{
  "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": "41983",
      "product_res_number": "Z-0197-06",
      "event_date_initiated": "2005-09-16",
      "event_date_posted": "2005-11-24",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-11-21",
      "res_event_number": "33513",
      "product_code": "MLR",
      "k_numbers": [
        "K991999"
      ],
      "product_description": "Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S",
      "code_info": "20220\tSTERRAO 100 Accessory Kit 1.8 20221\tSTERRAO 100 Accessory Kit 2.0 20222\tSTERRAO 100 Accessory Kit 2.0 \tSame as 20221 except single ply \tpaper 20223\tSTERRAO 1 DOS Accessory Kit A \t(For use with Block 1.8 \tSTERRAO 100S) 20224\tSTERRAO 1 DOS Accessory Kit B \t(For use with Block 2.0 \tSTERRAO 1 DOS) 20225\tSTERRAO 100S Accessory Kit C \t(For use with Block 2.0 \tSTERRAO System \t& Block 1.8 STERRAO with \tPrinter UpQrade kit install 03-53045- 1- 001\tVaporizer Plate, Shelf Pac 03-05660- 0- 001",
      "firm_fei_number": "3003662624",
      "recalling_firm": "Advanced Sterilization Products",
      "address_1": "33 Technology Dr",
      "city": "Irvine",
      "state": "CA",
      "postal_code": "92618-2346",
      "additional_info_contact": "Mizani Kebede\n949-789-3922",
      "reason_for_recall": "The STERRAD 100 and the STERRAD 100S vaporizer plates are prone to displacement allowing micro-droplets of H2O2 to contact the load. If the vaporizer plate is dislodged, there is an increased chance for operators to have contact with H2O2 resulting in transient burns during the removal of the load.",
      "root_cause_description": "Other",
      "action": "The recall strategy consists of supplying each customer of the STERRAD 100 and the STERRAD 1OOS with: a notification letter of the field action (mailed 09/22/05 ), a pack containing two vaporizer plates of the newly released design, and a set of instructions for self-installation.",
      "product_quantity": "5365",
      "distribution_pattern": "Nationwide and Canada, Germany, & Japan. \nNote: A more detail list of international consignees \n           pending.",
      "openfda": {
        "k_number": [
          "K071385",
          "K231893",
          "K102330",
          "K042116",
          "K160818",
          "K172319",
          "K111810",
          "K233762",
          "K250802",
          "K212174",
          "K223476",
          "K102394",
          "K190103",
          "K160903",
          "K131120",
          "K162413",
          "K142454",
          "K162007",
          "K220345",
          "K222093",
          "K160433",
          "K172754",
          "K092622",
          "K140498",
          "K234082",
          "K231169",
          "K943654",
          "K120632",
          "K083097",
          "K112760",
          "K030429",
          "K252843",
          "K140464",
          "K981625",
          "K190917",
          "K220404",
          "K924380",
          "K991999",
          "K233065",
          "K111377",
          "K212200",
          "K223015",
          "K112813",
          "K190005",
          "K182568",
          "K062297",
          "K151725"
        ],
        "registration_number": [
          "3016075971",
          "3001124136",
          "3013934196",
          "3012494290",
          "3014848734",
          "9680353",
          "3000268902",
          "3035366890",
          "3030733800",
          "3015542154",
          "3005646850",
          "3003950207",
          "3015392401",
          "2084725",
          "3014302784",
          "1822565",
          "3013557562",
          "3005899764",
          "3013176080",
          "3012892649",
          "3011683674",
          "3043237009",
          "1527821",
          "3014272734",
          "3015207155"
        ],
        "fei_number": [
          "3016075971",
          "3001124136",
          "3003662624",
          "3013934196",
          "3012494290",
          "3014848734",
          "3000268902",
          "3035366890",
          "3030733800",
          "3015542154",
          "3005646850",
          "3003950207",
          "3004097451",
          "3015392401",
          "3014302784",
          "3013557562",
          "3005899764",
          "3013176080",
          "3012892649",
          "3011683674",
          "3043237009",
          "1527821",
          "3014272734",
          "3015207155",
          "1000220733"
        ],
        "device_name": "Sterilizer, Chemical",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.6860",
        "device_class": "2"
      }
    }
  ]
}