{
  "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": "169071",
      "product_res_number": "Z-0619-2019",
      "event_date_initiated": "2018-11-08",
      "event_date_created": "2018-12-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-10-13",
      "res_event_number": "81615",
      "product_code": "MRZ",
      "k_numbers": [
        "K171346"
      ],
      "product_description": "SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02\n\nSapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets are intended for use with Sapphire Infusion Systems.",
      "code_info": "UDI 108877870074, All codes",
      "firm_fei_number": "3013319212",
      "recalling_firm": "ICU Medical Inc",
      "address_1": "600 N FIELD DRIVE",
      "city": "LAKE FOREST",
      "state": "IL",
      "postal_code": "60045",
      "additional_info_contact": "customer care\n877-946-7747",
      "reason_for_recall": "There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.",
      "root_cause_description": "Device Design",
      "action": "On 11/08/18, Stericycle, Inc. sent  a \"URGENT MEDICAL DEVICE CORECTION\" letter to its consignees. The letter described the product, problem and actions to be taken via traceable mailing. Delivery will be confirmed via traceable mailing. Consignees who further distributed the product were asked to notify their customers.\n\nFor further inquiries, please contact ICU US Field Action Manager at  224-706-2487 or  veasna.seth@icumed.com.",
      "product_quantity": "31,050 units",
      "distribution_pattern": "US distribution and Internationally to Canada.",
      "openfda": {
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          "3003098013",
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          "1121996",
          "3013756811"
        ],
        "device_name": "Accessories, Pump, Infusion",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5725",
        "device_class": "2"
      }
    }
  ]
}