BEUDAMED
    FDA Recall Terminated

    EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits. Each kit contains the following components: Blood Glucose Meter; Test Strip x 10 ct.; Normal Control Solution; Carrying Case; Alkaline Battery x 2 ct.; Lancets x 5 ct.; Lancing Device; AST Lancing Device Cap; User's Manual; Test Strip Instructions and Control Solution Instructions. Indicated for use at home by persons with diabetes or in clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control.

    Recall: Z-1937-2009 · Initiated May 26, 2009

    Recall

    Recall Number
    Z-1937-2009
    Event Number
    52352
    Firm
    Oak Tree International Holdings, LLC, Inc.
    FEI Number
    3007644653
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 26, 2009
    Posted
    September 10, 2009
    Terminated
    September 27, 2012
    Address
    1209 Lowell St, Ste 10, Elyria, OH, 44035-4803

    Description

    EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits. Each kit contains the following components: Blood Glucose Meter; Test Strip x 10 ct.; Normal Control Solution; Carrying Case; Alkaline Battery x 2 ct.; Lancets x 5 ct.; Lancing Device; AST Lancing Device Cap; User's Manual; Test Strip Instructions and Control Solution Instructions. Indicated for use at home by persons with diabetes or in clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control.

    Reason

    Blood glucose meters, which were set to the mmol/L. unit of measure, rather than the accepted/labeled mg./dL unit of measure, were distributed.

    Action

    EPS Technology issued a certified notification letter to the sole distributor/customer: GEMCO, Coconut Creek, FL dated May 26, 2009. The letter describes the potential preset error and its possible consequences to the user/customer. The letter goes on to inform the distributor that EPS Technology Corp. will be sending out letters to all affected user/customers during a direct mailing. If the error is found, the user/customer can either: 1) have the firm's Customer Service Dept. instruct them as to how to fix the unit, or 2) request that a replacement meter be sent to them. For further information, contact EPS Technology Customer Service at 1-866-994-3345.

    Distribution

    Nationwide Distribution -- AL, AR, AZ, CA, CT, FL, GA, IL, IN, KS, KY, LA, MD, ME, MI, MS, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, VA, WA, WY and HI.

    Quantity

    5,396 units