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Terminated

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

FDA Recall Z-0603-2014 · Posted 2013-12-27

Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeMNJ
Date Initiated2013-06-04
Date Terminated2014-10-01
Product Quantity24,227.

Reason for Recall

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

Firm Action

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.

Root Cause

Component design/selection

Distribution Pattern

Nationwide Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K820297WM. HARVEY OVERPRESSURE SAFETY VALVEC.R. Bard, Inc. · 1982-03-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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