Class I

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

Fresenius Kabi USA, LLC · August 1, 2024

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).

Distribution

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

States Affected

CO, ID, NJ, UT

Quantity Affected

180 cases/4,500 pieces

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2721-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.