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U.S. Department of Health and Human Services

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

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  Class 1 Device Recall Alaris SE Pump (formerly Signature Edition Infusion Pump) see related information
Date Initiated by Firm August 10, 2006
Date Posted September 19, 2006
Recall Status1 Terminated 3 on July 06, 2010
Recall Number Z-1484-06
Recall Event ID 36064
510(K)Number K931549  K012383  K022209  K032147  K043590  
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 2		 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 and Original Applicant = ALARIS MEDICAL SYSTEMS, INC.
510(K)s with Product Code = FRN and Original Applicant = CARDINAL HEALTH, ALARIS PRODUCTS
510(K)s with Product Code = FRN and Original Applicant = Y
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