BEUDAMED
    FDA Recall Open, Classified

    Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)

    Recall: Z-1969-2023 · Initiated May 8, 2023

    Recall

    Recall Number
    Z-1969-2023
    Event Number
    92322
    Firm
    Galt Medical Corporation
    FEI Number
    3000718472
    Product Code
    DYB
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    May 8, 2023
    Posted
    June 15, 2023
    Address
    2220 Merritt Dr, Garland, TX, 75041-6137

    Description

    Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)

    Reason

    Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the use of a replacement device.

    Action

    On 5/5/23, recall notices were sent to customers who were asked to do the following: 1) Identify and segregate the affected lot(s) that are in your possession as well as those in the possession of your end-users. 2) Complete and return the field correction reply form to [email protected] 2) Return affected product to the recalling firm. Customers with questions can email: [email protected]

    Distribution

    Worldwide - US Nationwide distribution in the states of PA, UT, FL, PA, OH, GA, MA, NV, CA, NY, NJ and the countries of UK, AU, TR, FR, CH, NO.

    Quantity

    6036