Device product
HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001
Z-1131-2023
Product summary
- Event
- Event 91426
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 302 HydroPICC devices
- Official record key
device-enforcement:Z-1131-2023
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)00862559000456; Lot Number: 11398679, 11416178
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.