| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00568-1 |
| Product Name/Description |
Coiled Tube Baxter Infusors (Portable Elastomeric Infusion Systems)
Product Codes: 2C1071KJP, 2C1073KJP, 2C1082KJP, 2C1075KJP, 2C1080KJP
Manufactured between November 2008 and September 2009
Multiple Lot Numbers Affected |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/06/2013 |
| Responsible Entity |
|
| Reason/Issue |
There has been an increase in complaints of leaks at the distal male Luer and Luer cap. |
| Recall Action |
Recall |
| Recall Action Instructions |
End users and distributors are requested to locate and remove all affected units from use. The affected product should be returned to Baxter for a credit. |
| Contact Information |
02 9848 1111 - Baxter Healthcare |