Recalls / —

—#50180

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 0033 through 0355 are potentially affected by the problem. Serial numbers 0033, 0041, 0049, 0052, 0105, 0115, 0117, 0119, 0122, 0145, 0151, 0159, 0160, 0161, 0162, 0170, 0174, 0218, 0226, 0242, 0257, 0262, 0277, 0279, 0290, 0299, 0300, 0305, 0306, 0331, 0334, 0339, 0343 and 0360 have been corrected.

Why it was recalled

A belt slip message may be displayed on the roller pump due to low belt tension or the presence of grease.

Root cause (FDA determination)

Other

Action the firm took

The firm is visiting consignees and making corrections as complaints are received. These corrections, to date, have been made between 04/04 and 09/06. The firm will correct other units as complaints are received and issued a Device Correction Letter dated 6/6 /07 notifying all users of the problem and appropriate responses should it occur.

Recalling firm

Firm

Terumo Cardiovascular Systems Corp

Address

6200 Jackson Rd, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern

Worldwide: USA, Belgium, Canada, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Singapore and United Arab Emirates.

Timeline

Recall initiated

2004-04-01

Posted by FDA

2007-06-30

Terminated

2008-06-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #50180. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.