{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
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  "results": [
    {
      "cfres_id": "50469",
      "product_res_number": "Z-0597-2007",
      "event_date_initiated": "2007-02-07",
      "event_date_posted": "2007-03-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-06-12",
      "res_event_number": "37393",
      "product_code": "MCW",
      "k_numbers": [
        "K060016"
      ],
      "product_description": "ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01.  It is a single-use, disposable device that is used to perform percutaneous maceration and removal of thrombus and restoration of blood flow.",
      "code_info": "Lot number 54877 exp December 2007, Lot number 55318 exp January 2008, Lot number 55218 exp January 2008, and Lot number 54821 exp December 2007",
      "firm_fei_number": "1000307073",
      "recalling_firm": "Kensey Nash Corp",
      "address_1": "735 Pennsylvania Dr",
      "city": "Exton",
      "state": "PA",
      "postal_code": "19341-1130",
      "additional_info_contact": "Robin M. Fatzinger\n484-713-2100",
      "reason_for_recall": "Face seal may wear excessively and cause particulate matter.",
      "root_cause_description": "Other",
      "action": "On 2/7/07, a voice mail message was sent to all KNC Sales Representatives instructing them to contact affected accounts immediately. On 2/9/07, recall notices were faxed to all affected accounts that had affected product. The recall notices instructed hospitals to quarantine the affected lots and to contact their KNC Sales Representative to arrange for retrieval of the product.",
      "product_quantity": "165 units",
      "distribution_pattern": "Nationwide.",
      "openfda": {
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        "device_name": "Catheter, Peripheral, Atherectomy",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4875",
        "device_class": "2"
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}