Z-0950-2017Class I

Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump...

Name: Z-0950-2017 Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump...
Creator: CareFusion 303, Inc.
Published: 2016-12-02
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2016-12-02 / Terminated

FDA source

CareFusion 303, Inc. began a recall of Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under... on 2016-12-02. FDA classified it as Class I and gives the reason as "During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0950-2017
Classification: Class I
Status: Terminated
Initiated: 2016-12-02
Posted: 2017-01-18
Terminated: 2018-07-24
Recalling firm: CareFusion 303, Inc
Product: Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural
Product code: FRN Pump, Infusion
Reason for recall: During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.
FDA root cause: Component change control
Action: Carefusion (BD) sent a Medical Device Safety Notification letter dated December 2, 2016, to all affected customers. The letter informed customers that BD has identified an issue with the Alaris Pump module. The letter informs the customers that the firm has received reports of Air-In-Line (AIL) alarms that have occurred when no air is observed in the line. Customers were informed of the issue and of the potential risk involved. The letter informs the customers of the actions for users and additional actions for biomedical engineering. Customers with questions regarding recall related questions were instructed to contact BD Support Center at (888) 562-6018, 7-4pm PT, M-F or email [email protected]. Customers with adverse event reports are instructed to contact Customer Advocacy at (888) 812-3266, 24 hrs/day, 7days/wk. or email [email protected]. For questions regarding this recall call 858-617-2000.
Quantity in commerce: 382,635 units
Distribution: Nationwide Distribution
Product codes and lots: All products manufactured or serviced in the time period October 2011 through June 2015.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0950-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0950-2017	Class I	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-18

Product code FRN

K950419Class IIThe Imed Orion Infusion Pump and Administration SetsImed Corp. / cleared 1995-06-21

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)