{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Raynham",
      "address_1": "325 Paramount Drive",
      "reason_for_recall": "Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not  perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination",
      "address_2": "",
      "product_quantity": "29280 units",
      "code_info": "All lot codes",
      "center_classification_date": "20131108",
      "distribution_pattern": "Worldwide Distribution - USA (Nationwide) and in the countries of: Australia , Austria , Belgium , Canada , Czech Republic , Denmark , Finland , France, Germany , India, Ireland , Israel, Italy , Latvia , Netherlands , Norway , Nepal, Poland , Portugal , Spain , Sweden , Switzerland , United Kingdom.",
      "state": "MA",
      "product_description": "DePuy Mitek FMS Outflow Tubing with One-Way valve  Product Code:284649    Product Usage:  The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Outflow Tubing with One-Way valve is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy.",
      "report_date": "20131120",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "DePuy Mitek, Inc., a Johnson & Johnson Co.",
      "recall_number": "Z-0192-2014",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "66145",
      "termination_date": "20160512",
      "more_code_info": "",
      "recall_initiation_date": "20130829",
      "postal_code": "02767-5199",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}