{
  "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,
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  "results": [
    {
      "cfres_id": "64551",
      "product_res_number": "Z-0058-2008",
      "event_date_initiated": "2007-07-23",
      "event_date_posted": "2007-10-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2009-04-06",
      "res_event_number": "44938",
      "product_code": "EXF",
      "k_numbers": [
        "K990428"
      ],
      "product_description": "Remington Medical, Inc, (RMI) --  Urinary Drainage Bags: 500ml Disposable Urinary Leg Bag (Order number: 500-D) and 1000ml Disposible Urinary Leg Bag (Order number 1000-D) -- Sterile Fluid Path, For Single Use Only, Remington Medical, Inc., Alpharetta, GA 30005.",
      "code_info": "Lot # 20070423 (500-D), and Lot #20070420 (1000-D)",
      "firm_fei_number": "1000132370",
      "recalling_firm": "Remington Medical Inc.",
      "address_1": "6830 Meadowridge Ct.",
      "city": "Alpharetta",
      "state": "GA",
      "postal_code": "30005",
      "additional_info_contact": "Cindy Croft\n770-888-8520",
      "reason_for_recall": "Sterility, inadequate -- Pathway may not be sterile as labeled.",
      "root_cause_description": "Process control",
      "action": "Consignees were notified by Urgent Recall Letter (dated 07/23/07) via fax from 07/24/2007 through 07/27/2007.  They were instructed to quarantine all affected product in inventory.  If product was distributed they were instructed to identify their customers and notify them of the recall via copy of the notification letter.",
      "product_quantity": "45,000 units",
      "distribution_pattern": "Nationwide Distribution -- including states of AL, AR, AZ, CA, CO, CT, GA, HI, IL, IN, KS, KY, MD, MI, MT, NB, NC, OH, NY, PA, RI, TN, WA, WV, and WY.",
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          "K003078",
          "K961986",
          "K911129",
          "K980005"
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        "device_name": "Bag, Bile Collecting",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5010",
        "device_class": "2"
      }
    }
  ]
}