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Recall Observatory FDA recall evidence

Device product

Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119

Z-2364-2021

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-2364-2021

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: 1708800198 1714400174 1904900098 2009300086

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).