CLASS II Device recall · Reported 19 Sep 2012 · FDA Enforcement Report

Safety monitor included with System 8000 Base The Sarns" recalled

Terumo Cardiovascular Systems is recalling Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is. The recall was initiated on 12 Aug 2009 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codescatalog number 16404 and serial numbers: 4357, 4381, 4386, 4387, 4389, 4391, and 4392.

Quantity recalled8

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

Recall details

Recall number: Z-2348-2012
FDA event ID: 62321
Recalling firm: Terumo Cardiovascular Systems, Ann Arbor, MI
Classification: Class II
Status: Terminated
Recall initiated: 12 Aug 2009
FDA classified: 11 Sep 2012
Reported: 19 Sep 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

12 Aug 2009	Recall initiated by company
11 Sep 2012	Classified by FDA	+1126 days
19 Sep 2012	Published in enforcement report	+8 days

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

Reason for recall

Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo Dubai that the safety monitors were tripping off. Terumo CVS' investigation determined that 8 monitors were manufactured with an underrated circuit breaker due to an error where an associate pulled an underrated circuit breaker from an incorrect inventory location. Since this time, inventory locations hav

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The safety monitor is indicated to warn when the blood level in the reservoir reaches the operator-set limit, and to stop the arterial and cardioplegia pumps.

Where it was distributed

Worldwide distribution: International only-country of: Terumo Dubai, UAE

Stores named: CVS

Questions about this recall

Why was it recalled?

Which lots are affected?

catalog number 16404 and serial numbers: 4357, 4381, 4386, 4387, 4389, 4391, and 4392.

Where was it sold?

Worldwide distribution: International only-country of: Terumo Dubai, UAE

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 26 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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