{
  "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": {
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      "cfres_id": "161398",
      "product_res_number": "Z-0695-2018",
      "event_date_initiated": "2017-08-31",
      "event_date_created": "2018-02-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-04-09",
      "res_event_number": "79117",
      "product_code": "JCY",
      "product_description": "1113 Gravity Tube Set Pk/24 -SH\n\nProduct Usage:\nThe FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures.",
      "code_info": "Lot codes: 138, 194, 633, 1067, 1741, 2576, 2608, and 2645",
      "firm_fei_number": "1221934",
      "recalling_firm": "DePuy Mitek, Inc., a Johnson & Johnson Co.",
      "address_1": "325 Paramount Dr",
      "city": "Raynham",
      "state": "MA",
      "postal_code": "02767-5199",
      "additional_info_contact": "Jennifer Lawrence\n508-880-8100",
      "reason_for_recall": "Leakage of FMS gravity tub sets (281113) at the bulb and tube connection",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On September 6, 2017 an URGENT MEDICAL DEVICE RECALL letter was issued to customers titled \"FMS Gravity Tubing\" requesting that customers cease further distribution or use, quarantine all remaining products and contact sales consultant for the coordination of return and replacement. Questions or concerns can be directed to the recall coordinator at 508-828-6609",
      "product_quantity": "15,678",
      "distribution_pattern": "US Nationwide Distribution",
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        "device_name": "Catheter, Infusion",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4200",
        "device_class": "1",
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