| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00827-1 |
| Product Name/Description |
COSEAL Surgical Sealant 2ml and 4ml
COSEAL 2ml
Product Code: 934073
COSEAL 4ml
Product Code: 934074
Multiple lot numbers affected
ARTG Number: 181132 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
Out of specification results were observed at the 18-month time point (out of 18-month licensed shelf life to expiration) during a COSEAL stability study. The parameter that is out of specification is an indicator of possible failure for the product to gel appropriately. COSEAL's failure to gel does not represent a serious risk for the patient's life. All other stability requirements were met. The investigation into this issue is ongoing, and appropriate actions will be taken. |
| Recall Action |
Recall |
| Recall Action Instructions |
Baxter is requesting their customers to discontinue use of the affected lots. Baxter Customer Service can be contacted to arrange for the return of affected inventory. This action has been closed-out on 04/08/2016. |
| Contact Information |
02 9848 1111 - Baxter Healthcare |