FDA-Device2014-08-20Class II
Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.
Beevers Manufacturing & Supply, Inc.
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.
Sold states
Product was distributed to US, Germany, Austria, France, Italy, Spain, Australia.
Affected count
240 total (112/ lot 66812; 92/ lot 66813; 17/ lot 30660; and 19/ lot 67879).
Manufactured in
850 SW Booth Bend Rd, N/A, McMinnville, OR, United States
Products
Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2181-2014Don't want to check this manually?
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