Z-1962-2012Class II

Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The electronic gas blender provides...

Name: Z-1962-2012 Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The electronic gas blender provides...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2012-06-22
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2012-06-22 / Terminated / root cause: labeling and UDI

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The electronic gas blender provides control and monitoring of the gas flow rate and oxygen... on 2012-06-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1962-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-22
Posted: 2012-07-09
Terminated: 2013-02-19
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: 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.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Terumo CVS sent an "URGENT MEDICAL DEVICE RECALL-SAFETY ADVISORY" letter dated June 22, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions regarding this recall.
Quantity in commerce: 1095 Units
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1962-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1962-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-09
Z-1963-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-09
Z-1964-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-09

Product code DTQ

K022947Class IIAdvanced Perfusion System 1 (100/120 Volt),advanced Perfusion System 1 (220/240 Volt, Roller Pumps (6, 4 InchTerumo Cardiovascular Systems Corp. / cleared 2003-03-20

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)