BEUDAMED
    FDA Enforcement Class II Terminated

    RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0

    Recall: Z-1682-2019 · Reported June 5, 2019

    Enforcement

    Recall Number
    Z-1682-2019
    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. : 102004-000040, REF 102004, SIZE I.D. mm 4,0

    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, 14171, 14211, 14231, 14271, 14281, 14321, 14441, 14461, 14501, 14511, 15031, 15051, 15091, 15101, 15251, 15271, 15411, 16051, 16071, 16101, 16161, 16171, 16201, 16231, 16271, 16291, 16301, 16311, 16361, 16381, 16401, 16421, 16431, 16451, 16481, 16501, 16511, 17021, 17031, 17051, 17071, 17091, 17111, 17121, 17161, 17181, 17191, 17201, 17251, 17261, 17271, 17281, 17351, 17371, 17461, 18021, 18031, 18061, 18101, 18121, 18161, 18201, 18351, 18361, 18401

    Distribution

    Nationwide

    Quantity

    1787 units