| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00844-1 |
| Product Name/Description |
CONMED CORE Suction Irrigation Handpieces (used to perform suction and irrigation during endoscopic procedures)
Reference Numbers: CD8185, CD8190, CD8302
Lot Numbers: 110609X to 20160308X
Manufactured between 9 June 2011 and 8 March 2016
ARTG Number: 131326 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
CONMED have identified that certain CORE Suction Irrigation product have creases in the packaging seal which sometimes can result in an open channel. These channels may compromise sterility of the product. There have been no reports of injuries as result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
CONMED Australia is advising users to discontinue use of the affected product and return it to ConMed for credit or replacement with unaffected product. This action has been closed-out on 17/02/2017. |
| Contact Information |
1800 238 238 - ConMed Australia |