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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:182163

Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

Official recall number

Z-2825-2020

Evidence summary

Product code
FRN
Recall status
Open, Classified
Event initiated
June 30, 2020
Root cause
Device Design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2825-2020