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
01/15/1991
FDA Enforcement for the week of January 16, 1991
FDA ENFORCEMENT REPORT
FOR JANUARY 15, 1991
January 16, 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: Pre-filled candy ball dispensing machines and candy ball
refills: (a) Carousel Pixie, World's Smallest Working
Gumball Machine, only 3 inches tall, packaged loose, in 24
piece counter display boxes, and individual blister pack
cards, containing approximately 1 ounce of candy;
(b) Carousel Pixies, Teenie Weenie Candie Refills, net
weight 1.5 ounces. Recall #F-047/048-1.
Code: All lots.
Manufacturer: Carousel Industries, Inc., Des Plains, Illinois.
-1-
Recalled by: Manufacturer, by letter September 7, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 45,000 pounds of candy have been distributed;
firm estimates very little remains on the market.
Reason: Products contain Cochineal Red A, an unapproved color for
food use.
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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 pastry products, shipped in 2.65 ounce, 12 ounce,
13 ounce, 15 ounce, 16 ounce, 17 ounce and 20 ounce
packages and boxes:
1. Apple Raisin Coffee Cake
2. Cheese Crumb Babka
3. Cherry Cheese Danish
4. Individual Cheese Danish Deli
5. Pineapple Cheese Strudel
6 Pineapple Filled Cheese Cake
7 Raspberry Danish Twist
8 Sticky Buns
9 Walnut Danish Twist
10 Filled Chocolate Chip
11 Lemon Glazed Sponge Ring
12 Cheese Coffee Cake
13 Cheese Topped Buns
14 Apple Puffs
15 Butter Sunshine
16 Crumb Coffee Cake
17 Cinnamon Buns/Cinnamon Twist
18 Lemon Twist
19 Strawberry Twist
20 Pecan Ring
21 Cinnamon Filbert Ring
22 Walnut Danish Ring
23 Danish Ring
24 Cinnamon Raisin Nut Ring
25 Cinnamon Nut Ring
26 Danish Ring Butter Filling
27 Almond Coffee Cake. Recall #F-071/097-1.
Code: (1-9) 807; (10) 808; (11) 808; (12) 803; (13) 803
(14) 804; (15) 808; (16) 803; (17) 804; (18) 804;
(19) 804; (20) 803; (21) 803; (22) 804; (23) 804;
(24) 807; (25) 807; (26) 807; (27) 807.
Manufacturer: Entenmann's Bakery Inc., Bayshore, New York, by letter
August 2, 1990. Firm-initiated recall ongoing.
Distribution: New York, New Jersey, Maryland, Boston, Pennsylvania,
Connecticut.
Quantity: Total units distributed:
-2-
1. 15,639
2. 16,568
3. 23,623
4. 5,784
5. 23,828
6. 18,559
7. 32,123
8. 18,624
9. 13,048
10. 11,964
11. 6,979
12. 16,942
13. 18,833
14. 17,501
15. 8,376
16. 19,951
17. 13,048 (buns), 10,518 (twists)
18. 9,143
19. 5,364
20. 32,548
21. 19,708
22. 24,248
23. 13,337
24. 11,554
25. 15,204
26. 11,052
27. 15,798.
Reason: Off taste due to oxidative rancidity.
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COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-059/060-1.
Code: Unit numbers 59R36220, 59G75088.
Manufacturer: American Red Cross Blood Services, Petoskey, Michigan.
Recalled by: Manufacturer, by telephone February 16, 1990 and by letters
February 19, 1990 and also October 29, 1990.
Firm-initiated recall ongoing.
Distribution: Michigan and California.
Quantity: 2 units of each component.
Reason: Blood products collected from donors who reported
1) needlestick injury or 2) high risk behavior, were
distributed.
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Class III -
NONE
MEDICAL DEVICES AND RADIOLOGY
Class I -
Product: Vitek Proplast II Temporomandibular (TMJ) Interpositional
Implants (IPI's), concave trapezoidal shape with articular
eminence extension, used in replacing the meniscus disk
in the temporomandibular joint:
(a) Product No. 912.71, 26 x 26 x 1.3 mm, non-porous
teflon laminate;
(b) Product No. 912.72, 26 x 26 x 2.3 mm, non-porous
teflon laminate;
(c) Product No. 912.74, 26 x 26 x 4.3 mm, non-porous
teflon laminate;
(d) Product No. 912.76, 26 x 26 x 1.3 mm, non-porous
teflon laminate with reinforced polyaramid fabric;
(e) Product No. 912.77, 26 x 26 x 2.3 mm, non-porous
teflon laminate with reinforced polyaramid fabric;
(f) Product No. 912.78, 26 x 26 x 4.3 mm, non-porous
teflon laminate with reinforced polyaramid fabric.
Recall #Z-162/167-1.
(Note: This action was originally classified as a
Safety Alert, M-040/045-0 which appeared in the May 16,
1990 Enforcement Report.)
Code: All units.
Manufacturer: Vitek, Inc., Houston, Texas.
Recalled by: Manufacturer, by safety alert letter of March 23, 1990.
Firm-initiated recall ongoing. See also FDA press release
P91-3, January 7, 1991.
Distribution: Nationwide and international.
Quantity: Approximately 25,000 units were distributed.
Reason: The Proplast/Teflon material is not substantially
equivalent to Silastic. TMJ IPI's made from this
material may fragment, delaminate or otherwise be damaged
or punctured in a load-bearing position. Debris in the
joint from the implants can contribute to progressive bone
degeneration of the condyle of the mandible and/or glenoid
fossa and to foreign body response which could start in
this area and be carried throughout the immune system.
----
Product: LP6 Volume Ventilator, an Rx medical device intended to
mechanically control or assist in delivery of breathing
gas to a patient. Recall #Z-170-1.
Code: All serial numbers.
Manufacturer: Aequitron Medical, Inc., Minneapolis, Minnesota.
-4-
Recalled by: Manufacturer, by letter November 23, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 7,008 units were distributed.
Reason: Intermittent changes in electrical characteristics of
either the volume or breathing effort control components
may result in the device delivering tidal volumes above or
below the control setting. Under certain conditions, the
units may delay or fail to provide an audible/visual high
or low pressure alarm. In addition, a liquid spill entry
into the device may cause the device to fail to cycle or
alarm, cause motor stalls, volume fluctuations, or other
problems.
----
Class II -
Product: AML Collarless Hip Stem, a sterile, implantable hip stem.
Recall #Z-119-1.
Code: Lot numbers: 821301, 821300.
Manufacturer: DePuy, Inc., Division of Boehringer-Mannheim Corporation,
Warsaw, Indiana.
Recalled by: Manufacturer, West Germany, Canada and Argentina.
October 22, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide and International.
Quantity: 32 units were distributed.
Reason: Product/packaging mix-up. The device contained in
packaging was not the modified medical aspect (MMA)
configuration as labeled, but rather a standard
configuration device.
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Product: AML Hip Stem, a sterile hip stem intended for non-
cemented implant, packaged one to a box.
Recall #Z-120-1.
Code: Lot number 518870.
Manufacturer: Depuy, Inc., Division of Boehringer-Mannheim Corporation,
Warsaw, Indiana.
Recalled by: Manufacturer, by telephone beginning September 1, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 9 units were distributed.
Reason: Product/packaging mix-up - Product etched as 1357-03,
lot 518870 (modified medical aspect) (MMA) contained in
box labeled 1354-04 lot 521270 (standard width).
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-5-
Product: Sirecust 403-N, a compact bedside monitor for neonatal
application: (a) Software Version VCO-BNX;
(b) Software Version NA and NA1. Recall #Z-149/150-1.
Code: Software versions: NA, released 7/11/86;
NA1 released 9/9/86; VCO-BNX released 3/15/89.
Manufacturer: Siemens Ag. UB-Medical, Bensheim, Germany.
Recalled by: Siemens Medical Electronics, Inc., Danvers, Massachusetts,
by memorandum October 24, 1988 and by product safety
notice April 25, 1989. Firm-initiated field correction
ongoing.
Distribution: Nationwide and international.
Quantity: 259 units were distributed.
Reason: Devices may fail to detect apnea under certain
conditions of use.
----
Product: Baxter Clinical Assay Gammadab (125I) Alphafetoprotein
Radioimmunoassay Kit, for the quantitative determination of
AFP in serum or amniotic fluid. Recall #Z-152-1.
Code: Catalog number: CA-585/B5690-27.
Kit lot No. EXP Date
0329, 0330, 0331, 0332 10/28/89
0335 11/26/89
0336, 0337, 0338, 0341 12/23/89
Tracer Lot No. EXP Date
6178 10/28/89
6232 11/26/89
6283 12/23/89
Manufacturer: Baxter Healthcare Corporation, Cambridge, Massachusetts.
Recalled by: Manufacturer, by letter November 3, 1989. Firm-initiated
recall complete.
Distribution: Nationwide and international.
Quantity: Firm estimates none remains on market.
Reason: Lypholized tracers did not go into solution. Incompletely
dissolved AFP tracers could cause poor replication of
intravial variability and consequently inaccurate test
results.
----
Product: Philips Cardio-Diagnost 9 U-Arm Fluoroscopic X-ray
System. Recall #Z-169-1.
Code: Model 9804-404-6..07. All serial numbers up to
January 1990 manufacturing date.
Manufacturer: Philips Medical Systems N.A. Company, Shelton,
Connecticut.
Recalled by: Manufacturer, by field correction December 1989.
Firm-initiated field correction ongoing.
Distribution: Georgia, Ohio, Pennsylvania, New York, Michigan,
Maryland, Washington, D.C., Texas, Japan.
Quantity: 18 units were distributed.
Reason: Failure of weld at the system base plate may cause U-arm
to fall.
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-6-
Product: Qualtex brand kits/trays, assembled by the recalling
firm: (a) Central Line Kit, item #50-3388;
(b) Dressing Tray, item #50-4067;
(c) Central Line Dressing Kit, item #50-5787.
Recall #Z-172/174-1.
Code: Sterilization lot numbers: (a) 12154; (b) 12163; (c) 12231.
Manufacturer: Sterling Multi-Products Inc., Prophetstown, Illinois.
Recalled by: DeRoyal Industries, Inc., Powell, Tennessee, by letter
September 19, 1990. Firm-initiated recall ongoing.
Distribution: (a) Massachusetts; (b) Indiana; (c) Illinois.
Quantity: (a) 300 kits; (b) 90 trays; (c) 50 kits were distributed.
Reason: The kits/trays were assembled using instruments subject
to recalls Z-089/092-1 (see Enforcement Report dated
November 28, 1990). A reddish-brown greasy residue may
form on the surface when the instruments are ETO
sterilized.
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Class III -
Product: Baxter Clinical Assays GammaDab (125I) B-hCG Radio-
immunoassay Kit for the evaluation of human chorionic
gonadotropin in serum. Recall #Z-153-1.
Code: Catalog #1511/B5690-29.
Kit Lot Nos. EXP Dates
0283 10/09/89
0284, 0285 10/23/89
0286 11/06/89
0288 l1/20/89
0290, 0291 11/30/90
Manufacturer: Baxter Healthcare Corporation, Cambridge, Massachusetts.
Recalled by: Manufacturer, by letter November 3, 1989. Firm-initiated
recall complete.
Distribution: Nationwide and international.
Quantity: Firm estimates none remains on the market.
Reason: The kit contains low, out of range controls and cloudy
standards.
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Product: Baxter Clinical Assays GammaDab M (125I) B-hCG
Radioimmunoassay Kit for the evaluation of human
chorionic gonadotropin in serum. Recall #Z-154-1.
Code: Catalog #1511/B5690-29.
Kit Lot Nos. EXP Dates
0213 05/09/88
0214 05/23/88
0215 06/06/88
0216 06/06/88
Manufacturer: Baxter Healthcare Corporation, Cambridge, Massachusetts.
Recalled by: Manufacturer, by letter May 13, 1988. Firm-initiated
recall complete.
Distribution: Nationwide and international.
Quantity: Firm estimates none remains on the market.
-7-
Reason: Product exhibits turbidity and there is a shift in the
standard curve resulting in low (out of range) control
performance.
----
Product: Software Package for A2, A3 and Paragon Imaging Systems,
for Medtronic and Medasys, Inc. The software is used for
the collection, display and analysis of clinical nuclear
images. Software package may be on hard disc, floppy disc
or tape, depending on system installation. Recall
#Z-171-1.
Code: All existing versions of software for A2, A3 and Paragon.
Manufacturer: Medasys, Inc., Ann Arbor, Michigan.
Recalled by: Manufacturer, by press release June 8, 1990 and by
telephone, followed by letter October 1, 1990.
Firm-initiated field correction ongoing.
Distribution: Nationwide and Canada.
Quantity: Unknown.
Reason: The computer will terminate operations (system shut down)
if a date later than January 1, 1991 is entered into or
booted on. In addition to an inaccurate date, additional
limitations exist which include tomagraphic reconstructions
rendered inoperative, keyboard lock and nonprocessing of
gated heart studies.
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EXTENSION NOTE: Handi-VAK II Disposable Collection Units (DCU),
Recall #Z-884/887-0 which appeared in the October 3,
1990 Enforcement Report has been extended. The firm,
Allied Healthcare Products, Inc., St. Louis Missouri,
has issued a second letter dated November 13, 1990 due
to continuing problems, with the canisters imploding.
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VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: Gentamicin Sulfate Injection, 50 mg/ml, in 50 ml vials,
packed 12 vials per case, an Rx used in treatment of
urinary tract infections in dogs, under the Butler
and Techamerica labels. Recall #V-053-1.
Code: Lot #8342A EXP 12/91.
Manufacturer: Fermenta Animal Health Company, Elwood, Kansas.
Recalled by: Fermenta Animal Health Company, Kansas City, Missouri,
by letters dated November 28, 1990 and December 7, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide, Canada.
Quantity: 17,941 vials were distributed.
Reason: Product was found to be cross-contaminated with Xylazine.
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Seizure Actions Filed:
Product: Various New Animal Drugs (90-552-981 et al).
Charge: Unapproved new animal drugs and misbranded animal drugs.
Firm: Ag America, Manson, Iowa.
Filed: July 17, 1990 - U.S. District Court for the Northern
District of Iowa; Civil #C90-3035, FDC #65883.