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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:210660

CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.

Official recall number

Z-0478-2025

Evidence summary

Product code
CAW
Recall status
Completed
Event initiated
October 04, 2024
Root cause
Nonconforming Material/Component
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0478-2025

Field note

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