Recall Z-2780-2015 ยท DPT Probe, Blood-Flow, Extravascular
Edwards Lifesciences, LLC
ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged sterile and non-pyrogenic in a sealed, peel-type pouch. The Knot Pusher is a sterile disposable plastic rod used to advance extracorporeal suture knots during minimally invasive cardiac surgery.
| Date | Sep 18, 2015 (initiated Aug 26, 2015) |
| Status | Terminated |
| Reason | The configuration of the slot at the tip of the knot pusher may inhibit intended ease of use. Fraying or splitting of the suture could occur, which could compromise the integrity of the suture knot. |
| Root cause | Process control |
| Action | Edwards sent an Urgent-Product Recall - Action Required letter dated August 26, 2015, to all affected customers. Letters were sent via Fed-Ex. Please check your inventory for the affected Lot Numbers listed above and return the enclosed confirmation form. If your inventory includes affected product, please contact Edwards Lifesciences to obtain an RGA number and return the affected product. We apologize for the inconvenience caused by this action and appreciate your attention to this matter. If you have questions that have not been answered by this letter, please call Edwards Customer Servi |
| Quantity | 759 units |
| Distribution | Worldwide Distribution - US (nationwide) Distribution and to the countries of : Canada, Japan and Europe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.