| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00211-1 |
| Product Name/Description |
StarClose SE Vascular Closure System (VCS), International Green Sheath
Part Number: 14679-02
Multiple Lot Numbers
ARTG Number: 240055 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
Product from the affected lots may exhibit difficulty or failure to deploy the StarClose SE Clip. Exchange sheath material variation with a higher sheath split force may result in difficulty or failure to deploy the device. Potential risks associated with this event include prolonged procedure times, use of another device or manual compression to achieve haemostasis. To date, there have been no long term or irreversible patient effects reported. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to cease use of devices from the affected lots immediately and return all unused stock to Abbott Vascular. Abbott Vascular has implemented corrective actions to ensure ongoing product performance and has ceased distributing any product built before the corrective actions. Abbott Vascular will work with customers to replace returned units with similar product, pending availability.
This action has been closed-out on 19/03/2018. |
| Contact Information |
1800 550 939 - Abbott Vascular Customer Service Department |