The Recall Desk

FDA (Devices) recall action 79531

Halyard Health, Inc recalled 3 products on 2018-04-25

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2018-04-25
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2018-04-25

    Halyard Closed Suction System Flex Connectors May Disconnect During Use

    Halyard Health is recalling certain Closed Suction Systems because Flex Connectors may become loose or disconnect before or during use.

    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-7
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-25

    Halyard Closed Suction System Recall Due to Loose Flex Connectors

    Halyard Health is recalling certain Closed Suction Systems because the Flex Connectors may become loose or disconnect before or during use.

    Product
    Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* MULTI-PORT, DSY, ENDO 10FR; b. HALYARD* MULTI-PORT, DSY, ENDO 12FR; c. HALYARD* MULTI-PORT,
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-04-25

    Halyard Closed Suction System Flex Connectors May Disconnect During Use

    Halyard Health is recalling certain Closed Suction Systems because the Flex Connectors may become loose or disconnect before or during use.

    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 12
    Category
    Distribution
    1 state