| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01157-1 |
| Product Name/Description |
Karma Wheelchairs
Item Name: Flexx(KM-8022)18*18
Item Number: 935-0252H6
Serial Number: TM14-018192~2014
ARTG Number: 182294. |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/11/2015 |
| Responsible Entity |
|
| Reason/Issue |
Incorrect parts were supplied for Karma Wheelchairs. The bore diameter of the Flexx side frame and front caster mount should be Y8 to fit M8 screws. However, the Flexx that was provided was Y6 on the side frame and Y8 on the caster mount.
The production line did not realise the problem during production and assembled the caster mount to side frame by M6 screws. Since the castor mount has bigger holes (Y8), the wheelchair is likely to be wobbly while driving and more seriously, after a few months the M6 screws may fall off from the frame.
This action was taken prior to consultation with the TGA. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Independent Home Care & Surgical Supplies is contacting users to correct affected units.
This action has been closed-out on 11/11/2016. |
| Contact Information |
02 4227 4315 - Independentt Home Care & Surgical Supplies |