The Recall Desk
ModerateFDA (Devices)·Z-2369-2021·Announced 2021-09-08

Palindrome RT Repair Kit Withdrawn for Labeling and Instruction Enhancements

Covidien is voluntarily withdrawing the Palindrome RT Repair Kit (Lot 1925300162) worldwide to implement improved point-of-use labeling and enhanced Instructions for Use (IFU).

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a voluntary, precautionary action focused on labeling and instructional improvements. No illnesses, injuries, or deaths have been reported. The FDA Class II classification indicates moderate patient risk, but the preventive nature of these improvements and the absence of adverse events place this in the Moderate category per the rubric.

Plain-English summary

Covidien, LP is voluntarily withdrawing the Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile (Item Code 8888541155) from worldwide distribution.

The withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). These improvements address current gaps in device labeling and user guidance.

The affected product was distributed worldwide under Lot Number 1925300162.

The recalled product

Product
Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155
Manufacturer
Covidien, LP
Category
Medical Device — Repair Kit
Hazard
  • inadequate-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Numbers: 1925300162

Distribution

Distribution scope not specified by the agency.

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