| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00364-1 |
| Product Name/Description |
Askina Gel 15g
Item Code: 001419N
All Batches
ARTG Number: 177492
(B Braun Australia Pty Ltd - Dressing, hydrogel) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
B.Braun's manufacturing site it has determined that the irradiation dose qualified for sterilisation of specific products was too low. In consequence, the germ reduction through gamma irradiation may not have reached the requested sterility assurance level of 0.000001.
To date, there have been no reports of any adverse patient outcome as a result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
B.Braun is advising customers to identify quarantine and return affected stock as per the instructions given in the Customer letter.
This action has been closed out on 31/07/2019 |
| Contact Information |
1800 251 705 - B Braun Australia |