Class 1 Device Recall Alaris SE Pump (formerly Signature Edition Infusion Pump)

• Date Initiated by Firm: August 10, 2006
• Date Posted: September 19, 2006
• Recall Status: Terminated on July 06, 2010
• Recall Number: Z-1484-06
• Recall Event ID: 36064
• 510(K)Number: K012383 K022209 K032147 K043590 K931549
• Product Classification: infusion pump - Product Code FRN
• Product: Alaris SE Pump (formerly Signature Edition Infusion Pump); Model Numbers: 7000, 7100, 7101, 7130, 7131, 7132, 7200, 7201, 7230, 7231, and 7232
• Code Information: Model Numbers: 7000, 7100, 7101, 7130, 7131, 7132, 7200, 7201, 7230, 7231, and 7232. (ALL MODELS, ALL LOTS) The serial numbers are not sequential.
• Recalling Firm/ Manufacturer: Cardinal Health 303 Inc DBA Alaris Products; 10221 Wateridge Cir; San Diego CA 92121-2733
• For Additional Information Contact: Charles C. Nehring; 858-458-7006
• Manufacturer 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.
• FDA Determined Cause: Software design
• Action: 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.
• Quantity in Commerce: 147, 461
• Distribution: Nationwide and American Samoa, Guam, and Puerto Rico. Worldwide.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN; 510(K)s with Product Code = FRN; 510(K)s with Product Code = FRN