BEUDAMED
    FDA Enforcement Class II Terminated

    Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.

    Recall: Z-1820-2015 · Reported July 1, 2015

    Enforcement

    Recall Number
    Z-1820-2015
    Event ID
    70675
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hill-Rom, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 1, 2015
    Initiation Date
    March 2, 2015
    Classification Date
    June 19, 2015
    Termination Date
    May 13, 2016
    Address
    1069 State Road 46 E, Batesville, IN, 47006-7520, United States

    Description

    Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.

    Reason

    The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece.

    Code Info

    Product #s: 157400; 257400; 157500; 257500

    Distribution

    Worldwide Distribution-US (nationwide) including the states of MI & PA, and the countries of Belgium, England, Italy, Czech Republic, Turkey, Greece, Ireland, Scotland, Spain, and Lebanon.

    Quantity

    66691 units