FDA Medical devices recall ·
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm recall
- Recall number
- Z-1251-2025
- Date
- (initiated October 18, 2024)
- Company / brand
- Human Med Ag
Wilhelm-Hennemann-Str. 9, Schwerin, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 775 devices
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot number 24-20198, UDI (01)04260170881014(11)240611(17)270611(10)24-20198; and Lot number 23-19612, UDI (01)04260170881014(11)240109(17)270109(10)23-19612.
Distribution
US Nationwide distribution in the state of FL.
States: Florida
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1251-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.