Recall Z-1484-2024 ยท FRN Pump, Infusion
Fresenius Kabi USA, LLC
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
| Date | Apr 11, 2024 (initiated Mar 7, 2024) |
| Status | Open, Classified |
| Reason | Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death. |
| Root cause | Software Design Change |
| Action | A letter titled URGENT - Medical Device Field Correction, dated 3/7/24, was delivered by hand to consignees or by mail notifying them of this recall event. This notice details eleven software anomalies that could pose a potential risk of serious patient harm or death and the mitigations consignees should perform until software is updated. Consignees are to update their software to LVP software version 5.9.1 by reaching out to their Fresenius Kabi representative at 1-978-775-8100 to schedule installation. Consignees are to complete and return the Customer Reply Form via fax or email. Questions |
| Quantity | 17 units |
| Distribution | US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183311 | Ivenix Infusion System (IIS) Ivenix, Inc., Jun 7, 2019 |