| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01002-1 |
| Product Name/Description |
Disposable Myringotomy blade with handle (used during surgery on the ear drum to relieve pressure)
Item Code: 70130791
Lot Number: SD954316
ARTG Number: 142726 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/10/2015 |
| Responsible Entity |
|
| Reason/Issue |
Olympus Australia is issuing a product recall of the affected lot of the Disposable Myringotomy blade with handle, due to missing or compromised seals in the sterile packaging, therefore compromising the sterility of the product. |
| Recall Action |
Recall |
| Recall Action Instructions |
Olympus is requesting users inspect stock and quarantine any affected units. Affected stock will be replaced or a credit issues. This action has been closed-out on 29/08/2016. |
| Contact Information |
1300 657 699 - Olympus Customer Service |