Class 1 Device Recall Ivenix Infusion System

• Date Initiated by Firm: March 10, 2023
• Date Posted: April 18, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1313-2023
• Recall Event ID: 91783
• 510(K)Number: K183311
• Product Classification: Pump, infusion - Product Code FRN
• Product: Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
• Code Information: UDI-DI: 00811505030320; Serial No.: 2118200008, 2118200011, 2119300411, 2119300412, 2119300414, 2119300415, 2119300416, 2119300417, 2119300418, 2119300421, 2119300422, 2119300424, 2119300426, 2119300427, 2119300428, 2119300429, 2119300430, 2119300431, 2119300432, 2119300434, 2119300435, 2119300436, 2119300437, 2119300438, 2119300439, 2119300440, 2119300442, 2124300049, 2124300051, 2124300052, 2124300053, 2124300054, 2124300058, 2124300059, 2124300060, 2124300061, 2124300062, 2124300063, 2124300064, 2124300065, 2124300066, 2124300068, 2124300069, 2124300070, 2124300072, 2124300074, 2124300075, 2124300076, 2124300077, 2124300078, 2124300080, 2124300082, 2124300083, 2124300084, 2124300085, 2124300086, 2124300087, 2124300089, 2124300090, 2124300091, 2124300093, 2124300094, 2124300096, 2124300097, 2124300099, 2124300100, 2124300101, 2124300102, 2124300103, 2124300104, 2124300106, 2124300107, 2124300108, 2124300109, 2124300110, 2124300111, 2124300112, 2124300113, 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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: Matt Kuhn; 847-550-5751
• Manufacturer Reason for Recall: Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.
• FDA Determined Cause: Process control
• Action: The firm distributed via email a URGENT - Medical Device Recall notification to consignees identifying all large volume pumps (LVP) of the Ivenix Infusion System as requiring repair or replacement due to potential fluid ingress, which could lead to interrupted infusion of medication. Customers are instructed to have a secondary LVP readily available when the device is being used to deliver life-sustaining medication if the provided troubleshooting instructions do not resolve the cessation of infusion. Additionally, customers are to ensure no buildup of liquid on the Air Detector region surfaces by wiping away any fluid buildup and reloading the cassette if the LVP exhibits an alert. Additional instructions were provided based upon varying clinical situations and should be posted above each nursing station where the device is in use. Fresenius will be contacting their customers to arrange service in response to this recall event. Adverse events or quality problems should be reported to Fresenius at Ivenix_support@fresenius-kabi.com. Customers are asked to return the Customer Reply Form provided with the recall notification and to forward the recall notice to any customers/satellite locations at which recalled devices were further distributed.
• Quantity in Commerce: 1,546 units
• Distribution: Domestic: CA, CO, NJ, WI, & UT. No foreign distribution.
• 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.