# FDA recall Z-1427-2018

> **Halyard Health, Inc** · Class II · device recall initiated 2018-02-07.

## Product

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. 

## 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.

## Distribution

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.

## Key facts

- **Recall number:** Z-1427-2018
- **Recalling firm:** Halyard Health, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-07
- **Report date:** 2018-04-25
- **Termination date:** 2022-01-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Alpharetta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1427-2018

## Citation

> AI Analytics. FDA recall Z-1427-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1427-2018. Source: US FDA. Licensed CC0.

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