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Open, Classified

Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

FDA Recall Z-1867-2025 · Posted 2025-06-06

Recalling FirmZyno Medical LLC
Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2025-05-07
Product Quantity613 units

Reason for Recall

Unreleased software versions were installed on distributed devices without verification or validation.

Firm 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 [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.

Root Cause

Software design (manufacturing process)

Distribution Pattern

US Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K130690Z-800 INFUSION SYSTEMZyno Medical, LLC · 2013-06-12K100705ZYNO Z-800 INFUSION SYSTEM MODEL Z-800Zyno Medical, LLC · 2010-07-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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