Beevers Manufacturing & Supply, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2181-2014)
See the recall detail below. You can also see other recalls from the same firm in 2014.
Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.
Class II
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.
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.
Voluntary: Firm initiated