Recall Z-2126-2014 ยท DPW Flowmeter, Blood, Cardiovascular
Baxter Healthcare Corporation
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.
| Date | Jul 29, 2014 (initiated Jul 11, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | Synovis Micro Companies Alliance, Inc. (a subsidiary of Baxter International Inc.) sent an Urgent Medical Device Recall letter on July 11, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informs the customers that the recall is being conducted as a precautionary measure due to the 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 paten |
| Quantity | 1,315 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of United Kingdom, Germany, Sweden, Spain, Israel and Denmark. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132727 | GEM FLOW COUPLER DEVICE AND SYSTEM Synovis Life Technologies, Inc., Oct 22, 2013 |