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.

May 7, 1997 97-19

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Smilowitz Home Made Baking Chocolate Rugelech, net
weight 1 pound (454 g), in cellophane packages. Recall
#F-398-7.
CODE None. EXP Date 11/28/96.
MANUFACTURER Future Fortune, Inc., Brooklyn, New York.
RECALLED BY Manufacturer, by telephone and by letter dated
November 5, 1996. Completed recall resulted from
sample analysis and followup by New York State
Department of Agriculture and Markets.
DISTRIBUTION New Jersey and New York.
QUANTITY 576 packages were distributed.
REASON Product contains undeclared certified colors, FD&C
Yellow No. 5, Red No. 40 and Blue No. 1.

_______________
PRODUCT A & S Bakery Italian Biscuits in plastic 1 pound bags.
Recall #F-402-7.
CODE None.
MANUFACTURER Abbate, Salbatore & Victor, Brooklyn, New York.
RECALLED BY Manufacturer, by visit on January 29, 1997.
Completed recall resulted from sample analysis and
followup by the New York State Department of
Agriculture and Markets.
DISTRIBUTION New York.
QUANTITY Approximately 800 bags were distributed.
REASON The product contains undeclared certified colors, FD&C
Yellow No. 5, Red No. 40, and Blue No. 1.

_______________
PRODUCT Jamaican Pride Bakery (also known as Jamaica
Prestigious Bakery) "JPB Spiced Bun", net wt. 22 ounces
(1 lb. 6 oz.) 624 grams.
Recall #F-403-7.
CODE None.
MANUFACTURER Jamaican Pride Bakery, Inc., Brooklyn, New York.
RECALLED BY Manufacturer, by visit beginning January 22, 1997.
Completed recall resulted from sample analysis and
followup by the New York State Department of
Agriculture and Markets.
DISTRIBUTION New York.
QUANTITY Approximately 900 packages were distributed.
REASON The product contains undeclared certified colors, FD&C
Yellow No. 5 and Red No. 40

_______________
PRODUCT Minute Maid Orange Juice in 16 ounce glass bottles.
Recall #F-406-7.
CODE Lot numbers: 6187MD, 6270MD.
MANUFACTURER The Minute Maid Company, Chicago, Illinois.
RECALLED BY The Minute Maid Company, Houston, Texas, by
instructing customers to remove product from
shelves on December 9, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 19,913 cases of lot 6187MD and 22,142 cases of lot
6270MD were distributed.
REASON Product is adulterated due to the presence of glass.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Minute Maid Calcium-Rich Orange Juice in 96 ounce
plastic packages. Recall #F-400-7.
CODE Container MAY12PWECT349 - Shipping Case
XX:XXPWEMAY12T37586A "XX:XX" is a 24 hour code.
MANUFACTURER The Minute Maid Company, Paw Paw, Michigan.

-2-RECALLED BY The Minute Maid Company, Houston, Texas, by
telephone March 20-21, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,725 cases were distributed.
REASON The product is adulterated due to the presence of
yeast.

_______________
PRODUCT Table Syrup packed in 1.5 ounce plastic cups. Recall
#F-401-7.
CODE The lot #11156171J stamped on case.
MANUFACTURER Portion Pak, Inc., Jacksonville, Florida.
RECALLED BY Portion Pak, Inc., Mason, Ohio, by telephone on
March 25, 1997. Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 360 cases (100 cups per case) were distributed.
REASON The product is adulterated due to the presence of mold.

_______________
PRODUCT Rainbo brand, 6 Cherry Danish, packaged in 12 ounce
plastic covered foil trays.
Recall #F-404-7.
CODE Products are coded with the sell by date, "MAR 4", "MAR 5",
"MAR 6", "MAR 7", or "MAR 8"
MANUFACTURER Mary Ann's Baking Co., Inc., Sacramento,
California.
RECALLED BY Manufacturer, by telephone on March 5, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION California.
QUANTITY 1,399 packages were distributed.
REASON The product contains Undeclared certified colors, FD&C
Red No. 40 and Blue No. 1.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
===========
_______________
PRODUCT Minocycline HCl Capsules, USP, 50 mg in bottles of 100
and 100 mg, in bottles of 50 and 1,000, used as an
antimicrobial.
Recall #D-122/123-7.
CODE Lot numbers: 59175L EXP8/97, 59075L EXP 8/97, 58975L EXP
8/97, 10516L EXP 12/97, 10616L EXP 12/97, 10716L EXP 12/97,
10816L EXP 12/97 (50 mg); 59775L EXP 7/97, 59975L EXP 7/97,
60075L EXP 7/97, 59875L EXP 7/97, 60175L EXP 7/97 (100 mg,
in bottles of 50); 137D5L EXP 12/97, 138D5L EXP 12/97.
10916L EXP 1/98 (100 capsules of 1000).

-3-MANUFACTURER Warner Lambert Company, Lititz, Pennsylvania.
RECALLED BY Warner Chilcott, Rockaway, New Jersey, by letter
dated February 11, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 34,234 bottles of 50 mg in 100 capsule bottles; 48,824
bottles of 100 mg in 50 capsule bottles; and 1,436
bottles of 100 mg in 1000 capsule bottles were
distributed.
REASON Bulk substance was manufactured using processes that
did not conform to the firm's filed processes.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Source Plasma. Recall #B-604-7.
CODE Unit numbers: 0540054846, 0540053497, 0540053141,
0540052463, 0540051050, 0540047936, 0540047520, 0540047080,
0540045688, 0540045271, 0540044224, 0540043613, 0540042491.
MANUFACTURER NABI Biomedical Center, Louisville, Kentucky.
RECALLED BY North American Biologicals, Inc., Boca Raton,
Florida, by letter dated February 1 or 9, 1995,
followed by second letters dated October 8, 1996.
Firm-initiated recall complete.
DISTRIBUTION France, West Germany, Italy, South Korea,
Switzerland.
QUANTITY 13 units were distributed.
REASON Blood products were collected from a donor who reported
an accidental blood exposure.

_______________
PRODUCT Red Blood Cells. Recall #B-637-7.
CODE Unit #36R52269.
MANUFACTURER American Red Cross Blood Services, Columbia, South
Carolina.
RECALLED BY Manufacturer, by telephone on January 13, 1997.
Firm-initiated recall complete.
DISTRIBUTION South Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of platelets that
was positive for Clostridium butyricum.

_______________
PRODUCT Red Blood Cells. Recall #B-656-7.
CODE Unit #18S52634.
MANUFACTURER American Red Cross, Lansing, Michigan.
RECALLED BY Manufacturer, by telephone on July 25, 1996, and
by letter dated August 15, 1996. Firm-initiated
recall complete.
-4-DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who
experienced vomiting and diarrhea at the collection
site immediately following the donation and unit was
inappropriately distributed.

_______________
PRODUCT Platelets, Pheresis. Recall #B-657-7.
CODE Unit #21P63953.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by telephone on October 29, 1996.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product had a platelet yield below the acceptable
limit.

_______________
PRODUCT (a) Platelets; (b) Recovered Plasma.
Recall #B-658/659-7.
CODE Unit #36R51047.
MANUFACTURER American Red Cross Blood Services, Columbia, South
Carolina.
RECALLED BY Manufacturer, by telephone followed by letter
dated October 21, 1996. Firm-initiated recall
complete.
DISTRIBUTION South Carolina and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with
Polycythemia vera.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets (c) Plasma. Recall
#B-660/662-7.
CODE Unit #53R30973.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated July 16, 1996.
Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who reported
a history of hepatitis A.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-665/666-7.
CODE Unit #11J13273.
MANUFACTURER American Red Cross Blood Services, St. Louis,
Missouri.
-5-RECALLED BY Manufacturer, by telephone on or about April 3,
1996, followed by letter dated April 11, 1996.
Firm-initiated recall complete.
DISTRIBUTION Missouri and Switzerland.
QUANTITY 1 unit of each component.
REASON Blood products were collected from a donor whose arms
showed evidence of intravenous (IV) drug use.

_______________
PRODUCT Red Blood Cells. Recall #B-667-7.
CODE Unit #40GK03742.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on December 2, 1996,
followed by letter dated December 4, 1996. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported
travel to an area considered endemic for malaria.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-668/669-7.
CODE Unit #49G60074.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.
RECALLED BY Manufacturer, by letter dated January 16, 1997.
Firm-initiated recall complete.
DISTRIBUTION Oklahoma and Texas.
QUANTITY 1 unit of each component.
REASON Blood products were collected from a donor who reported
travel to an area considered endemic for malaria.

_______________
PRODUCT Red Blood Cells. Recall #B-670-7.
CODE Unit #11Y34123.
MANUFACTURER American Red Cross Blood Services, St. Louis,
Missouri.
RECALLED BY Manufacturer, by requesting return of product on
September 26, 1996. Firm-initiated recall
complete.
DISTRIBUTION Missouri.
QUANTITY 1 unit was distributed.
REASOn Blood product corresponded to a unit of Platelets which
was positive for gram positive cocci.

-6-_______________
UPDATE Recall #B-560/561-7, Venoglobulin-S 5% - 50ml (2.5
grams in 50 ml) and Venoglobulin-S 5% (5.0 grams in 100
ml) which appeared in the April 23, 1997, Enforcement
Report is being rescinded due to the fact that
incorrect vial size were submitted on these products.
The correct recall is B-562-7, Venoglobulin-S 5% -
200ml (10.0 grams in 200ml).

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Mononine Monoclonal Antibody Purified (Coagulation
Factor IX, Human).
Recall #B-466-7.
CODE Lot #P13609 EXP 9/25/98.
MANUFACTURER Centeon L.L.C., Bradley, Illinois.
RECALLED BY Centeon L.L.C., A Company of Armour and Behring,
King of Prussia, Pennsylvania, by telephone on
February 27-28, 1997, followed by letter dated
February 28, 1997. Firm-initiated recall ongoing.
See also FDA Talk Paper T96-91, dated October 4,
1996.
DISTRIBUTION Nationwide.
QUANTITY 883 vials were distributed.
REASON Biological product with lack of assurance of product
sterility.

_______________
PRODUCT Red Blood Cells. Recall #B-615-7.
CODE Unit #12Y68093.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by telephone on February 4, 1997,
followed by letter dated February 7, 1997. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product, which may have been incorrectly typed
for the C antigen, was labeled C negative.

_______________
PRODUCT Recovered Plasma. Recall #B-635-7.
CODE Unit #26R84884.
MANUFACTURER American Red Cross, Mobile, Alabama.
RECALLED BY Manufacturer, by fax on or about February 13,
1995. Firm-initiated recall complete.
DISTRIBUTION Switzerland.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with a history
of cancer.
-7-_______________
PRODUCT Recovered Plasma. Recall #B-638-7.
CODE Unit #36R52269.
MANUFACTURER American Red Cross Blood Services, Columbia, South
Carolina.
RECALLED BY Manufacturer, by telephone and fax on January 13,
1997. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of platelets that
was positive for Clostridium butyricum.

_______________
PRODUCT Red Blood Cells. Recall #B-663-7.
CODE Unit numbers: 26146-5173, 26146-9352, 26146-9354, 26146-9494, 26146-9506, 26146-9507, 26146-9508, 26147-0755, 26147-0759, 26147-0760, 26147-0762, 26147-0764.
MANUFACTURER United Blood Services, Fort Smith, Arkansas.
RECALLED BY Blood Systems, Inc., Fort Smith, Arkansas, by
letter dated September 20, 1996. Firm-initiated
recall complete.
DISTRIBUTION Oklahoma.
QUANTITY 12 unit were distributed.
REASON Unlicensed blood products were shipped interstate.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
==========
_______________
PRODUCT HeartMate IP LVAS Blood Pump, Catalog #1000A, a
pulsatile ventricular assist system intended for
hemodynamic and circulatory support. Recall #Z-443-7.
CODE All pumps manufactured between 8/1/94 and 4/30/96.
MANUFACTURER Thermo Cardio Systems, Inc. (TCI), Woburn,
Massachusetts.
RECALLED BY Manufacturer, by visit beginning October 16, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 47 pumps.
REASON The percutaneous drive line may separate from the lower
housing nipple located on the blood pump.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT First Medic 710 Semi-Automatic External Defibrillator,
Part #300762-01, 02, 03.
Recall #Z-428-7.
-8-CODE Serial numbers: 1284, 1546, 1668-1671, 1673, 1678, 1776,
1777, 1781, 1782, 1784, 1785, 1794, 1804, 1818, 1830, 1833,
1837, 1840, 1841, 1843, 1846-1849, 1851-1854, 1856-1860,
1862-1865, 1867-1882, 1884-1890, 1892-1898, 1900-1907, 1909,
1910, 1913, 1915-1918, 1920-1924, 1926-1945, 1947-1949,
1951, 1953, 1955, 1958-1964, 2065-2067, 2069-2075, 2077.
MANUFACTURER Physio Control Corporation, Redmond, Washington.
RECALLED BY Manufacturer, by visit beginning on March 24,
1997, followed by letter dated March 1997. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 134 units were distributed.
REASON Depressing the ON/OFF switch may result in only partial
power-up and functioning of the device. Failure to
completely power-up can lead to failure to defibrillate
the patient. The device defect appears to be
attributable to a software source code deficiency.

_______________
PRODUCT Allan brand High Volume IV and Irrigation Tower,
designed for hospital operating room use. Recall #Z-435-7.
CODE Serial numbers: GK-001 through GK-025, and GL003, GL008,
GL010, GL012, GL013, GL021, and GL022.
MANUFACTURER Habco Tool and Development, Mentor, Ohio
(component).
RECALLED BY Allen Medical Systems, Garfield Heights, Ohio, by
letter on February 21, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 32 units were distributed.
REASON The device would drop from the raised position to the
lowest position, resulting in a minor disruption of the
irrigation function, and in some cases would cause the
fluid bag to rupture.

_______________
PRODUCT Navarre Percutaneous Access Sets and Mandrel
Guidewire. Sets are intended to be used to facilitate
the placement of a working guidewire for interventional
radiology procedures, and are contraindicated for
intravascular use:
(a) Percutaneous Access Set, Model No. 610-PAS-30
(b) Percutaneous Access Set, Model No. 610-PAS-45
-9- (c) Mandrel Guidewire, Model No. 615-MGW-021. Recall #Z-449/451-7.
CODE Lot Numbers: (a) 960005, 960061, 960640, 960853, 961083;
(b) 960004, 960060, 960641, 960693; (c) 960471, 960778.
MANUFACTURER Navarre Biomedical, Ltd., Plymouth, Minnesota.
RECALLED BY Manufacturer, by letter on April 11, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 460 guidewires were distributed as part of the
Percutaneous Access Sets or alone as Mandrel
Guidewires.
REASON The guidewire packaged and distributed as part of the
access sets and alone is subject to breakage due to
brittleness.

_______________
PRODUCT SONOLINE Ultrasound Systems with OB Calculation Package
Option:
(a) SONOLINE Prima Ultrasound System, Part No.
5118505-LH300, All Serial Numbers
(b) SONOLINE Versa Pro Ultrasound System, Part No.
4396771-LH400. Recall #Z-452/453-7.
CODE All Serial Numbers.
MANUFACTURER Siemens Medical Systems, Inc., Issaquah,
Washington.
RECALLED BY Manufacturer, by letter on March 28, 1997. Firm-initiated field correction ongoing.
DISTRIBUTION (a) California, North Carolina, New York,
Pennsylvania, Illinois, South Carolina, Ohio,
Michigan, Virginia, New Jersey, Rhode Island, and
international; (b) Nationwide and international.
QUANTITY (a) 158 units; (b) 46 units were distributed.
REASON A software error was discovered in the Enhanced OB
Calculation of an estimated delivery date (EDC) of a
fetus based on an in-vitro fertilization date. The
system incorrectly calculates the EDC by an
overestimation of four weeks. This software design
error may lead to misdiagnosis of the fetus size.

_______________
PRODUCT Oschner 200 Bifurcated Vascular Graft, Catalog No.
OCW1608, used for replacement or bypass procedures in
aneurysmal and occlusive disease of the abdominal
aorta, visceral arteries and proximal peripheral
arteries exclusive of the coronary arteries. Recall
#Z-455-7.
CODE Lot Numbers: 40615, 40623, 40631, 40766, 40775, 40802,
41137, 41147.

-10-MANUFACTURER Intervascular, Inc., Clearwater, Florida.
RECALLED BY Manufacturer, by fax and certified mail on
February 19, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and France.
QUANTITY 68 grafts were distributed.
REASON The water permeability of the graft may be increased,
due to a weaving defect along one leg of the graft.

_______________
PRODUCT VACUTAINER brand PLUS Plasma Separation Tubes (PST),
evacuated blood collection tubes with an anticoagulant
interior (known as Heparin) and also an interior
polymer gel coating used for the collection,
separation, and transport of blood specimens.
Recall #Z-458-7.
CODE Catalog #367960, Lot #6B516, EXP 11/96.
MANUFACTURER Becton Dickinson Vacutainer Systems, Broken Bow,
Nebraska.
RECALLED BY Becton Dickinson Vacutainer Systems, Franklin
Lakes, New Jersey, by telephone September 23-30,
1996, and by notices mailed October 22, 25, and
31, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Undetermined.
QUANTITY 116,100 units were distributed.
REASON Some tubes in this lot were manufactured with an
incorrect anticoagulant, K2EDTA, instead of Heparin;
and the tubes were labeled as containing Lithium
Heparin.

_______________
PRODUCT VACUTAINER Brand Lok-On Needle Holder, a light blue
color, polycarbon, reusable, non-sterile holder used
with VACUTAINER Brand Blood Collection Needles during
venipuncture. The needle holder is packaged 250 units
in a clear plastic bag within a corrugated box.
Recall #Z-463-7.
CODE Catalog #366221, Lot numbers: 5M450, 5M451, 5M452, 5M453,
5M454, 5M455, 5M456, 5M457, 6A450, 6A451, 6C450, 6C451,
6C452.
MANUFACTURER Becton Dickinson Vacutainer Systems, Sumpter,
South Carolina.
RECALLED BY Becton Dickinson Vacutainer Systems (BDVS),
Franklin Lakes, New Jersey, by fax on December 9,
1996, by letters on December 3 and 19, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 52,750 units were distributed.

-11-REASON The device is subject to a locking mechanism failure
which can result in an uncontrolled sharp exposure to
both patient and users.

_______________
PRODUCT Uldall Double Lumen Hemodialysis Catheter Tray and
Uldall Double Lumen Hemodialysis Exchange Trays. The
catheters are intended for vascular access, distributed
in Canada under the following reorder numbers:
C-DDSCY-1600-26-5.0-ULDALL;
C-DDSCY-1600-26-5.0-ULDALL-XCH;
C-DDSCY-1600-26-7.0-ULDALL;
C-DDSCY-1600-26-7.0-ULDALL-XCH;
C-DDSCY-1600-28-2.5-ULDALL-XCH-RAP-031596;
C-DDSCY-1600-26-2.5-ULDALL-XCH-RAP-031596;
C-DDSCY-1600-26-7.0-ULDALL-XCH-RAP-031596;
C-DDSCY-1600-28-2.5-ULDALL-XCH-RAP-031596.
Recall #Z-469-7.
CODE All lots distributed to Canada.
MANUFACTURER Cook Incorporated, Bloomington, Indiana.
RECALLED BY Cook Canada, A Cook Group Company, Stouffville,
Ontario, Canada, by letter on February 24, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Canada.
QUANTITY 337 catheters were distributed.
REASON The labeling for the device states the lumens hold from
1.3cc to 1.6cc while the lumen is stamped as holding 2
cc which could result in a heparin overdose.

_______________
UPDATE Recall #Z-347-7, Baxter Capillary Flow Dialyzer, Model
CF 15 5M1709, which appeared in the April 30, 1997
Enforcement Report should read:
MANUFACTURER: Baxter Healthcare Corporation, Mountain Home,
Arkansas.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT ANTI-SSB Microassay, Catalog #783-260, in-vitro
diagnostic test set. Recall #Z-430-7.
CODE Lot #71106.
MANUFACTURER Diamedix, Miami, Florida.
RECALLED BY Manufacturer, by letter February 4, 1997. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 128 sets were distributed.
REASON The product may be giving a higher than usual number of
equivocal/low positive test results.
-12-_______________
PRODUCT Ortho Brain Thromboplastin, used for prothrombin time
determination, for in-vitro diagnostic use. Recall #Z-447-7.
CODE Product #732400, Lot #0BT257 EXP 2/5/98.
MANUFACTURER Ortho Diagnostic Systems, Raritan, New Jersey.
RECALLED BY Manufacturer, by letter dated November 1, 1996.
Firm-initiated recall complete.
DISTRIBUTION Iowa, North Carolina, South Dakota, Oklahoma, New
Jersey, Tennessee.
QUANTITY 25 packages (25 vials per package) were distributed;
firm estimates none remains on the market.
REASON The 12 ml. vials were labeled as 20 ml.

_______________
PRODUCT Microalbumin Test Kit ELISA, for the determination of
microalbumin concentration in human urine 960 assays
kit.
Recall #Z-448-7.
CODE Catalog #0700, Lot #070062.
MANUFACTURER Diagnostic Specialties, Inc., Metuchen, New
Jersey.
RECALLED BY Manufacturer, by letter January 22, 1997. Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 80 units were distributed; firm estimated that 20 units
remained on market at time of recall initiation.
REASON The label had an incorrect expiration date.

_______________
PRODUCT VACUTAINER Brand PLUS Serum Tubes, plastic evacuated
blood collection tubes with silicone-coated interior
(known as SILWET L-720) and clot activator for the
collection, separation, and transport of blood
specimens.
Recall #Z-456-7.
CODE Catalog #367819, Lot #6G801, EXP Date 12/97.
MANUFACTURER Becton Dickinson Vacutainer Systems, Sumter, South
Carolina.
RECALLED BY Becton Dickinson Vacutainer Systems, Franklin
Lakes, New Jersey, by telephone on September 3 and
9, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Louisiana.
QUANTITY 40,000 units were distributed.
REASON The tubes labeled incorrectly, an identification stripe
was omitted.

-13-_______________
PRODUCT VACUTAINER Brand Blood Collection Sets are sterile,
disposable, single use devices used for the collection
of blood samples by venipuncture. Recall #Z-457-7.
CODE Catalog #007253, Lot #'s 6B081 and 6B091.
MANUFACTURER NISSHO Corporation, Nipro Medical Ind. LTD,
Tatebayashi, Gunma Japan.
RECALLED BY Becton Dickinson Vacutainer Systems, Franklin
Lakes, New Jersey, by letter September 11, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Undetermined.
QUANTITY 240,600 units were distributed.
REASON The device has holes in the tubing which may result in
blood leakage from the collection set or introduce air
into the collection tubing.

_______________
PRODUCT Proclear Daily Wear Soft Contact Lenses. Recall #Z-459-7.
CODE Lot #B613317.
MANUFACTURER Biocompatibles, Inc., Norfolk, Virginia.
RECALLED BY Manufacturer, by telephone on October 26 and 28,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Great Britain.
QUANTITY 124 lenses were distributed.
REASON Some contact lenses were labeled with incorrect diopter
values that did not reflect the measured value of the
product.

_______________
PRODUCT Ciba Vision Focus Toric Soft Contact Lenses. Recall
#Z-460-7.
CODE Catalog #SKU 200484, Lot #6155113.
MANUFACTURER Ciba Vision Corporation, Atlanta, Georgia.
RECALLED BY Ciba Vision Corporation, Duluth, Georgia, by
letter on March 24, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 681 6-packs were distributed.
REASON The lenses were labeled with incorrect diameter values
that did not reflect the measured value of the product.

_______________
PRODUCT Ciba Vision Focus Toric Soft Contact Lenses. Recall
#Z-461-7.
CODE Catalog #SKU 200409, Lot #6184121.
MANUFACTURER Ciba Vision Corporation, Atlanta, Georgia.
RECALLED BY Ciba Vision, Duluth, Georgia, by letter on or
about March 24, 1997. Firm-initiated recall
ongoing.
-14-DISTRIBUTION Nationwide.
QUANTITY 1,102 6-packs were distributed.
REASON Lot integrity has been violated because some +3.00
diopter Contact Lenses were mixed in with the -1.00
diopter lenses of this lot (lot no. 6184121).

_______________
PRODUCT EBV Viral Capsid Antigen IgM Elisa Test Kit, used for
for the detection of IgM antibodies to Epstein-Barr
viral capsid antigen and infectious monoculeosis.
Recall #Z-470-7.
CODE Lot #2325750-139.
MANUFACTURER Wampole Labs, Division Carter-Wallace, Inc.,
Cranbury, New Jersey.
RECALLED BY Clark Laboratories, Inc., Jamestown, New York, by
letter June 26, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 190 kits were distributed.
REASON The positive control was labeled with a range of 4.4 -
8.2, the correct range is 2.7 - 5.0 ISR.

_______________
PRODUCT Bartels Viral Respiratory Screening and Identification
Kit and Anti-Viral Antibody Identification Reagents:
(a) Catalog No. B1029-86, Viral Respiratory Kit
(b) Catalog No. B1029-87A, Anti-Adenovirus Antibody
(c) Catalog No. B1029-87B, Anti-Influenza A Antibody
(d) Catalog No. B1029-87C, Anti-Influenza B Antibody
(e) Catalog No. B1029-87D, Anti-Parainfluenza 1 Antibody
(f) Catalog No. B1029-87E, Anti-Parainfluenza 2 Antibody
(g) Catalog No. B1029-87F, Anti-Parainfluenza 3 Antibody
(h) Catalog No. B1029-87G, Anti-RSV Antibody. Recall #Z-471/478-7.
CODE Lot Numbers: (a) 1338, 6H177, 6J302, 6J303, 6K329, 6M348;
(b) 1075, 1075-1, 1076-1, 1076-2;
(c) 1067R, 1067R-1, 6J254-1, 6K351-1, 6N157-1, 6N157-2;
(d) 1068, 1068-1, 6J255-1, 6J255-2, 7A193-1;
(e) 1064R, 1065-1, 1065-2;
(f) 1065R, 1065R-1, 1066-1, 1066-2;
(g) 1061, 1061-1, 6J256-1, 6J256-2;
-15- (h) 1057R, 1057R-1, 1058-1, 1058-2.
MANUFACTURER Bartels, Inc., The Diagnostics Division of
Intracel, Corporation, Issaquah, Washington.
RECALLED BY Manufacturer, by letter beginning April 4, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY As of 1-23-97, the following quantities had been
distributed:
(a) 525 units; (b) 524 units
(c) 410 units; (d) 398 units
(e) 279 units; (f) 219 units
(g) 318 units; (h) 233 units. Firm estimated a total of 520
units remained on the market at time of recall initiation.
REASON Bottles containing the anti-viral antibody
identification reagents dispensed a larger drop than
the manufacturing specification allows.

_______________
PRODUCT Microvena Amplatz Goose-Neck Snare, a Nitinol Retrieval
Device, used to retrieve foreign bodies from the
cardiovascular system and hollow viscus. Recall #Z-479-7.
CODE Product #GN2500, Lot #971199.
MANUFACTURER Microvena Corporation, White Bear Lake, Minnesota.
RECALLED BY Manufacturer, by telephone on April 7, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 39 units were distributed.
REASON Some units in the recalled lot contain a 65 cm snare,
instead of a 120 cm snare as labeled.

_______________
PRODUCT NMC Arterial Bloodlines with reverse flow drip chamber.
Recall #Z-480-7.
CODE Catalog #03-7204-5, Lot #R6H095.
MANUFACTURER National Medical Care, Medical Products Division,
Mc Allen, Texas; and Erika De Reynosa, CD
Reynosa, Mexico.
RECALLED BY National Medical Care, Rockleigh, New Jersey, by
telephone by August 23, 1996. Firm-initiated
recall complete.
DISTRIBUTION California and Missouri.
QUANTITY 114 cases (24 units per case) were distributed.
REASON The device drip chamber may be occluded and cause the
user to be unable to prime the line.
-16-

END OF ENFORCEMENT REPORT FOR MAY 7, 1997. BLANK PAGES MAY FOLLOW.

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End of Enforcement Report for