Terumo Advanced Perfusion System, 1 Roller Pump, 4 inch diameter; Catalog No. 801040, Terumo Cardiovascular Systems, Ann Arbor, MI 48103
- Recall Initiated
- September 10, 2007
- Posted
- December 1, 2007
- Terminated
- February 23, 2008
- Recall Number
- Z-0321-2008
- Quantity
- 16
- Firm Location
- Ann Arbor, MI
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 2110 through 2125.
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.
More recalls by Terumo Cardiovascular Systems Corp
Cardiovascular Procedure Kit, P/N: 70932-01, HCSG-St. Mary's Hospital, Richmond, VA , X-coated Pump...
Mar 28, 2008
Cardiovascular Procedure Kit, P/N 70579-04, St. Louis University Hospital Pump & Table Pack, Terumo...
Mar 28, 2008
Cardiovascular Procedure Kit, P/N 70295-02, St. Louis University Hospital Pump & Table Pack, Teru...
Mar 28, 2008