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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:195571

Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)

Official recall number

Z-1684-2022

Evidence summary

Product code
QFJ
Recall status
Open, Classified
Event initiated
August 10, 2022
Root cause
Nonconforming Material/Component
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1684-2022