RecallDepth

Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.

Company
Terumo Cardiovascular Systems Corp
Recall Initiated
August 1, 2005
Posted
June 30, 2007
Terminated
February 23, 2008
Recall Number
Z-0932-2007
Quantity
1982 total for both models distributed
Firm Location
Ann Arbor, MI

Reason for Recall

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.

Distribution

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.

Lot / Code Info

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

Root Cause

Other

Action Taken

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.

More recalls by Terumo Cardiovascular Systems Corp

View all recalls by this company →