Z-2126-2014 Class II Terminated
FDA device recall Z-2126-2014 was initiated by Baxter Healthcare Corporation on Jul 11, 2014 and is designated Class II. 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… The recall status is terminated (terminated May 27, 2015). Affected quantity: 1,315 units.
Recall details
- Product Type
- Devices
- Report Date
- Aug 6, 2014
- Initiation Date
- Jul 11, 2014
- Termination Date
- May 27, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,315 units
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.
Distribution pattern
Worldwide Distribution - USA (nationwide) and the countries of United Kingdom, Germany, Sweden, Spain, Israel and Denmark.
Code information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2126-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026