BEUDAMED
    FDA Recall Terminated

    ARJO,Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden

    Recall: Z-0261-2008 · Initiated October 15, 2007

    Recall

    Recall Number
    Z-0261-2008
    Event Number
    45402
    Firm
    Arjo, Inc.
    FEI Number
    1419652
    Product Code
    FSA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 15, 2007
    Posted
    December 1, 2007
    Terminated
    July 27, 2009
    Address
    50 Gary Ave, Ste A, Roselle, IL, 60172-1684

    Description

    ARJO,Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden

    Reason

    Male patient genitals may be pinched between the seat and the frame of the patient lift chair when the Care Raiser seat is returned to its lowest position.

    Action

    Arjo sent Customer Field Correction Notification letters dated 10/15/07 to the end user accounts who received the affected chairs, advising them of the potential for the pinching of male patient genitals between moving parts of the care raiser function of the Carendo Hygiene Chair. They were instructed to review the enclosed revised Operating and Product Care Instructions manual, highlighting the warnings on pages 18 and 20; ensure all users receive refresher training in the chair's proper use and have access to the revised manual; and complete and return the enclosed customer response form, acknowledging the receipt and understanding of the letter. Any questions were directed to the Arjo Quality Department at 800-323-1245, ext. 6140 or 6165.

    Distribution

    Nationwide

    Quantity

    1,342 hygiene chairs