{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 18
    }
  },
  "results": [
    {
      "cfres_id": "197533",
      "product_res_number": "Z-0931-2023",
      "event_date_initiated": "2022-12-15",
      "event_date_posted": "2023-01-11",
      "recall_status": "Open, Classified",
      "res_event_number": "91350",
      "product_code": "PPG",
      "product_description": "Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile",
      "code_info": "a. Assembly Number 33066, UDI-DI: M752330661, Lot Numbers: 222782334, 222519530, 222438660;  \n\nb. Assembly Number 33068, UDI-DI: M752330681, Lot Numbers: 222145412, 220551558, 222508466",
      "firm_fei_number": "1450943",
      "recalling_firm": "Stradis Healthcare",
      "address_1": "3600 Burwood Dr",
      "city": "Waukegan",
      "state": "IL",
      "postal_code": "60085-8399",
      "additional_info_contact": "Tracy Melton\n425-343-4613",
      "reason_for_recall": "Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.",
      "root_cause_description": "Process control",
      "action": "Stradis Healthcare notified consignees on about 12/15/2022 via email.  The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed.  Consignees were also asked to complete and return the Recall Acknowledgement Form.",
      "product_quantity": "920 units",
      "distribution_pattern": "US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.",
      "openfda": {
        "registration_number": [
          "1061124",
          "3009888344",
          "3004111573",
          "2032112",
          "1643817",
          "3007329020",
          "9612030",
          "1921846",
          "1928237",
          "1423537",
          "3009086335",
          "9616088"
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          "3009888344",
          "3004111573",
          "1000512168",
          "3001236905",
          "1643817",
          "3007329020",
          "3002902735",
          "1921846",
          "1928237",
          "3003076831",
          "3002806934",
          "3009086335"
        ],
        "device_name": "Urinary Drainage Collection Kit",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5130",
        "device_class": "2"
      }
    }
  ]
}