Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.
FDA Recall Z-2181-2014 · Posted 2014-08-10
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Recalling FirmBeevers Manufacturing & Supply, Inc.
Recall StatusTerminated
Product CodePDH
Date Initiated2014-07-11
Date Terminated2015-07-17
Product Quantity240 total (112/ lot 66812; 92/ lot 66813; 17/ lot 30660; and 19/ lot 67879).
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.
Firm Action
BMS is contacting their customers and requesting that distributors report the amount of affected product they have in stock, prior to returning affected product.
BMS is also asking its distributors to forward the recall notification to its customers to whom affected product was sold.
BMS expects those customers to also report to BMS the amount of affected product they have.
Root Cause
No Marketing Application
Distribution Pattern
Product was distributed to US, Germany, Austria, France, Italy, Spain, Australia.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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