| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00151-1 |
| Product Name/Description |
3M Surgical Clipper
Model Number: Professional 9681
All Lot Numbers
ARTG Number: 101095
(3M Australia - Clipper, hair, electric) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
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.” |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
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.
This action has been closed out on the 16/11/2018. |
| Contact Information |
136 136 - Customer Service Support |