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
11/01/1995

ENFORCEMENT REPORT FOR 11/1/95

November 1, 1995 95-44

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Various Dinnerware: (a) Garden Basket Pattern 16-piece
Stoneware Dinnerware Set; Midnight Satin Pattern: (b) 26-
piece dinnerware set; (c) Tea Pot/Coffee Server; (d) 6-piece
Condiment Set; (e) Gravy Boat; (f) 14" Oval Platter; (g) Cup
and Saucer Set; (h) Orchard Splendor Pattern 24 piece
dinnerware Set. Recall #F-026/033-6.
CODE None.
MANUFACTURER Shantou Printing Factory, Guangdong Province, China.
RECALLED BY McCrory Corporation, York, Pennsylvania, by electronic mail
on May 26, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 36,105 sets were distributed.
REASON Products contain excessive levels of leachable lead.

_______________
PRODUCT Wheat bread, sometimes labeled whole wheat bread, 22-1/2
ounce loaves, in plastic bags, produced under the following
labels: Langendorf 100% Wheat Bread, QFC Quality Food
Centers 100% Wheat Bread; Stock Market Foods 100% Wheat;
Cascade Mills 100% Whole Wheat Bread; Western Family 100%
Wheat Bread. Recall #F-041/042-6.
CODE "SEP 27" or "27" ink stamped on green plastic bag closures.
MANUFACTURER Gai's Northwest Bakeries, Langendorf Plant, Seattle,
Washington.
RECALLED Gai's Northwest Bakeries Company, Seattle, Washington, by
visit September 20, 1995, followed by letter October 4,
1995. Firm-initiated recall complete.
DISTRIBUTION Washington State.
QUANTITY 3,363 loaves were distributed.
REASON Product was contaminated with glass, plastic resin, and
metal.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Breaded Shrimp: (a) Oriental Breaded Mini Shrimp, Item
#010559; (b) Breaded Shrimp IQF, Item #075630; (c) Imitation
Breaded Pouch Pack Shrimp IQF, Item #011726; (d) Breaded
Mini Shrimp IQF, Item #129513; (e) Imitation Breaded Shrimp
IQF Shrimp Pouch, Item #086726. Recall #F-035/039-6.
CODE Lot numbers: (a) 344604A; (b) 346450A; (c) 342941A; (d)
343250A; (e) 342942A.
MANUFACTURER Bee Gee Shrimp Company, Lakeland, Florida.
RECALLED BY Manufacturer, by telephone August 21, 1995, followed by
letter. Firm-initiated recall ongoing.
DISTRIBUTION Southeastern and Midwestern United States.
QUANTITY 6,153 cases were distributed; firm estimated that 620 cases
remained on market at time of recall initiation.
REASON Product is adulterated due to decomposition.

_______________
PRODUCT Golden Grain Mission Radiatore Enriched Macaroni Product,
Net weight 22 ounces. Recall #F-040-6.
CODE Bag code: FEB 21 97 S14 and FEB 21 97 S24; Case code: JUL
23 95 S1 and JUL 23 95 S2.
MANUFACTURER Golden Grain Company, Seattle, Washington.
RECALLED BY The Quaker Oats Company, Chicago, Illinois, by letters dated
October 5, 1995. Firm-initiated recall ongoing.
DISTRIBUTION California, Utah, Washington State.
QUANTITY 1,030 cases were distributed; firm estimated that 10 percent
of product remained on market at time of recall initiation.
REASON The radiatore pasta was packaged erroneously in poly bags
labeled Golden Grain Rigatoni.

_______________
UPDATE Recall #F-007-6, Strawberry Daiquiri Cocktail Mix, which
appeared in the October 11, 1995 Enforcement Report is a
Class III recall. The reason for recall should read:
REASON: The product contains undeclared FD&C Red No. 40.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I
======================
______________
PRODUCT (a) Red Blood Cells; (b) Source Leukocytes.
Recall #B-615/616-5.
CODE Unit numbers: 60GQ01310 and 60GQ01320.

-2-MANUFACTURER American National Red Cross, Miami, Florida.
RECALLED BY Manufacturer, by letters dated October 18, 1993, November
18, 1993, December 20, 1993, February 25, 1994, March 3 and
17, 1994. Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 2 units of each component.
REASON Blood products, which tested repeatedly reactive for the
antibody to the human T-lymphotropic virus type I (anti-
HTLV-1) and confirmed positive by unlicensed Western Blot,
were distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Red Blood Cells; (b) Source Leukocytes.
Recall #B-617/618-5.
CODE Unit numbers: (a) 60FG00115, 60FN01786; (b) 60GS01944,
60GM00297, 60GM00296, 60FW00317, 60FG00002, 60GQ01559,
60FG00013, 60GM01866, 60GX01017, 60GM00808.
MANUFACTURER American National Red Cross, Miami, Florida.
RECALLED BY Manufacturer, by letters dated October 18, 1993, November
18, 1993, December 20, 1993, February 25, 1994, March 3 and
17, 1994. Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY (a) 2 units; (b) 10 units.
REASON Blood products, tested initially reactive for the antibody
to the human immunodeficiency virus types 1 and 2 (anti-HIV-
1 and 2); tested initially reactive for the hepatitis B
surface antigen (HBsAg); tested repeatedly reactive for the
antibody to the hepatitis B core antigen (anti-HBc); tested
repeatedly reactive for the antibody the hepatitis C virus
encoded antigen (anti-HCV); tested repeatedly reactive for
syphilis by the Olympus PK7100 Treponema pallidum (TP) test
and were confirmed positive by the Fluorescent Treponemal
Antibody Absorption assay (FTA); and were prepared greater
than eight hours after phlebotomy, were distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma; (c) Recovered
Plasma, Pooled. Recall #B-009/011-6.
CODE (a) 31H93061, 31H20461; (b) 31G98745, 31S81508, 31H93061,
31H20461; (c) 86RB2810-1, 88RB2107-1.
MANUFACTURER American Red Cross, Buffalo, New York.
RECALLED BY Manufacturer, by letters dated between April 24, 1995 and
June 7, 1995. Firm-initiated recall complete.
DISTRIBUTION New York, Pennsylvania, California, Massachusetts,
Switzerland.
QUANTITY (a) 2 units; (b) 4 units; (c) 2 units.
REASON Blood products which: tested repeat reactive (RR) for
HBsAg; were collected from a donor who previously tested RR
for HBsAg; and were collected from a donor with a medical
history of hepatitis, were distributed.

-3-_______________
PRODUCT Red Blood Cells; (b) Recovered Plasma. Recall #B-013/014-6.
CODE Unit #47J33350.
MANUFACTURER American Red Cross Blood Services, Galesburg, Illinois.
RECALLED BY American Red Cross Blood Services, Peoria, Illinois, by
letter dated May 2 and 30, 1995. Firm-initiated recall
complete.
DISTRIBUTION Iowa, California.
QUANTITY 1 unit of each component.
REASON Blood products, collected from a donor who previously tested
repeatedly reactive for antibody to immunodeficiency virus
type 1 (anti-HIV-1) and was not reentered properly, were
distributed.

_______________
PRODUCT Platelets, Pooled. Recall #B-015-6.
CODE Unit #PP29443.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on May 4, 1995, followed by
letter dated May 8, 1995. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON Blood product, which was collected from a donor labeled with
an incorrect expiration date, was distributed.

_______________
PRODUCT Platelets. Recall #B-016-6.
CODE Unit #1156294.
MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, Kentucky.
RECALLED BY Manufacturer, by letter dated August 3, 1994. Firm-
initiated recall complete.
DISTRIBUTION Kentucky.
QUANTITY 1 unit.
REASON Blood product, which contained anti-Kell antibodies but was
labeled as negative for unexpected antibodies, was
distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-017/018-6.
CODE Unit #5F4785.
MANUFACTURER Puget Sound Blood Center, Seattle, Washington.
RECALLED BY Manufacturer, by letters dated July 6 and 7, 1995. Firm-
initiated recall complete.
DISTRIBUTION Washington state.
QUANTITY 1 unit of each component.
REASON Blood products, which were collected from a donor who had
close contact with an individual diagnosed with the
hepatitis C virus encoded antigen (HCV), were distributed.

-4-_______________
PRODUCT Red Blood Cells Leukocytes Removed. Recall #B-019-6.
CODE Unit numbers: 53F89420, 53FH37486, 53FH37487, 53FH37488,
53FH37489.
MANUFACTURER American National Red Cross, Baltimore, Maryland.
RECALLED BY Manufacturer, by letters dated October 3 and 17, 1994.
Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 5 units.
REASON Blood products which were prepared greater than eight hours
after phlebotomy, or were prepared from whole blood that was
stored at room temperature greater than eight hours, were
distributed.

_______________
PRODUCT Platelets, Pheresis. Recall #B-021-6.
CODE Unit #31KQ06234.
MANUFACTURER American Red Cross, Buffalo, New York.
RECALLED BY Manufacturer, by telephone on March 2, 1995. Firm-initiated
recall complete.
DISTRIBUTION New York.
QUANTITY 1 unit.
REASON Blood product, which was labeled with an incorrect
expiration date, was distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-034-6.
CODE Unit #FE01853.
MANUFACTURER Sacramento Medical Foundation Blood Center, Sacramento,
California.
RECALLED BY Manufacturer, by telephone on August 20, 1991, and by letter
dated September 12, 1991. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product, which was collected from a donor who was born
in or emigrated from an area of high risk for the human
immunodeficiency virus types 1 and 2 (HIV 1 and 2) was
distributed.

_______________
PRODUCT Plasma. Recall #B-035-6.
CODE Unit numbers: 17T49111021, 17T49819021, 17T5A510021,
17T5B131021, 17T5B414021.
MANUFACTURER Plasma Alliance, Inc., Tulsa, Oklahoma.
RECALLED BY Plasma Alliance, Inc., Knoxville, Tennessee, by letter dated
October 21, 1995. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 5 units.
REASON Blood products, which were collected from a donor at
increased risk for infectious diseases, were distributed.

-5-RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT (a) Source Leukocytes. Recall #B-619-5.
CODE Unit numbers: 60FG00115, 60GR00245, 60FG00012, 60L35357,
60GL00894, 60FN01786.
MANUFACTURER American National Red Cross, Miami, Florida.
RECALLED BY Manufacturer, by letters dated October 18, 1993, November
18, 1993, December 20, 1993, February 25, 1994, March 3 and
17, 1994. Firm-initiated recall complete.
DISTRIBUTION Florida and Switzerland.
QUANTITY 6 units.
REASON Blood products, which tested repeatedly reactive for the
antibody to the human T-lymphotropic virus type I (anti-
HTLV-1) tested repeatedly reactive for syphilis by the
Olympus PK7100 Treponema pallidum (TP) test and were
confirmed positive by the Fluorescent Treponemal Antibody
Absorption assay (FTA); tested initially reactive for
syphilis; were collected from a donor with a medical history
of cancer; and were prepared greater than eight hours after
phlebotomy, were distributed.

_______________
PRODUCT Single Donor Plasma. Recall #B-020-6.
CODE Unit #53F89420.
MANUFACTURER American National Red Cross, Baltimore, Maryland.
RECALLED BY Manufacturer, by letters dated October 3 and 17, 1994.
Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit.
REASON Blood products which were prepared greater than eight hours
after phlebotomy, or were prepared from whole blood that was
stored at room temperature greater than eight hours, were
distributed.

_______________
PRODUCT Platelets, Pheresis. Recall #B-022-6.
CODE Unit #33FP16182.
MANUFACTURER American Red Cross Blood Services, ¶, Connecticut.
RECALLED BY Manufacturer, by telephone on February 23, 1995. Firm-
initiated recall complete.
DISTRIBUTION Connecticut.
QUANTITY 1 unit.
REASON A unit of Platelets, Pheresis, labeled with the incorrect
expiration date, was distributed.

_______________
PRODUCT (a) Whole Blood CPDA-1; (b) Red Blood Cells; (c) Red Blood
Cells Leukocytes Removed; (d) Platelets, Pheresis; (e) Fresh
Frozen Plasma. Recall #B-024/028-6.

-6-CODE Unit numbers: (a) Unit Nos. 7002682, 7002683 and 7002684
(b) 4600173, 4600176 and 4600182, 6003902, 7002666, 7002667,
8048789, 8048790, 8048894, 8048895, 8048896, 8048897,
8048898, 8048900, 8048901, 8048908, 8048909,
8048910, 8048911, 8048912, 8048913, 8048915,
8960293, 8960294, 8960295, 8960296, 8960297,
8960298, 8960299, 8960300, 8960301, 8960302,
8960303, 8960304, 8960305, 8960306, 8960307,
8960308, 8960309, 8960310, 8960311, 8960312,
8960361, 8960363, 8960364, 8960365, 8960367,
8960368, 8960369, 8960370, 8960371, 8960372,
8960373, 8960374, 8960375, 8960376, 8960377,
8960378, 8960379, 8960380, 8960381, 8960382,
8960383, 8960384, 8960457, 8960458, 8960459,
8960460, 8960461, 8960462, 8960463, 8960464,
8960465, 8960466, 8960468, 8960469, 8960470,
8960471, 8960472, 8960474, 8960475, 8960476,
8960477, 8960478, 8960479, 8960480, 8960482,
8960483, 8960484, 8960485, 8960486 and 8960487;
(c) 8960390; (d) 5300363, 5300364, 5300365, 5300366,
5300367, 5300368 and 5300369; (e) 8048891 and 8048892.
MANUFACTURER West Tennessee Regional Blood Center, Inc., Jackson,
Tennessee.
RECALLED BY Manufacturer, by telephone on June 9, 1995. Firm-initiated
recall complete.
DISTRIBUTION Tennessee and Georgia.
QUANTITY (a) 3 units; (b) 92 units; (c) 1 unit; (d) 7 units;
(e) 2 units.
REASON Blood products, which were improperly tested for the
antibody to the hepatitis C virus encoded antigen (anti-
HCV), were distributed.

_______________
PRODUCT Platelets, Pheresis. Recall #B-029-6.
CODE Unit #42FR28305.
MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio.
RECALLED BY Manufacturer, by telephone on May 12, 1994, and by letter
dated June 2, 1994. Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit.
REASON A unit of Platelets, Pheresis which was incompatible by
crossmatch, was labeled as compatible and distributed for
transfusion.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma.
Recall #B-030/032-6.
CODE Unit #5710125.
MANUFACTURER BloodCare, Dallas, Texas.
RECALLED BY Manufacturer, by letter dated October 7, 1994. Firm-
initiated recall complete.
DISTRIBUTION Texas.

-7-QUANTITY 1 unit of each component.
REASON Blood products, which were collected from a donor who had
undergone a cornea transplant within twelve months of
donation, were distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-033-6.
CODE Unit #3188432.
MANUFACTURER Central Texas Regional Blood Center, Austin, Texas.
RECALLED BY Manufacturer, by telephone on October 16, 1995. Firm-
initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Autologous blood product, which tested positive for syphilis
but was not labeled with a "Biohazard" label, was
distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-036-6.
CODE Unit #GL02981.
MANUFACTURER Blood Bank of the Alameda-Contra Costa Medical Association,
Oakland, California.
RECALLED BY Manufacturer, by telephone March 20, 1992. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product, which was exposed to improper storage and
unacceptable temperatures was distributed.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Point of View Monitor, Model #0998-00-0105-01, used to
monitor heart rate and blood pressure. Recall #Z-044-6.
CODE All serial numbers.
MANUFACTURER Datascope Corporation, Paramus, New Jersey.
RECALLED BY Manufacturer, by telephone and fax on Marc 31, 1995,
followed by letter dated April 3, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 424 units were distributed.
REASON The monitor resets itself, causing monitoring information to
be suspended for up to several minutes until the unit powers
up. Upon reset, previously selected settings, including
alarm settings would need to be re-established.

_______________
PRODUCT Harris Precoat Plus Femoral Hip Stems:
(a) Product #9028-10, Harris Precoat Plus Femoral Stem,
Small (120mm Stem Length):
(b) Product #9028-20, Harris Precoat Plus Femoral Stem,
Medium (140mm Stem Length). Recall #Z-046/047-6.

-8-CODE All lots produced on or before 12/31/93.
MANUFACTURER Zimmer, Inc., Warsaw, New Jersey.
RECALLED BY Manufacturer, by letters sent August 28 and 29, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimated that no more than 100 to 200 units remained
on market at time of recall initiation.
REASON Laser etching may cause the femoral stems to fracture in
use, requiring revision surgery to replace the broken hip
implant.

_______________
PRODUCT SJS Partners Latex Examination Gloves, Powder Free, in boxes
of 100. Recall #Z-048-6.
CODE Lots prefixed 406 and 407; Reorder #GWZS 2220M.
MANUFACTURER Shanghai Latex Factory, Changzheng Branch, China.
RECALLED BY SJS Supreme, Inc., Yorba Linda, California, by letter dated
September 18, 1995. Firm-initiated recall ongoing.
DISTRIBUTION California, New Jersey, Illinois, Alabama, New York.
QUANTITY 1,100 cases (20 boxes per case) were distributed; firm
estimates none remains on the market.
REASON The gloves have the potential for spontaneous combustion,
demonstrated by signs of heat and possibly smoldering within
the cases.

_______________
PRODUCT Datascope's System 95 Intra-Aortic Balloon Pump (IABP),
Catalog #0998-00-0087XX, for use as a patient aid during
pre-, intra- or post operative open heart surgery.
Recall #Z-049-6.
CODE Serial numbers: 1000-1610 with the exception of the
following units: 1051, 1062, 1176, 1211, 1220, 1222, 1230,
1270, 1373, 1374, 1383, 1387, 1448, 1479, 1480, 1509, 1511,
1522, 1529, 1555, 1559, 1561, 1562, 1563, 1565, 1658, 1569,
1587, 1593, 1602, 1603, 1605, 1606.
MANUFACTURER Datascope Corporation, Paramus, New Jersey.
RECALLED BY Manufacturer, by letters dated May 2 and 31, 1995. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 439 units were distributed; firm estimated that 428 units
remained on market at time of recall initiation.
REASON Keypad failure causes the unit to become non-functional,
resulting in an inability to trigger balloon inflation.

_______________
PRODUCT Hewlett Packard Defibrillator Interface Cable,
Part #0012-00-0753-01. Recall #Z-050-6.
CODE None.
MANUFACTURER National Cable & Molding, Los Angeles, California.
RECALLED BY Datascope Corporation, Paramus, New Jersey, by letter May
25, 1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.

-9-QUANTITY 39 units.
REASON Due to incorrect wiring, the defibrillator may not recognize
the ECG input and, therefore, will not discharge. It may
also produce an intermittent condition which could cause a
false trigger, resulting in a random discharge.

_______________
PRODUCT AAMI Standard Defibrillator Interface Cable,
Part #0012-00-0731. Recall #Z-051-6.
CODE None.
MANUFACTURER National Cable & Molding, Los Angeles, California.
RECALLED BY Datascope Corporation, Paramus, New Jersey, by letter May
24, 1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 296 units were distributed.
REASON Due to a design flaw, there may be an intermittent
connection between the connector's ground shield and the
conductive coating in the Passport's housing. This
connection to ground can cause the random discharge of the
defibrillator during synchronized cardioversion.

_______________
PRODUCT ECG Electrodes:
(a) Medi-Trace Offset Dx ECG Electrodes, under the Graphic
Controls label;
(b) Matrx R.A.M. Electrodes, under the Matrx Medical label;
(c) Medi-Trace S'Offset ECG Electrodes, under the Graphic
Controls label. Recall #Z-057/059-6.
CODE Order No. Lot Numbers
(a) 8101 5111, 5141, 5151
8103 5101, 5111, 5121, 5141, 5151, 5161
8105 5101, 5111, 5121, 5151, 5161
8125 5091, 5101, 5121, 5141, 5151
(b) MPX 9114001 5111
(c) 8201 5101, 5111, 5121, 5141, 5151, 5161
8203 5101, 5111, 5141,5151
8205 5101, 5111, 5121, 5141, 5151
8225 5092, 5101, 5102, 5111, 5121.
MANUFACTURER Graphic Controls Corporation, Methuen, Massachusetts.
RECALLED BY Graphic Controls Corporation,Buffalo, New York, by letter
dated September 1, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,657,500 units were distributed.
REASON The electrodes produce excessive noise and artifact due to a
reworked silver strip component which was found to be
unstable.

_______________
PRODUCT Redman Motorized Wheelchairs:
(a) Model 107RW, Road Warrior, Motorized Wheelchair
(b) Model 107RS, Road Savage, Motorized Wheelchair
(c) Model 107RC, Geronimo, Motorized Wheelchair

-10- (d) Model 107PR, Geronimo PR, Motorized Wheelchair
(e) Model 107RU, Chief, Motorized Wheelchair
(f) Model 107SR, Chief SR, Motorized Wheelchair
(g) Model 07RP, Red Pack, Motorized Wheelchair.
Recall #Z-060/066-6.
CODE All wheelchairs having a Penny & Giles 60 AMP controller
with a serial number prefix of 9106XXXX to 9311XXXX, or if
the serial number has a "UG" suffix.
MANUFACTURER Redman, Inc., Tucson, Arizona.
RECALLED BY Manufacturer, by letter January 5, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, Israel.
QUANTITY 361 wheelchairs were distributed.
REASON The joystick circuitry can cause unintended starting and
stopping of the wheelchair. This defect presents a moderate
risk of serious adverse health consequences.

_______________
PRODUCT Venshield Heat and Moisture Exchange Filter.
Recall #Z-068-6.
CODE Lot numbers 2735 and 2747.
MANUFACTURER Colorado MEDtech, Inc., Boulder, Colorado.
RECALLED BY Manufacturer, by telephone during the week of August 21,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Arizona, California, Colorado, Florida, Illinois, Kentucky,
Massachusetts, Missouri, Oklahoma, Pennsylvania, Texas.
QUANTITY 15,000 units.
REASON The filter media can separate from the frame, obstructing
the respiration gas passage if the filter is saturated with
secretions.

_______________
PRODUCT CPU Software Version 1.07A in the Hydrajust IV Urological
Table: (a) Part #400001; (b) Part #400002;
(c) Part #400005; (d) Part #400006. Recall #Z-070/073-6.
CODE Serial Numbers for the tables are as follows:
4793-0132 2194-0177 3794-0200 2494-0182 2194-0176
0894-0160 2194-0175 1294-0166 4993-0127 2394-0179
3094-0191 2494-0181 2194-0174 3794-0199 2594-0185
2394-0180 3094-0192 3094-0188 3794-0198 2093-0117
2494-0183 3094-0186.
MANUFACTURER Liebel-Flarsheim Company, Cincinnati, Ohio.
RECALLED BY Manufacturer, by information sheet dated September 26, 1994.
Firm-initiated field correction complete.
DISTRIBUTION Nationwide, Mexico, Scotland.
QUANTITY 22 tables were subject to field correction.
REASON There is risk of patient or operator exposure when the X-ray
tube is in the park position.

-11-RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Ag 4000 (Ag/AgC1) Resting ECG Electrodes Unitrace, Silver
EEZ, Generic. Recall #Z-054-6.
CODE Lot numbers: UAG4-C 4178, 4201A, 4255A, 4170A, 5027; CDI
LAG4-CG; CII LAG4-CG, 4178, 4201A, 4297, 5027, 5107A, 5135;
CDI LAG4-C, 4178, 4201A, 4297.
MANUFACTURER LecTec Corporation, Minnetonka, Minnesota.
RECALLED BY Manufacturer, by letter dated August 10, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Arizona, California, Colorado, Connecticut, Florida,
Louisiana, Michigan, Minnesota, Missouri, New York, Rhode
Island, Texas, Wisconsin, France, Canada, Israel, Sweden.
QUANTITY 21,268,500 units were distributed.
REASON Certain lots of the Tracests Ag400 Silver/Silver Chloride
(Ag/AgCl) Resting ECG Electrodes may not satisfy the
Association for the Advancement of Medical Instrumentation
(AAMI) defibrillation overload recovery standard throughout
the product's 24-month shelf life, which could lead to
misdiagnosis by the clinician.

-12-

END OF ENFORCEMENT REPORT FOR NOVEMBER 1, 1995. BLANK PAGES MAY
FOLLOW.

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