BEUDAMED
    FDA Enforcement Class I Ongoing

    SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

    Recall: Z-0531-2026 · Reported December 3, 2025

    Enforcement

    Recall Number
    Z-0531-2026
    Event ID
    97877
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Glycar SA Pty., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 3, 2025
    Initiation Date
    October 9, 2025
    Classification Date
    November 25, 2025
    Address
    1 Albert Road, box 967, Irene, N/A, N/A, South Africa

    Description

    SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

    Reason

    The impacted lot may not meet the required tensile strength specification.

    Code Info

    UDI/DI 05414734007276, Lot Numbers: T2502257, exp. 20280128; T2505144, exp. 2028.04.11

    Distribution

    US

    Quantity

    30 units