| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00086-1 |
| Product Name/Description |
Biatain Ag Cavity Filler
Item number: 3962801800
Batch/Lot No: 5868783
Expiry: 5 September 2020
ARTG Number: 160599 |
| Recall Action Level |
Wholesale |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
Coloplast has been made aware of concerns regarding the sterility of Biatain Ag Cavity Filler. The device may be compromised due to a quality issue that has occurred in the production process.
No complaints for this issue have been reported to date. |
| Recall Action |
Recall |
| Recall Action Instructions |
Coloplast is advising affected customers to inspect inventory for affected stock. Affected stock should then be returned to the sponsor.
This action has been closed out on 22/10/2018 |
| Contact Information |
03 9541 1111 - Customer Service Support |