BEUDAMED
    FDA Enforcement Class II Ongoing

    The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201.

    Recall: Z-2252-2021 · Reported August 18, 2021

    Enforcement

    Recall Number
    Z-2252-2021
    Event ID
    88162
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Dutch Ophthalmic USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 18, 2021
    Initiation Date
    May 21, 2019
    Classification Date
    August 12, 2021
    Address
    10 Continental Dr Bldg 1, N/A, Exeter, NH, 03833-7507, United States

    Description

    The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201.

    Reason

    Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line

    Code Info

    Lot Number: 2000401997 Unique Device Identifier (UDI) 08717872021294

    Distribution

    US Nationwide Distribution in the states of AL, CA, CO, FL, MI

    Quantity

    16 boxes