{
  "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": "191376",
      "product_res_number": "Z-0567-2022",
      "event_date_initiated": "2021-12-10",
      "event_date_created": "2022-02-07",
      "recall_status": "Open, Classified",
      "res_event_number": "89383",
      "product_code": "LNR",
      "pma_numbers": [
        "P860003"
      ],
      "product_description": "THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA",
      "code_info": "Dunnage case consists of a random unknown lot, which may have been shipped in place of Kit lot K341",
      "firm_fei_number": "3013428851",
      "recalling_firm": "Mallinckrodt Pharmaceuticals Ireland Ltd",
      "address_1": "College Business & Technology Park Blanchardstown Road North",
      "postal_code": "Dublin 15",
      "country": "Ireland",
      "additional_info_contact": "Mallinkrodt Pharmaceuticals\n877-5669466",
      "reason_for_recall": "This recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. This Dunnage Case was shipped on 02-Dec-2021. Dunnage is used during the sterilization process and is not intended for customer use.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On December 10, 2021, the firm initiated phone calls to potentially affected customers. The firm identified the location of the Dunnage Case on the same day, and the Dunnage Case was returned to the recalling firm.",
      "product_quantity": "3",
      "distribution_pattern": "US Nationwide distribution in the states of CA, FL, GA, MA, MI, NC, NJ, NY, OH, TN, TX, VA, WV.",
      "openfda": {
        "device_name": "System, Photopheresis, Extracorporeal",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P860003"
        ],
        "registration_number": [
          "3005778453",
          "3002807314",
          "1317547",
          "3009171251",
          "3000236920",
          "1061124",
          "1319639",
          "3003630504",
          "3010155661",
          "3036773437"
        ],
        "fei_number": [
          "3005778453",
          "3002807314",
          "1317547",
          "1000138054",
          "1000086912",
          "3006759904",
          "3002468842",
          "3010155661",
          "3036773437",
          "1000512168"
        ]
      }
    }
  ]
}