Device evidence

device-recall:cfres:128768

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 recall number

Z-2181-2014

Evidence summary

Product code: PDH
Recall status: Terminated
Event initiated: July 11, 2014
Root cause: No Marketing Application
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-2181-2014