Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. (Not distributed within the United States).
This recall has been terminated (originally issued December 27, 2006).
- Recall Initiated
- May 1, 2004
- Posted
- December 27, 2006
- Terminated
- July 14, 2009
- Recall Number
- Z-0315-2007
- Quantity
- 5
- Firm Location
- Ann Arbor, MI
- Official Source
- View on FDA website ↗
Reason for Recall
The gas system may fail calibration prior to use due to incorrect gas system flowmeter software.
Distribution
Worldwide distribution, including USA, Belgium, Germany, Japan, Korea and Republic of China.
Lot / Code Info
Serial numbers 0040 through 0044.
Root Cause
Process control
Action Taken
U.S. consignees were visited and corrections made between May 2004 and November 2005. Foreign affiliates were instructed to make corrections on international units, but the firm has not received confirmation yet that these units have been corrected.
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