Luma Wrap Phototherapy Swaddler is designed to provide recall
Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive…
Why was Luma Wrap Phototherapy Swaddler is designed to provide recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive…
- Recalling firm
- Beevers Manufacturing & Supply, Inc.
- Quantity
- 240 total (112/ lot 66812; 92/ lot 66813; 17/ lot 30660; and 19/ lot 67879).
- Distribution
- Product was distributed to US, Germany, Austria, France, Italy, Spain, Australia.
- Recall date
- August 20, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)