BEUDAMED
    FDA Enforcement Class II Terminated

    BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608

    Recall: Z-0252-2020 · Reported November 6, 2019

    Enforcement

    Recall Number
    Z-0252-2020
    Event ID
    82351
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2019
    Initiation Date
    March 7, 2019
    Classification Date
    October 31, 2019
    Termination Date
    February 11, 2022
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608

    Reason

    BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle end of the product, causing blood leakage.

    Code Info

    Lot 8207894 ***UPDATED 7/11/19*** Lots 9025826 and 8354527 ***UPDATED 12/10/19*** Lot 9010765

    Distribution

    Distributed to accounts in AR, CT, FL, IL, IN, MI, MO, MS, NY, OH, TN, TX, and VA. Foreign distribution to Canada, Brazil, India, Mexico, Singapore, and Taiwan.

    Quantity

    2,624,160 (2,169,703 US; 454,457 OUS)