BEUDAMED
    FDA Enforcement Class II Ongoing

    SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961

    Recall: Z-2406-2024 · Reported July 24, 2024

    Enforcement

    Recall Number
    Z-2406-2024
    Event ID
    94831
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ethicon Sarl, a Johnson & Johnson Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 24, 2024
    Initiation Date
    June 11, 2024
    Classification Date
    July 17, 2024
    Address
    rue du Puits-Godet 20, Neuchatel, N/A, Switzerland

    Description

    SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961

    Reason

    Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.

    Code Info

    Product Number: 1961; UDI/DI: 10705031003118 (primary), 20705031003115 (box of 10); Lot numbers: TFB9151, TEB6531, TFB8781, TEB6861, TEB6511, SKE2201, SKE2101, TDB5981, SLE4411, TEB7821, TGB9291, SBB2291, TEB6411, TEB7071, TBB2481, TBB2491, TCB4081, TCB3751, TCB3781, TEB7211, TEB6871, TEB7601, TEB6521, TCB3351, SJE0361, TCB4071, TCB4481, TCB2931, TFB8381, TGB9801, TBB1511, SJE0241, SDB5001, RPE3591, RPE3181, RME2541, TBB1661, TCB4061, TCB4471, TCB4051, SKE2111, SKE1811, SKE1791, SJB9871, SJE0231, SHB9841, TJE1191, TDB5991, TGB9301, TDB5611, TDB5621, TFB8361, SKE1781, SKE1801, TFB8001, TFB8371, TJE1201, TCB3341, TDB5631, TDB5151, TDB6001;

    Distribution

    Worldwide distribution - US Nationwide and the countries of India and Japan.

    Quantity

    450,793 units (65,950 US, 384,843 OUS)