Recall Z-0875-2007 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo TenderFlow Pediatric Arterial Cannulae, 2.0mm (6Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813568.
| Date | Jul 10, 2007 (initiated May 22, 2007) |
| Status | Terminated |
| Reason | The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line). |
| Root cause | Other |
| Action | Consignees were notified via phone beginning on 5/22/07 and by follow-up letters sent between 5/23/07 and 6/14/07. |
| Quantity | 72 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063618 | TENDERFLOW PERIATRIC ARTERIAL CANNULA Terumo Cardiovascular Systems Corp., Mar 13, 2007 |