Reported Aug 20, 2014 · Terminated
Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive…
Beevers Manufacturing & Supply, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beevers Manufacturing & Supply, Inc. · 850 SW Booth Bend Rd · McMinnville, OR · 97128-9320
Is this the product you have?
- Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.
- Lot codes and dates
- Recalled units includeLW102 (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
- Amount recalled
- 240 total (112/ lot 66812; 92/ lot 66813; 17/ lot 30660; and 19/ lot 67879).
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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