Recall Z-2879-2016— CareFusion 303, Inc.

Name: FDA recall Z-2879-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-08

Class II · Terminated

Class II FDA medical device recall by CareFusion 303, Inc., initiated 2016-08-08, terminated 2018-10-26. It names one FDA 510(k) clearance: K023264. 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.. Reason: 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..

Recalling firm: CareFusion 303, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-08-08
Terminated: 2018-10-26
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K023264 — MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110Alaris Medical Systems, Inc.·cleared 2002-12-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.