Varisoft recallZ-3186-2024 · Unomedical A/S · initiated Jul 23, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Unomedical A/S or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".
FDA root cause category: Process change control
What the company is doing
Unomedical initially notified the consignee on 07/23/2024 via meeting and followed up with a letter via email on 07/25/2024. The notification instructed the consignee to identify and quarantine any affected product in inventory, notify customers immediately, complete and return the response form and arrange for return of affected units.
Recall details
- Recall number
- Z-3186-2024
- Status
- Open, Classified
- Initiated by the company
- Jul 23, 2024
- Posted by the FDA
- Sep 19, 2024
- Recalling firm
- Unomedical A/S
- Product code
- FPA
- FDA submissions
- K162812
- Distribution
- US Nationwide distribution in the state of California.
Product description
VariSoft Infusion Set, Single Use.
Code information (models, lots, serial numbers)
UDI-DI: 05705244018747. Product Code: 1726035. Lot Number: 6005241
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Varisoft™ 1002828Unomedical A/S · Set, Administration, Intravascular2 recalls172 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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