FDA Medical Device Recalls (openFDA)
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 number
- Z-2721-2024
- Recalling firm
- Fresenius Kabi USA, LLC
- Product
- LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
- Status
- Open, Classified
- Initiated
- 2024-08-01
- Posted
- 2024-09-04
- Terminated
- not on file
- Reason
- 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).
- Root cause
- Process control
- Action
- 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)
- Quantity
- 180 cases/4,500 pieces
- Distribution
- US Distribution to states of: CO, ID, NJ, UT.
- Lot, serial or model codes
- Product Code: SET-0013-25; UDI-DI: 00811505030054; Lot number: 3010538.
- 510(k) numbers
- ["K183311"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3014732157
- Firm city
- North Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28