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Beevers Manufacturing & Supply, Inc. recalls Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babi
Recalled August 20, 2014 · FDA recall Z-2181-2014 · Beevers Manufacturing & Supply
Hazard
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. · FDA Class II
Units
240 total (112/ lot 66812; 92/ lot 66813; 17/ lot 30660; and 19/ lot 67879).
Sold at
Product was distributed to US, Germany, Austria, France, Italy, Spain, Australia.
Description
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.
Product
Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.
Manufacturer(s)
Beevers Manufacturing & Supply, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →