BEUDAMED
    FDA Enforcement Class II Ongoing

    Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.

    Recall: Z-2649-2023 · Reported October 11, 2023

    Enforcement

    Recall Number
    Z-2649-2023
    Event ID
    92883
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 11, 2023
    Initiation Date
    May 23, 2023
    Classification Date
    September 29, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.

    Reason

    The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size.

    Code Info

    Lot #2022032501, exp. 2026-12-31, UDI-DI - (01)10653160312956

    Distribution

    US Nationwide distribution.

    Quantity

    106 units