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.

March 12, 1997 97-11

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT President's Choice brand: (a) Bittersweet
Chocolate Bars, 17.6 ounces; (b) Milk
Chocolate Bars, 17.6 ounces.
Recall #F-252/253-7.
CODE All Lots.
MANUFACTURER Societe Alimentaire du Forez, St. Etienne,
France.
RECALLED BY President's Choice International, Toronto,
Ontario, Canada, by E-mail followed by letter
dated December 30, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Illinois, Massachusetts, New York, Oregon,
Texas.
QUANTITY (a) 1,277 cases (24 bars per case); (b) 895
cases (24 bars per case) were distributed.
REASON Some candy bars may contain undeclared
hazelnuts or almonds.
_______________
PRODUCT Snow Crab Clusters, frozen, in 20 pound cases.
Recall #F-254-7.
CODE Master carton coded JA120796.
MANUFACTURER P Janes & Sons Ltd., Hants Harbour,
Newfoundland, Canada.
RECALLED BY Slade Gorton & Company, Inc., Boston,
Massachusetts, by letter issued December 26,
1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 1,337 cases were distributed.
REASON Product may be contaminated with Listeria
monocytogenes.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Glory Foods brand Southern Style String Beans,
& Potatoes, pre-seasoned, in 27 ounce cans.
Recall #F-243-7.
CODE Lot numbers: KD16X/KPGL, KD17X/KPGL,
KD18X/KPGL.
MANUFACTURER McCall Farms, Inc., Effingham, South Carolina.
RECALLED BY Manufacturer, by press release on May 10,
1996, and by telephone and letter on or about
May 2, 1996. Firm-initiated recall complete.
DISTRIBUTION Georgia, Kentucky, Ohio, Michigan, Tennessee,
North Carolina, Maryland, New Jersey.
QUANTITY 3,678 cases, 24 cans per case were
distributed.
REASON Product was contained in swollen cans and was
underprocessed.

_______________
PRODUCT Seagull brand Green Mango Sliced in Brine, in
16 ounce glass jars. Recall #F-244-7.
CODE All codes including TG-10.
MANUFACTURER Thai World Import & Export Company Ltd.,
Yannawa Bangkok, Thailand.
RECALLED BY Hong Thai Foods Corporation, Brooklyn, New
York (importer), by letter January 10, 1997.
Completed recall resulted from sample analysis
and follow-up by the New York State Department
of Agriculture and Markets.
DISTRIBUTION New York, New Jersey, Illinois, District of
Columbia.
QUANTITY 40 cases (24 jars per case) were distributed.
REASON Product contains undeclared sulfites and
undeclared FD&C Yellow No. 5.

_______________
PRODUCT Crystal Springs Pure Drinking Water, in 1
gallon plastic jugs. Recall #F-245-7.
CODE 35496, 36696, 00297, 00697, 00797, 00997,
01097, 01497, 01597, and 01697.
MANUFACTURER Crystal Springs Bottled Water Company, Inc.,
Hillsboro, Oregon.
RECALLED BY Manufacturer, by telephone beginning on
January 10, 1997, followed by fax, and by
press release on January 31, 1997. Firm-
initiated recall complete.

-2-DISTRIBUTION Oregon, Washington state, Idaho, Nevada,
California.
QUANTITY Product Code Cases Produced
35496 4,434
36696 4,584
00297 2,688
00697 2,622
00797 4,986
00997 2,058
01097 300
01497 2,952
01597 5,436
01697 3,660.
REASON Product contains excessive levels of chlorine.

_______________
PRODUCT Key Lime Sherbet and Tangerine Sherbet
packaged in 1 quart size clear plastic
containers with labeling on the lid.
Recall #F-255/256-7.
CODE None. All product with undeclared FD&C Yellow
No. 5 is under recall.
MANUFACTURER Coleman's Ice Cream, Inc., Lancaster,
Pennsylvania.
RECALLED BY Manufacturer, by relabeling product beginning
on or about February 11, 1997. Firm-initiated
field correction ongoing.
DISTRIBUTION Pennsylvania.
QUANTITY Approximately 25 quarts were distributed.
REASON Products contain undeclared FD&C Yellow No. 5.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT MW Polar brand Baby Clams, in 10 ounce metal
cans. Recall #F-251-7.
CODE Four 3-line codes are involved:
H14 H14 H14 H14
940615 940616 940617 940618
555S 555S 555S 555S.
MANUFACTURER State Run, Rongcheng Canning Factory, China.
RECALLED BY MW Polar Foods, Inc., doing business as Milky
Way Int'l Trading Corporation, Buena Park,
California, by letter on November 11, 1994.
Firm-initiated recall complete.
DISTRIBUTION Eastern United States.
QUANTITY Approximately 3,000 cases were distributed;
firm estimates none remains on the market.
REASON Product was decomposed and was held in swollen
cans.

-3-RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Platelets. Recall #B-385-7.
CODE Unit numbers: 2488424, 2488425, 2488246,
2488431, 1802383, 1902931, 1902937, 1902936,
1902938, 1902939.
MANUFACTURER Central Indiana Regional Blood Center, Inc.,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by telephone on June 11, 1996.
Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 10 units were distributed.
REASON Blood products were prepared from units of
whole blood which were shipped at unacceptable
temperatures.

_______________
PRODUCT Plasma Apheresis Bowl, Model 00625B, with
Ultra-Sonic Weld & Sterile Fluid Path, used
with Haemonetics Plasma Collection System.
Recall #B-432-7.
CODE Lot numbers T96 (starts with T96001), U96,
V96, W96 (ends W96069):
T96001-T96009; T96012-T96030; T96032-T96038;
T96040-T96069; T96071; T96073-T96085;
T96088-T96089; T96092-T96095; T96098-T96099;
T96102-T96107; T96110; T96112-T96114;
T96116-T96119; T96121-T96125; T96129-T96131;
T96134; T96136-T96137; T96141; T96143; T96144;
T96147-T96149; T96152-T96154; T96158.
U96015-U96027; U96029-U96037; U96039-U96042;
U96044-U96045; U96048-U96051; U96053-U96062;
U96064-U96070; U96072-U96078; U96080-U96082;
U96084-U96112.
V96001-V96007; V96010-V96012; V96014-V96019;
V96021-V96022; V96026-V96028; V96031-V96032;
V96034-V96035; V96037-V96039; V96041;
V96043-V96050; V96052-V96056; V96058-V96062;
V96064-V96065; V96067-V96087; V96091-V96092;
V96094; V96096-V96098; V96100-V96106;
V96108-V96139; V96141-V96145; V96147-V96153;
V96155- V96159; V96163.
W96001-W96004; W96007-W96008; W96010;
W96012-W96013; W96015; W96017-W96022;
W96024-W96030; W96032-W96037; W96039-W96042;
W96044-W96045; W96047-W96049; W96051-W96058;
W96060-W96080; W96085-W96086; W96088-W96089;
W96093-W96094; W96097-W96101; W96105-W96106;
W96108-W96110; W96113-W96115; W96117; W96120;
W96123; W96138; W96146; W96148; W96151;
W96154; W96157; W96160; W96161; W96163;
W96164.
-4-MANUFACTURER Haemonetics Corporation, Leetsdale,
Pennsylvania.
RECALLED BY Haemonetics Corporation, Braintree,
Massachusetts, by fax on February 20, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION California, Florida, Georgia, Iowa, Indiana,
Massachusetts, New York, Oklahoma,
Pennsylvania, South Carolina, Tennessee.
QUANTITY 2,073,099 bowls were distributed.
REASON Plasma Apheresis Bowls, determined to have an
incomplete seal in the ultrasonic weld joint
causing the bowl to leak during normal
plasmapheresis operations.

_______________
PRODUCT Platelets. Recall #B-434-7.
CODE Unit #20262-0505.
MANUFACTURER Blood Systems, Inc., doing business as United
Blood Services, Lafayette, Louisiana.
RECALLED BY Manufacturer, by telephone on January 22,
1996. Firm-initiated recall complete.
DISTRIBUTION Louisiana.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit which
was collected from a donor who had taken
aspirin within three days of donation.

_______________
PRODUCT Platelets. Recall #B-435-7.
CODE Unit #4515053.
MANUFACTURER Central Indiana Regional Blood Center,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by telephone on January 10,
1996, followed by letter dated January 18,
1996. Firm-initiated recall complete.
DISTRIBUTION Utah.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit which
was collected from a donor who had taken
aspirin within three days of donation.

_______________
PRODUCT BayRab brand, Rabies Immune Globulin (Human).
Recall #B-459-7.
CODE Lot #618R01A, EXP 21MAR98 (2 ml vials),
618R01B, EXP 21MAR98 (10 ml vials).
MANUFACTURER Bayer Corporation, Clayton, North Carolina.
RECALLED BY Manufacturer, by letter on December 2, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 6,000 doses of single dose vials
were distributed.
-5-REASON Product was labeled as preservative free but
contained low levels of thimerosal.

_______________
UPDATE Fluogen (Influenza Virus Vaccine, Trivalent,
Types A & B), an extension of Recall #B-117-7,
which appeared in the December 11, 1996
Enforcement Report.
CODE Syringes: Lot #00296P.
Vials: Lot numbers: 00376P, 00476P, 00596P,
00696P, 01186P, 01286P, 01386P.
MANUFACTURER Warner-Lambert Company, Parke-Davis,
Sterile Products Division, Rochester,
Michigan.
RECALLED BY The Parke-Davis Division of Warner-Lambert
Company, Morris Plains, New Jersey, letter on
February 12, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 551,000 units were distributed.
REASON Parke-Davis Fluogen showed a decrease in
potency of one component of the vaccine after
distribution.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Platelets, Pheresis. Recall #B-433-7.
CODE Unit #53LT50303.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated July 22, 1996.
Firm-initiated recall complete.
DISTRIBUTION District of Columbia.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with
an unacceptable health history.

_______________
PRODUCT Monoclate-P Antihemophilic Factor (Human),
Factor VIII:C Pasteurized, Monoclonal Antibody
Purified. Recall #B-436-7.
CODE Lot P68201 EXP 01/18/98.
MANUFACTURER Centeon L.L.C., Kankakee Industrial
Operations, Kankakee, Illinois.
RECALLED BY Centeon L.L.C., A Company of Armour and
Behring, King of Prussia, Pennsylvania, by
letter dated February 19, 1997. Firm-
initiated recall ongoing. See also FDA talk
paper T96-67, October 4, 1996.
DISTRIBUTION Nationwide.
-6-QUANTITY 1,908 vials were distributed; firm estimated
that little if any product remained on market
at time of recall initiation.
REASON Reconstitution difficulties in that vials
failed to transfer all of the diluent into a
lyophilized product.

RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS II =========
_______________
PRODUCT Sensi-Touch Regional Anesthesia Delivery
System, Spinal Anesthesia Tray, Catalog #8888-
828111, 22 ga plastic hub, diamond point,
Marcaine. Recall #Z-297-7.
CODE Lot #801685.
MANUFACTURER Kelsar S.A., Tijuana, B.C., Mexico.
RECALLED BY Sherwood Davis & Geck, St. Louis, Missouri, by
letter on January 31, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Michigan, Missouri, Connecticut, Texas, New
Jersey, Kentucky, Minnesota, Pennsylvania,
Massachusetts.
QUANTITY 400 trays were distributed between 8/25/96 and
1/27/97.
REASON The tray incorrectly identifies the contents
as product/catalog No. 8888-826115 containing
Tetracaine, however, it actually contains
Marcaine.

_______________
PRODUCT Imatron CT Scanner, a component of the patient
table potentiometer assembly
(Y-potentiometer): (a) Imatron C100 CT
Scanner; (b) Imatron C150 Series Scanners.
Recall #Z-298/299-7.
CODE Various model numbers and serial numbers are
involved.
MANUFACTURER Imatron, Inc., South San Francisco,
California.
RECALLED BY Manufacturer, by sending an "Advance Letter"
in July 1996, and issuing its own Field
Modification Instructions, followed by visit.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 81 units were distributed.
REASON The table would go beyond its limits and could
not be driven back due to a blown fuse.

_______________
PRODUCT Model CRC Laser Profilometer, used to
determine the surface characteristics of
paper. Recall #Z-300-7.
CODE None.
-7-MANUFACTURER International Paper Company, Tuxedo, New York.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan on March 1, 1997.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2 units were distributed.
REASON Noncompliance with performance standards for
laser products in that the products failed to
incorporate required safety interlocks on the
operator access door.

_______________
PRODUCT EEG Tend Monitor, Model OEE-7102B, intended
for long term EEG monitoring and analysis.
Recall #Z-303-7.
CODE Serial numbers: 00003, 00004, 00006-00016,
00020-00023, 00031, 00033-00035, 00038, and
00043.
MANUFACTURER Nihon Kohden Corporation, Shinjuku-Ku, Tokyo,
Japan.
RECALLED BY Nihon Kohden America, Inc., Irvine,
California, by letter dated October 16, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Arizona, California, Illinois, Kansas,
Louisiana, South Dakota, Texas, Utah.
QUANTITY 23 units were distributed.
REASON When the 12V DC power supply conductor is
broken, and the main power is turned on, a
higher than acceptable current leakage is
applied to the monitoring electrodes and a
chemical reaction is generated with EEG paste,
which can discolor the patient's skin when the
electrodes are placed on the patient skin.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Neurosign Straight Concentric Bipolar Probe
with Touch Proof Connectors, Catalog #7033-
0919, an accessory to the Neurosign 100 Motor
Nerve Monitor. Recall #Z-293-7.
CODE Serial numbers: 076, 078, 079, 080, 081, 082,
083, 084, 085, 087.
MANUFACTURER The MAGSTIM Company Ltd., United Kingdom.
RECALLED BY Smith & Nephew ENT, Smith & Nephew Richards,
Inc., Bartlett, Tennessee, by fax on October
16, 1996. Firm-initiated recall complete.
DISTRIBUTION Arizona, Kentucky, New York, Texas, Washington
state, Wisconsin.
QUANTITY 8 units were distributed and are accounted
for.
-8-REASON The device is subject to possible extrusion of
silicone from the end of the probe when the
device was autoclaved by the manufacturer.

_______________
PRODUCT Incstar VCA IgG Clin-ELISA Test Kit, Product
#4590, an in-vitro diagnostic test kit for
detecting antibodies in human serum to
Epstein-Barr Viral Capsid Antigen (VCA).
Recall #Z-294-7.
CODE Lot #395406.
MANUFACTURER Incstar Corporation, Stillwater, Minnesota.
RECALLED BY Manufacturer, by letter on February 3, 1997.
Firm-initiated recall complete.
DISTRIBUTION California, New Jersey, New York,
international.
QUANTITY 131 kits were distributed.
REASON Some negative samples may yield a positive
assay response.

_______________
PRODUCT Cytomegalovirus IgM ELISA Test Kit, Product
#2325250, used for the qualitative
determination of IgM antibody to
cytomegalovirus in human serum.
Recall #Z-302-7.
CODE Lot numbers 108 and 109.
MANUFACTURER Clark Laboratories, Inc., Jamestown, New York.
RECALLED BY Manufacturer, by letter January 23, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 495 kits were distributed.
REASON The absorbance values for controls and
specimens are lower than expected.

_______________
PRODUCT C-150XP CT Scanner Installed with Software
Version 12.22. Recall #Z-304-7.
CODE All models with 12.22 version software.
MANUFACTURER Imatron, Inc., South San Francisco,
California.
RECALLED BY Manufacturer, by "Software Notice" letter on
August 28, 1996. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 30 units were distributed.
REASON The device's software version 12.22 contains
an error which prevents it from detecting an
unexpected stop in table motion during certain
low velocity Continuous Volume Studies (CVS),
resulting in unnecessary x-ray radiation
exposures to the patient.

-9-________________
PRODUCT Software Versions 11.53 and 12.13 installed in
computed tomography scanners:
(a) Model C-100; (b) Model C-150XP;
(c) Model C-150L. Recall #Z-305/307-7.
CODE Models C100, C150XP, and C150L.
MANUFACTURER Imatron, Inc., South San Francisco,
California.
RECALLED BY Manufacturer, by sending Software Notice #20
on or about November 16, 1995. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 37 units were distributed.
REASON During reconstruction of images, the Fast
Reconstruction System software (FSR) may
produce an error condition which the computer
may interpret as a warning, causing the
computer to display erroneous data for the
image.

_______________
PRODUCT Nellcor Symphony N-3000 Pulse Oximeter, Model
N-3000. Recall #Z-308-7.
CODE 111 units with suspect printed circuit boards,
each with an individual serial number.
MANUFACTURER Nellcor Puritan Bennett, Inc., Chula Vista,
California.
RECALLED BY Nellcor Puritan Bennett, Inc., Carlsbad,
California, by letter on October 23, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 111 units were distributed.
REASON The device may be potentially subject to
printed circuit board damage which can result
in the monitor reporting Sp02 values slightly
outside the normal accuracy range stated in
the Operations Manual.

MEDICAL DEVICE SAFETY ALERTS: ==============================
_______________
PRODUCT Sherpa Vector and Sherpa Vector X Coronary
Guiding Catheters, designed to provide a
pathway through which therapeutic devices are
introduced:
(a) Vector 6F, Catalog numbers PA5xx;
(b) Vector 7F, Catalog numbers AS7xxx;
(c) Vector 8F, Catalog numbers AS8xxx;
(d) Vector X 6F, Catalog numbers S26xxx;
(e) Vector X 7F, Catalog numbers S27xxx;
(f) Vector X 8F, Catalog numbers S28xxx.
Safety Alert #N-007/012-7.

-10-CODE All lots.
MANUFACTURER Medtronic Interventional Vascular Inc.,
Danvers, Massachusetts.
ALERTED BY Manufacturer, by letter on November 25, 1996.
DISTRIBUTION Nationwide.
QUANTITY Approximately 38,796 units were distributed.
REASON Resistance may be experienced while passing
interventional devices through the lumen of
the guiding catheter, which may result in the
inability to move the interventional device
within the lumen of the guiding catheter.

-11-

END OF ENFORCEMENT REPORT FOR MARCH 12, 1997. BLANK PAGES MAY FOLLOW.

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End of Enforcement Report for