Z-0603-2014Class II

Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B...

Name: Z-0603-2014 Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2013-06-04
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2013-06-04 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line on 2013-06-04. FDA classified it as Class II and gives the reason as "Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0603-2014
Classification: Class II
Status: Terminated
Initiated: 2013-06-04
Posted: 2013-12-27
Terminated: 2014-10-01
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
Product code: MNJ Valve, Pressure Relief, Cardiopulmonary Bypass
Reason for recall: Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.
Root cause tag: design
FDA root cause: Component design/selection
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.
Quantity in commerce: 24,227.
Distribution: Nationwide Canada
Product codes and lots: N/A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0603-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0603-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-27

Product code MNJ

K820297Class IIWm. Harvey Overpressure Safety ValveC.R. Bard, Inc. / cleared 1982-03-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)