Events

Rappel de Device Recall VariSafe

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 US Endoscopy Group 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
    74590
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0289-2017
  • Date de mise en oeuvre de l'événement
    2016-05-18
  • Date de publication de l'événement
    2016-10-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147998
  • 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
    endoscopic injection needle, gastroenterology-urology - Product Code FBK
  • Cause
    Us endoscopy is conducting a voluntary product recall of one lot of the vari-safe injection needle as it was identified that the lot was incorrectly distributed. the lot was assembled with internal catheter components which differ from the original vari-safe needle internal catheter components. all components are dimensionally similar to the original vari-safe needle internal catheter components and the components have history of use on other us endoscopy needle products.
  • Action
    US Endoscopy sent an Urgent- (Vari Safe) injection needle recall letter dated July 6, 2016. US Endoscopy requests that you: 1.Quarantine the affected Vari-Safe Injection devices in your stock. 2. Destroy each affected device by opening the device package, cutting the device catheter with a scissors, and then discarding the device and package. 3.Complete the attached Customer Response Card and return to the attention of US Endoscopy Customer Service, via fax 1-440-639-4495 or email orders@us endos copy.com . A no charge replacement will be provided for each unused Vari-Safe Injection Needle device from the affected lot. We apologize for any inconvenience this matter may cause you, and as always, US Endoscopy is dedicated to supporting our products and valued Customers. For further questions please call (800) 769-8226.

Device

Device Recall VariSafe
  • Modèle / numéro de série
    Model #: 00711819; Lot 1520268
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of : OH, OR, WA and Internationally to the country of Italy.
  • Description du dispositif
    Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 || A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flexible endoscopes
  • Manufacturer
    US Endoscopy Group Inc

Manufacturer

US Endoscopy Group Inc
  • Adresse du fabricant
    US Endoscopy Group Inc, 5976 Heisley Rd, Mentor OH 44060-1873
  • Société-mère du fabricant (2017)
    Steris Plc
  • Source
    USFDA