Device product
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P
Z-2375-2021
Product summary
- Firm
- Covidien, LP
- Event
- Event 88250
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-2375-2021
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: 1726300131 1805900130 1911900083 2019900069 1731900198 1813600105 1926100249 2023300142 1800300137 1827600140 1926100293 2023300118 1802400067 1835100109 2002100137 2034400093
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).