the seam or rings that did not
allow the finished device to function properly.
----
Product: The Life Design System (LDS) Pulmanex Adult Manual
Resuscitator with Oxygen Reservoir (a) Model No. 9550-47;
(b) Model No. 9012-473;
(c) Pulmanex Neonatal Manual Resuscitator, Model No.
9358-47. These are used for manual resuscitation of adults
and neonates in emergency situations. Recall #Z-381/383-0.
-8-
Code: Lot Nos. 9192, 9235, 9228-6, 9139, 9235-6, 9230-6;
(b) 9230-6; (c) 9235-6.
Manufacturer: Life Design Systems, Carrollton, Texas.
Recalled by: Manufacturer, by telephone on or about September 2, 1989
followed by letter September 6, 1989. Firm-initiated
recall ongoing.
Distribution: Michigan, West Virginia, Illinois.
Quantity: (a) 8 cases (16 units/case); (b) 4 cases (6 units/case);
(c) 5 cases (7 units/case) were distributed.
Reason: An open swivel elbow (incomplete) instead of a closed swivel
elbow was assembled onto the main resuscitator body, causing
oxygen to flow through the top of the swivel instead of to
the patient.
----
Product: The Life Design System (LDS) Pulmanex Adult Manual
Resuscitator (a) Model Nos. LDS-9550-62; (b) LDS-9550-631,
used to manually resuscitate patients in emergency
situations. Recall #Z-384/385-0.
Code: Lot No. 9277.
Manufacturer: Life Design Systems, Carrollton, Texas.
Recalled by: Manufacturer, by visit on or about October 5, 1989.
Firm-initiated recall ongoing.
Distribution: Missouri, Utah.
Quantity: (a) 6 units; (b) 16 units were distributed; firm estimates
(a) 6 units; (b) none remains on market.
Reason: An incorrect glue was used to attach the mini-duckbill
housing. This defect may cause the mini-duckbill housing to
detach from the device.
----
Product: The Life Design System Pulmanex Adult Manual Resuscitator
with Swivel Elbow & Popple Tubing as Oxygen Reservoir,
used to resuscitate patients in emergency situations.
Recall #Z-386-0.
Code: All lots of model numbers followed by suffixes containing the
numbers 47, 62, 63 or 87.
Manufacturer: Life Design Systems, Carrollton, Texas.
Recalled by: Manufacturer, by letter September 25, 1989. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: Unknown.
Reason: The resuscitators may break during shipping or use because
the elbows did not have a gusset at the inside portion of
the elbow 90 degree joint.
----
-9-
Class II-
Product: Al/FE Clark Specific Bicompatible Hemoperfusion Cartridge, is
alleged to remove aluminum and iron from the blood by
hemoperfusion. Recall #Z-061-0.
Code: All lots.
Manufacturer: Clark Research and Development, Inc, Folsom, Louisiana.
Recalled by: Manufacturer, by telephone July 26, 1989. Firm-initiated
recall ongoing.
Distribution: Alabama, California, Louisiana, Maryland, Massachusetts,
Michigan, Missouri, New Jersey, New York, Ohio, Pennsylvania,
Tennessee, Virginia, Washington state.
Quantity: 601 units were distributed.
Reason: Product is an unapproved medical device.
----
Product: Mammography System Model No. 6050MHD. Recall #Z-208-0.
Code: Model No. 6050MHD.
Manufacturer: Roen Tec USA, Inc., Wyandotte, Michigan.
Recalled by: Manufacturer. FDA approved the firm's corrective plan
November 24, 1989. Firm-initiated field correction ongoing.
Distribution: California.
Quantity: 1 unit was distributed.
Reason: Noncompliance with performance standard for x-ray products
in that the "half-value layer" of the system was 0.65 mm
instead of 0.5 mm aluminum equivalent.
----
Product: Model 531-34 Graphics Program Module, an electronic
memory cartridge containing instructions needed by the
Rx2000 Graphics Programmer to program and obtain data
from Intermedics Intertach II Model 262-16 Pulse
Generator. Recall #Z-422-0.
Code: All serial numbers lower than 1500.
Manufacturer: Intermedics Pacemakers, Inc., Freeport, Texas.
Recalled by: Manufacturer, by letter January 4, 1990. Firm-initiated
field correction ongoing.
Distribution: Nationwide, Korea.
Quantity: 77 units were distributed.
Reason: An unintended parameter change may occur with the model
531-34 program module when used with the Intertach II
Model 262-16.
----
Product: Balloon Dilatation Catheter 5 French. Recall #Z-423-0.
Code: Catalog #200406, lot #514477.
Manufacturer: USCI Angiographics Systems, Glensfalls, New York.
-10-
Recalled by: C.R. Bard, Inc., Cardiosurgery Division, Billerica,
Massachusetts, by telephone December 27, 1989 followed by
letter January 2, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 72 units were distributed.
Reason: The product may be labeled as a 6 mm x 4 cm balloon
catheter on the catheter shaft, however, it is actually
an 8 mm x 3 cm balloon catheter.
----
Product: Quinton brand Mahurkar 11.5 Fr. Catheter Kit, size
3.83 mm 0.D. x 195 mm usable length. Recall #Z-425-0.
Code: Catalog #13793-001 - lot number 401722 89047 is ink stamped
by hand on the individual kit pouch and carton labels prior
to application.
Manufacturer: Quinton Instrument Company, Seattle, Washington.
Recalled by: Manufacturer, by telephone on or about December 15,
1989. Firm-initiated recall ongoing.
Distribution: Nationwide, Japan.
Quantity: 1,500 kits were distributed.
Reason: The inner package may incorrectly label the catheter as
a 10 Fr. x 150 mm catheter kit while it actually contains a
11.5 Fr. x 195 mm catheter kit.
----
Product: 1.5 to 2.0 mW HeNe Laser Tubes and Laser Power Supply
Kits. Recall #Z-426-0.
Code: Various.
Manufacturer: Allied Action, Ltd., Rochester, New York.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan January 29, 1990. Firm-initiated field
correction ongoing.
Distribution: Nationwide.
Quantity: Approximately 1,480 units were distributed.
Reason: Noncompliance with performance standards for laser
products in that the devices are not properly labeled,
lack adequate written instructions for use and lack
warning statements.
----
Product: Medi-Tech brand Teg-Wire Balloon Catheter, used to dilate
peripheral narrow vessel segments. Recall #Z-427-0.
Code: TW/6-2/100, Reorder No. 11-108, Lot #171906.
Manufacturer: Boston Scientific, doing business as Medi-Tech, Watertown,
Massachusetts.
Recalled by: Manufacturer, by telephone September 6, 1989. Firm-initiated
recall ongoing.
Distribution: Nationwide, Italy, France, Germany.
-11-
Quantity: 64 units were distributed.
Reason: The product may be labeled as containing a dilatation
balloon 6 mm x 2 mm when the balloon enclosed is a 6 mm x
4 mm size.
----
Product: Micro-Aire Surgical Instruments Model 1620 Micro Wire
Driver, used by surgeons during small bone surgery of
the hands, feet and face. The wire driver is used by
the surgeon to insert a wire (K-wire) into the bone during
surgical repair. Recall #Z-428-0.
Code: All serial numbers between 1663 and 1702.
Manufacturer: Micro-Aire Surgical Instruments, Inc., Valencia,
California.
Recalled by: Manufacturer, by letters January 24, 26, 1990 and
February 1, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 173 units were distributed; firm estimates 90 units
remain on market.
Reason: Uncontrolled and unanticipated ejection of K wire may
occur after autoclaving.
----
Product: Theratron Phoenix Cobalt 60 Radiotherapy Treatment Unit.
Recall #Z-429-0.
Code: Serial numbers: 1, 3, 5, 8, 10, 12, 14.
Manufacturer: Theratronics International, Ltd., formerly Atomic Energy
of Canada, Ltd. (AECL Medical), Ontario, Canada.
Recalled by: Theratronics International, Ltd., Carrollton, Texas, by
Service Bulletin August 1, 1988. Firm-initiated field
correction ongoing.
Distribution: New York, Florida, Missouri, Georgia, Illinois,
Connecticut.
Quantity: 7 units were distributed.
Reason: Patients may be inadvertently over-exposed or under-exposed
to gamma radiation because indeterminate operation may occur
after activation of the emergency switch.
----
Product: Theratron 780C Cobalt 60 Radiotherapy Treatment Units
equipped with dual timers. Recall #Z-430-0.
Code: Serial numbers: 2, 9, 20, 24, 30, 32, 35, 36, 38, 43.
Manufacturer: Theratronics International, Ltd., formerly Atomic Energy
of Canada, Ltd. (AECL Medical), Ontario, Canada.
Recalled by: Theratronics International, Ltd., Carrollton, Texas, by
Service Bulletin January 12, 1988. Firm-initiated
recall ongoing.
Distribution: Massachusetts, Kansas, Missouri, New Jersey, Texas, Ohio.
Quantity: 10 units were distributed.
-12-
Reason: The dual timers may lock up due to an electrical
malfunction.
----
Product: Theratron 780C Cobalt 60 Radiotherapy Treatment Units
equipped with dual timers. Recall #Z-431-0.
Code: Serial numbers 2 and 20.
Manufacturer: Theratronics International, Ltd., formerly Atomic Energy
of Canada, Ltd. (AECL Medical), Ontario, Canada.
Recalled by: Theratronics International, Ltd., Carrollton, Texas, by
letter September 2, 1986. Firm-initiated field correction
ongoing.
Distribution: Massachusetts, Missouri.
Quantity: 2 units were distributed.
Reason: The "Tens" button may be inadvertently set during treatment
time selection which could inadvertently increase the
treatment time up to a potential 10 minutes more than
intended.
----
Product: Model LP6 Volume Ventilator, an Rx medical device
intended to mechanically control or assist in delivery
of breathing gas to a patient. Recall #Z-432-0.
Code: All serial numbers.
Manufacturer: Aequitron Medical, Inc., Minneapolis, Minnesota.
Recalled by: Manufacturer, by letter January 15, 1990. Firm-initiated
field correction ongoing.
Distribution: Nationwide and international.
Quantity: 6,069 units were distributed.
Reason: The ventilator may not perform as intended in back-up
mode operation, in that volume delivery may vary from
volume settings.
----
Class III -
NONE
VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: Furosemide Tablets, 50 mg., labeled under the name
Tech America Distal Tablets, in bottles of 500, an Rx
diuretic-saluretic for oral use in the treatment of
edema (pulmonary congestion, ascites) associated with
cardiac insufficiency and acute noninflammatory tissue edema.
Recall #V-032-0.
-13-
Code: Lot #8263G EXP 9/91.
Manufacturer: Fermenta Animal Health Company, Elwood, Kansas.
Recalled by: Manufacturer, by letter January 12, 1990 followed by
telephone to nonresponding accounts February 16, 1990.
Firm initiated recall ongoing.
Distribution: Nationwide.
Quantity: 1,015 bottles were distributed; firm estimates 105
bottles remain on market.
Reason: Product is contaminated with mold.
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Product: Prednisolone Oral Suspension, in 60 ml. bottles, 5 mg/ml,
an Rx corticosteroid for use in dermal, allergic, ocular,
otic, and musculoskeletal conditions in dogs and cats,
that are responsive to corticosteroid therapy, under the
Butler, VEDCO, Qualis, and BVS labels. Recall #V-033-0.
Code: Lot numbers: 01F9D, 21G9A, 28C9C, 10J9A, 20I9A, 15F9A.
Manufacturer: Qualis, Inc., Des Moines, Iowa.
Recalled by: Manufacturer, by telephone on or about February 5, 1990
followed by letter dated February 5, 1990. Firm-
initiated recall ongoing.
Distribution: Nationwide.
Quantity: 55,644 bottles were distributed.
Reason: The product is an unapproved new animal drug which
requires an approved New Animal Drug Application for
legal marketing.
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Class III -
NONE