—#48573

Product

Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. (Not distributed within the United States).

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 0040 through 0044.

Why it was recalled

The gas system may fail calibration prior to use due to incorrect gas system flowmeter software.

Root cause (FDA determination)

Process control

Action the firm took

U.S. consignees were visited and corrections made between May 2004 and November 2005. Foreign affiliates were instructed to make corrections on international units, but the firm has not received confirmation yet that these units have been corrected.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution, including USA, Belgium, Germany, Japan, Korea and Republic of China.

Timeline

Recall initiated: 2004-05-01
Posted by FDA: 2006-12-27
Terminated: 2009-07-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48573. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.