BEUDAMED
    FDA Recall Terminated

    Laborie Medical Technologies Urodynamic Catheters, Twin Lumen 6 Fr , 40cm For Cystometry. Catalog Number: CAT-206.

    Recall: Z-1711-2009 · Initiated April 9, 2009

    Recall

    Recall Number
    Z-1711-2009
    Event Number
    52431
    Firm
    Laborie Medical Technologies Cor
    FEI Number
    3017448360
    Product Code
    EXQ
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    April 9, 2009
    Posted
    July 21, 2009
    Terminated
    August 20, 2009
    Address
    400 Avenue D, Ste 10, Williston, VT, 05495-7828

    Description

    Laborie Medical Technologies Urodynamic Catheters, Twin Lumen 6 Fr , 40cm For Cystometry. Catalog Number: CAT-206.

    Reason

    Laborie Medical Technologies reports that there was a mix up in the labeling and packaging of their Urodynamic Catheters. There were 8Fr catheters mixed inside the 6Fr catheter packages.

    Action

    Laborie Medical Technologies notified customers by telephone/email beginning April 10, 2009 advising them of the mislabelled product. For further questions, contact Laborie Medical Technologies at 1-800-522-6743.

    Distribution

    Nationwide Distribution -- CA, GA, IL, KS, MD, PA, OH, OK, UT and WA.

    Quantity

    28 boxes (10's)