BEUDAMED
    FDA Recall Terminated

    Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk

    Recall: Z-0400-2022 · Initiated October 28, 2021

    Recall

    Recall Number
    Z-0400-2022
    Event Number
    89046
    Firm
    Stradis Medical, LLC dba Stradis Healthcare
    FEI Number
    1000111025
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 28, 2021
    Terminated
    August 7, 2023
    Address
    3025 Northwoods Pkwy, Peachtree Corners, GA, 30071-1524

    Description

    Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk

    Reason

    This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile version of the same Intravascular Administration Set.

    Action

    Stradis Healthcare immediately contacted all 28 customers via email and/or phone between 10/28/21 and 10/29/21. The firm has requested the return of the units.

    Distribution

    NJ, MI, MA, NY, TX, CO, NC, CT, OR, OH

    Quantity

    620 tube sets