Reported Sep 18, 2024 · Ongoing

Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U

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 · 200 Boulder Dr · Breinigsville, PA · 18031-1532

Is this the product you have?

  • Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
Lot codes and dates
  • UDI-DI (GUDID) - 04046963716752 Serial Numbers 52226, 107529, 123259, 123815, 123843, 139003, 147678, 147721, 147725, 239018, 239165, 239231, 239279, 339337
Amount recalled
14

Where it was sold

Why it was recalled

Stop using this product now

Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge during operation triggering false downstream and upstream occlusion alarms. Additional devices have been affected.

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, 6:54 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.