Recalls / —

—#48570

Product

Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 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 number 0391(correct) was labeled as serial number 3091 (incorrect).

Why it was recalled

An incorrect serial number was placed on one roller pump.

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 #48570. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.