Z-2879-2016Class II

Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the...

Name: Z-2879-2016 Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the...
Creator: CareFusion 303, Inc.
Published: 2016-08-08
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2016-08-08 / Terminated / root cause: software

FDA source

CareFusion 303, Inc. began a recall of Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a... on 2016-08-08. FDA classified it as Class II and gives the reason as "A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is transitioning from one rate to another". 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-2879-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-08
Posted: 2016-09-23
Terminated: 2018-10-26
Recalling firm: CareFusion 303, Inc
Product: Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the Alaris PC unit which is the central programming, monitoring and power supply component for the Alaris System. The syringe pump uses standard, single-use administration sets and syringes with luer-lock connectors.
Product code: FRN Pump, Infusion
Reason for recall: A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is transitioning from one rate to another.
Root cause tag: software
FDA root cause: Software design
Action: The firm, BD, sent an "Urgent: Medical Device Recall Notification" letter dated 8/8/16 to customers to inform them that BD has identified a software anomaly associated with the Alaris Syringe module software version 9.15. The letter describes the product, problem and actions to be taken. The customers were instructed to follow the instructions and promptly complete and return the Customer Response Card to expedite the corrective action process. Customers with recall related questions are instructed to contact the BD Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact customer advocacy at (888) 812-3266. Customers with technical questions regarding the Alaris System are instructed to contact Technical Support at (888) 812-3229.
Quantity in commerce: 12,000 units
Distribution: Worldwide Distribution: US(nationwide) and countries of: Canada, Australia and United Arab Emirates.
Product codes and lots: Software version 9.15

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2879-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2879-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-05	2016-09-23

Product code FRN

K023264Class IIMedley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. / cleared 2002-12-19

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)