—#50427

Product

Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000; Catalog No. 16410.

FDA product code: DTW — Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K900815
Affected lot / code info: Hand crank serial numbers 1621 and 1622.

Why it was recalled

The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Summer of 2006.)

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by phone between 1/12/07 and 2/23/07 and informed replacement hand cranks would be shipped.

Recalling firm

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

Distribution

Distribution pattern: Worldwide, including USA, Belgium, Hong Kong, Japan, Taiwan and United Arab Emirates.

Timeline

Recall initiated: 2007-01-12
Posted by FDA: 2007-03-27
Terminated: 2008-06-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50427. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.