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U.S. Department of Health and Human Services

Class 2 Device Recall Flow Coupler Monitor

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  Class 2 Device Recall Flow Coupler Monitor see related information
Date Initiated by Firm June 02, 2020
Create Date June 30, 2020
Recall Status1 Open3, Classified
Recall Number Z-2474-2020
Recall Event ID 85782
510(K)Number K191252  
Product Classification Device, anastomotic, microvascular - Product Code MVR
Product Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
Code Information Product Code: 5156-00000-011, All Serial numbers
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MVR and Original Applicant = Baxter/ Synovis Micro Companies Alliance Inc.
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