# FDA recall Z-1428-2018

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

## Product

Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adults,¿Double¿Swivel¿Elbow (DSE).  Used to aspirate liquids or semisolids from a patient's upper airway.      a. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54 CM (GREEN);    b. HALYARD* TRACH CARE-72 DSE ENDO 14FR;    c. HALYARD* TRACH CARE-72 WET PAK* 14FR;    d. HALYARD* TRACH CARE-72 WET PAK* T-PIECE SWVL/FLEX ENDO 14FR;    e. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5 CM (GREEN);    f. HALYARD* TRACH CARE-72 DSE TRACH 14FR;    g. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 14FR;    h. HALYARD* TRACH CARE-72 DSE ENDO 10FR;    i. HALYARD* TURBO-CLEANING 10FR DSE 12IN/30.5CM (BLACK);    j. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 10FR;    k. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 12FR;    l. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE);   m. HALYARD* 72 DSE MDI BUILT IN ENDO 12FR;    n. HALYARD* 72 DSE TRACH CARE 12FR;    o. HALYARD* 14FR DSE 22.2IN/56CM (GREEN);    p. HALYARD* TRACH CARE

## 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-1428-2018
- **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-1428-2018

## Citation

> AI Analytics. FDA recall Z-1428-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1428-2018. Source: US FDA. Licensed CC0.

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