Recall Z-1567-2014— CareFusion 303, Inc.

Name: FDA recall Z-1567-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-23

Class I · Terminated

Class I FDA medical device recall by CareFusion 303, Inc., initiated 2014-04-23, terminated 2017-03-01. It names one FDA 510(k) clearance: K950419. Product: Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature 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.. Reason: CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature is used..

Recalling firm: CareFusion 303, Inc.
Classification: Class I
Status: Terminated
Initiated: 2014-04-23
Terminated: 2017-03-01
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K950419 — THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETSImed Corp.·cleared 1995-06-21

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 Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature 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.

Reason for recall

CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature is used.

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