CLASS II ONGOING Device recall · Reported 25 Sep 2024 · FDA Enforcement Report
VariSoft Infusion Set, Single Use recalled by Unomedical A/S
Unomedical A/S is recalling VariSoft Infusion Set, Single Use, distributed nationwide in the US. The recall was initiated on 23 Jul 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3186-2024
- FDA event ID
- 95224
- Recalling firm
- Unomedical A/S, Lejre
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Jul 2024
- FDA classified
- 19 Sep 2024
- Reported
- 25 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Packaging Defects
- Device type
- Infusion Pumps
Timeline
| 23 Jul 2024 | Recall initiated by company | |
| 19 Sep 2024 | Classified by FDA | +58 days |
| 25 Sep 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
VariSoft Infusion Set, Single Use.
Where it was distributed
US Nationwide distribution in the state of California.
Questions about this recall
Is VariSoft Infusion Set, Single Use recalled?
Yes. Unomedical A/S recalled VariSoft Infusion Set, Single Use on 23 Jul 2024. The recall is Class II and its status is Ongoing. Recall number Z-3186-2024.
Why was it recalled?
Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".
Which lots are affected?
UDI-DI: 05705244018747. Product Code: 1726035. Lot Number: 6005241
Where was it sold?
US Nationwide distribution in the state of California.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Unomedical A/S
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neria Soft Infusion Set, Product recalled by Unomedical A/S | Unomedical A/S | Other | Nationwide |
| Device | CLASS I | VariSoft infusion set recalled by Unomedical A/S | Unomedical A/S | Device Malfunction | Nationwide |
| Device | CLASS I | VariSoft infusion set recalled by Unomedical A/S | Unomedical A/S | Device Malfunction | Nationwide |
| Device | CLASS I | VariSoft infusion set recalled by Unomedical A/S | Unomedical A/S | Device Malfunction | Nationwide |
| Device | CLASS II | Autosoft 90, model numbers 1000282 recalled by Unomedical A/S | Unomedical A/S | Other | CA |
Other Infusion Pumps recalls
All 546| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS I | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product recalled | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical | ICU Medical | Other | Nationwide |
| Device | CLASS II | Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled | Boston Scientific | Packaging Defects | Nationwide |