Recall Z-1251-2025— HUMAN MED AG

Name: FDA recall Z-1251-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-18

Class II · Ongoing

Class II FDA medical device recall by HUMAN MED AG, initiated 2024-10-18. It names one FDA 510(k) clearance: K082025. Product: human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.. Reason: 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..

Recalling firm: HUMAN MED AG
Classification: Class II
Status: Ongoing
Initiated: 2024-10-18
Firm location: Schwerin, Germany

510(k) clearances named in this recall

1 on FDA's record

K082025 — BODY-JETHuman Med AG·cleared 2008-08-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.