BEUDAMED
    FDA Enforcement Class II Terminated

    Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06

    Recall: Z-2091-2021 · Reported July 28, 2021

    Enforcement

    Recall Number
    Z-2091-2021
    Event ID
    88153
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Dutch Ophthalmic USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    July 28, 2021
    Initiation Date
    February 25, 2021
    Classification Date
    July 19, 2021
    Termination Date
    November 5, 2021
    Address
    10 Continental Dr Bldg 1, N/A, Exeter, NH, 03833-7507, United States

    Description

    Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06

    Reason

    Mislabeled: 1281.B1D Disposable Replacement Backflush Brush Needles label states (20 gauge/0.9 mm) instead of the correct size of 23 gauge/0.6 mm and the correct product code 1281.B1D06

    Code Info

    Lot Number(s) 3420011396 Unique Device Identifier (UDI) 08717872003757

    Distribution

    Distribution in US states of IL, IN, MO, PA.

    Quantity

    12 US