Recall Z-1828-2015 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.
| Date | Jun 23, 2015 (initiated May 6, 2015) |
| Status | Terminated |
| Reason | The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user. |
| Root cause | Component design/selection |
| Action | Consignees were notified of the recall by phone beginning on 5/7/2015 and a Urgent Medical Device Recall letter, dated 5/7/2015. The letter identified the affected device, reason for recall, potential hazard, and correction. Customers were asked to review the notice and ensure that all users are aware of the issue. In addition, they are to confirm the quantity of procedure kits for return; and, complete and return the Customer Response Form. Customers can call Terumo CVS Customer Service at 1-800-521-2818 with questions. |
| Quantity | 163 devices |
| Distribution | Distributed to the states of MO and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K820297 | WM. HARVEY OVERPRESSURE SAFETY VALVE C.R. Bard, Inc., Mar 12, 1982 |