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Unomedical A/S FDA Recalls
6 recalls on file across devices, 3 of them Class I and 5 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| VariSoft Infusion Set, Single Use.Class IIJul 23, 2024Specific VariSoftTM Infusion Sets were packaged using incorr |
| Neria Soft Infusion Set, Product Code 507302, intravascular administration setClass IIMar 5, 2024Specific lots of Neria Soft Infusion Sets, which have been s |
| VariSoft infusion set, Model Number 1002827Class IOct 11, 2023The Varisoft infusion set is used in conjunction with tandem |
| VariSoft infusion set, Model Number 1002828Class IOct 11, 2023The Varisoft infusion set is used in conjunction with tandem |
| VariSoft infusion set, Model Number 1002830Class IOct 11, 2023The Varisoft infusion set is used in conjunction with tandem |
| Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. InfusioClass IIJul 21, 2022The IFU incorrectly states the insulin fill value of two siz |