Events

Recall of BURN RELIEF - BODY TOWEL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by O-TWO MEDICAL TECHNOLOGIES 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
    23506
  • Event Risk Class
    II
  • Event Initiated Date
    2015-10-16
  • 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
    Fabricator could not provide testing records to demonstrate continued validity of the sterilization dose for the burn relief products.

Device

BURN RELIEF - BODY TOWEL
  • Model / Serial
    Model Catalog: 06BK1231 (Lot serial: ); Model Catalog: 06BK1222 (Lot serial: ); Model Catalog: 06BK1232 (Lot serial: ); Model Catalog: 06BK1221 (Lot serial: ); Model Catalog: 06BK1201 (Lot serial: 5210); Model Catalog: 06BK1200 (Lot serial: 5210); Model Catalog: 06BK1201 (Lot serial: 5183); Model Catalog: 06BK1200 (Lot serial: 5183); Model Catalog: 06BK1201 (Lot serial: 1152); Model Catalog: 06BK1200 (Lot serial: 1149); Model Catalog: 06BK1201 (Lot serial: 1151); Model Catalog: 06BK1200 (Lot serial: 1151); Model Catalog: 06BK1201 (Lot serial: 1150); Model Catalog: 06BK1200 (Lot serial: 1150); Model Catalog: 06BK1201 (Lot serial: 1149); Model Catalog: 06BK1200 (Lot serial: 1152)
  • Product Description
    BURN RELIEF - BODY TOWEL
  • Manufacturer
    O-TWO MEDICAL TECHNOLOGIES INC.

Manufacturer

O-TWO MEDICAL TECHNOLOGIES INC.