Z-800F Infusion System Recall Due to Unvalidated Software Versions
Zyno Medical LLC is recalling the Z-800F Infusion System because unreleased software versions were installed on distributed devices without verification or validation. This poses a risk to patients receiving intravenous infusion therapy.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I for a medical device involved in critical patient care (intravenous infusion). Unvalidated software on a life-sustaining infusion system poses a direct risk of serious patient harm, meeting the Class I + medical device criteria for Severe classification.
Plain-English summary
Zyno Medical LLC is recalling the Z-800F Infusion System, which is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to patients. The reason for the recall is that unreleased software versions were installed on distributed devices without verification or validation.
Approximately 613 units of the Z-800F Infusion System have been distributed nationwide. The affected devices are Model No. Z800F with the UDI-DI: 00814371020013 and specific serial numbers listed in the FDA recall notice.
Healthcare facilities and providers who have received this device should immediately cease use and contact Zyno Medical LLC for further instructions regarding the device and any necessary corrective actions.
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 — Infusion System
- Hazard
- software-validation
- device-failure
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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