Alaris SE Pump (formerly Signature Edition Infusion Pump); Model Numbers: 7000, 7100, 7101, 7130, 7131, 7132, 7200, 7201, 7230, 7231, and 7232
FDA Recall Z-1484-06 · Posted 2006-09-19
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Recalling FirmCardinal Health 303 Inc DBA Alaris Products
Recall StatusTerminated
Product CodeFRN
Date Initiated2006-08-10
Date Terminated2010-07-06
Product Quantity147, 461
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Nationwide and American Samoa, Guam, and Puerto Rico. Worldwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K043590SE INFUSION SYSTEM WITH MMSCardinal Health, Alaris Products · 2005-03-25K032147SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIESAlaris Medical Systems, Inc. · 2003-07-25K022209ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETSAlaris Medical Systems, Inc. · 2002-08-06K012383GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT CAlaris Medical Systems, Inc. · 2001-10-02K931549MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMPY · 1993-10-12
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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