Infiltration Cannula Recalled Due to Incorrect Water Jet Pattern
HUMAN MED AG is recalling 775 Biofill Infiltration Cannulas because the water jet may emerge as a spot jet rather than the specified fan-shaped spray pattern, affecting device functionality.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II device with specification non-compliance affecting the water jet delivery pattern. No illnesses or injuries related to this defect are reported.
Plain-English summary
HUMAN MED AG is recalling 775 Biofill Infiltration Cannulas distributed nationwide. The cannula tubes do not comply with manufacturing specifications. The water jet emerging from the nozzle may emerge as a spot jet instead of the required fan-shaped spray jet.
This defect affects the device's functionality as designed. The affected lot numbers are 24-20198 and 23-19612.
Healthcare providers and organizations with this device should verify the lot number and contact HUMAN MED AG or the FDA for appropriate next steps.
The recalled product
- Product
- human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
- Manufacturer
- HUMAN MED AG
- Hazard
- Affected units
- 775
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 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
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