Device product
HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
Z-1129-2023
Product summary
- Event
- Event 91426
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,789 HydroMID devices
- Official record key
device-enforcement:Z-1129-2023
Official wording
Reason: Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
Code information: UDI-DI: (01)00850030354006; Lot Number: 11428361, 11393260, 11395226
Distribution pattern: US Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX.
Derived failure modes
-
Unknown
Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.