{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "45077",
      "product_res_number": "Z-0843-06",
      "event_date_initiated": "2006-03-22",
      "event_date_posted": "2006-05-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-02-07",
      "res_event_number": "34988",
      "product_code": "MEQ",
      "pma_numbers": [
        "P030006"
      ],
      "product_description": "Prolieve Thermodilatation Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exchanger cartridge and 500 ml bag of sterile water, Catalog # 880-8023, Material Number M0068808023, labeled in part *** Distributed by Boston Scientific Corporation, Natck, MA***Manufacturer: Celsion Corporation, Columbia, MD***.",
      "code_info": "Lot 600783 Exp Feb-08 Lot 600815 Exp Jan-08 Lot 600874 Exp Feb-08 Lot 600875 Exp Jan-08 Lot 600814 Exp Jan-08 Lot 600771 Exp Jan-08 Lot 600692 Exp Dec-07 Lot 600540 Exp Nov-07 Lot 600630 Exp Dec-07 Lot 600538 Exp Dec-07 Lot 600408 Exp Dec-07 Lot 600145 Exp Sep-07 Lot 600146 Exp Sep-07 Lot 600147 Exp Sep-07",
      "firm_fei_number": "1122126",
      "recalling_firm": "Celsion Corporation, Inc.",
      "address_1": "10220 Old Columbia Road",
      "address_2": "Suite L",
      "city": "Columbia",
      "state": "MD",
      "postal_code": "21046-2364",
      "additional_info_contact": "Carolyn Finkle\n410-290-5390",
      "reason_for_recall": "Surgical treatment kits containing medical device components were mislabeled with extended expiration dates.",
      "root_cause_description": "Other",
      "action": "The recalling firm notified the contract distributor on 2/17/06 to cease shipments. The distributor subsequently notified accounts on 3/22/06 with lot and shipment specific recall letters. The letters advised that consignees discontinue use of the affected lots for return to the distributor. Consignees were requested to return the reply verification form enclosed.",
      "product_quantity": "1515 kits",
      "distribution_pattern": "Products were distributed to one distributor in MA and eight medical device users in MA, IL, NJ, FL, NY, CO, OH, and MI.",
      "openfda": {
        "pma_number": [
          "P970008",
          "P970044",
          "P000043",
          "P950014",
          "P030006",
          "P010055"
        ],
        "registration_number": [
          "3007029079",
          "2183744",
          "2183967",
          "2025851",
          "3010806653",
          "2133936",
          "1721676",
          "3009969279"
        ],
        "fei_number": [
          "3007029079",
          "1000115735",
          "3000718675",
          "2183744",
          "2025851",
          "3010806653",
          "1721676",
          "3009969279"
        ],
        "device_name": "System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}