FDA Medical devices recall ·
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0763-2025
- Date
- (initiated December 6, 2024)
- Company / brand
- Fresenius Kabi USA, LLC
50 High St Ste 50, North Andover, MA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 1,520 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Why was it recalled?
Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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, 2212201043, 2215401572, 2219200223, 2219200257, 2219200268, 2219200273, 2219200304, 2219200317, 2219200381, 2223703322, 2223703362, 2223703372, 2223703378, 2223703388, 2223703421, 2223703437, 2223703461, 2223703484, 2223703490, 2223703494, 2223703508, 2223703523, 2223703534, 2223703541, 2223703547, 2318600285, 2318600382, 2318600387, 2321600019, 2321600020, 2321600022, 2321600023, 2321600026, 2321600027, 2321600039, 2321600046, 2321600048, 2321
Distribution
US distribution to states of: ID, MN, NV, TX, VA, WI.
States: Idaho Minnesota Nevada Texas Virginia Wisconsin
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0763-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.