{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Waltham",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "96827",
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "address_1": "920 Winter St Bld 920",
      "address_2": "N/A",
      "postal_code": "02451-1521",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "US Nationwide distribution in the state of Massachusetts.",
      "recall_number": "Z-1992-2025",
      "product_description": "5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models:  a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7.  b. 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C.  c. 5008X Standard HDF Bloodline w/ Twister, Model Number: 03-5150-2.",
      "product_quantity": "Model Number, Cases (Eaches):  03-5100-7, 76 (1,824); 03-5100-7C, 5 (120); 03-5150-2, 8 (192)",
      "reason_for_recall": "Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.",
      "recall_initiation_date": "20250429",
      "center_classification_date": "20250618",
      "report_date": "20250625",
      "code_info": "a. Model Number: 03-5100-7; UDI-DI: 00840861102365 (Bag), 10840861102362 (Case); Lot Numbers: 24LR01214, 24SR01010, 25ER01800.  b. Model Number: 03-5100-7C; UDI-DI: 0084086110237 (Bag), 10840861102379 (Case); Lot Number: 24LR01215, 24SR01011, 25ER01804.  c. Model Number: 03-5150-2; UDI-DI: 00840861102389 (Bag), 10840861102386 (Case); Lot Number: 24LR01216, 24SR01012, 25ER01805.",
      "more_code_info": ""
    }
  ]
}