BEUDAMED
    FDA Enforcement Class II Terminated

    UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. Used to cover the opening to the biopsy/suction channel of an endoscope.

    Recall: Z-0861-2015 · Reported December 31, 2014

    Enforcement

    Recall Number
    Z-0861-2015
    Event ID
    69809
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    US Endoscopy Group Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 31, 2014
    Initiation Date
    October 31, 2014
    Classification Date
    December 23, 2014
    Termination Date
    June 1, 2015
    Address
    5976 Heisley Rd, Mentor, OH, 44060-1873, United States

    Description

    UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. Used to cover the opening to the biopsy/suction channel of an endoscope.

    Reason

    Packaging non-conformance related to the integrity of the sterile pouch seal.

    Code Info

    Lot 1417696

    Distribution

    Distributed to the states of FL, MO, OH and WI.

    Quantity

    100 units