Recall Z-0549-2024 ยท FRN Pump, Infusion
Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
| Date | Dec 20, 2023 (initiated Nov 29, 2023) |
| Status | Open, Classified |
| Reason | The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death. |
| Root cause | Process change control |
| Action | On November 29, 2023, the firm began notifying affected customers via" URGENT-Medical Device Recall" letter dated November 28, 2023. Customers were provided with precautions to take until the affected LVPs are able to be returned for repair or replacement of internal hardware. Customers will be contacted by a Fresenius Kabi service representative to create a plan for addressing any affected LVPs at their facility. This effort is expected to begin in January 2024. Fresenius Kabi will repair LVPs that may encounter mechanical interference causing the Fluid Valve Actuation System not to move pr |
| Quantity | 938 US |
| Distribution | US distribution to states of: CA, CO, NJ, UT, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183311 | Ivenix Infusion System (IIS) Ivenix, Inc., Jun 7, 2019 |