{
  "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",
    "results": {
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  "results": [
    {
      "cfres_id": "204253",
      "product_res_number": "Z-0507-2024",
      "event_date_initiated": "2023-10-10",
      "event_date_posted": "2023-12-07",
      "recall_status": "Open, Classified",
      "res_event_number": "93396",
      "product_code": "KDJ",
      "k_numbers": [
        "K083542"
      ],
      "product_description": "Stay Safe Cap",
      "code_info": "Model No. 050-95012; UDI-DI: 00840861100835; All Lots.",
      "firm_fei_number": "3001451489",
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "address_1": "920 Winter St Bld 920",
      "city": "Waltham",
      "state": "MA",
      "postal_code": "02451-1521",
      "additional_info_contact": "Global medical information and Education Office\n1-855-616-2309",
      "reason_for_recall": "Updating the labeling to include additional warnings and contraindications for potential side effects.",
      "root_cause_description": "Labeling design",
      "action": "Consignees were mailed an IMPORTAND MEDICAL DEVICE INFORMATION notification dated 10/10/23 vis USPS. This notification is to bring awareness to consignees that Fresenius is updating the labeling to their Stay Safe Cap to include additional warnings and contraindications for potential side effects for P/N 05-95012. Increased exposure to povidone-iodine, which is present in the Stay Safe Cap, could lead to iodine-induced hypothyroidism and hypersensitivity. Clinicians are asked to not use these devices in known cases of povidone-iodine allergy. Fresenius is updating labeling to include these medical warnings and contraindications. Any clinical or medical questions can be directed to the firm at 1-855-616-2309. Consignees are asked to return the provided Reply Form by fax to 781-966-9796 or 781-472-7413, ATTN: Quality Department, or by email to NOTIFYRA@fmc-na.com.",
      "product_quantity": "18,236,160 eaches",
      "distribution_pattern": "US Nationwide distribution.",
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        "device_name": "Set, Administration, For Peritoneal Dialysis, Disposable",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5630",
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