{
  "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": "103921",
      "product_res_number": "Z-0033-2012",
      "event_date_initiated": "2011-05-19",
      "event_date_posted": "2011-10-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-02-19",
      "res_event_number": "59879",
      "product_code": "FJP",
      "k_numbers": [
        "K993272"
      ],
      "product_description": "Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model # MD-380, Serial Numbers: 5103031102, 5101101101, 5102161007, 5103221007, 5104221007, 5105101008, 5109131010, 5111231011, 5114301012, 5102131101 & 5113091012.  Manufactured by: Isopure Corp, Simpsonville, KY\n\nSystem is used to mix and distribute bicarbonate as a part of a clinical dialysis system.",
      "code_info": "Model # MD-380, Serial Numbers: 5103031102, 5101101101, 5102161007, 5103221007, 5104221007, 5105101008, 5109131010, 5111231011, 5114301012, 5102131101 & 5113091012.",
      "firm_fei_number": "3013942511",
      "recalling_firm": "Isopure Corp",
      "address_1": "141 Citizens Blvd",
      "city": "Simpsonville",
      "state": "KY",
      "postal_code": "40067-6548",
      "additional_info_contact": "502-722-1000",
      "reason_for_recall": "Software problem causes transfer line between mixing and storage tank to not be rinsed after disinfection, leaving residual chlorine in the line.",
      "root_cause_description": "Software design",
      "action": "Isopure sent a letter dated May 19, 2011, to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.  \nIsopure devised an immediate solution which must be implemented at their faclity in conjunction with the disinfection procedure.  Customers were asked to inform all appropriate personnel, clinical and technical, who may be involved in operating the system during the normal disinfection schedule.\nOn 5/19/2011, the firm sent letters to their customers via US mail and email.  They also telephoned their customers to notify them of the problem.",
      "product_quantity": "11 units",
      "distribution_pattern": "Nationwide Distribution including AR, CT, GA, MA, ME, NJ, PA, TN and WV.",
      "openfda": {
        "device_name": "Adaptor, Y",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5820",
        "device_class": "2"
      }
    }
  ]
}