{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "86454",
      "product_res_number": "Z-0481-2010",
      "event_date_initiated": "2009-11-02",
      "event_date_posted": "2009-12-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-10-27",
      "res_event_number": "53748",
      "product_code": "MRZ",
      "k_numbers": [
        "K080587"
      ],
      "product_description": "Animas ezManager Max Diabetes Management System version 2.0.9",
      "code_info": "version 2.0.9",
      "firm_fei_number": "3002920072",
      "recalling_firm": "Animas Corporation",
      "address_1": "200 Lawrence Dr",
      "city": "West Chester",
      "state": "PA",
      "postal_code": "19380-3428",
      "additional_info_contact": "Customer Services\n866-423-4087",
      "reason_for_recall": "Printed hard copy of results is not the same as the system screens- carbohydrate to insulin ratio incorrect.",
      "root_cause_description": "Software design",
      "action": "Animas issued an Urgent Medical Device Correction letter dated 11/2/09 to the pump user and another letter to the health care professional that prescribed the pump.  The letters explain the issue. The patient letter is accompanied with a CD that contains the upgraded software and instructions to follow.",
      "product_quantity": "20,648 units",
      "distribution_pattern": "Nationwide distribution, and Canada, Cayman Islands, and Denmark.",
      "openfda": {
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        ],
        "device_name": "Accessories, Pump, Infusion",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5725",
        "device_class": "2"
      }
    }
  ]
}