BEUDAMED
    FDA Enforcement Class II Terminated

    AVID TruCustom GYN LAPAROSCOPY convenience kits, Item Code: LGHM013-06 and LGHM013-07

    Recall: Z-0790-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0790-2018
    Event ID
    79162
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Avid Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 7, 2018
    Initiation Date
    June 22, 2017
    Classification Date
    February 28, 2018
    Termination Date
    October 12, 2018
    Address
    9000 Westmont Dr, N/A, Toano, VA, 23168-9351, United States

    Description

    AVID TruCustom GYN LAPAROSCOPY convenience kits, Item Code: LGHM013-06 and LGHM013-07

    Reason

    Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

    Code Info

    Lot, Expiration Date: 1191787, 7/1/2018; 1216674, 9/1/2019

    Distribution

    Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

    Quantity

    160