{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
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  },
  "results": [
    {
      "status": "Terminated",
      "city": "Waltham",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87998",
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "address_1": "920 Winter St Bld 950",
      "address_2": "N/A",
      "postal_code": "02451-1521",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "US Distribution to: TX only",
      "recall_number": "Z-2082-2021",
      "product_description": "(1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE    (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case      For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting GRANUFLO & NATURALYTE: Concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.",
      "product_quantity": "(1) 20 cases (2) 30 cases",
      "reason_for_recall": "Exposed to freezing temperatures due to refrigerated truck malfunctions",
      "recall_initiation_date": "20210428",
      "center_classification_date": "20210716",
      "termination_date": "20220808",
      "report_date": "20210728",
      "code_info": "(1) Lot Number: B4MA27140  BAG GTIN CASE GTIN  BIBAG 650 GRAMS 08-4078-BB 00840861101313 10840861101310    (2) Lot Number: B5MB24110  BAG GTIN CASE GTIN  BIBAG 900 GRAMS 08-4080-BB 00840861101320 10840861101327",
      "more_code_info": ""
    }
  ]
}