Home / Recalls / Beevers Manufacturing & Supply, Inc. / Z-2181-2014

Z-2181-2014 Class II Terminated

Recalled by Beevers Manufacturing & Supply, Inc. — McMinnville, OR

Recall Details

Product Type: Devices
Report Date: August 20, 2014
Initiation Date: July 11, 2014
Termination Date: July 17, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 240 total (112/ lot 66812; 92/ lot 66813; 17/ lot 30660; and 19/ lot 67879).

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.

Reason for Recall

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.

Distribution Pattern

Product was distributed to US, Germany, Austria, France, Italy, Spain, Australia.

Code Information

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.