Reported Dec 27, 2023 · Ongoing
Ivenix Infusion System (IIS), Large Volume Pump 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 LVP-0004
- Lot codes and dates
- UDI-DI 00811505030320 Serial numbers
938 of 938 codes
221380036322138003432213800328221380022222138001732212201120221220111922122011182212201115221220111322122011112212201100221220109522122010932212201088221220107622122010742212201061221220105922122010462212201029221220102422122010032212201002221220099322122009902212200987221220098622122009822212200978221220095822122009522212200945221220093822122009292212200914220590017722059001762205900170220590016722059001582205900152220590015022059001432205900133220590013222059001282205900126220590012522059001132205900112220590011022059001092205900108220590010722059001062205900098220590009622059000942205900091
- UDI-DI 00811505030320 Serial numbers
- Amount recalled
- 938 US
Where it was sold
Why it was recalled
Stop using this product now
The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death.
Using this product could cause serious injury, illness or death — stop using it now.
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