Events

Recall of FACE SHIELD WITH DRAPE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SOUTHMEDIC 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
    26686
  • Event Risk Class
    III
  • Event Initiated Date
    2015-03-05
  • 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
    Marketlab had determined that the face shield with drape required a recall since the hook-and-loop fasteners application was on the incorrect side of the drape. as a result of the hook-and-loop fasteners being on the incorrect side of the drape the drape will not gather and stay gathered for the under chin hugging effect.

Device

FACE SHIELD WITH DRAPE
  • Model / Serial
    Model Catalog: ML6009 (Lot serial: >10 contact mfg.)
  • Product Description
    Face Shield with Drape
  • Manufacturer
    SOUTHMEDIC INC.

Manufacturer

SOUTHMEDIC INC.