{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "190074",
      "product_res_number": "Z-0309-2022",
      "event_date_initiated": "2021-10-14",
      "event_date_created": "2021-11-26",
      "recall_status": "Open, Classified",
      "res_event_number": "88941",
      "product_code": "POD",
      "k_numbers": [
        "K183190"
      ],
      "product_description": "NuStat 8\" x12\" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding\nREF: XR-0812-5",
      "code_info": "Lot Code: 20C015 UDI: 00850392006544",
      "firm_fei_number": "3009348684",
      "recalling_firm": "Beeken Biomedical, LLC",
      "address_1": "378 Page St Ste 201 378 Page St",
      "address_2": "Ste 201",
      "city": "Stoughton",
      "state": "MA",
      "postal_code": "02072-1124",
      "additional_info_contact": "SAME\n508-274-5510",
      "reason_for_recall": "Endotoxin levels exceeded allowable limits.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Beeken initiated notification via e-mail on October 14, 2021 and follow-up Urgent Medical Device Voluntary Recall Notification Letter, Certified mail dated October 20, 2021. Letter states reason for recall, health risk and action to take:\nImmediately check your inventory and quarantine all NuStat 8\"x12\" Trauma Pad XR-0812-5\nHemostatic Dressing (Lot Code: 20C015) to prevent further use.\n\" Ensure relevant staff members, including clinicians, surgeons, OR staff and product return staff\nare informed of this recall.\n\" If you have supplied any NuStat 8\"x12\" Trauma Pad XR-0812-5 Hemostatic Dressing (Lot Code:\n20C015) to any other organization or clinical site, please advise that organization of this recall\nand notify Beeken Biomedical of that organization's name, address, and contact person so that\nwe may contact them immediately.\n\" Please immediately complete the attached Acknowledgement form - even if you have none of\nthis product- and return the form to Beeken Biomedical by email to:\nrkendall@beekenbiomedical.com or by mail to\nRecall Administrator\nBeeken Biomedical, LLC\n378 Page Street, Suite 201\nStoughton, MA 02072\n\nquestions about this recall, please email or phone Beeken Biomedical\nCustomer Service at 888-497-7376, Monday through Friday, between the hours of 8:30 am\nand 4:00 pm (EST) or otherwise leave a message which will be returned on the next working day.",
      "product_quantity": "15 units",
      "distribution_pattern": "US in the state of MO",
      "openfda": {
        "k_number": [
          "K200167",
          "K220971",
          "K183190",
          "K243553",
          "K213198",
          "DEN160012"
        ],
        "registration_number": [
          "9680271",
          "1220477",
          "2245304",
          "1219313",
          "3015205402",
          "3009600453",
          "3017391151",
          "3004138549",
          "1047843",
          "3003898360",
          "3007829657",
          "3009348684",
          "3015437221",
          "3015525200",
          "3011137372"
        ],
        "fei_number": [
          "3003259710",
          "2245304",
          "1219313",
          "3015205402",
          "3009600453",
          "3017391151",
          "3004138549",
          "1047843",
          "3009348684",
          "3003898360",
          "3005747797",
          "3007829657",
          "3015437221",
          "3015525200",
          "1220477"
        ],
        "device_name": "Temporary, Internal Use Hemostatic",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4454",
        "device_class": "2"
      }
    }
  ]
}