Recall Z-1868-2025 ยท FRN Pump, Infusion
Zyno Medical LLC
Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
| Date | Jun 6, 2025 (initiated May 7, 2025) |
| Status | Open, Classified |
| Reason | Unreleased software versions were installed on distributed devices without verification or validation. |
| Root cause | Software design (manufacturing process) |
| Action | 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 Z |
| Quantity | 613 units |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |