{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Waukegan",
      "address_1": "3651 Birchwood Dr",
      "reason_for_recall": "A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.",
      "address_2": "",
      "product_quantity": "8,928 kits total",
      "code_info": "Product Code SP4692448A (Lot Numbers 820351, 821944, 822521, 828183).  Product Code SP4692448B (Lot Number 851604).",
      "center_classification_date": "20180718",
      "distribution_pattern": "US Nationwide Distribution in the states of California.",
      "state": "IL",
      "product_description": "Presource PBDS, Kit, No Spiro.  Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches.    Product Usage:  The kit is provided to a patient pre-surgery, as part of the  Enhanced Recovery After Surgery  protocol. Items included at 1) an  exerciser volumetric 5000ML  device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative complications, 2) up to two items of  cloth, skin prep 2% CHG,  a packet of for chlorhexidine gluconate antiseptic cloths utilized by the patient to reduce the risk of surgical site infections by wiping the body in a prescribed manner, 3) up to two  Gatorade  to help restore the body s electrolytes when fasting prior to surgery.",
      "report_date": "20180725",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Cardinal Health 200, LLC",
      "recall_number": "Z-2482-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "80289",
      "termination_date": "20191104",
      "more_code_info": "",
      "recall_initiation_date": "20180220",
      "postal_code": "60085-8337",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}