{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
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  "results": [
    {
      "cfres_id": "168923",
      "product_res_number": "Z-0643-2019",
      "event_date_initiated": "2018-10-09",
      "event_date_created": "2018-12-19",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-08-18",
      "res_event_number": "81537",
      "product_code": "IWJ",
      "product_description": "Theragenics Applicator Needle (18g x 20cm)\n\nThe device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a protective needle sleeve and the hollow steel needle.",
      "code_info": "Box part number CPPS-MN-1820; Multipack part number CPPS-MN-1820-5;    UDI: (01)00813787021515(10)18090480(11)180904(17)220831;    Lot # 180904-80",
      "firm_fei_number": "1037598",
      "recalling_firm": "Theragenics Corporation",
      "address_1": "5203 Bristol Industrial Way",
      "city": "Buford",
      "state": "GA",
      "postal_code": "30518-1799",
      "additional_info_contact": "Betsy Cortelloni\n770-831-4294",
      "reason_for_recall": "Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed",
      "root_cause_description": "Under Investigation by firm",
      "action": "Theragenics notified customers on about 10/09/2018 via phone call and follow up email.  Instructions included to return any affected product to Theragenics for replacement.",
      "product_quantity": "480 packs (5 needles each)  NOTE:  The multipacks are part of a box of 25 needles, containing five (5) single packs and four (4) 5-packs.",
      "distribution_pattern": "Nationwide distribution to FL, CA, AL, DE, NC, TX, UT, MS.  \n\nInternational distribution to South Africa.",
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        "device_name": "System, Applicator, Radionuclide, Manual",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.5650",
        "device_class": "1"
      }
    }
  ]
}