Recall Z-0763-2025 ยท FRN Pump, Infusion
Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
| Date | Jan 8, 2025 (initiated Dec 6, 2024) |
| Status | Open, Classified |
| 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 w |
| Quantity | 1,520 units |
| Distribution | US distribution to states of: ID, MN, NV, TX, VA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183311 | Ivenix Infusion System (IIS) Ivenix, Inc., Jun 7, 2019 |