BEUDAMED
    FDA Enforcement Class II Ongoing

    3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; and 3M Tube Securement Device, Large, 2.2 IN/PO x 3.5 IN/PO, REF 1501U, Sterile. Product is packaged 1 device per pouch, 25 pouches per primary carton, and 4 primary cartons per shipper box.

    Recall: Z-1475-2024 · Reported April 10, 2024

    Enforcement

    Recall Number
    Z-1475-2024
    Event ID
    94039
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    3M Company - Health Care Business
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 10, 2024
    Initiation Date
    February 20, 2024
    Classification Date
    April 3, 2024
    Address
    3m Center 2510 Conway Ave, Bldg 275-5w-06, Saint Paul, MN, 55144-0001, United States

    Description

    3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; and 3M Tube Securement Device, Large, 2.2 IN/PO x 3.5 IN/PO, REF 1501U, Sterile. Product is packaged 1 device per pouch, 25 pouches per primary carton, and 4 primary cartons per shipper box.

    Reason

    Manufacturing nonconformities are in some lots of the Tube Securement Device, such as the top film layer may be partially or completely missing and some devices may exhibit the appearance of an incorrect shape due to excess material not being removed from the product liner.

    Code Info

    REF 1500U, SKU 70-2011-8908-4, UDI-DI 30707387792405, Lot numbers: 33TNNN: Exp. 2025-11-09; 33TNMH: Exp. 2025-11-08; 33KNWC: Exp. 2024-06-02; 33KNJD: Exp. 2024-06-01; 33KND8: Exp. 2024-05-31. REF 1501U, SKU 70-2011-8924-1, UDI-DI 30707387792399, Lot numbers: 33TNH3: Exp. 2025-11-08; 33TNDC: Exp. 2025-11-07; 33KTDY: Exp. 2024-06-11; 33KWM3: Exp. 2024-06-15; 33KTWT: Exp. 2024-06-13; 33KWHE: Exp. 2024-06-14; 33KTLA: Exp. 2024-06-12; 33KTFP: Exp. 2024-06-11; 33KT9M: Exp. 2024-06-10; 33KP6M: Exp. 2024-06-03.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KS, MD, MN, NC, NH, NY, OH, PA, TX, VA, and WA, including PR. The countries of Australia, Austria, Canada, China, Finland, Germany, Ireland, New Zealand, Norway, Poland, Sweden, and the United Kingdom.

    Quantity

    265,435 eaches