BEUDAMED
    FDA Recall Terminated

    Versa TREK REDOX 2 80 ml Anaerobic blood culture bottles, Product Code: 7103-44. The product was distributed in cases containing 50 bottles per case.

    Recall: Z-0708-05 · Initiated March 4, 2005

    Recall

    Recall Number
    Z-0708-05
    Event Number
    31375
    Firm
    Trek Diagnostic Systems
    FEI Number
    1000515493
    Product Code
    MDB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 4, 2005
    Posted
    April 13, 2005
    Terminated
    December 28, 2005
    Address
    982 Keynote Cir, Ste 6, Cleveland, OH, 44131-1873

    Description

    Versa TREK REDOX 2 80 ml Anaerobic blood culture bottles, Product Code: 7103-44. The product was distributed in cases containing 50 bottles per case.

    Reason

    Blood culture bottles with an error in the bar code on the labels, were shipped.

    Action

    The firm contacted its customers and notified them of the recall via telephone and fax on 3/4/2005 and a recall letter dated 3/4/2005 was sent to each customer via U.S. Mail on 3/7/2005. The letter states that a ''Return Goods Authorization'' for the amount of product shipped to each facility has been issued and asks that the customers return any unused portion of this lot to the firm for replacement.

    Distribution

    The blood culture bottles were distributed to the following states within the U.S.: MA, NY, TX, OH, MD, KY, OR, MO, NJ, PA, MI, FL, IN, NC, KS, GA, WI, & IL.

    Quantity

    223 cases [11,150 bottles]