| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01200-1 |
| Product Name/Description |
C-series carry bars (used with C300, C450 Manual, C625 ceiling lifts/hoists)
Model Numbers: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, 360757 (identifiable by a black plastic swivel/puck)
ARTG Number: 169639 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
Some C-Series carry bars are attached to the track using a plastic swivel. If the plastic swivel in these bars becomes damaged there is the potential for it to separate from the carry bar, resulting in a patient fall. Rehab Assist will supply a free metal insert to be placed inside affected carry bars to prevent separation if the plastic swivel becomes damaged.
There have been nine incidents worldwide in which the plastic swivel mechanism has been reported as damaged. No incidents have been reported in Australia and there have been no injuries reported as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Rehab Assist is advising distributors to contact all end users and inspect the swivels to determine if there are any damaged swivels in use. Customers are advised to inspect the swivel for damage or contact their distributor to arrange for a technician to do an inspection. If there is no damage the lift can continue to be used as normal. The metal insert should be installed as soon as practicable. If the swivel appears damaged, do not use the lift until the metal insert has been inserted. Wherever the plastic swivel is damaged, users are also advised to purchase and replace the carry bar as soon as possible. For more details, please see https://www.tga.gov.au/alert/rehab-assist-c-series-ceiling-hoists .
This action has been closed out on 25/09/2018 |
| Contact Information |
1300 364 534 - Rehab Assist |