BEUDAMED
    FDA Enforcement Class II Terminated

    RUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm 7,0

    Recall: Z-1685-2019 · Reported June 5, 2019

    Enforcement

    Recall Number
    Z-1685-2019
    Event ID
    82552
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 5, 2019
    Initiation Date
    April 1, 2019
    Classification Date
    May 29, 2019
    Termination Date
    June 3, 2025
    Address
    3015 Carrington Mill Blvd, N/A, Morrisville, NC, 27560-5437, United States

    Description

    RUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm 7,0

    Reason

    The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.

    Code Info

    Lot Numbers: 14161, 14171, 14201, 14211, 14231, 14261, 14301, 14311, 14361, 14431, 14481, 14491, 15041, 15051, 15081, 15091, 15121, 15131, 15161, 15171, 15201, 15221, 15241, 15261, 15371, 15411, 15421, 15501, 16031, 16071, 16111, 16151, 16161, 16181, 16201, 16221, 16241, 16251, 16271, 16281, 16291, 16301, 16351, 16361, 16371, 16381, 16391, 16401, 16421, 16441, 16461, 16471, 16481, 17061, 17071, 17161, 17191, 17211, 17221, 17251, 17271, 17291, 17301, 17311, 17381, 17391, 17411, 17471, 17481, 17511, 18021, 18081, 18091, 18151, 18161, 18211, 18241, 18291, 18381, 18411, 18421, 18431, 18441

    Distribution

    Nationwide

    Quantity

    4312 units