{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "171320",
      "product_res_number": "Z-0797-2020",
      "event_date_initiated": "2019-02-27",
      "event_date_created": "2020-01-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-09-06",
      "res_event_number": "82307",
      "product_code": "NNY",
      "product_description": "Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M",
      "code_info": "GTIN 24026704549843 Lot Numbers:  74A1800577, 74G1802121, 74A1801939, 74H1700894, 74B1800363, 74J1700864, 74B1801604, 74J1702489, 74B1802746, 74C1801178, 74K1702257, 74L1700074, 74C1801294\t, 74L1701701, 74C1802132, 74M1700121, 74G1800047, 74M1701150, 74G1800891, 74M1701769, 74G1801166",
      "firm_fei_number": "3005747797",
      "recalling_firm": "Teleflex Medical",
      "address_1": "3015 Carrington Mill Blvd",
      "city": "Morrisville",
      "state": "NC",
      "postal_code": "27560-5437",
      "reason_for_recall": "The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an alternative to incontinence pads. In normal use, the device is neither expected nor required to be sterile.",
      "root_cause_description": "Under Investigation by firm",
      "action": "The firm initiated the recall by letter on 02/27/2019.  The notice stated that the device label incorrectly identified the products as sterile.  Although incorrectly labeled as sterile, there is no requirement for sterility for its use.  The firm requested that the distributors notify their customers.  The firm did not request the return of the units, only to attach the notice to any recalled product in stock.",
      "product_quantity": "13104 devices",
      "distribution_pattern": "ME,NC, WA, MO, NJ, FL, CAL, TX, OH, IL, MA, GA, FL, GA, Canada",
      "openfda": {
        "device_name": "Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5250",
        "device_class": "1",
        "registration_number": [
          "3011197191",
          "3012187635",
          "3011137372",
          "3003898360",
          "3031582449",
          "3010339057",
          "3011814545",
          "3017896419",
          "3003965134",
          "3009086335"
        ],
        "fei_number": [
          "3011197191",
          "3012187635",
          "3003898360",
          "3031582449",
          "3005747797",
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        ]
      }
    }
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}