PlainRecalls
FDA Devices Critical Class I Ongoing

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

Reported: September 11, 2024 Initiated: August 1, 2024 #Z-2721-2024

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.

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).

Details

Recalling Firm
Fresenius Kabi USA, LLC
Units Affected
180 cases/4,500 pieces
Distribution
US Distribution to states of: CO, ID, NJ, UT.
Location
North Andover, MA

Frequently Asked Questions

What product was recalled?
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.. Recalled by Fresenius Kabi USA, LLC. Units affected: 180 cases/4,500 pieces.
Why was this product recalled?
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).
Which agency issued this recall?
This recall was issued by the FDA Devices on September 11, 2024. Severity: Critical. Recall number: Z-2721-2024.