—#64437

Product

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 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 0006 through 0066, 0100 through 0322 and 1001 through 1017.

Why it was recalled

The units may exhibit blank or distorted displays, loss of local control and/or may have local control knobs that are difficult to use.

Root cause (FDA determination)

Other

Action the firm took

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.

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: 2008-11-06
Terminated: 2009-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64437. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.