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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:185960

BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.

Official recall number

Z-1335-2021

Evidence summary

Product code
FFT
Recall status
Open, Classified
Event initiated
February 26, 2021
Root cause
Process change control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1335-2021