Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.
This recall has been terminated (originally issued December 30, 2006).
- Recall Initiated
- October 12, 2004
- Posted
- December 30, 2006
- Terminated
- February 1, 2007
- Recall Number
- Z-324-2007
- Quantity
- 4740 for all affected products
- Firm Location
- Ann Arbor, MI
- Official Source
- View on FDA website ↗
Reason for Recall
Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
Distribution
Worldwide Distribution-USA and countries Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
Lot / Code Info
Serial numbers 0031, 0032, 0034 through 0041, 0045, 0047 through 0050, 0052, 0054, 0056 through 0059, 0064, 0067, 0071 through 0073, 0075 through 0080, 0082 through 0086, 0088 through 0095, 0097 through 0099, 0101 through 0105, 0107, 0108, 0110, 0111, 0113 through 0117, 0120-0123, 0125-0131, 0133-0135, 0137 through 0140, 0142 through 0165, 0167 through 0180, 0182 through 0191, 0194, 0195, 0197 through 0204, 0206, 0207, 0209, 0211 through 0235, 0237 through 0250, 0252 through 0291, 0293 through 0437, 0440 through 0522, 0524 through 0527, 0700 through 0725, 0727, 0730 through 0858, 0860 through 0878, 0880, 0881, 0885 through 0903, 0906 through 0912, 0922 and 0924.
Root Cause
Other
Action Taken
U.S. consignees were sent an addendum to the operators manual on October 12, 2004 instructing them to cycle power to the unit to clear the error. International distributors were requested to provide this information to their customers on 12/15/04, but Terumo has not yet received confirmation that this was completed.