{
  "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": "189725",
      "product_res_number": "Z-0212-2022",
      "event_date_initiated": "2021-10-04",
      "event_date_created": "2021-11-05",
      "recall_status": "Open, Classified",
      "res_event_number": "88852",
      "product_code": "LNR",
      "pma_numbers": [
        "P860003"
      ],
      "product_description": "THERAKOS CELLEX Photopheresis Procedural Kit\nPRODUCT CODE:\tCLXUSA",
      "code_info": "LOT #\tK307\nEXPIRATION DATE: 2023-02-01\nUDI:  (01)20705030200003(10)K307(17)230201",
      "firm_fei_number": "2523595",
      "recalling_firm": "Therakos, Inc.",
      "address_1": "10 N High St Ste 300 10 N High St",
      "address_2": "Ste 300",
      "city": "West Chester",
      "state": "PA",
      "postal_code": "19380-3014",
      "additional_info_contact": "SAME\n908-367-5447",
      "reason_for_recall": "Product was released prior to all testing being completed. If used and a drive tube leak were to occur,  may cause illness or injury.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Mallincrodt intiated recall by telephone on 10/04/21 and by follow-up letter. Letter states reason for recall, health risk and action to take:\nIf you are receiving this notification, you have been identified as a customer who\nreceived CELLEX Procedural Kit Lot #K307. Immediately examine your\ninventory and quarantine the product subject to this recall. Mallinckrodt\nPharmaceuticals will provide you with a pre-paid shipping label to return it to the\nMallinckrodt Pharmaceuticals warehouse. If you have any questions regarding\nthe return of the recalled product, please contact Mallinckrodt Pharmaceuticals at\n(877) 566-9466 to receive further instructions.\nThis recall is being carried out to the direct customer level. Your assistance is\nappreciated. Please complete and return the enclosed response form as soon as possible.",
      "product_quantity": "Five (5) Cases -3 Kits/Case= 15 Kits",
      "distribution_pattern": "IL",
      "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"
        ]
      }
    }
  ]
}