Alaris SE Pump (formerly Signature Edition Infusion Pump); Model Numbers: 7000, 7100, 7101, 7130, 7131, 7132, 7200, 7201

FDA device recall Z-1484-06 · posted 2006-09-19 · Terminated

Recall details

Recalling firm

Cardinal Health 303 Inc DBA Alaris Products

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.

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.

Root cause

Software design

Status

Terminated

Product code

FRN

Quantity affected

147, 461

Distribution

Nationwide and American Samoa, Guam, and Puerto Rico. Worldwide.

Date initiated

2006-08-10

Date posted

2006-09-19

Date terminated

2010-07-06

Location

San Diego, CA

Related 510(k) clearances