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U.S. Department of Health and Human Services

Class 2 Device Recall Ivenix Infusion System

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 Class 2 Device Recall Ivenix Infusion Systemsee related information
Date Initiated by FirmJune 24, 2025
Date PostedAugust 01, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2232-2025
Recall Event ID 97165
510(K)NumberK183311 
Product Classification Pump, infusion - Product Code FRN
ProductLVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
Code Information Product Code: SET-0013-25. UDI-DI: 00811505030054. Lot Codes: FA24I26149, FA24I30133, FA24I30141, FA24J01131, FA24J01149.
Recalling Firm/
Manufacturer		 Fresenius Kabi USA, LLC
50 High St Ste 50
North Andover MA 01845-2620
For Additional Information ContactRebecca McCandless
847-550-2913
Manufacturer Reason
for Recall		Potential for external cassette leaks
FDA Determined
Cause 2		Process design
ActionFresenius Kabi notified consignees on about 06/24/2025 via telephone call and followed up with a letter. Consignees were instructed to discontinue use and distribution immediately, quarantine any affected units on hand, notify users of the issue, and complete and return the Customer Reply Form. If affected units were further distributed, consignees were instructed to notify those customers. If Affected units were on hand, consignees were instructed to either destroy or arrange for their return. Replacement of affected units can be arranged.
Quantity in Commerce19,225 units
DistributionUS Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FRN
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