Device product
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55cm, Item Code 8888541055
Z-2363-2021
Product summary
- Firm
- Covidien, LP
- Event
- Event 88250
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-2363-2021
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: 1725600159 1831000117 1906000012 1910600263 1732700137 1902800146 1908400348 2009300117
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).