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
05/18/1994

Recalls and Field Corrections: Drugs -- Class II -- 05/18/1994

May 18, 1994 94-20

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Transfilled Compressed Medical Oxygen in D & E size
cylinders. Recall #D-274-4.
CODE All fill dates.
MANUFACTURER ADR Home Care Services, East Setauket, New York.
RECALLED BY Manufacturer, by telephone and letter April 25, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 53 E and 17 D cylinders were distributed.
REASON Current good manufacturing practice deficiencies.

_______________
PRODUCT (a) Loestrin FE 1/20 Tablets, Norethindrone Acetate and
Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets,
USP, (5 packages of 28 tablets);
(b) Loestrin 1/20 Tablets, Norethindrone Acetate and Ethinyl
Estradiol Tablets, USP, (5 packages of 21 tablets).
Recall #D-275/276-4.
CODE Lot numbers: (a) 05632FC EXP 3/95, 05632FG EXP 2/95;
(b) 05632FA EXP 3/95, 05632FB EXP 3/95, 05632FF EXP 3/95.
MANUFACTURER Warner Lambert, Fajardo, Puerto Rico.
RECALLED BY Parke-Davis, Division of Warner Lambert Company, Morris
Plains, New Jersey, by letter January 17, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY Approximately 63,284 units were distributed in the United
States and 56,540 units in Canada.
REASON Products did not meet content uniformity specifications.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Recovered Plasma. Recall #B-268-4.
CODE Unit #93-2300.
MANUFACTURER St. Joseph Hospital Blood Bank, Reading, Pennsylvania.
RECALLED BY Manufacturer, by telephone December 3, 1993, followed by
letter December 13, 1993. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit.
REASON Blood product, untested for viral markers, was distributed.

_______________
PRODUCT (a) Whole Blood; (b) Platelets. Recall #B-269/270-4.
CODE Unit numbers: (a) 2067539; (b) 1743562.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by telephone and by Fax February 25, 1994,
followed by letter March 9, 1994. Firm-initiated recall
complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit of each component.
REASON Blood products, which tested repeatedly reactive for the
antibody to hepatitis B core antigen (anti-HBc), were
distributed.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Advantx CFM Fluoroscopic X-Ray Imaging System Positioning
Arm, Model numbers 45200707, 45554027, 45554448, 45553680,
and 45561622. Recall #Z-373/377-4.
CODE Model number serial number
45200707 3059000
45200707 3058400
45200707 7156401
45200707 7458100
45554027 02157BU6
45554027 17134BU8
45554027 11830BU7
45554027 15373BU4
45554027 08727BU0
45554027 16813BU8
45554027 04870BU2
45554027 10208BU7
45554027 11961BU0
45554027 13534BU3
45554027 7478601

-2- 45554448 9963801
45554448 99305
45553680 45553680
45561622 08837BU7
MANUFACTURER GE Medical Systems - Europe, Buc (Paris), France.
RECALLED BY General Electric Company, Medical Systems Division,
Waukesha, Wisconsin, by Urgent Safety Notice sent February
17, 1994. Firm-initiated recall complete.
DISTRIBUTION California, Florida, Indiana, Kentucky, Massachusetts,
Michigan, Ohio, Pennsylvania, Tennessee, Texas, Argentina,
Chile.
QUANTITY 19 units.
REASON An improper weldment on the arm structure for the image
intensifier may crack and fail permitting the image
intensifier to separate from its support and fall.

_______________
PRODUCT Manometric Catheters:
(a) Esophageal Catheters Catalog No. EMC-3;
(b) Esophageal Catheters Catalog No. EMC-4;
(c) Esophageal Catheters Catalog No. EMC-6;
(d) Esophageal Catheters Catalog No. EMC-8;
(e) Anorectal Catheters Catalog No. AMC-4;
(f) Anorectal Catheters Catalog No. AMC-8;
(g) Vector Volume Catheters Catalog No. VMC-4;
(h) Vector Volume Catheters Catalog No. VMC-6;
(i) Vector Volume Catheters Catalog No. VMC-8.
Recall #Z-482/490-4.
CODE Serial numbers: ZX00-ZR99. All catheters throughout these
serial codes except ZW44 and ZU62 which were removed from
stock and scrapped.
MANUFACTURER Zinetics, Salt Lake City, Utah.
RECALLED BY Manufacturer, by letter October 26, 1993. Firm-initiated
recall complete.
DISTRIBUTION Texas, Colorado, Idaho, Pennsylvania, Illinois, South
Carolina, New Mexico, Washington state, California,
Michigan, New York, Indiana, Utah, Wyoming, Missouri,
Maryland.
QUANTITY 700 units.
REASON The depth reference markings can be partially or completely
removed during reuse.

_______________
PRODUCT Sterile Nealon Surgical Gloves with 100% Lactose Powder:
(a) Catalog No. 376655, Size 5-1/2
(b) Catalog No. 376660, Size 6
(c) Catalog No. 376665, Size 6-1/2
(d) Catalog No. 376670, Size 7
(e) Catalog No. 376675, Size 7-1/2
(f) Catalog No. 376680, Size 8
(g) Catalog No. 376685, Size 8-1/2
(h) Catalog No. 376690, Size 9. Recall #Z-512/519-4.

-3-CODE Last four digits of their lot number is less than 3279.
MANUFACTURER Becton Dickinson AcuteCare, Honed Path, South Carolina;
B-D Acute Care Plant, El Paso, Texas;
Elamex Company, Juarez, Mexico (related subsidiary).
RECALLED BY Becton Dickinson & Co., Franklin Lakes, New Jersey by letter
November 4, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY 714,800 pairs were distributed; firm estimates 150,000 pairs
remain on the market.
REASON Products are being manufactured and distributed without an
approved PMA for the 100% lactose powder donning agent.

______________
PRODUCT All unprotected patient cables and lead wires provided with
Corometrics Medical Systems brand Apnea Monitors. The
following products are affected:
Catalog No: Description:
1305AAO Model 502 Patient Cable
1306AAO Model 502 Lead Wires
1307AAO Model 502 (IEC) Lead Wires
1308AAO Model 556 Patient Cable
1309AAO/CAO Model 556 Lead Wires
1408AAO Model 505/506/515 Patient Cable
1408BAO Model 505/506/515 Patient Cable
2906AAO/BAO Electrodes w/Preattached Lead Wires
2906CAO Preemie Electrodes w/Preattached Lead Wires
5109AAO Model 505/506/515 Lead Wires
5109BAO Model 505/5-6/515 Lead Wires.
Recall #Z-544-4.
CODE All models with unprotected (exposed pin style) lead wires
and unprotected patient cables.
MANUFACTURER Corometrics Medical Systems, Inc., Wallingford, Connecticut.
RECALLED BY Manufacturer, by letter dated October 11, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Device labeling fails to provide adequate directions for use
and the devices pose an unwarranted risk of injury to
patients, because the product is not labeled to warn against
the hazards of unprotected electrode lead wires being
connected to electrical power sources.

_______________
PRODUCT G4A electrode lead wires used with model EGS 300 Portable
High Voltage Galvanic Stimulator. Recall #Z-547-4.
CODE All codes distributed from January 1991 to January 1994.
MANUFACTURER Electro-Med Health Industries, North Miami, Florida.
RECALLED BY Manufacturer, by letter dated February 10, 1994.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 1500 cable sets.

-4-REASON Product labeling fails to provide adequate directions for
use and the devices pose an unwarranted risk of injury to
patients, because the products are not labeled to
contraindicate use with apnea monitors.

_______________
PRODUCT Cobe Spectra Apheresis System - Pump Rotor, used for the
collection of blood products:
(a) Catalog No. 950000-000
(b) Catalog No. 950000-001
(c) Catalog No. 950000-002
(d) Catalog No. 950000-003
(e) Catalog No. 950000-004
(f) Catalog No. 950000-005
(g) Catalog No. 950000-006
(h) Catalog No. 950000-007
(i) Catalog No. 950000-008. Recall #Z-711/719-4.
MANUFACTURER Cobe BCT, Incorporated, Lakewood, Colorado.
RECALLED BY Manufacturer, by letter January 19, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 227 instruments.
REASON The adjustment screw which provides for proper tubing
occlusion and rotor tension was not assembled correctly and
may cause delivery of the anticoagulant at levels greater
than expected.

_______________
PRODUCT Hardware Trigger Board, part #0005-1030, for console in BVS
5000 Bi-ventricular Support System. Recall #Z-732-4.
CODE Console serial numbers 1121-1150, 1154, 1157-1161 and two
hardware trigger boards serial numbers 0992-E0009 and 0992-
E0010 which were not in consoles and put into spare parts
kits.
MANUFACTURER Electronic Associates, Inc. (EAI), West Long Branch, New
Jersey (Hardware Trigger board part #0005-1030);
Abiomed, Inc., Danvers, Massachusetts (Bi-Ventricular
Support Console part #0005-9007).
RECALLED BY Abiomed, Inc., Danvers, Massachusetts, by letter June 16,
1993. Firm-initiated recall ongoing.
DISTRIBUTION California, Illinois, Ohio, Missouri, New York, North
Carolina, Pennsylvania, Wisconsin, Austria.
QUANTITY 15 boards in console and 2 in spare parts kits.
REASON Capacitors in the hardware trigger board may short causing
the board to fail and the console to shut down.

_______________
PRODUCT Baxter Pharmaseal Aquamatic K-Modules, Model K-20 Series; a
small reservoir/heater/pump used to warm and circulate water
for a heat therapy pad:
(a) Catalog #S64N00100
(b) Catalog #S64N02000

-5- (c) Catalog #S11185-FRE
(d) Catalog #S64N02500
(e) Catalog #S64N03000
(f) Catalog #S64N03500
(g) Catalog #S64N04000. Recall #Z-733/739-4.
CODE All serial numbers starting with 10001S through 14470S
serial numbers: T00671 through T01170, T01321 through
T01820, T03091 through T03390, T04891 through T05190, T06191
through T06490, T06991 through T07590, T08205 through
T08534, T09035 through T09334, T10335 through T11144, T12145
through T12644, T13680 through T16759.
MANUFACTURER (a) Baxter Healthcare, Savage, Maryland (plant is now
closed).
(b) Baxter Healthcare, Largo, Florida.
(c) Bront Machinery, Dayton, Ohio. (sub-assembly
manufacturer, most responsible for problem).
RECALLED BY Baxter Healthcare Corporation, Convertors/Custom
Sterile/Pharmaseal Division, Deerfield, Illinois, by letter
November 15, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 11,903 units were distributed.
REASON After repeated use, the solder affixing the heating element
to the reservoir could fail, and could result in the
potential for the heating element to come into contact with
the device's plastic housing, potentially causing smoke
and/or melting of the plastic housing.

_______________
PRODUCT Inflation Pro II Model IP 9001, used to inflate
cardiovascular balloon catheters for PCTA procedures.
Recall #Z-745-4.
CODE All lots with the first two digits of the of number reading
"2A" through "2L" and "3A" through "3L".
MANUFACTURER Edwards Critical-Care, Interventional Cardiology Division,
Irvine, California.
RECALLED BY Manufacturer, by letter January 24, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 86,002 units.
REASON The balloon may oversize or rupture due to a defective
gauge.

_______________
PRODUCT Disposable Vinyl Examination Gloves, 100 pieces per carton.
Recall #Z-747-4.
CODE LCL Taiwan & Company, Taipei, Taiwan.
RECALLED BY C&K Manufacturing and Sales Company, Westlake, Ohio, by
letter June 28, 1993, followed by telephone June 29, 1993.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 1,469 cases were distributed.

-6-REASON The gloves contain more holes than allowed by FDA's
Compliance Policy Guide 7424.31.

_______________
PRODUCT Tooth Conditioner Gel, in 3 ml plastic syringes.
Recall #Z-749-4.
CODE All product manufactured since 1986 to October 1993.
MANUFACTURER L.D. Caulk, Division of Dentsply International, Milford,
Delaware.
RECALLED BY Manufacturer, by letter May 3, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 922 units.
REASON The syringe may split or explode when the user attempts to
eject the contents (34% phosphoric acid gel) or the tip may
clog which could cause the product to shoot out of the tip
of the syringe in an uncontrolled manner when the clog is
overcome.

_______________
PRODUCT Thora-Seal I, Plastic Underwater Chest Drainage System.
Recall #Z-750-4.
CODE Lot #632104 or lower.
MANUFACTURER Sherwood Medical Company, St. Louis, Missouri.
RECALLED BY Manufacturer, by letter October 13, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 19,500 units.
REASON When water is added to the fill line marked on the bottle,
the opening at the bottom of the water seal tube may not be
completely immersed in water as required, which may result
in air entering the chest cavity.

_______________
PRODUCT Medfusion Model 2001 and 2010 Syringe Infusion Pumps.
Recall #Z-751/752-4.
CODE Serial numbers 9900 to 13400.
MANUFACTURER Medfusion, Inc., Duluth Georgia.
RECALLED BY Manufacturer, by letter on or about November 2, 1992. Firm-
initiated recall complete.
DISTRIBUTION Nationwide, Canada, England, Germany.
QUANTITY 3,500 units were distributed.
REASON Use of incorrect inserts (screws) placed in the bottom
housing of the infusion pump which may become loose
completely detached, causing the pump to fail.

_______________
PRODUCT Sci-O-Tech Full Electric and Semi-Electric Adjustable
Hospital Beds, Catalog 1000 series and semi-electric
adjustable hospital beds and the electric control boxes for
the hand controls on the beds, which raise and lower head
and foot sections, and the entire bed:

-7- (a) Semi-Foot Section, Part #9541125
(b) Electric Foot Section, Part #9541120
(c) 2-Motor Control Box, Part #5685552
(d) 3-Motor Control Box, Part #5685554.
Recall #Z-759/762-4.
CODE (a) Part #9541125; (b) Part #9541120; (c) Part #5685552;
(d) Part #5685554.
MANUFACTURER Sci-O-Tech, Inc., Lancaster, Pennsylvania.
RECALLED BY Manufacturer, by letter. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 15,000 beds were distributed.
REASON Beds foot and head sections may raise or lower suddenly
without warning.

_______________
PRODUCT Cobe Optima HVRF (Hollow Fiber Oxygenators), Catalog
#050212-000. Recall #Z-763-4.
CODE 02Z7000.
MANUFACTURER Cobe Cardiovascular, Inc., Arvada, Colorado.
RECALLED BY Manufacturer, by telephone beginning February 25, 1994,
followed by letter March 1, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Michigan, New York, New Jersey, North Dakota, Oklahoma,
Ohio.
QUANTITY 112 units.
REASON A defect exists in the heat exchangers which may make them
prone to premature failure under severe pulsatile flow
conditions, resulting in small water to blood leaks.

_______________
PRODUCT Shampaine Surgical Tables: (a) Model 4900B, Battery Powered
Surgical Tables; (b) Model 4900E, Mains Operated Surgical
Tables. Recall #Z-790/791-4.
CODE All manufactured between October 1992 through December 1993.
MANUFACTURER MDT Diagnostic Company, North Charleston, South Carolina.
RECALLED BY Manufacturer, by letter February 4, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, Greece, Hong Kong, Korea.
QUANTITY 289 units.
REASON A potential manufacturing defect by a component supplier may
result in the tables failing to function as intended.

_______________
UPDATE HAID Universal Bone Plate (UBP) System, Recall #Z-755/758-4,
which appeared in the May 11, 1994 Enforcement Report should
read:
(d) Part #650005-005, Catalog No. S/L 50-4551 (Evaluation
Set).

-8-
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Raichem Calcium Reagent Standard Reagent found in Raichem
Calcium Reagent In-vitro Diagnostic Kits:
(a) Catalog #84104; (b) Catalog #84105; (c) Catalog #85188;
(d) Catalog #85210. Recall #Z-726/729-4.
CODE All kits with lot numbers 54106, 55010, 06011, 58022.
MANUFACTURER Reagents Applications, Inc., San Diego, California.
RECALLED BY Manufacturer, by telephone June 15, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION California, Idaho, Illinois, Massachusetts, Nebraska, New
York, Wisconsin, Puerto Rico, Israel, Mexico.
QUANTITY 119 vials were distributed.
REASON Defective closures (vial stoppers) are uncoated on the
standard and may lead to leaching of contents causing
inaccurate test results.

_______________
PRODUCT Versacath Introduction Trays, for introduction of Versacath
Mainline Central Venous Catheter Systems Catalog #C1-IT.
Recall #Z-746-4.
CODE Lot #05042 and 10071.
MANUFACTURER Menlo Care, Inc., Menlo Park, California.
RECALLED BY Manufacturer, by telephone followed by letter June 28, 1993.
Firm-initiated recall complete.
DISTRIBUTION New York, Florida.
QUANTITY Firm estimates none remains on the market.
REASON A crack may develop in the side arm of the hemostasis valve
with sideport component and the mainline catheter system,
which could result in back bleeding.

_______________
PRODUCT Promotional Materials for the Electone brand Hearing Aids.
Recall #Z-764-4.
CODE All codes.
MANUFACTURER Electone, Inc., Longwood, Florida.
RECALLED BY Manufacturer, by letter May 28-29, 1993. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 197 dispensers.
REASON Advertising and promotional materials contain misleading
statements that could result in consumers having unrealistic
expectations about the products benefits.

-9-

END OF ENFORCEMENT REPORT FOR MAY 18, 1994. BLANK PAGES MAY FOLLOW.
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