{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "122138",
      "product_res_number": "Z-0137-2014",
      "event_date_initiated": "2013-08-22",
      "event_date_created": "2015-06-26",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-06-09",
      "res_event_number": "66353",
      "product_code": "JCA",
      "product_description": "Surgicutt fully automated incision making device for bleeding time determination.  ITC 8 Olsen Avenue, Edison, NJ  08820.  732.548.5700.  www.itcmed.com.  A subsidiary of Thoratec Corporation.\n\nThe device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations.",
      "code_info": "Product Code: SUB50I; Lot No. AK301M. Lot Expiration Date 8/31/2017",
      "firm_fei_number": "2250033",
      "recalling_firm": "ITC-Nexus Dx",
      "address_1": "23 Nevsky St",
      "city": "Edison",
      "state": "NJ",
      "postal_code": "08820-2425",
      "additional_info_contact": "Ms. Ellie Fox\n732-548-7000 Ext. 4476",
      "reason_for_recall": "ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "ITC sent a Medical Device Recall letter dated September 20, 2013, to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.  Customers were instructed to remove/quarantine affected product in their inventory and to return the affected product to ITC. Customers with questions were instructed to call 1-800-631-5945.\nQuestions regarding this recall call 732-548-7000, ext 4476.",
      "product_quantity": "6 boxes (Each box contains 50 Surgicutt Devices plus 55 sheets of Blotting Paper).",
      "distribution_pattern": "Nationwide Distribution including Arizona andTexas.\n\n.",
      "openfda": {
        "k_number": [
          "K830645",
          "K801815",
          "K911996",
          "K850542",
          "K761250",
          "K871318",
          "K911745"
        ],
        "device_name": "Device, Bleeding Time",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.6100",
        "device_class": "2",
        "registration_number": [
          "1217183",
          "2029275",
          "3002721930",
          "3014150341"
        ],
        "fei_number": [
          "1217183",
          "3014150341",
          "2250033",
          "1000306431"
        ]
      }
    }
  ]
}