Recall Z-0002-2023— Fresenius Kabi USA, LLC

Name: FDA recall Z-0002-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-08

Class I · Terminated

Class I FDA medical device recall by Fresenius Kabi USA, LLC, initiated 2022-09-08, terminated 2024-09-10. It names one FDA 510(k) clearance: K183311. Product: Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0. Reason: 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..

Recalling firm: Fresenius Kabi USA, LLC
Classification: Class I
Status: Terminated
Initiated: 2022-09-08
Terminated: 2024-09-10
Firm location: North Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K183311 — Ivenix Infusion System (IIS)Ivenix, Inc.·cleared 2019-06-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.