{
  "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,
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    }
  },
  "results": [
    {
      "cfres_id": "216321",
      "product_res_number": "Z-0234-2026",
      "event_date_initiated": "2025-09-11",
      "event_date_posted": "2025-10-23",
      "recall_status": "Open, Classified",
      "res_event_number": "97675",
      "product_code": "NGT",
      "k_numbers": [
        "K173348"
      ],
      "product_description": "Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240.  Prefilled saline flush syringes",
      "code_info": "UDI (Case): 10363807000039, UDI (Box): 363807000032, UDI (Each): 363807100114, Lot Numbers:  25AJA049, 25BJA001, 25BJA032, 25CJA053, 25CJA105, 25CJA158.",
      "firm_fei_number": "1417592",
      "recalling_firm": "Medline Industries, LP",
      "address_1": "3 Lakes Dr",
      "city": "Northfield",
      "state": "IL",
      "postal_code": "60093-2753",
      "additional_info_contact": "Karin Johnson\n866-369-1704",
      "reason_for_recall": "Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.",
      "root_cause_description": "Process control",
      "action": "Medline issued an Urgent Medical Device Recall notice to its consignees on 9/11/2025 via email and mail.  The notice discussed the issue, potential risk, and noted that affected boxes of syringes were also inadvertently packaged within cases of syringe lots that meet all requirements and were still safe for use.  Within the item number, EMZ111240, the firm specified which lots were to be destroyed and which lots were safe to use.  Cases of certain lots labeled with safe to use codes must be opened and inspected for affected units which must be destroyed.   A response is required to receive credit for the destroyed affected units.  \nFor questions, please contact the Recall Department at 866-359-1704 or recalls@medline.com.",
      "product_quantity": "8,267,150 syringes",
      "distribution_pattern": "Distribution US nationwide and Canada",
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        "device_name": "Saline, Vascular Access Flush",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5200",
        "device_class": "2"
      }
    }
  ]
}