VariSoft Infusion Sets recalled due to incorrect secondary packaging
Unomedical A/S is recalling specific VariSoft Infusion Sets packaged in boxes incorrectly branded as 'Trusteel Infusion Set' instead of 'VariSoft.' No injuries or illnesses have been reported.
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 medical device recall involving incorrect product branding on secondary packaging. No injuries, illnesses, or product defects reported. The issue is limited to labeling and packaging mismatch, classified as a minor labeling error per the severity rubric.
Plain-English summary
Unomedical A/S is recalling specific VariSoft Infusion Sets due to incorrect secondary packaging. The affected units were packaged in boxes branded 'Trusteel Infusion Set' instead of 'VariSoft Infusion Set.'
The recall applies to units distributed nationwide in California. The affected lot number is 6005241 (Product Code 1726035). No illnesses or injuries have been reported in connection with this packaging issue.
Healthcare facilities and individuals who have received VariSoft Infusion Sets should verify that the product packaging matches the actual device brand.
The recalled product
- Product
- VariSoft Infusion Set, Single Use.
- Manufacturer
- Unomedical A/S
- Category
- Medical Device — Infusion Set
- Hazard
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 (1)
- UDI-DI: 05705244018747. Product Code: 1726035. Lot Number: 6005241
Distribution
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