Events

Rappel de American Surgical Sponges/15252/sponges

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 American Surgical Sponges.

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
    20013
  • Date de mise en oeuvre de l'événement
    2016-04-12
  • 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: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
  • Cause
    A failure in the sterile peel pouch has been discovered during a quality control inspection. this failure may result in a small tear in the pouch of the device leading to a potential compromised sterile barrier. a leak in the sterile barrier may allow contamination of the device increasing the risk of infection. after the failure was identified, a comprehensive investigation has shown an occurrence rate of less than 0.01% for the affected lots., the customer was credited & the supplier agreed to have the product destroyed off site.
  • Action
    Product to be destroyed

Device

American Surgical Sponges/15252/sponges
  • Modèle / numéro de série
    Model: AS-30-00, AS-30-02, AS-30-03, AS-30-04, AS-30-07 and AS-63-01, Affected:
  • Manufacturer
    American Surgical Sponges

Manufacturer

American Surgical Sponges