BEUDAMED
    FDA Recall Terminated

    Flexible Support Arm Assembly. Breathing Tube Support. Catalog number BE 122-30

    Recall: Z-0427-06 · Initiated October 14, 2005

    Recall

    Recall Number
    Z-0427-06
    Event Number
    33923
    Firm
    Instrumentation Industries Inc
    FEI Number
    2518436
    Product Code
    JAY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 14, 2005
    Posted
    January 24, 2006
    Terminated
    May 9, 2006
    Address
    2990 Industrial Blvd, Bethel Park, PA, 15102-2536

    Description

    Flexible Support Arm Assembly. Breathing Tube Support. Catalog number BE 122-30

    Reason

    potential for the flexible tube portion of the assembly to become brittle and break

    Action

    All customers (and/or end-users) were notified on October 14 and 17, 2005 by telephone. Formal notification letters were sent (certified) to each customer (and/or end-user) on October 17 and 18, 2005.

    Distribution

    The products were shipped to medical facilities in FL, NY, and WV.

    Quantity

    22 units