BEUDAMED
    FDA Enforcement Class II Ongoing

    Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS #3 BLADE HANDLE (BH3PAS), Product Code I68290

    Recall: Z-1436-2024 · Reported April 10, 2024

    Enforcement

    Recall Number
    Z-1436-2024
    Event ID
    94136
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 10, 2024
    Initiation Date
    February 23, 2024
    Classification Date
    March 29, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS #3 BLADE HANDLE (BH3PAS), Product Code I68290

    Reason

    Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

    Code Info

    a) 66825, UDI/DI 60653160053588 (case) 00653160053586 (each), Lot Numbers: 2023091990, 2023111590; b) I68290 UDI/DI 00653160275056 (case) 10653160275053 (each), Lot Numbers: 2023100690

    Distribution

    Worldwide distribution - US Nationwide and the countries of Panama, Canada.

    Quantity

    3860 units