{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Westlake Village",
      "address_1": "1 Baxter Way",
      "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.",
      "address_2": "",
      "product_quantity": "1,315 units",
      "code_info": "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",
      "center_classification_date": "20140729",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and the countries of United Kingdom, Germany, Sweden, Spain, Israel and Denmark.",
      "state": "CA",
      "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.",
      "report_date": "20140806",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Baxter Healthcare Corporation",
      "recall_number": "Z-2126-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "68789",
      "termination_date": "20150527",
      "more_code_info": "",
      "recall_initiation_date": "20140711",
      "postal_code": "91362-3889",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}