{
  "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": "175040",
      "product_res_number": "Z-0197-2020",
      "event_date_initiated": "2019-07-03",
      "event_date_created": "2019-10-26",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-06-24",
      "res_event_number": "83386",
      "product_code": "LZG",
      "k_numbers": [
        "K103825"
      ],
      "product_description": "DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01",
      "code_info": "UDI:  (01)10385609020015(17)XXXXXX(10)XXXXXXXX  Lot Numbers: DM418011 DM418012 DM418013  DM418014 DM418015 DM418016 DM418017 DM418031 DM418033 DM418037",
      "firm_fei_number": "3003154078",
      "recalling_firm": "Valeritas, Incorporated",
      "address_1": "293 Boston Post Rd W Ste 330 293 Boston Post Rd W",
      "address_2": "Ste 330",
      "city": "Marlborough",
      "state": "MA",
      "postal_code": "01752-4615",
      "additional_info_contact": "908-927-9920",
      "reason_for_recall": "There is a potential for \"No Needle Demo Units\" to contain a needle.",
      "root_cause_description": "Employee error",
      "action": "On July 3, 2019, Valeritas issued notices to customers via first class U.S. postal service.   The removal strategy is to notify active HCP office accounts from the manufacturing start date of effected product (January 2018) who may have No Needle Demo units in their possession.  The removal letter instructs HCP offices to dispose of any No Needle Demo product on hand and acknowledgement by signing and returning the removal letter as instructed.",
      "product_quantity": "21,714 devices",
      "distribution_pattern": "Nationwide within U.S.",
      "openfda": {
        "k_number": [
          "K022317",
          "K042792",
          "K013807",
          "K043000",
          "K160482",
          "K160056",
          "K900498",
          "K021439",
          "K223372",
          "K994186",
          "K093364",
          "K991376",
          "K142619",
          "K041317",
          "K100567",
          "K031738",
          "K042873",
          "K141758",
          "K082595",
          "K905693",
          "K062323",
          "K030531",
          "K133593",
          "K041318",
          "K071788",
          "K022394",
          "K071613",
          "K960001",
          "K103825",
          "K032164",
          "K063126",
          "K162296",
          "K031373",
          "K100504",
          "K180045",
          "K160252",
          "K050312",
          "K082590",
          "K022831",
          "K192659",
          "K023471",
          "K111353",
          "K143189",
          "K211575",
          "K131294",
          "K993012",
          "K032257",
          "K050760",
          "K182630",
          "K053177",
          "K080639",
          "K073356",
          "K210714",
          "K253534",
          "K901588",
          "K111210",
          "K083225",
          "K884978",
          "K040676",
          "K963948",
          "K162080",
          "K042887",
          "K031541",
          "K001604",
          "K090245",
          "K070844",
          "K140439",
          "K120206",
          "K973044",
          "K240158",
          "K993184",
          "K122483",
          "K051041",
          "K020655",
          "K050971",
          "K013309",
          "K990801",
          "K060876",
          "K111669",
          "K021725",
          "K972107",
          "K122953",
          "K063674",
          "K241622"
        ],
        "registration_number": [
          "3009515470",
          "3005340341",
          "3027453514",
          "3042027705",
          "9616814",
          "1313700",
          "3012421607",
          "3008824097",
          "2029275",
          "3006479639",
          "3020976354",
          "3010162782",
          "3007007790",
          "3007981285",
          "3005627859",
          "9610126",
          "3013636348",
          "2246552",
          "3010047442",
          "3007710663",
          "3014585508",
          "1721676",
          "3009337401",
          "3006194679",
          "3001058982",
          "9617604",
          "3016540876",
          "3015218509",
          "1220477",
          "3008810357",
          "3010291427",
          "3011393376",
          "3002806818",
          "2032227",
          "3007939342",
          "3007871880",
          "3013756811"
        ],
        "fei_number": [
          "3009515470",
          "3002806559",
          "3005340341",
          "3027453514",
          "3042027705",
          "1313700",
          "3003166194",
          "3002558692",
          "3012421607",
          "3008824097",
          "3006479639",
          "3004173703",
          "3020976354",
          "1000306431",
          "3010162782",
          "3007007790",
          "3007981285",
          "3005627859",
          "3013636348",
          "2246552",
          "3010047442",
          "3014585508",
          "1721676",
          "3009337401",
          "3006194679",
          "3003024060",
          "3001058982",
          "3016540876",
          "3015218509",
          "1220477",
          "3008810357",
          "3010291427",
          "3011393376",
          "3002806818",
          "3007939342",
          "3007871880",
          "3013756811"
        ],
        "device_name": "Pump, Infusion, Insulin",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5725",
        "device_class": "2"
      }
    }
  ]
}