BEUDAMED
    FDA Enforcement Class II Ongoing

    BD 23 G x .75 in. BD Vacutainer¿ Push Button Blood Collection Set with 12 in. Tubing Catalog # 367342 Intended for venipuncture to obtain blood specimens from patients.

    Recall: Z-0745-2017 · Reported December 21, 2016

    Enforcement

    Recall Number
    Z-0745-2017
    Event ID
    75252
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2016
    Initiation Date
    August 8, 2016
    Classification Date
    December 12, 2016
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD 23 G x .75 in. BD Vacutainer¿ Push Button Blood Collection Set with 12 in. Tubing Catalog # 367342 Intended for venipuncture to obtain blood specimens from patients.

    Reason

    BD has received multiple reports of units associated with the 23 G x .75 in. BD Vacutainer¿ Push Button Blood Collection Set with 12 in. Tubing whose lots are exhibiting separation of front and rear barrels upon activation of the safety feature, which retracts the needle.

    Code Info

    5355531 5355533 5356681 5356682 6006629 6006630 6006631 6006633 6006634 6006650

    Distribution

    Worldwide distribution- US (nationwide) and countries of: Canada, Belgium, Brazil.

    Quantity

    1,788,150 units