BEUDAMED
    FDA Enforcement Class II Terminated

    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc Port Access Kit 19G x 1 in, PowerLoc Port Access Kit 20G x 1 in, , , PowerLoc Port Access Kit 20G x 1.5in, PowerLoc Port Access Kit 20G x 0.75in, , , PowerLoc Port Access Kit 22G x 1 in, PowerLoc Port Access Kit 22G x 0.75in, , PowerLoc Port Access Kit 19G x 1 in with Y-Site, , , PowerLoc Port Access Kit 19G x 0.75in with Y-Site, PowerLoc Port Access Kit 20G x 1 in with Y-Site, PowerLoc Port Access Kit 20G x 0.75in with Y-Site The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.

    Recall: Z-1272-2015 · Reported March 25, 2015

    Enforcement

    Recall Number
    Z-1272-2015
    Event ID
    70430
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Access Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 25, 2015
    Initiation Date
    August 8, 2014
    Classification Date
    March 13, 2015
    Termination Date
    August 5, 2015
    Address
    605 N 5600 W, Salt Lake City, UT, 84116-3738, United States

    Description

    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc Port Access Kit 19G x 1 in, PowerLoc Port Access Kit 20G x 1 in, , , PowerLoc Port Access Kit 20G x 1.5in, PowerLoc Port Access Kit 20G x 0.75in, , , PowerLoc Port Access Kit 22G x 1 in, PowerLoc Port Access Kit 22G x 0.75in, , PowerLoc Port Access Kit 19G x 1 in with Y-Site, , , PowerLoc Port Access Kit 19G x 0.75in with Y-Site, PowerLoc Port Access Kit 20G x 1 in with Y-Site, PowerLoc Port Access Kit 20G x 0.75in with Y-Site The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.

    Reason

    Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), PowerGlide kits, Midline kits, and Convenience kits.

    Code Info

    Lot Numbers: REYE1714, REYE1713, REXD1617, REXE0089, REXE0077, REYE1233, REXE0085, REXE0971, REYE1709, REYE1579, REXD2157, REYE1269, REXD1932, REXE0826, REXE0086, REXD2155, REXD2156, REXE0697. Product codes: 2651910, 2652010, 2652015, 2652034, 2652210, 2652234, 2671910, 2671934, 2672010, 2672034.

    Distribution

    US Nationwide Distribution.

    Quantity

    16,410 units