{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "48645",
      "product_res_number": "Z-0174-2007",
      "event_date_initiated": "2006-10-12",
      "event_date_posted": "2006-11-14",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-11-28",
      "res_event_number": "36430",
      "product_code": "MSE",
      "k_numbers": [
        "K983720"
      ],
      "product_description": "Asahi AM-BIO D Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Model AM-BIO-75D - 1.5 m2 surface area and Model AM-BIO-100D - 2.0 m2 surface area",
      "code_info": "Model AM-BIO-75D and Model AM-BIO-100D, all lots",
      "firm_fei_number": "1000599821",
      "recalling_firm": "Asahi Medical Co., Ltd",
      "address_1": "3100 Dundee Rd Ste 201/202 201/202 dundee rd ste",
      "city": "Northbrook",
      "state": "IL",
      "postal_code": "60062-2437",
      "additional_info_contact": "Ms. Karen  Borling, R.N.\n847-498-8500",
      "reason_for_recall": "There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possibly damaging the dialyzer nozzle.",
      "root_cause_description": "Other",
      "action": "Asahi sent Safety Alert letters on 10/12/06 to their re-use dialyzer customers advising them of the reports of difficulty separating the blood set from the dialyzer and not to use the Gambro Cartridge Blood Set with Asahi Reuse/Multiple Use Dialyzers in a reuse situation.  Enclosed were copies of the temporary revision Instructions For Use with the following warning added at the top of the page: 'Additional Warning for Reuse/Multiple Use Dialyzers: Ashai Reuse/Multiple use dialyzers must not be used in connection with the Gambro cartridge Blood Set in a reuse environment.'  Any questions were directed to Karen Borling, RN at 847-498-8500.",
      "product_quantity": "100,000 for all models",
      "distribution_pattern": "Nationwide",
      "openfda": {
        "k_number": [
          "K001685",
          "K970700",
          "K970654",
          "K974090",
          "K970650",
          "K970661",
          "K983720"
        ],
        "device_name": "Hemodialyzer, Re-Use, Low Flux",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5820",
        "device_class": "2",
        "registration_number": [
          "1721676"
        ],
        "fei_number": [
          "1721676"
        ]
      }
    }
  ]
}