Device product
Radial Artery Catheterization Kit; Model: AK-04020
Z-1282-2018
Product summary
- Event
- Event 79314
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50,263
- Official record key
device-enforcement:Z-1282-2018
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: 13F16H0263, 13F16J0335, 13F16K0145, 13F16M0246, 13F17C0500, 13F17F0199, 13F17F0473, 13F17F0530, 13F17G0325, 23F16E1189, 23F16E1190, 23F16F0474, 23F16F1041, 23F16H0164; 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.