| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00414-1 |
| Product Name/Description |
Versaport Bladeless Optical 5mm Trocar with Fixation Cannula (Abdominal and thoracic trocar)
Multiple product codes and lot numbers:
ONB5LGF (Lots N2K0019X through N3A0294X)
ONB5SHF (Lots N2J0265X through N3A0391X)
ONB5STF (Lots N2H0353X through N3D0033X)
ONB5STF2C (Lots N2J0211X through N3D0118X)
ONBFCA5SH (Lots N2J0315X through N3A0389X)
ONBFCA5ST (Lots N2J0150X through N3C0683X)
ARTG Number: 178557 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
Covidien has received reports of seals disengaging from the cannula which may result in a component inadvertently disengaging into the patient's abdominal and thoracic cavity. |
| Recall Action |
Recall |
| Recall Action Instructions |
Covidien is asking customers to quarantine and discontinue use of all affected lot numbers. Covidien will arrange for pick-up of the affected lots. |
| Contact Information |
1800 252 467 - Covidien Customer Service |