{
  "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": "2026-09-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 13
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  "results": [
    {
      "cfres_id": "221862",
      "product_res_number": "Z-3067-2026",
      "event_date_initiated": "2026-07-20",
      "event_date_posted": "2026-08-31",
      "recall_status": "Open, Classified",
      "res_event_number": "99561",
      "product_code": "OFT",
      "product_description": "Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators\r\n\r\nPAIN PRE OP KIT\t\r\n\tDYKS1476A",
      "code_info": "UDI-DI 10198459362835\nLots 25IBJ918\n25KBN677\n25LBU066\n26BBD775",
      "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": "Haley Barclay\n800-633-5463",
      "reason_for_recall": "Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Firm began notifying consignees on 7/20/2026 via First-Class Mail and email.\n\nMedline Industries LP instructed customers to request stickers to over-label the affected convenience kits with a label indicating to remove the affected component and replace it with product from supply. No kits are to be returned.",
      "product_quantity": "222,653 total",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "device_name": "Spinal Epidural Anesthesia Kit",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5120",
        "device_class": "2",
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