| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01203-1 |
| Product Name/Description |
ArthroCare Corporation HipVac 50 Coblation Wand
Model Number: ASHA4730-01
ARTG number: 221504 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
Based on internal investigation, ArthroCare has confirmed that the packaging tray that houses the HipVac Wand may have been damaged, which could result in a breach of the sterile barrier. This failure was discovered during final inspection. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are requested to Immediately discontinue use of the HipVac Wand immediately and take steps to quarantine the devices. If affected product is identified, Smith & Nephew Surgical Customer Service will be in contact with customers once the disposition form is returned, to arrange for the product to be returned and suggest alternate products. This action has been closed-out on 06/07/2016. |
| Contact Information |
02 9857 3999 - Smith & Nephew Surgical |