Class II

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

HUMAN MED AG · October 18, 2024

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

US Nationwide distribution in the state of FL.

States Affected

NATIONWIDE

Quantity Affected

775 devices

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1251-2025

Status: ongoing

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