Class 1 Device Recall Ivenix Infusion System (IIS), Large Volume Pump

• Date Initiated by Firm: November 29, 2023
• Date Posted: December 20, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0549-2024
• Recall Event ID: 93474
• 510(K)Number: K183311
• Product Classification: Pump, infusion - Product Code FRN
• Product: Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
• Code Information: UDI-DI 00811505030320 Serial numbers 2213800363 2213800343 2213800328 2213800222 2213800173 2212201120 2212201119 2212201118 2212201115 2212201113 2212201111 2212201100 2212201095 2212201093 2212201088 2212201076 2212201074 2212201061 2212201059 2212201046 2212201029 2212201024 2212201003 2212201002 2212200993 2212200990 2212200987 2212200986 2212200982 2212200978 2212200958 2212200952 2212200945 2212200938 2212200929 2212200914 2205900177 2205900176 2205900170 2205900167 2205900158 2205900152 2205900150 2205900143 2205900133 2205900132 2205900128 2205900126 2205900125 2205900113 2205900112 2205900110 2205900109 2205900108 2205900107 2205900106 2205900098 2205900096 2205900094 2205900091 2205900090 2205900074 2205900072 2205900071 2205900067 2205900062 2205900061 2201811620 2201811615 2201811614 2201811605 2118200011 2201811603 2201811600 2201811598 2201811597 2201811596 2201811594 2201811590 2201811585 2201811584 2201811582 2201811579 2201811577 2201811568 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• Recalling Firm/ Manufacturer: Fresenius Kabi USA, LLC; 50 High St Ste 50; North Andover MA 01845-2620
• For Additional Information Contact: Customer Support; 978-775-8100
• Manufacturer Reason for Recall: The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death.
• FDA Determined Cause: Process change control
• Action: On November 29, 2023, the firm began notifying affected customers via" URGENT-Medical Device Recall" letter dated November 28, 2023. Customers were provided with precautions to take until the affected LVPs are able to be returned for repair or replacement of internal hardware. Customers will be contacted by a Fresenius Kabi service representative to create a plan for addressing any affected LVPs at their facility. This effort is expected to begin in January 2024. Fresenius Kabi will repair LVPs that may encounter mechanical interference causing the Fluid Valve Actuation System not to move properly. If the LVP cannot be repaired, it will be replaced at no cost to the customer. If you have any questions contact Customer support at, email: Ivenix_support@fresenius-kabi.com or phone at 1-978-775-8100.
• Quantity in Commerce: 938 US
• Distribution: US distribution to states of: CA, CO, NJ, UT, and 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 = FRN and Original Applicant = Ivenix, Inc.