Reported Aug 6, 2014 · Terminated
FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of…
Baxter Healthcare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corporation · 1 Baxter Way · Westlake Village, CA · 91362-3889
Is this the product you have?
- 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.
- Lot codes and dates
- Lot NumberPart No.
SPSGT14-02B0027aSPSGT14-04D0005SPSGT14-04D0023SPSGT13-10J0016SPSGT13-11K0041SPSGT13-12L0008SPSGT14-01A0009SPSGT14-02B0026SPSGT14-04D0015SPSGT14-04D0026SPSGT13-10J0017SPSGT13-11K0039SPSGT13-11K0042SPSGT13-12L0015SPSGT14-01A0028SPSGT14-02B0028SPSGT14-02B0033SPSGT14-04D0014SPSGT14-04D0027SPSGT14-05E0005SPSGT13-10J0018SPSGT13-11K0040SPSGT13-12L0007SPSGT13-12L0012SPSGT14-01A0027
5151-01200-0105151-01200-0105151-01200-0105151-01200-0115151-01200-0115151-01200-0115151-01200-0115151-01250-0105151-01250-0105151-01250-0105151-01250-0115151-01250-0115151-01250-0115151-01250-0115151-01250-0115151-01300-0105151-01300-0105151-01300-0105151-01300-0105151-01300-0105151-01300-0115151-01300-0115151-01300-0115151-01300-0115151-01300-011
- Lot Number
- Amount recalled
- 1,315 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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