AB5000 Console Circulatory Support System Catalog Number: 0015-0000
This recall has been terminated (originally issued March 7, 2007).
- Company
- Abiomed, Inc.
- Recall Initiated
- January 8, 2007
- Posted
- March 7, 2007
- Terminated
- February 7, 2008
- Recall Number
- Z-0574-2007
- Quantity
- 55 units
- Firm Location
- Danvers, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Unit may alarm ''Low Flow'' and ''Low Pressure'' due to manufacturing material in the pressure source.
Distribution
Worldwide, including USA, Japan, Germany, Australia, and Mexico.
Lot / Code Info
Serial Numbers: 5261- 5317
Root Cause
Other
Action Taken
Abiomed notified customers by letter dated 1/08/07. Service reps will inspect units and replace the defective components.
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