Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
FDA Recall Z-1239-2016 · Posted 2016-03-24
Recalling FirmCareFusion 303, Inc.
Recall StatusTerminated
Product CodeFRO
Date Initiated2016-02-12
Date Terminated2017-06-23
Product Quantity170 units
Reason for Recall
CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a "System Error" or "Missing Battery" error code (120.4630).
Firm Action
A customer notification letter dated 2/25/16 will be sent to all their customers who purchased the Alaris PC unit (Model 8000) to inform them that CareFusion is recalling it because a component on the PC unit power supply board may cause a "System Error" or "Missing Battery" error code (120.4630). The letter informs the customers of the potential risk involved and the actions to be taken. Customers with recall related questions are instructed to call CareFusion Support Center at (888) 562-6018, 7am-4pm PST, Mon-Fri or email at [email protected]. Customers with clinical inquires, product complaints or clinical troubleshooting are instructed to contact customer advocacy at (888) 812-3266, 24 hrs/day, 7 days/wk or email at [email protected]. Customers with technical questions regarding the Alaris system are instructed to contact technical support at (888) 812-3229, 6am-5pm PST, Mon-Fri or email at [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
Nationwide in US: AR, AZ, CA, FL, GA, IN, KY, MD, MI, MN, MO, NJ, NM, NY, OH, OR, PA, SC, TN, TX, VA, WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.