BEUDAMED
    FDA Recall Open, Classified

    DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elbow for use with breathing circuits

    Recall: Z-1581-2023 · Initiated April 5, 2023

    Recall

    Recall Number
    Z-1581-2023
    Event Number
    91975
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    BZA
    Status
    Open, Classified
    Root Cause
    Labeling False and Misleading
    Initiated
    April 5, 2023
    Posted
    May 12, 2023
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elbow for use with breathing circuits

    Reason

    DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.

    Action

    Smiths Medical issued an URGENT MEDICAL DEVICE RECALL notice on 04/05/2023 by mail (traceable method). The notice explained the issue, potential risk, and request the following actions be taken: "Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. If you have expired product, do not use. 2) Inform potential users of the product in your organization of this notification and complete the attached response form. Return the completed response form to the fax number or e-mail address on the form, even if you do not have the affected product. 3) Return affected product using the return label provided with this letter. Contact Sedgwick at 1-844-861-6220 (MF, 8am-5pm ET) if you have not received a return label or require additional labels for returning the affected product." "If you have distributed the product further, immediately notify your accounts that received the product identified in the Affected Product / Table 1 sections of this notification and ask them to contact Sedgwick at 1-844-861-6220 (M-F, 8am-5pm ET) to obtain a response form."

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, New Zealand, and Hong Kong.

    Quantity

    2101 units