LVP Primary Administration Set — Class I medical device recall Z-2721-2024
Ongoing recall by Fresenius Kabi USA, LLC, reported 2024-09-11, distributed in CO, ID, NJ, UT. A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribe
| Recall number | Z-2721-2024 |
|---|---|
| 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 | 2024-08-01 |
| Classified | 2024-09-04 |
| Reported by FDA | 2024-09-11 |
| Distributed | CO, ID, NJ, UT |
| UPC / GTIN / UDI-DI | 00811505030054 |
| Lot numbers | 3010538 |
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 for recall
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).
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-2721-2024. 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.