Events

Rappel de Unomedical Suction System Tubing (non-sterile)

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 Unomedical Sdn Bhd.

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
    18739
  • Date de mise en oeuvre de l'événement
    2015-07-07
  • 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: Convatec (New Zealand) Ltd, WHK Gosling Chapman, Level 6, 51-53 Shortland Street, Auckland
  • Cause
    An internal assessment of product complaints has confirmed that these devices are not meeting the manufacturer's specifications. specifically, the connector part for application to the suction devices in these lots, has failed to meet its required durability. the connector parts of the specified lots have a higher probability to crack once applied to suction devices outlets.
  • Action
    Product to be returned to supplier

Device

Unomedical Suction System Tubing (non-sterile)
  • Modèle / numéro de série
    Model: 533.25.200, 533.25.300, 533. 25.450, 533.30.300, Affected: Selected lot numbers
  • Manufacturer
    Unomedical Sdn Bhd

Manufacturer

Unomedical Sdn Bhd