Events

Retiro De Equipo (Recall) de REUSABLE SURGICAL SCISSORS TIPS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MICROLINE SURGICAL 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
    77842
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-07-18
  • 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
    Microline surgical inc. has initiated this global voluntary recall which applies to all renew reusable tips (scissors graspers and dissectors). this recall is due to a malfunction related to the heat shrink insulation tube that is located immediately proximal to the metal tip. milcroline surgical has received customer reports that the heat-shrink insulation tube may split during autoclave (sterilization/re-sterilization) and could fall-off during surgery and if cautery is used there is potential for burn.

Device

REUSABLE SURGICAL SCISSORS TIPS
  • Modelo / Serial
    Model Catalog: 3161 (Lot serial: all); Model Catalog: 3111 (Lot serial: all); Model Catalog: 3121 (Lot serial: all); Model Catalog: 3141 (Lot serial: all); Model Catalog: 3151 (Lot serial: all); Model Catalog: 3281 (Lot serial: all); Model Catalog: 3291 (Lot serial: all); Model Catalog: 3421 (Lot serial: all); Model Catalog: 3411 (Lot serial: all); Model Catalog: 3401 (Lot serial: all); Model Catalog: 3361 (Lot serial: all); Model Catalog: 3381 (Lot serial: All); Model Catalog: 3371 (Lot serial: All); Model Catalog: 3351 (Lot serial: All); Model Catalog: 3341 (Lot serial: All); Model Catalog: 3331 (Lot serial: All); Model Catalog: 3311 (Lot serial: All); Model Catalog: 3301 (Lot serial: All); Model Catalog: 3251 (Lot serial: All); Model Catalog: 3241 (Lot serial: All); Model Catalog: 3231 (Lot serial: All); Model Catalog: 3201 (Lot serial: All); Model Catalog: 3221 (Lot serial: All); Model Catalog: 3321 (Lot serial: all); Model Catalog: 3431 (Lot serial: all); Model Catalog: 3261 (Lot serial: all); Model Cat
  • Descripción del producto
    ReNew Reusable Scissor Grasper and Dissector Tips;ReNew Reusable Scissor Grasper and Dissectors;ReNew Reusable ScissorGrasper adn Dissectors
  • Manufacturer
    MICROLINE SURGICAL INC.

Manufacturer

MICROLINE SURGICAL INC.
  • Dirección del fabricante
    BEVERLY
  • Empresa matriz del fabricante (2017)
    HOYA Corp.
  • Source
    HC