—#30166

Product

Terumo Advanced Perfusion System 1 Roller Pump; 4 inch diameter; Catalog number 801040.

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 0001 through 0599.

Why it was recalled

The roller pump tube clamp mechanism may fail to release , making it difficult to remove or insert the tubing, and thereby delaying perfusion.

Root cause (FDA determination)

Other

Action the firm took

Letters entitled Urgent Safety Alerts were sent to each customer on 10/16/03. Customers were made away of the problem and advised to develop a protocol for action, in case the problem occurred in their facility.

Recalling firm

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

Distribution

Distribution pattern: United States, Belgium, Canada, Dubai, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Singapore, South Korea.

Timeline

Recall initiated: 2003-10-16
Posted by FDA: 2003-11-07
Terminated: 2005-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #30166. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.