{
  "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": "175038",
      "product_res_number": "Z-0195-2020",
      "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 20 U/D, Part Number 2260-03",
      "code_info": "UDI: (01)10385609020039(17)XXXXXX(10)XXXXXXXX  Lot Numbers: DM218001 DM218002 DM218003 DM218004 DM218005 DM218006 DM218020 DM218025 DM218034 DM218035   DM218036",
      "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": "49,074 devices",
      "distribution_pattern": "Nationwide within U.S.",
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        "device_name": "Pump, Infusion, Insulin",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5725",
        "device_class": "2"
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    }
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}