Recall Z-1089-06 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Edwards Lifesciences Research Medical, Inc.
Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm Edwards Lifesciences
| Date | Jun 9, 2006 (initiated Apr 18, 2006) |
| Status | Terminated |
| Reason | Due to potential embrittlement of the plastic tip which may crack or separate during use. |
| Root cause | Other |
| Action | Consignees were notified by letter and visit beginning 04/18/2006. |
| Quantity | 320 units (Domestic) |
| Distribution | CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU, India, Singapore, Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K831769 | VARIOUS CARDIOVASCULAR SURGICAL DEVICE Research Industries Corp., Aug 12, 1983 |