Reported Jan 15, 2025 · Ongoing
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Fresenius Kabi USA, LLC
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: Fresenius Kabi USA, LLC · 50 High St Ste 50 · North Andover, MA · 01845-2620
Is this the product you have?
- Ivenix Infusion System (IIS), Large Volume Pump
- Model NumberLVP-0004
- Lot codes and dates
- Model NumberLVP-0004
- UDI Number00811505030320
- Serial Numbers
1,520 of 1,520 codes
923353210692334218309233421828923353215892335220769233522041923342183392334218299233421808923342165492334216269233421621923332134022154015172215401545923342178992334218099233532167923353210092335220709233421825923342182492334217949233421783923342178192334217719233421768923342175692334217369233421713923342170292334216179233421611923339151392333914919233532098923342182292334217979233421678923342166692334216019233532114923342179292334217669233421687221540137292335220409233522037923342176492334217529233421665923249060292335220629233421817923342183292335220949233421805923342174092335321619233532111
- Amount recalled
- 1,520 units
Where it was sold
Why it was recalled
Stop using this product now
Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
Using this product could cause serious injury, illness or death — stop using it now.
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