510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-0763-2025Class I

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

Fresenius Kabi USA, LLC / initiated 2024-12-06 / Open, Classified / root cause: manufacturing process
FDA source (opens on fda.gov)

Fresenius Kabi USA, LLC began a recall of Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 on . FDA classified it as Class I and gives the reason as "Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0763-2025
Classification
Class I
Status
Open, Classified
Initiated
Posted
Recalling firm
Fresenius Kabi USA, LLC
Product
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Product code
FRN Pump, Infusion
Reason for recall
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 tag
manufacturing process
FDA 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: [email protected].
Quantity in commerce
1,520 units
Distribution
US distribution to states of: ID, MN, NV, TX, VA, WI.
Product codes and lots
Model Number: LVP-0004, UDI Number: 00811505030320. 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9232750818, 9232750817, 9232750816, 9232750813, 9232750811, 9232750809, 9232750808, 9232750805, 9232750804, 9232750803, 9232750802, 9232750801, 9232720799, 9232720797, 9232720795, 9232720793, 9232720792, 9232720788, 9232720787, 9232720785, 9232720782, 9232720781, 9232720779, 9232720775, 9232720772, 9232720770, 9232720768, 9232720767, 9232720766, 9232720765, 9232720763, 9232720762, 9232720761, 9232720760, 9232720758, 9232720755, 9232720752, 9232720751, 9232720749, 9232720748, 9232720746, 9232720745, 9232720744, 9232720743, 9232720742, 9232720741, 9232720740, 9232720738, 9232720735, 9232720734, 9232720733, 9232490732, 9232490729, 9232490728, 9232490723, 9232490722, 9232490721, 9232490720, 9232490719, 9232490718, 9232490717, 9232490716, 9232490715, 9232490714, 9232490713, 9232490712, 9232490711, 9232490710, 9232490709, 9232490707, 9232490706, 9232490704, 9232490702, 9232490701, 9232490700, 9232490699, 9232490698, 9232490695, 9232490693, 9232490691, 9232490690, 9232490689, 9232490687, 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.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0763-2025
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0763-2025Class IOngoingVoluntary: Firm initiated