BEUDAMED
    FDA Recall 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 · Initiated January 11, 2011

    Recall

    Recall Number
    Z-1848-2014
    Event Number
    68456
    Firm
    SteriGear, LLC
    FEI Number
    3007608536
    Product Code
    FCN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 11, 2011
    Posted
    June 23, 2014
    Terminated
    January 2, 2015
    Address
    362 S University Ave, Provo, UT, 84601-4472

    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.

    Action

    SteriGear, LLC sent a special note to all affected customers between January 12, 2011 and September 28, 2012. The note identified the product, the problem, and the action to be taken by the customer. Customers were instructed on how to reposition the inlet tube. Customers with questions were instructed to contact Director of Product Development at 801-607-3211. No correction or removal was performed. For questions regarding this recall call 801-607-3209.

    Distribution

    Nationwide Distribution

    Quantity

    110,560