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.
ENFORCEMENT
10/18/1995
ENFORCEMENT REPORT FOR 10/18/95
October 18, 1995 95-42
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Jewel Vanilla Sandwich Cookies, in 20 ounce packages.
Recall #F-025-6.
CODE All lots.
MANUFACTURER Sugar Kake, Tonawanda, New York.
RECALLED BY Ripon Foods, Ripon, Wisconsin, by letter September 13, 1995.
Firm-initiated recall complete.
DISTRIBUTION Indiana, Illinois, Iowa, Michigan.
QUANTITY 146,495 packages were distributed.
REASON Product contains undeclared peanut butter.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Ming River brand Canned Sliced Mushrooms, Net Weight 92
ounces. Recall #F-009-6.
CODE MRS-2/950104.
MANUFACTURER JeenHaut Foodstuffs Industries, Penang, Malaysia.
RECALLED BY Summit Import Corporation (SIC), New York, New York, by
letter September 25, 1995. Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 1,000 cartons (6 cans per carton) were distributed.
REASON Product contains staphylococcal enterotoxin.
_______________
PRODUCT Corn Bread/Pan Maiz, 9 ounces, in aluminum dish with rigid
plastic cover. Recall #F-010-6.
CODE Date of manufacture on or about 7/1/95. (Firm uses the date
of manufacture and an expiration date of one week after
manufacture as a coding system).
MANUFACTURER Caribe Portuguese Bakery, Newark, New Jersey.
RECALLED BY Manufacturer, by telephone on or about July 5, 1995. Firm-
initiated recall complete.
DISTRIBUTION New Jersey, New York.
QUANTITY Approximately 300 corn bread cakes were distributed; firm
estimates none remains on the market.
REASON Product contained undeclared FD&C Yellow No. 5.
_______________
PRODUCT Various ice cream, sherbet, and punch base mix products
packaged in quart, 1/2 gallon and 3 gallon containers:
(a) Buttered Pecan Ice Cream 1/2 & 3 gallon
(b) Butter Brickle Ice Cream 1/2 & 3 gallons
(c) Mint Chip Ice Cream 1/2 & 3 gallon
(d) Cookies & Cream Ice Cream 1/2 & 3 gallon
(e) Caramel Toffee Crunch Ice Cream 1/2 & 3 gallon
(f) Mackinac Island Fudge Ice Cream 1/2 & 3 gallon
(g) French Vanilla Ice Cream 1/2 & 3 gallon
(h) Praline Pecan Ice Cream 1/2 & 3 gallon
(i) Peach Ice Cream 1/2 & 3 gallon
(j) Lime Sherbet quart, 3 gallon
(k) Lime Punch Base Mix quart
(l) Lemon Punch Base Mix quart. Recall #F-011/022-6.
CODE All lots.
MANUFACTURER Freers Ice Cream Company, Inc., Elkhart, Indiana.
RECALLED BY Manufacturer, by visits conducted the week of November 1,
1994. Firm-initiated field correction (relabeling)
complete.
DISTRIBUTION Indiana and Michigan.
QUANTITY Firm estimates none remains on market.
REASON Product contained undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Regular Pepsi Cola, in 12 ounce cans, packed 12 and 24 cans
per case. Recall #F-024-6.
CODE MAR0496 on cans and cardboard overwrap,0900PY06045 through
1030PY06045 on cardboard overwrap.
MANUFACTURER Pepsi Cola Corporation, Piscataway, New Jersey.
RECALLED BY Pepsi Cola Corporation, Valhalla, New York, by visit on or
about June 20, 1995. Firm-initiated recall complete.
DISTRIBUTION New Jersey, Pennsylvania, Maryland, Virginia.
QUANTITY 643 cases (24 cans per case) were distributed.
REASON Product had an off odor and taste.
-2- RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT NutraLab Oral Chelate Tablets, in 300 tablet bottles, and
promotional booklets. Recall #D-004-6.
CODE All lots.
MANUFACTURER Nature's Products, Inc., Davie, Florida.
RECALLED BY NutraLab Company, Springfield, Missouri, by letter dated
September 29, 1995. FDA-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 150 bottles with booklets were distributed.
REASON Product marketed with unapproved therapeutic claims.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Dilantin brand Phenytoin Sodium Injection, 100 mg, in 2 ml
vials. Recall #D-005-6.
CODE Lot #00815P, N0071-4488-47, EXP 11/96.
MANUFACTURER Warner Lambert Company, Park-Davis Sterile Products
Division, Rochester, Michigan.
RECALLED BY The Parke-Davis Division of Warner Lambert Company, Morris
Plains, New Jersey, by letter August 11, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and Virgin Islands, Trinidad, Jamaica.
QUANTITY 15,416 packages were distributed.
REASON Product discoloration resulting from use of incorrect
stopper.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Platelets. Recall #B-012-6.
CODE Unit #40LZ02226.
MANUFACTURER American Red Cross Blood Services, Peoria, Illinois.
RECALLED BY Manufacturer, by telephone on May 1, 1995. Firm-initiated
recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON Blood product, which tested initially reactive for the
antibody to the immunodeficiency virus type 1 (anti-HIV-1),
and was not retested in duplicate, was distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Femoral Stems:
(a) Mallory Head Interlok w/NTS Femoral Stems
Part No. Size
11-104505 5.0 mm
11-104507 7.0 x 140 mm
11-104509 9.0 x 150 mm
11-104511 11.0 x 160 mm
-3- 11-104513 13.0 x 170 mm
11-104515 15.0 x 180 mm
(b) Bi-Metric Interlok w/NTS Femoral Stems - Type NC
11-162301 7.0 x 115 mm
11-162302 9.0 x 125 mm
11-162303 11.0 x 135 mm
11-162304 13.0 x 145 mm
11-162305 15.0 x 155 mm
11-162306 17.0 x 165 mm
(c) Bi-Metric Interlok w/NTS HK/NK Femoral Stems
11-162380 9.0 x 30 x 140
11-162381 9.0 x 40 x 140
11-162382 11.0 x 35 x 145
11-162383 11.0 x 45 x 145
11-162384 11.0 x 55 x 145
11-162385 13.0 x 40 x 150
11-162386 13.0 x 50 x 150
(d) Bi-Metric Interlok kw/NTS Femoral Stems - Type C
11-162387 7 x 115
11-162388 9 x 125
11-162389 11 x 135
11-162390 13 x 135
11-162391 15 x 155
11-162392 17 x 165
(e) Integral Interlok Centralizer w/NTS Femoral Stems
11-162649 9 x 125
11-162651 11 x 135
11-162652 13 x 145
11-162653 15 x 155
11-162654 17 x 165. Recall #Z-1064/1068-5.
CODE All lots and all codes manufactured by Biomet, Inc.
MANUFACTURER Biomet, Inc., Warsaw, Indiana.
RECALLED BY Manufacturer, by telephone November 12-13, 1992. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 10,044 stems were produced.
REASON Complaints of hip stem fractures.
_______________
PRODUCT Micro-Lite Phototherapy Unit, Model PTL-68, used for
treatment or prevention of hyperbilirubinemia in neonates.
Recall #Z-1140-5.
CODE All units where the last 5 digits of the serial number are
between 00001 and 00692.
MANUFACTURER Air Shields, Inc., Hatboro, Pennsylvania.
RECALLED BY Manufacturer, by letter September 4, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 597 units were distributed.
REASON Device has the potential to cause overheating of the infant.
-4- _______________
PRODUCT Inflation Handle Subassembly in K05 Custom kits:
(a) Catalog #K05-00633;(b) Catalog #K05-60251;
(c) Catalog #K05-00503A; (d) Catalog #K05-00543.
Recall #Z-1141/1144-5.
CODE Lot numbers: 297109, 291723, 291681, 291688.
MANUFACTURER Merit Medical Systems, Inc., South Jordan, Utah.
RECALLED BY Manufacturer, by telephone February 8, 1995. Firm-initiated
recall complete.
DISTRIBUTION Arkansas, Arizona, Florida, Georgia, Kentucky, Texas,
Virginia.
QUANTITY 435 units were distributed; firm estimates none remains on
the market.
REASON The inflation handle subassembly had an inadequate amount of
adhesive, which could result in handle separation during
clinical use.
_______________
PRODUCT Liquid Bicarbonate Dialysate Concentrate, in 1 gallon
plastic containers:
(a) Formula BC-101 Dial Medical Supply;
(b) Formula BC-102 Dial Medical Supply;
(c) Formula BC 103 Dial Medical Supply.
Recall #Z-1152/1154-5.
CODE All lots.
MANUFACTURER Dial Medical of Florida, Division of Cobe Renal Care, Inc.,
DeLand, Florida.
RECALLED BY Manufacturer, by letter mailed July 21, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimated that 3,000 cases remained in commerce at time
of recall initiation.
REASON Possible bacterial contamination.
_______________
PRODUCT Johnson and Johnson Medical Observed Central Station which
constantly monitors a patients' various vital signs at a
central station at another location from the patient's room:
(a) Model #8775; (b) Model #8776. Recall #Z-1155/1156-5.
CODE All serial numbers.
MANUFACTURER Pacific Communications, Santa Ana, California.
RECALLED BY Johnson and Johnson Medical, Inc., Tampa, Florida, by
telephone on April 5, 1995 followed by telephone, and by
letter April 6, 1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 36 units were distributed.
REASON Incorrect message may be displayed at Central Station.
-5- _______________
PRODUCT Medic 5 Defibrillators and DC200 Defibrillators:
(a) Medic 5 Defibrillators, Serial Nos. 29948, 29949,
29951, 29952, 29954, 29955, 29957, 30014, 30016, 30076,
30078, 30079, 30081, 30083 to 30097, 30224, 30246, 30247,
30254, 30268, 30271, and 30275.
(b) DC200 Defibrillators, Serial Nos. 30985 to 30987, 30990
to 30995, 30997, 30998, 31017. Recall #Z-005/006-6.
CODE (a) Lot No. 925229, (b) Lot No. 910634.
MANUFACTURER Burdick, Inc., Milton, Wisconsin.
RECALLED BY Manufacturer, by telephone and by fax August 14, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION (a) Alaska, Florida, Georgia, Indiana, Michigan, Missouri,
North Carolina, New Jersey, New York, Ohio, Tennessee,
Virginia, Washington state, Italy, Korea, India, Pakistan,
Germany; (b) California, Florida, Indiana, Kentucky,
Louisiana, North Carolina, New York, Pennsylvania, Texas.
QUANTITY (a) 35 units; (b) 12 units were distributed.
REASON The devices contain a diode which might fail during the
charging of energy at the higher joule selections causing
the device not to charge the selected defibrillation energy.
_______________
PRODUCT Cardioplegia Stainless Steel Cooling Coil, used for
cardiopulmonary surgery to reduce the temperature of the
heart. Recall #Z-007-6.
CODE Part #103574-01; Lot numbers: S015331010 and S015331020.
MANUFACTURER Baxter Healthcare Corporation of Puerto Rico, Anasco, Puerto
Rico.
RECALLED BY Bentley Division, Baxter Healthcare Corporation, Irvine,
California, by letter April 20, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,546 units were distributed.
REASON Metal particulate matter has been observed within the tubing
sets during priming.
_______________
PRODUCT Vivalink Defibrillator Electrode, Model 9010.
Recall #Z-008-6.
CODE Survivalink lot numbers: 10170A.1.1/10170A.1.2 (all lots),
Dade Code Y080995-11.
MANUFACTURER Katecho, Des Moines, Iowa.
RECALLED BY Survivalink Corporation, Minneapolis, Minnesota, by letter
August 31, 1995. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 750 units were distributed.
REASON The electrode may tear during removal from plastic liner
packaging.
-6- _______________
PRODUCT 3M Red Dot Neonatal Monitoring Electrode, Catalog #2269T, a
disposable silver/silver chloride electrode for ECG
monitoring. Recall #Z-010-6.
CODE Lot numbers: 023, 024, 025.
MANUFACTURER 3M Company Valley Plant, Valley, Nebraska.
RECALLED BY 3M Company, St. Paul, Minnesota, by letter dated September
1, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 112,500 electrodes were distributed.
REASON There may be difficulty in, or inability to, obtain ECG
trace and respiration signal.
_______________
PRODUCT 0.025" Stiff Shaft Guidewire, contained within the RediGuard
and TaperSeal Intra-Aortic Balloon Catheter Insertion Trays.
Recall #Z-011-6.
CODE RediGuard IAB Percutaneous Introducer Kit Catalog numbers:
060-0606, 060-0607, 060-0608, 060-0609, 060-0596, 0600597,
060-600, 060-0601, 060-0598, 060-0599, 060-0602, 060-0603,
060-0239, 060-0265, 060-0254, 060-0251, 060-0257, 060-0258.
TaperSeal IAB and Percutaneous Introducer Kit Catalog
numbers: 030-0156, 030-0157, 030-0152, 030-0153, 030-0134,
030-0135, 030-0160, 030-0161, 030-0610, 060-0611, all lot
numbers.
MANUFACTURER Lake Region Manufacturing, Inc., Chaska, Minnesota.
RECALLED BY St. Jude Medical, Cardiac Assist Division, Chelmsford,
Massachusetts, by visit and by letter on or about July 25,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 9,400 units were distributed.
REASON The guidewire may break if blockage or excessive resistance
is met, which may require surgical intervention.
_______________
PRODUCT Welch Allyn MicroTymp II Printer/Charger, for use with the
MicroTymp 2 portable tympanometric handle component, for the
diagnoses of otitis media:
(a) Model 71170; (b) Model 71171; (c) Model 71172;
(d) Model 71174. Recall #Z-012/015-6.
CODE Serial numbers 308100 through 401841.
MANUFACTURER Welch Allyn, Inc., Skaneateles Falls, New York.
RECALLED BY Manufacturer, by letter mailed on or about September 1,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,603 units were distributed.
REASON Product contain a potentially defective electrical component
which could result in a potentially hazardous malfunction in
the device's operation and may cause the device to catch on
fire.
-7- _______________
PRODUCT Mentor Leaf-Valve Saline Breast Implants:
(a) Saline-filled (smooth surface shell) Mammary Prosthesis
with Mentor Leaf Valve;
(b) Siltex Saline-Filled (textured surface shell) Mammary
Prosthesis with Mentor Leaf Valve. Recall #Z-017/018-6.
CODE Catalog
Numbers Size Lot Numbers
(a) 350-1815M 150cc 114818
350-1820M 175cc 113010, 114683, 115605, 118224
350-1825M 200cc 105112, 105552, 112503, 113014,
114820, 118225
350-1830M 225cc 102656, 102956, 102957, 105928,
110176, 110177, 112480, 112481,
113016, 114287, 114689, 114821,
102958
350-1835M 250cc 102959, 104999, 105929, 110178,
112504, 113018, 114824, 118226,
118227
350-1840M 275cc 103182, 105001, 105113, 105114,
105407, 105408, 105409, 107513,
110179, 110180, 110471, 113011,
113240, 114290, 114291, 116450,
118228, 118229
350-1845M 300cc 101271, 101272, 103173, 105930,
107368, 107512, 107755, 112505,
112506, 113950, 116455, 116456
350-1850M 325cc 102047, 103176, 103665, 105000,
105413, 106708, 109752, 109753,
110175, 111033, 113012, 113546,
113547, 114292, 115608, 116461,
116462, 116463, 118230, 118231
350-1860M 375cc 106703, 106704, 107756, 110173,
111032, 112135, 113023, 114293,
116464, 118232, 118906
350-1870M 425cc 100882, 102955, 107369, 110174,
113009
350-1880M 475cc 100883, 112789
350-1930MT 225cc 103667, 113013
350-1940MT 275cc 104804, 110474, 112493, 115307,
115345, 115616
350-1950MT 325cc 102052, 104805, 112494, 115617
Catalog Numbers ending with "M" are round in
style, and Catalog Numbers ending with "MT" are
oval in style.
(b) Catalog
Numbers Sizes Lot Numbers
354-2810M 125cc 105587, 115622, 116328, 116446
354-2815M 150cc 109776, 113550, 117350
354-2820M 175cc 105588, 105589, 105944, 109468,
111537, 113971
-8- 354-2830M 225cc 110488, 112156, 114297, 118685
354-2835M 250cc 105676, 105677, 105945, 109200,
109469, 110207, 113549, 115351,
118253
354-2840M 275cc 109202, 110654, 111526, 113972,
116329
354-2845M 300cc 117836
354-2850M 325cc 110655, 111528, 111529, 113973,
117351, 118686
354-2860M 375cc 110656, 111767, 112157, 118687
354-2870M 425cc 109201, 110489, 115352
354-2880M 475cc 105678, 105947.
MANUFACTURER Mentor H/S, Inc., Irving, Texas.
RECALLED BY Manufacturer, by letter dated September 1, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 9,997 units were distributed; firm estimated that 10 percent
of implants remained on market at time of recall initiation.
REASON The valve channels may open and the implant deflate when
autoclaved prior to surgery as previously instructed.
_______________
PRODUCT IOLAB Intraocular Lenses, Model LI41IU. Recall #Z-019-6.
CODE Sterilization lot #101994, Control numbers 3743 through
3761.
MANUFACTURER Iolab Corporation, Claremont, California.
RECALLED BY Manufacturer, by telephone March 24, 1995, followed by
letter March 27, 1995. Firm-initiated recall complete.
DISTRIBUTION Alabama, Arizona, Iowa, Illinois, Michigan, Missouri, North
Carolina, New York, Oklahoma, Pennsylvania, Tennessee,
Texas.
QUANTITY 18 lenses were distributed.
REASON The 18.0 diopter lenses and cases are labeled as being 22.0
diopter lenses for control numbers 3743 through 3761
(sterilization lot #101994).
_______________
PRODUCT IPI Single Use Ventilator Circuits with Swivel Elbow
Component:
(a) Product Code 1578, Vent-Flex 4" Flex Tube (15mm I.D. x
15mm I.D.) with Swivel Elbow and Cap without Suction Port
and with 22mm I.D. x 15mm O.D. Connector;
(b) Product Code 1579, Vent-Flex 4" Flex Tube (15mm I.D. x
15mm I.D.) with Swivel Elbow and Cap with Suction Port and
Cap and with 22mm I.D. x 15mm O.D. Connector;
(c) Product Code 1580, Vent-Flex 4" Flex Tube (15mm I.D. x
15mm I.D.) with Swivel Elbow and Cap with Luer Lock Port and
Cap and with 22mm I.D. x 15mm O.D. Connector;
(d) Product Code 1581, Vent-Flex 4" Flex Tube (15mm I.D. x
15mm I.D.) with Swivel Elbow and Cap with MDI Port and Cap
and with 22mm I.D. x 15mm O.D. Connector;
-9- (e) Product Code 6003, Custom Ventilator Circuit 7200
Bennett Dome Cast;
(f) Product Code 6412A, Home Care Manifold with 4" Spiroflex
Tube with Swivel Elbow with Suction Port, Cap & 22mm I.D. x
15mm O.D. Connector - Ambu;
(g) Product Code 6427, Portable Volume Ventilator Circuit
for Portable Ventilator Compatible with (Life Products)
LP - 6;
(h) Product Code 6428, Portable Volume Ventilator Circuit
for Portable Ventilator Compatible with (Life Products) LP -
3, LP - 4, & LP - 5, (Life Care) PLV 100 & PLV 102 and
(Bear) 33;
(i) Product Code 6428S, Portable Volume Ventilator Circuit
for Portable Ventilator Compatible with (Life Products) LP -
3, LP - 4, & LP - 5, (Life Care) PLV 100 & PLV 102;
(j) Product Code 6429, Portable Volume Ventilator Circuit
for Portable Ventilator Compatible with (Life Products) LP -
3, LP - 4, & LP - 5, (Life Care) PLV 100 & PLV 102 and
(Bear) 33, and with Supply Line Exhalation Adapter
compatible with Puritan Bennett #2800 and 2801;
(k) Product Code 6527, Breathing Circuit with Manifold Ambu;
(l) Product Code 6528, Breathing Circuit without Manifold
Ambu;
(m) Product Code 6677, Elbow Swivel without Suction Ports;
(n) Product Code 6678, Swivel Elbow with Suction Port and
Cap;
(o) Product Code 6679, Swivel Elbow, 15mm O.D. x 15mm I.D. x
22mm O.D. with Luer Lock Port and Cap;
(p) Product Code 6681, Elbow - Swivel with MDI Port.
Recall #Z-022/037-6.
CODE All lots.
MANUFACTURER IPI Medical Products, Division of Inhalation Plastics, Inc.,
Chicago, Illinois.
RECALLED BY Manufacturer, by telephone beginning August 16, 1995,
followed by fax and letter. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 59,430 units were distributed.
REASON The swivel elbow component can crack under stress, thereby
rendering the device unusable.
_______________
UPDATE Recall #Z-1095-5, Sonoline SI-450D Ultrasound Imaging System
with Version 1.1.5 Software Installed, which appeared in the
August 16, 1995 Enforcement Report as a Class III recall has
been reclassified as Class II.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Model 2680 Rev 11.2 Program Disk for Model 2850 Prescriptor
System. Recall #Z-009-6.
CODE Serial numbers range 5502-7433.
MANUFACTURER Cardiac Pacemakers, Inc., St. Paul, Minnesota.
-10- RECALLED BY Manufacturer, by voice mail message August 24, 1995. Firm-
initiated field correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY 157 units were distributed.
REASON The STAT SHOCK and STAT PACE functions were inadvertently
reassigned to other locations on the keyboard by the new
disk, Revision 11.2.
_______________
PRODUCT Dobbhoff PEG Kit (Percutaneous Endoscopic Gastrostomy)
"PULL" Style. Recall #Z-016-6.
CODE Reorder #8884-751911, Lot #970212.
MANUFACTURER Biosearch Medical Products, Inc., Sommerville, New Jersey.
RECALLED BY Sherwood Medical Company, St. Louis, Missouri, by letters
dated September 14, 1995. Firm-initiated recall complete.
DISTRIBUTION South Carolina, Florida, Australia.
QUANTITY 54 kits were distributed.
REASON Some packages contained a guide wire instead of a looping
wire.
_______________
PRODUCT Arrow Intra Aortic Balloons. Recall #Z-020-6.
CODE Lot numbers: 032495 through 040795, IAB-04230, IAB-04240,
IAB 04240S, plus "J" versions (Japan only).
MANUFACTURER Arrow International, Inc., Everett, Massachusetts.
RECALLED BY Arrow International, Inc., Reading, Pennsylvania, by letters
on August 18, 1995, and September 18, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,136 units were distributed; firm estimated that 568 units
remained on market at time of recall initiation.
REASON The product's outer catheter body may be oblique or
flattened in shape possibly causing excess bleeding between
the catheter and the hemostasis sheath introducer as well as
between the catheter and the cuff seal.
_______________
PRODUCT USCI Super 7 (7 FR) PTCA Guiding Catheter Multipurpose
Curve, used to provide a pathway through which coronary
dilatation systems are introduced. Recall #Z-021-6.
CODE Item #030091, Lot #08CF0153.
MANUFACTURER USCI Division, C.R. Bard, Inc., Billerica, Massachusetts.
RECALLED BY Manufacturer, by telephone August 15, 1995, followed by
letter September 1, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Georgia, Nebraska, Alabama, Pennsylvania.
QUANTITY 12 units were distributed.
REASON The label identifies the product as a Super 7 with
Multipurpose curve; however, the product enclosed in the
packages is a Femoral Left Curve.
-11-
END OF ENFORCEMENT REPORT FOR OCTOBER 18, 1995. BLANK PAGES MAY
FOLLOW.
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