{
  "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": "73484",
      "product_res_number": "Z-0218-2009",
      "event_date_initiated": "2008-09-03",
      "event_date_posted": "2008-11-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-10-13",
      "res_event_number": "49463",
      "product_code": "MLY",
      "k_numbers": [
        "K002596"
      ],
      "product_description": "Gebauer's Fluro-Ethyl Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) P/N 0386-0020-20.  The product consists of a can, a valve and an actuator.  \n\nGebauer's Fluro-Ethyl is a vapocoolant (skin refrigerant), topical anesthetic intended to control the pain associated with minor surgical procedures, dermabrasion and injection.  It is also effective in providing temporary relief from the pain associated with minor sports injuries.",
      "code_info": "Model Number:  P/N 0386-0002-20.  Lot Numbers:  7010, 7011, and 7012.",
      "firm_fei_number": "1519179",
      "recalling_firm": "Gebauer Company",
      "address_1": "4444 E 153rd St",
      "city": "Cleveland",
      "state": "OH",
      "postal_code": "44128",
      "additional_info_contact": "Amy J. Paukovits\n216-581-3030 Ext. 120",
      "reason_for_recall": "Some units of Fluro-Ethyl containing the defective valve which could malfunction and spray refrigerant out from the side of the valve in addition to or instead of spraying in the normal inverted position from the product's actuator.  The product can also leak coolant from the side of the valve onto the fingers of the user.",
      "root_cause_description": "Component design/selection",
      "action": "A recall notification letter (Recall Notice) (dated 9/3/2008) was issued on 9/16/2008 to customers.  The notice instructs customers to check their inventory for any remaining recall product and if found, return the product to the Gebauer Company.  The letter also advises distributors to notify their customers and follow instructions as noted above, i.e. customers inventory their stock for recalled product and if found, return to the Gauber Company.  For questions or additional information, contact Gebauer Company at 216-581-3030 (ext. 120) or 800-321-9348.",
      "product_quantity": "12,717 Units",
      "distribution_pattern": "Nationwide Distribution.",
      "openfda": {
        "k_number": [
          "K031036",
          "K030281",
          "K172203",
          "K001624",
          "K991514",
          "K162218",
          "K193349",
          "K984564",
          "K002596",
          "K201248",
          "K033720",
          "K203661",
          "K930915",
          "K172598",
          "K992286",
          "K190161",
          "K243654",
          "K021726",
          "K232674",
          "K093951",
          "K032671",
          "K172028",
          "K202782"
        ],
        "registration_number": [
          "3005740500",
          "3010543854",
          "3014615644",
          "3021853802",
          "1420763",
          "1417592",
          "3018382913",
          "3003925093",
          "3015177815",
          "3012448339",
          "1519179",
          "2110420",
          "1037559",
          "3003775072",
          "3013034812",
          "3016733629",
          "3015351183",
          "3005779557",
          "1121142"
        ],
        "fei_number": [
          "3005740500",
          "3010543854",
          "3014615644",
          "3021853802",
          "1417592",
          "3018382913",
          "3003925093",
          "3015177815",
          "3012448339",
          "1519179",
          "2110420",
          "1037559",
          "3003775072",
          "3013034812",
          "3016733629",
          "3015351183",
          "1833338",
          "3005779557",
          "1121142"
        ],
        "device_name": "Vapocoolant Device",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "U"
      }
    }
  ]
}