BEUDAMED
    FDA Enforcement Class II Ongoing

    ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.

    Recall: Z-2725-2020 · Reported August 5, 2020

    Enforcement

    Recall Number
    Z-2725-2020
    Event ID
    85983
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 5, 2020
    Initiation Date
    June 30, 2020
    Classification Date
    July 28, 2020
    Address
    Three Lakes Drive, N/A, Northfield, IL, 60093, United States

    Description

    ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.

    Reason

    There are reports of the suction catheter coming apart from the device assembly during use.

    Code Info

    Model: DYNCPTP14T, Lot #6918100021:

    Distribution

    US Nationwide distribution including in the states of AR, AZ, CA, FL, GA, IL, MS, NY, NV, OH, PA, TX.

    Quantity

    680 units