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
04/23/1991
FDA Enforcement for the week of April 24, 1991
FDA ENFORCEMENT REPORT
FOR APRIL 24, 1991
April 24, 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: Various cases of bread dough:
1. White Bread Dough;
2. Raisin Bread Dough;
3. French Bread Dough;
4. Italian Bread Dough;
5. White Bread Dough 18 oz.;
6. Submarine Roll Dough;
7. Hoagie Rolls;
8. Deluxe Hamburger Roll Dough;
9. Potato Roll Dough;
10. Vienna Roll Dough;
11. French Roll Dough;
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12. Crusty Kaiser Roll Dough;
13. Meltaway Sweet Roll Dough;
14. Petite Cinnamon Sweet Roll Dough;
15. Hot Cross Bun Dough;
16. Natural Grain Bread Dough;
17. Petite French French Roll Dough;
18. Donut Shell Dough;
19. French Baguette Dough;
20. Deluxe Baguette Bread Dough;
21. Deluxe Sandwich Bun Dough;
22. Coney Island Bun Dough;
23. Butter & Egg Dinner Roll Dough;
24. Rye Dinner Roll Dough;
25. Pumpernickel Dinner Roll Dough;
26. F.S. 6 oz. White Bread Dough;
27. Family Pack Dough;
28. Pizza Dough Medium;
29. Onion Roll Dough;
30. Super Rite Kaiser Roll Dough;
31. Cinnamon Loaf Dough;
32. Mini Italian Bread Dough;
33. Mini Raisin Bread Dough;
34. Pizza Dough;
35. In-Store Bakery Onion Roll Dough;
36. Wheat Hamburger Bun Dough;
37. Hoagie Roll Dough;
38. Submarine Roll Dough. Recall #F-315/352-1.
Code: Product Code Date Code
1. 01564 1030
01564 1029
2. 03025 1031
3. 03033 1031
03033 1032
03033 1028
4. 03041 1029
03041 1032
5. 03068 1028
6. 03148 1031
03148 1026
7. 03199 1032
8. 03210 1028
9. 03228 1029
10. 03236 1026
11. 03295 1030
12. 03412 1029
03412 1028
13. 03420 1031
14. 03480 1031
15. 03498 1030
16. 03500 1032
17. 03543 1026
18. 03623 1030
19. 03885 1031
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20. 03893 1028
21. 04087 1026
22. 04095 1032
23. 04280 1031
24. 04298 1032
25. 04319 1032
26. 06154 1030
27. 06699 1028
28. 06752 1032
29. 06998 1028
30. 07851 1029
31. 08969 1030
32. 10225 1032
33. 10831 1031
34. 11236 1029
35. 11252 1028
36. 11308 1031
37. 12010 1031
38. 12028 1031.
Manufacturer: Rich Products Corporation, Winchester, Virginia.
Recalled by: Rich Products, Inc., Buffalo, New York, by telephone
and by letter February 6 & 7, 1991. Firm-initiated
recall ongoing.
Distribution: Virginia, West Virginia, Maryland, New York, Indiana,
Pennsylvania.
Quantity: 47,844 cases of the various products were distributed;
firm estimates none remains on the market.
Reason: Product is contaminated with brass shavings.
----
Product: Fresh unlabeled bulk eggplant, in 30 pound cases.
Recall #F-353-1.
Code: Not coded.
Manufacturer: Dubois Farms, Inc., Boynton Beach, Florida (grower).
Recalled by: A. Duda and Sons, Inc., Belle Glade, Florida, by
telephone March 15, 1991. Firm-initiated recall ongoing.
Distribution: Louisiana New York.
Quantity: 41 cases were distributed.
Reason: Product contains illegal pesticide residues.
----
Product: Pudding and pie filling, 3-1/2 ounces and 5-1/8 ounces:
Jell-O Cook'n Serve Pudding and Pie Fillings -
(a) Chocolate Flavor; (b) Milk Chocolate Flavor;
(c) Chocolate Fudge Flavor;
Jell-O Instant Pudding and Pie Filling -
(d) Chocolate Flavor; (e) Milk Chocolate Flavor;
(f) Chocolate Fudge Flavor. Recall #F-354/359-1.
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Code: Lot numbers Date Code
(a) 1032S1D, 1032S1E, 1032S1F 1 Feb 91 (5-1/2 oz)
1036S1, 1036S2 5 Feb 91 (3-1/2 oz)
1039S1D, 1039S1E, 1039S1F
1039S2D, 1039S2E, 1039S2F 8 FEB 91 (5-1/8 oz)
1042S1D, 1042S1E, 1042S1F,
1042S2D, 1042S2E, 1042S2F 11 FEB 91 (5-1/8 oz)
(b) 1033S1, 1033S2 2 FEB 91 (3-1/2 oz)
1035S1, 1035S2 4 FEB 91 (3-1/2 oz)
(c) 1035S1, 1035S2 4 FEB 91 (3-1/2 oz)
(d) 1037S1D, 1037S1E, 1037S1F
1037S2D, 1037S2F 6 FEB 91S (5-1/8)
1038S1, 1038S2 7 FEB 91S (3-1/2)
(e) 1037S1, 1037S2 6 FEB 91S (3-1/2 oz)
1043S1 12 FEB 91 (3-1/2 oz)
(f) 1038S1D, 1038S1E, 1038S1F
1038S2D, 1038S2E, 1038S2F 7 FEB 91S 5-1/8 oz
Manufacturer: General Foods USA, San Leandro, California.
Recalled by: General Foods USA White Plains, New York, by letters
of March 15 and 19, 1991. Firm-initiated recall ongoing.
Distribution: California, Texas, Arizona, Nevada, Hawaii, Oregon,
Washington state, Colorado, New Mexico, Utah, Montana,
Idaho.
Quantity: Approximately 5,200 cases (24 packages/case) were
distributed.
Reason: The product is contaminated with metal fragments.
----
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
NONE
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: Disposable Flow Probes for Bio-Probe Disposable Blood
Flow Monitoring Systems Models DP-38 (adult insert);
and DP-38P (pediatric insert), pre-sterilized,
disposable electrodes for precise blood flow measure-
ments. Recall #Z-447/448-1.
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Code: All serial numbers for both products.
Manufacturer: Medtronic Bio-Medicus, Eden Prairie, Minnesota.
Recalled by: Manufacturer, by letter January 21, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: Approximately 275,000 inserts were distributed; firm
estimated 8,000 units remained on market at time of recall.
Reason: Product sterility has been compromised as evidenced by
loss of package integrity.
----
Product: Burdick E550 Interpretive Electrocardiograph.
Recall #Z-449-1.
Code: All units with software revision 3.16. Units with
serial numbers of 55364 and greater are not affected.
Manufacturer: Siemens-Burdick, Milton, Wisconsin.
Recalled by: Manufacturer, by memorandum dated August 12, 1990.
Firm-initiated field correction ongoing.
Distribution: Nationwide and Canada.
Quantity: 269 units were distributed.
Reason: When the device has a full directory of 45 tracings and
batch entering of demographics is being performed, new
waveforms being entered into the system may be deleted
instead of the old waveforms already in the directory.
----
Product: Universal Therapy Table Used in Conjunction with Linear
Accelerator (SL25 Series). Recall #Z-451-1.
Code: All SL25 series.
Manufacturer: Philips Radiotherapy Systems, Crawley, England.
Recalled by: Philips Medical Systems North America, Shelton, Connecticut.
by letter October 9, 1990. Firm-initiated field
correction ongoing.
Distribution: Nationwide and Canada.
Quantity: 38 systems were distributed.
Reason: A software error may cause the system to detect an
"unauthorized movement" and react by releasing all brakes
on the table.
----
Product: SL25 Series Linear Accelerator. Recall #Z-452-1.
Code: All SL25 series.
Manufacturer: Philips Radiotherapy Systems, Crawley, England.
Recalled by: Philips Medical Systems, North America, Shelton, Connecticut.
Distribution: Nationwide and Canada.
Quantity: 38 systems were distributed.
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Reason: Leaks in the ion chamber may cause inaccurate calibration
which may cause the dose of radiation delivered to the
patient to vary from that prescribed.
----
Product: Laser Fiber Adapters, used to connect fiber optic
delivery probe to surgical laser.
Model numbers: (a) 90-1460; (b) 90-1461; (c) 90-8000;
(d) 90-2100; (e) 90-5330; (f) 90-5370; (g) 90-5380;
(h) 90-5382Recall #Z-482/489-1.
Code: Serial numbers: Unknown.
Manufacturer: Surgimedics/SLP, The Woodlands, Texas.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan April 28, 1991. Firm-initiated field correction
ongoing.
Distribution: Nationwide.
Quantity: 126 units were distributed.
Reason: Noncompliance with the performance standard for laser
products in that the adaptors permanently defeated required
fiber cable interlock on the host cable on the system.
----
Product: Schneider Softrac-PTA (Percutaneous Transluminal Anioplasty)
Catheters 5.6 French:
(a) Model P506-495, 6 mm x 4 cm;
(b) Model P506-095, 6 mm x 10 cm. Recall #Z-497/498-1.
Code: Lot numbers: (a) LNC902501; (b) LNJ902401.
Manufacturer: Schneider (USA), Inc., Plymouth, Minnesota.
Recalled by: Manufacturer, by letter February 5, 1991. Firm-initiated
recall complete.
Distribution: Nationwide and Canada.
Quantity: (a) 58 units; (b) 26 units were distributed.
Reason: Some units were labeled with the wrong balloon size.
During reworking the labeling these two lots were
mixed up so that some catheters labeled as having a
6 mm x 4 cm balloon actually have 6 mm x 10 cm balloon.
----
Product: Ultraclam, Electronic Dental Anesthesia Device, an
Rx device intended for the relief of pain during
dental operative procedures. Recall #-Z-512-1.
Code: Serial numbers: 001314, 001315, and 101319.
Manufacturer: Sion Technology, Inc., Aurora, Colorado.
Recalled by: Manufacturer, by telephone February 15, 1991 followed by
letter February 18, 1991. Firm-initiated recall complete.
Distribution: California and Colorado.
Quantity: 3 units were distributed.
Reason: The device was distributed without an approved 510(k).
----
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Product: Sterile Bio-Medicus Venous Femoral Cannula, 23, 25, 27, and
29 French sizes, a sterile, single-packed product used
primarily during open heart surgery reoperation.
Recall #Z-513/516-1.
Code: Product #96350 -- All lots.
Manufacturer: Bio-Medicus, Inc., Eden Prairie, Minneasota.
Recalled by: Manufacturer, by letter January 7, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 1,664 units were distributed.
Reason: The sterility of the device may be compromised by abrasion
of the Tyvek or Mylar near the connector.
----
Product: COBE Spectra Apheresis Machine, a microprocessor-
controlled device intended to separate and collect
blood components from both donors and patients:
(a) Pump Rotor System; (b) Stand Alone Pump Rotor.
Recall #Z-518/519-1.
Code: (a) Catalog numbers 950000-000, 950000-001, 950000-002,
950000-003, 950000-004, 950000-005 -- Serial numbers:
1S00028 through 1S00618;
(b) Part #700536002 -- All serial numbers.
Manufacturer: Cobe Blood Component Technology (BCT), Inc., Lakewood,
Colorado.
Recalled by: Manufacturer, by memorandum March 14, 1991 and by letters
March 20, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: (a) 590 units were distributed; (b) Undetermined.
Reason: The pump rotors have been found to have the following
potential failure modes which can lead to partial or
complete loss of pump tubing occlusion, resulting in
over-delivery or under-delivery of blood components
depending on the location of the failed rotor: (1) an
occlusion spring may break; (2) the rotor arm movement may
be misadjusted; and (3) the roller may become dislodged from
its seat in the roller arm.
----
Product: SIA Data Plus Microplate Software, Catalog #S2272,
computer software for immunoassay diagnoses.
Recall #Z-553-1.
Code: None.
Manufacturer: Sigma Diagnostic, St. Louis, Missouri.
Recalled by: Manufacturer, by telephone between May 4 and 10, 1990
followed by letter June 26, 1990. Firm-initiated field
correction ongoing.
Distribution: Michigan, California, Utah, New York, Pennsylvania, Canada.
Quantity: 8 discs were distributed.
Reason: Program software errors yielded erroneous laboratory test
results.
----
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Product: OEC-Diasonics X-Ray Imaging Table Model UroView 2000,
an integrated X-ray imaging and patient positioning
system for use in a variety of urological diagnostic
and surgical applications. Recall #Z-556-1.
Code: Serial numbers: T2-2001, T2-2002, T2-2004, T2-2005,
T9-2001 through T9-2004; T9-2006 through T9-2019; T9-2021
through T9-2026, T2/T9-2027, T9-2028 through T9-2032,
T9-2034 thru T9-2036.
Manufacturer: OEC Diasonics, Salt Lake City, Utah.
Recalled by: Manufacturer, by Field Service Bulletin dated November 2,
1990. Firm-initiated field correction ongoing.
Distribution: Nationwide and Canada.
Quantity: 38 units were distributed.
Reason: The side rail clamp which mounts the accessory leg support
to the table may break
----
Class III -
Product: Lyme Disease Test Kit. Recall #Z-454-1.
Code: Lot numbers: KF05069 and KF05071.
Manufacturer: Medical Diagnostic Technologies, Inc., Augusta, Georgia.
Recalled by: Manufacturer, by telephone June 14, 1990. Firm-initiated
recall ongoing.
Distribution: Pennsylvania, North Carolina, Florida, New Mexico,
Kentucky, Virginia.
Quantity: 13 kits were distributed.
Reason: Due to a new formulation of the conjugate rinse (Reagent C)
for the bulk test kit, if the user follows the directions
for use instructions, then all three wells react "positive"
to include the "negative control" well.
----
Product: "ABL" Clostridium Difficile Agar, a selective and
differential medium used for the primary isolation
and presumptive identification of C. difficile from
stool samples. Recall #Z-511-1.
Code: Catalog #01293, Lot #FE061 EXP 5/2/90.
Manufacturer: Austin Biological Labs, Inc., Austin, Texas.
Recalled by: Manufacturer, by telephone April 1990. Firm-initiated
recall complete.
Distribution: Texas, Mississippi.
Quantity: 61 packages (10 plates/package) were distributed.
Reason: Product is contaminated with bacteria or mold.
----
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Product: Cobalt 57 Dose Calibrator Source, a gamma source used for
calibrating ionization chambers mainly in the nuclear
medicine departments of hospitals. Recall #Z-520-1.
Code: #C057-EGAG90, NO. 1587, Lot #183.
Manufacturer: Cis-Bio-Oris, Sadey, France.
Recalled by: Cis-US Inc., Bedford, Massachusetts, by telephone February
4, 1991 followed by letter February 5, 1991. Firm-initiated
recall complete.
Distribution: Nationwide and Canada.
Quantity: 23 vials were distributed.
Reason: The calibration date on the label and calibration
certificate is incorrect. The calibration date was
incorrectly written on the label as "Jan 90", but it
should have been "Jan 91".
----
Product: K-Y Lubricating Jelly, in 4 ounce clear blister
packages, used as a lubricant for insertion of medical
instruments as well as a vaginal lubrication.
Recall #Z-542-1.
Code: All codes and expiration dates that are in blister packaging.
Manufacturer: Tama Promotions, Inc., Deer Park, New York.
Recalled by: Manufacturer, by letter mailed on or about February 15,
1991. Firm-initiated recall ongoing.
Distribution: New York.
Quantity: Approximately 70,560 units were distributed.
Reason: There are no directions for use or warning statements on the
blister package, the expiration date is not visible at
the point of purchase and the packaged product does not
conspicuously provide the name and address of the
manufacturer, repacker or distributor.
----
Product: Sigma Disgnostics Glucose Standard Solution, 10.0 mg/ml
or 55.5 mmol/l, 100 ml solution in 4 fluid ounce
amber glass vials. Recall #Z-552-1.
Code: Catalog #14-11, Lot numbers: 89F-6105 and 38F-6127.
Manufacturer: Sigma Diagnostics, St. Louis, Missouri.
Recalled by: Manufacturer, by letter February 5, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: Firm estimates none remains on the market.
Reason: Some bottle labels show a concentration of 100 mg/ml
instead of 10.0 mg/ml.
----
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Product: Sigma Diagnostics (a) Ethanol Control-H (high);
(b) Ethanol Control-L (low), in-vitro diagnostic kits
used as a control in the determination of ethyl alcohol,
both kits are packaged 6/2 ml vials per carton.
Recall #Z-554/555-1.
Code: (a) Catalog #E 5258, lot #79F-6094 EXP 8/90;
(b) Catalog #E 5133, lot #79F 6093 EXP 8/90.
Manufacturer: Sigma Diagnostics, St. Louis, Missouri.
Recalled by: Manufacturer, by letter February 5, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: (a) 5,856 vials; (b) 6,024 vials were distributed;
firm estimates none remains on the market.
Reason: Both controls were found either at or below the lower
specified values.
----
VETERINARY PRODUCTS
NONE
Medical Device Safety Alerts:
Product: Omni-Flow I.V. Pump, Model 4000. Safety Alert #M-005-1.
Code: All units.
Manufacturer: Omni Flow, Inc., subsidiary of Abbott Labs., Wilmington,
Massachusetts.
Alerted by: Abbott Hospital Products Division, Abbott Park, Illinois,
by letter November 6, 1990.
Distribution: Nationwide and Canada.
Quantity: Approximately 3,800 units were distributed.
Reason: Existance of artifacts in patient monitoring devices,
such as ECG, EMG and EEG machines may be produced by
electronic noise, (e.g. static electricity) produced by
the I.V. pump. These artifacts, if not recognized as such
may lead to an erroneous interpretation of the readings
from the patient monitoring devices.
----
Product: Cordis brand Dual Chamber Cardiac Pacers:
(a) Model 233F, Sequicor II;
(b) Model 415A Gemini (Theta), implantable pacemakers
which are Class III critical devices.
Safety Alert #M-013/014-1.
Code: Various individually serialized units produced between
1981 and 9184.
Manufacturer: Cordis Corporation, Pacing Division, Miami, Florida.
Alerted by: Telectronics Pacing Systems, Englewood, Colorado, by
letter February 15, 1991.
Distribution: Nationwide and international
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Qantity: (a) 1,007 units; (b) 415 units were distributed.
Reason: Certain units of listed models may have a reduced service
life due to premature individual cell depletion.
----
Product: Cordis brand Stanicor Lambda Model 188A7 Pacemaker, an
implantable, single chamber cardiac pacer.
Recall #M-015-1.
Code: Various individually serialized units produced between
1975 and 1978.
Manufacturer: Cordis Corporation, Pacing Division, Miami, Florida.
Alerted by: Telectronics Pacing Systems, Englewood, Colorado, by
letter February 15, 1991.
Distribution: Nationwide and international.
Quantity: 2,942 were distributed.
Reason: Certain listed units of this model may not provide an
adequate end-of-life indicator, which is due to changes
in the carbon composition resistor valve.