BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1820-2015 · Initiated March 2, 2015

    Recall

    Recall Number
    Z-1820-2015
    Event Number
    70675
    Firm
    Hill-Rom, Inc.
    FEI Number
    1824206
    Product Code
    HMX
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    March 2, 2015
    Posted
    June 19, 2015
    Terminated
    May 13, 2016
    Address
    1069 State Road 46 E, Batesville, IN, 47006-7520

    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.

    Action

    Customers were notified via telephone and e-mail by 03/02/2015. The firm is requiring customers to complete a submitted response form and certificate of destruction for recalled devices by 03/31/2015. If recalled devices were further distributed the firm is asking customers to conduct a sub recall and forward notice of the recall. Public contact is Aspen Medical Europe Ltd, QA Department, Lynda McConaghy-QARA Manager, [email protected] , or +44 (0)1527 587716.

    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