Recall of Device Recall Luma Wrap

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beevers Manufacturing & Supply, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68803
  • Event Risk Class
    Class 2
  • Event Number
    Z-2181-2014
  • Event Initiated Date
    2014-07-11
  • Event Date Posted
    2014-08-10
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2015-07-17
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    blanket, neonatal phototherapy - Product Code PDH
  • 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.

Device

  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to US, Germany, Austria, France, Italy, Spain, Australia.
  • Product 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.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Beevers Manufacturing & Supply, Inc., 850 SW Booth Bend Rd, McMinnville OR 97128-9320
  • Manufacturer Parent Company (2017)
  • Source
    USFDA