FDA Device recall Z-2235-2025
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25)
- FDA Device
- Class II
- ongoing
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class II recall of LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25) by Fresenius Kabi Usa, citing potential for external cassette leaks.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2235-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-24 |
| Published | 2025-08-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
Product
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
Reason
Potential for external cassette leaks
Identifiers
| code_info | Product Code: SET-0032-25. UDI-DI: 00811505030214. Lot Codes: FA24J03137, FA24J03145, FA24J07013, FA24J07021, FA24J1401…Product Code: SET-0032-25. UDI-DI: 00811505030214. Lot Codes: 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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa
All Fresenius Kabi Usa recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2235-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.