Class 1 Device Recall IVENIX INFUSION SYSTEM LVP Blood Products Administration Set

• Date Initiated by Firm: May 12, 2025
• Date Posted: June 06, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1869-2025
• Recall Event ID: 96880
• 510(K)Number: K183311
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
• Code Information: Model No. SET-0014-20; UDI 20811505030034; Lot No. FA24K05015.
• Recalling Firm/ Manufacturer: Fresenius Kabi USA, LLC; 50 High St Ste 50; North Andover MA 01845-2620
• For Additional Information Contact: Rebecca McCandless; 847-550-2913
• Manufacturer Reason for Recall: Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
• FDA Determined Cause: Under Investigation by firm
• Action: Consignees received an "URGENT - VOLUNTARY RECALL" notification via email dated 5/11/25. This notification instructs consignees to discontinue use and distribution of affected devices immediately. Consignees are to check their inventory for affected devices and place them in quarantine until product can be returned for replacement. The provided recall notification is to be distributed to users of the affected devices. Consignees are instructed to return the completed Customer Reply Form via fax or email to facilitate return of affected devices for replacement. Consignees with any questions can contact Fresenius Kabi by phone at 855-354-6387x1 or by email at Ivenix_support@fresenius-kabi.com.
• Quantity in Commerce: 14,280 units (724 cases)
• Distribution: US distribution: CA, CO, DE, GA, IL, MD, MI, MN, MS, NC, NJ, NV, OK, SC, TX, VA, WA & WI.
• 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