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.

August 5, 1998
98-31

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

PRODUCT
Ice Cream: a) Walgreen's Chocolate Cookies & Cream Ice Cream, in half gallon round paper cartons, labeled as distributed by Walgreen Company, Deerfield, Illinois; b) Becker's Chocolate Cookies N Cream Ice Cream, in half gallon round paper cartons, labeled as distributed by L. Pritkin & A. Becker Inc., Chicago, Illinois. Recall #F-563-8.

CODE
0168/55-477 on bottom of cartons.

MANUFACTURER
Schoep's Ice Cream Company, Inc., Madison, Wisconsin.

RECALLED BY
Manufacturer, by telephone on June 22, 1998, by voice mail on June 23, 1998, and by press release on June 24, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Arizona, California, Florida, Illinois, Indiana, Iowa, Kentucky, Minnesota, New York, Ohio, Texas, Wisconsin.

QUANTITY
5,546 half-gallon cartons were distributed.

REASON
Product may contain undeclared pecans.

PRODUCT
Golden Lion brand Dried Potato, in 6 ounce plastic bags. Recall #F-564-8.

CODE
None.

MANUFACTURER
Taishan Foodstuffs Import and Export, Guangdong, China.

RECALLED BY
Blooming Import Company, Inc., Brooklyn, New York, by letter on March 4, 1998. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
New York.

QUANTITY
Approximately 24 cases (100 6-ounce packages per case) were distributed.

REASON
Product contained undeclared sulfites.

PRODUCT
Golden Lion brand Dried Potato, in 6 ounce plastic bags. Recall #F-565-8.

CODE
None.

MANUFACTURER
Taishan City Huafeng Food Company, Ltd., Guangdong, China.

RECALLED BY
Blooming Import, Inc., Brooklyn, New York, by letter dated October 27, 1997, and by visit. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
New York.

QUANTITY
14 cases were distributed.

REASON
Product contained undeclared sulfites.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

PRODUCT

Mineral Water with Juice, Flavored Mineral Water, and Spring
Water, in 10 ounce bottles:
a) Calistoga Sparkling Mineral Water with Juice, Black Current
Flavor
b) Calistoga Sparkling Mineral Water with Juice, Cranberry Flavor
c) Calistoga Sparkling Mineral Water with Juice, Wild Berry 
Flavor
d) Calistoga Sparkling Mineral Water with Juice, Lemonade Flavor
e) Calistoga Sparkling Mineral Water with Juice, Raspberry Guava
Flavor
f) Calistoga Sparkling Mineral Water with Juice, Mango Berry
Flavor
g) Calistoga Sparkling Mineral Water, Original Flavor
h) Calistoga Sparkling Mineral Water, Lemon Flavor
I) Calistoga Sparkling Mineral Water, Lime Flavor
j) Calistoga Sparkling Mineral Water, Mandarin-Orange Flavor
k) Calistoga Sparkling Mineral Water, Black Cherry Flavor
l) Calistoga Non-Sparkling Spring Water.  Recall
#F-551/562-8.

CODE
75403 00504, 75403 00506, 75403 00508, 75403 00512, 75403 00516, 75403 00522, 75403 00600, 75403 00601, 75403 00602, 75403 00603, 75403 00604, 75403 00040.

MANUFACTURER
Calistoga Mineral Water Company, Calistoga, California.

RECALLED BY
Manufacturer, by telephone, letter beginning on May 18, 1998, and by press release on May 21, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
California and other Western states.

QUANTITY
172,533 cases or 4,140,792 bottles were distributed.

REASON
Products were bottled in defective glass bottles whose rims may chip and allow glass to enter the product.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

PRODUCT
Geneva Pharmaceuticals brand Methocarbamol Tablets, USP, Rx skeletal muscle relaxant: a) 500 mg, in 500 tablets bottles, NDC #0781-1760-05; b) 750 mg, in bottles of 100, NDC #0781-1750-01, in bottles of 500, NDC #0781-1750-05. Recall #D-204/205-8.

CODE
Lots numbers: a) 90940; b) 90620, 90702, 90803, 91209, 90802, 90817, 90935, 91002, 91172.

MANUFACTURER
Geneva Pharmaceuticals, Inc., Broomfield, Colorado.

RECALLED BY
Manufacturer, by letter on July 8, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
a) 1,307,500 tablets; b) 7,444,700 tablets were distributed.

REASON
Tablets may contain metal particle contamination.

PRODUCT
Miochol E Intraocular Solution (acetylcholine chloride), 20 mg/2mL vials, Rx, used to obtain miosis of the iris in seconds after delivery of the lens in cataract surgery, in penetrating keratoplasty, iridectomy and other anterior segment surgery where rapid miosis may be required. NDC #58768-773-52 and NDC 58768-773-53. Recall #D-206-8.

CODE
Lot numbers: V2328 EXP 1/99 and V2325 EXP 1/99.

MANUFACTURER
OMJ Pharmaceuticals, San German, Puerto Rico.

RECALLED BY
CIBA Vision Ophthalmics (CVO), Duluth, Georgia, by letter mailed during the month of July 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
Undetermined.

REASON
Low pH values (10 month stability test).

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

PRODUCT
Comhist(R) LA, Extended Release Capsules, Chlorpheniramine maleate 4mg/Phenyltoloxamine citrate 50 mg/phenylephrine hydrochloride 20mg, in 100 capsule bottles, Rx used in the treatment of rhinorrhea and congestion associated with seasonal and/or perennial allergic rhinitis and vasomotor rhinitis, under the Roberts Pharmaceuticals label. NDC #54092-065-01. Recall #D-207-8.

CODE
Lot #M069H.

MANUFACTURER
Time-Cap Labs, Inc., Farmingdale, New York.

RECALLED BY
Manufacturer, by telephone on June 11, 1998, and by letter dated June 12, 1998. Firm-initiated recall complete.

DISTRIBUTION
New Jersey.

QUANTITY
2,013 bottles were distributed.

REASON
Dissolution failure.

PRODUCT
Extra Strength Tylenol Tablets, 500 mg, in 100 tablet bottles, OTC pain reliever. Recall #D-208-8.

CODE
Lot #AMA032 EXP 9/2001.

MANUFACTURER
McNeil Consumer Products Company, Las Piedras, Puerto Rico.

RECALLED BY
McNeil Consumer Products Company, Fort Washington, Pennsylvania, by letter on May 11, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
114,432 bottles were distributed.

REASON
Tablet discoloration, growth of penicillium and aspergillus species.

PRODUCT
Myco-Triacet II Cream, Dermatologic use only, (Nystatin and Triamcinolone Acetonide Cream, USP), Rx, in 15 gram tubes, under the Lemmon label. Recall #D-209-8.

CODE
Lot #7088 EXP 10/99.

MANUFACTURER
Teva Pharmaceuticals USA, Inc., Sellersville, Pennsylvania.

RECALLED BY
Manufacturer, by letter on July 6, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
94,123 tubes were distributed.

REASON
Subpotent at 18 month stability testing.

PRODUCT
Triamcinolone Acetonide Cream USP, 0.5%, in 15 gram tubes, Rx topical corticosteroid. NDC #49158-141-20. Recall #D-210-8.

CODE
Lot numbers: M267 EXP 1/2002, K910 EXP 6/2001.

MANUFACTURER
Thames Pharmacal Company, Ronkonkoma, New York.

RECALLED BY
Manufacturer, by letter faxed on July 2, 1998, followed by telephone. Firm-initiated recall ongoing.

DISTRIBUTION
New York, California, Colorado, Florida, Indiana, Michigan, Ohio, Texas, Puerto Rico.

QUANTITY
28,116 units of lot M267 and 1,641 units of lot K910 were distributed.

REASON
Mispackaging - Some tubes of 0.1% cream were packaged into cartons labeled as 0.5%.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

PRODUCT
a) Red Blood Cells; b) Platelets, Pheresis. Recall #B-1321/1322-8.

CODE
Unit numbers: a) 17183-3896, 28108-9019; b) 17183-3845, 28109-1965, 28109-2700, 28109-3783.

MANUFACTURER
United Blood Services, McAllen, Texas.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated April 7, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
a) 2 units; b) 4 units were distributed.

REASON
Blood products were collected from donors who traveled to an area considered endemic for malaria, were distributed.

PRODUCT
a) Red Blood Cells; b) Platelets, Pheresis; c) Single Donor Plasma; d) Source Leukocytes; e) Recovered Plasma; f) Platelets, for further manufacture. Recall #B-1370/1375-8.

CODE
Unit numbers: a) 56H28856, 56G59821, 56K35193, 56H30947, 56F43223, 56F43207, 56J29402, 56H31389, 56G61648, 56F43212, 56G61383, 56Q03375, 56G62579, 56Q03727, 56K37817, 56H32522, 56H29112, 56K35213, 56F40961, 56F44797, 56F44923, 56F45388; b) 56P21418, 56P21610; c) 56F44797, 56F44923, 56F45388; d) 56F43207; e) 56H30947, 56F43223, 56F43207, 56J29402, 56H31389, 56G61648, 56F43212, 56G61383, 56Q03375, 56G62579, 56Q03727, 56K37817, 56H32522, 56G59821, 56H28856, 56K35213, 56H29112 f) 56G59821, 56K35213, 56H30947, 56H29112.

MANUFACTURER
American Red Cross Blood Services, Albany, New York.

RECALLED BY
American Red Cross Blood Services, Rochester, New York by letters between November 1995 and April 1996. Firm-initiated recall complete.

DISTRIBUTION
New York, Missouri, California.

QUANTITY
a) 22 units; b) 2 units; c) 3 units; d) 1 unit; e) 17 units; f) 4 units were distributed.

REASON
Blood products, which tested repeatedly reactive for the hepatitis B surface antigen (HBsAg), or which tested negative for HBsAg, were collected from donors who previously tested repeatedly reactive for HBsAg.

PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-1377/1378-8.

CODE
Unit #19KP06904.

MANUFACTURER
American Red Cross Blood Services, Paducah, Kentucky.

RECALLED BY
Manufacturer, by letters dated February 20, 1996 and March 8, 1996. Firm-initiated recall complete.

DISTRIBUTION
Kentucky and California.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor with a history of Hodgkins Disease.

PRODUCT
Red Blood Cells. Recall #B-1379-8.

CODE
Unit #40GN70426.

MANUFACTURER
American Red Cross Blood Services, Peoria, Illinois.

RECALLED BY
Manufacturer, by letter dated May 13, 1998. Firm-initiated recall complete.

DISTRIBUTION
Missouri.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-1381/1383-8.

CODE
Unit #26149-9803.

MANUFACTURER
United Blood Services, Fort Smith, Arkansas.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letters dated September 18, 1997, and April 23, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas and Switzerland.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor with a history of cancer.

PRODUCT
Red Blood Cells. Recall #B-1384-8.

CODE
Unit numbers: 17183-5807, 28109-0621, 28109-3619.

MANUFACTURER
United Blood Services, McAllen, Texas.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated May 20, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
3 units were distributed.

REASON
Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT
Platelets. Recall #B-1385-8.

CODE
Unit #49GF12298.

MANUFACTURER
American Red Cross Blood Services, Tulsa, Oklahoma.

RECALLED BY
Manufacturer, by telephone on April 29, 1998. Firm-initiated recall complete.

DISTRIBUTION
Oklahoma.

QUANTITY
1 unit was distributed.

REASON
Blood product corresponded to a unit of clotted red blood cells.

PRODUCT
a) Red Blood Cells; b) Platelets, Pooled; c) Platelets, Pheresis. Recall #B-1386/1388-8.

CODE
Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.

MANUFACTURER
The Blood Center of Central Iowa, Des Moines, Iowa.

RECALLED BY
Manufacturer, by letter dated between June 6, 1997 and January 23, 1998. Firm-initiated recall complete.

DISTRIBUTION
Connecticut, Iowa, Illinois, Maryland, Mississippi, North Carolina, New Jersey, New York, Pennsylvania, Utah.

QUANTITY
a) 42 units; b) 25 units; c) 3 units were distributed.

REASON
Blood products were collected from donors who reported travel to areas designated as endemic for malaria.

PRODUCT
Source Plasma. Recall #B-1389-8.

CODE
Unit #0720519

MANUFACTURER
Stillwater Plasma Center, Inc., Stillwater, Oklahoma.

RECALLED BY
Manufacturer, who notified the trucking company of the recall and requested that the unit be pulled from the shipment and returned. Firm-initiated recall complete.

DISTRIBUTION
Kentucky.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor with an elevated ALT.

PRODUCT
a) Red Blood Cells; b) Frozen Plasma. Recall #B-1393/1394-8.

CODE
Unit #21FL24154.

MANUFACTURER
American Red Cross, Portland, Oregon.

RECALLED BY
Manufacturer, by telephone on January 30, 1998, and letter dated February 2, 1998. Firm-initiated recall complete.

DISTRIBUTION
Oregon.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products tested negative for anti-HCV, but were collected from a donor who had previously tested positive for anti-HCV.

PRODUCT
Platelet Pheresis. Recall #B-1399-8.

CODE
Unit #KZ51179.

MANUFACTURER
Virginia Blood Services, Richmond, Virginia.

RECALLED BY
Manufacturer, by letter dated July 13, 1998. Firm-initiated recall complete.

DISTRIBUTION
Virginia.

QUANTITY
1 unit was distributed.

REASON
A unit of platelets, pheresis was collected from a donor who had taken aspirin on the day of donation.

PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-1401/1402-8.

CODE
Unit #39G95285.

MANUFACTURER
American Red Cross, Huntington, West Virginia.

RECALLED BY
Manufacturer, by April 30, 1998. Firm-initiated recall complete.

DISTRIBUTION
West Virginia.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were mislabeled as CMV antibody negative.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

PRODUCT
Red Blood Cells. Recall #B-1294-8.

CODE
Unit #6064944.

MANUFACTURER
LifeSource, Inc., Glenview, Illinois.

RECALLED BY
Manufacturer, by telephone on April 23, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

QUANTITY
1 unit was distributed.

REASON
Blood product was not retested for the antibody to the hepatitis B core antibody (anti-HBc), after the initial testing was invalidated.

PRODUCT
Platelets, Pheresis. Recall #B-1380-8.

CODE
11319-3485-01, 11319-3488, 11319-3491-01, 11319-3491-02.

MANUFACTURER
United Blood Services, El Paso, Texas.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on June 18, 1998, and by letter dated June 25, 1998. Firm-initiated recall complete.

DISTRIBUTION
New Mexico.

QUANTITY
4 units were distributed.

REASON
Unlicensed blood product was distributed in interstate commerce.

PRODUCT
Red Blood Cells. Recall #B-1392-8.

CODE
Unit H78194.

MANUFACTURER
Tacoma-Pierce County Blood Bank, doing business as Cascade Regional Blood Services, Tacoma, Washington.

RECALLED BY
Manufacturer, by telephone on April 21, 1998. Firm-initiated recall complete.

DISTRIBUTION
Washington state.

QUANTITY
1 unit was distributed.

REASON
Blood product was labeled with an extended expiration date.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

PRODUCT
ACS Coronary Stent System an Dilatation Catheters, intended to improve coronary luminal diameter in patients with heart disease use to coronary artery lesions: a) ACS MULTI-LINK Coronary Stent System; b) ACS RX Comet Dilatation Catheter; c) - ACS Tx2000 Dilatation Catheter. Recall #Z-408/410-8.

CODE

Catalog/Product #       Size                Lot #

a) 1001091                 (3.0mm x 15mm)      7091951
                                               7100751
                                               7102552
                                               7103051
                                               7110451
   1001092                 (3.0mm x 15mm)      7100351
                                               7100451
                                               7102451
                                               7103051
                                               7110551
                                               7110552
   1001594                 (3.0mm x 15mm)      7091854
                                               7092552
                                               7092553
   1001595                 (3.0mm x 15mm)      7090552
                                               7090951
                                               7091752
   1001597                 (3.0mm x 25mm)      7090351
                                               7090353
                                               7090452
                                               7100254
                                               7100856
   1001598                 (3.5mm x 25mm)      7090852
                                               7092551
   1001093                 (4.0mm x 15mm)      7092651
                                               7100851
                                               7101551
   1001596                 (4.0mm x 15mm)      7092352
                                               7100651
   1001599                 (4.0mm x 25mm)      7090551
                                               7090552
                                               7090651
                                               7102251
   1001600                 (3.0mm x 35mm)      7092451
                                               7100351
                                               7101551
   1001601                 (3.5mm x 35mm)      7092451
                                               7100351
                                               7101752
                                               7102351
   1001602                 (4.0mm x 35mm)      7080451
                                               7081151
b) 1000389-20              (2.5mm x 20mm)      7032152
   1000391-20              (3.0mm x 20mm)      7032252
c) 1000404-20              (2.5mm x 20mm)      6110551
                                               6110651
   1000406-20              (3.0mm x 20mm)      6110452
                                               6110453
   1000408-20              (3.5mm x 20mm)      6072951.

MANUFACTURER
Guidant Corporation, Temecula, California.

RECALLED BY
Guidant Corporation, Advanced Cardiovascular Systems, Santa Clara, California (responsible firm), by letters dated November 26, 1997, and December 3, 1997. Firm-initiated recall complete.

DISTRIBUTION
Puerto Rico.

QUANTITY
Firm estimates none remains on the market.

REASON
The labeled "FOR EXPORT ONLY" devices were shipped to a U.S. territory with two sizes of the stent system lacking PMA approval, while the other devices lacked approved labeling and patient tracking information required for use within the U.S.

PRODUCT
Chick Ultralux Hi-Profile Birthing Room Lights, Model 78100, intended for use in illuminating the procedure site during childbirth. Recall #Z-411-8.

CODE
All serial numbers manufactured from 1987 to May 1993.

MANUFACTURER
Midmark Corporation, Versailles, Ohio.

RECALLED BY
Manufacturer, by letter mailed beginning on January 20, 1998. Firm-initiated field correction complete.

DISTRIBUTION
Nationwide.

QUANTITY
879 units were distributed.

REASON
The cap (trunnion housing) on the actuator component which opens and closes the light, can weaken and break, causing the surgical light to swing out of the ceiling weld, which could possibly strike anyone beneath the light.

PRODUCT
Ami Infant Central Apnea/Heart Rate Monitors, intended for use with infants in the home or hospital, to detect episodes of central apnea, bradycardia, or tachycardia, and sound an alarm: Model L-9700 (monitor without modem); Model L-9700A (monitor with modem), Model L-9700-G (monitor without modem for distribution in Germany); Model L-9700-S (monitor without modem for distribution in Spain; Model L-REF9700A (refurbished monitor with modem); Model L-REF9700 (refurbished monitor without modem). Recall #Z-605-8.

CODE
All serial numbers.

MANUFACTURER
Nellcor Puritan Bennett, Inc., Minneapolis, Minnesota.

RECALLED BY
Manufacturer, by letter dated June 8, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide, Argentina, Spain.

QUANTITY
886 monitors were distributed.

REASON
Possible false alarms and failure to alarm during apnea.

PRODUCT
KXO-80G Diagnostic X-ray High Voltage Generator. Recall #Z-666-8.

CODE
None.

MANUFACTURER
Toshiba America Medical Systems, Inc., Tustin, California.

RECALLED BY
Manufacturer. FDA approved the firm's corrective action plan July 21, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
171 units were distributed.

REASON
Noncompliance with 21 CFR 1020.32(b)(1) in that when used in combination with the DUA series R/F tables it may exhibit a coefficient of variation of radiation exposures greater than 0.05 in the manual spot-film mode.

PRODUCT
Cordis Brite Tip Sheath Introducer with "black tip" (Note: This recall does not apply to this device with the "yellow tip"), used to facilitate percutaneous entry of an intravascular device. There are two packaging configurations for the Brite Tip sheath. The sheaths which are 5.5, 11 and 23 cm in length are individually packaged in a "blister" tray with tyvec backing and sold in an outer carton containing five sheaths. This would be catalog numbers 401-X05M, 401-X11M, and 401-X23M, where "X" is the french size. The other packaging configuration is for sheaths of 35, 45, 55 and 90 cm in length. These are packaged individually on a paper mounting card with a mylar wrap and sold in an outer carton containing two sheaths. These would be catalog numbers 401-X35M, 401-X45M, 401-X55M and 401-X90M. Recall #Z-683/702-8. a) The following is a list of Catalog Numbers that are under recall (all lot numbers of these catalog numbers are included in recall (ONLY THE "BLACK TIP INTRODUCERS)

401-411M       401-423M       401-511M       401-523M      
401-535M        
401-545M
401-555M       401-605M       401-690M       401-611M      
401-623M        
401-635M
401-645M       401-655M       401-705M       401-790M      
401-711M        
401-723M
401-735M       401-745M       401-755M       401-805M      
401-890M        
401-811M
401-823M       401-835M       401-845M       401-855M      
401-911M        
401-923M
401-935M       401-945M       401-955M

b) The following are "transition" lot numbers of earlier lots made using a newer "black tip" instead of the yellow tip of the past. These lot numbers would represent the first lot of that catalog number having the black tip (under recall). This lot number and all later lot numbers (greater) than these are covered by the recall. Note that not all catalog numbers will have a transition lot number since some catalog numbers were added after the initial product introduction.

CATALOG NUMBER                        LOT NUMBER
401-611M                              K1097286
401-623M                              K1097116
401-635M                              K1097164
401-645M                              K1097168
401-655M                              K1097165
401-711M                              K1097118
401-723M                              K1097287
401-735M                              K1097117
401-745M                              K1097221
401-755M                              K1097235
401-811M                              K1097119
401-823M                              K1097212
401-835M                              K1097252
401-845M                              K1097291
401-855M                              K1097288
401-911M                              A1197307
401-923M                              A1097805
401-935M                              41097620
401-945M                              41097632
401-955M                              A1197185.

MANUFACTURER
Cordis Corporation, a Johnson & Johnson Company, Miami Lakes, Florida.

RECALLED BY
Manufacturer, by letter on June 5, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
28,757 units were distributed.

REASON
Introducer tip detachment.

PRODUCT
Compressor Compact, Part #6150440, a silent compressor supplying dried, filtered compressed air. Recall #Z-707-8.

CODE
All units.

MANUFACTURER
Siemens-Elema AB, Solna, Sweden.

RECALLED BY
Siemens Medical Systems, Inc., Danvers, Massachusetts, by letter dated April 30, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
187 units were distributed.

REASON
There were two failure modes: (1) the cooler/dehumidifier overloads the power supply; and (2) an inadequate motor starting torque blows a fuse.

PRODUCT
Fletcher-Van Doren Uterine Polyps Forceps, 9 1/2 inches, Catalog #GL1805, used in gynecological surgical procedures. Recall #Z-708-8.

CODE
Lot numbers: BB039, BB040, BB041.

MANUFACTURER
August Reuchlen, Germany.

RECALLED BY
Allegiance Healthcare Corporation, McGaw Park, Illinois, by letter dated July 17, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Mexico.

QUANTITY
167 forceps were distributed.

REASON
Forceps have the potential for premature cracking at the jaw of the instrument.

PRODUCT
Storz Tanne Disposable Trephine Blade, Catalog #E3050 8.25, for use in ophthalmic procedures. Recall #Z-709-8.

CODE
Lot #S1144.

MANUFACTURER
Bausch & Lomb Surgical, St. Louis, Missouri.

RECALLED BY
Manufacturer, by letter on June 16, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Connecticut, North Carolina, South Carolina, Indiana, Minnesota, Texas, Michigan, South America.

QUANTITY
26 blades were distributed.

REASON
The edge of the blade may be brittle and break during use.

PRODUCT
First Temp Genius Calibrator, used for recalibration of tympanic thermometer: a) FirstTemp Genius - Model No. 3000-PC Calibrator, Catalog No. 8884-830129; b) FirstTemp Genius - Model No. 3000-PC Calibrator w/DeskTop Interface Kit, Catalog No. 8884-830160. Recall #Z-710/711-8.

CODE
Serial Nos. H9712346 through H9713066.

MANUFACTURER
Sherwood-Davis & Geck, Watertown, New York.

RECALLED BY
Sherwood-Davis & Geck, Hazelwood, Missouri, by letter dated June 30, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and Australia.

QUANTITY
541 units were distributed.

REASON
When using software version 1.04, the "calibration Check"feature may incorrectly identify whether the thermometer being checked requires calibration.

PRODUCT
Aztech 65 Dental X-Ray System, used in dental radiography. Recall #Z-712-8.

CODE
Model Aztech 65. Equipment manufactured prior to December 12, 1997.

MANUFACTURER
Villa Sistemi Medicali, S.p.A.,.

RECALLED BY
The Aztech Group, Inc., Boulder, Colorado. FDA approved the firm's corrective action plan July 29, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
1,200 units were distributed.

REASON
The diagnostic x-ray device was found defective under 21 CFR 1003.11. The defect occurs as a result of incomplete equipment specifications and installation instructions on equipment manufactured prior to December 12, 1997.

PRODUCT
Gambro Healthcare Acid Concentrate for Bicarbonate Dialysate, 3-K, in one gallon containers, used with concentrated bicarbonate solution in conjunction with artificial kidney equipment in administering dialysis procedures. Recall #Z-714-8.

CODE
Product #AC-1002-4, Lot #G7K021.

MANUFACTURER
Di-Chem Concentrate, Inc., Lewisberry, Pennsylvania.

RECALLED BY
Gambro Healthcare, DeLand, Florida, by telephone on March 20, 1998, followed by letter dated March 25, 1998. Firm-initiated recall complete.

DISTRIBUTION
Missouri, Virginia, New York, District of Columbia, New Jersey, Illinois, Michigan.

QUANTITY
1,118 cases (4 gallons per case) were distributed.

REASON
Product was diluted towards the end of production, causing alarms during use.

PRODUCT
Model 9952A Software, used in Medtronic 9790C Programmers Medtronic Kappa 400 series Pacemakers. Recall #Z-715-8.

CODE
All Model 9952A software.

MANUFACTURER
Medtronic, Inc., Milaca, Minnesota.

RECALLED BY
Medtronic, Inc., Minneapolis, Minnesota, by letter dated June 25, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
California, Australia, Japan.

QUANTITY
133 of the Model 9790 Programmers in use have the Model 9952A software.

REASON
Bench testing has identified a software anomaly that could result in the delivery of an unintended pacing mode or pacing interval.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

PRODUCT
Lumax Catheters: a) LuMax Reusable Urodynamic Fiber Optic Pressure Transducer Catheters. Models 10F-1LR and 10F-1R; b) LuMax Fiber Optic Pressure Transducer Catheters, Models 10F-1L, 10F-1, and 4F-1, fiber optic pressure transducer catheters used with the LuMax Cystometry System module to measure pressures in the bladder, abdomen, and urethra for the diagnosis of urinary incontinence, bladder outflow obstruction, and other bladder disorders. Recall #Z-517/518-8.

CODE

Lot numbers:
203302     203344     203411     203416     203528
203303     203387     203412     203417
203324     203408     203413     203418
203340     203409     203414     203420
203342     203410     203415     203520.

MANUFACTURER
MedAmicus, Inc., Minneapolis, Minnesota.

RECALLED BY
Manufacturer, by letter on April 10, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
1,320 units were distributed.

REASON
Inability to scan the serial number bar code prevents the use of some units.

PRODUCT
Alexon-Trend ProSpecT Cryptosporidium Rapid Assay Kit, Product number 340-20, an in-vitro diagnostic test kit for the qualitative detection of Cryptosporidium Specific Antigen in aqueous extracts of fecal specimens. Recall #Z-607-8.

CODE
Lots numbers: 970605, 970452, 970400, 970327A, 970327, 970173, 960961, 960800, and 960650.

MANUFACTURER
Alexon, Inc., Sunnyvale, California. (Since the recall, this firm has relocated, and is now Alexon-Trend, Inc., Ramsey, Minnesota.)

RECALLED BY
Manufacturer, by letter dated September 15, 1997, followed by telephone on October 3, 1997. Firm-initiated recall complete.

DISTRIBUTION
Nationwide, Germany, Israel, Japan, Korea, New Zealand, Switzerland.

QUANTITY
637 assay kits were distributed.

REASON
False positive test results.

PRODUCT
ACS:180 VANCOMYCIN, Part No. 672361000 for 50 Test Kits, used for the quantitative determination of vancomycin in serum or plasma using the CIBA Corning Automated Chemiluminescence Systems (ACS). Recall #Z-628-8.

CODE
Lot Numbers: 4884017,4974317, 5118117, 5201717, 5181718; Part No. 672360000 for 300 Test Kits, Lot Nos. 4883917, 5016817, 5129017, 5135518, 5161118.

MANUFACTURER
Chiron Diagnostics Corp., East Walpole, Massachusetts.

RECALLED BY
Manufacturer, by telephone on June 12 and 13, 1997. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
315 kits of part #672361000 and 126 kits of part #672360000 were distributed.

REASON
The lite reagent exhibited bottle-to-bottle variations due to excessive exposure to light in the warehouse.

PRODUCT
NeuroControl FreeHand System Implantable Receiver-Stimulator Model 1060-1, an implantable hand grasp neuroprosthesis intended to enable persons with C5/C6 level spinal cord injury to grasp, hold, and release objects. Recall #Z-706-8.

CODE
All serial numbers.

MANUFACTURER
NeuroControl Corporation, Cleveland, Ohio.

RECALLED BY
Manufacturer, by telephone, followed by telephone on May 27, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
45 units were distributed.

REASON
The device has the potential for a malfunction which results in an inability to regulate output current on all eight channels causing the clinician to be unable to lower the current amplitude setting from the default value.

PRODUCT
Fenlin Shoulder Femoral Stem. Recall #Z-713-8.

CODE
Catalog #00-4065-043-00, Lot #55319300.

MANUFACTURER
Zimmer, Inc., Warsaw, Indiana.

RECALLED BY
Manufacturer, by letter dated June 8, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Arizona, California, Florida, Pennsylvania, Texas, Virginia, Wisconsin, Canada, Germany, Italy.

QUANTITY
18 units.

REASON
The stem length etched on the device is 160 mm, but the actual length is 130 mm.

RECALLS AND FIELD CORRECTIONS: VETERINARY -- CLASS II

PRODUCT
Land O' Lakes Medi-Flex S-Guard Medicated-Type B Medicated Premix For use in swine feeds only - containing fenbendazole - 5/10 lb bag bales. Recall #V-026-8.

CODE
8050511D.

MANUFACTURER
ADM Animal Health & Nutrition Division, Des Moines, Iowa.

RECALLED BY
ADM Animal Health & Nutrition Division, Ft. Wayne, Indiana, by telephone on June 9, 1998. Firm-initiated recall complete.

DISTRIBUTION
Iowa and Minnesota.

QUANTITY
122 5/10 pound bag bales were distributed; firm estimates none remains on the market.

REASON
Product is super and subpotent in fenbendazole.

END OF ENFORCEMENT REPORT FOR AUGUST 5, 1998.