Recall Z-2517-2025
Flosonics Medical (R/A 1929803 ONTARIO CORP.) · initiated August 7, 2025
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
FloPatch FP120, REF: FP120-FOT01-005
Codes / lots: UDI-DI: 10627987360148. Lot: 03250602
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.
FDA-determined 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
Details
- Recall number
- Z-2517-2025
- Initiated
- August 7, 2025
- Posted by FDA
- September 4, 2025
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Quantity
- 9
- Distribution
- US Nationwide distribution in the state of California.
- Recalling firm
- Flosonics Medical (R/A 1929803 ONTARIO CORP.), Toronto