{
  "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": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "cfres_id": "140988",
      "product_res_number": "Z-0277-2016",
      "event_date_initiated": "2015-10-14",
      "event_date_created": "2015-11-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-12-11",
      "res_event_number": "72418",
      "product_code": "GBW",
      "k_numbers": [
        "K992907"
      ],
      "product_description": "Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93.  To provide an access port into the peritoneal cavity.",
      "code_info": "Lot Numbers - 73A1500175, 73A1500306, 73B1500116, 73B1500418",
      "firm_fei_number": "3005747797",
      "recalling_firm": "Teleflex Medical",
      "address_1": "2917 Weck Dr",
      "city": "Research Triangle Park",
      "state": "NC",
      "postal_code": "27709-0186",
      "additional_info_contact": "Melissa Lewis\n610-378-0131",
      "reason_for_recall": "The defective component can cause gas leakage through the device.  This can result in loss of pneumoperitoneum, potentially necessitating removal  of the defective device and insertion of another device.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Recall letters were sent to customers and distributors.  The letter requested that the accounts discontinue use and quarantine for return any product.  The distributors were requested to conduct a sub-recall.  The letters included a Recall Acknowledgement Form which was to be returned to Teleflex.",
      "product_quantity": "2050 ea.",
      "distribution_pattern": "Nationwide Distribution including the states of  AK, AZ, AR, CA, CT, FL, GA, ID, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MO, MT, NE, NJ, NY, NC, OH, OK, PA, TN, TX, VA, VT, and WI.",
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        "device_name": "Catheter, Peritoneal",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4200",
        "device_class": "1"
      }
    }
  ]
}