| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00686-1 |
| Product Name/Description |
Back Table Cover supplied in a limited range of Operating Room Packs
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
ITL Healthcare has identified an issue as a result of one customer complaint with the standard Back Table Cover from one supplier. Once the outer bag is opened the Back Table Cover serves as a trolley cover. In some instances the sterility will be breached if the permeability of the Back Table Cover is challenged.
This issue was not observed in all batches; the extent is still under investigation |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
ITL Healthcare is providing workaround instructions to be undertaken during surgery setup. Alternative Back Table Covers will be provided free of charge to facilitate the workaround. Should the hospital be unable to implement the workaround, ITL will provide replacement Operating Room Packs. This action has been closed-out on 15/08/2016. |
| Contact Information |
1300 133 804 - Customer Care Hotline |