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
04/05/1995

Recalls and Field Corrections: Foods -- Class I -- 04/05/1995

April 5, 1995 95-14

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Smoked Salmon, vacuum packed in various weights.
Recall #F-568-5.
CODE 12 22 94 on package and 269 on case carton.
MANUFACTURER Tony's Smoke House and Cannery, Oregon City, Oregon.
RECALLED BY Manufacturer, by telephone February 11-12, 1995. Firm-
initiated recall complete.
DISTRIBUTION Oregon, Washington state.
QUANTITY 857 pounds were distributed.
REASON Product is contaminated with Listeria monocytogenes.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Alba Dairy Shake Mix, Artificial Vanilla Flavor, Alba 77,
available in retail cartons containing 8 x 0.75 ounce
pouches of product. Recall #F-530-5.
CODE Lot numbers: H2374, H238, H239, H2404, H2414.
MANUFACTURER Near East Food Products, Leominster, Massachusetts.
RECALLED BY Heinz U.S.A., Pittsburgh, Pennsylvania, by fax September 27,
1994, and October 4, 1994 and by letter October 17, 1994.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Undetermined
REASON Product contains undeclared FD&C Yellow No. 5.

_______________
PRODUCT Power Ade Beverage, in 64 ounce plastic bottles, bottled for
the Coca-Cola Company, Atlanta, Georgia, by Hi Country,
Selah, Washington. Recall #F-577-5.
CODE 3257****2 (**** = Time) is stamped on some of the bottles.
Majority of the bottles were not coded.
MANUFACTURER Johnson Controls Inc., Tacoma, Washington.
RECALLED BY Manufacturer, by meeting held March 3, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Washington state.
QUANTITY 14,000 bottles were distributed.
REASON Product contains undeclared FD&C Yellow No. 5.

_______________
PRODUCT Frozen, preformed cookie dough:
(a) Mrs. Rich's Chocolate Chip Cookie Dough, 22 pound 8
ounce case, approximately 240 cookies per case; (b) Mrs.
Rich's Oatmeal Raisin Cookie Dough, 22 pound 8 ounce case,
Approximately 240 cookies per case; (c) Marquee Macadamia
Nut with White Chunks, Ready to Bake Gourmet Cookie Dough,
11 pound 4 ounce case, (12 15-ounce boxes per case); (d)
Marquee Honey & Nut Oatmeal Raisin, Ready to Bake Gourmet
Cookie Dough, 11 pound 4 ounce case (12 15-ounce boxes per
case); (e) Marquee Chocolate Chunk, Ready to Bake Gourmet
Cookie Dough, 11 pound 4 ounce case (12 15-ounce per case).
Recall #F-596/600-5.
CODE Product Code Lot Numbers
(a) 39642 M5051, M5052, M5056, M5058
(b) 39677 M5045, M5055
(c) 11205-45577-39407 M5047, M5054
(d) 11205-45575-39415 M5048, M5056
(e) 11205-45576-39423 M5040, M5055.
MANUFACTURER Rich Products Corporation, Murfreesboro, Tennessee.
RECALLED BY Rich Products Corporation, Buffalo, New York, by letter
March 2, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 1,779 cases were distributed.
REASON The products may be contaminated with aluminum wire.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Alba Dairy Shake Mix, Artificial Strawberry Flavor, in
individual serving envelopes of 0.75 ounces each.
Recall #F-529/530-5.
CODE Lot numbers: _H1974 J2, _H2314 J2, _H2324 J2, _H2574 J2,
_H2594 J2 (first character of code is an Alpha character
designating hour of day).
MANUFACTURER Near East Food Products, Leominster, Massachusetts.

-2-RECALLED BY Heinz U.S.A., Pittsburgh, Pennsylvania, by fax September 27,
1994, and October 4, 1994 and by letter October 17, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined
REASON Product is misbranded -- incorrect ingredient statement.

_______________
PRODUCT Various tomatoes packed in olive oil:
(a) Bella Sun Luci Sun Dried Tomatoes in Olive Oil and
Herbs, 35 ounces; (b) Trader Joe's Sun Dried Tomato Pesto in
Olive Oil, 8.5 ounces;
(c) Bella Sun Luci Sun Dried Tomato Pesto in Pure Olive Oil,
6.5 ounces. Recall #F-593/595-5.
CODE None.
MANUFACTURER Mooney Farms, Chico, California.
RECALLED BY Manufacturer, by telephone April 4, 1994; (b & c) by
telephone February 22, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Alaska, Arizona, California, Colorado, Connecticut, Florida,
Hawaii, Maryland, Massachusetts, Montana, Nevada, New
Hampshire, New Jersey, New Mexico, New York, Oregon,
Vermont, Washington state, Canada.
QUANTITY Undetermined.
REASON The products are misbranded in that the label states the
products are packed in olive oil instead of packed in a
blend of soybean oil and olive oil.

RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II
=====================
_______________
PRODUCT Vinegar and Water Extra Mild Douche, in 6 fluid ounce
plastic bottles, under the following brand names: Fresh
Gards, Freddy's Rx, and Kroger Disposable Douche.
Recall #F-578-5.
CODE Lot numbers: 4245C, 4246C, 4249C, 4250C.
MANUFACTURER Hospital Specialty Company, Cleveland, Ohio.
RECALLED BY Manufacturer, by letter December 2, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and The Philippines.
QUANTITY Approximately 2,300 cases (12 retail boxes per case) were
distributed.
REASON Product is contaminated with the Aeurobasadium pullulan (an
airborne mold).

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Preparation H Hemorrhoidal Ointment, in 1 ounce tubes.
Recall #D-094-5.
CODE Lot #93-34 EXP 9/95.
MANUFACTURER Whitehall Laboratories, Madison, New Jersey.

-3-RECALLED BY Manufacturer, by letters of May 16, 1994 and July 15, 1994.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 3,596 dozen 1-ounce tubes were distributed; firm estimates
none remains on the market.
REASON Presence of mold.

_______________
PRODUCT Searle Calan Tablets, verapamil hydrochloride 40 mg, in 100
tablet bottles, an immediate action Rx oral calcium slow-
channel blocker for the treatment of angina, arrhythmias and
essential hypertension. Recall #D-105-5.
CODE Lot numbers: 3J043, 3L045, 3N046, 3P047, 4A048, 4A049.
MANUFACTURER G.D. Searle & Company, Caguas, Puerto Rico.
RECALLED BY G.D. Searle & Company, Skokie, Illinois, by letters dated
March 22, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 147,698 bottles were distributed; firm estimated that 20% of
the product remained on market at time of recall initiation.
REASON Product does not meet dissolution specifications.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Claforan (Cefotaxime Sodium) Sterile Powder for Injection
(IM/IV), Rx broad spectrum cephalosporin antibiotic:
(a) 500 mg vials; (b) 1.0 gram vials; (c) 2.0 gram vials.
Recall #D-095/097-5.
CODE All lots within expiration date.
MANUFACTURER Hoechst Aktiengesellschaft, Federal Republic of Germany or
Roussel Uclaf Plant 4, Romainville, France.
RECALLED BY Hoechst Roussel Pharmaceuticals, Inc., Somerville, New
Jersey by letter February 20, 1995. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimated that 740,000 vials remained on the market at
time of recall initiation.
REASON Subpotency/stability problems. Field correction labeling
change to assure withdrawable assay specifications after
reconstitution.

_______________
PRODUCT Hydrocortisone Spray, 0.5% in 1.5 fluid ounce (45ml) plastic
bottles, OTC, used for the temporary relief of itching,
under the following labels: Superx Drugs, Goldline, Rugby.
Recall #D-098-5.
CODE Lot #U393 EXP 5/95.
MANUFACTURER Clay Park Laboratories, Inc., Bronx, New York.
RECALLED BY Manufacturer, by letter mailed March 16, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Florida.

-4-QUANTITY Approximately 2,841 45ml-units were distributed.
REASON Product does not meet pH specifications.

_______________
PRODUCT Facial Soap (liquid scrub), in 8 ounce plastic bottles, OTC,
used for the control of acne. Recall #D-099-5.
CODE Lot numbers: T148 EXP 7/95, V775 EXP 6/96.
MANUFACTURER Clay Park Laboratories, Inc., Bronx, New York.
RECALLED BY Manufacturer, by letter mailed March 10, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION California and Tennessee.
QUANTITY Approximately 2,199 bottles were distributed.
REASON Subpotency.

_______________
PRODUCT Benzoyl Peroxide 5% Gel, 45 grams (1.5 ounce) plastic tubes,
OTC, used for the treatment of acne bacteria on skin.
Recall #D-100-5.
CODE Lot numbers: S285 EXP 3/95, T960 EXP 10/95, V238 EXP 3/96,
V770 EXP 6/96, W180 EXP 8/96, W832 EXP 11/96, W868 EXP
10/96, X043 EXP 11/96, X052 EXP 11/96.
MANUFACTURER Clay Park Laboratories, Inc., Bronx, New York.
RECALLED BY Manufacturer, by letter mailed March 14, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION California, Ohio, Georgia, New York, Kentucky, Florida,
Michigan, Maine, Maryland, Alabama, Pennsylvania, West
Indies.
QUANTITY Approximately 37,998 units were distributed.
REASON Product separation.

_______________
PRODUCT Medadyne Liquid, in 0.5 ounce and 1 ounce glass bottles, OTC
used for the treatment of canker sores, fever blisters, and
cold sores, under the Vetco and Dal-Med labels.
Recall #D-101-5.
CODE Lot numbers: T247 EXP 7/95, U202 EXP 11/95.
MANUFACTURER Clay Park Laboratories, Inc., Bronx, New York.
RECALLED BY Manufacturer, by letter mailed March 16, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 29,456 bottles were distributed.
REASON Superpotency.

_______________
PRODUCT (a) Qualitest brand Promethazine with Codeine Cough Syrup,
in 4 fluid ounce bottles, indicated for the temporary
relief of coughs and upper respiratory symptoms associated
with allergy or the common cold;
(b) Qualitest brand Promethazine VC with Codeine Cough
Syrup, in 4 fluid ounce bottles, indicated for the temporary
relief of coughs and upper respiratory symptoms.
Recall #D-102/103-5.

-5-CODE Lot numbers: RA5051, RA5048;
Catalog numbers: L-0603-1578-54, L-0603-1581-54.
MANUFACTURER Barre National, Inc., Baltimore, Maryland.
RECALLED BY Manufacturer, by letter March 1, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Alabama.
QUANTITY 12,024 bottles of lot RA5051, and 2,340 bottles of lot
RA5048.
REASON Label does not bear name and address of manufacturer or
distributor.

_______________
PRODUCT Selenium Sulfide Lotion/Shampoo, USP 2.5%, in 4 ounce
plastic bottles, Rx, used for the treatment of dandruff and
seborrheic dermatitis of the scalp. Recall #D-104-5.
CODE Lot #P819 EXP 8/95.
MANUFACTURER Clay Park Laboratories, Inc., Bronx, New York.
RECALLED BY Manufacturer, by letter to be mailed on April 17, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION New York, Texas, Florida, Iowa, Ohio, Mississippi, Nebraska,
New Jersey, Tennessee, California.
QUANTITY Approximately 1,151 bottles were distributed.
REASON Use of an unapproved raw material source.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Lifestyles Assorted Color Condoms with Spermicidal
Lubricant. Recall #Z-519-5.
CODE Lot numbers: 410046500, 410049100, 410049200.
MANUFACTURER Ansell, Inc., Dothan, Alabama.
RECALLED BY Manufacturer, by telephone December 2, 1994, followed by fax
December 3, 1994. Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 189,000 condoms were distributed.
REASON The subject lots had been recorded as passing the
accelerated aging tests for tensile strength, when, in fact
they had failed this testing. The failing test results may
indicate that the product does not have the shelf life which
is claimed on its labeling.

_______________
PRODUCT Drake Willock System 1000 Single Patient Delivery System for
single patient hemodialysis. Recall #Z-553-5.
CODE Units within serial number block from 1001 to 3873.
However, each unit within this block does not require
replacement of all of the suspect parts.
MANUFACTURER Althin Medical, Inc., Portland, Oregon.
RECALLED BY Manufacturer, by telephone starting in June 1994. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide and international.

-6-QUANTITY 2,865 units are subject to field correction.
REASON The CPVC may swell and impede the flow of liquid through the
system. The defect may affect the ultrafiltration flow
meter, the flow equalizer, supply regulator, rinse block
fitting, concentrate connectors, ultrafiltration removal
regulator and dialyzer fittings.

_______________
PRODUCT Drake Willock Systems 1000 Single Patient Delivery System
fir single patient hemodialysis. Recall #Z-556-5.
CODE Units within serial number block 1001 to 3439.
MANUFACTURER Althin Medical, Inc., Portland, Oregon.
RECALLED BY Manufacturer, by telephone beginning June 1994. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 2,428 units are subject to field correction.
REASON The pump head is cutting or abrading the blood tubing
causing blood leaks.

_______________
PRODUCT Laser Sensing Devices: (a) Autosense Vehicle Sensors;
(b) Miles ATS-101 Aerial Target System; (c) Ocean Wave Laser
System (OWLS). Recall #Z-566/568-5.
CODE None.
MANUFACTURER Schwartz Electro-Optics, Inc., Orlando, Florida.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan February 24, 1995. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 9 units; (b) 2 units; (c) 25 units.
REASON Units exceeded the Class I accessible emission limits.

_______________
PRODUCT Storz +4.0 Posterior Chamber D Intraocular Lenses:
(a) Model 121UV; (b) Model P431UV. Recall #Z-570/571-5.
CODE Serial numbers: (a) 19UP01 to 19UP32. 19UP34 to 19UP45,
19UP82 to 19UP85; (b) 19LV15, 19LV16 and 19LV18.
MANUFACTURER Storz Ophthalmics, Inc., Clearwater, Florida.
RECALLED BY Manufacturer, by letter January 3, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Arizona, Florida, New York, Colorado, Wisconsin, Kansas,
Maryland, South Dakota, California, Texas, Ohio,
Pennsylvania, Missouri, Arizona, Massachusetts, Tennessee,
Iowa, Utah, Puerto Rico, Canada, Taiwan.
QUANTITY 47 lenses were distributed.
REASON Devices may be labeled with the incorrect diopter.

_______________
PRODUCT Oxford Medilog Sleep and Respiration Interface (SRI) which
monitors respiration. Recall #Z-572-5.
CODE All serial numbers.
MANUFACTURER Oxford Medilog Systems, Abingdon, England.

-7-RECALLED BY Oxford Instruments Medical Systems, Division, Clearwater,
Florida, by telephone October 7, 1993, followed by letter
October 19, 1993. Firm-initiated field correction complete.
DISTRIBUTION Florida, Alabama, Georgia, Utah, Missouri, Massachusetts,
Pennsylvania, Washington State, Louisiana, Virginia, Puerto
Rico, Canada, Mexico, Brazil.
QUANTITY 41 units were distributed.
REASON If the electrodes are plugged into the SRI incorrectly,
excessive current may be transmitted to the patient causing
a tingling sensation.

________________
PRODUCT 1. Intermate SV 50 ml/HR, product code 044050;
2. Intermate SV 100 ml/HR, product code 044120;
3. Intermate SV 200 ml/HR, product code 044220;
4. Intermate LV 50 ml/HR, product code 049050;
5. Intermate LV 100 ml/HR, product code 049100;
6. Intermate LV 250 ml/HR, product code 049250;
7. Italian Intermate SV 200 ml/HR, product code 42200;
8. French Intermate SV 50 ml/HR, product code 43050;
9. French Intermate SV 100 ml/HR, product code 43100;
10. French Intermate SV 200 ml/HR, product code 43200;
11. French Intermate LV 50 ml/HR, product code 439050;
12. French Intermate LV 100 ml/HR, product code 439100;
13. French Intermate LV 250 ml/HR, product code 439250;
14. Australian Intermate LV 250 ml/HR, product code 2C1006;
15. Australian Intermate SV 200 ml/HR, product code 2C1017;
16. Australian Intermate LV 50 ml/HR, product code 2C1018;
17. Australian Intermate LV 100 ml/HR, product code 2C1019;
18. Australian Intermate SV 50 ml/HR, product code 2C1028;
19. Australian Intermate SV 100 ml/HR, product code 2C1029.
Recall #Z-573/591-5.
CODE Product Code: Lot Numbers:
044050 94G010, 94H015, 94J002, 94J014, 94J030,
94M008, AND 94N003
044120 94G002, 94G003, 94G004, 94H002, 94H003,
94H004, 94J003, 94J004, 94J005, 94J011,
94K001, 94K002, 94K003, 94M001, 94M002,
94M003, 94M004, AND 94N001
044220 94H013, 94H014, 94H016, 94H017, 94J007,
94J015, 94J028, 94K004, 94W001, 94W002,
94W003, 94W004
049050 94G015, 94J013 AND 94N002
049100 94H012, 94H019, 94J018, AND 94M009
049250 94G014, 94H007, 94H018, 94J010, 94J017,
94K005, AND 94M005
42200 94D006 AND 94E015
43050 94C009 AND 94D011
43100 94C005, 94D014, 94J001, 94J009, 94K006,
94K007, 94K008, 94M011
43200 94C007, 94D003 AND 94K009
439050 94E011

-8- 439100 94E006, 94J019, AND 94M011
439250 94E004 AND 94J020
2C1006 94F014
2C1017 94F019
2C1018 94G016
2C1019 94F017
2C1028 94G011
2C1029 94F018.
MANUFACTURER I.V. Systems Division, Baxter Healthcare Corporation,
Irvine, California.
RECALLED BY Manufacturer, by letter dated December 6, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 621,072 units were distributed; FDA estimated that 150,000
units remained on market at time of recall initiation.
REASON The adhesive which bonds the flow restricting stainless
steel cannula to the acrylic stress member fails and allows
fluid to bypass the flow restricting cannula and can result
in solution infusion rates higher than intended.

_______________
PRODUCT Bear-1000 Ventilator, Catalog #50-0850-00, indicated for the
delivery of medical gases to pediatric and adult patients.
Recall #Z-593-5.
CODE 136 units containing EPROM release #7 bearing a unique
serial number were manufactured.
MANUFACTURER Bear Medical Systems, Inc., Riverside, California.
RECALLED BY Manufacturer, by memorandum November 4, 1994, and by letter
on November 8, 1994. Firm-initiated field correction
complete.
DISTRIBUTION California, Delaware, Florida, Kansas, Louisiana, Maine,
Michigan, North Carolina, New Jersey, New York,
Pennsylvania, South Dakota, Tennessee, Utah, Virginia, and
internationally.
QUANTITY 115 units were distributed.
REASON The ventilator does not deliver the lower tidal volumes in
increments of 1 ml as described in the labeling due to
defective software.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Drake Willock System 1000 Single Patient Delivery System, a
single-patient delivery hemodialysis delivery system.
Recall #Z-554-5.
CODE The following serial numbers are for domestic machines that
had pumps replaced in the field: 3583-3584, 3587-3590,
4084-4088, 4096-4101, 4104, 4107, 4182, 4194, 4203. The
following serial numbers are for overseas machines that had
pumps replaced in the field: 4089, 4090, 4102, 4111-4124,
4132-4137, 4144-4147, 4166-4170, 4175-4181, 4234, 4241,
4242.

-9- The following serial numbers are for machines that were
returned to the manufacturing facility for pump replacement:
4091-4095, 4103, 4105, 4106, 4148-4165, 4171-4174,
4183-4193, 4195-4202, 4204-4207, 4226, 4227, 4229-4233,
4238-4240.
MANUFACTURER Micropump, Inc., Vancouver, Washington (component).
RECALLED BY Althin Medical, Inc., Portland, Oregon. On August 29, 1994,
it was decided that no more System 1000 machines would be
installed, and that all shipped machines would be tracked.
On this day, shipping hold #94-002 was instituted. On
August 30, 1994, all undelivered domestic machines were
located and stopped. Firm-initiated field correction
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 127 machines were subject to field correction.
REASON Mercury was found in the pump head.

_______________
PRODUCT Drake Willock System 1000 Single Patient Delivery for single
patient hemodialysis. Recall #Z-555-5.
CODE 1001 to 2870 (non-inclusive).
MANUFACTURER Althin Medical, Inc., Portland, Oregon.
RECALLED BY Manufacturer, by telephone starting in June 1994 to arrange
for retrofitting. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,857 units are subject to field correction.
REASON The air trap float which controls the incoming water supply
absorbs water and becomes deformed.

_______________
PRODUCT Clinical Chemistry Analyzer, Summit Series 7000.
Recall #Z-569-5.
CODE Serial numbers 5306, 8319, 5315.
MANUFACTURER Integrated Clinical Systems, Inc., Indianapolis, Indiana.
RECALLED BY Manufacturer, by sending an update bulletin and field repair
kits on January 14, 1994, and by fax January 23, 1995.
Firm-initiated field correction complete.
DISTRIBUTION Tennessee, France, England.
QUANTITY 3 units were distributed.
REASON If a serum tube is not fully seated in the primary tube
sampler (an optional unit designed to alert the instrument
operator when a tube does not contain enough blood serum to
run all of the chemistry test specified), it can interfere
with the drive bar stops causing the glass tube to break,
which may cause injury.

_______________
PRODUCT OPUS Myoglobin Test Modules, an in-vitro diagnostic device
used with the OPUS and OPUS Plus Immunoassay System in the
quantitative measurement of myoglobin in serum as an aid in
the diagnosis of acute myocardial infarction.
Recall #Z-592-5.

-10-CODE Catalog #700-50, Lot #MYB8 EXP 11/24/94.
MANUFACTURER Behring Diagnostics, Inc., Westwood, Massachusetts.
RECALLED BY Manufacturer, by telephone between April 28, 1994 and May 3,
1994, and by letter May 4, 1994. Firm-initiated field
correction complete.
DISTRIBUTION Nationwide, Canada.
QUANTITY 209 boxes (containing 50 modules each) were distributed;
firm estimates none remains on the market.
REASON Defective OPUS Myoglobin Test Modules may cause an inability
by the user to perform or correctly read test results.

_______________
UPDATE Beckman Synchron CX7 Clinical Analyzer, computer enhanced,
CX4CE/CX5CE, Recall #Z-520-5 which appeared in the March 22,
1995 Enforcement Report should read:
RECALLED BY: Beckman Instruments, Inc., Brea, California,
by letter dated July 14, 1994. Firm-initiated field
correction ongoing.
REASON: Defective software may cause patient ammonia test
results to be inaccurate.

-11-

END OF ENFORCEMENT REPORT FOR APRIL 5, 1995. BLANK PAGES MAY FOLLOW.

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