{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "204702",
      "product_res_number": "Z-0594-2024",
      "event_date_initiated": "2023-11-30",
      "event_date_posted": "2024-01-03",
      "recall_status": "Open, Classified",
      "res_event_number": "93546",
      "product_code": "NXA",
      "product_description": "Catalog No. 9251R1, 9251R2, 9251R3\nTRACHEOSTOMY CARE SET / STERILE - LATEX FREE",
      "code_info": "UDI-DI 00849233011069\nLots 2210087\n2210165\n2310361",
      "firm_fei_number": "2433012",
      "recalling_firm": "Busse Hospital Disposables, Inc.",
      "address_1": "75 Arkay Dr",
      "city": "Hauppauge",
      "state": "NY",
      "postal_code": "11788-3707",
      "additional_info_contact": "Clarissa Sabillon\n631-435-4711 Ext. 2200",
      "reason_for_recall": "Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On November 21, 2023, the firm notified affected distributors via URGENT MEDICAL DEVICE RECALL letters. Customers were asked to segregate and destroy any affected kits. Distributors should also inform their customers of the recall. Customers should return any affected product to their distributor.\n\nFor questions, email NurseAssistRecall@busseinc.com",
      "product_quantity": "240",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "device_name": "Tracheotomy Care Kit",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5800",
        "device_class": "2",
        "registration_number": [
          "3005595283",
          "3007329020",
          "3014257280",
          "3005460813",
          "1643817",
          "1422634",
          "3009888344",
          "3004519921",
          "2433012",
          "1030451",
          "3004111573",
          "3045816907",
          "1423537",
          "1928237",
          "1423395",
          "1123010",
          "3026197444",
          "9616088",
          "3035642068",
          "3005012805",
          "3015173212",
          "1061124",
          "3004122598",
          "3045816902"
        ],
        "fei_number": [
          "3000717925",
          "3005595283",
          "3002902735",
          "3001236905",
          "3007329020",
          "3014257280",
          "3005460813",
          "1643817",
          "3009888344",
          "2433012",
          "1030451",
          "3004111573",
          "3045816907",
          "1000123297",
          "1000514656",
          "1928237",
          "3026197444",
          "3035642068",
          "1000512168",
          "3005846326",
          "3005012805",
          "3015173212",
          "3004122598",
          "3045816902"
        ],
        "k_number": [
          "K844051"
        ]
      }
    }
  ]
}