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FDA (Device enforcement)Recalled 2022-09-08closedclass i

Fresenius Kabi USA, LLC: Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Domestic distribution to NJ and WI. Quantity: 4 instances Lot/code info: UDI-DI: 00811505030122 version 5.2.0

UPC codes

00811505030122

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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