FDA Device recall Z-2721-2024
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infu…
- FDA Device
- Class I
- ongoing
- Published 2024-09-11
On 2024-09-11 the FDA classified a Class I recall of LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infu… by Fresenius Kabi Usa, citing A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2721-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-08-01 |
| Published | 2024-09-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | CO, ID, NJ, UT |
Product
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
Reason
A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).
Identifiers
| code_info | Product Code: SET-0013-25; UDI-DI: 00811505030054; Lot number: 3010538. |
|---|
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-2721-2024%22
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