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.

June 4, 1997 97-23

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ============
_______________
PRODUCT Knaub's Cakes, « lemon pound.
Recall #F-257-7.
CODE All codes with manufacture date of earlier than 10/1/96 that are in
commercial channels.
MANUFACTURER Knaub's Cakes, Inc., York, Pennsylvania.
RECALLED BY Manufacturer, by telephone on or about October 4, 1996. Ongoing recall
resulted from sample analysis and followup by the New York State
Department of Agriculture and Markets.
DISTRIBUTION New York.
QUANTITY 478 cases (12 cakes per case) were distributed.
REASON Product contained undeclared FD&C Yellow #5.

_______________
PRODUCT Pecan Chips, net weight 2 ounces.
Recall #F-413-7.
CODE Date code: 11-24-97, 11-25-97, 11-26-97, 11-27-97, 11-28-97, 12-1-97,
12-4-97, 12-8-97, 12-10-97, 12-12-97 - The date code is stamped on the
bottom right corner of each package.
MANUFACTURER Planters Company, Suffolk, Virginia.
RECALLED BY Nabisco Inc., Parsippany, New Jersey, by letter dated February 3, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 23,338 cases (12 bags per case) were distributed; firm estimated that 3% of
product remained on market at time of recall initiation.
REASON Product contains undeclared milk.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ===========
_______________
PRODUCT Isomil brand Soy Protein Infant Formula with Iron. Recall #F-414-7.
CODE All lot numbers. Product expires in February 1998.
MANUFACTURER Abbott Laboratories, The Netherlands.
RECALLED BY First National Supermarkets, Inc., doing business as Finast Inc., Maple
Heights, Ohio, by fax on September 10 and 16, 1996. Firm-initiated recall
complete.
DISTRIBUTION Ohio.
QUANTITY 104 cases (6 cans per case) were distributed.
REASON The infant formula does not contain the labeled amount of inositol, a
nutrient required under 21 CFR section 107.100. This product was
originally formulated for distribution in the United Kingdom which does
not require the addition of inositol.

_______________
PRODUCT Sunsweet Chopped Dates, in 10 ounce canisters. Recall #F-415-7.
CODE Julian Date: Exp. Date:
3166 11MAY98
3176 12MAY98
3186 13MAY98
3196 14MAY98
3206 15MAY98
3406 05JUN98
3416 06JUN98
3446 09JUN98
0108 08JUL98
0107 10JUL98
0137 13JUL98
0157 15JUL98.
MANUFACTURER Sunsweet Growers, Inc., Stockton, California.

-2-RECALLED BY Manufacturer, by telephone on February 3, 1997. Firm initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 46,105 cases were distributed; 23,880 cases remained on market at time of
recall initiation.
REASON Product contains undeclared dextrose.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
============
_______________
PRODUCT Norpace Disopyramide Phosphate Capsules, 150 mg, in bottles of 100 and
1,000, Rx oral antiarrhythmic. Recall #D-182-7.
CODE Lot numbers: 6B75B and 6B758A EXP 2/89.
MANUFACTURER Searle, Caguas, Puerto Rico.
RECALLED BY Searle, Skokie, Illinois, by letter dated May 8, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 9,000 100-capsule bottles and 1,668 1000-bottles were distributed; firm
estimated that 10-25% of the product remained on market at time of recall
initiation.
REASON Some capsules may be partially filled.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ===========
_______________
PRODUCT Panafil Ointment, in 1 pound jars, and 1 ounce tubes, Rx product intended
for the treatment of acute or chronic lesions and infected wounds. Recall
#D-181-7.
CODE LOT PKG SIZE EXP DATE
0719P-1 pound jars Exp Aug 99
0719P-1 ounce tubes Exp Aug 99
0816P-1 ounce tubes Exp Sep 99.
MANUFACTURER Rystan Company, Inc., Little Falls, New Jersey.
RECALLED BY Manufacturer, by letter on October 30, 1996. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates none remains on the market.
REASON Subpotent at stability testing.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ========
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-803/804-7.
CODE Unit #24LH23822.

-3-MANUFACTURER American Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letters dated October 16 and 20, 1995 and December 7,
1995. Firm-initiated recall complete.
DISTRIBUTION Kentucky.
QUANTITY 1 unit of each component
REASON Blood products had undergone atypical viral testing for HIV and were then
tested into compliance with no confirmatory test.

_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-809/810-7.
CODE Unit #24GV21975.
MANUFACTURER American Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letters dated December 21, 1995, and January 5, 1996.
Firm-initiated recall complete.
DISTRIBUTION Indiana and New Jersey.
QUANTITY 1 unit of each component was distributed.
REASON Blood products had undergone atypical viral testing for HBsAg and were
then tested into compliance with no confirmatory test.

_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-811/812-7.
CODE Unit #24LK21280.
MANUFACTURER American Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letters dated December 16 and 20, 1995. Firm-initiated
recall complete.
DISTRIBUTION Indiana and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products had undergone atypical viral testing for HBsAg and were
then tested into compliance with no confirmatory test.

_______________
PRODUCT a) Red Blood Cells; b) Platelets;
c) Recovered Plasma. Recall #B-813/815-7.
CODE Unit #24GV22380.
MANUFACTURER American Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letters dated January 24 and 30, 1996. Firm-initiated
recall complete.
DISTRIBUTION Indiana and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products had undergone atypical viral testing for HBsAg and were
then tested into compliance with no confirmatory test.

-4-_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-816/817-7.
CODE Unit #24LX03326.
MANUFACTURER American Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letters dated January 24 and 30, 1996. Firm-initiated
recall complete.
DISTRIBUTION Indiana and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products had undergone atypical viral testing for HBsAg and were
then tested into compliance with no confirmatory test.

_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-818/819-7.
CODE Unit #24GV22325.
MANUFACTURER American Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letters dated January 24 and 30, 1996. Firm-initiated
recall complete.
DISTRIBUTION Indiana and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood product had undergone atypical viral testing HIV and were then
tested into compliance with no confirmatory test.

_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-820/821-7.
CODE Unit #24LK22310.
MANUFACTURER American Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letters dated January 24 and 30, 1996. Firm-initiated
recall complete.
DISTRIBUTION Indiana and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products had undergone atypical viral testing for HBsAg and were
then tested into compliance with no confirmatory test.

_______________
PRODUCT Red Blood Cells. Recall #B-822-7.
CODE Unit #24LQ05996.
MANUFACTURER American Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letter dated February 13, 1996. Firm-initiated recall
complete.
DISTRIBUTION Tennessee.
QUANTITY 1 unit was distributed.
REASON Blood product had undergone atypical viral testing for HBsAg and was
then tested into compliance with no confirmatory test.

-5-_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-826/828-7.
CODE Unit #24GS05529.
MANUFACTURER American Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letter dated February 28, 1996. Firm-initiated recall
complete.
DISTRIBUTION Kentucky, Indiana, Illinois.
QUANTITY 1 unit of each component was distributed.
REASON Blood products had undergone atypical viral testing for HBsAg and were
then tested into compliance with no confirmatory test.

_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-829/830-7.
CODE Unit #24LC02286.
MANUFACTURER American Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letter dated February 28, 1996. Firm-initiated recall
complete.
DISTRIBUTION Kentucky and Pennsylvania.
QUANTITY 1 unit of each component was distributed.
REASON Blood products had undergone atypical viral testing for HBsAg and were
then tested into compliance with no confirmatory test.

_______________
PRODUCT Red Blood Cells. Recall #B-831-7.
CODE Unit #24LJ18935.
MANUFACTURER American Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letter dated April 2, 1996. Firm-initiated recall complete.
DISTRIBUTION Kentucky.
QUANTITY 1 unit was distributed.
REASON Blood product had undergone atypical viral testing for HBsAg and was
then tested into compliance with no confirmatory test.

_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-832/833-7.
CODE Unit #24LS15937.
MANUFACTURER American Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letter dated March 29, 1996. Firm-initiated recall
complete.
DISTRIBUTION Kentucky and Pennsylvania.
QUANTITY 1 unit of each component was distributed.
REASON Blood products had undergone atypical viral testing for HBsAg and were
then tested into compliance with no confirmatory test.

-6-_______________
PRODUCT Red Blood Cells. Recall #B-834-7.
CODE Unit #24GS13484.
MANUFACTURER American Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letter dated April 2, 1996. Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood product had undergone atypical viral testing for HBsAg and was
then tested into compliance with no confirmatory test.

_______________
PRODUCT a) Whole Blood; b) Red Blood Cells; c) Recovered Plasma. Recall
#B-835/837-7.
CODE Unit numbers: a) 24LR01232; b) 24GW12345, 24LK19071, 24LZ09016,
24LE07707, 24LE30261, 24LE08409; c) 24GW12345, 24LK19071,
24LZ09016, 24LE07707, 24LE30261, 24LE08409.
MANUFACTURER American Red Cross, Louisville, Kentucky.
Recalled by Manufacturer, by letters dated October 17, and 23, 1996. Firm-initiated
recall complete.
DISTRIBUTION Indiana, Kentucky, California, Switzerland.
QUANTITY a) 1 unit; b) 6 units; c) 6 units were distributed.
REASON Blood products had undergone atypical viral testing for HBsAg and units
were then tested into compliance with no confirmatory test.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d)
Cryoprecipitate; e) Recovered Plasma. Recall #B-838/842-7.
CODE Unit numbers: a) 24KM09887, 24LL34069, 24LK16585, 24LG55854; b)
24LL34069, 24LK16585; c) 24LK16585; d) 24KM09887, 24LG55854; e)
24KM09887, 24LL34069, 24LG55854.
MANUFACTURER American Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letter dated April 8, 1996. Firm-initiated recall complete.
DISTRIBUTION Indiana, Kentucky, California.
QUANTITY a) 4 units; b) 2 units; c) 1 unit; d) 2 units; e) 3 units were distributed.
REASON Blood products tested negative for antibody to the human
immunodeficiency virus type 1 (anti-HIV-1), but were collected from a
donor who previously tested repeatedly reactive for anti-HIV-1, Western
Blot negative and was incorrectly reentered.

-7-_______________
PRODUCT Red Blood Cells. Recall #B-843-7.
CODE Unit #21FL15804.
MANUFACTURER American Red Cross Blood Services, Portland, Oregon.
RECALLED BY Manufacturer, by telephone on October 7, 1996. Firm-initiated recall
complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASOn Blood product tested negative for the antibody to the hepatitis C virus
encoded antigen (anti-HCV), but was collected from a donor who
previously tested repeatedly reactive for anti-HCV.

_______________
PRODUCT Platelets, Pheresis. Recall #B-844-7.
CODE Unit #03LQ10771.
MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia.
RECALLED BY Manufacturer, by telephone on January 16, 1997. Firm-initiated recall
complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an incorrect platelet yield.

_______________
PRODUCT Red Blood Cells. Recall #B-845-7.
CODE Unit #T72600.
MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois.
RECALLED BY Manufacturer, by telephone on March 26, 1997. Firm-initiated recall
complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who had been deferred for ear
piercing.

_______________
PRODUCT Red Blood Cells. Recall #B-847-7.
CODE Unit #29FK22697.
MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia.
RECALLED BY Manufacturer, by letters dated February 21, 1997, and March 4, 1997.
Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.

-8-REASON Blood product was collected from a donor who traveled to an area
considered endemic for malaria.

_______________
PRODUCT Red Blood Cells. Recall #B-848-7.
CODE Unit #53FM16771.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY Manufacturer, by letter dated March 4, 1997. Firm-initiated recall
complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who traveled to an area
considered endemic for malaria.

_______________
PRODUCT Red Blood Cells. Recall #B-849-7
CODE Unit #18R64035.
MANUFACTURER American Red Cross Blood Services, Lansing, Michigan.
RECALLED BY Manufacturer, by letter dated October 19, 1995. Firm-initiated recall
complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who traveled to an area
considered endemic for malaria.

_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-851/852-7.
CODE Unit #81-03425.
MANUFACTURER Michigan Community Blood Center, Traverse City, Michigan.
RECALLED BY Manufacturer, by letter dated March 20, 1996. Firm-initiated recall
complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who traveled to an area
considered endemic for malaria.

______________
PRODUCT Platelets. Recall #B-853-7.
CODE Unit #38FC06170.
MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana.
RECALLED BY Manufacturer, by letter dated December 14, 1995. Firm-initiated recall
complete.
-9-DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who traveled to an area
considered endemic for malaria.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Abbott HTLV-1 2.0 EIA diagnostic Kit, Human T-Lymphotropic Virus
Type 1. Recall #B-735-7.
CODE Lot #25685M301 EXP 7/11/97.
MANUFACTURER Abbott Laboratories, Diagnostic Division, Abbott Park, Illinois.
RECALLED BY Manufacturer, by telephone on April 25, 1997, and by letter dated April 28,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Arizona, Louisiana, New York, North Carolina, Oklahoma, Pennsylvania,
Rhode Island, South Dakota, Texas.
QUANTITY 2 kits and 237 bulk tests were distributed.
REASON HTLV-1 2.0 coated bead bottles contain inappropriate Corzyme beads.

_______________
PRODUCT Streptokinase Kabikinase, a sterile purified preparation of bacterial protein
elaborated by group C B-hemolytic streptococci:
a) Streptokinase Kabikinase 250,000 IU; b) Streptokinase Kabikinase
1,500,000 IU.
Recall #B-781/782-7.
CODE Lot numbers: a) 14476A51, 14476B51, 14476C51; b) 14304A51,
14304D51.
MANUFACTURER Pharmacia AB, Stockholm, Sweden.
RECALLED BY Pharmacia & Upjohn Company, Kalamazoo, Michigan, by letter dated May
5, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 16,000 vials were distributed.
REASON Streptokinase Kabinase did not meet potency specification throughout the
labeled shelf-life.

_______________
PRODUCT a) HIV-1 Western Blot Kit; b) OraSure HIV-1 Western Blot Kit. Recall
#B-783/784-7.
CODE Lot numbers: a) M0613601, M0617602, M0625601, M0709601,
M0719602, M0725601, M0813601, M0814601, M0815602, M0815603,
M0910601, M0916601, M0919601, M1004602, M1009601, M1022601,
M1101604
-10- b) M0730601, M0910602, M1016601, M1205601, M0117703.
MANUFACTURER Epitope, Inc., Beaverton, Oregon.
RECALLED BY Manufacturer, by letter on February 27, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY a) 3,654 kits; b) 712 kits were distributed.
REASON High positive control vials were mislabeled as the conjugate vials for the
test kits.

_______________
PRODUCT Whole Blood. Recall #B-796-7.
CODE Unit #C19760.
MANUFACTURER South Bend Medical Foundation, Inc., South Bend, Indiana.
RECALLED BY Manufacturer, by telephone on January 5, 1996. Firm-initiated recall
complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood product tested positive for syphilis and was not labeled with
"Biohazard" label.

_______________
PRODUCT Red Blood Cells. Recall #B-797-7.
CODE Unit #38W02971.
MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana.
RECALLED BY Manufacturer, by letter in February 1996. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who traveled in an area
considered endemic for malaria.

_______________
PRODUCT Red Blood Cells. Recall #B-799-7.
CODE Unit #FY70981.
MANUFACTURER Inova Health Care Services, Annandale, Virginia.
RECALLED BY Manufacturer, by telephone on October 22, 1996, followed by letter dated
October 23, 1996. Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.
REASON Blood product tested initially reactive for the hepatitis B surface antigen
(HbsAg), and was not repeated in duplicate.

-11-_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B- 805/807-7.
CODE Unit #13FN15443.
MANUFACTURER American Red Cross, Detroit, Michigan.
RECALLED BY Manufacturer, by letter dated February 26, 1997. Firm-initiated recall
complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who exceeded the donation
acceptance criterion for body temperature.

_______________
PRODUCT Coulter HIV-1 p24 Antigen Elisa Test System. Recall #B-808-7.
CODE Lot #2065J376.
MANUFACTURER Coulter Corporation, Miami, Florida.
RECALLED BY Manufacturer, by letter dated April 2, 1996. Firm-initiated recall complete.
DISTRIBUTION California, Florida, Louisiana, Maryland, New York, Pennsylvania,
Tennessee, Texas, Washington, state.
QUANTITY 53 kits were distributed.
REASON Antigen Test system with higher optical density (OD) negative control
values than originally obtained, however, results were within labeled
specifications.

_______________
PRODUCT Fresh Frozen Plasma. Recall #B-846-7.
CODE Unit #55C04488.
MANUFACTURER American Red Cross Blood Services, Little Rock, Arkansas.
RECALLED BY Manufacturer, by telephone on March 10, 1997. Firm-initiated recall
complete.
DISTRIBUTION Arkansas.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of whole blood with an extended
collection time.

_______________
PRODUCT Platelets for further manufacture.
Recall #B-850-7.
CODE Unit #18R64035.
MANUFACTURER American Red Cross Services, Lansing, Michigan.
RECALLED BY Manufacturer, by letter dated October 19, 1995. Firm-initiated recall
complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
-12-REASON Blood product was collected from a donor who traveled to an area
considered endemic for malaria.

_______________
PRODUCT Red Blood Cells for Further Manufacture. Recall #B-854-7.
CODE Unit #38FC06170.
MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana.
RECALLED BY Manufacturer, by letters dated December 14, 1995, March 18, 1996, and
April 12, 1996. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who traveled to an area
considered endemic for malaria.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
==========
_______________
PRODUCT E.C.C. Neonatal Percutaneous Catheters and Trays:
a) Fr. E.C.C. Neonatal Percutaneous Catheter Order No. 2184.00,
b) Fr. E.C.C. Neonatal Percutaneous Catheter Tray Order No. 218400K,.
Recall #Z-464/465-7.
CODE a)Lot No. E28A51; b) Lot No. 3464 and Lot No. 4029.
MANUFACTURER Vygon GmbH & Company, KG, Germany.
RECALLED BY Vygon Corporation, East Rutherford, New Jersey, by telephone and by fax
on July 19, 1996, and by letter on July 22, 1996. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 3,068 catheters were distributed.
REASON Leaks are occurring at the integral section sets, at the point where the
female luer lock hub is bonded to the extension.

_______________
PRODUCT Multinex Plus ID, used to monitor gases in a patient:
a) Multinex Plus ID
b) Multinex Plus ID
c) Multinex Plus ID
d) Multinex Plus ID Recall #Z-586/589-7.
CODE a) Model No. 0998-00-00071-17
b) Model No. 0098-00-00071-18
c) Model No. 0098-00-00071-19
-13- d) Model No. 0098-00-00071-20.
MANUFACTURER Datascope Corporation, Paramus, New Jersey.
RECALLED BY Manufacturer, by letter August 2, 1996. Firm-initiated field correction
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 876 units were distributed.
REASON The labeling for the devices does not state that the Agent Identification
mode should be disabled prior to injection of anesthesia gases. Failure to
do so will cause erroneous CO2, N2O, and Agent readings.

_______________
PRODUCT Vail Enclosed Bed System, used for the containment of patients who have
been identified as being at risk and in need of physical, or chemical
restraints:
a) Vail 1000 Enclosed Bed System
b) Vail 2000 Enclosed Bed System.
Recall #Z-580/581-7.
CODE Lot numbers: a) 100-194; b) 100-289.
MANUFACTURER Vail Products, Inc., Toledo, Ohio.
RECALLED BY Manufacturer, by mailing questionnaires on July 3, 1996 and by letter on
April 9, 1997. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY a) 131 bed systems; b) 262 bed systems were distributed.
REASON Possible breakage of the spring mechanism within the bed side rails. This
breakage may hinder the protective side rails from being placed in the
upright position, and remain in that position.

_______________
PRODUCT Vision FX Series Digital Nuclear Imaging systems, used to produce tomographic
images of the body which can aid in the diagnosis of ailments such as cancer and
heart disease:
a) Model FX-40; b) Model FX-80.
Recall #Z-626/627-7.
CODE Serial numbers 93-96, 100-173, P2, and PP3. All vision FX series model numbers are
affected.
MANUFACTURER SMV America, Twinsburg, Ohio.
RECALLED BY Manufacturer, by letter on March 19, 1997. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 79 units were distributed.

-14-REASON The collimator of the devices was sliding off the
collimator server because it was difficult for the
operator to determine when the collimator was
properly engaged on the collimator server. This
falling collimator problem may result in potential
injuries to the operator and/or patient.

_______________
PRODUCT Acromioplasty Electrode Basic Kit, Catalog #9801B,
used in the shoulder area when performing an
Acromioplasty.
Recall Z-628-7.
CODE Lot numbers: 58738 and 60683.
MANUFACTURER Linvatec, Inc., Largo, Florida.
RECALLED BY Manufacturer, by letter dated April 29, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and England.
QUANTITY 904 kits were distributed.
REASON Some kits may contain a Meniscectomy Electrode
instead of the labeled Acromioplasty Electrode.

______________
PRODUCT Force Argon II Gas Delivery System (includes regulator) GR200 Pressure
Regulator (for second
argon bottle, used to provide energy delivery for
argon-enhanced electrosurgery.
Recall #Z-629/630-7.
CODE Force Argon II System, Serial Nos. G6L101U through
G7D160U;
GR200 Regulator, Lot Nos. PCA563-03, 97095322,
9705322G, 9705323.
MANUFACTURER Tescom, Minneapolis, Minnesota (regulator unit).
RECALLED BY Valleylab, Inc., Boulder, Colorado, by telephone
on May 2, 1997, followed by fax with confirming
letters sent on May 2, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION International.
QUANTITY 3 units.
REASON Under certain conditions, the high pressure
regulator may fail and cause the hose on the low
pressure side of the regulator to rupture, which
could cause injury to patients, surgical personnel
or service technicians.

-15-_______________
PRODUCT AL-800PA Sp02 Module, used with the Nihon Kohden
Multi-Parameter Patient Monitor, for pulseoxymetry
monitoring in patients.
Recall #Z-631-7.
CODE All modules bearing serial number 06354 and below.
MANUFACTURER Nihon Kohden, Inc., Irvine, California.
RECALLED BY Manufacturer, by letter dated January 24, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 3,109 units were distributed.
REASON Crosstalk (noise) between the LED driver circuit
and the SpO2 sensing circuit is due to spatial
limitations of the printed circuit board layout
which caused an increase of the SpO2 sensing
circuit offset current to give incorrect readings.

_______________
PRODUCT Sensicare Non-Sterile Medical Examination Gloves,
powder free. Recall #Z-632-7.
CODE Catalog #484302A, Lot #0121637, Sublot #63753N (on
individual boxes).
MANUFACTURER Maxxim Medical, Inc., Los Gatos, California.
RECALLED BY Manufacturer, by letter on April 16, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 819 cases of lot #0121637 and 59 cases of sublot
#63753N were distributed.
REASON The gloves are mislabeled as "Powder Free," which
indicates the gloves do not contain powder. The
gloves appear to have powder dusted on the
interior surface.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III =========
_______________
PRODUCT Hydron Proactive 55 (Ocufilcon D) Disposable
Contact Lenses, in blister package that is put
into a box. Recall #Z-625-7.
CODE 2400516503, 2400516937, 2400516838, 2400516210,
2400516747, 2400517385, 2400516638, 2400517066,
2400516936, 2400516946, 2400516592, 2400516805,
2400517482, 2400516738, 2400516522, 2400516996,
2400517202, 2400516128, 2400516878, 2400516503.
MANUFACTURER Ocular Science/American Hydron, San Francisco,
California.

-16-RECALLED BY Manufacturer, by telephone and by letter on April
24, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,577 boxes are subject to recall.
REASON The wrong label on the blister is for the HYDRON
PROACTIVE FW (POLYMACON) contact lens, however,
the lens in the blister is a HYDRON PROACTIVE 55
contact lens.

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PRODUCT Measles (Rubeola) IgG ELISA Test Kit, an in-vitro
diagnostic test kit for the detection of IgG
antibody to the measles virus.
Recall #Z-633-7.
CODE Lot #2326000-114 EXP 5/97.
MANUFACTURER Clark Laboratories, Inc., Jamestown, New York.
RECALLED BY Manufacturer, by letter dated July 9, 1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 126 kits were distributed.
REASON The calibrator was incorrectly labeled "Herpes
simplex virus type 2 IgG ELISA" instead of
"Measles (Rubeola) IgG ELISA".

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PRODUCT 2.5 mm Disposable Optical Valvulotome, Model
#A5205, used for valve incision during in-situ
saphenous vein arterial bypass procedures. Recall
#Z-639-7.
CODE Lot numbers: 95L268, R5N009, 96B137.
MANUFACTURER Applied Medical Resources, Laguna Hills,
California.
RECALLED BY Manufacturer, by telephone followed by fax on on
August 1, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Florida, Illinois, New Mexico, Spain.
QUANTITY 9 units were distributed.
REASON The product labeled as 2.5 mm disposable
angioscopes but contain 2.5 mm disposable optical
valulotomes.

-17-

END OF ENFORCEMENT REPORT FOR JUNE 4, 1997. BLANK PAGES MAY FOLLOW.

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End of Enforcement Report for