{
  "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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      "cfres_id": "209941",
      "product_res_number": "Z-0004-2025",
      "event_date_initiated": "2024-08-30",
      "event_date_posted": "2024-10-02",
      "recall_status": "Open, Classified",
      "res_event_number": "95303",
      "product_code": "BTL",
      "k_numbers": [
        "K093913"
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      "product_description": "Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.",
      "code_info": "Part Number: 1050805; UDI/DI: 10641043508053, 30641043508057; Lot Numbers: 2417650805, 2417750805.\n\nPart Number: 1050832; UDI/DI: 10641043508329, 30641043508323; Lot Numbers: 2423550832, 2417850832.",
      "firm_fei_number": "1024404",
      "recalling_firm": "Mercury Enterprises, Inc. dba Mercury Medical",
      "address_1": "11300 49th St N",
      "city": "Clearwater",
      "state": "FL",
      "postal_code": "33762-4807",
      "additional_info_contact": "727-573-0088",
      "reason_for_recall": "Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.",
      "root_cause_description": "Process control",
      "action": "Mercury Medical notified customers on 09/04/2024 via letter.  Consignees who are medical facilities were instructed to immediately review inventory and quarantine any affected units on hand, contact customer service to arrange return of units, and complete the return response form.  Consignees who are distributors were instructed to notify customers if further distributed, obtain a response form from those customers, arrange for any return of affected units, and complete the return response form.",
      "product_quantity": "1,300 units",
      "distribution_pattern": "US distribution to MI, FL, SC, PA, IN. International distribution to Albania.",
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