BEUDAMED
    FDA Recall Terminated

    Hill-Rom Century+ Bed Model P1400 HBSW siderail upgrade kits; accessory model numbers P9964-11, P9964-12, P9964-13, P-9964-14, P9964-15, P9964-16, P9964-41 and/or P9964-42.

    Recall: Z-1777-2008 · Initiated April 28, 2008

    Recall

    Recall Number
    Z-1777-2008
    Event Number
    47819
    Firm
    Hill-Rom, Inc.
    FEI Number
    1824206
    Product Code
    FNL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 28, 2008
    Posted
    August 27, 2008
    Terminated
    September 22, 2009
    Address
    125 E Pearl St, Batesville, IN, 47006

    Description

    Hill-Rom Century+ Bed Model P1400 HBSW siderail upgrade kits; accessory model numbers P9964-11, P9964-12, P9964-13, P-9964-14, P9964-15, P9964-16, P9964-41 and/or P9964-42.

    Reason

    A risk of entrapment will exist between the head and foot rails if installation instructions are followed.

    Action

    Hill-Rom issued an Urgent Medical Device Correction letter on 4/28/2008 notifying consignees that they will be visited by a qualified Hill-Rom service technician or designee and provide a revised copy of the instruction sheet. The technician will either assist the facility to ensure proper installation or verify by signature that the facility understands the issue and will verify their beds had the upgrade kits installed in such a way that an entrapment gap does not exist.

    Distribution

    Class II Recall - Nationwide Distribution --- including states of Florida, Illinois, New Mexico, Texas and Virginia.

    Quantity

    69