Recall Z-1869-2025
Fresenius Kabi USA, LLC · initiated May 12, 2025
Class I – dangerous or defective products that could cause serious health problems or death
Product
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
Codes / lots: Model No. SET-0014-20; UDI 20811505030034; Lot No. FA24K05015.
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1869-2025
- Initiated
- May 12, 2025
- Posted by FDA
- June 6, 2025
- Product code
- FPA – Set, Administration, Intravascular
- 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.
- Recalling firm
- Fresenius Kabi USA, LLC, North Andover, MA