| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01040-1 |
| Product Name/Description |
HeartWare Sterile Surgical Tool Sets (Supplied as part of the HeartWare Ventricular Assist System, artifical heart (HVAS))
Catalogue Number: 1318
Lot Number: 520863
ARTG Number: 181875 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
31/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
There is an error with labelling regarding the “Use by Date” of Sterile Surgical Tool products (ref. Cat # 1318). More specifically, some units were labelled with a “Use by Date” corresponding to 2-years shelf life instead of the approved 1-year shelf life. |
| Recall Action |
Recall |
| Recall Action Instructions |
The sponsor is advising users of changes to the approved use by date and is asking users to inspect current inventory and amend the use by dates of affected products. |
| Contact Information |
02 8078 6164 - Heartware |