Reported Oct 25, 2017 · Ongoing

Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP…

CareFusion 303, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: CareFusion 303, Inc. · 10020 Pacific Mesa Blvd · San Diego, CA · 92121-4386

Is this the product you have?

  • 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.
Lot codes and dates
  • All Alaris Pump module model 8100 manufactured and serviced with the bezel assembly manufactured between October 2011 and November 2011; Serial Numbers - Serial

    3,262 of 3,262 codes

    • 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
Amount recalled
31,622 units (28,224 in US)

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:16 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.