Z-2375-2021 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 Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P
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: 1726300131 1805900130 1911900083 2019900069 1731900198 1813600105 1926100249 2023300142 1800300137 1827600140 1926100293 2023300118 1802400067 1835100109 2002100137 2034400093