BEUDAMED
    FDA Recall 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 · Initiated March 26, 2020

    Recall

    Recall Number
    Z-1795-2020
    Event Number
    85380
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    GCB
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    March 26, 2020
    Terminated
    August 21, 2020
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    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.

    Action

    On March 26, 2020, an Urgent Medical Device Recall Notification was sent to consignees stating that Lot #0001304986 of the Safe-T-Centesis 8 Fr Catheter Drainage Trays shipped between June 27, 2019 and September 6, 2019 should be discarded. In addition, they were instructed to complete the Customer Response form regardless of whether or not they have any of the product. Customers with discarded product were instructed to indicate the number of affected products that were discarded on the response form and replacements would be issued to those customers.

    Distribution

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

    Quantity

    900