Device product
Radial Artery Catheterization Kit; Model: AK-04122
Z-1285-2018
Product summary
- Event
- Event 79314
- Status
- Terminated
- Classification
- Class II
- Quantity
- 570
- Official record key
device-enforcement:Z-1285-2018
Official wording
Reason: The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Code information: Lots: 13F16H0329, 13F17F0074, 13F17G0237; Expiration dates: October 2018 through March 2020
Distribution pattern: US nationwide distribution, including Puerto Rico.
Derived failure modes
-
Unknown
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.