Recalls / —

—#48086

Product

Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268.

FDA product code

DTW — Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K882758

Affected lot / code info

Serial numbers 1997-2005, 2011-2068, 2070-2077, 2079-2137, 2141-2154, 2156-2241, 2243-2257, 2259, 2260, 2262, 2263, 2265-2274, 2276-2278, 2280, 2282-2310, 2312- 2350, 2353-2365, 2367-2460, 2462-2475, 2477-2485, 2488-2523, 2526-2555, 2558-2583, 2585-2600, 2602, 2606-2621, 2624-2628, 2630-2636, 2638, 2639, 2641-2645, 2647, 2650, 2652-2657 and 2661 through 2668.

Why it was recalled

The hand crank handle may separate and detach from the unit during use.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified via letter dated 9/14/06 and mailed between 9/15/06 and 9/28/06 to check their handle type and to contact Terumo for replacement if they have Boutet-style handles. The recall was extended to additional serial numbers and consignees via additional letter sent on 11/17/06.

Recalling firm

Firm

Terumo Cardiovascular Systems Corp

Address

6200 Jackson Rd, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern

Worldwide Distribution, USA and Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.

Timeline

Recall initiated

2006-09-14

Posted by FDA

2006-12-07

Terminated

2008-06-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #48086. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.