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U.S. Department of Health and Human Services

Class 2 Device Recall Luma Wrap

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  Class 2 Device Recall Luma Wrap see related information
Date Initiated by Firm July 11, 2014
Date Posted August 10, 2014
Recall Status1 Terminated 3 on July 17, 2015
Recall Number Z-2181-2014
Recall Event ID 68803
Product Classification blanket, neonatal phototherapy - Product Code PDH
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Beevers Manufacturing & Supply, Inc.
850 SW Booth Bend Rd
McMinnville OR 97128-9320
For Additional Information Contact Tim Beevers
503-472-9055
Manufacturer 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.
FDA Determined
Cause 2		 No Marketing Application
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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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