Device product
HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
Z-1605-2023
Product summary
- Event
- Event 92124
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 240 units
- Official record key
device-enforcement:Z-1605-2023
Official wording
Reason: The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package.
Code information: UDI-DI: 00862559000487; Lot Number: 11423949
Distribution pattern: US distribution to States of: FL, TN, TX.
Derived failure modes
-
Unknown
The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package.