Events

Rappel de EYE TRAYS/PACKS

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
    50774
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-11-17
  • 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 industries received a product field safety notice from beaver visitec concerning their beaver xstar safety knives. beaver visitec has received reports of the blade protective shield retracted (deactivated) upon receipt and inadvertent cuts to the user. the position of the shield (i.E. activated in place covering the blade or retracted) can be visualized through the clear cover of the tray that holds the knife. the beaver visitec beaver xstar safety knives are components in the above medline custom procedure pack. medline canada is therefore informing its customers of the beaver visitec field safety notice.

Device

EYE TRAYS/PACKS
  • Modèle / numéro de série
    Model Catalog: DYNJ41769X (Lot serial: 16JB8311); Model Catalog: DYNJ41769X (Lot serial: 16LB3606); Model Catalog: DYNJ41769X (Lot serial: 17MB2124); Model Catalog: DYNJ41769X (Lot serial: 179B1510); Model Catalog: DYNJ41769X (Lot serial: 17QB3629); Model Catalog: DYNJ41769X (Lot serial: 17SB0224); Model Catalog: DYNJ41769X (Lot serial: 17OB8381)
  • Description du dispositif
    MEDLINE CUSTOM OPHTHALMOLOGY PACK CKHA-LF
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION