Events

Recall of HEPA FILTER 100105-01

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by NATUS MEDICAL INCORPORATED.

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
    44013
  • Event Risk Class
    II
  • Event Initiated Date
    2016-05-04
  • 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
    Filter contained a two part urethane sealant that was not mixed with the proper ratio to ensure a full cure. it was discovered that the uncured sealant can leak out and drip inside the drier at higher temperatures.

Device

HEPA FILTER 100105-01
  • Model / Serial
    Model Catalog: (Lot serial: N/A)
  • Product Description
    HEPA FILTER 100105-01
  • Manufacturer
    NATUS MEDICAL INCORPORATED

Manufacturer

NATUS MEDICAL INCORPORATED