Reported Jul 6, 2016 · Terminated

Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply…

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 System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.
Lot codes and dates
  • Serial no.

    3,259 of 3,259 codes

    • 14566816
    • 14566942
    • 14566976
    • 14567039
    • 14567041
    • 14567050
    • 14567060
    • 14567079
    • 14567084
    • 14567085
    • 14567126
    • 14567131
    • 14567132
    • 14567144
    • 14412839
    • 14509419
    • 14509442
    • 14509601
    • 14510079
    • 14510087
    • 14517114
    • 14517126
    • 14517135
    • 14517137
    • 14517139
    • 14517179
    • 14517183
    • 14517186
    • 14517193
    • 14517202
    • 14517205
    • 14517208
    • 14517214
    • 14517218
    • 14517220
    • 14517246
    • 14517250
    • 14517253
    • 14517254
    • 14517256
    • 14517257
    • 14517259
    • 14517260
    • 14517282
    • 14517286
    • 14517287
    • 14517296
    • 14517297
    • 14517301
    • 14517303
    • 14517305
    • 14517309
    • 14517310
    • 14517312
    • 14517314
    • 14517315
    • 14517316
    • 14517318
    • 14517319
    • 14517323
Amount recalled
69,693 units

Where it was sold

  • Nationwide

Why it was recalled

A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110.

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

Notice updated Dec 24, 2018 · Data as of Sep 19, 6:01 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.