BEUDAMED
    FDA Recall Open, Classified

    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

    Recall: Z-1289-2025 · Initiated February 13, 2025

    Recall

    Recall Number
    Z-1289-2025
    Event Number
    96263
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    3012307300
    Product Code
    BTR
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    February 13, 2025
    Posted
    March 12, 2025
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

    Reason

    Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.

    Action

    On February 13, 2025, the firm began to notify affected consignees via Urgent Medical Device Correction letters. Customers were informed that affected sizes of endotracheal tube products may have a smaller diameter than expected. Customers were instructed to check all inventory locations for affected products and discontinue use. Affected product should be destroyed following your institution's process for destruction. Product should be quarantined until disposal. All potential users of the device should be informed. If you have distributed affected product, please immediately forward the recall notice to your customers.

    Distribution

    Worldwide - US Nationwide distribution.