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 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.