BEUDAMED
    FDA Enforcement Class II Terminated

    Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 ENDOCUFF-V S PURPLE PK8, Part Number: E0420502; ARV140 ENDOCUFF-V XL ORANGE PK8 ARV110, Part Number: E0420503 Intended to be attached to the distal end of the endoscope to facilitate endoscopic therapy

    Recall: Z-2423-2021 · Reported September 15, 2021

    Enforcement

    Recall Number
    Z-2423-2021
    Event ID
    88235
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 15, 2021
    Initiation Date
    August 3, 2021
    Classification Date
    September 3, 2021
    Termination Date
    January 10, 2023
    Address
    3500 Corporate Pkwy, PO Box 610, Center Valley, PA, 18034-0610, United States

    Description

    Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 ENDOCUFF-V S PURPLE PK8, Part Number: E0420502; ARV140 ENDOCUFF-V XL ORANGE PK8 ARV110, Part Number: E0420503 Intended to be attached to the distal end of the endoscope to facilitate endoscopic therapy

    Reason

    Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection.

    Code Info

    Lot numbers: 60780 62151 64141 65464 66365 60862 62405 64263 65465 66367 60865 62407 64265 65466 66634 60867 62469 64268 65489 66636 60869 62471 64533 65490 66638 61168 62473 64535 65491 66640 61171 62781 64537 65496 66910 61176 62783 64674 65497 66912 61285 62787 64676 65498 66914 61578 63035 64678 65499 67021 61580 63037 64738 65521 67023 61582 63039 64831 65523 67025 61662 63310 64844 65525 69148 61664 63314 65173 65527 69150 62007 63316 65340 66017 69260 62009 63582 65342 66019 69554 62011 63584 65344 66021 69556 62013 63586 65390 66023 69774 62146 64132 65391 66361 69776 62149 64134 65392 66363

    Distribution

    Nationwide

    Quantity

    711,157 units units