Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Recall
- Recall Number
- Z-1867-2025
- Event Number
- 96796
- Firm
- Zyno Medical LLC
- FEI Number
- 3006575795
- Product Code
- FRN
- Status
- Open, Classified
- Root Cause
- Software design (manufacturing process)
- Initiated
- May 7, 2025
- Posted
- June 6, 2025
- Address
- 177 Pine St, Natick, MA, 01760-1331
Description
Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Unreleased software versions were installed on distributed devices without verification or validation.
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 [email protected]. 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.
US Nationwide
613 units