LEJRE, N/A, Denmark
Unomedical A/S recalls
4 recalls recorded since 2018, most recently on 23 July 2024. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)3
Terminated or completed1
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 23 July 2024
- Reason
- Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".
- Distribution
- US Nationwide distribution in the state of California.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3186-2024
- VariSoft Infusion Set, Single Use.
Ongoing Class II Medical devices
- Recall started
- 5 March 2024
- Reason
- 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 the Rest of World (ROW) countries. The difference between the US IFU and the ROW IFU is the addition of an intended use section in the ROW IFU.
- Distribution
- US Nationwide distribution in the state of Florida.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1544-2024
- Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Ongoing Class I Medical devices
- Recall started
- 11 October 2023
- Reason
- 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 from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sleep, leads to missed basal dosing. which in turn can result in elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis.hyperglycemia). Diabetic ketoacidosis.
- Distribution
- US Nationwide distribution in the state of CA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0233-2024, Z-0232-2024, Z-0234-2024
- VariSoft infusion set, Model Number 1002828
- VariSoft infusion set, Model Number 1002827
- VariSoft infusion set, Model Number 1002830
Terminated Class II Medical devices
- Recall started
- 21 July 2022
- Terminated
- 4 May 2026
- Reason
- 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.
- Distribution
- Distribution was made to California. There was no government/military distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1810-2022
- Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.