Recall Z-1106-2020 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cardiac Assist, Inc
TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory
| Date | Nov 19, 2019 |
| Status | Terminated |
| Reason | The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula. |
| Root cause | Employee error |
| Action | Initial communications were delivered verbally to quarantine devices starting November 19, 2019. Subsequently, on November 25, 2019 TandemLife issued Medical Device Correction notices to customers via letter 1st class mail (certified return receipt). Actions to be taken by the Customer 1. Check your inventory for the affected product listed within the notice 2. Discontinue use and Quarantine the product 2. Using the Response Form, please respond by email to USFSN@livanova.com to confirm appropriate action has been executed. 3. A replacement TandemLife ECLS Procedure Kit V24/A17 (Reference |
| Quantity | 11 kits |
| Distribution | US Nationwide distribution in the states of AZ, AL, ME, LA, PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162214 | Protek Solo 24 Fr Venous Cannula Set Cardiacassist, Inc., Nov 30, 2016 |