Events

Retiro De Equipo (Recall) de Device Recall PADPRO DULT Radiotranslucent Pad w/Zoll connector

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Conmed Corporation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    37495
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0756-2007
  • Fecha de inicio del evento
    2007-03-08
  • Fecha de publicación del evento
    2007-04-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50638
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Defibrillation/Pacing/Cardioversion/Monitoring Electrodes - Product Code MLN
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    Lots Y040605-1, Y040605-2, Y052605-4, Y120805-2, Y111605-3, Y092805-6, Y010506-10, Y010506-9.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide, including USA, Canada, Romania, Chile, and Belgium
  • Descripción del producto
    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
  • Dirección del fabricante
    Conmed Corporation, 525 French Road, Utica NY 13502-5945
  • Source
    USFDA