Events

Rappel de Device Recall PADPRO DULT Radiotranslucent Pad w/Zoll connector

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
    37495
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0756-2007
  • Date de mise en oeuvre de l'événement
    2007-03-08
  • Date de publication de l'événement
    2007-04-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50638
  • 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
    Defibrillation/Pacing/Cardioversion/Monitoring Electrodes - Product Code MLN
  • Cause
    Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. this error makes the product unusable. the zoll and medtronic connectors are not interchangeable and are unique to their specific device.
  • Action
    On 3/08/07, "URGENT DEVICE RECALL" letters (dated 3/05/07) will be sent via UPS to the US distributors and direct user accounts. The letters inform them of the problem and of the recall. The letters instruct them to immediately discontinue using the affected lots, inspect their stocks, and to return them as soon as possible. The letters instruct the consignees to notify their customers of the recall of the devices to the user level if they have been distributed, and request the return of the products. Additionally, when requested, ConMed will notify distributor's customers (sub-accounts) by the same means. Returned devices will be automatically replaced by ConMed Corporation. A separate letter is being sent to the foreign accounts today instructing them to return the devices back to ConMed Corporation for final disposition. The letters also instruct the consignees to complete the accompanying reply form and fax it to Nancy Crisino at (315) 624-3089. ConMed has contracted Stericycle in Indianapolis, IN, to handle the recall and returns from the domestic accounts.

Device

Device Recall PADPRO DULT Radiotranslucent Pad w/Zoll connector
  • Modèle / numéro de série
    Lots Y040605-1, Y040605-2, Y052605-4, Y120805-2, Y111605-3, Y092805-6, Y010506-10, Y010506-9.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, including USA, Canada, Romania, Chile, and Belgium
  • Description du dispositif
    PADPRO ADULT Radiotranslucent Pad w/Zoll¿ connector. Defibrillation/Pacing/Cardioversion/Monitoring Electrodes, REF/Catalog # 2516Z. RX ONLY. Made in USA for: CONMED CORPORATION Utica, New York, 13502.
  • Manufacturer
    Conmed Corporation

Manufacturer

Conmed Corporation
  • Adresse du fabricant
    Conmed Corporation, 525 French Road, Utica NY 13502-5945
  • Source
    USFDA