Z-1251-2025 Class II Ongoing
FDA device recall Z-1251-2025 was initiated by HUMAN MED AG on October 18, 2024 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 775 devices.
Recall Details
- Product Type
- Devices
- Report Date
- March 12, 2025
- Initiation Date
- October 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 775 devices
Product Description
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the state of FL.
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.