FDAFDA · Food and drugs·Recall number Z-1251-2025
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
Published March 12, 2025 · Recall initiated: October 18, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- HUMAN MED AG
- Distributor
- US Nationwide distribution in the state of FL.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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