{
  "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": "2026-04-15",
    "results": {
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  "results": [
    {
      "country": "United States",
      "city": "El Cajon",
      "address_1": "2030 Gillespie Way Ste 109",
      "reason_for_recall": "PureWick is recalling external catheter for women Wicks because the labeling did not contain the phrase \"This product contains dry natural rubber\" and/or erroneously included the phrase \"Latex-free.\"  The white gauze component of the PureWick contains dry natural rubber.",
      "address_2": "",
      "product_quantity": "176,863 units",
      "code_info": "Item # 625",
      "center_classification_date": "20170318",
      "distribution_pattern": "US: Nationwide Distribution",
      "state": "CA",
      "product_description": "PureWick External Catheter for Women-Wick    Product  Usage:  A flexible, contoured external catheter (a Wick) is positioned between the labia and gluteus muscles. The function of the Wick is to draw urine away from the body through the Wick to a storage container away from the body through a PVC tube via a continuous, low pressure vacuum pump (PureWick DryDoc) or to a hospital wall vacuum. There is never a reversal of flow direction or static state of fluid between the device and the patient. Also, the dry natural rubber component is double wrapped with 75D polyester and it is not stretched in its application to expose bare rubber to a user. The Wick does not enter the vagina (Figure 1).",
      "report_date": "20170329",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Purewick Corporation",
      "recall_number": "Z-1485-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "76571",
      "termination_date": "20170509",
      "more_code_info": "",
      "recall_initiation_date": "20160224",
      "postal_code": "92020-0910",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}