Recall Z-1749-2013 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Edwards Lifesciences, LLC
Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.
| Date | Jul 17, 2013 (initiated Jun 19, 2013) |
| Status | Terminated |
| Reason | Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particulate inside the sterile pouch and within the internal diam ether of the wand. |
| Root cause | Component design/selection |
| Action | Edwards sent an Urgent Field Safety Notice Product Recall letter, dated June 19, 2013, via FedEx to all affected customers. Two additional attempts will be made to notify customers to return products. The letter idenditifed the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory for any affected device in their inventory, quarantine all affected product from their inventory and return all devices to Edwards. Customers were instructed to acknowledge that they have reviewed the Recall Notice and confirm that they have taken a |
| Quantity | S099: 171,587 units and S099B: 505,107 units |
| Distribution | Worldwide Distribution - USA (nationwide) and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K831759 | INTRACARDIA SUCKERS Research Industries Corp., Aug 12, 1983 |