Z-2671-2017Class II

Alaris PC Unit, Model 8015

Name: Z-2671-2017 Alaris PC Unit, Model 8015
Creator: CareFusion 303, Inc.
Published: 2017-06-12
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2017-06-12 / Terminated / root cause: software

FDA source

CareFusion 303, Inc. began a recall of Alaris PC Unit, Model 8015 on 2017-06-12. FDA classified it as Class II and gives the reason as "BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrupted infusions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2671-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-12
Posted: 2017-06-19
Terminated: 2018-10-26
Recalling firm: CareFusion 303, Inc
Product: Alaris PC Unit, Model 8015
Product code: FRN Pump, Infusion
Reason for recall: BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrupted infusions.
Root cause tag: software
FDA root cause: Software design
Action: BD sent an Medical Device Safety Notification Letter dated June 12, 2017 , to customers to inform them that BD is issuing this Safety Notification letter to inform you of reports of customers experiencing a System Error (error code: 255-16-275) with Alaris System PC unit model 8015 that can result in interruption of infusions. Customers are informed of the issue, potential risk, and required actions to be taken by users and by BD. Customers with questions with the safety notification are instructed to call (888) 562-6018 or email [email protected]. Customers with adverse event reports are instructed to call (888) 812-3266 or email [email protected]. Customers with technical questions are instructed to call (888) 812-3229 or email [email protected]. For further questions, please call (858) 617-5925.
Quantity in commerce: 568,283 units
Distribution: Worldwide Distribution - USA (nationwide) and to the countries of : Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, and Canada.
Product codes and lots: Notification will be distributed to all Alaris PC Unit model 8015 customers with software versions greater than 9.12.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2671-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2671-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-12	2017-07-03

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)