BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated June 30, 2020

    Recall

    Recall Number
    Z-2725-2020
    Event Number
    85983
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    BSY
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 30, 2020
    Address
    Three Lakes Drive, Northfield, IL, 60093

    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.

    Action

    Customer letter dated 06/29/2020 was issued to consignees. Consignees are asked to check their inventory for impacted product and destroy affected product. Consignees are asked to complete and return a destruction form listing quantity of affected product destroyed or indicate no product was on hand. Additionally, if product has been further distributed, consignees are asked to notify those customers who may be impacted.

    Distribution

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

    Quantity

    680 units