{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "75563",
      "product_res_number": "Z-0903-2009",
      "event_date_initiated": "2008-10-15",
      "event_date_posted": "2009-01-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2009-02-26",
      "res_event_number": "50512",
      "product_code": "OEX",
      "product_description": "Spectranetics SLS II 14Fr. Laser Sheath Kit, REF 500-012, Sterile EO, individually packaged, Lot number 080314B, Spectranetics, 96 Talamine Court, Colorado Springs, Colorado 80907. \nA catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.",
      "code_info": "Serial numbers: 080314B02 thru 080314B11, 080314B13 thru 080314B21, and 080314B23 thru 080314B27.",
      "firm_fei_number": "3007284006",
      "recalling_firm": "Spectranetics Corporation",
      "address_1": "96 Talamine Ct",
      "city": "Colorado Springs",
      "state": "CO",
      "postal_code": "80907",
      "additional_info_contact": "Mike Handley\n719-447-2319",
      "reason_for_recall": "Catheter pouch was mislabeled with the wrong size.",
      "root_cause_description": "Error in labeling",
      "action": "Consignees were notified by sales representatives who visually inspected their inventory.  The sales representatives were given a form to fill out to confirm whether the consignee had the catheters with the serial number still in inventory.  The forms were faxed back to Spectranetics indicating if the catheters were used or not and if they were not used, were they labeled correctly.  For assistance, contact Spectranetics Corporation at 1-719-447-2319.",
      "product_quantity": "24 units",
      "distribution_pattern": "CA, FL, MI, NC, NY, OH, PA, TX, and VA.",
      "openfda": {
        "registration_number": [
          "1423537",
          "1724474",
          "1123137",
          "3015225571",
          "1721504",
          "3006950086",
          "3012536737",
          "9616088",
          "3020368143",
          "3015309643",
          "3033589330",
          "1061124",
          "3009888344",
          "1643817",
          "3007329020",
          "3011642792",
          "3004111573",
          "1721676"
        ],
        "fei_number": [
          "3015225571",
          "1721504",
          "1000512168",
          "3006950086",
          "3012536737",
          "3003094851",
          "3020368143",
          "3015309643",
          "3033589330",
          "3001236905",
          "3002902735",
          "1000123180",
          "3009888344",
          "1643817",
          "3007329020",
          "3011642792",
          "3004111573",
          "1721676"
        ],
        "device_name": "Cardiovascular Catheter Sheath Introducer Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1340",
        "device_class": "2"
      }
    }
  ]
}