Fresenius Kabi USA, LLC: Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

Recall number

Z-0763-2025

Recalling firm

Fresenius Kabi USA, LLC

Product

Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

Status

Open, Classified

Initiated

2024-12-06

Posted

2025-01-08

Terminated

not on file

Reason

Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.

Root cause

Process control

Action

Fresenius Kabi notified consignees on 12/06/2024 via "URGENT - Medical Device Recall" letter. Consignees were instructed to do the following: 1. Review the facilities list of affected Serial Numbers and post the list in a public place. 2. If an LVP exhibits a Pump Problem during use, remove the LVP from circulation, and notify Fresenius Kabi. 3. Inform potential users of the product within your organization of this notification. 4. Notify customers if product was further distributed. 5. Complete and return the Customer Reply Form included in the letter to acknowledge receipt. Customers will be contacted by a Fresenius Kabi service representative to create a plan for repairing any affected LVPs at your facility at no cost. Fresenius Kabi will also repair LVPs that may encounter pneumatic valve failures at no additional charge. For customer support and questions, call 1-855-354-6387 normal hours are from Monday thru Friday 8:30am-5pm Easter Time, after hours supported by voicemail messaging or email: Ivenix_support@fresnius-kabi.com.

Quantity

1,520 units

Distribution

US distribution to states of: ID, MN, NV, TX, VA, WI.

Lot, serial or model codes

Model Number: LVP-0004, UDI Number: 00811505030320. Serial Numbers: 9233532106, 9233421830, 9233421828, 9233532158, 9233522076, 9233522041, 9233421833, 9233421829, 9233421808, 9233421654, 9233421626, 9233421621, 9233321340, 2215401517, 2215401545, 9233421789, 9233421809, 9233532167, 9233532100, 9233522070, 9233421825, 9233421824, 9233421794, 9233421783, 9233421781, 9233421771, 9233421768, 9233421756, 9233421736, 9233421713, 9233421702, 9233421617, 9233421611, 9233391513, 9233391491, 9233532098, 9233421822, 9233421797, 9233421678, 9233421666, 9233421601, 9233532114, 9233421792, 9233421766, 9233421687, 2215401372, 9233522040, 9233522037, 9233421764, 9233421752, 9233421665, 9232490602, 9233522062, 9233421817, 9233421832, 9233522094, 9233421805, 9233421740, 9233532161, 9233532111, 9233522061, 9233421836, 2212200949, 2212200956, 2212200959, 2212200960, 2212200964, 2212200965, 2212200983, 2212200999, 2212201000, 2212201001, 2212201006, 2212201008, 2212201009, 2212201011, 2212201017, 2212201020, 2212201021, 2212201035, 2212201037, 2212201038, 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510(k) numbers

["K183311"]

PMA numbers

not on file

Product code

FRN

Firm FEI

3014732157

Firm city

North Andover

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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