Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS)
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Ivenix Infusion System (IIS), Large Volume Pump, Model Number:LVP-0004UDI NumberModel Number400 affected lots92335321069233421830923342182892335321589233522076923352204192334218339233421829
+392 more
92334218089233421654923342162692334216219233321340221540151722154015459233421789923342180992335321679233532100923352207092334218259233421824923342179492334217839233421781923342177192334217689233421756923342173692334217139233421702923342161792334216119233391513923339149192335320989233421822923342179792334216789233421666923342160192335321149233421792923342176692334216872215401372923352204092335220379233421764923342175292334216659232490602923352206292334218179233421832923352209492334218059233421740923353216192335321119233522061923342183622122009492212200956221220095922122009602212200964221220096522122009832212200999221220100022122010012212201006221220100822122010092212201011221220101722122010202212201021221220103522122010372212201038221220104322154015722219200223221920025722192002682219200273221920030422192003172219200381222370332222237033622223703372222370337822237033882223703421222370343722237034612223703484222370349022237034942223703508222370352322237035342223703541222370354723186002852318600382231860038723216000192321600020232160002223216000232321600026232160002723216000392321600046232160004823216000492321600051232160005223216000532321600054232160005723216000582321600059232160006123216000622321600063232160006523216000662321600067232160006923216000702321600072232160007723216000792321600081232160008223216000832321600086232160008723216000882321600089232160009023216000912321600093232160009423216000952321600096232160017023230000312323000032232300011423230001152323000117232300011923230001642323000167232300016823230001692323000170232410070423326001052333300378233330053923333005442333300545233330054723333005482333300549233330055023333005522333300553233330055423333005552333300557233330055823333005592333300560233330056123333005882333300591233330059223333005932333300594233330059523333005962333300597233480004023348000432334800044233480004523348000462334800047233480004923348000502334800052233480005423348000562334800188233560040123356004022335600409233560041023356004122335600413233560042423356004272335600430233560043123356004322335600433233560043523356004372335600438233560043923356004402335600442233560044424003000022212200950221220095122122009682212201054221920018323216000212321600042232300016523230001662333300532233330058923333005982335600411233560041722122009552212200997221920024023216001792215401536222640008292335220749233421777923342176392334217589233421670923339155392333914899233311310923320121492332011989233201193923320115892329609769232490688923233041292334217469233421733923342173092334217289233421718923342170592334216989233421697923342169592334216929233421681923342167992334216779233421674923342166192334216599233421658923342165392334216529233421646923342163592334216349233421633923342163192334216189233421615923342161292334216109233421602923342159392334215929233421590923342158992334215889233421587923339158492333915829233391580923339157992333915779233391576923339157592333915749233391573923339157292333915719233391570923339156792333915659233391564923339156192333915609233391559923339155792333915569233391555923339155492333915529233391551923339155092333915499233391548923339154792333915469233391542923339154192333915399233391538923339153692333915359233391531923339153092333915299233391524923339152292333915179233391514923339151192333915109233391509923339150892333915079233391505923339150492333915029233391500923339149892333914979233391496923339149592333914949233391493923339149292333914889233391487923339148692333914859233391484923339148192333914809233381479923338147892333814779233381475923338147392333814729233381471923338147092333814699233381468923338146792333814669233381465923338146492333814629233381461923338146092333814579233381456923338145592333814549233381453923338145192333814509233381447923338144692333814459233351443923335144092333514399233351437923335143692333514359233351434923335143392333514319233351430923335142992333514289233351427923335142692333514259233351424
What the firm 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: Ivenix_support@fresnius-kabi.com.
DistributionShow detailsHide
US distribution to states of: ID, MN, NV, TX, VA, WI.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0763-2025
- FDA 510(k) clearance · K183311The device's official FDA premarket clearance record
- FDA device classification · FRNOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.5725The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Fresenius Kabi USA, LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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