BEUDAMED
    FDA Recall 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 · Initiated July 11, 2014

    Recall

    Recall Number
    Z-2181-2014
    Event Number
    68803
    Firm
    Beevers Manufacturing & Supply, Inc.
    FEI Number
    3023468
    Product Code
    PDH
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    July 11, 2014
    Posted
    August 10, 2014
    Terminated
    July 17, 2015
    Address
    850 SW Booth Bend Rd, McMinnville, OR, 97128-9320

    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.

    Action

    BMS is contacting their customers and requesting that distributors report the amount of affected product they have in stock, prior to returning affected product. BMS is also asking its distributors to forward the recall notification to its customers to whom affected product was sold. BMS expects those customers to also report to BMS the amount of affected product they have.

    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).