{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "211432",
      "product_res_number": "Z-0820-2025",
      "event_date_initiated": "2024-11-22",
      "event_date_posted": "2025-01-08",
      "recall_status": "Open, Classified",
      "res_event_number": "95878",
      "product_code": "KPO",
      "k_numbers": [
        "K171750"
      ],
      "product_description": "Citric Complete - Dry Citric Acid Concentrate\nModel Number: DCA+225-25",
      "code_info": "Model Number: DCA+225-25. Lot Numbers: NDC4F001, NDC4G006, NDC4H009, NDC4H010.",
      "firm_fei_number": "1000142899",
      "recalling_firm": "Nipro Renal Soultions USA, Corporation",
      "address_1": "509 Fishing Creek Rd",
      "city": "Lewisberry",
      "state": "PA",
      "postal_code": "17339-9517",
      "additional_info_contact": "Jessica Oswald-McLeod\n717-938-8391",
      "reason_for_recall": "The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.",
      "root_cause_description": "Process control",
      "action": "Nipro notified their distributor on 11/22/2024 via email. Direct customers were notified via email on 11/25/2024. The firm sent a \"Medical Device Recall\" letter dated 11/11/2024 to its customers.  The letter instructed customers to place any affected units in inventory on hold and return them immediately. They were also instructed to complete the  quantity in stock  column on the attached response form and return to USorders@nipromed.com for processing. \n\nNipro Partner Solutions team will coordinate the return of all recalled products from your facility back to Nipro.\n\nIf you have any questions, contact Director QA/RA at 717-938-8391.",
      "product_quantity": "2,810 units",
      "distribution_pattern": "US distribution to states of: AZ, FL, GA, GA, IL, MI, NC, NJ, OH, TN, TX.",
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        "device_name": "Dialysate Concentrate For Hemodialysis (Liquid Or Powder)",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5820",
        "device_class": "2"
      }
    }
  ]
}