{
  "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": {
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  "results": [
    {
      "cfres_id": "190432",
      "product_res_number": "Z-0411-2022",
      "event_date_initiated": "2021-11-04",
      "event_date_posted": "2021-12-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-08-07",
      "res_event_number": "89078",
      "product_code": "MLS",
      "product_description": "regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.",
      "code_info": "Lot #90074, Exp. 04/17/2023.  UDI (01)10194717112938(17)230417(10)90074.",
      "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": "Ms. Lacy Stewart\n417-647-3205",
      "reason_for_recall": "The kit contains a non-sterile needle.",
      "root_cause_description": "Process control",
      "action": "The firm issued a letter dated 11/4/2021 via email on 11/4/2021 explaining the reason for recall, the health risk involved, and the actions to be taken by the customer.  The customer was requested to check their inventory for the affected kits and immediately quarantine them without further distribution.  The attached reply form was to be completed so that return of the affected kits could be arranged.  If the kits were further distributed, the customer was requested to notify their customers.",
      "product_quantity": "40 kits",
      "distribution_pattern": "Distribution was made to Missouri.  There was no foreign/military/government distribution.",
      "openfda": {
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          "K936120",
          "K931722",
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        "device_name": "Labor And Delivery Kit",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.4530",
        "device_class": "2"
      }
    }
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}