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
04/19/1995
Recalls and Field Corrections: Foods -- Class I -- 04/19/1995
April 19, 1995 95-16
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT (a) French Vanilla Ice Cream; (b) Strawberry Cheesecake Ice
Cream packaged in 3 gallon cardboard bulk containers.
Recall #F-608/609-5.
CODE All bulk product manufactured in 1994 and in 1995 until
January 27, 1995.
MANUFACTURER Hagan Ice Cream Company, Uniontown, Pennsylvania.
RECALLED BY Manufacturer, by issuing a "Products Information Notice" on
February 1, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, Maryland, West Virginia, Ohio, Kentucky,
Virginia.
QUANTITY Undetermined.
REASON Products contain undeclared eggs.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Caviar (Sevruga fish and Beluga fish) packed in blue colored
metal containers, net weight 2.2 kg. Recall #F-607-5.
CODE All coded and uncoded product imported since 9-30-94.
MANUFACTURER Geros, Moscow, Russia.
RECALLED BY Caspian Star Caviar, Inc., Brooklyn, New York, by telephone
January 4, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Florida, New York.
QUANTITY 1,932 pounds of Sevruga Caviar and 430 pounds of Beluga
Caviar were distributed.
REASON Product contains borates, a nonpermitted food additive.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Sam's Choice Cola in 2 liter bottles. Recall #F-610-5.
CODE All lots in retail stores and warehouses.
MANUFACTURER Cott Beverages USA, Inc., Columbus, Georgia.
RECALLED BY Manufacturer, by telephone December 13, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 1.3 million cases (8 bottles per case) were distributed.
REASON Product is mislabeled. The ingredient statement on the cola
label is actually the ingredient statement for the firm's
orange drink.
_______________
UPDATE Recall #F-593/595-5, Various tomatoes packed in olive oil
which appeared in the April 5, 1995 Enforcement Report
should read: (b) Sun Dried Tomato Pesto in Olive Oil, 8.5
ounces under the Trader Joe and Bella Sun Luci labels.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Dilantin (extended phenytoin sodium capsules, USP),
Kapseals, 100 mg, in bottles of 100, used in the treatment
of seizures. Recall #D-112-5.
CODE Lot #05634FA EXP 2/96.
MANUFACTURER Warner Lambert Company, Fajardo, Puerto Rico.
RECALLED BY Parke Davis, Division of Warner Lambert Company, Morris
Plain, New Jersey, by letter January 26, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 40,242 bottles were distributed.
REASON Product does not meet dissolution specifications through
expiration date.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Robichem AC formulated products containing 100 mg
Guaifenesin and 10 mg codeine Phosphate and 3.5 percent
alcohol per each 5 ml, in 4 ounce, pint, and gallon
containers. Products are antitussive expectorants, under
the LuChem Pharmaceuticals, and Goldline labels.
Recall #D-113-5.
CODE Lot numbers: 7132, 7594, 7595, 7596, 7705, 7706, 7925,
7947, 7948, 7987, 8080, 8261.
MANUFACTURER H.N. Norton Company, Shreveport, Louisiana.
-2- RECALLED BY Manufacturer, by letter March 1, 1995. Firm-initiated
recall complete.
DISTRIBUTION Alabama, Arkansas, Arizona, California, Florida, Georgia,
Illinois, Louisiana Maryland, Michigan, Mississippi,
Oklahoma, Texas, Virginia, Washington State.
QUANTITY 202,403 4-ounce bottles; 68,963 pint bottles, and 3,617
gallon containers were distributed.
REASON Product does not meet specifications through expiration
date.
_______________
PRODUCT Congess SR, packaged in 100 capsule bottles, Rx
decongestant. Recall #D-114-5.
CODE 4011352 EXP 7/1/96.
MANUFACTURER Fleming and Company, Fenton, Missouri.
RECALLED BY Manufacturer, by letter dated March 13, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 705 bottles were distributed.
REASON Stability data does not support expiration date.
_______________
PRODUCT Carbamide Peroxide Otic Drops 15 ml, packed in glass
bottles, under the Clay Park label and the following private
labels: Longs Ear Drops 1/2 fluid ounce (15 ml),
distributed by Longs Drug Stores Inc.; Valumed Ear Drops 1/2
fluid ounce (14.79 ml) Distributed by H.L. Moore, Drug
Exchange; Treasury Ear Drops 1/2 fluid ounce (15 ml),
distributed by Thrift Drug Inc.; Thrifty Ear Drops 0.5 fluid
ounce (15 ml), distributed by Thrifty Drug Stores a
Division of Thrifty Corporation; Select Brand Ear Wax
Removal System Net. Cont. 0.5 fluid ounce (14.8 ml),
distributed by Select Brand Distributors; Fays Quality Ear
Drops 1/2 fluid ounce (14.79 ml), distributed by Fay's Drug
Stores, Div. of Fay's Inc.; CVS Ear Wax Removal System 0.5
fluid ounce (14.8 ml), distributed by Consumer Value Stores,
Division of Melville Corp.; Rite Aid Ear Drops 1/2 fluid
ounce (15 ml), distributed by Rite Aid Corporation; The
Medicine Shoppe Ear Drops Earwax Removal Aid Net. Cont. 1/2
fluid ounce (14.79 ml), Distributed by Medicine Shoppe
Int'l; PayLess Ear Drops Carbamide Peroxide Net Cont. 1/2
ounce (15 ml), distributed by Payless Drugs Stores, Inc.;
Goldline Ear Drops 1/2 fluid ounce (15 ml), distributed by
Goldline Laboratories; Arbor Ear Drops 0.5 fluid ounce (15
ml), distributed by Arbor Drugs, Inc.; REVCO Ear Drops Net.
Wt 1/2 ounce (15 ml), distributed by Revco D.S. Inc.; Valu
Rite Ear Drops 1/2 fluid ounce (15 ml), distributed by
McKesson Corp.; Medalist Ear Drops 1/2 fluid ounce (15 ml),
distributed by McKesson Corp.; K&B Ear Wax Removal System,
Net Cont. 0.5 fluid ounce (14.8 ml). distributed by Super
Distributors, Inc., Osco Ear Drops 1/2 fluid ounce (14.8
ml), distributed by Osco Drug. Recall #D-115-5.
-3- CODE Lot # EXP Lot # EXP Lot # EXP
S427 4/95 T879 9/95 V754 6/96
S691 5/95 T882 9/95 V931 7/96
S913 6/95 U302 11/95 V937 7/96
T106 7/95 U429 12/95 W126 8/96
T438 8/95 U895 2/96 W237 8/96
T465 8/95 V098 4/96 W366 9/96
T751 9/95 V582 5/96 W730 10/96
T843 9/95 V586 5/96 W944 11/96.
MANUFACTURER Clay Park Laboratories, Inc., Bronx, New York.
RECALLED BY Manufacturer, by letter April 10, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Guyana, Virgin Islands.
QUANTITY Approximately 961,882 bottles were distributed.
REASON Subpotency.
_______________
PRODUCT Loxitane (Loxapine Succinate) Capsules 10 mg base, in
bottles of 100, 1000 and unit dose 10 strips, Rx
tranquilizer. Recall #D-116-5.
CODE Control numbers: 372-366 EXP 12/98 (100s),
372-367 EXP 12/98 (1000); 372-368 EXP 12/96 (unit dose
strips).
MANUFACTURER Lederle Laboratories, Inc., Division of American Home
Products, Pearl River, New York.
RECALLED BY Manufacturer, by letter March 31, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 14,715 packages were distributed.
REASON Marginally subpotent.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Platelet, Pheresis. Recall #B-220-5.
CODE Unit #12T80373.
MANUFACTURER American Red Cross, Charlotte, North Carolina.
RECALLED BY Manufacturer, by telephone followed by letter dated October
4, 1994. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit.
REASON Platelets, Pheresis, which was labeled with an incorrect
expiration date, was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-223/225-5.
CODE Unit #40GT58385.
MANUFACTURER American Red Cross Blood Services, Peoria, Illinois.
RECALLED BY Manufacturer, by letters of December 14 and 16, 1994. Firm-
initiated recall complete.
DISTRIBUTION Illinois, California.
QUANTITY 1 unit of each component.
-4- REASON Blood products, which tested initially reactive for antibody
to human immunodeficiency virus type 1 (anti-HIV-1) and were
not retested in duplicate, were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-230-5.
CODE Unit #59G12938.
MANUFACTURER American Red Cross Blood Services, Petoskey, Michigan.
RECALLED BY American Red Cross Blood Services, Flint, Michigan, by
letter September 28, 1993. Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit.
REASON Blood product, collected from a donor who had taken
antimalarial prophylaxis and traveled to an area designated
as endemic for malaria, was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma, Liquid; (c) Whole
Blood. Recall #B-231/233-5.
CODE Unit numbers: (a) A10471; (b) A10471; (c) M56469.
MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City,
Missouri.
RECALLED BY Manufacturer, (a&b) by letters dated May 12 and 13, 1994;
(c) by letter dated January 16, 1995. Firm-initiated recall
complete.
DISTRIBUTION Arizona, Missouri.
QUANTITY 1 unit of each component.
REASON Blood products, collected from donors with a history of
hepatitis, were distributed for transfusion and for further
manufacturing into injectable or non-injectable products.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Red Blood Cells. Recall #B-219-5.
CODE Unit #KH09226.
MANUFACTURER Central California Blood Center, Fresno, California.
RECALLED BY Manufacturer, by letter July 27, 1994. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product which was exposed to unacceptable storage
temperatures was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-221-5.
CODE Unit numbers: 7524780, 7524796.
MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City
Missouri.
RECALLED BY Manufacturer, by telephone February 14, 1994. Firm-
initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 2 units.
-5- REASON Blood products, stored under unmonitored temperature
conditions, were distributed.
_______________
PRODUCT Blood Bank Quality Assurance (BBQA II) Testing Reagents.
Recall #B-222-5.
CODE Lot numbers: BBK-532, BBK-533. Both expired 1/21/95.
MANUFACTURER Baxter Diagnostics, Inc., Miami, Florida.
RECALLED BY Manufacturer, by letter mailed on or about December 15,
1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 385 kits were distributed; firm estimates none remains on
market.
REASON Blood Bank Assurance II Testing Regents which were found to
be hemolyzed were distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-226-5.
CODE Unit #9308896.
MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical
Center, Cincinnati, Ohio.
RECALLED BY Manufacturer, by letter March 7, 1994. Firm-initiated
recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit.
REASON Blood product, collected from a donor with a reported
history of cancer, was distributed.
_______________
PRODUCT Platelets, Pheresis. Recall #B-227-5.
CODE Unit #53P46623.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY Manufacturer, by letter dated December 12, 1993. Firm-
initiated recall complete.
DISTRIBUTION Washington, D.C.
QUANTITY 1 unit.
REASON Unlicensed blood product was distributed interstate.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-228/229-5.
CODE Unit #47G91031.
MANUFACTURER American Red Cross Blood Services, Galesburg, Illinois.
RECALLED BY American Red Cross Blood Services, Peoria, Illinois, (a) by
telephone December 6, 1994, followed by letter December 7,
1994; (b) by telephone December 6, 1994, followed by letter
December 9, 1994. Firm-initiated recall complete.
DISTRIBUTION (a) Iowa; (b) California.
QUANTITY 1 unit of each component.
REASON Blood components which tested initially reactive for
hepatitis B surface antigen (HBsAg), and were not retested
as required, were distributed.
-6- RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Renasol Bicarbonate Concentrate, Product #BC-1-R, in drums
labeled as containing 11.60 Kg of sodium chloride and 32.45
kg of sodium bicarbonate. Recall #Z-557-5.
CODE Lot #06Y407.
MANUFACTURER Renal Systems, Division of Minntech Corporation, Plymouth,
Minnesota.
RECALLED BY Manufacturer, by telephone December 30, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Indiana, New York, Oklahoma, Rhode Island.
QUANTITY 90 drums.
REASON A tare weight was not used during the filling process
shorting the drum by 2.8 Kg. of sodium chloride. This would
result in a sodium level 2% lower and a chloride level 4.3%
lower in dialysate solutions prepared from this concentrate.
_______________
PRODUCT Borning and Hill-Rom "Stabilet" Radiant Infant Warmers, used
to achieve/maintain adequate neonate body temperatures:
(a) Borning Stabilet, Model 200; (b) Borning Stabilet, Model
300; (c) Hill-Rom Stabilet, Model 2000/3000;
(d) Hill-Rom Stabilet, Model 2200/3200;
(e) Hill-Rom Stabilet, Model 1500;
(f) Hill-Rom Stabilet, Model 1250. Recall #Z-594/599-5.
(Model numbers may be followed by A, B, or C.)
CODE All heater elements with the date code of 0294 which
indicates the date of manufacture.
MANUFACTURER Baume Corporation, Grasonville, Maryland (heater element).
RECALLED BY Hill-Rom Company Inc., Batesville, Indiana, by sending
Technical Bulletin, dated June 9, 1994. Firm-initiated
field correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY 341 heater elements were distributed.
REASON Pieces of hot quartz glass can fall from the device's heater
element.
_______________
PRODUCT Compass Model VM 200 Patient Gas Volume Monitor, designed
for use with the Newport "Wave" Mechanical Ventilator.
Recall #Z-637-5.
CODE Serial numbers: 9403VM063, 9403VM067, 9403VM068, 9403VM069,
9403VM070, 9403VM085, 9403VM056, 9404VM101, 9404VM102,
9404VM103, 9404VM104.
MANUFACTURER Newport Medical Instruments, Inc. (NMI), Costa Mesa,
California.
RECALLED BY Manufacturer, by letters of June 27, 1994, and August 1,
1994. Firm-initiated field correction complete.
DISTRIBUTION Texas, California, Florida, South Africa.
QUANTITY 10 units were distributed. No unrepaired units remain in
commerce.
REASON Product contains defective software.
-7- _______________
PRODUCT Olympus Heat Probe Unit (HPU) Instruction Manuals. Heat
probe unit is used as a cauterizer during surgical
procedures in the gastrointestinal tract. Recall #Z-643-5.
CODE Catalog #33100. All units.
MANUFACTURER Olympus America, Inc., Rio Rancho, New Mexico;
Shirakawa Olympus Co., Ltd., Japan.
RECALLED BY Olympus America, Inc., Lake Success, New York, by letter
sent on or about December 30, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Canada, South America.
QUANTITY 3,160 units were distributed nationwide. Total units
distributed internationally is undetermined.
REASON The internal water lines may be contaminated with
microorganisms.
_______________
PRODUCT Software Versions 2000-9A, 2000-10, and 2000-11 for the
Model 2000 Controller Microprocessor used with the Model
1000 series and Model 2000 series Reverse Osmosis Water
Purification Systems for dialysis applications.
Recall #Z-644-5.
CODE Software distributed with 133 controllers within the serial
number range of 5026 through 5232.
MANUFACTURER Continental Water Systems, San Antonio, Texas.
RECALLED BY Manufacturer, by letters of January 24, 1995, and February
20, 1995. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide, Australia, Mexico.
QUANTITY 133 units.
REASON Software revisions were made but never validated, which
could possibly lead to patient exposure to heavy metals and
bacteria.
_______________
PRODUCT Bacteria Filter with Green Tube for Expiratory Pressure
Transducer, a sub-assembly used with the Servo Ventilator
300 device. Recall #Z-645-5.
CODE Order #6079979. Batch numbers: 60P100, 08P101, 09P102,
10P101, 11P102, 12P101, 02R101, 02R103TP31/V, 03R102TP31/V,
05R100TP31/V.
MANUFACTURER Siemens-Elema AB, Life Support Systems, Division Solna,
Sweden.
RECALLED BY Siemens Medical Systems (SMS), Inc., Danvers, Massachusetts,
by letter February 10, 1994, July 6, 1994, and November 29,
1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON The tube connector, which allows the green tube to be placed
in the expiratory channel of the Servo Ventilator 300, has
been determined to have been improperly manufactured and can
potentially flex and occlude when subjected to heat and
humidity, which is present in the exhaled gases of
ventilator patients.
-8- _______________
PRODUCT Components of the Sensormedics Model 3100A HFO Neonatal
Ventilator: (a) Patient Circuit Body Part #766895, (b)
Bellows/Watertrap, Part #766897. Recall #Z-646-5.
CODE Lot numbers: (a) 110794, 111094, 111494; (b) 110294,
111194.
MANUFACTURER Contech Plastics, Yorba Linda, California (elbow fitting).
RECALLED BY Sensormedics Corporation, Yorba Linda, by letter dated
January 13, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 99 boxes of patient circuit body and 84 boxes of the
Bellows/Watertrap were distributed; FDA estimates little
product remains on the market.
REASON The elbow fitting for the patient circuit and bellows
assembly is totally or partially occluded due to a molding
defect, which may cause increased air volume/pressure to the
patient and water back-up into the patient circuit.
_______________
PRODUCT Cordis Webster Fixed-Curve Electrophysiology Catheters.
Recall #Z-647-5.
CODE Sterilization lot numbers 834 through 857.
MANUFACTURER Cordis Webster, Inc., Baldwin Park, California.
RECALLED BY Manufacturer, by letter on or about December 30, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 5,638 catheters were distributed.
REASON The sterility of the medical device may be compromised as
evidenced by loss of package integrity.
_______________
PRODUCT Fluoroplastic & Platinum Pistons, Fluoroplastic & Stainless
Steel Pistons and Fluoroplastic Wire Pistons:
1. Fluoroplastic & Platinum Piston, 0.5x4.0 mm,
Product No. 11-56221;
Fluoroplastic & Platinum Piston, 0.5x4.25 mm,
Product No. 11-56222;
Fluoroplastic & Platinum Piston, 0.5x4.50 mm
Product No. 11-56223;
Fluoroplastic & Platinum Piston, 0.5x4.75 mm
Product 11-56224;
2. Fisch Platinum Piston, 0.4x6.00 mm
Product No. 11-56234;
Fisch Platinum Piston, 0.5x6.00 mm
Product No. 11-56235;
Fisch Platinum Piston, 0.6x6.00 mm
Product 11-56236;
3. Fluoroplastic & Platinum, 0.6x4.00 mm
Product No. 11-56255;
Fluoroplastic & Platinum, 0.6x4.25 mm
Product No. 11-56256;
Fluoroplastic & Platinum, 0.6x4.50 mm
Product No. 11-56257;
-9- Fluoroplastic & Platinum, 0.6x4.75 mm
Product No. 11-56258;
4. De la Cruz Platinum Piston, 0.6x3.75 mm
Product No. 11-56278;
De la Cruz Platinum Piston, 0.6x4.00 mm
Product No. 11-56279;
De la Cruz Platinum Piston, 0.6x4.25 mm
Product No. 11-56280;
De la Cruz Platinum Piston, 0.6x4.50 mm
Product No. 11-56281;
De la Cruz Platinum Piston, 0.6x4.75 mm
Product No. 11-56282;
De la Cruz Platinum Piston, 0.6x5.00 mm
Product No. 11-56283;
5. Fisch Stainless Steel Piston, 0.5x6.00 mm
Product No. 11-56325;
Fisch Stainless steel Piston, 0.6x6.00 mm
Product No. 11-56326;
6. De la Cruz Stainless Steel Piston, 0.6x3.75 mm
Product No. 11-56478;
De la Cruz Stainless Steel Piston, 0.6x4.00 mm
Product No. 11-56479;
De la Cruz Stainless Steel Piston, 0.6x4.25 mm
Product No. 11-56480;
De la Cruz Stainless Steel Piston, 0.6x4.50 mm
Product No. 11-56481;
De la Cruz Stainless Steel Piston, 0.6x4.75 mm
Product No. 11-56482;
7. Sanna Fluoroplastic - Wire Piston,
Product No. 91-22100;
8. Special Fisch Piston, Product No. 91-33155
9. Mass Eye & Ear Piston, 4.50 mm,
Product No. 91-36000;
10. Mass Eye & Ear Piston, 4.0 mm,
Product No. 91-36001;
Mass Eye & Ear Piston, 4.25 mm
Product No. 91-36002;
11. Fluoroplastic - Platinum Piston,
0.5x3.75 mm, Product No. 91-56220;
12. Fisch Malleus Piston, 0.4x9 mm,
Product No. 91-56238. Recall #Z-652/662-5.
CODE All lot numbers.
MANUFACTURER Xomed Surgical Products, Jacksonville, Florida.
RECALLED BY Manufacturer, by letter January 10, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimates 600 unimplanted units in commerce.
REASON The wire may separate from the piston during
surgery/manipulation of the wire to custom fit the patient's
ear space.
-10- _______________
PRODUCT RMI Pediatric Retrograde Coronary Sinus Perfusion Cannulae.
Recall #Z-663/664-5.
CODE (a) Product Code RC-09-M, Lot numbers: 75243 and 75990; (b)
Product Code RC-09-W, Lot #72625.
MANUFACTURER Research Medical, Inc., Midvale, Utah.
RECALLED BY Manufacturer, by fax March 8, 1994, followed by letter.
Firm-initiated recall ongoing.
DISTRIBUTION Florida, Texas, Virginia, Michigan, Minnesota, Maine,
California, Oregon, Missouri, Germany, South Africa, Canada,
Sweden, France, Israel, Greece, Japan.
QUANTITY 346 units were distributed.
REASON Device has out of specification tip hole dimensions which
may cause elevated cardioplegia infusion line pressures
during the use of the cannula.
_______________
PRODUCT Nonin Model 8800G ECG Cables, used with Nonin Model 8800
Cardio-Respiratory Oximeters. Recall #Z-665-5.
CODE Cable Serial numbers: KRE2769 through KRE3052.
MANUFACTURER Nonin Medical, Inc., Plymouth, Minnesota.
RECALLED BY Manufacturer, by letter February 17, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Alabama, California, Georgia, Illinois, Kentucky, Louisiana,
Massachusetts, Minnesota, Oregon, Pennsylvania, Tennessee,
international.
QUANTITY 63 cables.
REASON The ECG cables are miswired which results in incorrect
electrode placement or continuous LEAD alarm. Misplaced
electrodes can alter the electrocardiogram waveform.
_______________
PRODUCT Advanced TMR Treatment System, Rx iontophoresis and
electrotherapy device powered by rechargeable batteries.
Recall #Z-666-5.
CODE A portion of the units are coded with serial numbers 1018-
1068.
MANUFACTURER Lake Medical Products, Inc., St. Louis, Missouri.
RECALLED BY Manufacturer, by telephone on or about the week of January
8, 1995. Firm-initiated recall complete.
DISTRIBUTION Missouri, Kansas, New York, Ohio, Pennsylvania, South
Carolina, Virginia, West Virginia.
QUANTITY 49 units were distributed; firm estimates none remains on
the market.
REASON Product was distributed without 510(k) approval.
_______________
PRODUCT Turbo Membrane Oxygenators: (a) Catalog #9444, Turbo
Membrane Oxygenator for Water Delivery System, Part numbers
98-0702-0575-6, 98-0702-0592-1; (b) Catalog #9445, Turbo
Membrane Oxygenator with Integral Reservoir, Part numbers
98-0702-0591-3; (c) Catalog #9446, Turbo Membrane Oxygenator
-11- with Integral Cardiotomy Reservoir, Part number
98-0702 -577-2); (d) Catalog #4408, Holder with Water System
for Turbos 9444, 9445, 9446; (e) Catalog #5574, Reservoir
Support Bracket, Requires Holder 4408. Recall #Z-667/671-5.
CODE All lots of each product.
MANUFACTURER Sarns, 3M Health Care, Ann Arbor, Michigan.
RECALLED BY Manufacturer, by telephone beginning November 12, 1993, and
by letter November 17, 1993. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 11,497 units were distributed.
REASON Blood to air leaks at the heat exchanger seal area which
have resulted in blood loss and subsequent oxygenator
changeout.
_______________
UPDATE Recall #Z-553-5, Drake Willock System 1000 Single Patient
Delivery System, which appeared in the April 5, 1995
Enforcement Report should read:
REASON: The CPVC may swell and impede the flow meter, the
input pressure equalizer and the output pressure equalizer,
supply regulator, rinse block fitting, concentrate
connectors, ultrafiltration removal regulator and dialyzer
fittings.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT EVIS Video Endoscopes, used for endoscopic diagnosis and
therapeutic procedures: (a) Model GIF-130;
(b) Model GIF-1T130; (c) Model JF-130; (d) Model TJF-130.
Recall #Z-648/651-5.
CODE Serial numbers included are:
(a) GIF-130:
2412211 2412385 2412445
2412247 2412386 2412446
2412248 2412388 2412447
2412252 2412389 2412448
2412254 2412390 2412449
2412271 2412392 2412450
2412272 2412393 2412451
2412276 2412394 2412452
2412281 2412395 2412453
2412283 2412397 2412454
2412285 2412400 2412455
2412289 2412402 2412456
2412292 2412403 2412457
2412296 2412404 2412458
2412302 2412407 2412459
2412304 2412408 2412460
2412314 2412409 2412461
2412317 2412411 2412462
-12- 2412319 2412412 2412463
2412320 2412413 2412464
2412323 2412414 2412465
2412324 2412415 2412466
2412325 2412416 2412467
2412326 2412417 2412468
2412327 2412418 2412469
2412335 2412419 2412470
2412337 2412422 2412471
2412338 2412423 2412472
2412339 2412424 2412473
2412340 2412425 2412474
2412349 2412426 2412475
2412354 2412427 2412476
2412357 2412428 2412478
2412362 2412429 2412479
2412364 2412430 2412480
2412365 2412431 2412481
2412367 2412432 2412482
2412368 2412434 2412483
2412371 2412435 2412484
2412373 2412436 2412485
2412374 2412437 2412486
2412375 2412438 2412487
2412376 2412439 2412488
2412377 2412440 2412489
2412378 2412441 2412490
2412381 2412442 2412491
2412382 2412443 2412492
2412383 2412444 2412493
2412384 2412445 2412494
2412495 2412559 2412649
2412496 2412560 2412654
2412497 2412561 2412655
2412498 2412562 2412659
2412499 2412563 2412676
2412500 2412566 2412681
2412501 2412568 2412682
2412502 2412569 2412685
2412503 2412573 2412689
2412504 2412574 2412690
2412505 2412575 2412696
2412506 2412576 2412698
2412507 2412577 2412699
2412508 2412578 2412700
2412509 2412581 2412701
2412511 2412582 2412702
2412512 2412583 2412703
2412514 2412585 2412704
2412515 2412586 2412706
2412516 2412587 2412710
2412517 2412588 2412711
2412518 2412590 2412713
-13- 2412519 2412592 2412715
2412520 2412600 2412716
2412521 2412602 2412717
2412522 2412604 2412718
2412524 2412605 2412720
2412526 2412606 2412722
2412527 2412607 2412723
2412529 2412608 2412724
2412531 2412609 2412725
2412533 2412611 2412726
2412534 2412612 2412728
2412535 2412615 2412729
2412536 2412616 2412732
2412538 2412619 2412738
2412539 2412621 2412739
2412541 2412622 2412742
2412543 2412623 2412753
2412544 2412624 2412757
2412546 2412625 2412758
2412547 2412626 2412760
2412549 2412627 2412765
2412551 2412632 2412767
2412552 2412634 2412768
2412554 2412639 2412773
2412555 2412642 2412776
2412556 2412644 2412777
2412557 2412646 2412781
2412558 2412482 2412786
2412788 2412790 2412792
2412797 2412798 2412800
2412803 2412805 2412807
2412809 2412815 2412816
2412817 2412820 2412821
2412822 2412826 2412831
2412833 2412834 2412835
2412836 2412838 2412840
2412845 2412846 2412848
(b) GIF-1T30
2400164 2400173 2400175
2400177 2400179 2400182
2400185 2400187 2400189 2400191
(c) JF-130
2410484 2410494 2410511 2410512
2410518 2410524 2410525 2410529
2410532 2410534 2410538 2410541
2410542 2410543 2410544 2410546
2410547 2410548 2410549 2410550
2410551 2410553 2410554 2410555
2410558 2410560 2410561 2410562
2410563 2410566 2410567 2410568
2410571 2410572 2410573 2410574
2410575 2410576 2410577 2410578
2410579 2410580 2410581 2410582
-14- 2410590 2410593 2410597 2410599
2410600 2410604
(d) TJF-130:
2400111 2400116 2400117 2400118
2400123 2400126 2400133 2400135
2400145 2400147 2400148 2400149
2400151 2400153 2400154 2400155
2400156 2400158 2400159 2400161
2400162 2400164 2400166 2400167
2400168 2400169 2400172 2400173
2400174 2400176 2400177 2400178
2400179 2400180 2400181 2400182
2400183 2400185.
MANUFACTURER Olympus Optical Co., Ltd., Tokyo, Japan
RECALLED BY Olympus America Inc., Lake Success, New York, by letters of
February 8, 1995 and March 27, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Canada, South American, Central America.
QUANTITY Approximately 422 units are affected by this recall.
REASON The video endoscopes are more susceptible to surges of
electrical current due to a manufacturing defect in the
charged coupled device (CCD) chip which will cause the video
endoscopes to lose their images.
_______________
PRODUCT Candela PLDL and PLTL Dermatology Laser Systems, used to
treat vascular lesions, brown lesions, and tattoos.
Recall #Z-672/679-5.
CODE 1. PLDL 9914-00-0200: serial no. 9914-0200-0139, 0153,
0175, 0181, 0182, 0192, 0193, 0194, 0195, 0198, 0199, 0200,
0202, 0204, 0206, 0207, 0209, 0210, 0216, 0217, 0221, 0223
2. PLTL 9914-00-0100: serial no. 9914-0100-4092
3. PLTL 9914-00-0150: serial no. 9914-0150-4101, 4140
4. PLTL 9914-00-0151: serial no. 9914-0151-4126, 4138
5. PLTL 9914-00-0152: serial no. 9914-0152-4098, 4100,
4104, 4115, 4116, 4118, 4119, 4121, 4125, 4127, 4132, 4135,
4136, 4144
6. PLTL 9914-00-1000: serial no. 9914-1000-4152
7. PLTL 9914-00 1010: serial no. 9914-1010-4082, 4097,
4106, 4129, 4131, 4134, 4137, 4141, 4142, 4147, 4148, 4149
8. PLTL 9914-00-1110: serial no. 9914-1110-4113, 4154,
4156, 4158 - 4174, 4176 - 4180, 4183, 4184, 4186 - 4191,
4196, 4197, 4201, 4203, 4205, 4208, 4211 - 4215, 4218 -
4220, 4222.
MANUFACTURER Candela Laser Corporation, Wayland, Massachusetts.
RECALLED BY Manufacturer, by letter May 13, 1994. Firm-initiated field
correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY All 94 products on the market have been upgraded and all 8
products in house have also been upgraded.
REASON The design allowed for possible internal fires.
-15- RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT Kent MAX-E-CAL SOW 27 NT Medicated Type B Feed, in 50 pound
bags. Recall #V-028-5.
CODE Lot RA126 and R126.
MANUFACTURER Kent Feeds, Inc., Rockford, Illinois.
RECALLED BY Manufacturer, by telephone October 19 and 26, 1994. Firm-
initiated recall complete.
DISTRIBUTION Illinois, Wisconsin.
QUANTITY 396 bags were distributed.
REASON Feed was subpotent for neomycin base.
MEDICAL DEVICE SAFETY ALERT:
=============================================
_______________
PRODUCT Servo 300 Ventilator. Safety Alert #N-026-5.
CODE Product #6079391 E338E.
MANUFACTURER Siemens-Elema AB, Solna, Sweden.
ALERTED BY Siemens Medical Systems (SMS), Inc., Danvers, Massachusetts,
by letter March 7, 1995.
DISTRIBUTION Nationwide.
QUANTITY 161 units.
REASON When the product is exposed to high levels of electrostatic
or electromagnetic interference the device may exhibit
functional irregularities.
-16-
END OF ENFORCEMENT REPORT FOR APRIL 19, 1995. BLANK PAGES MAY
FOLLOW.
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