Fresenius Kabi USA, LLC LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
Brand
Fresenius Kabi USA, LLC
Lot Codes / Batch Numbers
Product Code: SET-0013-25, UDI-DI: 00811505030054, Lot number: 3010538.
Products Sold
Product Code: SET-0013-25; UDI-DI: 00811505030054; Lot number: 3010538.
Fresenius Kabi USA, LLC is recalling LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product due to A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication over. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
On 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)
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CO, ID, NJ, UT
Page updated: Jan 10, 2026