BEUDAMED
    FDA Recall Open, Classified

    Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) STERILE UTERINE DILATOR 1MM/2MM, Product Code HUD12ST; c) HEGAR UTERINE DILATOR, 5-6MM, STERILE, Product Code HUD56ST; d) HEGAR UTERINE DILATOR, 9-10MM, STERILE, Product Code HUD910ST; e) HANK UTERINE DILATOR 11" 7/8FR STERILE, Product Code I68920; f) HANK UTERINE DILATOR 11" 13/14FR STERILE, Product Code I68930

    Recall: Z-1450-2024 · Initiated February 23, 2024

    Recall

    Recall Number
    Z-1450-2024
    Event Number
    94136
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    HDQ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 23, 2024
    Posted
    March 29, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) STERILE UTERINE DILATOR 1MM/2MM, Product Code HUD12ST; c) HEGAR UTERINE DILATOR, 5-6MM, STERILE, Product Code HUD56ST; d) HEGAR UTERINE DILATOR, 9-10MM, STERILE, Product Code HUD910ST; e) HANK UTERINE DILATOR 11" 7/8FR STERILE, Product Code I68920; f) HANK UTERINE DILATOR 11" 13/14FR STERILE, Product Code I68930

    Reason

    Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

    Action

    Medline Industries, LP, issued a Medical Device Recall notice to its consignees on 02/27/2024 via email and USPS First Class mail. The notice explained the problem with the devices, risk, and requested that the products be destroyed at the consignee. Distributors were directed to notify their customers.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Panama, Canada.

    Quantity

    270 units