Events

Rappel de PACEMAKER 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
    21521
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2017-01-23
  • 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 advisory notice from bd concerning their eclipse needle. bd has received reports of safety cover disengagement and needlestick injury (nsi) for the bd eclipse needle. based on the customer reports in some cases when the safety cover is pushed over the needle it disengages resulting in an exposed needle which can increase the risk of nsi. the bd eclipse needle is a component in several medline custom procedure packs. medline canada is therefore informing its customers of the bd advisory notice.

Device

PACEMAKER PACK
  • Modèle / numéro de série
    Model Catalog: DYNJ52472X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46890X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46856X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46726X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46729X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46858X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46877X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46859X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46745X (Lot serial: CONTACT MFG); Model Catalog: DYNJ48513X (Lot serial: CONTACT MFG); Model Catalog: DYNJ900660X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46835X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46860X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41876X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46736X (Lot serial: CONTACT MFG); Model Catalog: CDS982078X (Lot serial: CONTACT MFG); Model Catalog: DYNJ48536X (Lot serial: CONTACT MFG); Model Catalog: DYNJ37224X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41910X (Lot serial: CONTACT MFG); Model Catalog:
  • Description du dispositif
    PACEMAKER PACK;TVT WCH-LF;SHOULDER RVHS-LF;VAG HYS ANT PST REPAIR TEGH-LF;C SECTION TEGH-LF;MINOR PROCEDURE RVHS-LF;BREAST BIOPSY WCH-LF;MAJOR LIMB RVHS-LF;PACEMAKER TEGH-LF;ENDONASAL DCR MSH-LF;TMJ MSH-LF;C SECTION SJHC-LF;MINOR LIMB RVHS-LF;ANGIOGRAM LF
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION