BEUDAMED
    FDA Recall Terminated

    Mahurkar QPlus Dual Lumen Catheter Kit with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion. Reference: 8888-135192

    Recall: Z-0233-04 · Initiated December 2, 2003

    Recall

    Recall Number
    Z-0233-04
    Event Number
    27842
    Firm
    Kendall Healthcare Products Co
    FEI Number
    1282497
    Product Code
    MPB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 2, 2003
    Posted
    December 17, 2003
    Terminated
    May 15, 2012
    Address
    15 Hampshire St, Mansfield, MA, 02048-1113

    Description

    Mahurkar QPlus Dual Lumen Catheter Kit with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion. Reference: 8888-135192

    Reason

    Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5Fr x 16.0 cm

    Action

    Kendall''s recall letters requesting product return will be hand delivered to customers by Kendall sales representatives on December 1, 2003.

    Distribution

    IL, MA, OH, TN, TX, VA

    Quantity

    45 units