Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model No. Z800WF; UDI-DI: 00814371020037; Serial No. 500004; 500005; 500006; 500810; 500812; 500813; 501748; 503680; 503681; 503682.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Zyno Medical LLC
- Reason for Recall:
- Unreleased software versions were installed on distributed devices without verification or validation.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Product Codes/Lot Numbers:
Model No. Z800WF; UDI-DI: 00814371020037; Serial No. 500004; 500005; 500006; 500810; 500812; 500813; 501748; 503680; 503681; 503682.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1868-2025
Related Recalls
Unreleased software versions were installed on distributed devices without verification or validation.
Unreleased software versions were installed on distributed devices without verification or validation.
Unreleased software versions were installed on distributed devices without verification or validation.