| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00033-1 |
| Product Name/Description |
Vented Spike with Clearlink (fluid transfer set)
Product Code: EMC3481
All lot numbers affected
ARTG Number: 149588 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
23/01/2014 |
| Responsible Entity |
|
| Reason/Issue |
Baxter has determined that the Vented Spike with Clearlink, product code EMC3481 does not have sufficient stability data to support its labelling claims. As such, the sterile barrier cannot be assured for the duration of the claimed shelf life. Deterioration in the integrity of the device packaging has the potential to result in a breach of the sterile barrier which could lead to complications due to infection. |
| Recall Action |
Recall |
| Recall Action Instructions |
Baxter is requesting users to locate and quarantine affected product. Affected product can be returned to Baxter for credit. Baxter has no alternative products to propose at this stage. |
| Contact Information |
1300 789 646 - Baxter Healthcare Customer Service |