—#52629

Product

Terumo Ultrasonic air sensor, 3/8" by 3/32" (9.5 mm x 2.4 mm), Red, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5773, Terumo Cardiovascular Systems, Ann Arbor, MI 48103

FDA product code: KRL — Detector, Bubble, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K022947
Affected lot / code info: Serial Numbers: 1988 through 4450, 4452 through 4457, 4459 through 4485, 4487 through 4500, 4502 through 4525, 4527 through 4545 and 4551.

Why it was recalled

False Alarms: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Terumo Cardiovascular Systems Corp
Address: 6200 Jackson Rd, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2007-09-19
Posted by FDA: 2008-01-24
Terminated: 2009-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #52629. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.