{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "215902",
      "product_res_number": "Z-0041-2026",
      "event_date_initiated": "2025-08-29",
      "event_date_posted": "2025-10-03",
      "recall_status": "Open, Classified",
      "res_event_number": "97543",
      "product_code": "FJI",
      "k_numbers": [
        "K162488"
      ],
      "product_description": "Optiflux High Flux E-beam Dialyzer\nModel Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM",
      "code_info": "1. Model: 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, UDI-DI: 840861100149, All Lots manufactured after SEP/06/2023,\n\n2. Model: 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, UDI-DI: 840861100156, All Lots manufactured after SEP/06/2023,\n\n3. Model: 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, UDI-DI: 840861100163, All Lots manufactured after SEP/06/2023,\n\n4. Model: 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM, UDI-DI: 840861100170, All Lots manufactured after SEP/06/2023;",
      "firm_fei_number": "3001451489",
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "address_1": "920 Winter St Bld 920",
      "city": "Waltham",
      "state": "MA",
      "postal_code": "02451-1521",
      "additional_info_contact": "Fresenius Medical Care Customer Service\n800-323-5188",
      "reason_for_recall": "To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.",
      "root_cause_description": "Device Design",
      "action": "On August 29, 2025 IMPORTANT MEDICAL DEVICE INFORMATION letters were sent to customers.\nActions to be taken:\n1. Follow the  New Instructions for Use  provided in this letter when attaching\nthe dialyzer caps.\n2. Please report any complaints or adverse events to product.complaints@fmcna.\ncom or FDA MedWatch at https://www.fda.gov/safety/medical-product-safetyinformation/\nmedwatch-forms-fda-safety-reporting.\n3. Please forward this notice to any providers who may have received these products\nfrom you. Place this notification with the device to ensure awareness.\nFor product technical questions or concerns, please contact the Technical Support at 1-\n800-323-2732 or Customer Support at 1-800-323-5188. For any clinical or medical\nquestions, please contact the Global Medical Information and Education Office at 1-855-\n616-2309.\nThis notification serves as important medical device information. FMCRTG is not\nrequesting the return of any product.\nFMCRTG is working diligently to provide the updated Instructions for Use with the product\nand expects release in Q4 2025. The health and safety of your patients continue to be our\nhighest priority. Thank you for your cooperation.",
      "product_quantity": "172,494,732 units (14,374,561 cases @ 12 units per case)",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
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          "K883644",
          "K883748",
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          "K772290",
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          "K821690",
          "K990159",
          "K881811",
          "K890111",
          "K941708",
          "K874872",
          "K820743",
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          "K853591",
          "K950602",
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          "K772423",
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          "K801192",
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          "K945624",
          "K891477",
          "K790696",
          "K800270",
          "K760252",
          "K802894"
        ],
        "device_name": "Dialyzer, Capillary, Hollow Fiber",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5820",
        "device_class": "2",
        "registration_number": [
          "2028411",
          "1713747",
          "8030639",
          "1721676",
          "3038195011",
          "1225714",
          "1932668",
          "9611369"
        ],
        "fei_number": [
          "1713747",
          "1721676",
          "3038195011",
          "3002807035",
          "6898",
          "1000138417",
          "1000125241",
          "3001451489"
        ]
      }
    }
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}