—#50177

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 number range 0033 through 1308 may be affected by this problem. Serial numbers 1060 and 1148 have been corrected.

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 #50177. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.