Terumo Sarns Level Sensor II (red) (Part # 195274) alarm level sensor transducer for use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900; Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; REF 195274. Level sensors are distributed as a finished device, as part of a kit, with a perfusion system 8000 safety monitor or with an Advanced Perfusion System 1 base. Level sensors are attached to the color coded connectors on the module and then to a hard-shell reservoir. Level detection is used to monitor blood levels in hard-shell reservoirs.
FDA Recall Z-0296-2009 · Posted 2008-11-07
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Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDTQ
Date Initiated2008-05-23
Date Terminated2009-08-04
Product Quantity547
Reason for Recall
The level sensor may not properly couple to the reservoir, resulting in a sensor "not attached" message, an alert or alarm condition, or a failure to detect a low level condition.
Firm Action
U.S. consignees were notified by (Urgent Medical Device Removal) letter dated 5/23/08 via FedEx and international affiliates were notified via e-mail on 5/27/08. Consignees were advised of the problem, and to continue using the affected sensors until replacements are available in late 2008.
For questions or additional information, contact the Terumo CVS Customer Service at 1-800-521-2818.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide including USA and countries of Australia, Belgium, Bolivia, Canada, Chile, Ecuador, Egypt, Honduras, Hong Kong, India, Indonesia, Japan, Jordan, Latin America, Malaysia, Panama, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Sri Lanka, Taiwan, Thailand, United Arab Emirates, Venezuela and Vietnam.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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