Events

Rappel de VISTA Negative Pressure Wound Therapy Charger

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 Smith And Nephew, Inc. Wound Management Division.

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
    49566
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0162-2009
  • Date de mise en oeuvre de l'événement
    2008-08-07
  • Date de publication de l'événement
    2008-10-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-10-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73818
  • 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
    Battery Charger - Product Code BTA
  • Cause
    External battery chargers used with the version 29 vista negative pressure wound therapy pumps are failing to properly charge the pump's battery.
  • Action
    Each consignee was notified by recall letter (Field Correction Notification) dated 8/7/08 via FEDEX overnight. Within five (5) working days of the date of the customer notification a Smith & Nephew representative will contact the customers to assess their inventory and schedule delivery of replacement battery chargers. Contact Smith & Nephew, Inc. (Customer Care Center) at 1-800-876-1261 for for assistance.

Device

VISTA Negative Pressure Wound Therapy Charger
  • Modèle / numéro de série
    SSN: RoHS02492601 Last 4 digits of SSN identifies affected products: 05/08; 06/08; 07/08; 08/08; 09/08; 10/08; 11/08; 12/08; 13/08; 14/08 and 15/08.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide within U.S. and internationally to United Kingdom, New Zealand, Germany, Canada and Australia.
  • Description du dispositif
    GlobTek, Inc. Power Supply for Medical Use Part No: TR9CE4000LCP-Y-MED MODEL: GTM21097-5012, Made in China. || Indicated for patients who would benefit from a suction device particularly as the device may promote wound healing, including patients who would benefit from vacuum assisted drainage and removal of infectious materials or other fluid from wounds under the influence of continuous pressure.
  • Manufacturer
    Smith And Nephew, Inc. Wound Management Division

Manufacturer

Smith And Nephew, Inc. Wound Management Division
  • Adresse du fabricant
    Smith And Nephew, Inc. Wound Management Division, 11775 Starkey Road, Largo FL 33773-4727
  • Société-mère du fabricant (2017)
    Smith & Nephew plc
  • Source
    USFDA