Device Recall Luma Wrap

  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed to US, Germany, Austria, France, Italy, Spain, Australia.
  • Description du dispositif
    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
  • 1 Event

Fabricant

  • Adresse du fabricant
    Beevers Manufacturing & Supply, Inc., 850 SW Booth Bend Rd, McMinnville OR 97128-9320
  • Société-mère du fabricant (2017)
  • Source
    USFDA