BEUDAMED
    FDA Enforcement Class II Ongoing

    3M Durapore Surgical Tape, Catalog Number 1538-118

    Recall: Z-1633-2024 · Reported May 1, 2024

    Enforcement

    Recall Number
    Z-1633-2024
    Event ID
    94259
    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 1, 2024
    Initiation Date
    March 20, 2024
    Classification Date
    April 24, 2024
    Address
    3m Center 2510 Conway Ave, Bldg 275-5w-06, Saint Paul, MN, 55144-0001, United States

    Description

    3M Durapore Surgical Tape, Catalog Number 1538-118

    Reason

    Select lots of the 3M Durapore Surgical Tape, Catalog Number 1538-118, were incorrectly labeled with a shelf life of 5 years, rather than 3 years.

    Code Info

    UDI/DI 50707387793208, Lot Codes: 33DER3, 33DTMA, 33DTPN, 33EDDE, 33ETFA, 33ETHX, 33FDHA, 33FDYN, 33FE9D, 33FEY6, 33FTLA, 33FW6E, 33FWPC, 33JE7T, 33JEFK, 33JENC, 33JYPX, 33JYW5, 33K3EJ, 33KPWT, 33KT6R, 33KT8F, 33LJWC, 33LK5M, 33LLEY, 33LLPT, 33LM6R, 33LMET, 33LMX3, 33N56W, 33N5K4, 33N5TC, 33NF36, 33NF6A, 33NY98, 33NYP9, 33P37P, 33PKLN, 33PL6J, 33PMFA, 33R35M, 33R3P6, 33RMNF, 33RNP4, 33TL39, 33TL8F, 33TLF4, 33TN55, 33WEA8, 33WEHJ, 33WERX, 33WF5P, 33WFD5

    Distribution

    Worldwide distribution - US Nationwide in the states of TX, NY, NH, AZ, NC, CA, IL, GA, VA, MD, FL, and the country of Canada.

    Quantity

    3,515,200 rolls