Device product
Radial Artery Catheterization Kit; Model: AK-04120
Z-1284-2018
Product summary
- Event
- Event 79314
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2491
- Official record key
device-enforcement:Z-1284-2018
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: 13F16H0289, 13F16M0161, 13F17E0858, 13F17G0178, 23F16E1191, 23F16H0163; 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.