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.

December 26, 1996 96-52

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Piaxtla Mexican Style Corn Tortillas
(Blue/Green), in 32 ounce plastic bags.
Recall #F-130-7.
CODE None.
MANUFACTURER Tortilleria Piaxtla, Inc., Brooklyn, New York.
RECALLED BY Manufacturer, by letter dated October 18,
1996, followed by visit. Completed recall
resulted from inspection and followup by the
New York State Department of Agriculture and
Markets.
DISTRIBUTION New York.
QUANTITY 30 cases were distributed; firm estimates none
remains on the market.
REASON Product contains undeclared and unapproved
food coloring.

_______________
PRODUCT Holiday Candy Wreath, unlabeled, made of foil-
wrapped cherry and lime hard candies, braided
together. Recall #F-131-7.
CODE None.
MANUFACTURER Montes, Guadalahara, Mexico.
RECALLED BY Harry and David Corporation, Medford, Oregon
(distributor), by letter on November 26, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 113 wreaths were distributed.
REASON Product was shipped without an ingredient
statement and contained FD&C Yellow No. 5.

_______________
PRODUCT Ceramic Mugs, Garden Fresh Tableware Pattern:
(a) Carrot Design; (b) Corn Design; (c) Peas
Design; (d) Radish Design.
Recall #F-148/151-7.
CODE Sticker affixed on the bottom of the mugs read
in part: "*** Garden Fresh Mug Tabletops
Unlimited Made In China ***".
MANUFACTURER Jiangsu Yixing Ceramic Corporation, Yixing
City, Jiangsu, China.
RECALLED BY Tabletops Unlimited, Inc., Gardena, California
(importer), by letter on November 20, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION California, Kentucky, and international.
QUANTITY 14,040 mugs were distributed.
REASON The mugs contain excessive levels of leachable
lead.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Holsum 100% Pure Corn Oil, in 24 fluid ounce
plastic containers. Recall #F-132-7.
CODE H0796.
MANUFACTURER Ventura Foods, LLC (formerly Holsum Foods),
Waukesha, Wisconsin.
RECALLED BY Manufacturer telephone on September 20, 1996.
Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 174 cases (12 bottles per case) were
distributed.
REASON The product, labeled as 100% pure corn oil,
actually contains a blend of corn oil and
canola and/or soybean oil.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Amantadine Hydrochloride Capsules, USP, 100
mg, in bottles of 100 and 500, Rx indicated in
the treatment of idiopathic Parkinson's
disease. Recall #D-055-7.
CODE Lot #824959.
MANUFACTURER Chase Laboratories, Newark, New Jersey
(responsible firm).
RECALLED BY Banner Pharmacaps, High Point, North Carolina,
by letters on or about October 21, 1996.
Firm-initiated recall complete.
-2-DISTRIBUTION Nationwide.
QUANTITY 5,584 bottles were distributed.
REASON Product fails dissolution at 9 month stability
timepoint.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-079/081-7.
CODE Unit #36L20568.
MANUFACTURER American Red Cross, Columbia, South Carolina.
RECALLED BY Manufacturer, by telephone and by letter dated
October 2, 1995. Firm-initiated recall
complete.
DISTRIBUTION South Carolina, Virginia.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were incorrectly tested for
anti-HBc.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Recovered Plasma.
Recall #B-147/150-7.
CODE Unit numbers: (a) 1203886, 1263762, 1270937,
1285581, 1525012, 1541822, 1550335;
(b) 1270937; (c) 1270937; (d) 1203886,
1263762, 1541822, 1525012, 1285581.
MANUFACTURER Mississippi Blood Services, Inc., Jackson,
Mississippi.
RECALLED BY Manufacturer, by letters between the dates of
September 20, 1995, and July 18, 1996. Firm-
initiated recall complete.
DISTRIBUTION Mississippi, California, Switzerland.
QUANTITY (a) 7 units; (b) 1 unit; (c) 1 unit; (d) 5
units were distributed.
REASON Blood products tested negative for antibody to
the human immunodeficiency virus type 1 (anti-
HIV-1), but were collected from donors who
previously tested repeatedly reactive for
anti-HIV-1.

_______________
PRODUCT Red Blood Cells. Recall #B-156-7.
CODE Unit #53LV19980.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated June 5, 1996.
Firm-initiated recall complete.
DISTRIBUTION District of Columbia.

-3-QUANTITY 1 unit was distributed.
REASON Blood product was collected in a manner which
could have compromised the sterility of the
collection system.

_______________
PRODUCT Red Blood Cells. Recall #B-162-7.
CODE Unit #6E9304.
MANUFACTURER Puget Sound Blood Center, Seattle, Washington.
RECALLED BY Manufacturer, by telephone on April 11, 1996.
Firm-initiated recall complete.
DISTRIBUTION Washington state.
QUANTITY 1 unit was distributed.
REASON Blood product was positive for the Fya
antigen; was transfused to a patient with an
anti-Fya antibody.

_______________
PRODUCT Red Blood Cells. Recall #B-163-7.
CODE Unit #6E6336.
MANUFACTURER Puget Sound Blood Center, Seattle, Washington.
RECALLED BY Manufacturer, by telephone on January 21,
1995. Firm-initiated recall complete.
DISTRIBUTION Washington state.
QUANTITY 1 unit was distributed.
REASON Blood product was positive for the Kell (K)
antigen; was transfused to a patient with an
anti-K antibody.

_______________
PRODUCT Red Blood Cells. Recall #B-171-7.
CODE Unit #1530228.
MANUFACTURER Sylvan N. Goldman Center, Oklahoma Blood
Institute, Oklahoma City, Oklahoma.
RECALLED BY Manufacturer, by fax on February 22, 1996.
Firm-initiated recall complete.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
traveled to an area considered endemic for
malaria.

_______________
PRODUCT Recovered Plasma. Recall #B-175-7.
CODE Unit 1K1614.
MANUFACTURER Puget Sound Blood Center and Program, Seattle,
Washington.
RECALLED BY Manufacturer, by letter dated December 27,
1995. Firm-initiated recall complete.

-4-DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with
a possible history of jaundice.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Platelets, Pheresis. Recall #B-146-7.
CODE Split Unit #49P29381.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.
RECALLED BY Manufacturer, by telephone on May 7, 1996,
followed by fax. Firm-initiated recall
complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.
REASON Blood products were labeled with extended
expiration dates.

_______________
PRODUCT (a) Platelets, Pheresis; (b) Plasma.
Recall #B-164/165-7.
CODE Unit #53P62891.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by telephone on April 4, 1996,
followed by letter dated April 10, 1996.
Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected by apheresis,
using a blood cell separator which had an
unacceptable quality control value for the
Whole Blood Anticoagulant pump speed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-172/173-7.
CODE Unit numbers: (a) 9531986; (b) 9529667,
9529668, 9529682, 9531874, 9531954.
MANUFACTURER Sylvan N. Goldman Center, Oklahoma Blood
Institute, Oklahoma City, Oklahoma.
RECALLED BY Manufacturer, by fax on July 11 or 12, 1996.
Firm-initiated recall complete.
DISTRIBUTION New York, Texas, Oklahoma.
QUANTITY (a) 1 unit; (b) 5 units were distributed.
REASON Blood products were collected from donors who
reported receiving Rubella vaccine within four
weeks of donation.

-5-_______________
PRODUCT Recovered Plasma. Recall #B-174-7.
CODE Unit #1035913.
MANUFACTURER Scott & White Blood Center, Temple, Texas.
RECALLED BY Manufacturer, by letter dated April 18, 1996,
and by fax on April 19, 1996. Firm-initiated
recall complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit was distributed.
REASON Blood product tested negative for antibody to
the human T lymphotropic virus type 1 (anti-
HTLV-1); but was collected from a donor who
previously tested repeatedly reactive for
anti-HTLV-1, Western blot indeterminate.

RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS II =========
_______________
PRODUCT Sims/Intertech brand Manual Resuscitators with
PEEP Valve Bonded to the Exhalation Port:
(a) Product Code R1093;
(b) Product Code R1094;
(c) Product Code R1095. Recall #Z-049/051-7.
CODE Product codes: R1093, R1094, R1095.
MANUFACTURER Sims Medical Systems/Intertech, Fort Myers,
Florida.
RECALLED BY Manufacturer, by telephone on September 17,
1996. Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 5,352 units were distributed.
REASON The positive end expiratory pressure (PEEP)
valve may be inoperable on some of the manual
resuscitators because the solvent used to bond
the PEEP valve dripped on the disk, which may
have made the disk difficult or impossible to
move.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Medtronic Synchromed Programmable Pumps,
indicated for the intraspinal infusion of
morphine sulfate to treat chronic intractable
pain and baclofen for spasticity and the
intravascular infusion of drugs to treat
metastatic cancer and clindamycin for the
treatment to osteomyelitis:
(a) Medtronic Synchromed Programmable Pump,
Model 8611, Series (8611H, 8611HL);
(b) Medtronic Synchromed Programmable Pump,
Model 8615, Series (8615S, 8615LS, 8615L);

-6- (c) Medtronic Synchromed Programmable Pump,
Model 8616, Series (8616-10, 8616-18);
(d) Medtronic Synchromed Programmable Pump,
Model 8617, Series (8617-18, 8617L-18);
(e) Medtronic Synchromed Programmable Pump,
Model 8631. Recall Z-152/156-7.
CODE The units identified below by model and serial
numbers were retrieved by Medtronic Sales
Representatives. These units had not been
implanted, and are not past their expiration
dates:
Model 8615S: Serial numbers NBM007041R,
NBM007150R, NBM007170R, NBM008869R,
NBM007467R, NBM008226R, NBM008392R,
NBM008554R, NBM008942R, NBM008760R,
NBM008927R, NBM008507R, NBM007454R
Model 8615LS: Serial numbers NBM006888R,
NBM007549R
Model 8617L18: Serial number NDA000274R
Model 861718: Serial numbers NCY000808R,
NCY000811R, NCY000739R, NCY000938R,
NCY001358R.
The units identified below by model and serial
numbers are subject to retrieval by Medtronic
Sales Representatives, but have not been
retrieved because they cannot be located.
These units have not been registered as
implanted, and are not past their expiration
dates:
Model 8615S: Serial numbers NBM007177R,
NBM007469R, NBM008604R
Model 8615LS: Serial number NBM006889R
Model 8617L18: Serial number NDA000247R
Model 861718: Serial numbers NCY000640R,
NCY000980R
Medtronic recommended that the units
identified below by model and serial numbers
be returned. These units are past their
expiration dates. The first 53 serial numbers
listed below are of units that have been
located by Medtronic representatives, and the
following 37 numbers are the serial numbers of
units that have not been located.
Located:
Model 8615S/Serial numbers NBM005054R,
NBM005237R, NBM005272R, NBM005309R,
NBM005348R, NBM005323R, NBM005494R,
NBM005552R, NBM005553R, NBM005656R,
NBM005751R, NBM005818R, NBM005829R,
NBM005859R, NBM005883R, NBM005930R,
NBM005957R, NBM005961R, NBM005994R,
NBM006036R, NBM006048R, NBM006249R,

-7- NBM006459R, NBM006464R, NBM006472R,
NBM006620R, NBM006645R, NBM006648R,
NBM006703R, NBM006623R, NBM006955R,
NBM006960R, NBM007008R, NBM007015R,
NBM007062R, NBM007070R, NBM007079R,
NBM007105R, NBM007134R
Model 8615LS/Serial numbers NBM004993R,
NBM005519R, NBM005789R, NBM005974R,
NBM006190R, NBM006290R, NBM006333R,
NBM006445R, NBM006756R, NBM006897R
Model 8611H:
Serial number SJ1303852R, SJ1303747R
Model 8616-18:
Serial number NCV000051R
Model 8631:
Serial number DAB130095R
Not located:
Model 8615S/Serial numbers NBM004738R,
NBM005052R, NBM005136R, NBM005312R,
NBM005550R, NBM005300R, NBM005396R,
NBM005468R, NBM005477R, NBM005560R,
NBM005628R, NBM005780R, NBM005842R,
NBM005871R, NBM005863R, NBM005932R,
NBM005911R, NBM006012R, NBM006394R,
NBM006506R, NBM006512R, NBM006692R,
NBM006705R, NBM006918R, NBM006983R
Model 8615LS/Serial numbers NBM004970R,
NBM004967R, NBM005522R, NBM006130R,
NBM006132R, NBM006134R, NBM006136R,
NBM006163R, NBM006524R, NBM006563R,
Model 8611H:
Serial numbers SJ1303879R, SJ1303963R
Medtronic suspects that many of the unlocated
units with serial numbers listed above, are
implanted but not registered by physicians as
implanted. These unlocated units are to be
returned only if they have not been implanted.
MANUFACTURER Medtronic, Inc., Neurological Division,
Minneapolis, Minnesota.
RECALLED BY Medtronic, Inc., Neurological Division,
Columbia Heights, Minnesota, by sending a
technical brief to sales representatives on
November 1, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 118 pumps were distributed.
REASON The affected pumps have a failure rate of
about 1.6% due to motor stall caused by open
electrical circuits within the first 10 months
of use after implant.

-8-_______________
PRODUCT XiScan 1000 12x12, a diagnostic x-ray device.
Recall #Z-162-7.
CODE Various serial numbers.
MANUFACTURER Xi-Tec, Inc., Windsor Locks, Connecticut.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan on December 13, 1996.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 37 units were distributed.
REASON Device was found to be in noncompliance with
the Federal Performance Standard for
Diagnostic X-Ray Systems and Their Major
Components 21 CFR 1020.32(g), in that the
label on the systems prior to granting the
Variance 94V0330/VAR 1 was not correct because
the variance referred to on it (85V-0330) was
for another system.

_______________
PRODUCT Gesco brand Per-Q-Kit catheter kits:
(a) Per-Q-Kit 3 Fr. Single Lumen PICC
Insertion Kit with Guidewire Reorder Number
4133107 ;
(b) Per-Q-Kit 4 Fr. Single-Lumen PICC
Insertion Kit with Guidewire Reorder Number
4134107. Recall #Z-173/174-6.
CODE Lot Numbers (a) 51EG1023; (b) 51EG1024.
MANUFACTURER Gesco International, Inc., San Antonio, Texas.
RECALLED BY Bard Access Systems, Inc., Salt lake City,
Utah, by letter dated November 11, 1996;
firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 984 kits were distributed.
REASON The expiration date is incorrectly labeled.

_______________
PRODUCT Gent-L-Kare Sterile Procedure Trays, sterile,
single-use disposable trays packaged with
gloves and Tyvek lids:
(a) Urethral Catherization Trays, Catalog nos.
2498, 2499, 2502, 2503;
(b) Foley Catherization Trays, Catalog nos.
2510, 2512, 2513, 2524, 2526;
(c) I.V. Start Kits, Catalog No. 2608, reorder
nos. 51-2592, 3108033, 3008050, 3108044,
3108060, 3108031, 3108016, 51-2591;
(d) Tracheostomy Care Trays, Catalog Nos. 4118
(reorder no. RW031), 4120 (reorder nos.
3010028 & 3010037), 4128.
Recall #Z-177/180-7.

-9-CODE All lots beginning with "J", "K", "L" and "M".
MANUFACTURER Sterling Disposable Products, Inc., Chicago,
Illinois (tray assembler).
RECALLED BY Premium Plastics, Inc., Chicago, Illinois
(distributor), by letter dated October 11,
1996, and by telephone on October 16, 17, 23,
24, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 89,682 cases were distributed; firm estimated
that 3,000 cases remained on market at time of
recall initiation.
REASON Some of the trays may have part of the glove
sealed between the Tyvek lid and the tray,
therefore compromising the package integrity,
resulting in a lack of assurance of sterility.

_______________
PRODUCT Intraocular Lens, AMO Model PS-53ANB.
Recall #Z-181-7.
CODE Serial numbers 9408416245 through 9408416252.
MANUFACTURER Allergan Medical Optics Puerto Rico, Anasco,
Puerto Rico.
RECALLED BY Allergan, Inc., Irvine, California, by fax on
July 30, 1996, followed by letter dated
September 5, 1996. Firm-initiated recall
complete.
QUANTITY 17 lenses from two production lots.
DISTRIBUTION Washington state, Canada, England, Germany.
REASON The 16.0 diopter lenses are labeled as 11.0
diopter lenses which would result in a
refractive error if implanted.

_______________
PRODUCT VENTAK MINI AICD Automatic Implantable
Cardioverter Defibrillators, Model 1746.
Recall #Z-182-7.
CODE Serial numbers 602154, 602157, and 602164.
MANUFACTURER Guidant Corporation, Cardiac Pacemakers, Inc.,
St. Paul, Minnesota.
RECALLED BY Manufacturer, by telephone on November 21,
1996, and by letter dated November 22, 1996.
Firm-initiated recall complete.
DISTRIBUTION Florida, New Jersey, New York.
QUANTITY 3 units were distributed.
REASON Devices do not have the required medical
adhesive applied in the device's lead
connector block.

-10-_______________
UPDATE Recall #Z-147-7 which appeared in December 11,
1996, Enforcement Report should read:
PRODUCT: 3M Model 3000 Modular Infusion Pump.
REASON The pumps can disconnect from their
modular connection systems and can fall to the
floor.

-11-

END OF ENFORCEMENT FOR DECEMBER 26, 1996. BLANK PAGES MAY FOLLOW.

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End of Enforcement Report for