{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "221352",
      "product_res_number": "Z-2796-2026",
      "event_date_initiated": "2026-04-30",
      "event_date_posted": "2026-07-31",
      "recall_status": "Open, Classified",
      "res_event_number": "99339",
      "product_code": "OES",
      "product_description": "Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds.\n\nCARDIAC CATH PACK EAMC1000-05",
      "code_info": "UDI-DI 10809160377314\nLots\n1573593\n1583827\n1609541\n1612134\n1612516\n1619132\n1623384\n1627013\n1635459\n1672306\n1675159",
      "firm_fei_number": "1047429",
      "recalling_firm": "AVID Medical, Inc.",
      "address_1": "9000 Westmont Dr",
      "city": "Toano",
      "state": "VA",
      "postal_code": "23168-9351",
      "additional_info_contact": "Marlene Jones\n757-566-3510",
      "reason_for_recall": "Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On April 30, 2026, firm notified distributors via email. Distributors were tasked with notifying their end-users.\n\nCustomers were instructed to identify, segregate, and quarantine all impacted products. They were provided with a labeling template to print warning labels which should be affixed on all affected kits and cases in inventory. The firm is also able to provide pre-printed labels if needed. \n\nWarning labels inform users to remove and discard the manifold prior to use.",
      "product_quantity": "5168 kits",
      "distribution_pattern": "US Nationwide distribution in the states of NC and TX.",
      "openfda": {
        "registration_number": [
          "3010532612",
          "3007329020",
          "3011137372",
          "3008513424",
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        "fei_number": [
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          "3008513424",
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          "3045816907",
          "3005747797",
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          "1047429",
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        ],
        "device_name": "Cardiac Catheterization Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1200",
        "device_class": "2"
      }
    }
  ]
}