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-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
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:33 PM UTC

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