Z-800WF Infusion System. Intended to provide recall: Software Issue
Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Why was Z-800WF Infusion System. Intended to provide recalled?
Unreleased software versions were installed on distributed devices without verification or validation.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No. Z800WF; UDI-DI: 00814371020037; Serial No. 500004; 500005; 500006; 500810; 500812; 500813; 501748; 503680; 503681; 503682.
- Product
- Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
- Recalling firm
- Zyno Medical LLC
- Quantity
- 613 units
- Distribution
- US Nationwide
- Recall date
- June 18, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)