BEUDAMED
    FDA Enforcement Class II Terminated

    RUSCH LASERTUBE (Rubber), Order No. : 102004-000060, REF 102004, SIZE I.D. mm 6,0

    Recall: Z-1684-2019 · Reported June 5, 2019

    Enforcement

    Recall Number
    Z-1684-2019
    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. : 102004-000060, REF 102004, SIZE I.D. mm 6,0

    Reason

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

    Code Info

    Lot Numbers: 15411, 15421, 15431, 15441, 15451, 15461, 15471, 15501, 16031, 16061, 16081, 16091, 16101, 16131, 16151, 16161, 16171, 16181, 16191, 16201, 16221, 16231, 16241, 16251, 16261, 16281, 16291, 16301, 16311, 16351, 16361, 16371, 16381, 16391, 16421, 16431, 16441, 16451, 16461, 16471, 16481, 16501, 17021, 17031, 17041, 17051, 17061, 17081, 17091, 17101, 17111, 17121, 17131, 17161, 17171, 17181, 17191, 17201, 17221, 17231, 17251, 17261, 17271, 17281, 17291, 17301, 17361, 17381, 17411, 17421, 17431, 17441, 17451, 17461, 17471, 17481, 17491, 17501, 18021, 18031, 18041, 18051, 18061, 18071, 18091, 18101, 18111, 18121, 18131, 18141, 18151, 18161, 18171, 18201, 18221, 18231, 18241, 18251, 18281, 18301, 18311, 18381, 18401, 18411, 18421, 18431, 18441

    Distribution

    Nationwide

    Quantity

    4312 units