Z-2360-2021 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 28 cm, Item Code 8888541028
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: 1726500092 1806600073 1833800146 2009200089 1728600060 1815800078 1904900089 2012100138 1733300161 1816400084 1906300059 2020400105 1733700172 1826200176 1910200093 2026000059 1733700178 1826800155 1917600105 2027200241 1800300143 1828200124 1926100255 2028200207 1804000125 1831000115 1931600120 2028200207 1804500144 1832300108 2000700070