BEUDAMED
    FDA Enforcement Class III Terminated

    Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexible endoscopes. SKU# EP-6W (The First Step 500 ml ADD WATER Kit comes with concentrated Simple2" Enzymatic Detergent and a cleaning pad in a re-sealable stand-up pouch).

    Recall: Z-1389-2016 · Reported April 20, 2016

    Enforcement

    Recall Number
    Z-1389-2016
    Event ID
    73568
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cygnus Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 20, 2016
    Initiation Date
    March 17, 2016
    Classification Date
    April 14, 2016
    Termination Date
    May 23, 2016
    Address
    965 W Main St, N/A, Branford, CT, 06405-3431, United States

    Description

    Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexible endoscopes. SKU# EP-6W (The First Step 500 ml ADD WATER Kit comes with concentrated Simple2" Enzymatic Detergent and a cleaning pad in a re-sealable stand-up pouch).

    Reason

    Foreign material in container

    Code Info

    Lot Numbers: EX20170714A and EX201720A

    Distribution

    US Distribution to the states of : CA , CO, FL, IL. MN, MT, NY, OH, PA, TX, VA, VT, WA and WI.

    Quantity

    39 cases of 120 units