BEUDAMED
    FDA Enforcement Class II Terminated

    Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled.

    Recall: Z-1368-2018 · Reported April 18, 2018

    Enforcement

    Recall Number
    Z-1368-2018
    Event ID
    79579
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical Europe Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 18, 2018
    Initiation Date
    March 15, 2018
    Classification Date
    July 5, 2018
    Termination Date
    October 5, 2020
    Address
    Ida Business Park, Athlone, N/A, Ireland

    Description

    Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled.

    Reason

    These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.

    Code Info

    Batch Numbers: 13DE17 13EE22 13FE24 13FE26 13GE28 13GE29 13GE31 13KE47 13LE49 14AE03 14AE04 14FE25 14GE27 14HE32 14HE33 14HE35 14IE37 14IE38 14LE49 15AE05 15BE08 15CE13 15DE15 15DE16 15DE17 15DE18 15FE23 15FE25 15FE26 15GE27 15GE28 15GE29 15GE30 15HE32

    Distribution

    US Nationwide Distribution

    Quantity

    6340 units