| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00261-1 |
| Product Name/Description |
Covidien LigaSure Exact Dissector Nano-Coated 20.6mm-21cm
Item Code: LF2019
Lot Numbers:72550127X, 72770140X, 72770141X, 73000048X
Shipped between November 2017 and February 2018
ARTG Number: 178655
(Medtronic Australasia - Electrode, electrosurgical, active, hand-controlled, single use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
This recall is being conducted due to the potential for the sterile packaging to be compromised, as a result of holes in the sterile packaging. The use of products with this condition may result in a potentially increased risk for infection. There have been no reports of infection associated with this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic is advising users to inspect stock and quarantine any remaining units of the affected batches. Affected stock can be returned to Medtronic for credit.
This action has been closed out on 16/04/2019 |
| Contact Information |
02 9429 3189 - Customer Service Support |