Events

Rappel de Medcomp Hemo-cath®LT and Hemo-cath®ST Hemodialysis Catheters

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Medcomp 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
    18956
  • Date de mise en oeuvre de l'événement
    2015-08-04
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: AA-Med NZ Ltd, 6 Church Lane, Point Howard, Lower Hutt, Wellington 5013
  • Cause
    Manufacturer notification of potential safety issue affecting medcomp hemo-cath lt and hemo-cath st hemodialysis catheters which may develop holes during use. investiagtion determined that during the insertion procedure engaging the extension line clamp over the guidewire may damage the inside of the tubing. a crack in the tubing on the inside can propagate over time and eventually travel through thickness of the tubing developong into a hole that leaks.
  • Action
    Manufacturer to issue advice regarding use

Device

Medcomp Hemo-cath®LT and Hemo-cath®ST Hemodialysis Catheters
  • Modèle / numéro de série
    Model: LT and ST, Affected: ECS1316 ECS1320 and ECS1324
  • Manufacturer
    Medcomp Inc

Manufacturer

Medcomp Inc