Device Recall FlowCOUPLER

Lot Number SPSGT14-02B0027a SPSGT14-04D0005 SPSGT14-04D0023  SPSGT13-10J0016 SPSGT13-11K0041 SPSGT13-12L0008 SPSGT14-01A0009  SPSGT14-02B0026 SPSGT14-04D0015 SPSGT14-04D0026  SPSGT13-10J0017 SPSGT13-11K0039 SPSGT13-11K0042 SPSGT13-12L0015 SPSGT14-01A0028  SPSGT14-02B0028 SPSGT14-02B0033 SPSGT14-04D0014 SPSGT14-04D0027 SPSGT14-05E0005  SPSGT13-10J0018 SPSGT13-11K0040 SPSGT13-12L0007 SPSGT13-12L0012 SPSGT14-01A0027   Part No. 5151-01200-010 5151-01200-010 5151-01200-010   5151-01200-011 5151-01200-011 5151-01200-011 5151-01200-011   5151-01250-010 5151-01250-010 5151-01250-010   5151-01250-011 5151-01250-011 5151-01250-011 5151-01250-011 5151-01250-011   5151-01300-010 5151-01300-010 5151-01300-010 5151-01300-010 5151-01300-010   5151-01300-011 5151-01300-011 5151-01300-011 5151-01300-011 5151-01300-011

Cardiovascular Devices

2

No

Worldwide Distribution - USA (nationwide) and the countries of United Kingdom, Germany, Sweden, Spain, Israel and Denmark.

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.