Events

Retiro De Equipo (Recall) de Progressive Medical Laparoscopic Electrode PTFE Coated J Hook

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 Progressive Medical 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
    64931
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1363-2013
  • Fecha de inicio del evento
    2013-04-12
  • Fecha de publicación del evento
    2013-05-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-05-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117485
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Causa
    Product coatings require 510k approval.
  • Acción
    Progressive Medical Inc. sent an Urgent Medical Device Recall letter dated April 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and segregate the affected units prior to return to Progressive Medical, Inc. If product was further distributed customers should notify their accounts of ther ecall and return the products. Customers were asked to complete and return the attached form by fax to 314-961-4535, even if they had no inventory remaining. Customers with questions were instructed to call 1-800-969-6331. For questions regarding this recall call 314-961-5786.

Device

Progressive Medical Laparoscopic Electrode PTFE Coated J Hook
  • Modelo / Serial
    Lot number 082712-10
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.
  • Descripción del producto
    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J- Hook 44cm Length, Product number P0021X Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. || Electrodes used in Electrosurgeries
  • Manufacturer
    Progressive Medical Inc

Manufacturer

Progressive Medical Inc
  • Dirección del fabricante
    Progressive Medical Inc, 997 Horan Dr, Fenton MO 63026-2401
  • Empresa matriz del fabricante (2017)
    Progressive Medical Inc
  • Source
    USFDA