Recall Z-0026-2018— CareFusion 303, Inc.

Name: FDA recall Z-0026-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-09

Class II · Ongoing

Class II FDA medical device recall by CareFusion 303, Inc., initiated 2017-08-09. It names one FDA 510(k) clearance: K950419. Product: Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012. 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 the IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.. Reason: The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps..

Recalling firm: CareFusion 303, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2017-08-09
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 Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012. 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 the IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.

Reason for recall

The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps.

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