Unomedical A/S recalls
4 official recalls and safety alerts involving Unomedical A/S since 2022-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Unomedical A/S or the relevant agency.
- 2024-09-25
USUnomedical A/S recalls VariSoft Infusion Set, Single Use.
Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".
- 2024-04-24
- US
Unomedical A/S recalls Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for…
- 2023-11-29
- US
Unomedical A/S recalls VariSoft infusion set, Model Number 1002828
The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily…
- 2022-10-05
- US
Unomedical A/S recalls Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with…
The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended.
FDA · DeviceUnomedical A/SDistribution was made to California. There was no government/military…Official notice →