BEUDAMED
    FDA Enforcement Class II Terminated

    SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-3259, SteriGear.com, Sterile, EO Urinary Drainage Collection Kit, for Indwelling Catheter. This device is intended to collect the Urine drained from an indwelling catheter

    Recall: Z-1848-2014 · Reported July 2, 2014

    Enforcement

    Recall Number
    Z-1848-2014
    Event ID
    68456
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SteriGear, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 2, 2014
    Initiation Date
    January 11, 2011
    Classification Date
    June 23, 2014
    Termination Date
    January 2, 2015
    Address
    362 S University Ave, N/A, Provo, UT, 84601-4472, United States

    Description

    SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-3259, SteriGear.com, Sterile, EO Urinary Drainage Collection Kit, for Indwelling Catheter. This device is intended to collect the Urine drained from an indwelling catheter

    Reason

    SteriGear notifed customers of circumstances in which The Fig Leaf urinary drain bag valve can close creating a negative pressure that can suck the non-return valve closed.

    Code Info

    UPD 851616002007, Part 10270

    Distribution

    Nationwide Distribution

    Quantity

    110,560