Z-2517-2025 Class III Ongoing
FDA device recall Z-2517-2025 was initiated by Flosonics Medical (R/A 1929803 ONTARIO CORP.) on August 7, 2025 and is designated Class III. 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. The recall status is ongoing. Affected quantity: 9.
Recall Details
- Product Type
- Devices
- Report Date
- September 10, 2025
- Initiation Date
- August 7, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9
Product Description
FloPatch FP120, REF: FP120-FOT01-005
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 Pattern
US Nationwide distribution in the state of California.
Code Information
UDI-DI: 10627987360148. Lot: 03250602