FDA Enforcement
Class II
Ongoing
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
Recall: Z-1251-2025
·
Reported March 12, 2025
Enforcement
- Recall Number
- Z-1251-2025
- Event ID
- 96137
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- HUMAN MED AG
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 12, 2025
- Initiation Date
- October 18, 2024
- Classification Date
- February 28, 2025
- Address
- Wilhelm-Hennemann-Str. 9, Schwerin, N/A, Germany
Description
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
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 Info
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
US Nationwide distribution in the state of FL.
Quantity
775 devices