FDA Device Recall Z-0002-2023: Fresenius Kabi USA, LLC

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0002-2023.

Recall Res Number

Z-0002-2023

Recalling Firm / Manufacturer

Fresenius Kabi USA, LLC

FEI Number

3014732157

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2022-09-08

Date Posted

2022-10-06

Date Terminated

2024-09-10

Product Code

PHC

Event Number

90845

Product Quantity

4 instances

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.

Action Details On September 8, 2022, the company notified affected customers via phone call and emailed letter. Customers were instructed to do the following: 1. If a high priority Pump Problem alarm occurs, the LVP should be powered down by holding the power button for 10 seconds then releasing the power button so that the screen goes dark, then pressing the power button again to re-start the pump. Alternatively, if you have another LVP available, you may use it to resume infusion. 2. Inform potential users of the product within your organization of this notification. If your facility further distributes or transfers products amongst satellite sites or other locations, please disseminate this information accordingly. Fresenius Kabi has updated the software to rectify the condition. The updated software is currently available. Please schedule a service call at your earliest convenience to have it installed. Customer support: Ivenix_support@fresenius-kabi.com; 1-978-775-8100

Distribution Pattern Domestic distribution to NJ and WI.

Code Information / Serial Numbers UDI-DI: 00811505030122 version 5.2.0

Related Establishments / Registrations

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BAXTER HEALTHCARE CORPORATION Registration: 1416980 View Registration
CAREFUSION 2200, INC. Registration: 1423507 View Registration
ISOMEDIX OPERATIONS INC Registration: 1643817 View Registration
CareFusion 303, INC. Registration: 2016493 View Registration
ICU MEDICAL, INC. Registration: 2024064 View Registration
Fresenius Vial S.A.S. Registration: 3000240707 View Registration
CareFusion 303, INC Registration: 3003879246 View Registration
InfuSystem Inc. Registration: 3004906872 View Registration
Jabil Circuit (Shanghai) Ltd. Registration: 3005210579 View Registration
FRESENIUS KABI WARRENDALE Registration: 3005778453 View Registration
Synergy Health AST, SRL Registration: 3007738736 View Registration
Jabil Circuit (Shanghai) Ltd. Registration: 3010972758 View Registration
ICU Medical, Inc. Registration: 3012307300 View Registration
InfuSystem Inc. Registration: 3012337868 View Registration
ICU MEDICAL, INC. Registration: 3013319212 View Registration
Fresenius Kabi USA, LLC Registration: 3014732157 View Registration
Baxter Innovations & Business Solutions Pvt. Ltd. Registration: 3015158050 View Registration
INTEGO SOFTWARE, LLC D/B/A CRITICAL ALERT Registration: 3015437214 View Registration
Sistemas Medicos Alaris S.A de C.V. Registration: 3024706751 View Registration
FENWAL INTERNATIONAL, INC. Registration: 9612051 View Registration
ICU Medical Costa Rica Ltd. Registration: 9615050 View Registration
ICU MEDICAL DE MEXICO, S. de R.L. de C.V. Registration: 9617594 View Registration

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Medical Device Recall: Z-0002-2023

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer