Recall Z-1313-2023 ยท FRN Pump, Infusion
Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
| Date | Apr 18, 2023 (initiated Mar 10, 2023) |
| Status | Open, Classified |
| Reason | Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion. |
| Root cause | Process control |
| Action | The firm distributed via email a URGENT - Medical Device Recall notification to consignees identifying all large volume pumps (LVP) of the Ivenix Infusion System as requiring repair or replacement due to potential fluid ingress, which could lead to interrupted infusion of medication. Customers are instructed to have a secondary LVP readily available when the device is being used to deliver life-sustaining medication if the provided troubleshooting instructions do not resolve the cessation of infusion. Additionally, customers are to ensure no buildup of liquid on the Air Detector region surface |
| Quantity | 1,546 units |
| Distribution | Domestic: CA, CO, NJ, WI, & UT. No foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183311 | Ivenix Infusion System (IIS) Ivenix, Inc., Jun 7, 2019 |