Recall Z-0005-2025— Zyno Medical LLC

Name: FDA recall Z-0005-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-13

Class I · Ongoing

Class I FDA medical device recall by Zyno Medical LLC, initiated 2024-09-13. It names 2 FDA 510(k) clearances: K130690, K100705. Product: Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z. Reason: There is a defect in the air-in-line software algorithm..

Recalling firm: Zyno Medical LLC
Classification: Class I
Status: Ongoing
Initiated: 2024-09-13
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 Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z

Reason for recall

There is a defect in the air-in-line software algorithm.

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