Recalls / —

—#50422

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

Affected lot / code info

Serial number range of 0031 through 1141 may be affected by this problem.

Why it was recalled

The tube clamp mechanism on the roller pump may not open when the rotation knob is turned, making it difficult to remove and/or insert tubing.

Root cause (FDA determination)

Other

Action the firm took

The firm is visiting the consignees as complaints are received and making corrections. Corrections were made in August 2005 and April 2006 to date. Other units will be repaired if complaints are received and the firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and appropriate action to take should it occur.

Recalling firm

Firm

Terumo Cardiovascular Systems Corp

Address

6200 Jackson Rd, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern

Worldwide; USA, Australia, Belgium, Canada, Dominician Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Mexico, Pakistan, Republic of Georgia, Singapore, South Africa, Taiwan, Thailand and United Arab Emirates.

Timeline

Recall initiated

2005-08-01

Posted by FDA

2007-06-30

Terminated

2008-02-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #50422. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.