Z-3186-2024Class II

VariSoft Infusion Set, Single Use

Name: Z-3186-2024 VariSoft Infusion Set, Single Use
Creator: Unomedical A/S
Published: 2024-07-23
License: https://open.fda.gov/license/

Unomedical A/S / initiated 2024-07-23 / Open, Classified / root cause: packaging

FDA source

Unomedical A/S began a recall of VariSoft Infusion Set, Single Use on 2024-07-23. FDA classified it as Class II and gives the reason as "Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set"". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-3186-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-23
Posted: 2024-09-19
Recalling firm: Unomedical A/S
Product: VariSoft Infusion Set, Single Use.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".
Root cause tag: packaging
FDA root cause: Process change control
Action: 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.
Distribution: US Nationwide distribution in the state of California.
Product codes and lots: UDI-DI: 05705244018747. Product Code: 1726035. Lot Number: 6005241

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3186-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3186-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-19

Product code FPA

K162812Class IIUnomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion SetUnomedical A/S / cleared 2017-11-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)