{
  "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": {
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    {
      "cfres_id": "170493",
      "product_res_number": "Z-0816-2019",
      "event_date_initiated": "2018-12-18",
      "event_date_created": "2019-02-07",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-08-23",
      "res_event_number": "81968",
      "product_code": "DWO",
      "k_numbers": [
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      "product_description": "J  Type Bone Marrow Needle  13ga x 6cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.",
      "code_info": "Model Number IMKBMN-13R-6,  Lot Number LFD9",
      "firm_fei_number": "1417485",
      "recalling_firm": "Angiotech (Manan Medical Products, Inc.)",
      "address_1": "241 W Palatine Rd",
      "city": "Wheeling",
      "state": "IL",
      "postal_code": "60090-5824",
      "additional_info_contact": "Rebecca Ellis\n469-731-1410",
      "reason_for_recall": "Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line",
      "root_cause_description": "Equipment maintenance",
      "action": "Argon Medical Devices notified customers on about 12/18/2018 via \"Urgent - Field Safety Notice\" letter.  Instructions included complete and return the response form a quickly as possible, return all affected product to their Argon Wheeling facility, and to provide the recall notification to all who need to be aware within the organization as well as any organization where the affected product was distributed.",
      "product_quantity": "180 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide in the states of New Jersey,  and countries of Mexico and South Korea.",
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        "device_name": "Needle, Biopsy, Cardiovascular",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4800",
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