Events

Recall of AMS AdVance XP Male Sling System - Needle passers

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by American Medical Systems Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    17127
  • Event Initiated Date
    2014-08-06
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Reason
    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