Recall Z-2517-2025 ยท DPW Flowmeter, Blood, Cardiovascular
Flosonics Medical (R/A 1929803 ONTARIO CORP.)
FloPatch FP120, REF: FP120-FOT01-005
| Date | Sep 4, 2025 (initiated Aug 7, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Labeling Change Control |
| 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: cchin@flosonicsmedical.com |
| Quantity | 9 |
| Distribution | US Nationwide distribution in the state of California. |
| FDA record | Open on fda.gov |