FDA recall Z-1251-2025

Product

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.

Distribution

US Nationwide distribution in the state of FL.

Key facts

Status

Ongoing

Initiation date

2024-10-18

Report date

2025-03-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Schwerin, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1251-2025