{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "149916",
      "product_res_number": "Z-0068-2017",
      "event_date_initiated": "2016-09-24",
      "event_date_created": "2016-10-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-12-06",
      "res_event_number": "75273",
      "product_code": "OMT",
      "product_description": "BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.",
      "code_info": "MAWX380, MAZD460, MAZR350, MBCF540",
      "firm_fei_number": "3010692967",
      "recalling_firm": "Surgical Specialties Mexico S DE RL DE CV",
      "address_1": "Corredor Tijuana - Rosarito 2000-24702 B Corredor Tijuana Rosarito 2000-24702 B Ejido Francisco Villa",
      "city": "Tijuana",
      "country": "Mexico",
      "additional_info_contact": "Kristine Liberacki\n262-994-8083",
      "reason_for_recall": "Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package.",
      "root_cause_description": "Process control",
      "action": "An Urgent Product Recall Notification Letter dated 9/24/16 was sent to customers to inform them that Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package.  The letter informs the customers to complete the customer acknowledgement form and return via fax to their quality assurance department at (610) 404-4010 or return via email to kknappenberger@surgicalspecialties.com.  Customers with questions are instructed to contact Kelly Knappenberger at (484) 220-2402 or Kris Liberacki at (262) 994-8083.",
      "product_quantity": "512 boxes (2560 units)",
      "distribution_pattern": "US: OH, PA, CO, MA, DE, CA, NY, VA, WA, NJ, CT, FL, TX, NH, ID, OK, AZ, GA, PA, NV, VT.\n\nWorldwide: Spain, Italy, United Kingdom, Portugal, Turkey, Germany, Denmark,",
      "openfda": {
        "k_number": [
          "DEN090007",
          "K243722"
        ],
        "device_name": "Absorbable Lung Biopsy Plug",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4755",
        "device_class": "2",
        "registration_number": [
          "3012536737",
          "2030624",
          "3015309643",
          "3006950086",
          "3033589330",
          "1724474",
          "1721676",
          "3011642792",
          "3015225571",
          "1721504"
        ],
        "fei_number": [
          "3012536737",
          "3015309643",
          "3006950086",
          "3033589330",
          "3003094851",
          "3000206435",
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        ]
      }
    }
  ]
}