Device product
HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004
Z-1156-2023
Product summary
- Event
- Event 91533
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 445 units
- Official record key
device-enforcement:Z-1156-2023
Official wording
Reason: Label with the incorrect component listed on the inner kit Tyvek header bag
Code information: UDI-DI: (01)00850030354020 Lot Numbers: 11424032, 11432076
Distribution pattern: US Nationwide distribution in the states of CT, FL, NE, TN, TX, WA.
Derived failure modes
-
Labeling or packaging
Label with the incorrect