FDA-Device2025-09-10Class III

FloPatch FP120, REF: FP120-FOT01-005

Flosonics Medical (R/A 1929803 ONTARIO CORP.)
Hazard

Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.

Sold states
US Nationwide distribution in the state of California.
Affected count
9
Manufactured in
Fourth Floor, Oneeleven, 325 Front St W, Toronto, N/A, Canada
Products
FloPatch FP120, REF: FP120-FOT01-005

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2517-2025

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