—#124644

Product

Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line

FDA product code: MNJ — Valve, Pressure Relief, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K820297
Affected lot / code info: N/A

Why it was recalled

Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.

Root cause (FDA determination)

Component design/selection

Action the firm took

Terumo Cardiovascular issued Customer notification letters on June 4, 2013. Accounts advised to: Review this notice and decide to continue to use or not use the Cardiovascular Procedure Kits as configured until a replacement kit with a one-way valve indicated for use on the arterial side of the perfusion circuit is available. If you have questions, contact Terumo CVS Customer Service: 800-521-2818.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 125 Blue Ball Rd, Elkton, Maryland 21921-5315

Distribution

Distribution pattern: Nationwide Canada

Timeline

Recall initiated: 2013-06-04
Posted by FDA: 2013-12-27
Terminated: 2014-10-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124644. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.