FDA-Device2025-03-12Class II
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
HUMAN MED AG
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.
Sold states
US Nationwide distribution in the state of FL.
Affected count
775 devices
Manufactured in
Wilhelm-Hennemann-Str. 9, Schwerin, Germany
Products
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1251-2025Don't want to check this manually?
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