Alaris CareFusion PC Unit - Recall Due to Error Code
August 3, 2012
FDA is informing healthcare providers of a Class I recall of CareFusion’s Alaris PC unit, model 8015, due to an error code that prevents programming of the Alaris infusion pump. An error code (120.4630) and message, “System Error” or “Missing Battery Error”, may occur on the PC unit screen along with an alarm due to an issue with the PC unit power supply board. The error code can occur at start-up preventing programming or during infusion when programming changes cannot be made. The error messages may lead to delay in therapy or harm to a patient. Affected units were distributed from January 1, 2011 to May 31, 2012. A list of affected serial numbers can be found at the following link:
If an error message occurs on an Alaris PC unit, do not use the device and contact the CareFusion Support Center. Facilities administering high-risk infusions should consider having alternative devices available until the issue is resolved. CareFusion alerted customers of the recall by letter on June 27, 2012. Do not return any affected PC units. The company will contact customers by phone to schedule a time to replace affected PC unit power supply boards.
Contact the CareFusion Support Center at 1-888-562-6018 with any inquiries regarding the recall and CareFusion Customer Advocacy at 1-800-854-7128 for adverse event reports.
Additional information is available at the following links:
- MedWatch Safety Alert:
- FDA Recall Notice:
- CareFusion Recall Letter:
August 3, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.