FDA-Device2025-03-12Class II
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
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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