BEUDAMED
    FDA Enforcement Class II Terminated

    Acuject Variable Injection Needle

    Recall: Z-2089-2019 · Reported August 7, 2019

    Enforcement

    Recall Number
    Z-2089-2019
    Event ID
    83135
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Wilson-Cook Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 7, 2019
    Initiation Date
    June 14, 2019
    Classification Date
    July 27, 2019
    Termination Date
    April 2, 2021
    Address
    4900 Bethania Station Rd, N/A, Winston Salem, NC, 27105-1203, United States

    Description

    Acuject Variable Injection Needle

    Reason

    Potential for occluded injection needles.

    Code Info

    Lot Code W413079; Catalog Number VIN-25; Expiration Date 10/24/2021; UDI Number (01)00827002225268(17)211024(10)W4136079

    Distribution

    Distributed to China

    Quantity

    24