Recall Z-0398-2016 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Edwards Lifesciences, LLC
Thin-Flex Venous Cannula, Model Number:TF292902A
| Date | Dec 9, 2015 (initiated Nov 4, 2015) |
| Status | Terminated |
| Reason | Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actual and correct connector size is 1/2 inch. |
| Root cause | Employee error |
| Action | Edwards Lifesciences sent an Urgent Medical Device Safety Notice dated November 17, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer Instructions 1. Review this field safety notice to understand the potential hazard. 2. Meet and review with appropriate clinical staff at your hospital. 3. Complete and return the acknowledgement form attached to this letter via fax to (800) 422-9329 within 5 business days of receiving this notice. 4. Distribute this notice within your organization or to any organiza |
| Quantity | 8,915 units |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution and to the countries of : United Arab Emirates , Belgium, Czech Republic, Spain, France, United Kingdom, Italy, Kuwait, Netherlands, Romania, Saudi Arabia, Sweden, Singapore, Thailand and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120072 | VENOUS DRAINAGE CANNULA WITH DURAFLO COATING Edwards Lifesciences, LLC, May 8, 2012 |