BEUDAMED
    FDA Enforcement Class II Terminated

    First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross contamination prior to manual cleaning and disinfection. Product Labeling: "The multi-tiered enzymatic detergent starts working instantly to break down all forms of bioburden.".

    Recall: Z-1182-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1182-2018
    Event ID
    79402
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Madison Polymeric Engineering
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 4, 2018
    Initiation Date
    November 3, 2017
    Classification Date
    March 26, 2018
    Termination Date
    July 17, 2018
    Address
    965 W Main St, Branford, CT, 06405-3453, United States

    Description

    First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross contamination prior to manual cleaning and disinfection. Product Labeling: "The multi-tiered enzymatic detergent starts working instantly to break down all forms of bioburden.".

    Reason

    Affected lots may have exceeded its microbial limits.

    Code Info

    EP-4 Lots EXP20 l 7 l 209A, EXP20 l 80512A; and EP-4D Lot EXP20 l80520A

    Distribution

    US Distribution. .

    Quantity

    285 cases