RecallDepth

FloPatch FP120, REF: FP120-FOT01-005

This recall is currently active, issued September 4, 2025. It was issued by Flosonics Medical (R/A 1929803 Ontario Corp.) Fourth Floor, Oneeleven 325 Front St W Toronto Canada.

Company
Flosonics Medical (R/A 1929803 Ontario Corp.) Fourth Floor, Oneeleven 325 Front St W Toronto Canada
Recall Initiated
August 7, 2025
Posted
September 4, 2025
Recall Number
Z-2517-2025
Quantity
9
Official Source
View on FDA website ↗

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.

Lot / Code Info

UDI-DI: 10627987360148. Lot: 03250602

Root Cause

Labeling Change Control

Action Taken

On 8/7/2025, recall notices were emailed to customers who were asked to do the following: 1. Customers to confirm receipt of recall notice. 2. Customers should dispose of the outer shipping packaging. 3. If desired, customers may request replacement product. For questions, please contact: cchin@flosonicsmedical.com