BEUDAMED
    FDA Enforcement Class II Terminated

    PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. The PowerLoc MAX SWIS is also indicated for power injection of contrast media into the central venous system only with an implanted port that is also indicated for power injection.

    Recall: Z-1560-2015 · Reported May 6, 2015

    Enforcement

    Recall Number
    Z-1560-2015
    Event ID
    70834
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Access Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2015
    Initiation Date
    March 13, 2015
    Classification Date
    April 30, 2015
    Termination Date
    June 24, 2015
    Address
    605 North 5600 West, Salt Lake City, UT, 84116-3738, United States

    Description

    PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. The PowerLoc MAX SWIS is also indicated for power injection of contrast media into the central venous system only with an implanted port that is also indicated for power injection.

    Reason

    Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum Flow rate label associated to the power injection IFU for the PowerLoc MAX Safety Infusion Set (SWIS) was attached to the outside of the unit pouch.

    Code Info

    Lot D430107

    Distribution

    US Distribution to states of: GA and MN.

    Quantity

    700 units