Recalls / —

—#49678

Product

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

FDA product code

KFM — Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K882758

Affected lot / code info

Serial numbers 0001 through 2696.

Why it was recalled

Internal friction may cause the centrifugal manual drive to be inoperable when a disposable pump is attached.

Root cause (FDA determination)

Other

Action the firm took

Consignees will be notified via letter dated 12/12/06, which provides instructions for identifying defective manual drives and to contact the firm if their unit is defective.

Recalling firm

Firm

Terumo Cardiovascular Systems Corp

Address

6200 Jackson Rd, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern

Woldwide, including USA, Canada, and Mexico

Timeline

Recall initiated

2006-12-12

Posted by FDA

2007-03-14

Terminated

2008-06-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #49678. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.