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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