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
08/08/1995
ENFORCEMENT REPORT FOR 08/09/1995
August 9, 1995 95-32
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Cooked, Ready-To Eat Crabmeat in 8-16 ounce plastic
containers. Recall #F-717-5.
CODE None. Product manufactured between April 17 to June 27,
1995.
MANUFACTURER John W. Dunbar Company, West Tremont, Maine.
RECALLED BY Manufacturer, by telephone June 27, 1995. Firm-initiated
recall complete.
DISTRIBUTION Massachusetts, Rhode Island, Maine.
QUANTITY Firm estimates none remains on the market.
REASON The product is contaminated with Listeria monocytogenes.
_______________
PRODUCT Kroger brand Deluxe Butter Pecan Ice Cream and Texas Gold
Butter Pecan Ice Cream in 1/2 gallon cartons.
Recall #F-718-5.
CODE NOV 95YE.
MANUFACTURER The Kroger Company, Cincinnati, Ohio.
RECALLED BY Manufacturer, by letters sent June 2 and 7, 1995. Firm-
initiated recall complete.
DISTRIBUTION South Carolina, Georgia, Alabama, Tennessee, Kentucky.
QUANTITY 1,440 half gallon cartons were distributed.
REASON The product contains undeclared peanuts.
_______________
PRODUCT Fancy Extra Large Pecan Pieces BRS (Butter Roasted Salted)
in bulk 30 pound cases. Recall #F-719-5.
CODE Lot 554.
MANUFACTURER Young Pecan Company, Florence, South Carolina.
RECALLED BY Manufacturer, by telephone. Firm-initiated recall complete.
QUANTITY 551 30-pound cases were distributed; firm estimates none
remains on the market.
REASON Peanuts in pecan pieces.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Zetov brand Supersnacks in 2.5 ounce packages:
(a) Falafel Flavored Snacks;
(b) BBQ Flavored Snacks;
(c) Taco Flavored Snacks. Recall #F-697/699-5.
CODE Production code on cellophane bags: 5004 and 50043;
Code on master shipping carton - 6253 or 6254.
MANUFACTURER OSEM Food Industries, Ltd., Petach-Tikva, Israel.
RECALLED BY Zetov, Inc., Brooklyn, New York, by telephone and by letter
April 6, 1995. Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 2,202 cases were distributed; firm estimates none remains on
the market.
REASON Product is contaminated with Salmonella tennessee.
_______________
PRODUCT Osem brand Bissli Snacks, in 2.5 ounce packages:
(a) Falafel Flavored Snacks; (b) BBQ Flavored Snacks;
(c) Taco Flavored Snacks. Recall #F-710/712-5.
CODE Production code on cellophane bags - 5005, 50043 or 41983;
Code on master shipping carton - 6253, 6254, 5968, 6250.
MANUFACTURER OSEM Food Industries, Ltd., Petach-Tikva, Israel.
RECALLED BY OSEM USA, Inc., Englewood Cliffs, New Jersey, by telephone
and by letter April 5, 1995. Firm-initiated recall ongoing.
DISTRIBUTION California, Florida, Illinois, Louisiana, Massachusetts,
Maryland, Michigan, Minnesota, North Carolina, New Jersey,
New York, Pennsylvania, Texas.
QUANTITY 2,654 cartons were distributed; firm estimates that little
or no product remains on the market.
REASON Product is contaminated with Salmonella.
_______________
PRODUCT Kellogg's brand Apple Jacks Cereal, in 15 ounce cartons.
Recall #F-715-5.
CODE Carton #K-0292D with "better if used before" date of SEP 11,
1995 MB009.
MANUFACTURER Kellogg's, Inc., Memphis, Tennessee.
RECALLED BY Kellogg's USA, Battle Creek, Michigan, by telephone October
28, 1994, followed by fax and press release. Firm-initiated
recall complete.
DISTRIBUTION Arkansas Georgia, Mississippi, Tennessee, Missouri, Texas.
QUANTITY 79,170 cartons were distributed.
REASON Product contained undeclared almonds.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Hi-C Fruit Punch in 8.45 ounce aseptic containers packaged
in (a) Three pack containers; and (b) Variety pack
containers, containing 3 fruit punch packages and six
packages of 2 other flavors. Recall #F-713/714-5.
CODE (a) MAR1996HC (container), MAR1996HCD (case); (b) 1st line:
01914XXXXXX; 2nd line: Contains at some point MAR1996.
MANUFACTURER Coca-Cola Foods, Highstown, New Jersey.
RECALLED BY Coca-Cola Foods, Division of The Coca-Cola Company, Houston,
Texas, by visit on June 29, 1995. Firm-initiated recall
complete.
DISTRIBUTION Massachusetts, New York, Pennsylvania.
QUANTITY (a) 1,680 packages;(b) 9,600 packages were distributed.
REASON Product is contaminated with yeast.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Just One Per Day, plus any other private labels listed on
the carton of Phenylpropanolamine 75 mg, OTC, Time Released
Caplets for Weight Loss, packed in cartons containing 24 or
48 caplets each. Recall #D-228-5.
CODE Lot #53D16J4 EXP 6/96.
MANUFACTURER Davis Pharmaceuticals, Norwich, Connecticut.
RECALLED BY The Reese Chemical Company, Cleveland, Ohio, by letter July
19, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 112,292 individual caplets were distributed.
REASON Product does not meet dissolution specifications.
_______________
PRODUCT Dilantin Kapseals, 30 mg, Rx antiepileptic drug.
Recall #D-229-5.
CODE Lot #27224L EXP 2/96.
MANUFACTURER Warner-lambert Company, Lititz, Pennsylvania.
RECALLED BY Manufacturer, by letters dated June 23, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Product does not meet dissolution specifications.
_______________
PRODUCT Bulk Medical Oxygen USP. Recall #D-230-5.
CODE Lot numbers: 141-0149-95-02-A and 145-0149-95-02-B.
MANUFACTURER Air Liquide America Corporation, Ingleside, Texas.
RECALLED BY Air Liquide America Corporation, Houston, Texas, by letters
dated June 6, 1995, followed by visits. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY Firm estimates none remains on the market.
REASON Current good manufacturing practice deficiencies.
_______________
PRODUCT Rifadin I.V. (rifampin for injection), 600 mg, Rx for the
treatment of tuberculosis. Recall #D-231-5.
CODE Lot 025A EXP 7/97.
MANUFACTURER Gruppo Lepetit S.p.A., Lainate, Italy.
RECALLED BY Marion Merrell Dow, Inc., Kansas City, Missouri, by
telephone June 23, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 18,237 vials were distributed.
REASON Lack of assurance of sterility.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Hydrosol Anesthetic Medicated Ointment, packed in 1 ounce
tubes and in 1 pound jars, OTC used for the treatment of
minor skin irritations. Recall #D-227-5.
CODE RAES, WCJA, WBGA on 1 pound jars; P-3, P-4, P-5 on 1 ounce
tubes.
MANUFACTURER Hydrosol Manufacturing Company, Miamitown, Ohio.
RECALLED BY Manufacturer, by letter July 25, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 7,452 tubes and 348 jars of the product were
distributed.
REASON Current good manufacturing practice deficiencies.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Red Blood Cells. Recall #B-492-5.
CODE Unit #12FZ16639.
MANUFACTURER American National Red Cross, Charlotte, North Carolina.
RECALLED BY Manufacturer, by letters dated February 24, 1995. Firm-
initiated recall complete.
DISTRIBUTION North Carolina, Switzerland.
QUANTITY 1 unit.
REASON Blood products, which were collected from a donor with a
medical history of cancer, were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-494-5.
CODE Unit #32GQ91533.
MANUFACTURER American National Red Cross, Madison, Wisconsin.
RECALLED BY Manufacturer, by letters dated July 13 or 14, 1994. Firm-
initiated recall complete.
DISTRIBUTION Missouri, Switzerland.
QUANTITY 1 unit.
REASON Blood products, which were collected from a donor with a
medical history of cancer, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-498/499-5.
CODE Unit #s (a) 53LZ18012, (b) 50LZ18012.
MANUFACTURER American National Red Cross, Baltimore, Maryland.
RECALLED BY Manufacturer, by letters dated February 18, 1994. Firm-
initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit of each component.
REASON Blood products, which were collected from a donor who had
traveled to an area designated as endemic for malaria and
had taken prophylactic antimalarial medications, were
distributed.
_______________
PRODUCT Source Plasma. Recall #B-500-5.
CODE Unit #23921214.
MANUFACTURER Binary Associates, Inc., Colorado Springs, Colorado.
RECALLED BY Manufacturer, by fax October 28, 1992. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON A unit of Source Plasma, which tested repeatedly reactive
for antibody to the hepatitis C virus encoded antigen (anti-
HCV), was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-501/503-5.
CODE Unit numbers: (a) 29107-9179, 29116-7728, 29113-7652, 9106-
3643; (b) 29106-3643, 29116-7728; (c) 29107-9179, 29116-
7728, 29113-7652, 29106-3643.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by letters dated May 24, 25, 31, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Illinois, Nevada, Switzerland.
QUANTITY (a) 4 units; (b) 2 units; (c) 4 units.
REASON Blood products, which were incorrectly tested for antibody
to human immunodeficiency virus types 1 and 2 (anti-HIV) or
hepatitis B surface antigen (HBsAg), were distributed.
_______________
PRODUCT Platelets. Recall #B-508-5.
CODE Unit #11FG16601.
MANUFACTURER American National Red Cross, St. Louis, Missouri.
RECALLED BY Manufacturer, by telephone on March 31, 1994. Firm-
initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 1 unit.
REASON Blood product, which was manufactured from Whole Blood that
was exposed to unacceptable storage temperatures, was
distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
===================
_______________
PRODUCT Granulocytes-Platelets, Pheresis. Recall #B-247-5.
CODE Unit #17GS65645.
MANUFACTURER American Red Cross Blood Services, St. Paul, Minnesota.
RECALLED BY Manufacturer, by telephone October 31, 1994, followed by
letter November 3, 1994. Firm-initiated recall complete.
DISTRIBUTION Minnesota.
QUANTITY 1 unit.
REASON Blood product, which was improperly tested for antibody to
human immunodeficiency virus types 1 and 2, (anti-HIV) when
an incorrect conjugate dispenser was used to add conjugate,
was distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-493-5.
CODE Unit #12FZ16639.
MANUFACTURER American National Red Cross, Charlotte, North Carolina.
RECALLED BY Manufacturer, by letters dated February 24, 1995. Firm-
initiated recall complete.
DISTRIBUTION North Carolina, Switzerland.
QUANTITY 1 unit.
REASON Blood products, which were collected from a donor with a
medical history of cancer, were distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-495-5.
CODE Unit #32GQ91533.
MANUFACTURER American National Red Cross, Madison, Wisconsin.
RECALLED BY Manufacturer, by letters dated July 13 or 14, 1994. Firm-
initiated recall complete.
DISTRIBUTION Missouri, Switzerland.
QUANTITY 1 unit.
REASON Blood products, which were collected from a donor with a
medical history of cancer, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma;
(d) Recovered Plasma. Recall #B-504/507-5.
CODE Unit numbers: (a) 29108-5721, 29108-5789, 29117-5514,
29116-6810, 29115-9953; (b) 29108-5721, 29108-5789; (c)
29117-5514, 29116-6810, 29115-9953; (d) 29108-5721, 29108-
5789.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by letters dated May 24, 25, 31, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Illinois, Nevada, Switzerland.
QUANTITY (a) 5 units; (b) 2 units; (c) 3 units; (d) 2 units.
REASON Blood products, which were incorrectly tested for antibody
to human immunodeficiency virus types 1 and 2 (anti-HIV) or
hepatitis B surface antigen (HBsAg), were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Apnea Monitors (multiple models). Recall #Z-544-5.
CODE Units with unprotected (exposed pin style) lead wires and
unprotected patient cables.
MANUFACTURER Medical Data Electronics, Arleta, California.
RECALLED BY Manufacturer, by letter on or about April 10, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 2,244 units.
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 Apnea Monitors (multiple models) and Patient
Cables/Electrodes. Recall #Z-935/936-5.
CODE Apnea monitors with unprotected (exposed pin style) lead
wires and unprotected patient cables.
MANUFACTURER Nihon Kohden America, Inc., Irvine, California.
RECALLED BY Manufacturer, by letters sent beginning June 30, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, The Bahamas, Canada.
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 UTS brand of the PGS-3000 Portable Pulsed Galvanic
Stimulator, designed to aid in the healing of soft tissue
injuries. Recall #Z-943-5.
CODE All serial numbers.
MANUFACTURER Universal Technology Systems, Inc., (UTS), Jacksonville,
Florida.
RECALLED BY Manufacturer, by letter March 23, 1994. Firm-initiated
field correction complete.
DISTRIBUTION Nationwide and Switzerland.
QUANTITY Approximately 3000-3500 units were distributed; firm
estimated that all units were corrected.
REASON The "positive-negative" switch was labeled in reverse order
on the "hot" stamped plastic lower shell housing the
devices.
_______________
PRODUCT Non Rigid Plastic Protective Sleeves and Promotional
Material. Products are accessories for the Ultra-Cam I
Intraoral Camera System and the Ultra-Cam II Intraoral
Camera System: (a) Part #DV-SSU, Non Rigid Plastic
Protective Sleeves; (b) Part #DVSSUII (1994 Promotional
Material) or V-200006 (1995 Promotional Material) Rigid
Plastic Sleeves; (c) Part #DV-SSUIIP (1995 Promotional
Material), Optically Clear Rigid Sterile Sleeves, in 100
count boxes.
Recall #Z-1024/1026-5.
CODE All units.
MANUFACTURER Dental Vision Direct, Inc., Carrolton, Texas.
RECALLED BY Manufacturer, by letter June 6, 1995. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
REASON Device labeling describes the sleeves as sterile, however,
the sleeves are not required to be sterile.
_______________
PRODUCT Diagnost 76A Plus, Multipurpose Fluoroscopic and
Radiographic System with Fluoroscopic Footswitch 9804 763
10002. Recall #Z-1027-5.
CODE All code.
MANUFACTURER Philips Medezine Systeme, Hamburg, Germany.
RECALLED BY Philips Medical Systems, Shelton, Connecticut, by conducting
field corrections per Field Change Order number FCO 00 261
001, dated 9/94. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 94 units were distributed; 75 units had been corrected at
time of recall initiation.
REASON Incorrect wiring of the footswitch causes unintended
exposure when the switch is grounded on contact and the DSI
(spot film) is in place.
_______________
PRODUCT Philips' Mobile C-Arm Fluoroscopic Diagnostic X-ray System
with Mobile Viewing Station: (a) Model BV25;
(b) Model BV25 N/HR; (c) Model BV25 FAM N/HR;
(d) Model BV26. Recall #Z-1031/1034-5.
CODE BV25 System: Serial numbers CF 1162 through CF 1692, CP
0467 through CP 1704, CA 0001 through CA 0581, CE 0001
through CE 0082, any serial number starting with CM, any
serial number with letters CF less than serial number 1162,
and any serial number with letters CP less than serial
number 0467; BV26 System: Serial numbers CB 0001 through CB
0137, and CD 0001 through CD 0024.
MANUFACTURER Philips Medical Systems, Best, Netherlands.
RECALLED BY Philips Medical Systems, Shelton, Connecticut, by
implementing field change order numbers 07 383 001/002 and
07 387 001. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY (a) 450 units; (b) 50 units were distributed.
REASON The trolley wheel may bend or break causing the trolley
(cart that contains the x-ray controls and mobile viewing
station) to tilt or topple over.
_______________
PRODUCT Tomascan CX and CX/S Computed Tomography System, a third
generation tomography system which measures different tissue
characteristics and displays the image with analytical data
on a video display screen:
(a) Tomoscan CX CT System with software ver. 3.0A, 3.1A,
3.1B and 3.1C;
(b) Tomoscan CX/S CT System with software ver. 3.0A, 3.1A,
3.1B, and 3.1C. Recall #Z-1035/1036.
CODE All lots.
MANUFACTURER Philips Medical Systems Nederlands, Best, Netherlands.
RECALLED BY Philips Medical Systems, Shelton, Connecticut, by field
change order (FCO) 08 703 004 dated August 1993, and
FCO # 08 703 006 October 1994. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY Thomoscan CX and CX/s: 135 systems; Thomoscan CX and CX/s
with Fast Reconstruction or Plus Option: 55 units.
REASON Patient data entry function errors may occur.
_______________
PRODUCT Bard Urine Meter Foley Tray. Device consists of a tray with
foley catheter connected to a urine meter.
Recall #Z-1042-5.
CODE Lot #76HE2619 EXP 5/97.
MANUFACTURER Productos Para El Cuidado De La Salud, Sonora, Mexico.
RECALLED BY C.R. Bard, Inc., Covington, Georgia, by telephone October
31, 1994, followed by letter November 15, 1994. Firm-
initiated field correction complete.
DISTRIBUTION Alabama.
QUANTITY 1 case containing 10 units was distributed.
REASON One unknown case in the lot was not sterilized.
_______________
PRODUCT Acrysof Intraocular Lens distributed in Acrypak packages.
Recall #Z-1045-5.
CODE All serial numbers in the AcryPak containers. Units
packaged in the "Wagon Wheel" case are not involved in the
recall.
MANUFACTURER Alcon Laboratories, Inc., Fort Worth, Texas.
RECALLED BY Alcon Laboratories, Inc./CILCO, Huntington, West Virginia,
by letters sent beginning April 3, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Opacities are observed in the lens after the lens had been
surgically implanted.
_______________
PRODUCT Rusch Sterile Catheter Irrigation Tray w/Piston Syringe, a
flexible tubular device that is inserted through the urethra
and used to pass fluid to or from the urinary tract.
Recall #Z-1044-5.
CODE Catalog #68895, Serial numbers: 3230A/C, 3231A/C, 3253A/c,
3256A/c, 3196A/C.
MANUFACTURER Rusch, Inc., Duluth, Georgia.
RECALLED BY Manufacturer, by letter Septemer 23, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 43,900 trays were distributed; frim estimates none remains
on the market.
REASON There is a possibility of tray lid seal(s) failing,
therefore compromising the sterility of the device.
_______________
PRODUCT 4.5 "Imagecath" Coronary Angioscope, Model COV45, indicated
for the pre-procedural or post-procedural visualization and
diagnosis of vascular disease within the peripheral and
coronary vessels. Recall #Z-1046-5.
CODE Lot numbers: 4G059, 4H1118, 4I1267, 4J1414, 4L1627, 4L1640,
5A0089.
MANUFACTURER Edwards Interventional Cardiology Division, Irvine,
California.
RECALLED BY Manufacturer, by letter dated February 22, 1995. Firm-
initiated recall complete.
DISTRIBUTION Arizona, California, Florida, Georgia, Illinois, Louisiana,
Michigan, Minnesota, New Jersey, New York, Ohio,
Pennsylvania, Tennessee, Texas, Wisconsin, Washington, D.C.,
France, Germany, India, Japan.
QUANTITY 360 units were distributed; no defective units are expected
to remain in commerce.
REASON Inter-lumenal tear causes leakage resulting in over-
inflation of the occlusion cuff.
_______________
PRODUCT Inflow Valve Conduit of the HeartMate Implantable Pneumatic
Left Ventricular Assist System (IP LVAS), for use in
patients on the cardiac transplant list, as a temporary
mechanical circulatory support for nonreversible left
ventricular failure as a bridge to cardiac transplantation.
Recall #Z-1047-5.
CODE All codes and serial numbers.
MANUFACTURER Thermo Cardiosystems, Inc. (TCI), Woburn, Massachusetts.
RECALLED BY Manufacturer, by letters of June 7, 1995, and July 14, 1995,
and by telephone between May 31, 1995 and June 23, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 281 units were distributed.
REASON Abrasion between the inflow valve conduit and the metal
graft cage portions of the device may result in the
development of holes in the valve portion of the device.
_______________
PRODUCT Ceiling Suspension unit 4153 240 0640 used in conjunction
with SL Series Multi-Energy Linear Accelerator, for use in
radiotherapy with ceiling suspension unit 4513 240 0640:
(a) Localizer/Simulator; (b) SL75-5; (c) SL75-20.
Recall #Z-1048/1050-5.
CODE (a) All serial numbers lower than 10.010, and all K series;
(b) Serial numbers 300-364; (c) Serial numbers 200-274.
MANUFACTURER Philips Medical Systems Radiotherapy, West Sussex, England.
RECALLED BY Philips Medical Systems, Shelton, Connecticut, by visit on
or about August 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 2 systems; (b) 5 systems; (c) 9 systems were
distributed.
REASON A weld failure on the ceiling suspension unit may cause the
ceiling suspension to fall part way to the floor.
_______________
PRODUCT (a) Ponsky "Pull" Peg Tray, 28 Fr; (b) Bard Guidewire System
PEG, 28 Fr; (c) PEG Support Tray. Recall #Z-1051/1053-5.
CODE (a) Catalog No. 000730, Lot Nos. 881E0231, 88KE0105,
88LE0080;
(b) Catalog No. 000731, Lot Nos. 88JE0181, 88LE0081;
(c) Catalog No. 000300, Lot Nos. 88GE0096,
88LE0285, 88CF0218, 88HE0189, 88AF0180, 88IE0233,
88AF0290, 88JE0381, 88BF0199.
MANUFCTURER Bard Interventional Products, Mentor, Ohio.
RECALLED BY Bard Interventional Products, C.R. Bard Inc., Products Div.,
Tewksbury, Massachusetts, by FeDex letter May 22, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,866 units.
REASON The tray seals may not be adequately sealed, therefore
compromising the sterility of the devices.
_______________
PRODUCT Bi-Ventricular Support System 5000, a mechanical circulatory
support system for use in patients suffering from
postcardiotomy ventricular dysfunction. Recall #Z-1054-5.
CODE Catalog #0005-000. All serial numbers.
MANUFACTURER Abiomed, Inc., Danvers, Massachusetts.
RECALLED BY Manufacturer, by letter June 21, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 230 units.
REASON High levels of electrostatic discharge may cause
inappropriate initiation of the fixed rate back-up system or
othr anomalous console behavior. The console may start
pumping in emergency system, a "System Failure" message may
appear on the display panel, or it may cease pumping.
_______________
PRODUCT Chest Drain In-Line Connector used in 5 models of the
Atrium-Water Seal Chest Drain:
(a) Single Collection Drain Model numbers 2002-000, 2002-
100, 2002-070; (b) Dual Collection Drain Model numbers 2020-
000, 2020-003; (c) Blood Recovery Chest Drain, Model numbers
2050-000, 2050-100, 2050-070; (d) Dual Blood Recovery Chest
Drain, Model numbers 2052-000; (e) Multipurpose Chest Drain,
Model numbers 2060-000, 2060-100. Recall #Z-1063-5.
CODE Model #s Lot #s.
(a) 2002-000, 2002-100, 2002-070 502065-000
502091-000
502098-000
502123-000
502125-000
502133-000
502134-000
502068-100
502104-100
502127-100
(b) 2020-000, 2020-003 520089-000
520130-000
520131-003
(c) 2050-000, 2050-100, 2050-070 550082-000
550083-070
550095-000
550096-100
550101-070
550121-100
550119-000
550141-000
(d) 2052-100 552079-000
552108-000
(e) 2060-000, 2060-100 560085-000
560105-000
560106-100
MANUFACTURER Atrium Medical Corporation, Hudson, New Hampshire.
RECALLED BY Atrium Medical Corporation, Hudson, New Hampshire, by letter
June 22, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international
QUANTITY 39,372 units were distributed.
REASON The affected lots were assembled with a defective silicone
o-ring which may allow room air to leak into the drainage
tube between the patient and the chest drain.
_______________
PRODUCT Optional Tract Mounting Light Systems manufctured with
support arms from lot G0741AW:
(a) Polaris Surgical Light System;
(b) Gemini Surgical Lights;
(c) Examiner 10 Lights. Recall #Z-1069/1071-5.
CODE Systems manufactured with support arms from lot G074AW.
MANUFACTURER American Sterilizer Company, Montgomery, Alabama.
RECALLED BY American Sterilizer Company, Erie, Pennsylvania, by
telephone December 29, 1994. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 75 units were distributed. None remain in commerce.
REASON There is a potential for the lights to fall due to failure
of the support arms from lot G074AW to meet tensile strength
specifications.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Exactech brand 6.5 x 40 mm Titanium Bone Screw, Catalog
#SC65-40. Recall #Z-923-5.
CODE Lot #824, Serial numbers: QLJV-QLJZ, QLKA-QLKC, QLKG, QLKI,
QLKP.
MANUFACTURER Exactech, Inc., Gainesville, Florida.
RECALLED BY Manufacturer, by telephone April 16, 1993, followed by
letter November 9, 1993. Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 21 screws were distributed; firm estimaes none remains on
the market.
REASON Bone screw may fracture.
_______________
PRODUCT SR1 Estradiol, an in-vitro diagnostic for the quantitative
determination of estradiol in human serum or heparinized
plasma without extraction. Recall #Z-1043-5.
CODE Lot #1238 EXP 8/95.
MANUFACTURER Biodata S.P.A., Rome, Italy.
RECALLED BY Biochem Immunosystems (U.S.), Inc., Allentown, Pennsylvania,
by letter dated May 11, 1995, and by telephone on May 11 and
12, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 365 boxes (32 cartridges per box) were distributed; firm
estimaed that 50 boxes remained on market at time of recall
initiation.
REASON There is a potential for aberrant (low) patient results,
which may be significantly contrary to the expected clinical
condition of the female patient.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT Bulk Beef Pro 6SBH Feedlot Premix, Category I Type B
Medicated Article containing lasalocid/melengestrol acetate
for increased weight gain, feed efficiency and suppression
of estrus in heifers. Recall #V-038-5.
CODE Lot #PB1005-3.
MANUFACTURER The Miller Company, Omaha, Nebraska.
RECALLED BY Manufacturer, by telephone February 13 and 14, 1995. Firm-
initiated recall complete.
DISTRIBUTION Iowa.
QUANTITY 2 tons were distributed.
REASON Product is superpotent.
SEIZURES:
=================================================================
_______________
PRODUCT Lubricated condoms (94-718-522 et al).
CHARGE Adulterated - The articles are class III medical devices for
which there is no approved premarket approval application in
effect; and, the articles' purity falls below that which
they purport and are represented to possess. Misbranded -
The articles' packaging fails to bear a label containing the
name and place of business of the manufacturer, packer, or
distributor; and no notices respecting the devices were pro-
vided to FDA as required.
LOCATION Handy Care, Paramount, California.
FILED May 8, 1995; U.S. District Court for the Central District of
California; Civ. #CV95-3074 RSWL; FDC #67077.
SEIZED June 8, 1995 - goods valued at approximately $173,126.
_______________
PRODUCT Raw Frozen Whole Tuna (95-714-095).
CHARGE Adulterated - The article consists in part of decomposed
tuna.
LOCATION Sea-Land Service, Inc., Long Beach, California.
FILED June 26, 1995; U.S. District Court for the Central District
of California; Civ. #95-4257 KN(JRx); FDC #67095.
SEIZED July 20, 1995 - goods valued at approximately $10,000.
_______________
PRODUCT Condensed Milk (LECHERA leche condensada azucarada) (95-741-
379).
CHARGES Misbranded - The article's label lacks an English language
statement of identity, declaration of net quantity of
contents, and statement of ingredients prominently and
conspicuously placed. The label further lacks: the name
and place of business of the manufacturer, packer, or
distributor in the required size of type; and, the required
nutrition information.
LOCATION La Bodega, Inc., Chicago, Illinois.
FILED July 18, 1995; U.S. District Court for the Northern District
of Illinois, Eastern Division; Civ. #95C 4148; FDC 67098.
SEIZED July 20, 1995 - goods valued at approximately $2,692.
_______________
PRODUCT Dinnerware (94-718-522 et al).
CHARGE Adulterated - The articles contain lead, an unsafe food
additive.
LOCATION Mid-America Tablewares, Inc., Eau Claire, Wisconsin.
FILED May 23, 1995; U.S. District Court for the Western District
of Wisconsin; Civ. #95C 0357C; FDC #67086.
SEIZED June 8, 1995 - goods valued at approximately $173,126.
END OF ENFORCEMENT REPORT FOR AUGUST 9, 1995. BLANK PAGES MAY
FOLLOW.
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