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
02/05/1991
FDA Enforcement for the week of February 6, 1991
FDA ENFORCEMENT REPORT
FOR FEB. 6, 1991
February 6, 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.
Product: Mrs. Kinsers brand: (a) Smooth Pimento Spread, in 7
ounce plastic containers coded on the bottom in ink
with 1115;
(b) Smooth Pimento Spread in 12 ounce and 7 ounce
plastic containers coded on the bottom in ink with 0101;
(c) Hot Jalapeno Spread in 7 ounce plastic containers,
codes on the bottom in ink with 1216;
(d) Hot Jalapeno Spread in 12 and 7 ounce plastic
containers coded on the bottom in ink with 1220.
Recall #F-129/130-1.
Code: Lot numbers: (a) 1115; (b) 0101; (c) 1216; (d) 1220.
Manufacturer: Mrs. Giles Country Kitchen, Inc., Lynchburg, Virginia.
Recalled by: Manufacturer, by visit on or about November 9, 1990.
Firm-initiated recall ongoing.
Distribution: Southeastern United States.
Quantity: (a) 87/36 pack cases and 708/12 pack cases;
(b) 351/24 pack cases, 59/36 pack cases, and
896/12 pack cases;
(c) 824/12 pack cases;
-1-
(d) 38/24 pack cases, 1664/12 pack cases and 68/6 pack
cases were distributed.
Reason: Products contaminated with Listeria monocytogenes.
----
Product: Lite Pimento Spread, Pimento Spread, Smooth Pimento
Spread, Chunky Pimento Spread, Deluxe Pimento Spread,
Hot Jalapeno Spread distributed under the following labels:
(a) Pimento Spread, in 7 ounce and 12 ounce plastic
containers under Giles, Janets and Laura
Lynn labels;
(b) Pimento Spread in 24 ounce plastic containers
under the Laura Lynn label;
(c) Pimento Spread, in 2 pound containers under
the Giles labels;
(d) Pimento Spread, in 5 pound containers under the
Giles/Kinser and Seaboard labels;
(e) Pimento Cheese Spread in 5 pound containers
under the Plantation label;
(f) Lite Pimento Spread in 7 ounce and 12 ounce plastic
containers, under the Kinser label;
(g) Smooth Pimento Spread, in 7 ounce and 12 ounce
containers under the Kinser label;
(h) Smooth Pimento Spread in 12 ounce containers,
under the M&M label;
(i) Smooth Pimento Spread, in 5 pound containers
under Giles/Kinser and Pocahontas labels;
(j) Deluxe Pimento Spread, in 7 ounce and 12 ounce containers
under the Jacks label;
(k) Deluxe Pimento Spread, in 5 pound container, under
the Giles/Kinser label;
(l) Chunky Pimento Spread in 7 ounce, 12 ounce and 24 ounce
containers, under the Kinser label;
(m) Chunky Pimento Spread, in 7 ounce containers under
the Food City label;
(n) Chunky Pimento Spread, in 3 and 5 pound containers
under the Giles/Kinser label;
(o) Chunky Pimento Spread in 5 pound containers under
the Pocahontas label;
(p) Hot Jalapeno Spread in 7 ounce and 12 ounce containers,
under the Kinser label;
(q) Hot Jalapeno Spread in 12 ounce containers, under
the Jacks label. Recall #F-170/174-1.
Code: Any cheese spread manufactured between July 15, 1990 and
October 14, 1990 with use by codes of 1015 to 1031, 1101 to
1130, 1201 to 1231 and 0101 to 0112.
Manufacturer: Mrs. Giles Country Kitchen, Inc., Lynchburg, Virginia.
Recalled by: Manufacturer, by letter January 10, 1991. FDA requested
recall ongoing.
Distribution: Virginia, North Carolina, South Carolina, Tennessee,
Kentucky, Alabama, Georgia, Florida.
Quantity: Not determined.
Reason: Probable contamination with Listeria monocytogenes.
----
-2-
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: Naturola fruit syrups, in 750 ml (24.4 fluid ounce)
glass bottles: (a) Orange Fruit Syrup;
(b) Crema Fruit Syrup; (c) Passion Fruit Syrup.
Recall #F-055/057-1.
Code: Not coded.
Manufacturer: Luis V. Pino, Santurce, Puerto Rico.
Recalled by: Manufacturer, by telephone and by letter.
Firm-initiated recall ongoing.
Distribution: New York, Puerto Rico.
Quantity: Approximately (a) 15 cases (12 bottles/case);
(b) 60 boxes (12 bottles/box); (c) 150 boxes (12
bottles/case) were distributed.
Reason: Products contain undeclared FD&C Yellow No. 5.
----
Product: Fruiti D'Lites brand Pineapple Flavored Drink, in 14
ounce, yellow-colored pineapple shaped plastic container
with screw-on cap. Recall #F-107-1.
Code: All lots.
Manufacturer: D'Lites Treats, Inc., Middeltown, Ohio.
Recalled by: Odd's-n-End's, Buffalo, New York, by memorandum
September 14, 1990. Firm-initiated recall ongoing.
Distribution: New York.
Quantity: 4,800 cases of the various flavors. (See also
Recall #F-108/110-1.)
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Product: Del Colegio brand fruit syrups, in 750 ml glass bottles,
and in 1 gallon plastic bottles:
(a) Orange Syrup; (b) Passion Fruit Syrup;
(c) Pineapple Syrup; (d) Cream Syrup; (e) Lemon Syrup;
(f) Ice Cream Syrup. Recall #F-138/143-1.
Code: Not coded.
Manufacturer: Productos Puro Y Del Colegio, Guaynabo, Puerto Rico.
Recalled by: Manufacturer, by correcting labels by January 10, 1991.
Firm-initiated field correction ongoing.
Distribution: Puerto Rico.
Quantity: Firm estimates approximately 1,000 pounds remain on the
market.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
-3-
Product: Farm Rich Artificially Flavored Egg Nog Non-Dairy
Drink, in 32 fluid ounce containers. Recall #F-154-1.
Code: All products.
Manufacturer: Rich Products Corporation, Buffalo, New York.
Recalled by: Manufacturer, by telephone December 7, 1990 followed by
letter December 10, 1990. Firm-initiated field
corrections complete.
Distribution: Northeastern United States.
Quantity: Approximately 95,000 cases (12 units/case) were
distributed; firm estimates 70 percent remains on the
market.
Reason: Product contains undeclared FD&C Yellow No. 5 and product
is not egg nog.
----
Product: Pocahontas brand frozen food products:
(a) Peach Cobbler, 2-5 pound pies/case;
(b) Apple Cobbler, 2-5 pound pies/case;
(c) Blackberry Cobbler, 2-5 pound pies/case;
(d) Cherry Cobbler, 2-5 pound pies/case;
(e) Blueberry Cobbler, 2-5 pound pies/case;
(f) Peach Turnover, 70 turnovers/case;
(g) Apple Turnover, 70 turnovers/case;
(h) Cherry Turnover, 70 turnovers/case;
(i) Onion Rings, 12 pound case;
(j) Frozen Food Service Pies, 6 pies/case.
Recall #F-158/167-1.
Code: All products shipped from 11/15/90 to 11/20/90.
Manufacturer: Good Old Farms, Inc., Little Rock, Arkansas (cobblers);
Progressive Foods, Inc., Memphis, Tennessee (turnovers);
Southern Frozen Foods, Montezuma, Georgia (onion rings);
Chef Pierre, Inc., Deerfield, Illinois (frozen food
service pies).
Recalled by: Alabama Institutional Foods, Inc., Tuscaloosa, Alabama.
by telephone. Firm-initiated recall complete.
Distribution: Alabama.
Quantity Firm estimates none remains on the market.
Reason: Products were contaminated with ammonia.
----
Product: Peanut covered caramel apples: Andrew's Caramel
Apples, 3 apple pak, 8 paks per case, not less than
8 ounces net weight per pak;
Andrew's Gourmet Caramel Apples, single apple pak,
8 per case, not less than 8 ounces net weight per pak.
Recall #F-168-1.
Code: Pull dates 10/18 through 11/01.
Manufacturer: Andrews Caramel Apples, Inc., Chicago, Illinois.
Recalled by: Manufacturer, by telephone October 26, 1990 followed by
letter. Firm-initiated recall ongoing.
Distribution: Illinois, Michigan.
-4-
Quantity: 22,305 cases were distributed; firm estimates that
little if any of the product remains on the market.
Reason: Glass particles in coating.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Various flavored drinks:
(a) Strawberry flavored drink in 14 ounce red-colored
strawberry shaped plastic container;
(b) Orange flavored drink, in 10 ounce orange-colored,
and orange fruit-shaped plastic container;
(c) Grape flavored drink, in 10 ounce purple-colored
and grape shaped plastic container. Recall #F-108/110-1.
Code: All lots.
Manufacturer: D'Lites Treats, Inc., Middletown, Ohio.
Recalled by: ODD's-n-END's, Buffalo, New York, by memorandum
September 14, 1990. Firm-initiated recall ongoing.
Distribution: Western New York.
Quantity: 4,800 cases of the various flavors. (See also
Recall #F-107-1.)
Reason: Contaminated with mold and yeast.
----
Product: Various nut snacks: (a) Pistachios, shelled, in 5 pound
and 25 pound cases; (b) Barcellona Mix (mixed nuts and
fruits), in 25 pound cases; (c) Sunflower Seeds In Shell,
roasted/salted, in 40 pound cases; (d) Apple Cinnamon
Granola, in 25 pound cases. Recall #F-150/153-1.
Code: Not coded.
Manufacturer: Premier Packing Company, Spokane, Washington.
Recalled by: Manufacturer, by telephone October 29-30, 1990.
Firm-initiated recall ongoing.
Distribution: Montana, Idaho, Washington state.
Quantity: (a) Three 25 pound cases and one 5 pound case;
(b) Three 25 pound cases;
(c) One 40 pound case; (d) One 25 pound case was
distributed.
Reason: Insect contamination.
----
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
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Class II -
Product: Thyroid Tablets USP, 60 mg, in 1000 tablet bottles.
Recall #D-156-1.
Code: Lot #R-650 EXP 4/91.
Manufacturer: JMI-Canton Pharmaceuticals, Inc., Canton, Ohio.
Recalled by: Manufacturer, by telephone followed by letter
on or about December 7, 1990. Firm-initiated recall
complete.
Distribution: California, Pennsylvania.
Quantity: 456 bottles were distributed; firm estimates none remains
on the market.
Reason: Superpotent.
----
Product: Abbott Aminosyn amino acid solutions, in glass containers,
Rx large volume parenterals administered with dextrose
solutions as a source of nitrogen in nutritional support
of patients to preserve protein and reduce catabolism
where oral intake is inadequate or undesirable:
a. Aminosyn 3.5% M, 1000 ml;
b. Aminosyn 5%, a crystalline amino acid solution,
700 ml partial fill diluent unit; and 1000 ml
c. Aminosyn-RF 5.2%, 300 ml;
d. Aminosyn 7%, a crystalline amino acid solution,
500 ml;
e. Aminosyn 7% with Electrolytes, 500 ml;
f. Aminosyn 8.5% a crystalline amino acid solution, 500
ml and 1000 ml
g. Aminosyn II 8.5%, an amino acid injection, 500 ml and
1000 ml;
h. Aminosyn 10%, a crystalline amino acid solution;
i. Aminosyn II 10%, an amino acid injection, 500 ml
and 1000 ml
j. Aminosyn 8.5% TPN Kit with 50% Dextrose Injection,
USP, containing one 500 ml bottle of Aminosyn 8.5%, one
500 ml partial fill in 1000 ml bottle of 50% Dextrose
Injection;
k. Aminosyn 7% TPN Kit, containing one 500 ml bottle of
Aminosyn 7%, one 500 ml partial fill in 1000 ml bottle of
50% Dextrose Injection. Recall #D-158/168-1.
Code: Lot numbers: (a) 34-012-DM
(b) 32-845-DM, 33-926-DM
(c) 32-851-DM
(d) 32-863-DM
(e) 33-928-DM
(f) 32-844-DM, 33-931-DM
(g) 33-930-DM
(h) 32-839-DM
(i) 34-002-DM, 32-855-DM 32-843-DM, 33-907-DM;
(j) 28-451-DM, 28-452-DM, 33-966-DM
(k) 28-450-DM, 32-871-DM, 32-872-DM
Manufacturer: Abbott Laboratories, Rocky Mount, North Carolina.
-6-
Recalled by Abbott Laboratories, Abbott Park, Illinois, by
letter December 21, 1990. Firm-initiated recall ongoing.
See also FDA talk paper T90-41, August 23, 1990.
Distribution: Nationwide.
Quantity: 473,441 units were produced; firm estimates little,
if any, remains on the market.
Reason: The products contain L-tryptophan manufactured by the
firm, Showa Denko, which has been shown to be associated
with the development of eosinophilia-myalgia syndrome.
----
Product: Amino acid injections, in glass containers, indicated
for patients requiring parenteral nutritional support:
(a) Procalamine (3% Amino acid and 3% Glycerin Injection
with Electrolytes), 1000 ml;
(b) 8.5% Freamine III Injection, 500 ml, 1000 ml;
(c) 10% Freamine III Injection, 500 ml and 1000 ml.
Recall #D-169/171-1.
Code: Lot numbers: (a) J9N006, J9J121, EXP 10/90
(b) J9J052, EXP 7/91 and J9B008, EXP 2/91 (500 ml);
J9N051, EXP 10/91, J9E093, EXP 6/91 (1000 ml);
(c) J9S030, EXP 6/91 (500 ml) and J9N052, EXP 10/91
(1000 ml).
Manufacturer: McGaw, Inc., Irvine, California.
Recalled by: Manufacturer, by letter December 11, 1990. Firm-
initiated recall ongoing. See also FDA talk paper
T90-41, August 23, 1990.
Distribution: Nationwide.
Quantity: 22,958 cases (6 bottles/case) were distributed.
Reason: Products contain L-tryptophan manufactured by the
firm, Showa Denko, which has been shown to be associated
with the development of eosinophilia-myalgia syndrome.
----
Product: GHB Gamma Hydroxy Butyrate (also known as Sodium Oxybate)
oral powder and granules, in 60 and 100 gram plastic
bottles, an OTC product used to enhance growth hormone
elevation. Recall #D-172-1.
Code: Not coded -- All product is being recalled.
Manufacturer: Diamond Gym and Fitness Center, doing business as
AST Research, Pascagoula, Mississippi.
Recalled by: Manufacturer, by letter January 18, 1991. Firm-initiated
recall ongoing. See also FDA press release P90-53,
November 8, 1990.
Distribution: Rhode Island, New Jersey, Maryland, Florida, Georgia,
Tennessee, Ohio, Wisconsin, Illinois, Oklahoma, Texas,
California, Hawaii.
Quantity: 1,070 bottles of 100 grams and 200 bottles of 60 grams
were distributed.
Reason: Product marketed without new drug approval.
----
-7-
Product: Platelets. Recall #B-079-1.
Code: Unit numbers: 18F51176, 18F51178, 18F51180, 18F51182,
18F51183, 18F51184, 18F51185, 18F51187, 18F51188,
18F51190, 18F51191, 18F51193, 18F51194, 18F51195,
18F51198, 18F51201, 18F51203, 18F51204, 18F51205,
18F51207, 18F51210, 18F51211, 18F51213,
18F51214, 18F51216, 18F51219 through 12F51225,
18F51227, 18F51228, 18F51230, 18F51234, 18F51236,
18H83886 through 18H83895, 18H83897, 18H83899, 18H83901
through 18H83908, 18H83910, 18H83912, through 18H83919,
18H83921 through 18H83924, 18H83926, 18H83927, 18H83930
through 18H83935, 18H83939, 18H83942, 18H83943, 18H83945.
Manufacturer: American Red Cross Blood Services, Lansing, Michigan.
Recalled by: Manufacturer, by telephone June 19, 1990. Firm-initiated
recall complete.
Distribution: Ohio, South Carolina, Michigan.
Quantity: 82 units.
Reason: Blood products labeled with incorrect expiration dates
were distributed.
----
Product: (a) Red Blood Cells; (b) Cryoprecipitated AHF;
(c) Recovered Plasma. Recall #B-100/102-1.
Code: Unit #33KR07645.
Manufacturer: American Red Cross Blood Services, Farmington,
Connecticut.
Recalled by: Manufacturer, by telephone March 16, 1987.
Firm-initiated recall complete.
Distribution: Kentucky, Connecticut, Switzerland.
Quantity: 1 unit of each component.
Reason: Blood components which 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 repeatably reactive for anti-HIV-1,
were distributed.
----
Class III -
Product: Upjohn brand Cortisone Acetate Tablets USP, 10 mg, in
bottles of 100, an Rx drug. Recall #D-155-1.
Code: Lot #876 DU EXP 7/31/94.
Manufacturer: The Upjohn Company, Kalamazoo, Michigan.
Recalled by: Manufacturer, by letter December 6, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Puerto Rico, Saudi Arabia.
Quantity: Approximately 11,500 bottles were distributed.
Reason: Product does not meet dissolution specifications
through expiration date.
----
-8-
Product: Provera brand Medroxyprogesterone Acetate 2.5 mg
Tablets, in cartons containing six 28 count blister cards,
an Rx product used for estrogen/progesterone therapy.
Recall #D-157-1.
Code: Lot numbers: 563FD EXP 4/92, 858FD EXP 6/92, 705FF
EXP 6/92, 579FK EXP 8/92.
Manufacturer: The Upjohn Company, Kalmazoo, Michigan.
Recalled by: Manufacturer, by letter December 20, 1990. Firm-initiated
recall ongoing.
Distribution: Michigan, Georgia, Louisiana, Colorado, Hawaii, Missouri,
Connecticut, California, Florida, Oregon, Washington,
D.C., Puerto Rico.
Quantity: 74,000 cartons were distributed.
Reason: Packaging is not consistent with the approved dosage
regimens of 5 to 10 mg for 5 days to 10 days.
----
Product: (a) Red Blood Cells; (b) Platelets. Recall #B-084/085-1.
Code: Unit #59K33110.
Manufacturer: American Red Cross Blood Services, Flint, Michigan.
Recalled by: Manufacturer, by telephone and by letter January 4, 1990.
Firm-initiated recall complete.
Distribution: Michigan, Arkansas.
Quantity: 1 unit of each component.
Reason: Blood products collected from a donor who had taken
anti-malaria prophylaxis during travel in countries
endemic for malaria, were distributed.
----
Product: (a) Red Blood Cells; (b) Platelets. Recall #B-098/099-1.
Code: Unit numbers: (a) 17G73800, 17L97074, 17H95760;
(b) 17G73800.
Manufacturer: American Red Cross, St. Paul, Minnesota.
Recalled by: Manufacturer, by letter July 30, 1990. Firm-initiated
recall ongoing.
Distribution: Minnesota.
Quantity: (a) 3 units; (b) 1 unit.
Reason: Blood products collected from a donor who took anti-
malarial prophylaxis while visiting an endemic area
for malaria were distributed.
-----
MEDICAL DEVICES AND RADIOLOGY
Class I -
Product: Alukart Hemoperfusion Device, an Rx device linked within
the blood circuit of hemodialysis machines.
Recall #Z-182-1.
-9-
Code: Catalog No. 01-6003-6. Lot numbers beginning with K8L
through K8S, K9, DK9 and DKOA through H. This comprises
37 lots as follows: K8L012, K8L012A, K8N012, K8N022,
K8P012, K8S012, K8S022, K8S032, K8S042, K8S052, K9A022,
K9B022, K9C012, K9C022, K9C042, K9D012, K9E012, DK9E022,
K9H012, K9J012, DK9K012, DK9L012, K9L022, DK9N012,
DK9N022, DK9P01, DK9P022, DK9S012, DK0A012, DK0A022,
DK0B012, DK0C012, DK0C022, DK0D012, DK0E012, DK0H012,
DK0H022.
Manufacturer: National Medical Care, Dublin, Ireland.
Recalled by: National Medical Care, Rockleigh, New Jersey, by
telephone December 14, 1990 followed by letters beginning
December 19, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 59,385 units were distributed.
Reason: Product contains residual levels of ether used in the
manufacturing process, which may expose patients who
are hemodialyzed with the devices to ether contamination
which may cause adverse patient reactions.
----
Class II -
Product: Agee Inside Job Carpal Tunnel Release System -
Disposable Blade Assembly, Catalog #81016, used in a
surgical technique for endoscopic release of the carpal
tunnel. Recall #Z-186-1.
Code: All lots -- NOV89001, DEC89002, AUG89004, AUG89005,
AUG89006, DEC90007, OCT90008, OCT90009.
Manufacturer: Questus Corporation, Marblehead, Massachusetts.
Recalled by: 3M Company, Orthopedic Products Division, St. Paul,
Minnesota, by letter November 21, 1990. Firm-initiated
recall complete.
Distribution: Nationwide.
Quantity: 3,714 assemblies were distributed.
Reason: The blade assembly does not fully elevate when activated
or remain fully elevated per specification after
activation and during use.
----
Product: AMS dilation and occlusion catheters:
(a) Ureteral Balloon Dilation Catheter with Hydrophilic
Coating, Standard Balloon (Coaxial), Part number
72401230.
(b) Ureteral Balloon Dilation Catheter with Hydrophilic
Coating, Low Profile, Part number 72401245.
(c) Ureteral Balloon Dilation Catheter, Long Balloon
(Coaxial), Part number 72401251.
(d) Ureteral Balloon Dilation Catheter No Tip Balloon
(Coaxial), Part number 72401260.
-10-
(e) Ureteral Balloon Dilation Catheter with Stone
Retriever, Part number 72401272.
(f) Ureteral Balloon Dilation Catheter, Part number
72401291.
(g) Ureteral Balloon Dilation Catheter Female (Coaxial),
Part number 72401300. Recall #Z-187/193-1.
Code: Lot numbers: (a) 3327R, (b) 3329R; (c) 3330R; (d) 3331R;
(e) 3334R; (f) 3341R; (g) 3342R.
Manufacturer: Baxter Health Care, Inc., Irvine, California.
Recalled by: American Medical Systems, Minnetonka, Minnesota, by
letters of December 7 and 9, 1990. Firm-initiated recall
ongoing.
Distribution: Washington, D.C., Alabama, Kentucky, Maryland, Michigan,
New Mexico, New York, North Carolina, Oregon,
Pennsylvania, South Carolina, Tennessee, Texas, Vermont,
Virginia, West Virginia.
Quantity: 56 catheters.
Reason: One of the external computer generated labels may have an
incorrect expiration date and the Low Profile Ureteral
Balloon Dilation Catheter (AMS PIN 72401245) is
mislabeled as a No Tip Ureteral Balloon Dilation Catheter
(AMS PIN 72401260).
----
Product: (a) Harris/Galante (HGP) Porous Femoral Stem,
Product #6520-18, 18 mm Diameter, X-Large;
(b) Harris/Galante (HGP) Porous Femoral Stem,
Product #6520-11, 11 mm Diameter, Small;
(c) Macrofit Femoral Stem, Product #6950-12, 12 mm
Diameter, Small. Recall #Z-200/202-1.
Code: Lot numbers: (a) 70997200; (b) 71288400; (c) 71448700.
Manufacturer: Zimmer, Inc., Warsaw, Indiana.
Recalled by: Manufacturer, by letter August 24, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: (a) 2 units; (b) 2 units; (c) 24 units were distributed.
Reason: Potential for a seal void in the outer sterile package
may compromise sterility.
----
Product: Merit Intellisystem Inflation Syringe, a sterile
single-use prescription device used, with the Merit
Medical Intellisystem Monitor, to create pressure in the
balloon of dilatation catheters during transluminal
angioplasty. Recall #Z-203-1.
Code: Catalog #IN1000, Lot numbers 101017 and 101120.
Manufacturer: Merit Medical Systems, Inc., Salt Lake City, Utah.
Recalled by: Manufacturer, by visit December 15, 1990 followed by
letter. Firm-initiated recall ongoing.
-11-
Distribution: Nationwide, West Germany, Japan, Canada.
Quantity: Approximately 4,102 units were distributed.
Reason: The syringe will not hold pressure during use at the
pressure desired or for the time desired.
----
NOTE: SD-2000 Series Ellipsometer, a laser device,
Recall #Z-185-1 which appeared in the January 30, 1991
Enforcement Report should read
Code: Serial numbers: 20130590, NR5011.03.
----
Class III -
NONE
VETERINARY PRODUCTS
NONE
Medical Device Safety Alert:
Product: Kendall McGaw Laboratories Infusion Pumps distributed
before October 25, 1989. The pump regulates the infusion
of I.V. fluids:
(a) Model No. 521 and Microrate Intelligent Infusion Pump.
(b) Model 522 Intelligent Infusion Pump with software
versions prior to D14C2. Safety Alert #M-003/004-1.
Code: All units shipped prior to October 25, 1989 with any
software version prior to D14C2.
Manufacturer: Kendall McGaw Laboratories, Inc., Carrollton, Texas.
Alerted by: Manufacturer, by letter October 25, 1989.
Distribution: Nationwide.
Quantity: 3,475 pumps were distributed.
Reason: The firm has notified users that the numeral "7" may be
easily confused with the numeral "1" on the top segment
of the LED display panel. Use of this product may result
in the overinfusion of primary and secondary I.V. fluids.