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.
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.
________
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.
####
![[FDA HOME PAGE]](/icon/iconhome.gif)