BEUDAMED
    FDA Enforcement Class II Terminated

    (1) VitreQ 20G BF Blunt Needles-Ref: BF20.D51 GTIN: 8719214221089 (2) VitreQ 20G BF Brush Needles-REF: BF20.D52 GTIN: 8719214221102

    Recall: Z-0848-2020 · Reported February 5, 2020

    Enforcement

    Recall Number
    Z-0848-2020
    Event ID
    84661
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vitreq Bv
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 5, 2020
    Initiation Date
    December 17, 2019
    Classification Date
    January 24, 2020
    Termination Date
    December 9, 2020
    Address
    Seggelant-Noord 2, N/A, Vierpolders, N/A, N/A, Netherlands

    Description

    (1) VitreQ 20G BF Blunt Needles-Ref: BF20.D51 GTIN: 8719214221089 (2) VitreQ 20G BF Brush Needles-REF: BF20.D52 GTIN: 8719214221102

    Reason

    Microscopic tears of the sterile pouch may compromise sterility

    Code Info

    All lots

    Distribution

    Nationwide

    Quantity

    N/A