FDA

Enforcement Report

October 6, 1999                                              99-40


RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS I
________
PRODUCT
Smoked Salmon Dip, in 8 ounce clear plastic containers.  Recall 
#F-670-9.
CODE
Lot #0040 EXP 4/22/99.
MANUFACTURER
Perona Farms Food Specialties, Andover, New Jersey.
RECALLED BY
Manufacturer, by telephone and by press release on April 2 and 5, 
1999, followed by visit.  Completed recall resulted from sample 
analysis and follow-up by the New York State Department of 
Agriculture and Markets.
DISTRIBUTION
New Jersey, Virginia, North Carolina, Indiana, Pennsylvania, 
Kentucky.
QUANTITY
60 units were distributed.
REASON
Product was contaminated with Listeria monocytogenes.
________
PRODUCT
Yankee Smoked Atlantic Salmon, cold smoked vacuumed packaged, 
refrigerated units of 4 ounces, 8 ounces, 20 ounces,2.2 pounds, 
3.72 pounds, 3.82 pounds, 3.87 pounds, and 4.31 pounds.  Recall 
#F-672-9.
CODE
"Sell by Date" of June 18.
MANUFACTURER
Wellington River Aqua Farm, Inc., doing business as Plymouth Rock 
Specialty Seafood Company, Plymouth, Massachusetts.
RECALLED BY
Manufacturer, by letter on June 14, 1999.  Completed recall 
resulted from sample analysis and follow-up by the Massachusetts 
Department of Public Health, Division of Food and Drugs.
DISTRIBUTION
Massachusetts.
QUANTITY
None.  All recalled products were destroyed at the firm on 
6/22/99.
REASON
Product was contaminated with Listeria monocytogenes.
________
PRODUCT
Sweet Melon Strips, in 14 ounce flexible plastic bags, Product of 
China.  Recall #F-674-9.
CODE
None.
MANUFACTURER
Sheng Li Trading Company, Guangdong, China (foreign distributor).
RECALLED BY
Eastern Oceanic Enterprises, Inc., Brooklyn, New York (importer), 
by letter and press release on June 24, 1999.
Completed field correction (relabeling) resulted from sample 
analysis and follow-up by the New York State Department of 
Agriculture and Markets.
DISTRIBUTION
New York.
QUANTITY
18 cases (50 packages per case) were distributed.
REASON
Product contained undeclared sulfites.

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS II
________
PRODUCT
Assorted Sugar Sticks, distributed under the Happiness brand 
label, packed in 4-ounce (113g) net weight retail plastic bags.  
Recall #F-645-9.
CODE
All bags distributed on or before 7/23/99.
MANUFACTURER
Papas Candies, Covington, Kentucky.
RECALLED BY
Miami Cigar & Tobacco Company, Dayton, Ohio 
(distributor/responsible firm), by telephone on July 23, 1999, 
followed by visit.  Completed recall resulted from an inspection 
by the Ohio Department of Agriculture (ODA).
DISTRIBUTION
Ohio, Kentucky, Indiana.
QUANTITY
Undetermined.
REASON
Product contains undeclared FD&C Yellow No. 5, FD&C Yellow No. 6, 
FD&C Red No. 40, FD&C Red No. 3, and FD&C Blue No. 1.
________
PRODUCT
Keebler Frosted Animal Cookies, in 16 ounce bags.
Recall #F-664-9.
CODE
All lots.
MANUFACTURER
Ripon Foods, Ripon, Wisconsin (cookies); Clasen Quality Coatings, 
Middleton, Wisconsin (frosting).
RECALLED BY
Keebler Company, Elmhurst, Illinois, by letters sent on August 20 
and 23, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
States east of the Rocky Mountains.
QUANTITY
380,000 cases (6 units per case) were distributed; firm estimated 
that 12,000 cases remained on market at time of recall 
initiation.
REASON
The frosting component of the cookies contains undeclared dairy 
ingredients.
________
PRODUCT
Blue Marlin Loins.  Recall #F-671-9.
CODE
Houmann's Fish and Seafood Lot #83992.
MANUFACTURER
Product originally obtained from Tasty Seafood Company, 
Mattapoisett, Massachusetts.
RECALLED BY
Houmann's Fish and Seafood, Racine, Wisconsin, by telephone.  
Firm-initiated recall complete.
DISTRIBUTION
Wisconsin.
QUANTITY
Approximately 160 pounds were distributed.
REASON
Product contained high levels of histamine and was associated 
with scombroid poisoning.
________
PRODUCT
Boneless, Skinless Tuna Loins under the Ocean Bright label, 
frozen, shipped 5 loins (approximately 12 pounds) per box, 
distributed by Stavis Seafood.  Product of Indonesia. 
Recall #F-673-9.
CODE
Batch Code is IAB303.  Production Date is 30.10.98 and
Best Before Date is 30.04.00.
MANUFACTURER
Product of Indonesia.
RECALLED BY
K. Heeps, Inc., Allentown, Pennsylvania, by telephone on August 
26, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Pennsylvania and New Jersey.
QUANTITY
Firm estimates none remains on the market.
REASON
Product contained high levels of histamine and was associated 
with histamine poisoning.

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS III
________
PRODUCT
Peppermint Sugar Sticks, distributed under the Happiness brand 
label, packed in 4.00 ounce  (113g) net weight retail plastic 
bags.  Recall #F-646-9.
CODE
All bags distributed on or before July 23, 1999.
MANUFACTURER
Papas Candies, Covington, Kentucky.
RECALLED BY
Miami Cigar & Tobacco Company, Dayton, Ohio 
(distributor/responsible firm), by telephone on July 23, 1999, 
followed by visit.  Completed recall resulted from an inspection 
by the Ohio Department of Agriculture (ODA).
DISTRIBUTION
Ohio, Kentucky, Indiana.
QUANTITY
Undetermined.
REASON
The product fails to declare certified colors by their common or 
usual names FD&C Red No. 40, FD&C Red No. 3, and FD&C Blue No. 1.

RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS II
________
PRODUCT
PRE-PENÆ Skin Test Antigen, (benzylpenicilloyl polylysine 
injection, USP), in single dose ampuls (5 per carton), Rx used in 
assessing a patient's allergy status to penicillin.
NDC #0091-1640-05.  Recall #D-424-9.
CODE
Lot #33911, 33912, 33913 EXP 10/99.
MANUFACTURER
Hollister-Stier Laboratories LLC, Spokane, Washington.
RECALLED BY
Manufacturer, by letters sent on September 3 and 8, 1999.  Firm-
initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
500 units of lot 33911, 4,716 units of lot 33912 and 200 units of 
lot 33913 were distributed.
REASON
Subpotency (30 month stability testing).

RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS III
_______
UPDATE
Recall #D-262/263-9, Hygroton Tablets (clorthalidone, USP), 50 
mg, manufactured by Rhone Poulenc Rorer, Manati, Puerto Rico, in 
100 tablet bottles, which appeared in the June 23, 1999 
Enforcement Report has been extended to include lot numbers:  
MN2564 and MN2882 EXP 9/30/99.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS II
________
PRODUCT
Visualizer 2000 Diagnostic X-Ray System.  Recall #Z-1242-9.
CODE
Model XV 903 C, Serial Numbers 848001 through 848062. 
MANUFACTURER
VF-Works, Inc., Palm Harbor, Florida.
RECALLED BY
Manufacturer.  FDA approved the firm's corrective action plan on 
September 27, 1999.  Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
62 units.
REASON
All units are in noncompliance with 21 CFR 1020.32(b)(2) because 
the collimator was not properly designed to provide necessary x-
ray field limitation.  In addition, 25 of the units manufactured 
on or before July 29, 1997, are also in noncompliance with 21 CFR 
1020.32(h) because they were not equipped with a five-minute 
cumulative timer.
________
PRODUCT
Aztech 70 X-Ray System, intended for use in dental radiography.  
Recall #Z-1254-9.
CODE
Model Number: Aztech 70 Dental System.
MANUFACTURER
Villa Sistemi Medicali S.p.A.
RECALLED BY
The Aztech Group, Inc., Boulder, Colorado.  FDA approved the 
firm's corrective action plan on September 27, 1999.  Firm-
initiated field correction ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
19 units were distributed.
REASON
The diagnostic x-ray devices were found defective under 21 CFR 
1003.11.  The defect occurs as a result of incomplete equipment 
specifications on equipment manufactured before September 1, 
1999.
________
PRODUCT
Codman Surgical Patties (size 1/2 x 1/2 inch), sterile, indicated 
use is protection of tissue, including brain and other tissues of 
the central nervous system, during surgery.
Recall #Z-1260-9.
CODE
Product Code: 80-1400, Lot #CR528.
MANUFACTURER
Codman - A Johnson & Johnson Company, Norton, Massachusetts.
RECALLED BY
Codman - A Johnson & Johnson Company, Raynham, Massachusetts, by 
letters on August 20, 1999, and August 23, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
67,200 patties were distributed.
REASON
Surgical Patties incorrectly assembled without a radiopaque 
marker and string.
________
PRODUCT
Model 35040 Keithley Therapy Dosimeter, intended use for 
calibration of dosimetry of therapeutic radiation treatment 
machine for high energy accelerators, cobalt 60, and 
brachytherapy equipment.  Recall #Z-1261-9.
CODE
Serial Numbers:  69450-69469;  80276-80295;  82666-82685;  
81909-81928;  86087-86106;  86597-86616; and 88276-88295.
MANUFACTURER
Inovision Radiation Measurements, Cleveland, Ohio.
RECALLED BY
Manufacturer, by letters on July 8, 1999, and September 10, 1999. 
 Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
89 units.
REASON
An incorrect fuse was installed on units causing power failures 
from flown fuse.
________
PRODUCT
The Tracker Display Model #35360A is sold with the Detector Model 
#35300A and marketed together as the Keithley Model #90100 
Tracker System, a radiation measurement system intended for use 
in quality assurance programs for high energy accelerators, and 
cobalt 60 machines.
Recall #Z-1262-9.
CODE
Serial Numbers:  83728-83747;  84582-84601;  85682-85701;  and 
87309-87328.
MANUFACTURER
Inovision Radiation Measurements, Cleveland, Ohio.
RECALLED BY
Manufacturer, by letters on July 8, 1999, and September 10, 1999. 
 Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
40 units.
REASON
An incorrect fuse was installed on units causing power failures 
from blown fuse.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS III
________
PRODUCT
The Kid Kart 19-Inch Lap Belts, a component of mechanical chair 
with casters.  Recall #Z-1239-9.
CODE
Part#: 9332100001, Model #s: EZ1, EZ2, EZB1, EZB2, EX1, EX2, 
EXB1, EXB2, SPICA, MT, MTB, AT, ATB, T-RACER.
MANUFACTURER
Sunrise Mobility Products Division, Kid Kart Operations, 
Belgrade, Montana.
RECALLED BY
Sunrise Medical, HHG, Mobility Products Division, Fresno, 
California, by letters dated August 17, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
68 units were distributed.
REASON
The lap belts were assembled incorrectly.
________
PRODUCT
Port-A-CATH Implantable Access System, designed to permit 
repeated access to the vascular system for the parenteral 
delivery of medications, nutritional solutions, and other fluids 
and for the sampling of venous blood.
Recall #Z-1259-9.
CODE
Catalog Number: 21-4023-22, Lot Number:  66161.
MANUFACTURERSims Deltec, Inc., St. Paul, Minnesota.
RECALLED BY
Manufacturer, by letter dated August 30, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Europe.
QUANTITY
122 units were distributed.
REASON
Product equipped with an incorrect size catheter introducer 
component.  The recalled lot contain size 6 French introducers 
rather than the specified size 8.5 French introducers.

MEDICAL DEVICE SAFETY ALERT
________
PRODUCT
Olympic Mini Bili-Lite, Model 70 and 71.
Safety Alert #N-010/011-9.
CODE
Catalog Numbers: 51470 and 51471.
MANUFACTURER
Burton Medical Products, Chatsworth, California.
ALERTED BY
Olympic Medical Corporation, Seattle, Washington, by fax during 
the week of September 7, 1999.
DISTRIBUTION
Nationwide and international.
QUANTITY
314 units were distributed.
REASON
Interior casting in Bili-Lites may fracture causing light to 
fall.

END OF ENFORCEMENT REPORT FOR OCTOBER 6, 1999.

####