FloPatch FP120, REF: FP120-FOT01-005
FDA Recall #Z-2517-2025 — Class III — August 7, 2025
Product Description
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.
Recalling Firm
Flosonics Medical (R/A 1929803 ONTARIO CORP.) — Toronto, N/A
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
9
Distribution
US Nationwide distribution in the state of California.
Code Information
UDI-DI: 10627987360148. Lot: 03250602
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated