Events

Rappel de Device Recall R2 Adult Zoll NonRadiolucent 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
    60700
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0735-2012
  • Date de mise en oeuvre de l'événement
    2011-03-09
  • Date de publication de l'événement
    2012-01-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-01-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106249
  • 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
    Dc-defibrillator, low-energy, (including paddles) - Product Code LDD
  • Cause
    The product lot was assembled with an r2 connector, rather than a zoll connector.
  • Action
    ConMed Corporation sent an "URGENT: DEVICE RECALL" letter dated March 9, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to review their inventory for the affected product and to stop use of the devices immediately. A Business Reply Form was attached for customers to complete and return to the firm via fax to 315-624-3225. Additionally, instructions were provided on how to return the affected devices. Contact the ConMed Recall Coordinator at 315-624-3237 for questions regarding this notice.

Device

Device Recall R2 Adult Zoll NonRadiolucent Multifunction Electrodes
  • Modèle / numéro de série
    Lot 1006284
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution-including the states of AZ, CA, IN, and MI.
  • Description du dispositif
    R2 Adult Zoll Non-Radiolucent Multifunction Electrodes, Catalog/REF 3111-1721, NON-STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13505. || This device, when connected to a monitor/defibrillator has the ability to monitor the electro-cardio function (ECG) of the patient. The device, when electrically activated by the monitor/defibrillator can pace the heart rate of the patient and may also transmit the electrical current to the patient for cardio-conversion. This is a non-sterile, disposable device.
  • 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