BEUDAMED
    FDA Enforcement Class II Terminated

    BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.

    Recall: Z-1317-2015 · Reported April 1, 2015

    Enforcement

    Recall Number
    Z-1317-2015
    Event ID
    70593
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 1, 2015
    Initiation Date
    February 19, 2015
    Classification Date
    March 25, 2015
    Termination Date
    May 25, 2017
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.

    Reason

    Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum.

    Code Info

    Lot #'s 4128925 and 4128926

    Distribution

    Distributed to the states of CA, CT, FL, IL, MA, ND, NY, OH and PA.

    Quantity

    315,800 units