Device product
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P
Z-2372-2021
Product summary
- Firm
- Covidien, LP
- Event
- Event 88250
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-2372-2021
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: 2034400130 1812200184 1911500092 2000700096 2034400084 1816400076 1914800226 2004400083 1724900107 1818500196 1924000133 2014900152 1731200157 1819100094 1926100267 2019500164 1731900150 1826200149 1926100246 2027200171 1801000137 1903500128 1927300072 2028200206 1802400068 1908800158 1930900080 2034400084 1810400148 1907800094 1930900081 2034400130
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).