BEUDAMED
    FDA Recall Terminated

    KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, DSE (Product Code 2271603); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, T-Piece (Product Code 227135).

    Recall: Z-1678-2015 · Initiated April 14, 2015

    Recall

    Recall Number
    Z-1678-2015
    Event Number
    71110
    Firm
    Halyard Health, Inc
    FEI Number
    3011270181
    Product Code
    BSY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 14, 2015
    Posted
    May 26, 2015
    Terminated
    July 7, 2015
    Address
    5405 Windward Pkwy, Alpharetta, GA, 30004-3894

    Description

    KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, DSE (Product Code 2271603); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, T-Piece (Product Code 227135).

    Reason

    The internal blue flapper valve of certain KimVent Turbo-Cleaning Closed Suction System for Adults may have a potential defect. If present, the defect potentially allows air to leak out of the closed ventilator circuit.

    Action

    Halyard Health Regulatory Affairs sent an Urgent Voluntary Product Recall letter dated April 16, 2015, to all affected consignees. Consignees were instructed to quarantine and discontinue use of the recalled product. Specific return instructions were provided in the Notice. The consignees were also requested to provide a response to to the recall notification. Wholesalers were instructed to follow their internal recall procedures to identify and address affected products. Consignees with questions were instructed to call Halyard Health Regulatory Affairs at 470-448-5700.

    Distribution

    Nationwide Distribution including CA, MA, MI, NC, TX, VA , and WA.

    Quantity

    11 cases each containing 20 individual endotracheal tubes