BEUDAMED
    FDA Enforcement Class II Terminated

    Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.

    Recall: Z-2181-2014 · Reported August 20, 2014

    Enforcement

    Recall Number
    Z-2181-2014
    Event ID
    68803
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beevers Manufacturing & Supply, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 20, 2014
    Initiation Date
    July 11, 2014
    Classification Date
    August 10, 2014
    Termination Date
    July 17, 2015
    Address
    850 SW Booth Bend Rd, N/A, McMinnville, OR, 97128-9320, United States

    Description

    Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.

    Reason

    Beevers Manufacturing & Supply Inc. is recalling Luma Wrap neonatal phototherapy blankets because the product was inadvertently misclassified and marketed without a cleared 510(k) submission from the US FDA.

    Code Info

    Recalled units include: LW102 (medium), Lot 66812; LW103 (large), Lots 66813 and 30660; and LW105 (extra large), Lot 67879. LumaWrap models with an adhesive strip (LW102 and LW103) have a 2-year shelf life.

    Distribution

    Product was distributed to US, Germany, Austria, France, Italy, Spain, Australia.

    Quantity

    240 total (112/ lot 66812; 92/ lot 66813; 17/ lot 30660; and 19/ lot 67879).