Reported Nov 1, 2023 · Ongoing

8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System

B. Braun Medical, 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: B. Braun Medical, Inc. · 901 Marcon Blvd · Allentown, PA · 18109-9512

Is this the product you have?

  • 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
Lot codes and dates
  • UDI-DI04046964660887
  • Serial Numbers868497 -892669 ***Updated 8/7/24***
  • SNs added
    • 430056
    • 430119
    • 430155
    • 430243
    • 551518
    • 685947
    • 703196
    • 705968
    • 726936
    • 737729
    • 753364
    • 774163
    • 790843
    • 814074
Amount recalled
9771

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions. In some cases, this may be life-threatening or may lead to death.

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

Data as of Sep 19, 5:38 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.