BEUDAMED
    FDA Enforcement Class II Ongoing

    Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460

    Recall: Z-2241-2023 · Reported August 2, 2023

    Enforcement

    Recall Number
    Z-2241-2023
    Event ID
    92213
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Davol, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 2, 2023
    Initiation Date
    April 25, 2023
    Classification Date
    July 27, 2023
    Address
    100 Crossings Blvd, N/A, Warwick, RI, 02886-2850, United States

    Description

    Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460

    Reason

    Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection

    Code Info

    UDI-DI: (01)00801741031724(17)240428(10) Lot Numbers: HUGS0481 HUGS0549 HUGS1019 HUGS2031 HUGS2079 HUGT1627 HUGS2025 HUGT1989

    Distribution

    Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic, France, Germany, Ireland, Italy, Netherlands, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK, India, Hong Kong, Greece, Chile, and Colombia.

    Quantity

    1188 units US; 5 units OUS