Events

Rappel de REUSABLE SURGICAL SCISSORS TIPS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MICROLINE SURGICAL INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    77842
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-07-18
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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
  • Description du dispositif
    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.
  • Adresse du fabricant
    BEVERLY
  • Société-mère du fabricant (2017)
    HOYA Corp.
  • Source
    HC