Z-1520-2017Class II

Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply...

Name: Z-1520-2017 Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply...
Creator: CareFusion 303, Inc.
Published: 2016-11-01
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2016-11-01 / Terminated

FDA source

CareFusion 303, Inc. began a recall of Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System on 2016-11-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1520-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-01
Posted: 2017-03-21
Terminated: 2020-04-24
Recalling firm: CareFusion 303, Inc
Product: Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.
Product code: FRN Pump, Infusion
Reason for recall: 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.
FDA root cause: Use error
Action: 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, [email protected]. Customers with adverse event reports are instructed to contact Customer Advocacy at (888) 812-3266, 24hrs/day, 7days/wk, [email protected]. Customers with technical questions regarding the Alaris System are instructed to contact Technical Support at (888) 812-3229, 6am-5pm PT, M-F, [email protected].
Quantity in commerce: 613,800 total units (575,221 units in US)
Distribution: Worldwide distribution. US nationwide, Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, and Canada.
Product codes and lots: all units

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1520-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1520-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-21

Product code FRN

K051641Class IIAlaris System Pc Unit, Model 8001Cardinal Health, Alaris Products / cleared 2005-10-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)