FDA

Enforcement Report

November 17, 1999                                              99-46

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS I
________
PRODUCT
Chocolate Covered Raisins, in 7 ounce clear plastic packages, 
labeled in part Western Family Quality Candies.  Recall #F-046-0.
CODE
17 59 59016.
MANUFACTURER
Associated Food Stores, Inc., Salt Lake City, Utah (repacker).
RECALLED BY
Repacker, by fax on June 15, 1999, and by press release issued by 
Western Family Foods, Inc., Portland, Oregon, on June 24, 1999.  
Firm-initiated recall complete.
DISTRIBUTION
Arizona, Colorado, Idaho, Montana, Nevada, Oregon, Utah, 
Washington state, Wyoming.
QUANTITY
116 cases (17 packages per case) were distributed.
REASON
Product contains undeclared chocolate covered peanuts.
________
PRODUCT
Chef's brand Pickled Lotus Rootlet (Cu' Sen Muoi) in 16 ounce 
glass jars.  Recall #F-047-0.
CODE
None.
MANUFACTURER
N.A. Food Products Company, Ltd., Sampran, Nakornprathom, 
Thailand.
RECALLED BY
Vasinee Food Corporation, Brooklyn, New York (importer), by press 
release on April 6, 1999, and by letter on April 12, 1999.  
Completed field correction (relabeling) resulted from sample 
analysis and follow-up by the New York State Department of 
Agriculture and Markets.
DISTRIBUTION
Massachusetts, New York, Rhode Island, Connecticut, New Jersey.
QUANTITY
99 cartons (24 jars per carton) were distributed.
REASON
Product contained undeclared sulfites.
________
PRODUCT
El Abuelito Queso Fresco Cheese, in 1 pound plastic conainers.  
Recall #F-048-0.
CODE
None.
MANUFACTURER
El Abuelito Cheese, Inc., Passaic, New Jersey.
RECALLED BY
Manufacturer, by telephone on June 1, 1999.  Completed recall 
resulted from sample analysis and follow-up by the New York State 
Department of Agriculture and Markets and the New Jersey State 
Department of Health.
DISTRIBUTION
New Jersey and New York.
QUANTITY
500 1-pound containers were distributed; firm estimates none 
remains on the market.
REASON
Product is contaminated with Listeria monocytogenes.
________
PRODUCT
Assorted Cookies (actually a tray of candied fruits and 
vegetables).  Recall #F-049-0.
CODE
None.
MANUFACTURER
Ever Billion Enterprise Ltd., Hong Kong, China.
RECALLED BY
BCN Trading Inc., Brooklyn, New York, by letter dated February 
10, 1999.  Firm-initiated recall complete.
DISTRIBUTION
New York, Connecticut, New Jersey, Massachusetts, Pennsylvania, 
Florida, Maryland, Georgia, District of Columbia.
QUANTITY
Undetermined.
REASON
Product contained undeclared sulfites.
________
PRODUCT
Fresh Express Farms brand: a) Fat Free Caesar Salad Kit in 7.5 
ounce plastic bags; b) Low Fat Caesar Salad Kit, in 10 ounce 
plastic bags.  Recall #F-051/052-0.
CODE
S229A and S229B.
MANUFACTURER
Fresh Express - West, Salinas, California.
RECALLED BY
Fresh Express Farms, Inc., Salinas, California, by telephone on 
August 18, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Washington state, Oregon, Arizona, Colorado, Utah, Texas, Iowa, 
Kansas, California, Oklahoma, Hawaii, Alaska.
QUANTITY
1,094 cases were distributed; firm estimates none remains on the 
market.
REASON
The egg-free salad dressing component of the kit was
unintentionally replaced with a Caesar Light Dressing which
contains egg yolks.  However, the label of the kit does not
declare eggs.

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS II
________
PRODUCT
Autumn Party Cookies, Autumn Shortbread, in 11 ounce plastic 
clamshell containers.  Recall #F-042-0.
CODE
Lot Numbers:  017C11, 034A11, 034A21, 034A31, 034B31, 035A11, 
035A31, 038A21, 039B11, 039B21, 039B31
MANUFACTURER
Parco Foods, L.L.C., Blue Island, Illinois.
RECALLED BY
Manufacturer, by telephone on October 22, 1999, followed by 
telephone and fax.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
4,255 cases of cookies were distributed; firm estimated that 30 
percent remained on market at time of recall initiation.
REASON
Product contained undeclared whey and whey protein.
________
PRODUCT
Green Giant Create a Meal Oven Roasted Garlic Herb Chicken, "Meal 
Starter", net weight 1 LB. 10 OZ. in retail plastic bags; and 
cases of Green Giant Create a Meal Oven Roasted Parmesan Herb 
Chicken, which each should contain twelve Green Giant Create a 
Meal Oven Roasted Parmesan Herb Chicken packages, net weight 1 
LB. 10 OZ., but contain some packages labeled Green Giant Create 
a Meal Oven Roasted Garlic Herb Chicken, net weight 1 LB. 10 OZ. 
 Recall #F-050-0.
CODE
Retail Package Code: 19S13; Case Code Date: 9-13-99 S.
MANUFACTURER
J.R. Simplot Company, Syracuse, New York.
RECALLED BY
The Pillsbury Company, Minneapolis, Minnesota, by electronic mail 
on October 21, 1999, and by issuing a notice to the Food Allergy 
Network.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
2,135 cases (12 packages per case) were distributed.
REASON
Product contains undeclared dairy and soy ingredients.
________
PRODUCT
12 Piece Porcelain Coffee Set (6 cups and 6 saucers), product 
from China.  Recall #F-053-0.
CODE
Manufacturer's Design Or Pattern Number: 29034.
MANUFACTURER
Raoping Shengxing Porcelain Craft Company, Ltd., Guandong 
Province, China.
RECALLED BY
Aroma Trading Corporation, Vernon, California, by letter on 
September 16, 1999.  Firm-initiated recall complete.
DISTRIBUTION
California.
QUANTITY
149 cases were distributed.
REASON
The saucers of the coffee sets contain excessive levels of 
leachable lead.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS II
________
PRODUCT
Spline HA-Coated Cylinder Dental Implants (Endosseous Implants), 
Part #1852.  Recall #Z-130-0.
CODE
Lot Numbers: Lot No.  990530, 990652, 990820.
MANUFACTURER
Sulzer Calcitek Inc., Carlsbad, California.
RECALLED BY
Manufacturer, by telephone and fax on May 3, 1999.  Firm-
initiated recall complete.
DISTRIBUTION
Nationwide and internationl.
QUANTITY
1,010 implants were distributed.
REASON
13mm and 15mm implants were interchanged, each size in trays 
intended (labeled) for the other.
________
PRODUCT
a) Percutaneous Transluminal Angioplasty (PTA) Catheter, Catalog 
Numbers: PTA-OS253, 303 and 403
b) Z-MED Dilation Catheter, Catalog #PDZ-S
c) Z-MED II Dilatation Catheter, Catalog Numbers PDS-630, 643 and 
655
d) PTA-OS Balloon Catheter, Catalog Numbers: VSB-030 and 040
e) Ghost II Dilation Catheter, Catalog Numbers GII-109, 113, 121, 
129, 130, 137, 138, 141.  Recall #Z-135/139-0.
CODE
Lot Numbers:
a) OS-0013 THRU OS-0014, AND OS-0022 THRU OS-0024
b) Z-0774
c) ZZ-0240 THRU ZZ-0242
d) OS-0025/0026 
e) GG0138 THRU GG0145
MANUFACTURER
NuMed, Inc., Hopkinton, New York.
RECALLED BY
Manufacturer, by fax sent between January 29, 1999 and February 
5, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Massachusetts, United Kingdom, South Africa.
QUANTITY 
302 catheters were distributed.
REASON
Non-sterility.
________
PRODUCT
IMMULITE Anti-Thyroglobulin Antibody and IMMULITE Anti-Thyroid 
Peroxidase Antibody, for in-vitro diagnostic use:
a) IMMULITE Anti-Thyroglobulin Antibody - 50 Tests;
b) IMMULITE Anti-Thyroglobulin Antibody - 100 Tests;
c) IMMULITE Anti-Thyroglobulin Antibody - 500 Tests;
d) IMMULITE Anti-Thyroid Peroxidase Antibody - 50 Tests;
e) IMMULITE Anti-Thyroid Peroxidase Antibody - 100 Tests;
f) IMMULITE Anti-Thyroid Peroxidase Antibody - 500 Tests.
Recall #Z-154/159-0.
CODE
a) Catalog No. LKTGZ, Lot Nos. 135 through 139, EXP 7/30/99; Lot 
No. 140, EXP 8/31/99; Lot Nos. 141, 142, EXP 9/30/99; and Lot 
Nos. 144, 145, EXP 10/31/99; 
b) Catalog No. LKTG1, Lot Nos. 135 through 139, EXP 7/30/99; Lot 
No. 140, EXP 8/31/99; Lot Nos. 141, 142, EXP 9/30/99; and Lot 
Nos. 144, 145, EXP 10/31/99;
c) Catalog No. LKTG5, Lot Nos. 135 through 139, EXP 7/30/99; Lot 
No. 140, EXP 8/31/99; Lot Nos. 141, 142, EXP 9/30/99; and Lot 
Nos. 144, 145, EXP 10/31/99;
d) Catalog No. LKTOZ, Lot No. 143, EXP 4/30/99; Lot No. 144, EXP 
6/30/99; Lot Nos. 145, 146, EXP 8/31/99; Lot No. 147, EXP 
9/30/99; Lot No.148, 149, EXP 10/31/99; Lot No. 150, EXP 
11/30/99;
e) Catalog No. LKTO1, Lot No. 143, EXP 4/30/99; Lot No. 144, EXP 
6/30/99; Lot Nos. 145, 146, EXP 8/31/99; Lot No. 147, EXP 
9/30/99; Lot No.148, 149, EXP 10/31/99; Lot No. 150, EXP 
11/30/99;
f) Catalog No. LKTO5, Lot No. 143, EXP 4/30/99; Lot No. 144, EXP 
6/30/99; Lot Nos. 145, 146, EXP 8/31/99; Lot No. 147, EXP 
9/30/99; Lot No.148, 149, EXP 10/31/99; Lot No. 150, EXP 
11/30/99.
MANUFACTURER
Euro/DPC Ltd., Gwynedd, United Kingdom.
RECALLED BY
Diagnostic Products Corporation, Los Angeles, California, by 
telephone July 15-16, 1999, followed by faxed technical bulletin. 
 Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and United Kingdom.
QUANTITY
1,269 kits were distributed.
REASON
The sample diluent is non-homogeneous and may produce inaccurate 
test results.
________
PRODUCT
PORT-A-CATH Implantable Access Systems in kits and trays.  The 
kits each contain a "portal" and a catheter, and the trays each 
contain a portal, a catheter and an introducer set:
Titanium Venous System (kit), Product Numbers 21-4024 and 21-
4024-22 (the Numbers ending in -22 are for exported product)
Titanium Venous System (tray), product Numbers 21-4025 and 21-
4025-22
Low Profile Titanium Venous System (kit), product Numbers 21-4036 
and 21-4036-22
Low Profile Titanium Venous System (tray), product Numbers 21-
4037 and 21-4037-22
Port-A-Cath II Polysulfone/Titanium Venous System (kit), product 
Numbers 21-4052 and 21-4052-22  
Port-A-Cath II Polysulfone/Titanium Venous System (tray), product 
Numbers 21-4053 and 21-4053-22  
Port-A-Cath II Low Profile Polysulfone/Titanium Venous System 
(kit), product Numbers 21-4082 and 21-4082-22  
Port-A-Cath II Low Profile Polysulfone/Titanium Venous System 
(tray), product Numbers 21-4083 and 21-4083-22  
P.A.S PORT Titanium Venous System (kit), product Number 21-4500
P.A.S PORT Fluoro-Free Titanium Venous System (kit), product 
Number 21-4505
P.A.S PORT Fluoro-Free Titanium Venous System (tray), product 
Number 21-4506 
P.A.S PORT T2 Titanium Venous System (kit), product Numbers 21-
4572 and 21-4572-22
P.A.S PORT T2 Titanium Venous System (tray), product Numbers 21-
4573 and 21-4573-22
Port-A-Cath II Fluoro-Free Polysulfone/Titanium Venous System 
(tray), product Number 21-4653 
P.A.S PORT T2 Fluoro-Free Titanium Venous System (kit), product 
Numbers 21-4672 and 21-4672-22
P.A.S PORT T2 Fluoro-Free Titanium Venous System (tray), product 
Numbers 21-4673 and 21-4673-22
Port-A-Cath II Low Profile Fluoro-Free Polysulfone/Titanium 
Venous System (tray), product Numbers 21-4683 and 21-4683-22.  
Recall #Z-160/169-0.
CODE
Product Number   Lot Numbers
21-4024          66596   67174   67672   66597   66930
                 67175   67445   67673
21-4025          66598   66931   67176   67446   67674
                 67929   66599   67177   67447   67675
                 67930
21-4036          66601   67179   67450   66362   66602
                 66934   67180   67451   67678
21-4037          66603   66935   66365   66604   66936
                 67181   67452
21-4052          66368   66607   66939   67183   67680
                 66369   66608   67184   67681   67939
21-4053          66370   66609   66940   67185   67453
                 67682   66371   66610   66941   67186
                 67454   67683
21-4082          66571   66948   67191   67459   67690
                 66381   66619   66949   67460   67691
21-4083          66382   66620   66950   67193   67462
                 67692   66621   66951   67194   67463
                 67693
21-4500          66623   66721   66752   66952   67195
                 67464
21-4505          67196   67716
21-4506          67197   67477
21-4572          66728   67125   67465   67694   67952
                 66729   67466   67695
21-4573          66731   67127   67468   67696   66732
                 67469   67697
21-4653          66631   66958   67198   67470   67698
21-4672          66960   67129   67471   66961   67130
                 67700   67814
21-4673          66733   66962   67131   67472   66734
                 66963   67132   67473
21-4683          66632   66964   67474   67701   66633
                 66965   67201   67702.
MANUFACTURER
Sims Deltec, Inc., St. Paul, Minnesota.
RECALLED BY
MANUFACTURER, by letter dated October 18, 1999. 
 Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
17,485 implantable access systems were distributed
REASON
Fracture of device catheter can result in leaks.
________
PRODUCT
Revision J Software in the Nellcor Puritan Bennett, 740 
Ventilator System and 760 Ventilator System.
Recall #Z-170/171-0.
CODE
Any ventilator with REV J Software.
MANUFACTURER
Nellcor Puritan Bennett Ireland, Ltd., Galway, Ireland.
RECALLED BY
Mallinckrodt, Inc., St. Louis, Missouri, by letter dated 
September 13, 1999.  Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
223 units.
REASON
Software can cause under or over-delivery of oxygen.
________
PRODUCT
Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, a 
sterile non-conductive tubing used with a vacuum-powered suction 
apparatus.  Recall #Z-172-0.
CODE
Catalog #N510, Lot Y9J1813.
MANUFACTURER
Allegiance Healthcare Corporation, Mexicali-Baja Cal, Mexico.
RECALLED BY
Allegiance Healthcare Corporation, McGaw Park, Illinois, by leter 
dated October 28, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
8,340 units were distributed.
REASON
The outer package seal may not hold, thus the sterility of the 
product may be compromised.
________
PRODUCT
ALM Prismalix (PRX)  Ceiling Mounted Surgical Lighting System, 
used to provide visible illumination of surgical 
patients and other patient examination procedures:
a) PRX 6401 Series;
b) PRX 8401 Series;
c) PRX 6601 Series;
d) PRX 8601 Series;
e) PRX 4401 Series;
f) PRX 6441 Series;
g) PRX 8441 Series; 
h) PRX 4441 Series; 
i) PRX 6001 Series;
j) PRX 8001;
k) PRX 4001 Series;
l) PRX 4401 Series;
m) PRX 4441 Series;
n) PRX 6601.  Recall #Z-176/189-0.
CODE
MODEL NUMBER   MODEL DESCRIPTION
0032           PRX 6401 ACS/DF/CFF
50118          PRX 6401 ACS/DF/VZ
50116          PRX 6401/ACS/SF/CFF
50117          PRX 6401 ACS/SF/VZ
50077          PRX 6401 SA/DF/CFF
50037          PRX 6401 SA/DF/VZ
50107          PRX 6401 SA/SF/CFF
50036          PRX 6401 SA/SF/VZ
50048          PRX 8401 ACS/DF/CFF
50127          PRX 8401 ACS/DF/VZ
50125          PRX 8401 ACS/SF/CFF
50126          PRX 8401 ACS/SF/VZ
50122          PRX 6601 ACS/CFF
50123          PRX 6601 ACS/VZ
50129          PRX 8601 ACS/CFF
50130          PRX 8601 ACS/VX
50010          PRX 4401 SAI/DF/CFF
50013          PRX 4401 SAI/DF/VZ
50012          PRX 4401 SAI/SF/CFF
50105          PRX 4401 SAI/SF/VZ
50038          PRX ACS/DF/CFF
50121          PRX 6441 ACS/DF/VZ
50119          PRX 6441 ACS/SF/CFF
50120          PRX 6441 ACS/SF/VZ
50147          PRX 6441 SA/DF/CFF
50148          PRX 6441 SA/DF/VZ
50108          PRX 6441 SA/SF/CFF
50109          PRX 6441 SA/SF/VZ
50128          PRX 8441 ACS/DF/CFF
50053          PRX 8441 ACS/DF/VZ
50149          PRX 8441 ACS SF/CFF
50150          PRX 8441 ACS/SF/VZ
50018          PRX 4441 SAI/DF/CFF
50101          PRX 4441 SAI/DF/VZ
50100          PRX 4441 SAI/SF/CFF
50102          PRX 4441 SAI/SF/VZ
50115          PRX 6001 ACS/T
50095          PRX 6001 SA/T
50124          PRX 8001 ACS/T
50004          PRX 4001 SAI/DF/T
50005          PRX 4001 SAI/SF/T
50015          PRX 4401 SAD/DF/CFF
50114          PRX 4401 SAD/DF/VZ
50112          PRX 4401 SAD/SF/CFF
50113          PRX 4401 SAD/SF/VZ
50021          PRX 4441 SAD/DF/CFF
50103          PRX 4441 SAD/DF/VZ
50106          PRX 4441 SAD/SF/CFF
50104          PRX 4441 SAD/SF/VZ
50111          PRX 4001 SAD/DF/T
50110          PRX 4001 SAD/SF/T
50046          PRX 6601 SA/T.
There are 491 devices under recall representing 52 different 
models (noted directly above) and with each having a different 
serial number.
MANUFACTURER
ALM SA, Parc De Limere, Ardon Orleans Cedex.
RECALLED BY
ALM Surgical Equipment, Inc., Anaheim, California, by telephone 
on September 17, 1999, followed by visit.  Firm-initiated field 
correction ongoing.
DISTRIBUTION
Nationwide, Guam, Canada.
QUANTITY
491 devices were distributed.
REASON
The main arm of the device may fall from the shaft because of 
missing shaft-retaining clips.
________
PRODUCT
Sri brand of Surgical Procedure Packs, an assembly of finished 
medical devices and other items used during the preparation 
and/or performance of surgical/medical procedures: 
a) Pack No. 1003C; b) Pack No. 1003D;
c) Pack No. 1724C; d) Pack No. 1808D;
e) Pack No. 2082A; f) Pack No. 2104D;
g) Pack No. 2106D; h) Pack No. 4148; 
i) Pack No. 7047A.  Recall #Z-190/198-0.
CODE
Sterilized under Lot #7192574150,
Work Order/Lot Numbers: a). 266908; b). 296909;
c) 296934; d) 296936; e) 296956; f) 296960;
g) 296961; h) 296973; i) 297054.
MANUFACTURER
Sterile Recoveries, Inc., Long Beach, California.
RECALLED BY
MANUFACTURER, by hand-delivered letter dated 
September 15, 1999.  Firm-initiated recall complete.
DISTRIBUTION
California.
QUANTITY
410 units were distributed.
REASON
The devices were labeled and distributed as sterile devices 
without assurance that they were sterile.  The total number of 
packs sterilized on the load exceeded the maximum validated 
QUANTITY allowed per load.
________
PRODUCT
Tyshak brand Peripheral Balloon Dilation Catheter, Model 610532, 
Rated Burst Pressure: 3.5 ATM.  Recall #Z-199-0.
CODE
T-1774.
MANUFACTURER
NuMed, Inc., Hopkinton, New York.
RECALLED BY
Manufacturer, by telephone on August 26, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Pennsylvania.
QUANTITY
7 catheters were distributed.
REASON
The firm inadvertently attached a Tyshak II balloon to a Tyshak I 
catheter.  The Tyshak I catheter is labeled with a Rated Burst 
Pressure of 3.5 ATM.  The Tyhsak II balloon has a Rated Burst 
Pressure of 3.0 ATM. As a result, the balloon could burst prior 
to the labeled burst pressure.
________
PRODUCT
OXY-PEEP Oxygen Diluter Kit, Model P-63000, dilutes oxygen being 
administered to a patient.  Recall Z-200-0.
CODE
Lot Numbers:  6309DX, 6309EW, 6309GP, 6309HP, 6309EV, 6309GJ, 
6309HJ, 6309HY.
MANUFACTURER
Pegasus Research Corporation, Santa Ana, California.
RECALLED BY
Manufacturer, by letter dated October 11, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
516 units were distributed.
REASON
The exhalation valve in the mask may stick.
________
PRODUCT
Blood Collection Safety Systems as follows:
a)  Safe Point M-D, Multi-Draw Needle Cover System, 21 gauge x 1 
1/2" needle, packaged 150 or 200 pieces per box, or individually 
packaged. (Reorder No. N-621)
b) Safe Point M-D, Multi-Draw Needle Cover System, 22 gauge x 1 
1/2" needle, packaged 150 or 200 pieces per box, or individually 
packaged. (Reorder No. N-622)
c) Safe Point VAC Needle Cover System with Blood Collection 
Needle Vacutainer Holder, 22 gauge x 1 1/2" needle (some labeled 
with 1" needle), packaged 150 or 200 pieces per box, or 
individually packaged. (Reorder No. S-621 VAC)
d) Safe Point VAC Needle Cover System with Blood Collection 
Needle and Vacutainer Holder, 22 gauge x 1 1/2" needle, (some 
labeled with 1" needle) packaged 150 or 200 pieces per box, or 
individually packaged. (Reorder No. S-722VAC).
Recall #Z-201/204-0.
CODE
All lots currently on the marketplace produced prior to 9/15/99.
MANUFACTURER
North American Medical Products, Inc., Yorba Linda, California.
RECALLED BY
North American Medical Products, Inc., Albany, New York, by 
letters dated September 23, 1999, and November 1, 1999.  Firm-
initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
28,900 catheters (bulk lots).
REASON
Lack of assurance of sterility.
________
PRODUCT
Proclear Compatibles Daily Wear Contact Lens.  
Recall #Z-205-0.
CODE
416 lots of lenses each identified with a 10 digit reference 
number.
MANUFACTURER
Biocompatibles Eyecare, Inc., Norfolk, Virginia.
RECALLED BY
Manufacturer, by letter November 3, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
119,028 lenses were distributed in the United States.
REASON
Leaking blister seal of contact lens packaging compromised 
sterility.

END OF ENFORCEMENT REPORT FOR NOVEMBER 17, 1999.  BLANK PAGES MAY FOLLOW.

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