Terumo Advanced Perfusion System 1, 6 inch diameter (Large) Roller Pump; Model 801041.
- Recall Initiated
- September 1, 2004
- Posted
- June 30, 2007
- Terminated
- July 7, 2009
- Recall Number
- Z-0601-2007
- Quantity
- 1,484 of both models
- Firm Location
- Ann Arbor, MI
Reason for Recall
The internal ribbon cable may loosen from the roller pump display board, resulting in loss of local control and/or local display.
Distribution
Worldwide: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Mexico, Malaysia, Singapore, South Africa, Taiwan, Thailand and United Arab Emirates.
Lot / Code Info
Serial numbers 0030 through 0998 may be affected. Serial numbers 0052, 0418, 0559, 0745 and 0767 have been corrected.
Root Cause
Other
Action Taken
The firm corrected units in the field or brought them back for evaluation and repair as complaints were received between 9/04 and 4/06. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that they will be visited and their units upgraded as replacement components become available.