{
  "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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  "results": [
    {
      "cfres_id": "203729",
      "product_res_number": "Z-0356-2024",
      "event_date_initiated": "2023-10-23",
      "event_date_posted": "2023-11-21",
      "recall_status": "Open, Classified",
      "res_event_number": "93229",
      "product_code": "NZU",
      "product_description": "stryker Sage PrimaFit External Urine Management System for the Female Anatomy",
      "code_info": "GTIN 00618029600417, Lot Codes:  93667, 93614, 93613",
      "firm_fei_number": "1419181",
      "recalling_firm": "Sage Products Inc",
      "address_1": "3909 3 Oaks Rd",
      "city": "Cary",
      "state": "IL",
      "postal_code": "60013-1804",
      "additional_info_contact": "800-421-6556",
      "reason_for_recall": "A small percentage of devices in three lots of product may contain a tape with a natural rubber latex adhesive which is not declared on the label",
      "root_cause_description": "Process change control",
      "action": "Stryker issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its consignees on 10/23/2023 via USPS Certified Mail.  The notice explained the issue and the potential risk to user and requested the following actions:  \n1.\tLocate the product listed above and if tape is detected on the product once the product is opened, do not use on patients that have a latex allergy.  Isolate and discard any impacted product with tape to avoid accidental use by a patient with a latex sensitivity.\n2.\tDistribute this notice to all hospital staff that need to be aware of the problem with this device.\n3.\tMaintain awareness of this communication internally by placing this notice at the point where the product is stored prior to use. \n4.\tInform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients appropriately.\nAdditional action for distributors only:\n1.\tLocate the product listed above in your inventory and attach a provided label to the side to each case of the impacted product to ensure that the End User will be made aware of this issue.",
      "product_quantity": "174,960 devices",
      "distribution_pattern": "US and Canada",
      "openfda": {
        "device_name": "Collector, Urine, Powered, Non Indwelling Catheter",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5250",
        "device_class": "1",
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