Events

Rappel de TRACHEOSTOMY TUBES TTS WIRE REINFORCED SILICONE PEDIATRIC/NEONATAL

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

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
    25569
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2011-11-23
  • 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
    Smiths medical has become aware of a small number of complaints of customers experiencing difficulty disconnecting accessories from the connectors of the affected tubes. in some cases the customer was unable to disconnect the accessory or excessive force lead to decannulation of the tube and an emergency tracheostomy tube change was required. if the accessory is correctly connected to the affected tubes then there will be no issue with disconnection.

Device

TRACHEOSTOMY TUBES TTS WIRE REINFORCED SILICONE PEDIATRIC/NEONATAL
  • Modèle / numéro de série
    Model Catalog: 67P040 (Lot serial: 1631477 through 1923406); Model Catalog: 67N030 (Lot serial: 1631477 through 1923406); Model Catalog: 67N035 (Lot serial: 1631477 through 1923406); Model Catalog: 67P055 (Lot serial: 1631477 through 1923406); Model Catalog: 67P050 (Lot serial: 1631477 through 1923406); Model Catalog: 67P045 (Lot serial: 1631477 through 1923406); Model Catalog: 67N025 (Lot serial: 1631477 through 1923406); Model Catalog: 67P035 (Lot serial: 1631477 through 1923406); Model Catalog: 67P030 (Lot serial: 1631477 through 1923406); Model Catalog: 67N040 (Lot serial: 1631477 through 1923406); Model Catalog: 65P055 (Lot serial: 1631477 through 1923406); Model Catalog: 60PFP40 (Lot serial: 1631477 through 1923406); Model Catalog: 65P045 (Lot serial: 1631477 through 1923406); Model Catalog: 65P040 (Lot serial: 1631477 through 1923406); Model Catalog: 65P035 (Lot serial: 1631477 through 1923406); Model Catalog: 65P030 (Lot serial: 1631477 through 1923406); Model Catalog: 65P025 (Lot serial: 1631477 thr
  • Description du dispositif
    Bivona Tracheostomy Tubes TTS - Pediatric/Neonatal
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

SMITHS MEDICAL CANADA LTD. (SIMS)
  • Adresse du fabricant
    MARKHAM
  • Société-mère du fabricant (2017)
    Smiths Group Plc
  • Source
    HC