Reported Nov 27, 2024 · Ongoing
Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to…
Zyno Medical LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zyno Medical LLC · 177 Pine St · Natick, MA · 01760-1331
Is this the product you have?
- Z-800 Infusion System
- Model/Catalog NumberZ-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
- Lot codes and dates
- Model/Catalog Number
Z-800Z-800FZ-800W
- Z-800WF Lot Code
Lots: 201016280200515888200406416230920212200413400200406602007169682010167202007163220121174020120825621031964021070990020121136021012210002109135602109132002310083522202054002202045482211141000230206980230620800230420548230420136230525452230620200
- Model/Catalog Number
- Amount recalled
- 34,994 units
Why it was recalled
Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
This product could cause temporary or reversible health problems — stop using it.
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