Events

Retiro De Equipo (Recall) de SAM JUNCTIONAL TOURNIQUET 2 TARGET COMPRESSION DEVICES (1 WITH EXTENDER) HAND PUMP AUXILIARY STRAP

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por FERNO 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
    129491
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-09-18
  • 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
    Sam medical is voluntarily recalling the sam junctional tourniquet (sjt) auxiliary (accessory) strap which is intended for use in the control of difficult bleeds in the axilla area. only the auxiliary strap is affected. the remaining components of the sjt are not impacted by this recall and function as intended. it was determined through customer feedback and subsequent internal testing that the rear retaining clip failed in a very small number of devices during training demonstrations. no report of patient injury nor has the device been reported to fail during actual patient use.

Device

SAM JUNCTIONAL TOURNIQUET 2 TARGET COMPRESSION DEVICES (1 WITH EXTENDER) HAND PUMP AUXILIARY STRAP
  • Modelo / Serial
    Model Catalog: SJT 102 (Lot serial: 5/15/13)
  • Descripción del producto
    AM JUNCTIONAL TOURNIQUET 2 TARGET COMPRESSION DEVICES (1 WITH EXTENDER) HAND PUMP AUXILIARY STRAP
  • Manufacturer
    FERNO CANADA INC.

Manufacturer

FERNO CANADA INC.