Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Reported: June 18, 2025 Initiated: May 7, 2025 #Z-1865-2025
Product Description
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Reason for Recall
Unreleased software versions were installed on distributed devices without verification or validation.
Details
- Recalling Firm
- Zyno Medical LLC
- Units Affected
- 613 units
- Distribution
- US Nationwide
- Location
- Natick, MA
Frequently Asked Questions
What product was recalled? ▼
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.. Recalled by Zyno Medical LLC. Units affected: 613 units.
Why was this product recalled? ▼
Unreleased software versions were installed on distributed devices without verification or validation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 18, 2025. Severity: Critical. Recall number: Z-1865-2025.
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