BEUDAMED
    FDA Enforcement Class II Terminated

    BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)

    Recall: Z-0500-2020 · Reported November 27, 2019

    Enforcement

    Recall Number
    Z-0500-2020
    Event ID
    84113
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 27, 2019
    Initiation Date
    October 14, 2019
    Classification Date
    November 20, 2019
    Termination Date
    October 16, 2020
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)

    Reason

    Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes.

    Code Info

    Lot Number: 9175971 UDI: 50382903065757

    Distribution

    Distribution US Nationwide and Canada

    Quantity

    967,680