Reported Aug 14, 2013 · Terminated

Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The…

CareFusion 303, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

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 PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices.
Lot codes and dates
  • 225 of 225 codes

    • 1005435
    • 10038007
    • 1300550
    • 3894703
    • 1003149
    • 19995706
    • 3895887
    • 19995118
    • 1022500
    • 1257000
    • 1010235
    • 3894799
    • 1264612
    • 1029800
    • 10032389
    • 3894714
    • 3894796
    • 1039450
    • 19995610
    • 3894886
    • 1058150
    • 1129100
    • 1003197
    • 1065900
    • 3894701
    • 10063252
    • 1610200
    • 1074200
    • 3894708
    • 10142044
    • 1296030
    • 1020387
    • 3894811
    • 1083900
    • 10115320
    • 1101500
    • 1102400
    • 1101601
    • 10038966
    • 19995620
    • 3894841
    • 1123000
    • 1135600
    • 1137240
    • 1353400
    • 3894860
    • 1547000
    • 1008565
    • 1186900
    • 6169100
    • 10008460
    • 3894844
    • 1155500
    • 3894711
    • 10032361
    • 10166465
    • 3894702
    • 10046069
    • 10037661
    • 10037647
Amount recalled
26,564 total units (26,220 units for US)

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is operating at an incorrect voltage and it could potentially experience a loss of communication between the PC Unit main Processor and Keyboard Processor.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated May 20, 2014 · Data as of Sep 19, 5:29 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.