{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Saint Paul",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "66234",
      "recalling_firm": "Smiths Medical ASD, Inc.",
      "address_1": "1265 Grey Fox Rd",
      "address_2": "N/A",
      "postal_code": "55112-6929",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA including AZ, AR, CA, GA, IL, IN, KY, MD, MA, MI, NV, NJ, NY, NC, OH, OR, PA, RI, SC, TN, TX, VA, WA, WV, WY.  Internationally to DENMARK, BELGIUM CANADA.",
      "recall_number": "Z-2268-2013",
      "product_description": "Smith Medical, Deltec,  REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, Rx Only    PORT-A-CATH¿ and PORT-A-CATH¿ II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications, fluids, and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein.",
      "product_quantity": "190",
      "reason_for_recall": "Smiths Medical is conducting a voluntary recall of PORT-A-CATH¿ and PORT-A-CATH¿ II Implantable Venous and Arterial  Access Systems and Introducer Sets.    Smiths Medical has become aware of a small number of customer reports regarding the introducer sheath and the introducer opening being too small for the width of the catheter with the use of these Sets.    Smiths Medical has received no reports",
      "recall_initiation_date": "20130910",
      "center_classification_date": "20130923",
      "termination_date": "20141021",
      "report_date": "20131002",
      "code_info": "1991524  1997100  2033224  2051222  2116286  2183921  2192487  2210967  2229821  2237453"
    }
  ]
}