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U.S. Department of Health and Human Services

Class 1 Device Recall Ivenix Infusion System LVP Primary Administration Set

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 Class 1 Device Recall Ivenix Infusion System LVP Primary Administration Setsee related information
Date Initiated by FirmAugust 01, 2024
Date PostedSeptember 04, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2721-2024
Recall Event ID 95113
510(K)NumberK183311 
Product Classification Set, administration, intravascular - Product Code FPA
ProductLVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
Code Information Product Code: SET-0013-25; UDI-DI: 00811505030054; Lot number: 3010538.
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		A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).
FDA Determined
Cause 2		Process control
ActionOn August 1, 2024, consignees were notified by phone with a follow-up "URGENT - VOLUNATERY RECALL" letter sent August 2, 2024. Required Actions for Users: 1. Discontinue use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2. Inform potential users of the product in your organization of this notification and replace with un-affected product. 3. Complete the attached Customer Reply Form, and return it via the fax number, or email address provided in the letter. Option A: if you have no remaining inventory of the affected product, please complete the response form, and return it to Fresenius Kabi. Option B: If you have affected product in inventory, please destroy or return the product and request replacement inventory. The enclosed Customer Reply Form acknowledges your receipt of this notification. If you have any questions, or require additional information, please contact Fresenius Kabi at 855-354-6387. 4. Please contact Fresenius Kabi Customer Service at 855-354-6387, Prompt 1, if you intend to destroy recalled product and/or request replacement product. If you intend to destroy recalled product, Fresenius Kabi will provide a certificate of destruction for completion. Once completed, the certificate should be returned to Fresenius Kabi. For Further Inquiries please contact Fresenius Kabi: Adverse Events/Quality Problems: Adverse reactions or quality problems experienced with the use of this product should be reported via the following: Ivenix_support@fresenius-kabi.com or 1/855-354-6387 (Normal Business Hours are Monday through Friday 8:30 AM to 5 PM Eastern Time, After Hours Supported with Voicemail Messaging)
Quantity in Commerce180 cases/4,500 pieces
DistributionUS Distribution to states of: CO, ID, NJ, UT.
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 = FPA
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