RegWardenFDA facility compliance records
Recall

Class II — CareFusion 303, Inc.

Recalling firmCareFusion 303, INC.
Registered facilityView this company's 3 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonAn issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. An infusion may start that is greater than or less than the hospital established limits for the specific medication.
ProductAlaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.
Quantity63 units
DistributionUS Nationwide Distribution
Initiated2015-05-13
Classified2015-06-16
Terminated2016-05-20
Recall numberZ-1811-2015
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — CareFusion 303, Inc. (Z-1811-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71081/

Not open yet

Alerts for CareFusion 303, INC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.