Recall Z-2126-2014— Baxter Healthcare Corporation

Name: FDA recall Z-2126-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-11

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2014-07-11, terminated 2015-05-27. It names one FDA 510(k) clearance: K132727. Product: FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Baxter Healthcare.. Reason: Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not maintain electrical continuity during handling intra-operatively and post-operatively, resulting in a loss of Doppler signal. This may result in the inability to monitor anastomotic patency, with the possibility that blood flow may not be appropriately monitored..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-07-11
Terminated: 2015-05-27
Firm location: Westlake Village, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K132727 — GEM FLOW COUPLER DEVICE AND SYSTEMSynovis Life Technologies, Inc.·cleared 2013-10-22

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

FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Baxter Healthcare.

Reason for recall

Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not maintain electrical continuity during handling intra-operatively and post-operatively, resulting in a loss of Doppler signal. This may result in the inability to monitor anastomotic patency, with the possibility that blood flow may not be appropriately monitored.

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