Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1520-2017

November 01, 2016

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 75353
Status
Terminated
Classification
Class II
Quantity
613,800 total units (575,221 units in US)
Official record key
device-enforcement:Z-1520-2017

Official wording

Reason: 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.

Code information: all units

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.