| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00308-1 |
| Product Name/Description |
Aegis Standing Sling - Lift, patient transfer, sling/harness/strap
ARTG Number: 203097 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/04/2015 |
| Responsible Entity |
|
| Reason/Issue |
During the use of the device it was noticed by the healthcare professional that the stitching on one of the loops holding the sling to the spreader bar of the hoist had come loose. No harm came to the patient or the healthcare worker. The stitching had become loose after more than twelve months use due to either wear or inadequate back stitching and could have been exacerbated if the operator had incorrectly twisted the loop when attaching it to the spreader bar. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Solaris Medical is contact end users through the distributors to advise of the potential issue. Solaris Medical will inspect all potentially affected units and repair if damaged. This action has been closed-out on 15/08/2016. |
| Contact Information |
08 9200 5814 - Solari Medical |