Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
- Recall Initiated
- August 1, 2005
- Posted
- June 30, 2007
- Terminated
- February 23, 2008
- Recall Number
- Z-0931-2007
- Quantity
- 1982 total for both models
- 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 0033 through 1308 may be affected by this problem. Serial numbers 1060 and 1148 have been corrected.
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.