Recall archive / FDA device enforcement
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25... — FDA record Z-2721-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 1, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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).
- Classification
- Class I
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 180 cases/4,500 pieces
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2721-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Product Code: SET-0013-25; UDI-DI: 00811505030054; Lot number: 3010538. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Distribution to states of: CO, ID, NJ, UT.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Sep 11, 2024
- Recall initiation date
- Aug 1, 2024
- Center classification date
- Sep 4, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.