{
  "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": "2026-08-15",
    "results": {
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      "cfres_id": "196223",
      "product_res_number": "Z-0202-2023",
      "event_date_initiated": "2022-08-19",
      "event_date_posted": "2022-11-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-03-20",
      "res_event_number": "90926",
      "product_code": "LJH",
      "k_numbers": [
        "K010607"
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      "product_description": "MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001",
      "code_info": "UDI/DI:  00628725001050, Lot Numbers:  159603, exp 2026-12-01 and 166945, exp 2027-06-01",
      "firm_fei_number": "3932",
      "recalling_firm": "Canadian Hospital Specialties",
      "address_1": "2760 Brighton Rd",
      "city": "Oakville",
      "country": "Canada",
      "reason_for_recall": "Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible barcode which prevents successful scanning of the package.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "The firm issued a MEDICAL DEVICE RECALL NOTICE to its consignees on 08/23/2022 by email.  The notice explained the issue and requested the following:\n\"TO IMPLEMENT THIS RECALL, PLEASE PERFORM THE FOLLOWING ACTIONS:\n1.Examine your stock and determine if you have any affected product and lot.\n2.Complete the attached Product Recall Response Form and send torecalls@chsltd.com.\n3.Please report any affected units of the product to CHS for further instructions.\"\n\nFor questions, contact:  recalls @chsltd.com",
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      "distribution_pattern": "US",
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        "device_name": "System, Irrigation, Urological",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5130",
        "device_class": "2"
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    }
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}