BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1684-2019 · Initiated April 1, 2019

    Recall

    Recall Number
    Z-1684-2019
    Event Number
    82552
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    BTR
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 1, 2019
    Terminated
    June 3, 2025
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437

    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.

    Action

    The firm initiated the recall by letter on 04/01/2019. The letter stated reason for the recall and requested the return of the recalled units. Distributors were directed to collect the recalled units from their customers, consolidate them, and complete and return the acknowledgement form. The recalled units will be returned.

    Distribution

    Nationwide

    Quantity

    4312 units