Device product
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
Z-2721-2024
Product summary
- Event
- Event 95113
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 180 cases/4,500 pieces
- Official record key
device-enforcement:Z-2721-2024
Official wording
Reason: 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).
Code information: Product Code: SET-0013-25; UDI-DI: 00811505030054; Lot number: 3010538.
Distribution pattern: US Distribution to states of: CO, ID, NJ, UT.
Derived failure modes
-
Unknown
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).