CLASS II Device recall · Reported 18 Jul 2012 · FDA Enforcement Report

Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer recalled

Terumo Cardiovascular Systems is recalling Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer, distributed nationwide in the US. The recall was initiated on 22 Jun 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codescatalog number: 801188 and Serial numbers: 0001-0006, 0008-00050, 00052-00123,00125-00152, 00154-0174,00176-00211, 00213-00241, 00245-00250, 00300-00356, 00358-00365, 00367-00449, 00451-00489, 00492-00522, 00524-00531, 00533-00649, 00651-00660, 00662-00825,0826-0830, 00831-01157, and 01160-01164.

Quantity recalled1095 Units

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-1962-2012
FDA event ID: 61231
Recalling firm: Terumo Cardiovascular Systems, Ann Arbor, MI
Classification: Class II
Status: Terminated
Recall initiated: 22 Jun 2012
FDA classified: 9 Jul 2012
Reported: 18 Jul 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

22 Jun 2012	Recall initiated by company
9 Jul 2012	Classified by FDA	+17 days
18 Jul 2012	Published in enforcement report	+9 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 two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Both were reported instances of users experiencing difficulty adjusting the System 1 Gas System local flow control knob.

Product as listed by the FDA

Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. It also provides monitoring of the carbon dioxide if 95-5 (%oxygen/%carbon dioxide) is used as the blending gas.

Where it was distributed

Worldwide Distribution-USA (nationwide) and the countries of ARGENTINA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.

Nationwide

Stores named: CVS

Questions about this recall

Is Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer recalled?

Yes. Terumo Cardiovascular Systems recalled Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer on 22 Jun 2012. The recall is Class II and its status is Terminated. Recall number Z-1962-2012.

Why was it recalled?

Which lots are affected?

catalog number: 801188 and Serial numbers: 0001-0006, 0008-00050, 00052-00123,00125-00152, 00154-0174,00176-00211, 00213-00241, 00245-00250, 00300-00356, 00358-00365, 00367-00449, 00451-00489, 00492-00522, 00524-00531, 00533-00649, 00651-00660, 00662-00825,0826-0830, 00831-01157, and 01160-01164.

Where was it sold?

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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