{
  "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": "140980",
      "product_res_number": "Z-0333-2016",
      "event_date_initiated": "2015-10-14",
      "event_date_posted": "2015-11-24",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-06-02",
      "res_event_number": "72416",
      "product_code": "NYU",
      "k_numbers": [
        "K123196"
      ],
      "product_description": "Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac\" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm\nItem Number: 8888145061P\n\nThe Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion.",
      "code_info": "Lot Numbers: 1425000092",
      "firm_fei_number": "1219930",
      "recalling_firm": "Covidien LLC",
      "address_1": "60 Middletown Ave",
      "city": "North Haven",
      "state": "CT",
      "postal_code": "06473-3908",
      "additional_info_contact": "SAME\n203-492-5000",
      "reason_for_recall": "Incorrectly packaged with a 90 degree bend at the distal tip",
      "root_cause_description": "Packaging process control",
      "action": "The firm, Medtronic (Covidien), sent an \"URGENT MEDICAL DEVICE RECALL\" letter dated 10/16/2015 to their customers.  The letter described the product, problem, and actions to be taken. Customers were instructed to quarantine and discontinue use of the product, return affected product and complete and return the RECALLED PRODUCT RETURN FORM via Fax to Medtronic to (800)-895-6140 or email to: feedback.customerservice@Covidien.com/Distributor to (203) 492-7719 or email to: PalCathFCA@Covidien.com.\n\nQuestions or concerns contact your Medtronic representative or Customer Service at (800) 882-5878.",
      "product_quantity": "10 units",
      "distribution_pattern": "Worldwide distribution: US (nationwide) and countries of: Canada, Belgium, Chile, Panama, Denmark, France, Germany , Netherlands,Spain, Switzerland, and United Kingdom.",
      "openfda": {
        "k_number": [
          "K112477",
          "K060509"
        ],
        "registration_number": [
          "3030574705",
          "1282497",
          "3017210488",
          "3015453963",
          "3009211636",
          "1319639",
          "3014461810",
          "9610849"
        ],
        "fei_number": [
          "3030574705",
          "1282497",
          "3017210488",
          "3002807391",
          "1000138054",
          "3015453963",
          "3009211636",
          "3014461810"
        ],
        "device_name": "Catheter, Hemodialysis, Implanted, Coated",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5540",
        "device_class": "2"
      }
    }
  ]
}