{
  "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": "2026-08-13",
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      "product_res_number": "Z-0253-2022",
      "event_date_initiated": "2021-08-10",
      "event_date_created": "2021-11-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-06-16",
      "res_event_number": "88463",
      "product_code": "MLS",
      "product_description": "REGARD Newborn Tray",
      "code_info": "Lot number: 86453F",
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      "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": "Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "The correction was sent via e-mail on 08-10-2021 instructing the consignees to removed the Swabsticks (3's) and be discarded at time of use.",
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}