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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:206181

Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system

Official recall number

Z-1390-2024

Evidence summary

Product code
DYB
Recall status
Open, Classified
Event initiated
February 20, 2024
Root cause
Process control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1390-2024

Field note

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