Terumo Advanced Perfusion System, 1 Roller Pump, 6 inch diameter; Catalog No. 801041, Terumo Cardiovascular Systems, Ann Arbor, MI 48103
This recall has been terminated (originally issued December 1, 2007).
- Recall Initiated
- September 10, 2007
- Posted
- December 1, 2007
- Terminated
- February 23, 2008
- Recall Number
- Z-0322-2008
- Quantity
- 76
- Firm Location
- Ann Arbor, MI
- Official Source
- View on FDA website ↗
Reason for Recall
Failure to Operate: The pump may fail to operate, and be difficult to hand crank, due to an internal electrical short condition.
Distribution
Worldwide Distribution-USA including states of Alabama, Arizona, Florida, Illinois, Indiana, Mississippi, Nebraska, North Carolina, Pennsylvania, and Virginia, and countries of Belgium, Hong Kong and United Arab Emirates.
Lot / Code Info
Serial Numbers 2135 through 2149 and 2230 through 2290.
Root Cause
Process control
Action Taken
Consignees were notified via an Urgent Medical Device Correction letter dated 9/10/07, which provided them guidance in the event the problem occurs and advised them they would be contacted to schedule replacement of the circuit boards.