Recall archive / FDA device enforcement
Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to... — FDA record Z-0506-2025
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 Oct 18, 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
- Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified healthcare professional.
- Reason
- Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
- Classification
- Class II
- Recalling firm
- Zyno Medical LLC
- Quantity
- 34,994 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0506-2025
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 | Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF Lot Code: Lots: 201016280, 200515888, 200406416, 230920212, 200413400, 20040660, 200716968, 201016720, 20071632, 201211740, 201208256, 210319640, 210709900, 201211360, 2101221000, 210913560, 210913200, 231008352, 220205400, 220204548, 2211141000, 230206980, 230620800, 230420548, 230420136, 230525452, 230620200. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
This product is distributed only in the United States.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Nov 27, 2024
- Recall initiation date
- Oct 18, 2024
- Center classification date
- Nov 21, 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.