Recall Z-0076-2018 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Sorin Group USA, Inc.
FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective working length of 11.2 inch (28.5 cm). The FlexFlow Venous Cannula is an open lumen polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated
| Date | Sep 28, 2017 |
| Status | Terminated |
| Reason | A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharper or pointier than expected. |
| Root cause | Process change control |
| Action | LivaNova sent an Urgent Medical Device Recall letter dated September 28 2017, to all affected consignees. The letter instructed customer to isolate products belonging to the lot involved. The level of the effectiveness check is Level A, where 100% of the consignees will be contacted. The customers were requested to send back any affected product and to complete the attached Customer Response Form by fax to 303-467-6502 or by email to USFSN@livanova.com. For questions customers were advised to contact Customer Service at 800-.650-2623. |
| Quantity | 40 units |
| Distribution | Worldwide Distribution - US (nationwide) Internationally to France and Spain |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052081 | REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA Estech, Inc., Dec 16, 2005 |