Events

Retiro De Equipo (Recall) de Device Recall Electrophysiology catheter cables

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 Sterilmed Inc.

¿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
    77190
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2669-2017
  • Fecha de inicio del evento
    2017-05-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-05-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155303
  • 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
    unknown device name - Product Code N/A
  • Causa
    Sterilmed is recalling all lots of specific product codes of unexpired sterilmed reprocessed ep ablation cables because sterilmed determined that the cables are class iii devices and thus require, but do not currently have, premarket review and approval.
  • Acción
    Sterilmed sent an Urgent Notice Medical Device Recall letter dated April 25, 2017, to all affected customers. The letter identified affected product, stated reason for recall. Affected devices were asked to be quarantined, until returned to Stericycle, by August 31, 2017 to qualify for credit. A response form was asked to be returned. Questions can be directed to Sterilmed's Customer Care Team at 1-888-541-0078. For further questions, please call ( 877 ) 787-0369.

Device

Device Recall Electrophysiology catheter cables
  • Modelo / Serial
    all lots
  • Distribución
    US Distribution to the states of : AL, AR, CO, FL, IL, MI, MO, MS, MT, NC, OH, PA, TN, TX, VA WI and WV.
  • Descripción del producto
    Electrophysiology catheter cables are designed || as electrode cables with a multi-pin connector on || the distal end and the appropriate number of tails || on the proximal end. The cables serve two || different purposes. They either serve as an || extension between an EP catheter and equipment || out of reach or they interface an EP catheter with || the appropriate external stimulation of recording || equipment.
  • Manufacturer
    Sterilmed Inc

Manufacturer

Sterilmed Inc
  • Dirección del fabricante
    Sterilmed Inc, 5010 Cheshire Pkwy N Ste 2, Minneapolis MN 55446-4101
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA