BEUDAMED
    FDA Enforcement Class II Terminated

    PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube

    Recall: Z-0411-2013 · Reported November 28, 2012

    Enforcement

    Recall Number
    Z-0411-2013
    Event ID
    63629
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Gyrus Acmi, Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 28, 2012
    Initiation Date
    October 17, 2012
    Classification Date
    November 20, 2012
    Termination Date
    April 9, 2013
    Address
    136 Turnpike Road, N/A, Southborough, MA, 01772-2118, United States

    Description

    PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube

    Reason

    One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer.

    Code Info

    JC470075

    Distribution

    Worldwide distribution: USA state of Kansas and country of Korea.

    Quantity

    10 boxes/60 units