FDAFDA · Food and drugs·Recall number Z-2126-2014
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.
Published August 6, 2014 · Recall initiated: July 11, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- Worldwide Distribution - USA (nationwide) and the countries of United Kingdom, Germany, Sweden, Spain, Israel and Denmark.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.