BEUDAMED
    FDA Enforcement Class II Terminated

    CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17) 210930(10)0001304986

    Recall: Z-1795-2020 · Reported May 6, 2020

    Enforcement

    Recall Number
    Z-1795-2020
    Event ID
    85380
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2020
    Initiation Date
    March 26, 2020
    Classification Date
    April 24, 2020
    Termination Date
    August 21, 2020
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17) 210930(10)0001304986

    Reason

    The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle.

    Code Info

    Lot Number: 0001304986

    Distribution

    Domestic distribution to the following states: Alabama, Colorado, Illinois, Massachusetts, Missouri, Oklahoma, Rhode Island, Virginia, and Wisconsin.

    Quantity

    900