{
  "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": "183449",
      "product_res_number": "Z-0309-2021",
      "event_date_initiated": "2020-08-13",
      "event_date_created": "2020-10-29",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-02-03",
      "res_event_number": "86347",
      "product_code": "QKY",
      "product_description": "Critical Care Decontamination System (CCDS)   Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for multiple-user3 reuse by healthcare personnel (HCP)4 to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of Filtering Facepiece Respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) pandemic.",
      "code_info": "All decontaminated compatible N95 respirators distributed from Providence, RI between 07/01/2020 and 08/12/2020.",
      "firm_fei_number": "1523658",
      "recalling_firm": "Battelle Memorial Institute",
      "address_1": "505 King Ave",
      "city": "Columbus",
      "state": "OH",
      "postal_code": "43201-2696",
      "additional_info_contact": "CCDS Customer Service\n614-424-4373",
      "reason_for_recall": "Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Customers were notified via email on 8/13/20:\n\nDear CCDSTM Customer,\nRecently, we became aware that masks processed at the Providence, RI CCDSTM site\nwere not maintained at levels of condensation during a portion of the decontamination\ncycle. The first phase (gassing phase) operated as intended. The next phase (dwell\nphase) had a gradual decline of condensation. The CCDSTM team has corrected this and\nhas confirmed that the system is operating correctly.\nThe normal CCDSTM decontamination cycles operate above the levels of regulatory\nguidelines. To ensure that our process decontaminated the masks effectively, our\nresearch team replicated this process cycle, including the deviated dwell phase, with a\nsimilar number of masks in the chamber. As expected, the results showed a 6-log\nreduction.\nThough this was a deviation to an internal operating procedure, out of caution, we are\nasking you to return your masks to the CCDSTM site to be reprocessed. We will send you\nreplacement masks if you need them while your masks are being decontaminated.\nBattelle CCDSTM is committed to maintaining the highest standards for our customers.\nPlease contact us with any questions.\nSincerely,\nBattelle CCDSTM Team\nCall us at 614-424-4373\nccdscustomerservice@battelle.org",
      "product_quantity": "898",
      "distribution_pattern": "US Nationwide distribution including in the states of CT, MA, RI.",
      "openfda": {
        "registration_number": [
          "3011310668"
        ],
        "fei_number": [
          "3011310668"
        ],
        "device_name": "Decontamination Systems For N95 Respirators",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N"
      }
    }
  ]
}