{
  "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": "174227",
      "product_res_number": "Z-2068-2019",
      "event_date_initiated": "2019-06-18",
      "event_date_created": "2019-07-24",
      "recall_status": "Terminated",
      "res_event_number": "83247",
      "product_code": "BSO",
      "k_numbers": [
        "K023140"
      ],
      "product_description": "Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED,  REF 181-2112, RX,  (01) 108187880213945, LOT 311291155   for  epidural or caudal anesthesia",
      "code_info": "Lot 31129155,  Exp: 2022-12-31",
      "firm_fei_number": "1316297",
      "recalling_firm": "Epimed International, Inc.",
      "address_1": "141 Sal Landrio Dr Crossroads Business Park",
      "city": "Johnstown",
      "state": "NY",
      "postal_code": "12095-3835",
      "additional_info_contact": "Bobbi Harrington\n518-848-3901 Ext. 1200",
      "reason_for_recall": "Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit.  The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included.",
      "root_cause_description": "Labeling mix-ups",
      "action": "On  June 19, 2019 , the firm mailed a lot specific, medical device market correction letter, via USPS to consignees who received the affected product(s).  The letter asked customers to do the following:\n\n1. Please examine your inventory and quarantine any product subject to the recall immediately. \n\n2. Once product has been Quarantined, please complete and return the response form as soon as possible. \n\n3. Please contact EPIMED sales administrative assistance, Bobbi Harrington at (518) 725-0209 ext. 1200 or bobbih@epimed.com, so that immediate replacement or credit for the affected product can be arranged. \n\n4. If you have any questions, please contact Mr. Kris Knapp at 1-800-866-3342 ext. 1305.",
      "product_quantity": "200 kits",
      "distribution_pattern": "Distribution in US states of CA, FL, OK, AR, WA, TX, ID, NY, South Africa, and Mexico",
      "openfda": {
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        "device_name": "Catheter, Conduction, Anesthetic",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5120",
        "device_class": "2"
      }
    }
  ]
}