{
  "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",
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      "cfres_id": "192325",
      "product_res_number": "Z-0878-2022",
      "event_date_initiated": "2022-03-03",
      "event_date_created": "2022-04-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2022-09-15",
      "res_event_number": "89737",
      "product_code": "OXQ",
      "product_description": "DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.",
      "code_info": "SKU/Part Number 47-670.06; UDI 00749756562942  Lot Numbers (Expiration Date): Lot 52585717 (exp 07/01/2021), Lot 52818525 (exp 07/01/2021), Lot 54354867 (exp 04/01/2022), Lot 55502331 (exp 04/01/2022)",
      "firm_fei_number": "1043214",
      "recalling_firm": "DeRoyal Industries Inc",
      "address_1": "200 Debusk Ln",
      "city": "Powell",
      "state": "TN",
      "postal_code": "37849-4703",
      "additional_info_contact": "Theresa Marsee\n865-362-6465",
      "reason_for_recall": "A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.",
      "root_cause_description": "Process control",
      "action": "DeRoyal issued their recall on March 3, 2022 to the end user level by mailing recall letters to its direct accounts. The direct accounts were instructed to forward our recall notification to their customers. The direct accounts and their customers were asked to identify the affected products and return the product and the notice of return form that was provided back to DeRoyal.",
      "product_quantity": "400 kits",
      "distribution_pattern": "US distribution to Florida, New Jersey, and Tennessee",
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        "medical_specialty_description": "General Hospital",
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