Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This product is not distributed in the United States. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.
FDA Recall Z-0204-2009 · Posted 2008-11-06
Advertisement
Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDTQ
Date Initiated2008-07-18
Date Terminated2009-07-07
Product Quantity300
Reason for Recall
The units may exhibit blank or distorted displays, loss of local control and/or may have local control knobs that are difficult to use.
Firm Action
Consignees were notified via letter dated 7/18/08 and instructed to use the central control module should the problem occur. Contact Terumo Cardiovascular Systems Corp at 1-800-521-2818 for assistance.
Root Cause
Other
Distribution Pattern
Nationwide, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, 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 and Viet Nam.
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.
Advertisement