BEUDAMED
    FDA Recall Terminated

    Oral-Eze (R) Oral Fluid Collection System, manufactured by Capitol Vial, Inc., Auburn, AL 36832 Product Usage: IVD for drugs of abuse

    Recall: Z-1101-2012 · Initiated October 7, 2011

    Recall

    Recall Number
    Z-1101-2012
    Event Number
    60981
    Firm
    Capitol Vial Inc
    FEI Number
    3000325731
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 7, 2011
    Posted
    February 24, 2012
    Terminated
    August 24, 2012
    Address
    2039 Mcmillan St, Auburn, AL, 36832-4271

    Description

    Oral-Eze (R) Oral Fluid Collection System, manufactured by Capitol Vial, Inc., Auburn, AL 36832 Product Usage: IVD for drugs of abuse

    Reason

    Low buffer fill volumes on Oral-Eze, an oral fluid collection system.

    Action

    Thermo-Fisher Scientific/Capital Vial sent a Recall Notification letter dated October 7, 2011 to the sole consignee. The letter identified the affected product, problem, result impact and necessary actions to be taken. The consignee was instructed to discontinue use of the affected product and follow the necessary actions provided. If you have any questions regarding this information, call Michael Hect, Manufacturing Manager through Customer Service at (800) 772-8871.

    Distribution

    (USA) Nationwide Distribution - in the state of KS

    Quantity

    135,000 units