{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "158023",
      "product_res_number": "Z-0087-2018",
      "event_date_initiated": "2017-07-24",
      "event_date_created": "2017-11-09",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-07-06",
      "res_event_number": "77842",
      "product_code": "OGE",
      "k_numbers": [
        "K053318"
      ],
      "product_description": "RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter",
      "code_info": "Lot No. 12168200; Ref No. 107-1416.",
      "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": "Bobbi Harrington\n518-848-3914",
      "reason_for_recall": "Potential for partially incomplete seal of product, impacting sterility.",
      "root_cause_description": "Employee error",
      "action": "Consignees were contacted 07/24/2017 via email and phone, notifying them of the recall. Consignees were asked to contact the recalling firm to report the number of affected product on hand.  A second, updated recall notification was sent on 08/04/2017.  Instructions included to examine inventory and quarantine any affected product, contact Epimed to arrange return/credit of the affected product, and complete and return the response form.",
      "product_quantity": "500 units",
      "distribution_pattern": "Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.",
      "openfda": {
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        "device_name": "Epidural Anesthesia Kit",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5120",
        "device_class": "2"
      }
    }
  ]
}