Events

Rappel de GENERAL LAPAROSCOPY CDS PACK

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

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
    20754
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-07-07
  • 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
    Medline has received a recall notice from conmed regarding their core reposable trumpet handpiece (conmed p/n cd8300). these handpieces are used as a component in several cds modules sold by medline canada. conmed is issuing this recall because the individual package seal may be compromised which could potentially affect the integrity of the sterile barrier. the handpieces are to be removed from the packs upon opening and discarded. the medline pack has been terminally sterilized therefore the remaining components within the pack are safe to use.

Device

GENERAL LAPAROSCOPY CDS PACK
  • Modèle / numéro de série
    Model Catalog: CDS983989 (Lot serial: > 10 numbers contact mfg.); Model Catalog: CDS983989A (Lot serial: > 10 numbers contact mfg.); Model Catalog: CDS984007B (Lot serial: > 10 numbers contact mfg.); Model Catalog: CDS984007 (Lot serial: > 10 numbers contact mfg.); Model Catalog: CDS984007A (Lot serial: > 10 numbers contact mfg.); Model Catalog: CDS983995 (Lot serial: 13BB3793); Model Catalog: CDS983995 (Lot serial: 13BB9766); Model Catalog: CDS983995 (Lot serial: 13MB1943); Model Catalog: CDS983995 (Lot serial: 13SB1980); Model Catalog: CDS983995 (Lot serial: 12JB8722)
  • Description du dispositif
    GENERAL LAPAROSCOPY CDS PACK;MAJOR GYN LAPAROSCOPY CDS PACK;MINOR GYN LAPAROSCOPY CDS PACK
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION