BEUDAMED
    FDA Enforcement Class II Terminated

    ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.

    Recall: Z-0058-2021 · Reported October 14, 2020

    Enforcement

    Recall Number
    Z-0058-2021
    Event ID
    86423
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 14, 2020
    Initiation Date
    September 1, 2020
    Classification Date
    October 6, 2020
    Termination Date
    May 27, 2022
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.

    Reason

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

    Code Info

    Model: DYNCPDS14T, Lots 06919010016 and 06919020016

    Distribution

    62 US consignees; 1 government consignee, 4 foreign consignees

    Quantity

    6225 units