Class 2 Device Recall VariSoft Infusion Set

• Date Initiated by Firm: July 23, 2024
• Date Posted: September 19, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3186-2024
• Recall Event ID: 95224
• 510(K)Number: K162812
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: VariSoft Infusion Set, Single Use.
• Code Information: UDI-DI: 05705244018747. Product Code: 1726035. Lot Number: 6005241
• Recalling Firm/ Manufacturer: Unomedical A/S; Osted; Aholmvej 1 - 3; Lejre Denmark
• For Additional Information Contact: 45 48 16 7000
• Manufacturer Reason for Recall: Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FPA