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

    • 00811505030320
    • Serial No.: 2118200008
    • 2118200011
    • 2119300411
    • 2119300412
    • 2119300414
    • 2119300415
    • 2119300416
    • 2119300417
    • 2119300418
    • 2119300421
    • 2119300422
    • 2119300424
    • 2119300426
    • 2119300427
    • 2119300428
    • 2119300429
    • 2119300430
    • 2119300431
    • 2119300432
    • 2119300434
    • 2119300435
    • 2119300436
    • 2119300437
    • 2119300438
    • 2119300439
    • 2119300440
    • 2119300442
    • 2124300049
    • 2124300051
    • 2124300052
    • 2124300053
    • 2124300054
    • 2124300058
    • 2124300059
    • 2124300060
    • 2124300061
    • 2124300062
    • 2124300063
    • 2124300064
    • 2124300065
    • 2124300066
    • 2124300068
    • 2124300069
    • 2124300070
    • 2124300072
    • 2124300074
    • 2124300075
    • 2124300076
    • 2124300077
    • 2124300078
    • 2124300080
    • 2124300082
    • 2124300083
    • 2124300084
    • 2124300085
    • 2124300086
    • 2124300087
    • 2124300089
    • 2124300090
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:37 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.