Events

Retiro De Equipo (Recall) de REAMING ROD W/BALL TIP

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    86264
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-07-26
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    During an open peel test it was identified that the seals for a reaming rod sealed in packaging aids corporation jaw sealer machine had gaps/channeling in the seals therefore resulting in the potential for non-sterile product. recall initiated due to potential gaps/channeling in the seal of the package.

Device

REAMING ROD W/BALL TIP
  • Modelo / Serial
    Model Catalog: 351.706S (Lot serial: H342583); Model Catalog: 351.706S (Lot serial: H333939); Model Catalog: 351.706S (Lot serial: H294402); Model Catalog: 351.706S (Lot serial: H297386); Model Catalog: 351.706S (Lot serial: H297335); Model Catalog: 351.706S (Lot serial: H325600); Model Catalog: 351.76S (Lot serial: H327067); Model Catalog: 359.083S (Lot serial: H327067); Model Catalog: 351.76S (Lot serial: H270855); Model Catalog: 359.083S (Lot serial: H270855); Model Catalog: 359.083S (Lot serial: H311231); Model Catalog: 359.083S (Lot serial: H306632); Model Catalog: 351.76S (Lot serial: H311231); Model Catalog: 355.042S (Lot serial: H354470); Model Catalog: 351.76S (Lot serial: H306632)
  • Descripción del producto
    REAMING ROD W/BALL TIP;REAMING ROD W/STRAIGHT BALL TIP;GUIDE ROD WITH SMOOTH TIP - STERILE
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    HC