Device product
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P
Z-2370-2021
Product summary
- Firm
- Covidien, LP
- Event
- Event 88250
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-2370-2021
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: 1725600117 1807300169 1904900113 2009300115 1729100070 1810400154 1909400116 2019500282 1731200151 1812900134 1920500220 2021000088 1732600132 1814300200 1926100254 2027200198 1734700110 1817100089 1930900078 2028200205 1800300131 1821300123 1930900075 2034400101 1805900127 1824700118 1930900076
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).