{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "cfres_id": "210281",
      "product_res_number": "Z-0195-2025",
      "event_date_initiated": "2024-09-24",
      "event_date_posted": "2024-10-23",
      "recall_status": "Open, Classified",
      "res_event_number": "95438",
      "product_code": "DPT",
      "product_description": "medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC",
      "code_info": "UDI/DI 50351688503921 (case), 10351688503923 (pouch), Lot Numbers: 4363257, 4385760",
      "firm_fei_number": "3012307300",
      "recalling_firm": "Smiths Medical ASD, Inc.",
      "address_1": "6000 Nathan Ln N",
      "city": "Minneapolis",
      "state": "MN",
      "postal_code": "55442-1690",
      "additional_info_contact": "Mrs. Mary J. Ferreira\n845-907-1429",
      "reason_for_recall": "Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.",
      "root_cause_description": "Process control",
      "action": "Smiths medical issued an URGENT MEDICAL DEVICE REMOVAL notice to its consignees on 09/24/2024 via traceable mailing.  The notice explained the issue, potential risk, and requested the destruction of all affected product.  Distributors were directed to forward the notice to their customers.",
      "product_quantity": "1110 units",
      "distribution_pattern": "Worldwide distribution.",
      "openfda": {
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        "device_name": "Probe, Blood-Flow, Extravascular",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.2120",
        "device_class": "2"
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}