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Ivenix Infusion System recallZ-0763-2025 · Fresenius Kabi USA, LLC · initiated Dec 6, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Fresenius Kabi USA, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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: [email protected].

Recall details

Recall number
Z-0763-2025
Status
Open, Classified
Initiated by the company
Dec 6, 2024
Posted by the FDA
Jan 8, 2025
Recalling firm
Fresenius Kabi USA, LLC
Quantity
1,520 units
Product code
FRN
FDA submissions
K183311
Distribution
US distribution to states of: ID, MN, NV, TX, VA, WI.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (18k characters)

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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9232490683, 9232490681, 9232490680, 9232490679, 9232490677, 9232490670, 9232490669, 9232490668, 9232490666, 9232490664, 9232490663, 9232490662, 9232490660, 9232490657, 9232490655, 9232490653, 9232490648, 9232490647, 9232490645, 9232490644, 9232490642, 9232490637, 9232490636, 9232490632, 9232490630, 9232490629, 9232490622, 9232490620, 9232490613, 9232490611, 9232490610, 9232490609, 9232490608, 9232490607, 9232490606, 9232490605, 9232490604, 9232490603, 9232490600, 9232490598, 9232490597, 9232490593, 9232490589, 9232490588, 9232490586, 9232490585, 9232490581, 9232490577, 9232490545, 9232490532, 9232330493, 9232330440, 9232330414, 9232300397, 9232300385, 9232300383, 9232300380, 9232190304, 9232190269, 9232190263, 9232090186, 9231910067, 9232750855, 9232490708, 9232490594, 9233532105, 9233522073, 9233522058, 9233421815, 9233421796, 9233421795, 9233421784, 9233421757, 9233421745, 9233421734, 9233421732, 9233421725, 9233421676, 9233421671, 9233421591, 9233391518, 9233522071, 9233421811, 9233421803, 9233421802, 9233421799, 9233421775, 9233421774, 9233421773, 9233421772, 9233421769, 9233421760, 9233421759, 9233421754, 9233421751, 9233421750, 9233421742, 9233421737, 9233421729, 9233421709, 9233421704, 9233421690, 9233421657, 9233421651, 9233421638, 9233421625, 9233391515, 9233201182, 9232750840, 9232190266.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

3 devices cleared under K183311 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page