| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01109-1 |
| Product Name/Description |
Cordis ExoSeal Vascular Closure Device (femoral artery compression device)
Product Numbers: EX500CE, EX600CE, EX700CE
All lot numbers from 15466779 to 15682751
ARTG Number: 176723 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer recently determined that distributed units of Cordis ExoSeal VCD were sterilised using a process that did not achieve the sterility
assurance level that is required for this class of product. |
| Recall Action |
Recall |
| Recall Action Instructions |
Quarantine and return affected product to Johnson & Johnson Medical. No additional patient follow up is required for patients treated with this device apart from normal post-procedure monitoring. |
| Contact Information |
1800 252 194 - Johnson & Johnson Medical Customers Service |