Recall Z-0506-2025— Zyno Medical LLC

Name: FDA recall Z-0506-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-18

Class II · Ongoing

Class II FDA medical device recall by Zyno Medical LLC, initiated 2024-10-18. It names 2 FDA 510(k) clearances: K130690, K100705. Product: Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified healthcare professional.. Reason: Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains..

Recalling firm: Zyno Medical LLC
Classification: Class II
Status: Ongoing
Initiated: 2024-10-18
Firm location: Natick, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K130690 — Z-800 INFUSION SYSTEMZyno Medical, LLC·cleared 2013-06-12
K100705 — ZYNO Z-800 INFUSION SYSTEM MODEL Z-800Zyno Medical, LLC·cleared 2010-07-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified healthcare professional.

Reason for recall

Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.

Data sourced from openFDA. This site is unofficial and independent of the FDA.