Events

Rappel de Replacement Gastrostomy Device

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par C R Bard Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    49523
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0417-2009
  • Date de mise en oeuvre de l'événement
    2008-09-23
  • Date de publication de l'événement
    2008-12-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-11-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73866
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Gastrointestinal Tube (and accessories) - Product Code KNT
  • Cause
    Gastrostomy device anti-reflux valve may allow leakage from the stomach.
  • Action
    Customers notified by letter (Product Field Action letter) on September 23, 2008 and instructed to remove and return any affected product to Bard Access Systems, Inc (BAS). Customers were instructed in the recall letter to respond by completing and faxing the enclosed Reply Form and Inventory Reconciliation Form. For assistance, contact BAS customer service at 800-290-1689.

Device

Replacement Gastrostomy Device
  • Modèle / numéro de série
    43AOA019,  43LNA053,  43AOA042,  43LOA024,  43APA033,  43LPA008,  43ARAOO2,  43LQAO29,  HURA1265,  43BOA016,  HURB2526,  43BOA038,  HURB4356,  43BQA043,  HURB4357,  43COA014,  HURD1917,  43COA037,  HURF0484,  43DOA011,  HURG1445,  HURH1079,  HURJ0002,  43DOA038,  43DOA203,  43DPA015,  HURJ0595,  43DPA044,  HURJ1549,  43DPA204,  HURK1491,  43DPA205,  HURB2425,  43DQA064,  HURB4421,  43EOA014,  HURD1916,  43EOA042,  HURE2890,  43EPA014,  HURF0485,  43EPAO41,  HURH0242,  43EPA209,  HURH1080,  43EPA216,  HURJ1557,  43EQA009,  43FOA077,  43FOA108,  43GOA034, 43GPA179R,  43GPA180R,  43GQA001,  43GQA032,  43HPA019R, 43HPA192,  43HPA225R,  43HQA001,  43HQA165,  43INA032,  43IOA039,  43IPAO18,  43IPA041,  43IPA199R,  43IQA002,  43JNA002,  43JNA045,  43JNA204,  43JOA015,  43JPA014,  43JPA037,  43JQA001,  43JQA027,  43KPA014,  43KQA001,  43KQA027, and  43LNA023.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution including US, Latin America and countries of Canada, Japan, Finland, Norway, Sweden, Austria, Belgium, Holland, Great Britain, Italy, France, Switzerland, Spain, Germany.
  • Description du dispositif
    Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00201W, 16F, 1.7cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. || Dual Port Wizard Low Profile Replacement Gastrostomy Device is a silicone low-profile balloon-type device designed for percutaneous insertion through an established, appropriately sized stoma tract. || The Dual Port Wizard Device is packaged in a kit which also includes two tubes, two gauze pads, and a syringe. The Wizard anti-reflux valve is a component of the Dual Port Wizard Gastrostomy Device. The inserted device is used for enteral feeding.
  • Manufacturer
    C R Bard Inc

Manufacturer

C R Bard Inc
  • Adresse du fabricant
    C R Bard Inc, 605 N 5600 W, Salt Lake City UT 84116-3738
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA