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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:185485

Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover intended for use during various surgeries where warm irrigation, slush and/or cold solution is required.

Official recall number

Z-1141-2021

Evidence summary

Product code
PUI
Recall status
Terminated
Event initiated
January 11, 2021
Root cause
Process control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1141-2021