Recalls / —

—#48569

Product

Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.

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 0976 and 0979.

Why it was recalled

Six inch roller pumps were mislabeled as 4 inch roller pumps.

Root cause (FDA determination)

Other

Action the firm took

The six inch roller pump labels were corrected during in-house servicing on 10/6/05 and 10/24/05. A corrected nameplate for the 4 inch roller pump with the incorrect serial number was printed and shipped to the foreign distributor on 10/11/06, and applied in the field by the international distributor on 10/18/06.

Recalling firm

Firm

Terumo Cardiovascular Systems Corp

Address

6200 Jackson Rd, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern

Worldwide-Michigan and Singapore.

Timeline

Recall initiated

2005-10-06

Posted by FDA

2007-01-09

Terminated

2007-02-01

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #48569. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.