Recall of TAPE FOG SHIELD SURGICAL MASK GREEN FIBERGLASS FREE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDICAL PRODUCTS 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
    75266
  • Event Risk Class
    III
  • Event Initiated Date
    2007-09-21
  • Event Country
  • 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
    A failure in manufacturing process which resulted in some masks having small slits under the folds of the mask thus they may not provide the protection necessary between the patient and the surgical staff.

Device

  • Model / Serial
    Model Catalog: 65-3320 (Lot serial: >10 numeros communiquer/fabric); Model Catalog: 65-3320 (Lot serial: VAROIUS LOT NUMBERS); Model Catalog: 65-3322 (Lot serial: VAROIUS LOT NUMBERS); Model Catalog: 65-3322 (Lot serial: >10 numeros communiquer/fabric)
  • Product Description
    Tape fog shield surgical mask green fib
  • Manufacturer

Manufacturer

  • Manufacturer Address
    ARDEN
  • Source
    HC