FDA recall Z-2721-2024

Product

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).

Distribution

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

Key facts

Status

Ongoing

Initiation date

2024-08-01

Report date

2024-09-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2721-2024