PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: March 12, 2025 Initiated: October 18, 2024 #Z-1251-2025

Product Description

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

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.

Details

Recalling Firm
HUMAN MED AG
Units Affected
775 devices
Distribution
US Nationwide distribution in the state of FL.
Location
Schwerin

Frequently Asked Questions

What product was recalled?
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.. Recalled by HUMAN MED AG. Units affected: 775 devices.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 12, 2025. Severity: Moderate. Recall number: Z-1251-2025.