Fresenius Kabi USA, LLC: Medical Device Recall in 2024 - (Recall #: Z-2721-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.

Product Classification:

Class I

Date Initiated: August 1, 2024

Date Posted: September 11, 2024

Recall Number: Z-2721-2024

Event ID: 95113

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).

Status: Ongoing

Product Quantity: 180 cases/4,500 pieces

Code Information:

Product Code: SET-0013-25; UDI-DI: 00811505030054; Lot number: 3010538.

Distribution Pattern:

US Distribution to states of: CO, ID, NJ, UT.

Voluntary or Mandated:

Voluntary: Firm initiated