Reported Aug 18, 2021 · Terminated

Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted…

BioMedical Equipment Service Co. (BMES)

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: BioMedical Equipment Service Co (BMES) · 2709 S Park Rd · Louisville, KY · 40219-3645

Is this the product you have?

  • Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
Lot codes and dates
  • Serial Numbers

    719 of 719 codes

    • 13414138
    • 13414659
    • 13414829
    • 13415843
    • 15221825
    • 15221825
    • 12744341
    • 12835089
    • 12861990
    • 12875918
    • 12959808
    • 13077410
    • 13077413
    • 13077474
    • 13681407
    • 15306396
    • 15306899
    • 12420646
    • 12421169
    • 12635894
    • 12781498
    • 12949510
    • 13367664
    • 13415216
    • 13931954
    • 2000189
    • 3000595
    • 3000883
    • 3060800
    • 3114560
    • 3163062
    • 3169497
    • 3704252
    • 3704268
    • 3704322
    • 3704343
    • 3704366
    • 3704476
    • 3704477
    • 3704485
    • 3704529
    • 3704536
    • 3704549
    • 3704639
    • 3704645
    • 3704810
    • 3704814
    • 3704853
    • 4109720
    • 4110277
    • 8000560
    • 9885878
    • 9923593
    • 9923615
    • 9923671
    • 9923800
    • 9928207
    • 13900270
    • 13895113
    • 13895704
Amount recalled
718 potentially affected pumps

Where it was sold

Why it was recalled

Stop using this product now

Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.

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

Want the full recall guide?

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 22, 2024 · Data as of Sep 19, 7:39 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.