Events

Rappel de Device Recall PadPro(R) Adult Radiotransparent Multifunction Electrodes

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
    65112
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1317-2013
  • Date de mise en oeuvre de l'événement
    2013-05-03
  • Date de publication de l'événement
    2013-05-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-08-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117902
  • 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
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Cause
    Conmed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the lead wire filaments and potentially render the device incapable of delivering the appropriate energy or shock to the patient and/or could cause potential injury to user or patient.
  • Action
    ConMed sent a URGENT: Field Safety Notice letter dated May 3, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to please review your inventory for any of the devices listed on Attachment I. Business Reply Forms were sent to the domestic and foreign consignees on May 3, 2013. The domestic notices were mailed by USP Priority Mail pouches. The recall is being conducted to the end user level. We ask that you contact all of those organizations within your facility and any other facilities that you may have supplied or given these affected products to. It is imperative that all end users of these devices receive this notice and respond immediately. If you have questions, please call 1 315-624-3237 or fax to +1 315-624-3225.

Device

Device Recall PadPro(R) Adult Radiotransparent Multifunction Electrodes
  • Modèle / numéro de série
    Lot Code Y092012-21, Manufacture Date 10/10/2012;  Lot Code Y102612-12, Manufacture Date 11/17/2012; Lot Code Y110912-20, Manufacture Date 11/30/2012; Lot Code Y112912-10, Manufacture Date 12/22/2012; Lot Code Y121312-19, Manufacture Date 01/03/2013; Lot Code Y011013-13, Manufacture Date 01/29/2013; Lot Code Y012513-02, Manufacture Date 02/12/2013;  Lot Code Y020713-05, Manufacture Date 02/26/2013; Lot Code Y021413-03, Manufacture Date 03/07/2013; Lot Code Y030113-04, Manufacture Date 03/23/2013
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and the country of: Saudi Arabia.
  • Description du dispositif
    PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. || The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are intended to be used in external pacing, defibrillation and monitoring applications
  • Manufacturer
    ConMed Corporation

Manufacturer

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