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 Model Number: 80004004
Z-1155-2023
Product summary
- Event
- Event 91529
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 155 units
- Official record key
device-enforcement:Z-1155-2023
Official wording
Reason: Product Mislabeled on the outer bag and inner kit Tyvek header bag
Code information: UDI: (01)00850030354020 Lot Number: 11434018
Distribution pattern: US Nationwide distribution in the states of FL, TX, WA.
Derived failure modes
-
Labeling or packaging
Mislabeled