Events

Recall of ASP Sterrad 100NX Cassette

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Advanced Sterilization Products.

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
    15098
  • Event Initiated Date
    2013-08-02
  • 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: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Reason
    The manufacturer, asp has determined it does not have adequate data to support the effectiveness of the packaging's leak indicator for the entire duration of the sterrad® 100nx® system cassette's 15-month shelf life. the likelihood of a leak is extremely low, and there have been no reported cases of a leak where the indicator was not effective in identifying the leak.
  • Action
    Manufacturer to issue advice regarding use

Device

ASP Sterrad 100NX Cassette

Manufacturer

Advanced Sterilization Products