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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:196944

DeRoyal KIT HEART B PACK, REF 89-9042.07

Official recall number

Z-0629-2023

Evidence summary

Product code
LRO
Recall status
Open, Classified
Event initiated
November 03, 2022
Root cause
Nonconforming Material/Component
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0629-2023