BEUDAMED
    FDA Enforcement Class II Terminated

    RUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm 8,0

    Recall: Z-1686-2019 · Reported June 5, 2019

    Enforcement

    Recall Number
    Z-1686-2019
    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. : 102004-000080, REF 102004, SIZE I.D. mm 8,0

    Reason

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

    Code Info

    Lot Numbers: 14151, 14161, 14201, 14281, 14301, 14321, 14431, 14491, 14511, 15041, 15371, 15441, 16071, 16131, 16191, 16221, 16241, 16271, 16311, 16371, 16391, 16441, 16451, 16481, 16491, 17091, 17121, 17181, 17211, 17241, 17281, 17351, 17381, 17451, 17471, 17491, 18181, 18301, 18411

    Distribution

    Nationwide

    Quantity

    2325 units