BEUDAMED
    FDA Enforcement Class II Terminated

    BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes.

    Recall: Z-1923-2013 · Reported August 14, 2013

    Enforcement

    Recall Number
    Z-1923-2013
    Event ID
    65322
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 14, 2013
    Initiation Date
    May 1, 2013
    Classification Date
    August 7, 2013
    Termination Date
    December 4, 2015
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes.

    Reason

    BD Vacutainer Multiple Sample and Direct Draw Luer Adapter may have blood leakage and low draw volume.

    Code Info

    Marketing Status: Class II, 510K # K991088 Device Listing Number: D030347 Catalog number 367290, 367300 (CE), 368491, and 303380.

    Distribution

    Nationwide Distribution

    Quantity

    37,906,400 units