Events

Recall of PUNCH HAIR MATIC-S.A.F.E.R.

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDICAMAT S.A..

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
    64879
  • Event Risk Class
    II
  • Event Initiated Date
    2015-05-11
  • 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
    It was found that the cleaning results were not in compliance with recognised standards such as iso 17664. impurities could remained inside of hollow parts of the device and could be a risk of contamination for the patient. also cracks have been detected at the end of the sterilization by the autoclave and damaged the products.

Device

PUNCH HAIR MATIC-S.A.F.E.R.
  • Model / Serial
    Model Catalog: NNEOSAFER24V11 (Lot serial: ALL LOTS)
  • Product Description
    PUNCH HAIR MATIC-S.A.F.E.R.
  • Manufacturer
    MEDICAMAT S.A.

Manufacturer

MEDICAMAT S.A.
  • Manufacturer Address
    MALAKOFF
  • Source
    HC