Z-2474-2020Class II

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

Name: Z-2474-2020 Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
Creator: Baxter Healthcare Corporation
Published: 2020-06-02
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2020-06-02 / Open, Classified / root cause: design

FDA source

Baxter Healthcare Corporation began a recall of Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only on 2020-06-02. FDA classified it as Class II and gives the reason as "A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2474-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-06-02
Posted: 2020-06-30
Recalling firm: Baxter Healthcare Corporation
Product: Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
Product code: MVR Device, Anastomotic, Microvascular
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.
Root cause tag: design
FDA root cause: Device Design
Action: Synovis Micro Companies Alliance (MCA), Inc., a subsidiary of Baxter International Inc., sent a notification to healthcare providers dated, June 2, 2020 titled, "Urgent Medical Device Recall". The notification was sent to the user level for the GEM1020M-2 Flow Coupler Monitor due to a firmware issue which may cause the monitor to intermittently shut down when a WiFi connection is not established. If a shutdown occurs, the monitor can be manually powered back on and will resume normal operation. Synovis is requesting the return of the monitors to perform a firmware upgrade to resolve the issue. Customers should contact Synovis to arrange for product return for the firmware upgrade and replacement of the product. Customers should complete the Baxter customer reply form and return it to Baxter by scanning and e-mailing it to [email protected], even if customers do not have any inventory. Customers should return the response form promptly. If customers have distributed the product to other facilities or departments within the institution, a copy of the communication should be forwarded to them. Questions regarding the communication, contact Synovis at 800-510-3318 or 205-941-0111, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday.
Quantity in commerce: 60 units
Distribution: U.S. distribution only: VA, GA, MD, PA, DC, WI, LA, MN, FL, IN, MI, AZ, TX, MS, MA, NY, SC, WI, WA, MI, CA.
Product codes and lots: Product Code: 5156-00000-011, All Serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2474-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2474-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-07-08	2020-06-30

Product code MVR

K191252Class IIGem FlowCoupler SystemBaxter/ Synovis Micro Companies Alliance, Inc. / cleared 2019-07-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)