FDA Device recall Z-2232-2025
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, 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, 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-2232-2025 |
| 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, Y-Site (Qty 25). Product Code: SET-0013-25.
Reason
Potential for external cassette leaks
Identifiers
| code_info | Product Code: SET-0013-25. UDI-DI: 00811505030054. Lot Codes: FA24I26149, FA24I30133, FA24I30141, FA24J01131, FA24J01149. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2232-2025%22
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