{
  "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": "140459",
      "product_res_number": "Z-0435-2016",
      "event_date_initiated": "2015-09-03",
      "event_date_created": "2015-12-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-05-02",
      "res_event_number": "72276",
      "product_code": "LRD",
      "product_description": "AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack,  8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only.\r\n\r\nUsed as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity.",
      "code_info": "160889, 161354",
      "firm_fei_number": "3008719017",
      "recalling_firm": "Summit Medical, Inc.",
      "address_1": "815 Northwest Pkwy Ste 100 815 Northwest Pkwy",
      "address_2": "Ste 100",
      "city": "Eagan",
      "state": "MN",
      "postal_code": "55121-1658",
      "additional_info_contact": "Nicole Dove\n651-789-3921",
      "reason_for_recall": "Summit Medical is recalling Doyle P/F Nasal Pack w/Airway, string 8 cm x 3 cm x 1.5 cm, Catalog # RH-7413-10, Lot # 160889 & 161354 because the product does not have the split in the packing.",
      "root_cause_description": "Process control",
      "action": "Consignees were sent a Summit Medical \"Medical Device Recall\" letter, dated September 2, 2015.  The letter described the problem and the product involved in the recall.  It also advised consignees to immediately examine their inventory, quarantine the product, and to complete the attached response form, as well as follow the instructions provided regarding the affected product.  For questions, contact Nicole Dove at 651-789-3921 or ndove@summitmedicalusa.com.",
      "product_quantity": "9 boxes (10 /box)",
      "distribution_pattern": "Distributed to CA.",
      "openfda": {
        "k_number": [
          "K932522",
          "K920842",
          "K942789",
          "K984345",
          "K925022",
          "K940133"
        ],
        "device_name": "Applicator, Ent Drug",
        "medical_specialty_description": "Ear, Nose, Throat",
        "regulation_number": "874.5220",
        "device_class": "1",
        "registration_number": [
          "2648727",
          "3004530184",
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}