Recall Z-2208-2023— Baxter Healthcare Corporation

Name: FDA recall Z-2208-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-19

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2023-06-19. It names one FDA 510(k) clearance: K191252. Product: GEM FLOW COUPLER Monitor, PN 5156-00000-011. Reason: An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the last active channel prior to powering down..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-06-19
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K191252 — Gem FlowCoupler SystemBaxter/ Synovis Micro Companies Alliance, Inc.·cleared 2019-07-09

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

GEM FLOW COUPLER Monitor, PN 5156-00000-011

Reason for recall

An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the last active channel prior to powering down.

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