Recall Z-2402-2008 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Edwards Lifesciences Research Medical, Inc.
Thin-Flex Venous Return Cannulae, 33/43 Fr. x 39 cm, REF TF3343OA, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. Intended for cannula drainage of the superior and inferior vena cava during extracorporeal circulation for a duration of less than and equal to 6 hours.
| Date | Sep 26, 2008 (initiated Jul 14, 2008) |
| Status | Terminated |
| Reason | Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow. |
| Root cause | Process control |
| Action | All domestic consignees were notified by a Product Recall letter on 07/15/2008 via FedEx. They were instructed to check their inventory for any affected product and return all unused product from their stock to Edwards. Customers are to contact Customer Service Organization to obtain a Returned Goods Authorization number and replacement product. Once inventory has been verified, the attached form needs to be completed and faxed to Edwards so that customer awareness can be confirmed. International accounts were notified on 07/14/2008. |
| Quantity | 690 units |
| Distribution | Worldwide Distribution --- USA including states of AL, CA, LA, MI, MN, MO, MS, NC, ND, SC, TX, and WA, and countries of Brazil, Israel, Japan, and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K831769 | VARIOUS CARDIOVASCULAR SURGICAL DEVICE Research Industries Corp., Aug 12, 1983 |