{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Grimes",
      "state": "IA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97659",
      "recalling_firm": "American Contract Systems Inc.",
      "address_1": "1601 Se Gateway Dr Ste 120",
      "address_2": "",
      "postal_code": "50111-5223",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the states of SD, IA, MN, WA, IL.",
      "recall_number": "Z-0177-2026",
      "product_description": "Medical convenience kits     Item Number/Description  UICL44P\tADULT CENTRAL LINE INSERTION SUPPLY KIT  UICL44R\tADULT CENTRAL LINE INSERTION SUPPLY KIT",
      "product_quantity": "32,433 total",
      "reason_for_recall": "Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.",
      "recall_initiation_date": "20250904",
      "center_classification_date": "20251016",
      "report_date": "20251022",
      "code_info": "UICL44P UDI-DI 191072194268 Lot 8003911 Bag serial number N/A;  UICL44R UDI-DI 191072234018 Lot 8317711 Bag serial number 68244081  * If bag serial number is listed as \"n/a\", then entire lot is affected",
      "more_code_info": ""
    }
  ]
}