{
  "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": "122397",
      "product_res_number": "Z-0166-2014",
      "event_date_initiated": "2013-09-27",
      "event_date_posted": "2013-11-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-03-04",
      "res_event_number": "66425",
      "product_code": "LZG",
      "k_numbers": [
        "K122953"
      ],
      "product_description": "OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490)\n\nProduct Usage:\nThe Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by healthcare professionals for patients to experience what wearing a Pod may feel like prior to purchase. Each Demonstration Kit includes a UST400 brochure, one Alcohol Pad, and a Pod. The OmniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger. The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared. Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test-strips are working together properly and that the test is performed correctly.",
      "code_info": "Lot Numbers: L13470",
      "firm_fei_number": "3004464228",
      "recalling_firm": "Insulet Corporation",
      "address_1": "9 Oak Park Drive",
      "city": "Bedford",
      "state": "MA",
      "postal_code": "01730-1413",
      "additional_info_contact": "866-941-0294",
      "reason_for_recall": "Alcohol Prep Pads contained within the kit are not properly labeled.",
      "root_cause_description": "Labeling design",
      "action": "Insulet sent an Important Corrective Action Notification letter dated September 27, 2013 to all affected customers.  The letter identified the affected product, problem and actions to be taken. Customers are asked to discontinue use and properly dispose of the affected product.  For questions contact Customer Care at (866) 941-0294.",
      "product_quantity": "5,050 kits",
      "distribution_pattern": "Worldwide Distribution - USA Nationwide and the country of Israel.",
      "openfda": {
        "k_number": [
          "K111669",
          "K031541",
          "K001604",
          "K990801",
          "K021439",
          "K023471",
          "K120206",
          "K972107",
          "K240158",
          "K973044",
          "K071613",
          "K090245",
          "K111353",
          "K082595",
          "K991376",
          "K050760",
          "K053177",
          "K900498",
          "K162296",
          "K042792",
          "K210714",
          "K031373",
          "K071788",
          "K022317",
          "K140439",
          "K960001",
          "K884978",
          "K060876",
          "K070844",
          "K133593",
          "K103825",
          "K162080",
          "K122483",
          "K051041",
          "K042887",
          "K192659",
          "K041318",
          "K100567",
          "K223372",
          "K160056",
          "K993184",
          "K041317",
          "K901588",
          "K020655",
          "K141758",
          "K211575",
          "K050971",
          "K073356",
          "K083225",
          "K100504",
          "K022831",
          "K160482",
          "K131294",
          "K013807",
          "K253534",
          "K905693",
          "K963948",
          "K062323",
          "K122953",
          "K063674",
          "K160252",
          "K021725",
          "K241622",
          "K143189",
          "K111210",
          "K082590",
          "K032257",
          "K142619",
          "K030531",
          "K180045",
          "K032164",
          "K050312",
          "K993012",
          "K043000",
          "K063126",
          "K093364",
          "K994186",
          "K013309",
          "K040676",
          "K031738",
          "K080639",
          "K182630",
          "K042873",
          "K022394"
        ],
        "registration_number": [
          "3010291427",
          "3012421607",
          "2029275",
          "3013636348",
          "3007007790",
          "3014585508",
          "3009515470",
          "3007939342",
          "3005627859",
          "1220477",
          "1721676",
          "3010047442",
          "3007981285",
          "1313700",
          "3042027705",
          "3007710663",
          "9617604",
          "3008810357",
          "9610126",
          "3006194679",
          "3027453514",
          "3016540876",
          "3011393376",
          "2032227",
          "3001058982",
          "3007871880",
          "3002806818",
          "3013756811",
          "2246552",
          "9616814",
          "3009337401",
          "3020976354",
          "3015218509",
          "3008824097",
          "3006479639",
          "3010162782",
          "3005340341"
        ],
        "fei_number": [
          "3010291427",
          "3012421607",
          "3013636348",
          "3007007790",
          "3003166194",
          "3014585508",
          "3009515470",
          "3007939342",
          "3005627859",
          "1220477",
          "1721676",
          "3010047442",
          "3007981285",
          "1313700",
          "3042027705",
          "3008810357",
          "3006194679",
          "3027453514",
          "3016540876",
          "3011393376",
          "1000306431",
          "3002806559",
          "3001058982",
          "3007871880",
          "3002806818",
          "3013756811",
          "2246552",
          "3003024060",
          "3004173703",
          "3009337401",
          "3020976354",
          "3015218509",
          "3008824097",
          "3006479639",
          "3010162782",
          "3002558692",
          "3005340341"
        ],
        "device_name": "Pump, Infusion, Insulin",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5725",
        "device_class": "2"
      }
    }
  ]
}