Alaris SE Pump (formerly Signature Edition Infusion Pump) 의 리콜

Recall

36064

Class 1

Z-1484-06

2006-08-10

2006-09-19

Terminated

United States

2010-07-06

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47889

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.

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.