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Recall Observatory FDA recall evidence

Device 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.

Z-0506-2025

October 18, 2024

Class II

Product summary

Firm
Zyno Medical LLC
Event
Event 95601
Status
Ongoing
Classification
Class II
Quantity
34,994 units
Official record key
device-enforcement:Z-0506-2025

Official wording

Reason: Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.

Code information: 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.

Distribution pattern: This product is distributed only in the United States.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.