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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:195890

Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561

Official recall number

Z-1836-2022

Evidence summary

Product code
DQX
Recall status
Open, Classified
Event initiated
August 16, 2022
Root cause
Under Investigation by firm
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1836-2022