{
  "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": "48658",
      "product_res_number": "Z-0081-2007",
      "event_date_initiated": "2006-09-21",
      "event_date_posted": "2006-10-28",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-05-03",
      "res_event_number": "36439",
      "product_code": "FFA",
      "k_numbers": [
        "K944290"
      ],
      "product_description": "Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set; REF/catalog no. 27-135.  Universal Product Number (UPN) M001271350.",
      "code_info": "Lot 8955327.",
      "firm_fei_number": "1828132",
      "recalling_firm": "Boston Scientific Corp",
      "address_1": "780 Brookside Dr",
      "city": "Spencer",
      "state": "IN",
      "postal_code": "47460-1080",
      "additional_info_contact": "Cindy Finney\n508-683-4678",
      "reason_for_recall": "Sterility compromised/package integrity : the bottom of the Tyvek pouch may not have been sealed.",
      "root_cause_description": "Other",
      "action": "Consignees were notified by letter dated 9/21/06 to discontinue use of recalled product, and to segregate the recalled product, and to follow instructions for responding to the firm and returning the product.",
      "product_quantity": "80",
      "distribution_pattern": "Nationwide.",
      "openfda": {
        "registration_number": [
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          "9681260",
          "2124215",
          "3004859241",
          "3005099803",
          "1225687",
          "3007695959"
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        "k_number": [
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          "K833061",
          "K944290"
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        "device_name": "Tube, Drainage, Suprapubic",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5090",
        "device_class": "2"
      }
    }
  ]
}