[pending] Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and bl
Pending LLM rewrite. Source: FDA_DEVICE Z-1866-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Unreleased software versions were installed on distributed devices without verification or validation.
The recalled product
- Product
- Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
- Manufacturer
- Zyno Medical LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No: Z800F
- UDI-DI: 00814371020013
- Serial No. 600091
- 600133
- 600203
- 600259
- 600320
- 600361
- 600404
- 600446
- 600482
- 600526
- 600565
- 600601
- 600094
- 600138
- 600204
- 600261
- 600321
- 600362
Distribution
Distributed nationwide across the United States.
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