{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "177065",
      "product_res_number": "Z-0369-2020",
      "event_date_initiated": "2019-09-05",
      "event_date_created": "2019-11-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-10-19",
      "res_event_number": "83827",
      "product_code": "KOY",
      "product_description": "Pedia Prep:\nMD0033T - 4 oz tubes\nMD0033--SUP - Single Use Cups    \nSkin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG, etc.)",
      "code_info": "MD0033T:  29769, 29915, 30067, 30643  MD0033-SUP:  29770,30027,30049, 30711",
      "firm_fei_number": "3017189082",
      "recalling_firm": "Carroll-Baccari, Inc.",
      "address_1": "6625 White Dr",
      "city": "Riviera Beach",
      "state": "FL",
      "postal_code": "33407-1209",
      "additional_info_contact": "Joanna Heyman\n561-585-2227",
      "reason_for_recall": "Product has the potential to be contaminated with Burholderia cepacia.",
      "root_cause_description": "Material/Component Contamination",
      "action": "The firm initiated the recall of Lemon Prep by email on 09/05/2019.  Distributors were directed to notify their customers and ask them to contact Mavidon directly.  Direct accounts were asked to cease use and contact the company for replacement.  The firm issued a press release on 09/30/2019 and posted a copy along with a copy of the recall notice on their website.\n\nThe firm initiated the recall of its Pedia Prep on 10/08/2019 by email and posted a copy of the recall letter on its website.",
      "product_quantity": "2445 units",
      "distribution_pattern": "US, Canada, Spain, England, and Australia",
      "openfda": {
        "registration_number": [
          "3016450032",
          "3021769057",
          "8030128",
          "3008808082",
          "3006552462",
          "3035479692",
          "3011534533",
          "3009486864",
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          "3042158718",
          "3009308084",
          "1214815",
          "3008973760",
          "3038637162",
          "3017417635"
        ],
        "fei_number": [
          "3016450032",
          "3021769057",
          "3008808082",
          "3038637162",
          "3006552462",
          "3035479692",
          "3011534533",
          "3009486864",
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          "3042158718",
          "3009308084",
          "1214815",
          "3008973760",
          "3006118668",
          "3017417635"
        ],
        "device_name": "Degreaser, Skin, Surgical",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4730",
        "device_class": "1"
      }
    }
  ]
}