BEUDAMED
    FDA Enforcement Class II Ongoing

    3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape

    Recall: Z-0256-2023 · Reported November 30, 2022

    Enforcement

    Recall Number
    Z-0256-2023
    Event ID
    90989
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    3M Healthcare Business
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 30, 2022
    Initiation Date
    October 6, 2022
    Classification Date
    November 18, 2022
    Address
    2510 Conway Ave E, N/A, Saint Paul, MN, 55144-4147, United States

    Description

    3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape

    Reason

    During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.

    Code Info

    UDI/DI (01)50707387497410, Lot numbers: 33HT9W, 33HWN8, 33J5T9, 33JL66, 33JLLW, 33JMKR, 33JN4N, 33K7Y7, 33K888

    Distribution

    Worldwide distribution.

    Quantity

    104,000 units