| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00234-1 |
| Product Name/Description |
ARCTICGEL Pads (used with the Arctic Sun Temperature Management System)
Multiple Product Codes and Lot Numbers affected
ARTG Number: 262560 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
Bard Medical Division (BMD) has received complaint reports of low flows associated with certain lots of the ARCTICGEL Pads.
The clinical risk associated with the restricted/low flow ARCTICGEL Pads is suboptimal therapy delivery. In the event that one or more ARCTICGEL Pads do not have sufficient flow, the ARCTICGEL Pads may need to be exchanged. This may result in a slight delay in the therapy delivery which, if done in a timely manner, is not associated with long-term or residual clinical consequences. If alternate pads are not available, the patient may require therapy delivery by alternate means. |
| Recall Action |
Recall |
| Recall Action Instructions |
Bard is advising users to inspect stock for the affected lot numbers. Any remaining affected product can be returned. This action has been closed-out on 30/01/2017. |
| Contact Information |
1800 257 232 - Bard Australia Customer Service |