Events

Recall of STERRAD NX STERILIZER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    67235
  • Event Risk Class
    III
  • Event Initiated Date
    2015-09-30
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Advanced sterlization products (asp) has recently determined the current sterrad nx system is exceeding the electromagnetic compatibility class a radiated emissions specification limit by 20 decibel micro-volt per meter which equates to 0.001 volt per meter at a distance of 10 meters. the risk is assessed as low for interference to active implantable and wearable devices and other nearby electrical equipment.

Device

STERRAD NX STERILIZER
  • Model / Serial
    Model Catalog: 10033 (Lot serial: 33130236); Model Catalog: 10033 (Lot serial: 33140013); Model Catalog: 10033 (Lot serial: 33140023); Model Catalog: 10033 (Lot serial: 33140064); Model Catalog: 10033 (Lot serial: 33130233); Model Catalog: 10033 (Lot serial: 1033150098); Model Catalog: 10033 (Lot serial: 1033142147); Model Catalog: 10033 (Lot serial: 1033141070)
  • Product Description
    STERRAD NX STERILIZATION SYSTEM
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.