{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "192280",
      "product_res_number": "Z-0837-2022",
      "event_date_initiated": "2022-02-24",
      "event_date_created": "2022-03-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2022-04-25",
      "res_event_number": "89710",
      "product_code": "LRS",
      "k_numbers": [
        "K991088"
      ],
      "product_description": "Regard Custom Procedure Kits containing BD Luer Lok Access  Devices",
      "code_info": "IV START LABOR BIRTH convenience kits:\n1) Item No. 830110, Lots 89222 and 87572 (exp. MAR/12/2022\n2) Item No. 830110002, Lots 91226, 90641, and 90446 (exp. MAY/12/2022)",
      "firm_fei_number": "3014527682",
      "recalling_firm": "ROi CPS LLC",
      "address_1": "3000 E Sawyer Rd",
      "city": "Republic",
      "state": "MO",
      "postal_code": "65738-2758",
      "additional_info_contact": "Lacy Stewart\n417-730-3900",
      "reason_for_recall": "Recalled devices were packaged in convenience kits.",
      "root_cause_description": "Material/Component Contamination",
      "action": "A customer letter dated February 24, 2022 was issued to the impacted consignee.  The letter instructs the consignee to perform a microscopy to confirm an elevated RBC count in a urine sample as the impacted component may shed contaminant particles that are identified as RBCs when used in conjunction with the Sysmex UF-1000i or UX-2000 analyzers.\nA reply form should be completed and returned to ROi confirming receipt and understanding of the notification.\nEnd users should retain a copy of the BD notice and post near the analyzer as a visual reminder of the potential issue with the BD product.",
      "product_quantity": "1750 kits",
      "distribution_pattern": "US Nationwide distribution in the state of Missouri.",
      "openfda": {
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        "device_name": "I.V. Start Kit",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5200",
        "device_class": "2"
      }
    }
  ]
}