Device product
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
Z-1251-2025
Product summary
- Firm
- HUMAN MED AG
- Event
- Event 96137
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 775 devices
- Official record key
device-enforcement:Z-1251-2025
Official wording
Reason: The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spray jet.
Code information: Lot number 24-20198, UDI (01)04260170881014(11)240611(17)270611(10)24-20198; and Lot number 23-19612, UDI (01)04260170881014(11)240109(17)270109(10)23-19612.
Distribution pattern: US Nationwide distribution in the state of FL.
Derived failure modes
-
Unknown
The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spray jet.