{
  "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": "49588",
      "product_res_number": "Z-0338-2007",
      "event_date_initiated": "2006-11-27",
      "event_date_posted": "2007-01-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-01-23",
      "res_event_number": "36934",
      "product_code": "DYG",
      "k_numbers": [
        "K812563"
      ],
      "product_description": "Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75",
      "code_info": "Model Number: 831FH75 Lot Number: 246HC197 Expiration Date: Feb. 2008",
      "firm_fei_number": "2648045",
      "recalling_firm": "Edwards Lifesciences Technology SARL",
      "address_1": "Hwy # 402 North, Km 1.4 Hwy # 402 North Km 1.4 International Industrial Park",
      "city": "Anasco",
      "state": "PR",
      "postal_code": "00610-1576",
      "reason_for_recall": "Misbranding-One lot of Swan-Ganz Thermodilution VIP Catheters, Model 831HF75, lot 246HC197 was labeled with different model information (831F75) on the edge label .  The edge label states the model is 831F75 which incorrectly indicates that product does NOT contain an antimicrobial heparin coating.  (The tray lid label correctly states the model is 831HF75, containing the heparin coating)",
      "root_cause_description": "Other",
      "action": "Edwards initiated the recall in the US by sending a Customer Letter by Federal Express on November 28, 2006, along with a Q&A to their customers Service and Direct Customers to facilitate the uderstanding of the recall and the request for verification and return of all unused product.",
      "product_quantity": "1,110 units",
      "distribution_pattern": "Worldwide Distribution ----USA and countries of Columbia and Venezuela.",
      "openfda": {
        "k_number": [
          "K841251",
          "K841876",
          "K811276",
          "K833918",
          "K961999",
          "K010253",
          "K812111",
          "K853383",
          "K841640",
          "K841705",
          "K771306",
          "K242451",
          "K893435",
          "K832324",
          "K963248",
          "K812563",
          "K843411",
          "K802288",
          "K231248",
          "K832380",
          "K233983",
          "K831854",
          "K823007",
          "K772059",
          "K904287",
          "K823433",
          "K193466",
          "K821057",
          "K821996",
          "K820229",
          "K820702",
          "K801865",
          "K822350",
          "K813578",
          "K771043",
          "K874465",
          "K862119",
          "K822806",
          "K802481",
          "K081052",
          "K233824",
          "K834036",
          "K900879",
          "K820883",
          "K883948",
          "K901247",
          "K003118",
          "K782071",
          "K160084",
          "K951566",
          "K924452",
          "K850952",
          "K940795",
          "K802338",
          "K911840",
          "K963336",
          "K810124",
          "K940547",
          "K821235",
          "K833572",
          "K770522",
          "K822034",
          "K832287",
          "K852294",
          "K001063",
          "K812324",
          "K841639",
          "K892530",
          "K831185",
          "K094048",
          "K935404",
          "K834037",
          "K012225",
          "K810352",
          "K901287",
          "K872770",
          "K771823",
          "K925444",
          "K822723",
          "K833836",
          "K823484",
          "K843409",
          "K830604",
          "K832957",
          "K955816",
          "K920869",
          "K851948",
          "K874117",
          "K934742",
          "K821099",
          "K820222",
          "K831945",
          "K841317",
          "K993245",
          "K821004",
          "K222117",
          "K893474",
          "K896466",
          "K760533"
        ],
        "pma_number": [
          "P810046"
        ],
        "registration_number": [
          "",
          "8043983",
          "2024311",
          "1713468",
          "1625425",
          "9680794",
          "2025816",
          "9673241",
          "1720929",
          "1035166",
          "3004832480",
          "3038791046",
          "2024168",
          "1319639",
          "2649622",
          "3002807314",
          "2521402",
          "3017060084",
          "3015859709",
          "1220948",
          "3004111573",
          "3013319212",
          "9615817",
          "3004091615",
          "3004784537",
          "1000563940",
          "3006425876",
          "1061927",
          "3013162291",
          "3013764800",
          "1061124",
          "3005718570",
          "9680260",
          "2133641",
          "2939561",
          "1018233",
          "2011171",
          "3008496528",
          "2182208",
          "3014656749",
          "2648045",
          "3032916632",
          "3006082230",
          "2523676",
          "1317547",
          "3010532612",
          "3013300026",
          "1721676"
        ],
        "fei_number": [
          "",
          "2024311",
          "3000203000",
          "1713468",
          "1625425",
          "2025816",
          "1720929",
          "3002315844",
          "3004832480",
          "1035166",
          "3038791046",
          "2024168",
          "2649622",
          "3002807314",
          "2521402",
          "3017060084",
          "3015859709",
          "1220948",
          "3004111573",
          "3013319212",
          "3004091615",
          "3004784537",
          "1000563940",
          "3006425876",
          "3013162291",
          "3003248396",
          "3013764800",
          "3016261803",
          "3005718570",
          "1000512168",
          "3000203466",
          "1000138054",
          "1018233",
          "2011171",
          "3008496528",
          "2182208",
          "3014656749",
          "3003081151",
          "3032916632",
          "2648045",
          "3006082230",
          "2523676",
          "3004635528",
          "1317547",
          "3003737899",
          "3010532612",
          "3013300026",
          "1721676"
        ],
        "device_name": "Catheter, Flow Directed",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1240",
        "device_class": "2"
      }
    }
  ]
}