Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids Recalled by Zyno Medical LLC Due to Update Instruction For Use for Preventative Maintenance (PM)...

Date: June 13, 2011
Company: Zyno Medical LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Zyno Medical LLC directly.

Affected Products

Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.

Quantity: 2589 units

Why Was This Recalled?

Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Zyno Medical LLC

Zyno Medical LLC has 16 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report