Events

Recall of NIOSH-K320-N95 REPSIRATORY MASK

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIO NUCLEAR DIAGNOSTICS 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
    26224
  • Event Risk Class
    II
  • Event Initiated Date
    2013-01-03
  • 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
    On december 16 2009 at the request of guangzhou weini technology and development co. ltd. (gwt - manufacturer of the k320 n95 mask bearing niosh certification # tc-84a-4536) the national institute for occupational safety and health (niosh) rescinded the following certificates of approval: tc-84a-4536.

Device

NIOSH-K320-N95 REPSIRATORY MASK
  • Model / Serial
    Model Catalog: K320 (Lot serial: 024704)
  • Product Description
    N95 PARTICULATE RESPIRATOR NIOSH MODEL NO. K320 BIONUCLEAR CAT. NO. N95-017 NIOSH CERTIFICATION # TC-84A-4536
  • Manufacturer
    BIO NUCLEAR DIAGNOSTICS INC.

Manufacturer

BIO NUCLEAR DIAGNOSTICS INC.