Recall Z-2181-2014— Beevers Manufacturing & Supply, Inc.
Class II · Terminated
Class II FDA medical device recall by Beevers Manufacturing & Supply, Inc., initiated 2014-07-11, terminated 2015-07-17. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Beevers Manufacturing & Supply, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-07-11
- Terminated
- 2015-07-17
- Firm location
- McMinnville, OR, United States
Product description
Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.