CLASS II Device recall · Reported 8 Jan 2014 · FDA Enforcement Report

Terumo Cardiovascular Custom Cardiovascular Procedure Kits recalled

Terumo Cardiovascular Systems is recalling Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure, distributed nationwide in the US. The recall was initiated on 4 Jun 2013 and the FDA has classified it as Class II.

Recall details

Recall number: Z-0603-2014
FDA event ID: 67064
Recalling firm: Terumo Cardiovascular Systems, Elkton, MD
Classification: Class II
Status: Terminated
Recall initiated: 4 Jun 2013
FDA classified: 27 Dec 2013
Reported: 8 Jan 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

4 Jun 2013	Recall initiated by company
27 Dec 2013	Classified by FDA	+206 days
8 Jan 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

Nationwide Canada

Nationwide

Questions about this recall

Is Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure recalled?

Yes. Terumo Cardiovascular Systems recalled Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure on 4 Jun 2013. The recall is Class II and its status is Terminated. Recall number Z-0603-2014.

Why was it recalled?

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

Where was it sold?

Nationwide Canada

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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