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.

January 2, 1997 97-01

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Refrigerated Shucked Mussel Meat Products, in
10 ounce cups, half gallons, or gallons:
(a) Lightly Poached Mussel Meats
(b) Marinated Mussel Meats
(c) Marinated Mussel Meats with Jalapeno
Peppers; (d) Mussel Meats in Tomato Basil
Sauce. Recall #F-152/155-7.
CODE Products produced between September 1 and
October 31, 1996 with sell by dates ranging
from September 14, 1996 to November 14, 1996
(10 ounce cups); and with sell by dates
ranging from September 21, 1996 to November
21, 1996 (half gallons and gallons).
MANUFACTURER Blue Gold Holdings, Inc., New Bedford,
Massachusetts.
RECALLED BY Manufacturer, by press release November 6,
1996. Firm-initiated recall complete.
DISTRIBUTION Massachusetts, New York, Pennsylvania,
Maryland, Virginia, Ohio, Florida.
QUANTITY Firm estimates none remains on the market.
REASON Products may be contaminated with Listeria
monocytogenes.
_______________
PRODUCT Pillsbury Date Quick Bread Mix, in 1 pound 0.6
ounce boxes. Recall #F-156-7.
CODE Codes beginning with C6M20.
MANUFACTURER The Pillsbury Company, Murfreesboro,
Tennessee.
RECALLED BY The Pillsbury Company, Minneapolis, Minnesota,
by electronic mail on November 26, 1996, and
by press release on November 27, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,271 cases (12 boxes per case) were
distributed.
REASON Product contains undeclared walnuts and
almonds.

_______________
PRODUCT Reese's Peanut Butter Chip variety of Mighty
Muffins, sold day old, in clear plastic or
styrofoam cartons. Each carton may contain
several varieties of muffins.
Recall #F-157-7.
CODE All packages of Mighty Muffins which contain
Reese's Peanut Butter Chip Muffin variety, but
do not declare peanuts on the label.
MANUFACTURER Various Tops Markets (grocery stores), in New
York and Pennsylvania.
RECALLED BY Tops Markets, Williamsville, New York, by
E-mail dated December 2, 1996, and by bulletin
sent on December 3, 1996. Firm-initiated
recall complete.
DISTRIBUTION New York and Pennsylvania.
QUANTITY Undetermined.
REASON Undeclared peanuts on the label of some
packages of Mighty Muffins containing Reese's
Peanut Butter Chip Muffins.

_______________
PRODUCT Fat Free Chocolate Brownies, individually
wrapped and packaged under the following
labels and configurations:
(a) Plantation Brownies, Baked by Plantation
Baking Company, Inc., Lake Bluff, Illinois:
i) individually wrapped brownies, Net Wt. 1.4
oz., sold as singles in vending machines and
from 15 count display trays
ii) five count multi-pack brownies, no
labeling on individual units, Net Wt. 7 oz.,
(b) Famous Amos Brownies, President Baking
Company, Inc., Atlanta, Georgia:
i) individually wrapped brownies, Net Wt. 1.4
oz., sold as singles from 5 count and 48 count
display trays
-2- ii) five count multi-pack brownies, no
labeling on individual units, Net Wt. 7 oz.
Recall #F-158-7.
CODE Plantation brownies have product codes XA621
and XA615; Famous Amos brownies have
production code 03097U3.
MANUFACTURER Plantation Baking Company, Inc., Lake Bluff,
Illinois.
RECALLED BY Manufacturer, by press release, interoffice
memo, and telephone beginning on November 27,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 877 cases were distributed.
REASON Product contains undeclared walnuts.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Poland Spring Natural Spring Water in .5 liter
(16.9 ounce) plastic bottles.
Recall #F-044-7.
CODE A. "101696 xxxx EXP101698 L8" stamped on
bottle neck. "101696 xxxx L8" on cases.
"xxxx" indicates 24 hour "military " time.
Firm is recalling military time code 0115 to
0200(indicating filling between 1:15AM and 2
AM ) on 10/16/96. NOTE: "xxxx" on cases
indicates time cased. L8= filling line 8
(only 0.5 liter is filled on line 8).
Additional codes being recalled:
B. "101696" with fill time code 2330-0000
[indicating filling 11:30PM to 12:00AM on
10/16/96].
C. "101796 xxxx EXP101798 L8" stamped on
bottle neck. "xxxx" indicates fill time codes
2330-0000 [filled 11:30PM to 12:00AM on
10/17/96].
D. "101896 xxxx EXP101898 L8" stamped on
bottle neck. "xxxx" indicates fill time codes
0000-0030 [filled 12:00AM to 12:30AM] **.
MANUFACTURER Great Spring Waters of America, Inc., doing
business as Poland Spring Bottling Company,
Poland Spring, Maine.
RECALLED BY Manufacturer, by letters of October 29 and 31,
1996, and November 8, 1996, followed by visit.
Firm-initiated recall ongoing.
DISTRIBUTION Massachusetts, Ohio, New York, New Jersey,
Pennsylvania, Connecticut, Vermont, Maryland,
Michigan, Virginia, North Carolina, Illinois,
Georgia, Wisconsin.
QUANTITY Undetermined.
REASON Product is contaminated with chlorine.

-3-_______________
PRODUCT Green Leaf Lettuce, 12 heads per carton under
the Western Express or the U.S. Fresh brand.
Recall #F-129-7.
CODE None.
MANUFACTURER Kophamer & Kophamer, Bakersfield, California
(grower and harvester).
RECALLED BY Norton Enterprises, Monterey, California
(broker), by telephone on or about April 19,
1995. Firm-initiated recall complete.
DISTRIBUTION California and New Jersey.
QUANTITY 1,612 cartons (12 heads per carton)
REASON Product contains endosulfan which exceeds the
established tolerance of 2.0 ppm for this
pesticide in lettuce.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Java Johnny, Natural Spring Water with
caffeine, in 20 fluid ounce plastic bottles
containing 24 bottles per case.
Recall #F-159-7.
CODE No codes are listed on the bottles. Lot
#2906, produced on 10/16/96.
MANUFACTURER Northstar Beverage, Inc., Detroit, Michigan.
RECALLED BY Thunderhead Beverages, Inc., Cincinnati, Ohio
(distributor), by telephone on November 1,
1996. Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 540 cases (24 bottles per case) were
distributed.
REASON Cracked pull-top tabs caused some bottles to
become contaminated and appear cloudy.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-118/120-7.
CODE Unit #8528717.
MANUFACTURER The Blood Center for Southeast Louisiana, New
Orleans, Louisiana.
RECALLED BY Manufacturer, by letter dated August 23, 1996.
Firm-initiated recall complete.
DISTRIBUTION Louisiana and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for antibody to
the human immunodeficiency virus type 1 (anti-
HIV-1), were collected from a donor who
previously tested repeatedly reactive for
anti-HIV-1 and was incorrectly reentered.

-4-_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-129/130-7.
CODE Unit #17035-4781.
MANUFACTURER United Blood Services, McAllen, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated October 9, 1996. Firm-initiated
recall complete.
DISTRIBUTION Texas and North Carolina.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
with a history of cancer.

_______________
PRODUCT (a) Red Blood Cells; (b) Cryoprecipitated AHF;
(c) Recovered Plasma. Recall #B-166/168-7.
CODE Unit numbers: 53FL52515 and 53FL51316; (b)
53FL52515; (c) 53FL52515.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated May 29, 1996.
Firm-initiated recall complete.
DISTRIBUTION Maryland, North Carolina, California, District
of Columbia, Switzerland.
QUANTITY (a) 2 units; (b) 1 unit; (c) 1 unit was
distributed.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1), were collected from a
donor who previously tested repeatedly
reactive for anti-HIV-1, Western blot
positive.

_______________
PRODUCT Platelets. Recall #B-169-7.
CODE Unit #1K1488.
MANUFACTURER Puget Sound Blood Center and Program, Seattle,
Washington.
RECALLED BY Manufacturer, by letter dated December 20,
1995. Firm-initiated recall complete.
DISTRIBUTION Washington state.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose
medical history screening was inadequately
performed.

_______________
PRODUCT (a) Red Blood Cells; (b) Single Donor Plasma.
Recall #B-177/178-7.
CODE Unit #KP02716.
MANUFACTURER Blood Bank of San Bernadino and Riverside
Counties, San Bernadino, California.

-5-RECALLED BY Manufacturer, by letter dated October 18,
1993. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were labeled with an extended
expiration date.

_______________
PRODUCT Recovered Plasma. Recall #B-179-7.
CODE Unit #N27938.
MANUFACTURER North Colorado Medical Center, Greeley,
Colorado.
RECALLED BY Manufacturer, by letter dated August 19, 1996.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with
a history of intravenous drug use.

_______________
PRODUCT Platelet, Pheresis. Recall #B-180-7.
CODE Unit #C59325.
MANUFACTURER Regional Health Resource Center, Community
Blood Services of Illinois, Urbana, Illinois.
RECALLED BY Manufacturer, by telephone on April 1, 1996.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.

_______________
PRODUCT Source Plasma. Recall #B-183-7.
CODE Unit numbers: VYC636, VYC933, VYD297, VYE642,
VYE838, VVT148, VVU598.
MANUFACTURER Bayer Corporation Plasma Center, Coon Rapids,
Minnesota.
RECALLED BY Manufacturer, by telephone and fax on January
19, 1995. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 7 units were distributed.
REASON Blood products were collected from a donor who
reported a history of an accidental
needlestick.

_______________
PRODUCT Source Plasma. Recall #B-184-7.
CODE Unit numbers: 45360268, 45351432, 45363917,
45365188, 45367595, 45368813, 45373787,
45375019, 45372643, 45376122, 45378638,
45379772, 45392375, 45393365, 45395697,

-6- 45396588, 45399114, 47380936, 47382411,
47384361, 47386020, 47387737, 47440210,
47442306, 47443785, 47446496.
MANUFACTURER Simi Biological Resources, Inc., Fort Smith,
Arkansas.
RECALLED BY Manufacturer, by telephone on April 17, 1995,
and by letter dated September 20, 1994. Firm-
initiated recall complete.
DISTRIBUTION California.
QUANTITY 26 units were distributed.
REASON Blood products were collected from a donor
with a previous history of hepatitis.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-185/187-7.
CODE Unit #53J17086.
MANUFACTURER American Red Cross, Baltimore, Maryland.
RECALLED BY Manufacturer, by letters dated September 19
and 25, 1996. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania, Virginia, California.
QUANTITY 1 unit of each component.
REASON Blood products were collected in a manner that
a contaminated unit was distributed.

_______________
PRODUCT Source Plasma. Recall #B-188-7.
CODE Unit numbers: 38551796, 38555893, 38556937,
38559440, 41992715, 41512517, 41513316,
41143889, 41157879, 45369643, 45375651,
45378768, 47389953.
MANUFACTURER Simi Biological Resources, Inc., Fort Smith,
Arkansas.
RECALLED BY Manufacturer, by letter dated September 20,
1994, and by telephone on April 17, 1995.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 13 units were distributed.
REASON Blood products were collected from a donor
previously deferred for high risk behavior.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Recovered Plasma.Recall #B-131-7.
CODE Unit #17035-4781.
MANUFACTURER United Blood Services, McAllen, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated October 9, 1996. Firm-initiated
recall complete.
DISTRIBUTION Texas and North Carolina.
QUANTITY 1 unit of each component.

-7-REASON Blood product was collected from a donor with
a history of cancer.

_______________
PRODUCT Recovered Plasma. Recall #B-170-7.
CODE Unit #1K1488.
MANUFACTURER Puget Sound Blood Center and Program, Seattle,
Washington.
RECALLED BY Manufacturer, by letter dated December 27,
1995. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor
whose medical history screening was
inadequately performed.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-181/182-7.
CODE Unit numbers: (a) 09GN00093;
(b) 09GN00094 09GN00102 09GN00113
09GN00123 09GN00095 09GN00104
09GN00114 09GN00124 09GN00096
09GN00106 09GN00115 09GN00125
09GN00097 09GN00107 09GN00116
09GN00126 09GN00098 09GN00108
09GN00117 09GN00128 09GN00099
09GN00110 09GN00118 09GN00129
09GN00100 09GN00111 09GN00119
09GN00130 09GN00101 09GN00112
09GN00120.
MANUFACTURER American Red Cross Blood Services, Omaha,
Nebraska.
RECALLED BY Manufacturer, by telephone on July 13 and 14,
1995. Firm-initiated recall complete.
DISTRIBUTION (a) Nebraska; (b) California.
QUANTITY (a) 1 unit; (b) 31 units were distributed.
REASON Blood products were prepared from whole blood
which may have reached unacceptable room
temperatures during shipment.

RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS II =========
_______________
PRODUCT Operator's Manual and Front Panel Decal for
the Medtronic M-300 Talc Sterilizer, dry heat
sterilizer used to sterilize talc which is
used by hospitals for thoracic surgeries.
Recall #Z-089-7.
CODE All manuals and units in distribution.
MANUFACTURER Dentronix, Inc., Ivyland, Pennsylvania (spec.
developer).

-8-RECALLED BY Dentronix, Inc., Ivyland, Pennsylvania, by
letter dated October 15, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Pennsylvania, Florida, Ohio, Hawaii,
California, Tennessee, Kentucky, Washington
state, Maryland, Michigan, Texas.
QUANTITY 14 units were distributed.
REASON The operators manual and the front panel of
the device makes reference to instrument
sterilization when the maximum temperature of
the sterilizer is not sufficient to sterilize
instruments.

_______________
PRODUCT Acetabular Reamer Shell, 54mm, Catalog No.
1207-354. Recall #Z-183-7.
CODE Lot Number 00041821.
MANUFACTURER Linvatec Corporation, Division of
Zimmer/Bristol-Squibb Company, Largo, Florida.
RECALLED BY Manufacturer, by letter dated October 18,
1996. Firm-initiated recall complete.
DISTRIBUTION Virginia, Texas, Pennsylvania, Wisconsin,
Minnesota, North Carolina, Tennessee,
Washington state, California, Maryland,
Arkansas, New York.
QUANTITY 19 devices were distributed.
REASON The reamer shell is etched to identify it as a
54mm shell when in fact it may be a 55mm
shell.

_______________
PRODUCT Posicam Auricle and Posicam HZL PET Laser
System, used for patient positioning.
Recall #Z-184/185-7.
CODE Various serial numbers.
MANUFACTURER Positron Corporation, Houston, Texas.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan on November 18, 1996
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 11 Auricle units and 5 HZL units were
distributed.
REASON Devices failed to comply with standards for
reporting and labeling of laser products.

_______________
PRODUCT Aurora Diode Laser, used in dental surgery.
Recall #Z-186-7.
CODE Various serial numbers.
MANUFACTURER Premier Laser Systems, Inc., Irvine,
California.

-9-RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan on December 12, 1996.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 52 units were distributed.
REASON Noncompliance with performance standards for
laser products in that the operator's manual
lacked calibration procedures.

_______________
PRODUCT HydroFlex Irrigation System Controller,
Product #0025000, Firmware reversions 2.2 and
1.5, a reusable electromechanical controller
intended to be used with either of two Davol
HydroFlex Irrigation Tubing Sets.
Recall #Z-188-7.
CODE All serial numbers, used with HydroFlex AD
Arthroscopic Distention/Irrigation Tubing Set
and HydroFlex LI Laparoscopic Irrigation
Tubing Set.
MANUFACTURER DEKA Research & Development Corporation,
Manchester, New Hampshire (contract
manufacturer).
RECALLED BY Davol, Inc., Subsidiary of C.R. Bard, Inc.,
Cranston, Rhode Island, by visit on or about
October 28, 1996, to upgrade firmware to
version 2.3. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 384 units were distributed.
REASON When the controller is set to within 10% of
the upper pressure limit, the controller motor
can run at a level which produces a higher
static pressure than specified and shown in
the display window.

_______________
PRODUCT MicroSeal Reusable Phacoemulsification
Needles, used during ophthalmic surgery:
(a) Catalog #DP8030, 30 Degree MicroSeal
Needle; (b) Catalog #DP8045, 45 Degree
MicroSeal Needle. Recall #Z-189/190-7.
CODE (a) Package date code 96085; (b) Package date
code 96086.
MANUFACTURER Storz Instrument Company, St. Louis, Missouri.
RECALLED BY Manufacturer, by letter dated October 28,
1996, followed by fax on December 9, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION International.
QUANTITY (a) 339 boxes (6 units per box); (b) 210 boxes
(6 units per box) were distributed.

-10-REASON The needles were packaged with the incorrect
instructions for use. "Microflow Needle
DP82XX Series Instructions for Use" were
packaged with the products and lacks a warning
statement instructing the user not to use the
needle if the brown thermoprotective sleeve is
missing or detached from the needle.

_______________
PRODUCT Powered and manual wheelchairs:
(a) Applause Manual Wheelchair, Product No.
E20300-5XX;
(b) Ovation Powered Wheelchair, Product No.
DE20300-501;
(c) Enabler Manual Wheelchair, Product No.
E20000-5XX;
(d) Electro-Lite Powered Wheelchair, Product
Nos. DE90003A & DE90003A/L.
Recall #Z-191/194-7.
CODE All serial numbers lower than 303974 shipped
prior to April 22, 1992.
MANUFACTURER Damaco, Inc., Moorpark, California.
RECALLED BY Manufacturer, by letters sent between July 2
and 5, 1996, and October 23, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 2,665 units were distributed; firm estimated
that 2,177 units remained in commerce at time
of recall initiation.
REASON The rear wheel axle bolt may break when
bending stress exceeds the carrying capacity.

_______________
PRODUCT Collimator for Multispect 2 Gamma Camera
Systems; designed for SPECT
acquisitions/imaging studies utilizing
Technetium and Thallium radionuclides.
Recall #Z-195-7.
CODE All units shipped prior to 2/18/96.
MANUFACTURER Siemens Medical Systems, Inc., Nuclear
Medicine Group, Hoffman Estates, Illinois.
RECALLED BY Manufacturer, by issuing a Mandatory Next
Service Call Field Modification Instruction
(FMI-00174) on December 11, 1996. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 215 units were distributed.
REASON The collimator latches intermittently fail to
latch or unlatch due to high contact
resistance of relays on the CLMD board inside
the gantry.

-11-RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Seprafilm Bioresorbable Membrane, Part #4301-
03, indicated for use in patients undergoing
abdominal or pelvic laparotomy as an adjunct
to reduce incidence of post-operative
adhesions. Recall #Z-025-7.
CODE Lot #N5043B.
MANUFACTURER Genzyme Corporation, Framingham,
Massachusetts.
RECALLED BY Genzyme Corporation, Cambridge, Massachusetts,
by letter on August 21, 1996. Firm-initiated
recall complete.
DISTRIBUTION Georgia, Florida, Pennsylvania.
QUANTITY 4 boxes (10 units per box) were distributed.
REASON Product was distributed without approved
labeling for marketing in the United States.

_______________
PRODUCT Extrude Putty Polyvinylsiloxant Dental
Impression Material, sold under the following
three configurations and part numbers:
Extrude Putty Refill, Part No.# 18919: Putty
packed in cardboard, package Contains:1-Jar
Putty Base 280 ml 1-Jar Putty Catalyst 28 ml
**"; Extrude Deluxe Introductory Kit, Part
No.# 20229: Each kit contains one set of
Extrude Putty Refill Part No. 18919. The
introductory kit comes in a cardboard box
labeled in part: "Extrude KERR Deluxe-Intro
Kit **"; Case Extrude Putty Package, Part No.#
25079: This box contains 12 sets of Extrude
Putty Refill Part No. 18919.
Recall #Z-187-7.
CODE All lot numbers with an expiration date of
9/96 through 7/97. This recall covers any
Extrude Putty made within the past twelve
months. The lot number and expiration date can
be found printed on the bar code label affixed
to the outer package.
MANUFACTURER KERR Corporation, Romulus, Michigan.
RECALLED BY Sybron Dental Specialties, Orange, California
(responsible firm), by letter dated July 1,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 16,950 sets were distributed; firm estimated
that 1,200 sets remained on market at time of
recall initiation.
REASON The device fails to set within the specified
time frame.

-12-_______________
PRODUCT Vitros DT NH3 Slides, for use with Vitros DT
Chemistry Systems to quantitatively measure
ammonia on the Ektachem (Vitros) DT60/DT60II
analyzer. NOTE: The NH3 slides are also used
in conjunction with Ektachem DT slides for
CREATININE where NH3 slides serve only as
a blank. Recall #Z-197-7.
CODE Catalog #153 2589; Lot numbers:
1051-0123-2067; 1051-0123-3756;
1051-0123-5162; 1051-0123-5163;
1051-0124-2065; 1051-0124-3055;
1051-0124-3855; 1051-0167-1911;
1051-0167-3672; 1051-0167-6801;
1051-0167-6802; 1051-0168-1723.
MANUFACTURER Johnson & Johnson Clinical Diagnostics,
Rochester, New York.
RECALLED BY Manufacturer, by letter dated October 15,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 37,092 boxes were distributed; firm estimated
that 4,000 boxes remained on market at time of
recall initiation.
REASON The DT NH3 results were biased up to 40%
higher than the reference method.

-13-

END OF ENFORCEMENT REPORT FOR JANUARY 2, 1997. BLANK PAGES MAY FOLLOW.

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End of Enforcement Report for