Z-2359-2021 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 23 cm, Item Code 8888541023
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: 1730500118 1813600098 1911900076 2002900137 1733300158 1819000139 1915800109 2009300076 1801700131 1822600144 1921700146 2023300126 1804000123 1830300170 1926100253 2027200177 1804500142 1831600080 1933700125 2028200196 1809400131 1910200092 1935100121