Recall Z-1101-06 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Ethicon, Inc.
Heartport Direct Flow Arterial Cannula, product code DFK24. The device is sold separately and also in the following Kit Model Numbers: EDNN241, EDnn242, EDNN243, and EDNN244.
| Date | Jun 9, 2006 (initiated Apr 27, 2006) |
| Status | Terminated |
| Reason | During cardiopulmonary bypass (CPB) the distal tip of the arterial cannula can become disconnected from the body of the cannula. |
| Root cause | Other |
| Action | The recall was initiated on 4/27/2006. The hospitals were notified via letters to the Director of Material Management, Director of the OR as well as the Director of the Cardiovascular Suite in the US. The letters were sent via certified mail delivery. For international, notification was made to the J&J affiliates (Gargrave and Italy) by the European Authorized Representative. Each country will follow local procedures for notitying customers. |
| Quantity | 368 |
| Distribution | There are 25 direct customers. There are no distributors, wholesalers and retailers. The firm ships direct to the medical facility. There are 11 International customers located in United Kingdom and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990772 | DIRECTFLOW ARTERIAL CANNULA Heartport, Inc., Mar 23, 1999 |