{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "130457",
      "product_res_number": "Z-0155-2015",
      "event_date_initiated": "2014-09-29",
      "event_date_posted": "2014-10-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-03-10",
      "res_event_number": "69412",
      "product_code": "NNW",
      "product_description": "Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174.\n\nUrine Collection Bag.",
      "code_info": "Lot Numbers:  3880261, 3880268, 3932929, 3932933, 3940329, 3940332, 3949825, 3949828, 3968997, 3969002, 3997492, 3997778, 3997782, 4006822, 4019572, 4019574, 4047072, 4047075, 4056422, 4056423, 4056428, 4073930, 4073934, 4092990, 4092991, 4100228.",
      "firm_fei_number": "2125050",
      "recalling_firm": "Coloplast Manufacturing US, LLC",
      "address_1": "1601 W River Rd",
      "city": "Minneapolis",
      "state": "MN",
      "postal_code": "55411-3431",
      "additional_info_contact": "Coloplast Customer Service\n800-533-0464",
      "reason_for_recall": "Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.",
      "root_cause_description": "Process control",
      "action": "Consignees were sent a Coloplast \"Recall Voluntary Notification \" letter on 9-30-2014.  The letter described the problem and the product affected by the recall. Requested consignees to complete the attached Acknowledgement Form and return to Coloplast or contact Coloplast Customer Service at 800-533-0464 to communicate the status of any product in their possession. If the product was distributed, they advised consignees to contact customers immediately and advise them of the recall and have them return the product to them.  \n\nFor questions they can contact Coloplast at Customer Service at 800-533-0464.",
      "product_quantity": "217,540",
      "distribution_pattern": "Nationwide Distribution including Puerto Rico and the states of AL, AZ, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS,MO,NE,NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WV.",
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        "device_name": "Bag, Urine Collection, Leg, For External Use, Non-Sterile",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5250",
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}