{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Alpharetta",
      "state": "GA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79531",
      "recalling_firm": "Halyard Health, Inc",
      "address_1": "5405 Windward Pkwy",
      "address_2": "",
      "postal_code": "30004-3894",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution.  US nationwide including Puerto Rico, ARGENTINA, AUSTRALIA, BAHAMAS, BELGIUM, BOLIVIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REP., ECUADOR, EL SALVADOR, GUATEMALA, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, LEBANON, MALAYSIA, MEXICO, NEW ZEALAND, PERU, PHILIPPINES, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, THAILAND, UNITED KINGDOM, and UNITED ARAB EMIRATES.",
      "recall_number": "Z-1427-2018",
      "product_description": "Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. Labeled as the following:      a. HALYARD* 12FR DSE 21.3IN/54CM (WHITE);    b. HALYARD* 12 FR TRACH CARE DSE ENDO;    c. HALYARD* 12FR DSE 12IN/30.5CM (WHITE);    d. HALYARD* 12FR TRACH CARE DSE TRACH;    e. HALYARD* 14FR DSE 21.3IN/54CM (GREEN);    f. HALYARD* 14FR TRACH CARE DSE ENDO;    g. HALYARD* 14FR DSE 12IN/30.5CM (GREEN);    h. HALYARD* 14FR TRACH CARE DSE TRACH;    i. HALYARD* 14FR DSE 12IN/30.5CM;    j. HALYARD* 14FR TRACH CARE WET PAK* DSE MDI TRACH;    k. HALYARD* 14FR TRACH CARE WET PAK* DSE ENDO;    l. HALYARD* 14FR TRACH CARE WET PAK* DSE DIR TIP ENDO;    m. HALYARD* 14 FR TRACH CARE DSE DUAL LUMEN ENDO;    n. HALYARD* 14FR TRACH CARE DSE MDI ENDO;    o. HALYARD* 14FR DSE 22.2IN/56 CM (GREEN);    p. HALYARD* 14FR TRACH CARE DSE DIR TIP ENDO;    q. HALYARD* 16FR DSE 21.3IN/54CM (ORANGE);    r. HALYARD* 16FR TRACH CARE DSE ENDO;    s. HALYARD* 16FR TRACH CARE WET PAK* DSE ENDO",
      "product_quantity": "32,189 cases (20 units per case - 643,780 units) total",
      "reason_for_recall": "Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.",
      "recall_initiation_date": "20180207",
      "center_classification_date": "20180418",
      "termination_date": "20220118",
      "report_date": "20180425",
      "code_info": "Product Description, (Product code):        a. HALYARD* 12FR DSE 21.3IN/54CM (WHITE), (2160);    b. HALYARD* 12 FR TRACH CARE DSE ENDO, (2160-5);    c. HALYARD* 12FR DSE 12IN/30.5CM (WHITE), (21603);    d. HALYARD* 12FR TRACH CARE DSE TRACH, (21603-5);    e. HALYARD* 14FR DSE 21.3IN/54CM (GREEN), (22108130, 2210, 22106, 22107, 22108, 22108147, 8224);    f. HALYARD* 14FR TRACH CARE DSE ENDO, (2210-5);    g. HALYARD* 14FR DSE 12IN/30.5CM (GREEN), (22103, 221037, 221038, 8223, 221036);    h. HALYARD* 14FR TRACH CARE DSE TRACH, (22103-5);    i. HALYARD* 14FR DSE 12IN/30.5CM, (221036-5);    j. HALYARD* 14FR TRACH CARE WET PAK* DSE MDI TRACH, (2210386-5);    k. HALYARD* 14FR TRACH CARE WET PAK* DSE ENDO, (22106-5);    l. HALYARD* 14FR TRACH CARE WET PAK* DSE DIR TIP ENDO, (221069-5);    m. HALYARD* 14 FR TRACH CARE DSE DUAL LUMEN ENDO, (22107-5);    n. HALYARD* 14FR TRACH CARE DSE MDI ENDO, (22108-5);    o. HALYARD* 14FR DSE 22.2IN/56 CM (GREEN), (22108148, 22109);    p. HALYARD* 14FR TRACH CARE DSE DIR TIP ENDO, (22109-5);    q. HALYARD* 16FR DSE 21.3IN/54CM (ORANGE), (2260, 22606);    r. HALYARD* 16FR TRACH CARE DSE ENDO, (2260-5);    s. HALYARD* 16FR TRACH CARE WET PAK* DSE ENDO, (22606-5)",
      "more_code_info": ""
    }
  ]
}