FDA Medical Device Recalls (openFDA)
Fresenius Kabi USA, LLC: IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
- Recall number
- Z-1869-2025
- Recalling firm
- Fresenius Kabi USA, LLC
- Product
- IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
- Status
- Open, Classified
- Initiated
- 2025-05-12
- Posted
- 2025-06-06
- Terminated
- not on file
- Reason
- Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
- Root cause
- Under Investigation by firm
- Action
- Consignees received an "URGENT - VOLUNTARY RECALL" notification via email dated 5/11/25. This notification instructs consignees to discontinue use and distribution of affected devices immediately. Consignees are to check their inventory for affected devices and place them in quarantine until product can be returned for replacement. The provided recall notification is to be distributed to users of the affected devices. Consignees are instructed to return the completed Customer Reply Form via fax or email to facilitate return of affected devices for replacement. Consignees with any questions can contact Fresenius Kabi by phone at 855-354-6387x1 or by email at Ivenix_support@fresenius-kabi.com.
- Quantity
- 14,280 units (724 cases)
- Distribution
- US distribution: CA, CO, DE, GA, IL, MD, MI, MN, MS, NC, NJ, NV, OK, SC, TX, VA, WA & WI.
- Lot, serial or model codes
- Model No. SET-0014-20; UDI 20811505030034; Lot No. FA24K05015.
- 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