Reported Oct 12, 2022 · Terminated
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
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), LVP Software; LVP-SW-0004 version 5.2.0
- Lot codes and dates
- UDI-DI00811505030122 version 5.2.0
- Amount recalled
- 4 instances
Where it was sold
Why it was recalled
Stop using this product now
The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.
Using this product could cause serious injury, illness or death — stop using it now.
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