Medical device recalls Moderate risk

HUMAN MED AG recalls human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.

Recall date
October 18, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1251-2025
FDA classification
Class II
Brand / firm
HUMAN MED AG
Sold / distributed
US Nationwide distribution in the state of FL.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.

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