Events

Recall of 3M Surgical Clipper

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by 3M Australia Pty Ltd.

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
    RC-2018-RN-00151-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-03-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00151-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    3m australia is notifying all users of an added product warning, stressing the importance of following proper clipper charging practices as documented in the instructions for use. current charging instructions recommend leaving the clipper body in the drop- in charger in between uses.Failure to follow proper charging practices can result in lithium-ion battery degradation, characterised by excessive heat during operation or failure to properly charge. in rare circumstances, battery degradation has been associated with battery venting, which is a rapid release of battery energy which may potentially result in patient/user burns, or electrical shocks. there have been three reported instances overseas where users have experienced electric shocks.3m is adding the following product warning to emphasise the importance of proper charging practices: “warning: to avoid potential battery degradation, charge the clipper after each use and store in the drop-in charger stand when not in use.”.
  • Action
    3M is advising users to inspect any devices, and discard any that do not hold charge or is uncomfortably hot to touch during use. Affected devices will be replaced by 3M. Unaffected devices are to be stored in the drop in charger stand when not in use.

Device

3M Surgical Clipper
  • Model / Serial
    3M Surgical ClipperModel Number: Professional 9681All lot numbers affectedARTG Number: 101095(3M Australia - Clipper, hair, electric)
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

3M Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    DHTGA