{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "85642",
      "product_res_number": "Z-0266-2010",
      "event_date_initiated": "2009-03-05",
      "event_date_posted": "2009-11-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-07-13",
      "res_event_number": "53497",
      "product_code": "CCT",
      "k_numbers": [
        "K070596"
      ],
      "product_description": "Nasal Mucosal Atomizer Device with syringe, LATEX FREE For Single Patient Use Only Packaged Clean -Non-Sterile- MADE IN CANADA.\n\nREF: LTAD-N1-25, Lot 121608, packed 25 per package.  \nREF: LTAD-N1-100, Lot 121608, packed 100 per package.  \n\nManufactured By:  Southmedic 50 alliance Blvd, Barrie, Ontario, Canada L4M 5K3.   \nDistributed By: Sharn Inc. Anesthesia 1-800-325-3671 813-886-2701 email: mailbox@sharn.com\n\nThe device is used to deliver a fine mist numbing agent to the nose or throat for intubating a patient immediately prior to undergoing anesthesia.",
      "code_info": "Lot 121608.",
      "firm_fei_number": "3020651884",
      "recalling_firm": "Sharn, Inc.",
      "address_1": "4517 George Rd Ste 200 4517 George Rd",
      "address_2": "Ste 200",
      "city": "Tampa",
      "state": "FL",
      "postal_code": "33634",
      "additional_info_contact": "813-889-9614",
      "reason_for_recall": "Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device.",
      "root_cause_description": "Device Design",
      "action": "Recalling firm is contacting all direct accounts (distributors & user facilities) by telephone and letter.  They request completion and return of the of the Return Goods Form and of any affected product by UPS using the firm's account number.",
      "product_quantity": "550",
      "distribution_pattern": "Nationwide Distribution",
      "openfda": {
        "k_number": [
          "K760759",
          "K760877",
          "K093584",
          "K810059",
          "K240114",
          "K002255",
          "K172956",
          "K894755",
          "K153470",
          "K070596"
        ],
        "registration_number": [
          "3003898360",
          "3011137372",
          "1832562",
          "3034654861",
          "3020460367"
        ],
        "fei_number": [
          "3003898360",
          "1832562",
          "3020460367",
          "3034654861",
          "3005747797"
        ],
        "device_name": "Applicator (Laryngo-Tracheal), Topical Anesthesia",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5170",
        "device_class": "2"
      }
    }
  ]
}