Events

Recall of ASP Sterrad Booster

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
    15596
  • Event Initiated Date
    2013-11-15
  • 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
    Issue 1: manufacturer has identified that the ifu for the sterrad booster and sterrad adaptor include incorrect instructions and potential consequences are failing to use the device when needed (potentially resulting in a lumen which is not sterile) or using the devices when not needed (potentially resulting in residual hydrogen peroxide left in the lumen), issue 2: the manufacturer has introduced a new verification tool that should be used with sterrad® boosters and sterrad® adaptors. this new tool is a checklist that should be printed and used to provide verification of the proper use of the sterrad® booster/adaptor before and after the sterrad® sterilization cycle.
  • Action
    Instructions for use to be updated

Device

ASP Sterrad Booster

Manufacturer

Advanced Sterilization Products