{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "176672",
      "product_res_number": "Z-0285-2020",
      "event_date_initiated": "2019-09-16",
      "event_date_created": "2019-11-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-06-29",
      "res_event_number": "83886",
      "product_code": "NIE",
      "k_numbers": [
        "K133456"
      ],
      "product_description": "13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023\n\nPower-Trialysis Short-Term Alphacurve Dialysis Catheter with a third internal umen for IV therapy, power injection of contrast media, and central venous pressure monitoring.",
      "code_info": "REDR0440",
      "firm_fei_number": "2243072",
      "recalling_firm": "Becton Dickinson & Company",
      "address_1": "1 Becton Dr",
      "city": "Franklin Lakes",
      "state": "NJ",
      "postal_code": "07417-1815",
      "additional_info_contact": "BD Recall Coordinator\n800-290-1689",
      "reason_for_recall": "A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On September 16, 2019, the firm distributed Urgent Medical Device Recall notices to affected customers. Customers were asked to take the following actions:\n\n1. Immediately examine your inventory for the product code and lot number listed above. Destroy\nall product subject to the recall following your institutions process for destruction.\n2. Please share this recall notification with all users of the product to ensure they are also aware of\nthe recall.\n3. Complete the Customer Response Form (even if you do not have affected lots in your inventory) and return to the BD contact noted on the form\nwhether or not you have any of the impacted material so that BD may acknowledge your receipt\nof this notification and process your product replacement or credit.\n4. If you have further distributed this product, please identify your customers and inform them of this\nnotification at once. You may include a copy of this letter in your notification to your customers.\n\nThe firm will provide product replacement or credit for all discarded inventory.\n\nIf you have any questions or require assistance with the return of the recalled product please contact our\nrecall coordinator at 1-800-290-1689 between 8 AM and 5 PM MST Monday through Friday.",
      "product_quantity": "75 units",
      "distribution_pattern": "Distributed to healthcare facilities in AR, FL, IL, NJ, TX, and WI.",
      "openfda": {
        "k_number": [
          "K133456",
          "K181175",
          "K183219",
          "K020089",
          "K141531",
          "K143102",
          "K033570",
          "K222170",
          "K102605",
          "K123292",
          "K232945",
          "K083675"
        ],
        "registration_number": [
          "3009888344",
          "9610849",
          "3010882065",
          "3009211636",
          "1721676",
          "3015859709",
          "1282497",
          "9617592",
          "2011171",
          "3006260740",
          "1000563940",
          "1018233",
          "2030624",
          "3007544634",
          "1319639",
          "2518902",
          "9680794",
          "3006082230",
          "3003915875",
          "3030574705"
        ],
        "fei_number": [
          "3002807391",
          "3009888344",
          "1000138054",
          "3009211636",
          "1721676",
          "3015859709",
          "1282497",
          "2011171",
          "3006260740",
          "3002468371",
          "1000563940",
          "3006097687",
          "1018233",
          "3007544634",
          "3003737899",
          "2518902",
          "3006082230",
          "3003915875",
          "3030574705",
          "3000206435"
        ],
        "device_name": "Catheter, Hemodialysis, Triple Lumen, Non-Implanted",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5540",
        "device_class": "2"
      }
    }
  ]
}