FDA-Device2024-09-11Class I
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
Hazard
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).
Sold states
US Distribution to states of: CO, ID, NJ, UT.
Affected count
180 cases/4,500 pieces
Manufactured in
50 High St Ste 50, North Andover, MA, United States
Products
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2721-2024Don't want to check this manually?
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