FloPatch FP120, REF: FP120-FOT01-005
FDA device recall Z-2517-2025 · posted 2025-09-04 · Open, Classified
Recall details
- Recalling firm
- Flosonics Medical (R/A 1929803 ONTARIO CORP.)
- 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.
- 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
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- DPW
- Quantity affected
- 9
- Distribution
- US Nationwide distribution in the state of California.
- Date initiated
- 2025-08-07
- Date posted
- 2025-09-04
- Location
- Toronto, Canada
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FloPatch FP120 (K223843) | Flosonics Medical | 2023-05-03 |
| FloPatch (FP120) (K200337) | Flosonics Medical (R/A 1929803 Ontario Corp.) | 2020-03-24 |