Recall Z-2474-2020— Baxter Healthcare Corporation

Name: FDA recall Z-2474-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-02

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2020-06-02. It names one FDA 510(k) clearance: K191252. Product: Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only. Reason: A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2020-06-02
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

Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only

Reason for recall

A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.

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