FDA recall Z-2517-2025

Flosonics Medical (R/A 1929803 ONTARIO CORP.) · Class III · device

Product

FloPatch FP120, REF: FP120-FOT01-005

Reason for recall

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.

Distribution

US Nationwide distribution in the state of California.

Key facts

Status
Ongoing
Initiation date
2025-08-07
Report date
2025-09-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Toronto, N/A, Canada

Primary source

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