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Recall Observatory FDA recall evidence

Device 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-72 DSE MDI BUILT IN ENDO 14FR; q. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5CM (GREEN); r. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 14FR; s. HALYARD* TC-72 WET PAK* DSE MDI ENDO 14FR; t. HALYARD* TC-72 WET PAK DSE MDI ENDO 14FR; u. HALYARD* TC-72 WET PAK DSE 14FR; v. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN); w. HALYARD* TURBO-CLEANING 12FR DSE 21.3IN/54 CM (WHITE); x. HALYARD* TRACH CARE-72 DSE ENDO 12FR; y. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE); z. HALYARD* TRACH CARE-72 DSE TRACH 12FR; aa. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 12FR; ab. HALYARD* TURBO-CLEANING 16FR DSE 21.3IN/54CM (ORANGE); ac. HALYARD* TRACH CARE-72 DSE 16FR 21.3IN/54CM; ad. HALYARD* TRACH CARE-72 DSE TRACH 16FR; ae. HALYARD* TRACH CARE-72 DSE ENDO 16FR; af. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 16FR; ag. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 16FR; ah. HALYARD* TRACH CARE-72 DSE MDI ENDO 16FR; ai. HALYARD* TRACH CARE-72 DSE 16FR; aj. HALYARD* TRACH CARE-72 WET PAK* DSE ENDO 12FR; ak. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN); al. HALYARD* TURBO-CLEANING 14FR DSE Endo;

Z-1428-2018

February 07, 2018

Class II

Product summary

Firm
Halyard Health, Inc
Event
Event 79531
Status
Terminated
Classification
Class II
Quantity
32,189 cases (20 units per case - 643,780 units) total
Official record key
device-enforcement:Z-1428-2018

Official wording

Reason: Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.

Code information: Product Description, Product code: a. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54 CM (GREEN), 227; b. HALYARD* TRACH CARE-72 DSE ENDO 14FR, 227-5; c. HALYARD* TRACH CARE-72 WET PAK* 14FR, 22701356-5; d. HALYARD* TRACH CARE-72 WET PAK* T-PIECE SWVL/FLEX ENDO 14FR, 2270156-5; e. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5 CM (GREEN), 22703; f. HALYARD* TRACH CARE-72 DSE TRACH 14FR, 22703-5; g. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 14FR, 227036-5; h. HALYARD* TRACH CARE-72 DSE ENDO 10FR, 227101-5; i. HALYARD* TURBO-CLEANING 10FR DSE 12IN/30.5CM (BLACK), 2271013; j. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 10FR, 2271018-5; k. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 12FR, 2271218-5; l. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE), 22712183; m. HALYARD* 72 DSE MDI BUILT IN ENDO 12FR, 22712186-5; n. HALYARD* 72 DSE TRACH CARE 12FR, 227121863-5; o. HALYARD* 14FR DSE 22.2IN/56CM (GREEN), 2271418; p. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 14FR, 2271418-5; q. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5CM (GREEN), 22714183; r. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 14FR, s. 22714183-5; s. HALYARD* TC-72 WET PAK* DSE MDI ENDO 14FR, 22714186; t. HALYARD* TC-72 WET PAK DSE MDI ENDO 14FR, 22714186-5; u. HALYARD* TC-72 WET PAK DSE 14FR, 227141863-5; v. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN), 227147; w. HALYARD* TURBO-CLEANING 12FR DSE 21.3IN/54 CM (WHITE), 22716; x. HALYARD* TRACH CARE-72 DSE ENDO 12FR, 22716-5; y. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE), 2271603; z. HALYARD* TRACH CARE-72 DSE TRACH 12FR, 2271603-5; aa. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 12FR, 22716036-5; ab. HALYARD* TURBO-CLEANING 16FR DSE 21.3IN/54CM (ORANGE), 227161; ac. HALYARD* TRACH CARE-72 DSE 16FR 21.3IN/54CM, 227161-5; ad. HALYARD* TRACH CARE-72 DSE TRACH 16FR, 2271613-5; ae. HALYARD* TRACH CARE-72 DSE ENDO 16FR, 2271616-5; af. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 16FR, ag. 2271618-5; ag. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 16FR, 22716183-5; ah. HALYARD* TRACH CARE-72 DSE MDI ENDO 16FR, 22716186-5; ai. HALYARD* TRACH CARE-72 DSE 16FR, 227161863-5; aj. HALYARD* TRACH CARE-72 WET PAK* DSE ENDO 12FR, 227166-5; ak. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN), 2276; al. HALYARD* TURBO-CLEANING 14FR DSE Endo, 2276-5;

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.