{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "188380",
      "product_res_number": "Z-2312-2021",
      "event_date_initiated": "2017-12-28",
      "event_date_created": "2021-08-18",
      "recall_status": "Completed",
      "res_event_number": "88317",
      "product_code": "BSO",
      "k_numbers": [
        "K981329"
      ],
      "product_description": "NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile",
      "code_info": "Reference Number 200-2430, Lot Numbers 16308275 (Expiration August 2022), 16308382 (Expiration October 2022)",
      "firm_fei_number": "1643059",
      "recalling_firm": "Epimed International",
      "address_1": "13958 Diplomat Dr",
      "city": "Farmers Branch",
      "state": "TX",
      "postal_code": "75234-8805",
      "additional_info_contact": "972-373-9090",
      "reason_for_recall": "Potential for stylet to protrude from the distal end of the catheter",
      "root_cause_description": "Process control",
      "action": "On about 12/28/2017, Epimed mailed their recall notification letter titled, URGENT Medical Device RECALL, to customers.  Those letters were followed up with a telephone call or email containing the letter on about 12/30/2017.  The letter explained the issue and hazard and requested that if any potentially affected product remains in the accounts inventory, Epimed will offer to replace/credit the affected product.  Each customer was asked to complete and return the RECALL RETURN RESPONSE FORM as soon as possible.",
      "product_quantity": "132 units",
      "distribution_pattern": "Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV.  International distribution to Canada and Iran.",
      "openfda": {
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        "device_name": "Catheter, Conduction, Anesthetic",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5120",
        "device_class": "2"
      }
    }
  ]
}