IVENIX INFUSION SYSTEM LVP Blood Products Administration Set — Class I medical device recall Z-1869-2025
Ongoing recall by Fresenius Kabi USA, LLC, reported 2025-06-18, distributed in CA, CO, DE, GA, IL, MD, MI, MN…. Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be inco
| Recall number | Z-1869-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, North Andover, MA, United States |
| Recall initiated | 2025-05-12 |
| Classified | 2025-06-06 |
| Reported by FDA | 2025-06-18 |
| Distributed | CA, CO, DE, GA, IL, MD, MI, MN, MS, NC, NJ, NV, OK, SC, TX, VA, WA, WI |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 20811505030034 |
| Lot numbers | FA24K05015 |
| Model numbers | SET-0014-20 |
Product
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
Reason for recall
Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1869-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.