{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
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  "results": [
    {
      "cfres_id": "159675",
      "product_res_number": "Z-0525-2018",
      "event_date_initiated": "2017-10-26",
      "event_date_created": "2018-02-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-02-03",
      "res_event_number": "78507",
      "product_code": "PQE",
      "product_description": "SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802.\n\nIntended for use as an ostomy protector providing a protective barrier to patient skin.",
      "code_info": "Lot 7H02242",
      "firm_fei_number": "3011987967",
      "recalling_firm": "ConvaTec, Inc",
      "address_1": "7900 Triad Center Dr Ste 400 7900 Triad Center Dr",
      "address_2": "Ste 400",
      "city": "Greensboro",
      "state": "NC",
      "postal_code": "27409-9076",
      "additional_info_contact": "336-547-3730",
      "reason_for_recall": "A portion of Lot 7H02242 outer boxes (market units) of the SUR-FIT Natura Moldable Durahesive Skin Barrier (10 pack, 45 mm, REF 411802) were incorrectly labeled as Natura Moldable Stomahesive\nSkin Barrier (10 pack, 45 mm, REF 411803).",
      "root_cause_description": "Mixed-up of materials/components",
      "action": "Customers were notified of the recall via Urgent: Voluntary Medical Device Recall letters on approximately 10/26/2017.  The letter identified the affected device and the reason for the recall.  The letter also provided instructions for distributors, retailers, and end users.  End Users are to 1.) Inspect all shippers of 411802 (Durahesive), and all loose market units of 411803 (Stomahesive) to confirm whether affected product is under their control;  2.) Perform a count of affected product currently in inventory and complete and return the enclosed response form to the address provided;  3.) If customers have any affected product in inventory they are to contact cic@convatec.com or call the Customer Interaction Center at the toll free number 1-800-422-8811 for further instructions regarding how to return affected product and receive correctly labeled replacement product.",
      "product_quantity": "47,630 units (4,763 market units, 10 per pack)",
      "distribution_pattern": "Nationwide Distribution - AK, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, and WI.",
      "openfda": {
        "device_name": "Ostomy Care Kit",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5900",
        "device_class": "1",
        "registration_number": [
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