Z-1286-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 11, 2018
- Initiation Date
- October 26, 2017
- Termination Date
- December 10, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6358
Product Description
Radial Artery Catheterization Kit; Model: AK-04220
Reason for Recall
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.
Distribution Pattern
US nationwide distribution, including Puerto Rico.
Code Information
Lots: 13F16H0429, 13F16M0214, 13F17F0281, 23F16H0161, 23F16J0018; Expiration dates: October 2018 through March 2020