| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00648-1 |
| Product Name/Description |
Biodesign Rectovaginal Fistula Plug Kit
Multiple Codes, Lot Numbers and Expiry Dates
ARTG 239011
(Endotherapeutics Pty Ltd - Biodesign Recto-Vaginal Fistula Plug Kit - Multi-purpose surgical mesh, collagen) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
8/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Cook Biotech Inc., has identified a discrepancy between the correct product shelf life versus the shelf life presented on the finished product label. The affected products expire prior to the expiration date printed on the product label. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to:
- Inspect stock on hand immediately to determine affected product is present, and if so quarantine it to prevent further use.
Endotherapeutics Pty Ltd will recall all affected LOTs to be sent back to the manufacturer, Cook Biotech Inc. for correction.
Endotherapeutics Pty Ltd has inventory of unaffected product to replace the recalled stock. |
| Contact Information |
(02) 9869 2868 - Customer Service Endotherapeutics Pty Ltd |