BEUDAMED
    FDA Enforcement Class II Terminated

    AVID Medical QA Pack AV10654-10

    Recall: Z-0581-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0581-2018
    Event ID
    79135
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Avid Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 21, 2018
    Initiation Date
    July 3, 2017
    Classification Date
    February 9, 2018
    Termination Date
    April 17, 2018
    Address
    9000 Westmont Dr, Toano, VA, 23168-9351, United States

    Description

    AVID Medical QA Pack AV10654-10

    Reason

    The swab stick collection device provided in a convenience kit expires prior to the kit expiration date.

    Code Info

    Avid Medical Kit Lot 1235229 (expiration date 2017-08-01); Swab Stick lots: 5M03A (expiration date 2017-06-03) and 6A21A (expiration date 2017-07-21)

    Distribution

    Seventeen sites located in 13 states: FL, IN, KS, KY, MA, OK, NC, NE, NY, OH, PA, VA, and TX.

    Quantity

    330