{
  "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,
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  },
  "results": [
    {
      "cfres_id": "175281",
      "product_res_number": "Z-0015-2020",
      "event_date_initiated": "2019-06-27",
      "event_date_posted": "2019-10-01",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-08-10",
      "res_event_number": "83435",
      "product_code": "KJJ",
      "k_numbers": [
        "K082470"
      ],
      "product_description": "Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355",
      "code_info": "UDI (01)10818207020410 Lot/Work Order Numbers: 20182545 20182665 20190198 20190432 20190724 20190953 20191314",
      "firm_fei_number": "3000209941",
      "recalling_firm": "Inter-Med Llc",
      "address_1": "2200 Northwestern Ave",
      "city": "Racine",
      "state": "WI",
      "postal_code": "53404-2500",
      "additional_info_contact": "Katy Scott\n414-639-9755",
      "reason_for_recall": "The affected lots may be packaged in syringes which include an incorrect bung.  The incorrect bung is made of a latex-free isoprene rubber material.  After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.",
      "root_cause_description": "Process control",
      "action": "The firm initiated the recall by letter on 06/27/2019. The letter directed the consignee to quarantine the product and contact the returns department for return instructions.",
      "product_quantity": "445 units",
      "distribution_pattern": "US, South Africa, Switzerland, Poland, Italy, Singapore, Australia",
      "openfda": {
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          "K112250",
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        "device_name": "Cleanser, Root Canal",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "U",
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