Events

Retiro De Equipo (Recall) de SINGLE-LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER KIT W/PLACEMENT WIRE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por TELEFLEX MEDICAL CANADA 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
    58132
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-01-16
  • 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
    Arrow international has received complaints for peel away sheaths flaring. the instructions for use included in the kits do not inform the user that a skin nick or alternate enlargement method may be required for difficult insertions. the use of a skin nick reduces the probability of sheath flare and subsequent complications. there is a remote possibility the device may cause a delay in treatment or minor vessel wall trauma and bleeding.

Device

SINGLE-LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER KIT W/PLACEMENT WIRE
  • Modelo / Serial
    Model Catalog: PR-05041 (Lot serial: > 10 numbers contact mfg); Model Catalog: PR-05042 (Lot serial: > 10 numbers contact mfg); Model Catalog: PI-01351-LS (Lot serial: > 100 numbers contact mfg); Model Catalog: PI-01451-LS (Lot serial: > 100 numbers contact mfg); Model Catalog: PI-01451-SS (Lot serial: > 100 numbers contact mfg); Model Catalog: PI-01552-LS (Lot serial: > 100 numbers contact mfg); Model Catalog: PI-01552-SS (Lot serial: > 100 numbers contact mfg); Model Catalog: PI-01351-SS (Lot serial: > 100 numbers contact mfg)
  • Descripción del producto
    SINGLE-LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER KIT;TWO-LUMEN PERIPHERALY INSERTED CENTRAL CATHETER KIT;PICC SELDINGER CONVERSION SET
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.