—#181768

Product

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

FDA product code: MVR — Device, Anastomotic, Microvascular
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K191252
Affected lot / code info: Product Code: 5156-00000-011, All Serial numbers

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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 fca@baxter.com, 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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-06-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181768. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.