Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
This recall is currently active, issued June 6, 2025. It was issued by Zyno Medical Llc.
- Company
- Zyno Medical Llc
- Recall Initiated
- May 7, 2025
- Posted
- June 6, 2025
- Recall Number
- Z-1868-2025
- Quantity
- 613 units
- Firm Location
- Natick, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Unreleased software versions were installed on distributed devices without verification or validation.
Distribution
US Nationwide
Lot / Code Info
Model No. Z800WF; UDI-DI: 00814371020037; Serial No. 500004; 500005; 500006; 500810; 500812; 500813; 501748; 503680; 503681; 503682.
Root Cause
Software design (manufacturing process)
Action Taken
Consignees received an "URGENT: MEDICAL DEVICE CORRECTION" notification dated 5/7/25 by email. The notification instructs consignees to check their stock for affected devices and to immediately stop use; recalled devices are to be returned to Zyno Medical via the provided Response Verification Form. The recall notice is to be provided to personnel at consignee locations who need to be informed and communicated to facilities to where devices were transferred to. Any questions about this recall action are to be directed via email to Frederick Lee at feedback@intuvie.com. A representative from Zyno Medical s partner company, Intuvie LLC, will be in contact with you to coordinate instructions on exchanging devices to remediate this action.