FDA recall Z-0026-2018

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 for recall

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

Distribution

Worldwide Distribution - USA (nationwide) and to the countries of : Canada, Australia, UAE, Kuwait, Saudi Arabia, South Africa

Key facts

Status

Ongoing

Initiation date

2017-08-09

Report date

2017-10-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0026-2018