FDA Recall
Open, Classified
FloPatch FP120, REF: FP120-FOT01-005
Recall: Z-2517-2025
·
Initiated August 7, 2025
Recall
- Recall Number
- Z-2517-2025
- Event Number
- 97427
- Firm
- Flosonics Medical (R/A 1929803 ONTARIO CORP.) Fourth Floor, Oneeleven 325 Front St W Toronto Canada
- FEI Number
- 3015139886
- Product Code
- DPW
- Status
- Open, Classified
- Root Cause
- Labeling Change Control
- Initiated
- August 7, 2025
- Posted
- September 4, 2025
Description
FloPatch FP120, REF: FP120-FOT01-005
Reason
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.
Action
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: [email protected]
Distribution
US Nationwide distribution in the state of California.
Quantity
9