BEUDAMED
    FDA Enforcement Class II Terminated

    BC Hammock Mesh Sling (Small), product number, 537010. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.

    Recall: Z-1554-2013 · Reported June 26, 2013

    Enforcement

    Recall Number
    Z-1554-2013
    Event ID
    65263
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Prism Medical Services USA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 26, 2013
    Initiation Date
    May 23, 2013
    Classification Date
    June 18, 2013
    Termination Date
    November 25, 2013
    Address
    45 Progress Pkwy, Maryland Heights, MO, 63043-3701, United States

    Description

    BC Hammock Mesh Sling (Small), product number, 537010. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.

    Reason

    The product does not meet the firm's size standards, the product was produced in the incorrect size.

    Code Info

    Lot: PHM000053, PHM000648, PHM000732, PHM000733 and PHM000734.

    Distribution

    Worldwide distribution: USA (nationwide) including states of: CA, IL, OH, and TX. and country of: Canada.

    Quantity

    5 slings