{
  "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-2269-2013",
      "product_description": "Smiths Medical, Deltec:    REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access System.  REF 21-8052-24 & REF 21-8053-24 , Port-A-Cath II Dual-Lumen, Polysulfone /Titanium Venous Access System.    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": "372",
      "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": "21-8011-24:    1971567  1979805  1984078  1997124  2006124  2038001  2090898  2151160  2196530  2216256  2249695    21-8052-24:    1971572  2012472  2022904  2067947  2080704  2146472  2168988  2196532  2207404  2237458  2249696  2269178  2282158    21-8053-24:    2168989  2249697"
    }
  ]
}