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.
Reported: November 27, 2024 Initiated: October 18, 2024 #Z-0506-2025
Product Description
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 for Recall
Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
Details
- Recalling Firm
- Zyno Medical LLC
- Units Affected
- 34,994 units
- Distribution
- This product is distributed only in the United States.
- Location
- Natick, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Zyno Medical LLC. Units affected: 34,994 units.
Why was this product recalled? ▼
Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 27, 2024. Severity: Moderate. Recall number: Z-0506-2025.
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