{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "130449",
      "product_res_number": "Z-0166-2015",
      "event_date_initiated": "2014-09-29",
      "event_date_posted": "2014-11-01",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-02-25",
      "res_event_number": "69408",
      "product_code": "MEA",
      "k_numbers": [
        "K072144"
      ],
      "product_description": "CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01.\n\nProduct  Usage:\nThe CADD-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP Ambulatory Infusion Pump, CADD-Solis Ambulatory Infusion Pump, or CADD-Prizm PCSII Ambulatory Infusion Pump (software revision H or higher). The CADD-Solis Medication Safety Software- Point of Care allows use of a computer to send therapy-based protocols developed by the CADD-Solis Medication Safety Software.- Administrator to the CADD -Solis Ambulatory Infusion Pump and CADD-Prizm PCS I I Ambulatory Infusion Pump (software revision H or higher).",
      "code_info": "Lot Number 2752712",
      "firm_fei_number": "2183502",
      "recalling_firm": "Smiths Medical ASD, Inc.",
      "address_1": "1265 Grey Fox Rd",
      "city": "Saint Paul",
      "state": "MN",
      "postal_code": "55112-6929",
      "additional_info_contact": "Customer Service Department\n800-258-5361",
      "reason_for_recall": "Smiths Medical has identified an issue with a single batch      (Lot Number 2752712) of CADD\"-Solis Medication Safety Software Administrator 3.1 CDs. CADD\"-Solis Medication Safety Software Administrator 3.1 CDs were sent with the CADD\"-Solis Medication Safety Software Point of Care 3.1 software loaded on them.",
      "root_cause_description": "Process control",
      "action": "Consignees were hand delivered by Smiths Medical Sales representatives on 9/29/2014 a Smiths Medical \"Urgent Field Safety Notice\" dated 25-September-14.  The letter described the problem and the product being recalled. The letter also provided the Advice on Action to be Taken by the User, Transmission of this Urgent Medical Device Recall Notice and requested consignees to complete and return the Confirmation Form  by fax to 1-800-237-8033 or via email to recall.response@smiths-medical.com.  For questions customers can contact Smiths Medical's Customer Service Department at 1-800-258-5361.",
      "product_quantity": "24",
      "distribution_pattern": "US Nationwide Distribution in the state of AK, CA, CO, CT, GA, MI, MN, NH, NC, SC, TX, VA, WI.",
      "openfda": {
        "k_number": [
          "K043299",
          "K143612",
          "K915270",
          "K020421",
          "K910257",
          "K934551",
          "K092313",
          "K911791",
          "K033054",
          "K921994",
          "K030661",
          "K022203",
          "K130394",
          "K013822",
          "K043256",
          "K031566",
          "K032233",
          "K990312",
          "K915063",
          "K002434",
          "K982839",
          "K162165",
          "K002739",
          "K051253",
          "K914502",
          "K072144",
          "K943310",
          "K020418",
          "K170982",
          "K042800",
          "K920637"
        ],
        "registration_number": [
          "3013764800",
          "2029275",
          "3010082909",
          "3009456923",
          "9680425",
          "3010381606",
          "9615050",
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          "1319660",
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          "3018071447",
          "2024064",
          "1054241",
          "3003879246",
          "2016493",
          "9617604",
          "3008717264",
          "2032112",
          "3013652261",
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          "9610825",
          "3012302888",
          "3007738736",
          "3009746061",
          "1047843",
          "3013319212",
          "3024706751"
        ],
        "fei_number": [
          "3013764800",
          "3010082909",
          "3009456923",
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          "3003076831",
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          "3008717264",
          "1000136478",
          "1000306431",
          "3013652261",
          "3004906872",
          "3002806469",
          "3007596547",
          "3012302888",
          "3007738736",
          "3009746061",
          "1047843",
          "1000112877",
          "3013319212",
          "3024706751",
          "3002999813",
          "3002558692"
        ],
        "device_name": "Pump, Infusion, Pca",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5725",
        "device_class": "2"
      }
    }
  ]
}