FDA Device recall Z-0026-2018

Alaris Pump Module model 8100 manufactured between November 2011 and March 2012

FDA Device
Class II
ongoing
Published 2017-10-25

On 2017-10-25 the FDA classified a Class II recall of Alaris Pump Module model 8100 manufactured between November 2011 and March 2012 by Carefusion 303, citing the recalling firm has received reports of increased or decreased flows that have occurred in certain pumps.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0026-2018
Classification	Class II
Status	ongoing
Initiated	2017-08-09
Published	2017-10-25
Last updated	2026-09-13 11:54 UTC
Company	Carefusion 303
Distribution	US

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.

Identifiers

code_info	All Alaris Pump module model 8100 manufactured and serviced with the bezel assembly manufactured between October 2011… All Alaris Pump module model 8100 manufactured and serviced with the bezel assembly manufactured between October 2011 and November 2011; Serial Numbers - Serial 13537720 13537735 13538005 13538811 13540340 13541935 13543108 13543503 13543666 13544201 13544350 13545092 13545892 13546315 13546638 13548091 13550608 13550614 13550629 13550670 13552666 13552667 13552781 13552782 13553628 13553661 13553714 13553730 13553739 13554035 12851369 12851850 9879510 9879561 9880323 9880838 9881158 12564799 13157405 13563286 13566911 13566932 13566933 13567118 13585121 13585213 13585493 13586248 13586314 13586329 13586339 13586340 13586408 13586578 13586723 13586731 13586733 13586738 13586746 13586758 13586763 13586764 13586768 13586775 13586782 13586784 13586793 13586795 13586797 13586798 13586819 13586820 13586835 13586836 13586839 13586855 13586860 13586877 13586878 13586898 13586952 13586957 13586960 13586967 13

code_info

All Alaris Pump module model 8100 manufactured and serviced with the bezel assembly manufactured between October 2011…

All Alaris Pump module model 8100 manufactured and serviced with the bezel assembly manufactured between October 2011 and November 2011; Serial Numbers - Serial 13537720 13537735 13538005 13538811 13540340 13541935 13543108 13543503 13543666 13544201 13544350 13545092 13545892 13546315 13546638 13548091 13550608 13550614 13550629 13550670 13552666 13552667 13552781 13552782 13553628 13553661 13553714 13553730 13553739 13554035 12851369 12851850 9879510 9879561 9880323 9880838 9881158 12564799 13157405 13563286 13566911 13566932 13566933 13567118 13585121 13585213 13585493 13586248 13586314 13586329 13586339 13586340 13586408 13586578 13586723 13586731 13586733 13586738 13586746 13586758 13586763 13586764 13586768 13586775 13586782 13586784 13586793 13586795 13586797 13586798 13586819 13586820 13586835 13586836 13586839 13586855 13586860 13586877 13586878 13586898 13586952 13586957 13586960 13586967 13

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0026-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.