VariSoft Infusion Set, Single Use.

FDA device recall Z-3186-2024 · posted 2024-09-19 · Open, Classified

Recall details

Recalling firm: Unomedical A/S
Reason for recall: Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".
Action taken: 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.
Root cause: Process change control
Status: Open, Classified
Product code: FPA
Distribution: US Nationwide distribution in the state of California.
Date initiated: 2024-07-23
Date posted: 2024-09-19
Location: Lejre, Denmark

Recalls and clearances share one API, with change alerts when new recalls post.

Record	Firm	Date
Unomedical 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 Set (K162812)	Unomedical A/S	2017-11-01