VariSoft Infusion Set — Class II medical device recall Z-3186-2024
Ongoing recall by Unomedical A/S, reported 2024-09-25, distributed nationwide. Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel
| Recall number | Z-3186-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Unomedical A/S, Lejre, Denmark |
| Recall initiated | 2024-07-23 |
| Classified | 2024-09-19 |
| Reported by FDA | 2024-09-25 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 05705244018747 |
| Lot numbers | 6005241 |
Product
VariSoft Infusion Set, Single Use.
Reason for recall
Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3186-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.