Alerts
Alaris System Class I Recall
August 7, 2009
An urgent Class I recall was issued by FDA to Alaris customers on June 12, 2009 describing device failures with the potential to cause under or over-infusion of medication. Alaris manufacturer, CareFusion (formerly Cardinal Health), is working to correct the affected devices. Until all updates are made, specific instructions have been provided to minimize patient risk. Potential failures include inadequate warning messages for blocked tubing and syringe volume, key pad malfunction, fluid flowing into the pumping mechanism, and corrosion of unit connectors. On July 29, 2009, the company provided additional safety instructions regarding for the syringe volume warning. Full descriptions and instructions for specific device failures can found at the following link: http://www.legacycarefusion.com/alaris/brochure/Recall_Update_29July2009.pdf
Devices affected include the Alaris Point-of-Care (PC) Unit (Model 8000 and 8015), the Alaris Pump Module (Model 8100), and the Alaris System. Serial numbers for the specific models are listed in the following link: http://www.legacycarefusion.com/alaris/brochure/SN-Combined%20Unique%20Serial%20List.pdf
Contact CareFusion at 1-800-854-7128 for adverse events and 1-888-562-6018 for general inquiries.
More information is available at the following links:
- CareFusion Recall Notice:
http://www.legacycarefusion.com/alaris/medical-device-recall/ - FDA Recall:
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm175886.htm - FDA Press Release:
http://www.fda.gov/Safety/Recalls/ucm174568.htm - FDA Medwatch:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm174797.htm
Updated
August 7, 2009; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
