Events

Rappel de AMS AdVance XP Male Sling System - Needle passers

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 Medical Systems 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
    17127
  • Date de mise en oeuvre de l'événement
    2014-08-06
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Cause
    As a result of routine periodic product shelf life testing, manufacturer has identified that the sterile barrier of some samples of packaging of the needle passer components supplied with the advance® xp male sling system, may have potentially been breached and therefore do not consistently meet the three (3) year shelf life stated on the product label. further testing confirms that the packaging of the needle passers continues to meet the requirements for the one (1) year shelf life., during implant procedures of the advance® xp male sling system, the two needle passers (left and right sides), are used by the surgeon to assist transobturator passage while the placing and positioning the sling. these tools are disposable and indicated for one-time-use only. there is a potential for an increased risk of patient infection due to breach in the sterile barrier (packaging) of the needle passer components.
  • Action
    Product to be returned to supplier

Device

AMS AdVance XP Male Sling System - Needle passers

Manufacturer

American Medical Systems Inc
  • Source
    NZMMDSA