FDA Device recall Z-3186-2024
VariSoft Infusion Set, Single Use
- FDA Device
- Class II
- ongoing
- Published 2024-09-25
On 2024-09-25 the FDA classified a Class II recall of VariSoft Infusion Set, Single Use by Unomedical A S, citing specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3186-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-23 |
| Published | 2024-09-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Unomedical A S |
| Distribution | US |
Product
VariSoft Infusion Set, Single Use.
Reason
Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".
Identifiers
| code_info | UDI-DI: 05705244018747. Product Code: 1726035. Lot Number: 6005241 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3186-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.