Events

Rappel de Device Recall CORE Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags

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 ConMed Corporation.

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
    74774
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0133-2017
  • Date de mise en oeuvre de l'événement
    2016-06-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-06-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148416
  • 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
    Catheter, peritoneal - Product Code GBW
  • Cause
    The packaging seal may contain a crease. the crease may result in an open channel. these channels may compromise sterility of the product.
  • Action
    ConMed sent an Urgent Device Recall letter dated June 27, 2016, to all affected customers with reply forms via USP First Class Mail. International customers received a notice dated July 11, 2016 by courier service. Customers were advised to inspect their inventory for any of the devices subject to recall. Customers were urged to contact all departments within their facility and any other facilities within their organization that may have received affected products. It is imperative that all end users of these devices receive the notification. Customers who have received any of the affected product are asked to complete and return the reply form along with the device to: CONMED Corporation 525 French Road Utica, NY 13502 USA Attn: Ed Kovac. Please do not return used devices. Replacement product will be issued unless otherwise requested. If customers do not have any affected devices to return, complete and return the business reply form indicating they have no devices and return by one of the means listed:1. Email to: coresihp@conmed.com 2. Fax to: Field Action Support Team at 315-624-3225. 3. US mail, using enclosed postage-paid envelope, to: CONMED, 525 French Road, Utica, NY 13502; Attn: Field Action Support Team. Customers with questions or requests, should contact the Field Action Support Team at 315-624-3237, fax to 315-624-3225, or email coresihp@conmed.com.

Device

Device Recall CORE Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags
  • Modèle / numéro de série
    Beginning Lot Code 110609X to Ending Lot Code 20160308X
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.
  • Description du dispositif
    CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags, Catalog Number CD8302 || The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation
  • Adresse du fabricant
    ConMed Corporation, 525 French Rd, Utica NY 13502-5945
  • Société-mère du fabricant (2017)
    CONMED Corp.
  • Source
    USFDA