Device product
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028
Z-2360-2021
Product summary
- Firm
- Covidien, LP
- Event
- Event 88250
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-2360-2021
Official wording
Reason: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
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
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).