—#64439

Product

Terumo Advanced Perfusion System 1 base, 110/120V; Model 801763. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.

FDA product code: DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K022947
Affected lot / code info: Serial numbers 0013 through 0610 and 1001 through 1026.

Why it was recalled

Local pump controls including start/stop button, select button and manual button may not function.

Root cause (FDA determination)

Component design/selection

Action the firm took

Consignees were notified by recall letter dated 7/18/08 and were provided with revised operating instructions telling them to revert to the central control module should these problems occur.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Rd, Ann Arbor, Michigan 48103

Distribution

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.

Timeline

Recall initiated: 2008-07-18
Posted by FDA: 2008-10-31
Terminated: 2009-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64439. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.