Alaris SE Pump (formerly Signature Edition Infusion Pump); Model Numbers: 7000, 7100, 7101, 7130, 7131, 7132, 7200, 7201, 7230, 7231, and 7232
- Recall Initiated
- August 10, 2006
- Posted
- September 19, 2006
- Terminated
- July 6, 2010
- Recall Number
- Z-1484-06
- Quantity
- 147, 461
- Firm Location
- San Diego, CA
Reason for Recall
This recall was initiated because of a potential for over infusion with all models of the Alaris SE Pumps (formerly the Signature Edition Infusion Pumps) caused by key bounce.
Distribution
Nationwide and American Samoa, Guam, and Puerto Rico. Worldwide.
Lot / Code Info
Model Numbers: 7000, 7100, 7101, 7130, 7131, 7132, 7200, 7201, 7230, 7231, and 7232. (ALL MODELS, ALL LOTS) The serial numbers are not sequential.
Root Cause
Software design
Action Taken
Corrective action for this recall will include notifications (five letters) being sent (Return Receipt) to all customers with affected product alerting them to this action. The letters are addressed to the Director of Biomedical Engineering, Director, Materials Management, Hospital Administration, Purchasing, and the fifth letter to the Director of Nursing. The August 15, 2006, recall letters and the warning labels will be sent return receipt requested. The verification of receipt of the notifications will be tracked and return receipt exceptions will be followed up. Follow up activities will be documented including customer contact.