{
  "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": "175272",
      "product_res_number": "Z-0012-2020",
      "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 Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300",
      "code_info": "Lot/Work Order Numbers: 2018-1348 2018-1585 2018-1586 2018-1852 20182106, UDI (01)10818207020465 20182302, UDI (01)10818207020465 20182458, UDI (01)10818207020465 20190725, UDI (01)10818207020465 20190835, UDI (01)10818207020465",
      "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": "1992 units",
      "distribution_pattern": "US, South Africa, Switzerland, Poland, Italy, Singapore, Australia",
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        "device_name": "Cleanser, Root Canal",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "U",
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