{
  "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,
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  },
  "results": [
    {
      "cfres_id": "150167",
      "product_res_number": "Z-0297-2017",
      "event_date_initiated": "2016-10-06",
      "event_date_created": "2016-10-21",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-11-14",
      "res_event_number": "75376",
      "product_code": "MJN",
      "k_numbers": [
        "K143613"
      ],
      "product_description": "The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during catheterization procedures.",
      "code_info": "Product Model ACX101, Manufacturer UDI *+ M465ACX10106*  Lot No: F1614503",
      "firm_fei_number": "3010142363",
      "recalling_firm": "AccessClosure, Inc., A Cardinal Health Company",
      "address_1": "5452 Betsy Ross Dr",
      "city": "Santa Clara",
      "state": "CA",
      "postal_code": "95054-1101",
      "additional_info_contact": "Doniell Baudin\n408-610-6500",
      "reason_for_recall": "AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device \nbecause it was made aware from customers that the device may be removed in the absence of vascular sheath across the arteriotomy.  This is a deviation from the firm's standard catheterization technique.",
      "root_cause_description": "Device Design",
      "action": "Cardinal Health sent an Urgent Medical Device Field Safety Notification letter to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.  Customers were instructed complete the attached Field Action Return Response Form as soon as possible indicating the number of devices that have been used as their location and the number that will be returned.   Customers should discuss the reimbursement for their purchased and return product with their sales representative, who will coordinate the process.  Customers with questions were instructed to call 408-610-6570.\nFor questions regarding this recall call 408-610-6500.",
      "product_quantity": "6 in USA",
      "distribution_pattern": "US distribution to FL and NJ",
      "openfda": {
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        "device_name": "Catheter, Intravascular Occluding, Temporary",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4450",
        "device_class": "2"
      }
    }
  ]
}