Events

Retiro De Equipo (Recall) de INLINE VALVE WITH ACCESSORIES AND UNITIZED BACTISEAL CATHETER

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
    34782
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-07-21
  • 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
    As stated in the codman programmable valve ifu the virtual off setting (setting 8) is intended to limit flow through the valve and has an average pressure greater than 400mm h2o. recent in-vitro testing of the virtual off setting showed that the operating pressure for an individual valve may fall below 400mm h2o. this may result in a delay in treatment for shunt-related complications.

Device

INLINE VALVE WITH ACCESSORIES AND UNITIZED BACTISEAL CATHETER
  • Modelo / Serial
    Model Catalog: 82-8803 (Lot serial: ALL LOTS); Model Catalog: 82-8804 (Lot serial: CNLCW4); Model Catalog: 82-8804 (Lot serial: CPBB3H); Model Catalog: 82-8802 (Lot serial: ALL LOTS); Model Catalog: 82-8804 (Lot serial: CNPB1V); Model Catalog: 82-8804 (Lot serial: CNNDH3); Model Catalog: 82-8804 (Lot serial: CNMDM3); Model Catalog: 82-8804 (Lot serial: CPBCR0); Model Catalog: 82-8805 (Lot serial: ALL LOTS); Model Catalog: 82-8801 (Lot serial: ALL LOTS); Model Catalog: 82-8806 (Lot serial: ALL LOTS); Model Catalog: 82-8800 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 82-8807 (Lot serial: ALL LOTS)
  • Descripción del producto
    INLINE VALVE UNIT. BACTISEAL CATHACC.
  • 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