BEUDAMED
    FDA Recall Terminated

    NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, 14F (Product Code 2V220135); NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece, 14F (Product Code 2V2205) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

    Recall: Z-2500-2015 · Initiated July 29, 2015

    Recall

    Recall Number
    Z-2500-2015
    Event Number
    71966
    Firm
    Halyard Health, Inc
    FEI Number
    3011270181
    Product Code
    BSY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 29, 2015
    Posted
    August 31, 2015
    Terminated
    January 12, 2016
    Address
    5405 Windward Pkwy, Alpharetta, GA, 30004-3894

    Description

    NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, 14F (Product Code 2V220135); NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece, 14F (Product Code 2V2205) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

    Reason

    The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.

    Action

    Halyard sent a Product Advisory Notice on July 29, 2015, via FEDEX with a second letter dated August 12, 2015, being issued via FEDEX. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to report any occurrence of a valve leak to Halyard Customer Service at 1-844-425-9273, option 1, option 3.

    Distribution

    Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada