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.

Fresenius Kabi USA, LLC 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. | SafeCheck