Z-0531-2008

Terumo ultrasonic air sensor, 1/4" by 1/16" (6.4 mm x 1.6 mm), Black, for use on Terumo perfusion systems 1...

Name: Z-0531-2008 Terumo ultrasonic air sensor, 1/4" by 1/16" (6.4 mm x 1.6 mm), Black, for use on Terumo perfusion systems 1...
Creator: Terumo Cardiovascular Systems Corp
Published: 2007-09-19
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2007-09-19 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corp began a recall of Terumo ultrasonic air sensor, 1/4" by 1/16" (6.4 mm x 1.6 mm), Black, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5785, Terumo... on 2007-09-19. The reason FDA records is "False Alarm: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0531-2008
Status: Terminated
Initiated: 2007-09-19
Posted: 2008-01-24
Terminated: 2009-07-07
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo ultrasonic air sensor, 1/4" by 1/16" (6.4 mm x 1.6 mm), Black, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5785, Terumo Cardiovalvular Systems, Ann Arbor, MI 48103
Product code: KRL Detector, Bubble, Cardiopulmonary Bypass
Reason for recall: False Alarm: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were notified of the defect/issue and what to do if it were to occur (short term work around) via an Urgent Medical Device Removal letter dated 9/14/07. As the permanent fix users were informed the sensor will be replaced when replacements become available.
Quantity in commerce: 232
Distribution: Worldwide: USA, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, Costa Rica, Dominican Republic, Equador, Germany, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, United Arab Emirates, Uruguay, Venezuela and Vietnam.
Product codes and lots: Serial Numbers: 1106 through 1370 and 1376.

Product code KRL

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