FDAFDA · Food and drugs·Recall number Z-2972-2024
Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
Published September 18, 2024 · Recall initiated: August 7, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- B Braun Medical Inc
- Distributor
- US distribution to AL, CA, GA, IL, MI, and TX.
- Lot
- UDI-DI (GUDID) - 04046963716752 Serial Numbers 52226, 107529, 123259, 123815, 123843, 139003, 147678, 147721, 147725, 239018, 239165, 239231, 239279, 339337
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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