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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:213159

IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.

Official recall number

Z-1688-2025

Evidence summary

Product code
GEH
Recall status
Open, Classified
Event initiated
March 24, 2025
Root cause
Process control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1688-2025

Field note

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