HUMAN MED AG: Device Recall

Recall #Z-1251-2025 · 10/18/2024

Class II: Risk

Recall Details

Recall Number
Z-1251-2025
Classification
Class II
Product Type
Device
Recalling Firm
HUMAN MED AG
Status
Ongoing
Date Initiated
10/18/2024
Location
Schwerin, Germany
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
775 devices

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.

Product Description

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

Distribution Pattern

US Nationwide distribution in the state of FL.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.