Reported Apr 19, 2023 · Ongoing
Ivenix Infusion System (IIS), Large Volume Pump, Model No. 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 No. LVP-0004
- Lot codes and dates
- UDI-DI
1,547 of 1,547 codes
00811505030320Serial No.: 21182000082118200011211930041121193004122119300414211930041521193004162119300417211930041821193004212119300422211930042421193004262119300427211930042821193004292119300430211930043121193004322119300434211930043521193004362119300437211930043821193004392119300440211930044221243000492124300051212430005221243000532124300054212430005821243000592124300060212430006121243000622124300063212430006421243000652124300066212430006821243000692124300070212430007221243000742124300075212430007621243000772124300078212430008021243000822124300083212430008421243000852124300086212430008721243000892124300090
- UDI-DI
- Amount recalled
- 1,546 units
Where it was sold
Why it was recalled
Stop using this product now
Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.
Using this product could cause serious injury, illness or death — stop using it now.
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