BEUDAMED
    FDA Enforcement Class II Terminated

    Convenience Kits, MOHS "OPENING" PROCEDURE TRAY

    Recall: Z-2589-2016 · Reported August 24, 2016

    Enforcement

    Recall Number
    Z-2589-2016
    Event ID
    73465
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Avid Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 24, 2016
    Initiation Date
    October 5, 2015
    Classification Date
    August 18, 2016
    Termination Date
    January 10, 2017
    Address
    9000 Westmont Dr, N/A, Toano, VA, 23168-9351, United States

    Description

    Convenience Kits, MOHS "OPENING" PROCEDURE TRAY

    Reason

    Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 em) was included in a limited number of convenience kits (custom procedure trays) that were not labeled as containing latex.

    Code Info

    Catalog No. MCVA0089-04 , LOT# 1010997

    Distribution

    Recalled product was distributed to 2 states: Virginia and Massachusetts.

    Quantity

    240