BEUDAMED
    FDA Recall Open, Classified

    PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter

    Recall: Z-2466-2023 · Initiated July 18, 2023

    Recall

    Recall Number
    Z-2466-2023
    Event Number
    92614
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    CAH
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    July 18, 2023
    Posted
    August 28, 2023
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter

    Reason

    Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product

    Action

    Smiths Medical issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 07/18/2023 by U.S. Mail. The notice explained the problem, potential risk, and requested the consignees perform the following actions: 1. Discontinue use and distribution of affected product; quarantine all product 2. Inform all users within your facility 3. If the product was further distributed, please indicate the contact information for the new owner of the product on the response form. Smiths Medical is seeking the return of the affected product.

    Distribution

    US Nationwide distribution.

    Quantity

    66,633 units