LVP Primary Administration Set — Class II medical device recall Z-2235-2025
Ongoing recall by Fresenius Kabi USA, LLC, reported 2025-08-06, distributed nationwide. Potential for external cassette leaks
| Recall number | Z-2235-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, North Andover, MA, United States |
| Recall initiated | 2025-06-24 |
| Classified | 2025-07-31 |
| Reported by FDA | 2025-08-06 |
| Distributed | Nationwide (US) |
| Quantity | 348,150 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00811505030214 |
| Lot numbers | FA24J03137, FA24J03145, FA24J07013, FA24J07021, FA24J14019, FA24J14027, FA24J21246, FA24J21253, FA24J24141, FA24J24166, FA24J28027, FA24J28035, FA24K01154, FA24K01162, FA24K11039, FA24K11047, FA24K11161, FA24K18034, FA24K18042, FA24K18059, FA24K25229, FA24L03133, FA24L09221, FA24L10203, FA24L11201, FA24L11219, FA24L16010, FA24L16028, FA24L16036, FA24L18180, FA24L19139, FA24L19147 |
Product
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
Reason for recall
Potential for external cassette leaks
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-2235-2025. 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.