BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0400-2022 · Reported December 29, 2021

    Enforcement

    Recall Number
    Z-0400-2022
    Event ID
    89046
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stradis Medical, LLC dba Stradis Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 29, 2021
    Initiation Date
    October 28, 2021
    Classification Date
    December 20, 2021
    Termination Date
    August 7, 2023
    Address
    3025 Northwoods Pkwy, N/A, Peachtree Corners, GA, 30071-1524, United States

    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.

    Code Info

    Lot code 20519-2103

    Distribution

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

    Quantity

    620 tube sets