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Recall Observatory FDA recall evidence

Device product

Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44cm, Item Code 8888541044

Z-2362-2021

May 28, 2021

Class II

Product summary

Firm
Covidien, LP
Event
Event 88250
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2362-2021

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: 1815000193 1920500218 2014900146 2012100124 1905600053

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).