VariSoft Infusion Set, Single Use. (Unomedical A/S Osted Aholmvej 1) – specific varisofttm infusion sets wer... (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VariSoft Infusion Set, Single Use.
Brand
Unomedical A/S Osted Aholmvej 1
Lot Codes / Batch Numbers
UDI-DI: 05705244018747. Product Code: 1726035. Lot Number: 6005241
Products Sold
UDI-DI: 05705244018747. Product Code: 1726035. Lot Number: 6005241
Unomedical A/S Osted Aholmvej 1 is recalling VariSoft Infusion Set, Single Use. due to Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026