{
  "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": "2026-10-22",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "186376",
      "product_res_number": "Z-1354-2021",
      "event_date_initiated": "2021-03-17",
      "event_date_posted": "2021-04-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-12-02",
      "res_event_number": "87596",
      "product_code": "HCA",
      "k_numbers": [
        "K031123"
      ],
      "product_description": "CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus. \n\nCatalog Number: NS5524",
      "code_info": "Lot Number: 5028205  UDI: \t(01)10381780526797 (17)210930(10)5028205",
      "firm_fei_number": "3003418325",
      "recalling_firm": "Integra LifeSciences Corp.",
      "address_1": "1100 Campus Rd",
      "city": "Princeton",
      "state": "NJ",
      "postal_code": "08540-6650",
      "additional_info_contact": "Lacey Gigante\n609-212-9004",
      "reason_for_recall": "Incorrect labeling, Catheter did not have the required holes and markings",
      "root_cause_description": "Labeling Change Control",
      "action": "Integra LifeSciences issued Voluntary Urgent Medical Device Recall letter via courier service, facsimile or email on March 17th for delivery on March 19th, 2021. Letter states reason for recall, health risk and action to take:\nIf you do have the affected product in Table 1, remove the product from service.\nb. Complete the attached acknowledgement form. If you do have affected product, check the box  I do have affected product.  Record the total quantity of the affected product you have.\nc. If you do not have affected product, check the box,  I do not have affected product. \nd. Return the completed acknowledgement form to FCA2@integralife.com\nor FAX to 1-609-750-4220\ne. Keep a copy of the form for your records.\nf. When your form is received, and it is noted that you have the affected product, Customer Service will\ncontact you and provide a Return Material Authorization (RMA) number and directions to return the product. A replacement order will also be placed for the quantity noted on the form.\n\nReceipt of the acknowledgement form ensures that Integra has achieved a level of effectiveness in\ncommunicating this information effectively. We recommend you also maintain a copy of this notification and\nsigned copy of the acknowledgement forms for your records. Regulatory agencies such as the FDA perform\naudits of field actions of this nature to verify that our customers have been notified and understand the nature\nof the field action.\nShould you have any questions regarding these instructions, please contact Customer Service:\nUSA: 800-654-2873\nMonday- Friday 8:00AM EST   6:00PM EST\ncustsvcnj@integralife.com",
      "product_quantity": "49 units",
      "distribution_pattern": "CA\nCO\nFL\nKY\nMD\nNC\nNC\nNY\nNY\nTX\nWI",
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          "K983331",
          "K021481",
          "K161731",
          "K020728",
          "K992796",
          "K003322",
          "K834477",
          "K013005",
          "K031123"
        ],
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          "8043933",
          "3013886523",
          "3015531529",
          "9612501",
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          "2011171",
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          "3012507533",
          "1721983",
          "2029275",
          "2032112",
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        "fei_number": [
          "3002619595",
          "3002534070",
          "3003076831",
          "3003495548",
          "3018094310",
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        ],
        "device_name": "Catheter, Ventricular",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.4100",
        "device_class": "2"
      }
    }
  ]
}