BEUDAMED
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    SJM PERICARDIAL PATCH WITH ENCAP AC TECHNOLOGY

    FDA Adverse Event
    Injury ·GLYCAR S.A. (PTY.) LTD.·Product code DXZ·August 31, 2016

    Glycar SA Pty Ltd

    Manufacturer
    🇿🇦 South Africa

    GLYCAR SA PTY., LTD.

    FDA registration
    GLYCAR SA PTY., LTD.·1 product·🇿🇦 South Africa

    MDSS GmbH

    Authorized representative
    🇩🇪 Germany·388 Manufacturers·16562 Devices

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

    FDA Recall
    Open, Classified ·Glycar SA Pty., Ltd.·Product code DXZ·October 9, 2025

    SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

    FDA Recall
    Open, Classified ·Glycar SA Pty., Ltd.·Product code DXZ·October 9, 2025

    SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

    FDA Enforcement
    Class I ·Ongoing·Glycar SA Pty., Ltd.·December 3, 2025

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

    FDA Enforcement
    Class I ·Ongoing·Glycar SA Pty., Ltd.·December 3, 2025