BEUDAMED
    FDA Enforcement Class II Ongoing

    3M Attest Steam Chemical Integrators, REF 1243A

    Recall: Z-1609-2023 · Reported May 24, 2023

    Enforcement

    Recall Number
    Z-1609-2023
    Event ID
    92041
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    3M Company - Health Care Business
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 24, 2023
    Initiation Date
    April 6, 2023
    Classification Date
    May 18, 2023
    Address
    3m Center 2510 Conway Ave, Bldg 275-5w-06, Saint Paul, MN, 55144-0001, United States

    Description

    3M Attest Steam Chemical Integrators, REF 1243A

    Reason

    3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle.

    Code Info

    UDI/DI: Pouch: 30707387785735, (Shipper: 50707387785739), Lot Numbers: EP112025, EX112025, FE112025, EE122025, EM122025, EV122025, FD122025, EC012026, EM012026, ET012026

    Distribution

    Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Austria, Australia, Bolivia, Brazil, Canada, Colombia, Czech Republic, Ecuador, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, New Zealand, Poland, Saudi Arabia, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, and Vietnam.

    Quantity

    16,229,000 units