Events

Rappel de Heartsine Pad-Pak/Pedi-Pak Electrode Pack

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 Heartsine Technologies Ltd.

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
    16881
  • Date de mise en oeuvre de l'événement
    2015-04-10
  • 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: Amtech Medical Ltd, 281 Heads Road, Wanganui 4501
  • Cause
    During testing at heartsine technologies ltd, an issue has been detected with the seal on the foil pouch which contains the electrodes within the pad-pak and pedi-pak. on a small number, the final seal on the defibrillation electrode pouch was found to be difficult to open. the investigation identified that the supplier of the electrodes to heartsine technologies ltd had made a change to the manufacturing process which meant that an excessive amount of hot melt glue was applied to the final seal of the pouches.
  • Action
    Product to be returned to supplier

Device

Heartsine Pad-Pak/Pedi-Pak Electrode Pack
  • Modèle / numéro de série
    Model: , Affected: Lot Numbers: A1754, A1795, A1792, A1789, A1802
  • Manufacturer
    Heartsine Technologies Ltd

Manufacturer

Heartsine Technologies Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    NZMMDSA