Z-2362-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 8, 2021
- Initiation Date
- May 28, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44cm, Item Code 8888541044
Reason for Recall
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Distribution Pattern
Worldwide distribution.
Code Information
Lot Numbers: 1815000193 1920500218 2014900146 2012100124 1905600053