—#150118

Product

Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K051641
Affected lot / code info: all units

Why it was recalled

Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped.

Root cause (FDA determination)

Use error

Action the firm took

A customer letter dated 11/1/2016 will be sent to all customers to inform them that BD has identified an issue with the Alaris System PC unit. The letter informs the customers that BD has received reports for the Alaris PC units where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped. The letter informs the customers of the issue and recommended steps to take. Customers with recall related questions are instructed to contact BD Support Center at (888) 562-6018, 7-4pm PT, M-F, supportcenter@carefusion.com. Customers with adverse event reports are instructed to contact Customer Advocacy at (888) 812-3266, 24hrs/day, 7days/wk, customerfeedback@carefusion.com. Customers with technical questions regarding the Alaris System are instructed to contact Technical Support at (888) 812-3229, 6am-5pm PT, M-F, DL-US-INF-TechSupport@carefusion.com.

Recalling firm

Firm: CareFusion 303, Inc.
Address: 10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

Distribution pattern: Worldwide distribution. US nationwide, Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, and Canada.

Timeline

Recall initiated: 2016-11-01
Terminated: 2020-04-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #150118. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.