Z-2721-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 11, 2024
- Initiation Date
- August 1, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 180 cases/4,500 pieces
Product Description
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 Pattern
US Distribution to states of: CO, ID, NJ, UT.
Code Information
Product Code: SET-0013-25; UDI-DI: 00811505030054; Lot number: 3010538.