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 contain s information on actions taken in connection with agency regulatory activities.

ENFORCE
09/10/1996

ENFORCEMENT REPORT FOR 09/11/1996

September 11, 1996 96-37

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ===========
_______________
PRODUCT Wilcox Dairy Ice Cream (a) Chocolate Chip
Cookie Dough Ice Cream packaged in pint,
quart, and half gallon retail plastic
containers and three gallon cardboard tubs for
Scoop Shops; (b) Heavenly Hash Ice Cream
packaged in pint, quart, and half gallon
retail plastic containers and three gallon
cardboard tubs for Scoop Shops; (c) Maple
Walnut Ice Cream packaged in pint, quart, and
half gallon retail plastic containers.
Recall #F-685/687.
CODES No date codes. All misbranded product is
under recall.
MANUFACTURER Wilcox Brothers Inc., doing business as
Wilcox Dairy, Manchester, Vermont.
RECALLED BY Chocolate Chip Cookie Dough ice cream by visit
on or about July 11, 1996; all three products
by letter on or about July 23, 1996 followed
by press release July 26, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION New Hampshire, Vermont, Massachusetts and New
York.
QUANTITY (a) Chocolate Chip Cookie Dough Ice Cream 58
quarts, 78 pints, 40 one-half gallons and 20
three-gallon cardboard tubs; (b) Heavenly Hash
Ice Cream 30 pints, 20 quarts, 20 one-half
gallon and 4 three-gallon cardboard tubs. (c)
Maple Walnut Ice Cream 72 pints, 48 quarts,
and 30 one half gallons.
REASON The products bear partial ingredient
statements or no ingredient statements and
contain undeclared allergens. The chocolate
Chip Cookie Dough ice cream contains
undeclared eggs, the Heavenly Hash ice cream
and the Maple Walnut ice cream contain
undeclared walnuts.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========
_______________
PRODUCT Raspberry Flaky Rugelech, packed in 10 ounce
clear plastic packages. Recall #F-661-6.
CODE 3/17/96.
MANUFACTURER Future Fortune, Inc., doing business as
Smilowitz Bakery, Brooklyn, New York.
RECALLED BY Manufacturer, by telephone, April 10-12, 1996.
Completed recall resulted from sample analysis
and followup by the New York State Department
of Agriculture and Markets.
DISTRIBUTION New Jersey, New York.
QUANTITY 90 packages were distributed.
REASON Product contains undeclared Red #40 and an
unapproved food coloring Red #2.

_______________
PRODUCT Wilcox Dairy brand Pistachio Ice Cream
packaged in quart and half gallon containers.
Recall #F-688-6.
CODE Not coded. All misbranded product is under
recall.
MANUFACTURER Wilcox Brothers, Inc. doing business as Wilcox
Dairy, Manchester, Vermont.
RECALLED BY Manufacturer by letter on or about July 23,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Massachusetts, Vermont, New York, New
Hampshire.
QUANTITY 56 pints, 30 quarts, and 30 one-half gallons.
REASON The product bears a partial ingredient
statement which does not list pistachio nuts,
an allergen.

-2-
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Wilcox Dairy Ice Cream (a) Pistachio ice
cream; (b) Maple Walnut Ice Cream packaged in
bulk three gallon containers.
Recall #F-689/690-6.
CODE No date coded. All misbranded product is
under recall.
MANUFACTURER Wilcox Brothers doing business as Wilcox
Dairy, Manchester, Vermont.
RECALLED BY Manufacturer by letter on or about July 23,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Massachusetts, Vermont, New York, New
Hampshire.
QUANTITY (a) 8 three gallon containers; (b) 18 three-
gallon containers.
REASON The products do not bear ingredient
statements.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Apothe'Cure brand (a) Progesterone Sr, 10 mg
and 200 mg capsules; (b)
Estriol/Testosterone/Progesterone (1 mg, 2 mg,
and 7.5 mg respectively) capsules; (c)
DHEA/Progesterone (25 mg each) capsules.
Recall #D-257/260-6.
CODE Lot numbers: (a) 05139687, 06089677 (200 mg);
(b&c) no lot numbers.
MANUFACTURER Apothe'Cure, Inc., Dallas, Texas.
RECALLED BY Manufacturer by letters dated August 5, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, United Kingdom.
QUANTITY Undetermined.
REASON FDA analysis found samples to be super and
sub-potent. Current GMP deficiencies.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Oral Suspension Pepcid, 40 mg per 5ml
constituted, 400 mg for constitution, product
is used for the treatment of duodenal and
gastric ulcers, gastroesophageal reflux and
various hypersecretory conditions.
Recall #D-255-6.
CODE Lot Numbers D0120, D0121, D0129, D0133, all
labeled with EXP SEP99.

-3-MANUFACTURER Merck Manufacturing Division, West Point, PA.
RECALLED BY Manufacturer by letter August 29, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,500 packages were distributed.
REASON Several lots were labeled with an incorrect
expiry date of Sep99; the correct expiry date
is Nov98.

_______________
PRODUCT Apothe'Cure brand 4-Aminopyridine Sr. 17.5 mg
capsules. Recall #D-261-6.
CODE Not coded.
MANUFACTURER Apothe'Cure, Inc., Dallas, Texas.
RECALLED BY Manufacturer by letters mailed and hand
delivered on August 5, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, United Kingdom.
QUANTITY Undetermined.
REASON FDA analysis found samples to be super and
subpotent. Current GMP deficiencies.

_______________
PRODUCT Zeneca brand Elavil (Amitriptyline HCl) 50 mg
tablets in bottles of 100, product is an
antidepressant with sedative effects.
Recall #D-262-6.
CODE Lot number 4404W, EXP March 2000.
MANUFACTURER Merck & Company, Inc., West Point,
Pennsylvania.
RECALLED BY Zeneca Pharmaceuticals Inc., Wilmington,
Delaware, by telephone August 28, 1996,
followed by letter August 29, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Massachusetts, New Jersey, Ohio, Pennsylvania,
Tennessee, Virginia, and Puerto Rico.
QUANTITY 50 cases (600 bottles per case) were
distributed between August 14 and 22, 1996.
REASON Some shipping cases for one Elavil lot were
mislabeled to indicate the contents were
another product, Sorbitrae 5 mg Chewable
Tablets.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-446-6
CODE Unit number 109187.
MANUFACTURER United Community Blood Center, Middleburg
Heights, Ohio.

-4-RECALLED BY Manufacturer by letter April 18, 1996. Firm-
initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product collected from a donor who had
tested anti-HCV repeat reactive on a previous
donation.

_______________
PRODUCT Source Plasma. Recall #B-606-6.
CODE Unit numbers: G-17273-101; G-19586-101;
G-20570-101; G-26190-101.
MANUFACTURER Silver State Plasma Products, Inc., Las Vegas,
Nevada.
RECALLED BY Manufacturer by facsimile on June 5, 1996.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 4 units were distributed.
REASON Blood products exposed to non-sterile air
after bowl and/or harness was broken on the
Haemonetics PCS II Blood Collection System.

_______________
PRODUCT Red Blood Cells. Recall #B-607-6.
CODE Unit #2643640.
MANUFACTURER Central Indiana Regional Blood Center,
Indianapolis, Indiana.
RECALLED BY Manufacturer by telephone and letter July 14,
1995. Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood product collected from a donor who
tested non-reactive for HCV but who previously
tested reactive for HCV and donor subsequently
reentered.

_______________
PRODUCT Red Blood Cells. Recall #B-608-6.
CODE Unit number 18W71986.
MANUFACTURER American Red Cross, Lansing, Michigan.
RECALLED BY Manufacturer by letter October 24, 1994.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
had been a resident of a malarial endemic
area.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-612/613-6.
-5-CODE Unit number 18R53920.
MANUFACTURER American Red Cross, Lansing, Michigan.
RECALLED BY Manufacturer by letter July 10, 1995. Firm-
initiated recall complete.
DISTRIBUTION Michigan, California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products collected from a donor who had
lived in a malarial endemic area.

_______________
PRODUCT Source Plasma, Recall #B-614-6.
CODE Unit #32218527.
MANUFACTURER Bio Blood Components, Inc., Hammond, Indiana.
RECALLED BY Manufacturer by letter on or about November
1995. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product tested repeatedly reactive for
anti-HIV, WB negative.

_______________
PRODUCT Source Plasma. Recall #B-615-6.
CODE Unit #XM60748.
MANUFACTURER Community Bio-Resources, Inc., Grand Rapid,
Michigan.
RECALLED BY Manufacturer by letter July 7, 1995. Firm-
initiated recall complete.
DISTRIBUTION Austria.
QUANTITY 1 unit was distributed.
REASON Blood product collected from a donor with a
history of IV drug use.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma. Recall #B-616/618-6.
CODE Unit #2642763.
MANUFACTURER Central Indiana Regional Blood Center,
Indianapolis, Indiana.
RECALLED BY Manufacturer by telephone and letter July 26,
1995. Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit of each component.
REASON Blood product collected from a donor who
reported high-risk behavior, was distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Platelets, Expired. Recall #B-619/620-6.

-6-CODE Unit numbers: (a) 8106331, 8109391, 8107844,
8113946, 8118793, 8125085, 8126507, 8129523,
8129666; (b) 8106514, 8118793, 8107844,
8109391, 8129523; (c) 8106331, 8126507.
MANUFACTURER Permian Basin Regional Blood Center, Midland,
Texas.
RECALLED BY Manufacturer by letter September 30, 1995.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 14 units.
REASON Blood products collected from donors who
traveled to areas considered endemic for
malaria were distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-622/623-6.
CODE Unit number 23-37579.
MANUFACTURER Michigan Community Blood Center, Saginaw,
Michigan.
RECALLED BY Manufacturer by letter June 17 and 18, 1993.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit of each component.
REASON Blood products collected from a donor who
received a new tattoo within twelve months of
donation were distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-624-6.
CODE Unit number: R05900.
MANUFACTURER South Bend Medical Foundation, Inc., South
Bend, Indiana.
RECALLED BY Manufacturer by telephone on or about
September 21, 1994. Firm-initiated recall
complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood product collected from a donor with a
history of IV drug use.

_______________
PRODUCT Source Plasma. Recall #B-627-6.
CODE Donor #459-M (67 bleeds); 12864-M (3 bleeds).
MANUFACTURER Community Bio-Resources, Inc., Grand Rapid,
Michigan.
RECALLED BY Manufacturer by letter August 11, 1994. Firm-
initiated recall complete.
DISTRIBUTION Austria.
QUANTITY 70 units.

-7-REASON Blood products, that: 1) previously tested
positive for HTLV-1 test; 2) were collected
from a donor with a history of IV drug use and
both donors were permanently deferred were
distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-628/629-6.
CODE Unit number: 09F44462.
MANUFACTURER American Red Cross Blood Services, Omaha,
Nebraska.
RECALLED BY Manufacturer by telephone July 19, 1995.
Firm-initiated recall complete.
DISTRIBUTION Nebraska.
QUANTITY 1 unit of each component.
REASON Blood products collected from a donor who
traveled to an area considered endemic for
malaria were distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-631/632-6.
CODE Unit numbers: 09T60373, 09T52495.
MANUFACTURER American Red Cross Blood Services, Omaha,
Nebraska.
RECALLED BY Manufacturer by letter dated November 10,
1995. Firm-initiated recall complete.
DISTRIBUTION Nebraska.
QUANTITY 2 units.
REASON Blood products collected from a donor whose
spouse was diagnosed as a hepatitis B carrier
were distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-633/634-6.
CODE Unit #40FQ21383.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer by letter March 7, 1996. Firm-
initiated recall complete.
DISTRIBUTION Iowa.
QUANTITY 2 units .
REASON Blood products collected from a donor who had
taken Methotrexate within four weeks prior to
donation were distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-643/644-6.
-8-CODE Unit numbers: 13Q76454.
MANUFACTURER American Red Cross, Detroit, Michigan.
RECALLED BY Manufacturer by letter June 6, 1995. Firm-
initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit of each component was distributed.
REASON Blood products collected from a donor who
traveled to a malarial endemic area, were
distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-645-6.
CODE Unit numbers 38Q78681, 13M87944, 13X77290.
MANUFACTURER American Red Cross, Detroit, Michigan.
RECALLED BY Manufacturer by telephone August 18, 1995.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 3 units were distributed.
REASON Blood products, corresponding to Platelets
which were contaminated with a gram negative
bacteria suspected to be Escherichia coli,
were distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Expired Platelets. Recall #B-621-6.
CODE Unit numbers: 8106331, 8126507.
MANUFACTURER Permian Basin Regional Blood Center, Midland,
Texas.
RECALLED BY Manufacturer by letter September 30, 1995.
Firm-initiated recall complete.
DISTRIBUTION Colorado.
QUANTITY 2 units.
REASON Blood products collected from donors who
traveled to areas considered endemic for
malaria were distributed.

_______________
PRODUCT Platelets, Pheresis. Recall #B-630-6.
CODE Unit #40P44995.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer by telephone March 8, 1996.
Firm-initiated recall complete.
DISTRIBUTION Tennessee.
QUANTITY 1 unit.
REASON Unlicensed blood product was distributed
interstate.

-9-_______________
PRODUCT Source Plasma. Recall #B-638-6.
CODE Unit numbers: DKU236, DKU499, DKU851.
MANUFACTURER Sera-Tec Biologicals, Inc., Fort Wayne,
Indiana.
RECALLED BY Manufacturer by facsimile on November 11,
1992. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 3 units were distributed.
REASON Blood products collected from a donor who
previously tested positive for syphilis were
distributed.

_______________
PRODUCT Platelets, Pheresis. Recall #B-639-6.
CODE Unit numbers: 5570811, 5570821, 5570841,
5570861, 5570871, 5570891, 5825481.
MANUFACTURER Central Indiana Regional Blood Center, Inc.,
Indianapolis, Indiana.
RECALLED BY Manufacturer by telephone July 7, 1995. Firm-
initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 7 units.
REASON Blood products incorrectly tested for anti-HBc
were distributed.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Vacutainer Brand Safety-Lok Needle Holder,
Catalog #366213, used during blood collection,
Recall #Z-1108-6.
CODE Lot numbers: 6A255, 6A256, 6B250, 6B251,
6B252, 6C250, 6C251, 6C252, 6C253, Lots
recalled in Europe: 5L251/55, 5M251, 6A250/53,
6A259.
MANUFACTURER Becton Dickinson Vacutainer Systems, Sumter,
South Carolina.
RECALLED BY Becton Dickinson Vacutainer Systems, Franklin
Lakes, New Jersey, by telephone April 22,
1996, followed by letter on May 13, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Europe.
QUANTITY 526,500 estimated amount remain on market.
REASON Improper assembly lock mechanism.

-10-_______________
PRODUCT Exeter Broach, a handheld, reusable orthopedic
device made of stainless steel used to prepare
(ream) the femoral canal for implantation of
the femoral stem during reconstructive hip
surgery. Recall #Z-1112/1113-6.
CODE All units.
MANUFACTURER Howmedica International, Inc., Herouville,
France.
RECALLED BY Pfizer Hospital Products Group, Rutherford,
New Jersey, by letter April 18, 1996. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 6 units were distributed.
REASON The distal tip of the broach may break off
during use.

_______________
PRODUCT Software Beta Version 4.5 with Gated 3-D EF,
used to create a image of the area where the
radiation emissions occurred.
Recall #Z-1114-6.
CODE Software beta version 4.5.
MANUFACTURER Trionix Research Laboratory, Twinsburg, Ohio.
RECALLED BY Manufacturer by letter August 16, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 38 units were distributed.
REASON The manufacturer is marketing the device
without a cleared premarket notification
submission under section 510 (k) of the Act.

_______________
PRODUCT Multi Diagnost 3 Radiographic Systems.
Recall #Z-1120-6.
CODE Serial numbers: 4411881093; 4411921193,
4411931193, 4411991293, 4452120904,
4452160394, 4452270494, 4492330594,
4492370694, 44200694, 4492410694, 4492510994,
4502591094, 4502601094, 4502611094,
4502681194, 4502701194, 4502731194,
4502761294, 4502771294, 4502791294.
MANUFACTURER Philips Medical Systems North America Company,
Shelton, Connecticut.
RECALLED BY Manufacturer by letter October 13, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 21 units were distributed.

-11-REASON The drive shaft connecting the lateral tilt
drive unit and table top could fracture at the
welded joint; thus allowing the table top to
rapidly and unexpectedly tilt as much as 25
degrees.

_______________
PRODUCT Argon Dental Laser Systems.
Recall #Z-1121/1123-6.
CODE Model Numbers: (a) ACL-5500; (b) ACL/PCU-5500,
(c) Genesis 2000.
MANUFACTURER Ion Laser Technology, Salt Lake City, Utah.
RECALLED BY Manufacturer by telephone July 30, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 62 units; (b) 106 units; (c) 77 units were
distributed.
REASON The devices failed to comply with 21 CFR
1040.11 (a)(2) in that the AL, PCU, and
Genesis operator's manuals lacked calibration
procedures and schedule for recalibration.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Vacutainer Brand Plus SST Test Tubes, used by
health care professionals to collect patient
blood at health care facilities packaged in a
paperboard box, 100 units per box.
Recall #Z-1109-6.
CODE Lot number 5L 305.
MANUFACTURER Becton Dickinson Vacutainer Systems, Sumter,
South Carolina.
RECALLED BY Becton Dickinson, Franklin Lakes, New Jersey
by telephone April 3, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION New Jersey, South Carolina.
QUANTITY 51,000 units were distributed.
REASON An incorrect tube dimension was printed on the
shelf cartons.

_______________
PRODUCT Coat-A-Count Total Testosterone Kits, use in
measurement of testosterone antibody.
Recall #Z-1115-6.
CODE Lot numbers: TTT1 544, TKTT5 679; TKTT2 789.
MANUFACTURER Diagnostic Products Corporation, Los Angeles,
California.
RECALLED BY Manufacturer by notice November 11, 1993.
Firm-initiated recall complete.
DISTRIBUTION Nationwide, international.
-12-QUANTITY 3,802 bags were distributed.
REASON The device was not coated, and therefore will
not perform accurately in the assay.

_______________
PRODUCT Columbia Calibre Liquid Spinal Fluid Control
Assayed Level 1, used as a clinical chemistry
control in spinal fluid assays.
Recall #Z-1116-6.
CODE Lot number 4001740.
MANUFACTURER Biocell Laboratories, Inc., Rancho Dominquez,
California.
RECALLED BY Manufacturer, by telephone June 15, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,910 vials were distributed.
REASON The device contains a fungal contamination and
is subject to leakage around the cap.

_______________
PRODUCT STACLOT Protein S Kit, 20 test/kit, used for
quantitative determination of functional
protein S based on the inhibition of factor
Va, for in vitro diagnostic use only.
Recall #Z-1117-6.
CODE Lot number 953124; EXP May 1997.
MANUFACTURER Diagonostica-Stago, France.
RECALLED BY American BioProducts Company (ABC),
Parsippany, New Jersey by letter December 6,
1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 1,519 kits were distributed, approximately
1,000 remain on market.
REASON An over estimation of the Protein S activity
level.

_______________
PRODUCT DELFIA LH-Spec Time-Resolved Fluoroimmunossay
Kit, used for the quantitative determination
of human luteinizing hormone in serum and
plasma for ovulation detection in urine.
Recall #Z-1118-6.
CODE Lot numbers: 651552, 651553, 651555, 653872,
655741, 656511.
MANUFACTURER Wallac Oy, Turku, Finland.
RECALLED BY Wallac, Inc., Gaithersburg, Maryland, by
telephone July 2, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Pennsylvania, Massachusetts, Missouri,
Georgia, Washington, New Jersey, Michigan,
Texas, California.
-13-QUANTITY 396 kits were distributed.
REASON The stability testing of the device revealed
that within-plate variation increased over
time.

_______________
PRODUCT Drug of Abuse Control CON-DOA Level 1, used in
the measurement of the level of drugs in
individuals. Recall #Z-1119-6.
CODE Lot numbers: DOAC1 008.
MANUFACTURER Diagnostic Products Corporation, United
Kingdom.
RECALLED BY Diagnostic Products Corporation, Los Angeles,
California by telephone and fax January 19,
1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Sweden, United Kingdom.
QUANTITY 2,374 vials were distributed.
REASON The level of THC in a single vial of DOAC1 008
was 2-3 times the targeted values.

_______________
PRODUCT Total Knee Flat Tibial Wedge.
Recall #Z-1125-6.
CODE AWWZA, AXOVA, AXPVB. Lot code written on the
outside of the box.
MANUFACTURER Howmedica, Inc., Rutherford, New Jersey.
RECALLED BY Manufacturer by a market withdrawal letter
dated December 5, 1995. Firm-initiated recall
complete.
DISTRIBUTION Nationwide, Australia, Ireland, Canada, New
Zealand.
QUANTITY 72 units were distributed.
REASON Instead of product containing a small right
component as labeled, it may contain a small
left component.

_______________
PRODUCT Total Knee Flat Tibial Wedge, a small,
vitallium alloy, kidney shaped device used in
conjunction with the tibial baseplate during
reconstructive knee surgery.
Recall #Z-1126-6.
CODE Catalog # 6630-6-110; lot number BPGEC.
MANUFACTURER Howmedica, Incorporated, Rutherford, New
Jersey.
RECALLED BY Manufacturer by letter April 19, 1996. Firm-
initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 25 devices were manufactured; firm estimates
none remain on market.

-14-REASON Product misbranded, instead of containing a
Right, Small -1 component as labeled, it may
contain a Left, Small - 1 component.

_______________
UPDATE Davis-Geck Valtrac Bar Biofragmentabl
Anastomosis Ring, Recall #Z-1043/1051-6, which
appeared in the August 28, 1996 Enforcement
Report listed an incorrect product number for
item (b). The correct product number is
8083-00.
RECALLED BY Sherwood Medical Company, St. Louis, Missouri,
issued two letters dated May 22, 1996, to U.S.
accounts and a letter dated May 23, 1996, to
foreign accounts.

-15-

END OF ENFORCEMENT REPORT FOR SEPTEMBER 11, 1996. BLANK PAGES MAY FOLLOW.

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