Recall Z-2234-2025 ยท FRN Pump, Infusion
Fresenius Kabi USA, LLC
LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
| Date | Aug 1, 2025 (initiated Jun 24, 2025) |
| Status | Open, Classified |
| Reason | Potential for external cassette leaks |
| Root cause | Process design |
| Action | Fresenius Kabi notified consignees on about 06/24/2025 via telephone call and followed up with a letter. Consignees were instructed to discontinue use and distribution immediately, quarantine any affected units on hand, notify users of the issue, and complete and return the Customer Reply Form. If affected units were further distributed, consignees were instructed to notify those customers. If Affected units were on hand, consignees were instructed to either destroy or arrange for their return. Replacement of affected units can be arranged. |
| Quantity | 35,925 units |
| Distribution | US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, 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 |