Recall Z-1282-2024— Fresenius Kabi USA, LLC

Name: FDA recall Z-1282-2024
Creator: U.S. Food and Drug Administration
Published: 2022-09-16

Class II · Completed

Class II FDA medical device recall by Fresenius Kabi USA, LLC, initiated 2022-09-16. It names one FDA 510(k) clearance: K183311. Product: LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004. Reason: Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and patient may experience from no to minimal to serious harm. This issue was resolved in all fielded product in software version 5.2.1, which was installed in September 2022..

Recalling firm: Fresenius Kabi USA, LLC
Classification: Class II
Status: Completed
Initiated: 2022-09-16
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

LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004

Reason for recall

Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and patient may experience from no to minimal to serious harm. This issue was resolved in all fielded product in software version 5.2.1, which was installed in September 2022.

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