BEUDAMED
    FDA Recall Terminated

    HACH SteriChek Residual Peroxide Reagent Strips, 5/100-strip bottles per kit, Kit Part #811905, Bottle part #1905LB, Hach Co., Ames, IA. SteriChek Residual Peroxide Reagent Strips provide a convenient means of measuring the concentration of peroxide remaining in water being used to rinse out dialysate lines and dialyzers following disinfection with peroxide/peracetic acid.

    Recall: Z-2016-2009 · Initiated April 21, 2009

    Recall

    Recall Number
    Z-2016-2009
    Event Number
    51966
    Firm
    Hach Co
    FEI Number
    1000518597
    Product Code
    LIF
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    April 21, 2009
    Posted
    September 4, 2009
    Terminated
    October 7, 2009
    Address
    100 Dayton Ave, Ames, IA, 50010-6402

    Description

    HACH SteriChek Residual Peroxide Reagent Strips, 5/100-strip bottles per kit, Kit Part #811905, Bottle part #1905LB, Hach Co., Ames, IA. SteriChek Residual Peroxide Reagent Strips provide a convenient means of measuring the concentration of peroxide remaining in water being used to rinse out dialysate lines and dialyzers following disinfection with peroxide/peracetic acid.

    Reason

    Some of the reagent strip bottles contain the incorrect strips

    Action

    Hach Company issued an "Urgent Medical Device Recall" letter dated April 21, 2009 explaining the reason for recall and requested product remaining in inventory be returned. Subrecall to the end-user level was requested. A Return Form was also enclosed to be completed to indicate the amount of product being returned. Between April 22-23, 2009, the firm telephoned their customers to assure they received the recall letter. For further information, contact Hach Customer Service at 1-800-548-4381 extension 3560.

    Distribution

    Nationwide Distribution -- NJ, CA, IN, PA, NV, CA, and ME.

    Quantity

    275 kits